[Senate Hearing 116-386]
[From the U.S. Government Publishing Office]


                                                        S. Hrg. 116-386

                   MEDICARE PHYSICIAN PAYMENT REFORM
                    AFTER TWO YEARS: EXAMINING MACRA
                   IMPLEMENTATION AND THE ROAD AHEAD

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                                HEARING

                               BEFORE THE

                          COMMITTEE ON FINANCE
                          UNITED STATES SENATE

                     ONE HUNDRED SIXTEENTH CONGRESS

                             FIRST SESSION

                               __________

                              MAY 8, 2019

                               __________

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            Printed for the use of the Committee on Finance

                               __________
                               

                    U.S. GOVERNMENT PUBLISHING OFFICE                    
42-739 PDF                  WASHINGTON : 2021                     
          
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                          COMMITTEE ON FINANCE

                     CHUCK GRASSLEY, Iowa, Chairman

MIKE CRAPO, Idaho                    RON WYDEN, Oregon
PAT ROBERTS, Kansas                  DEBBIE STABENOW, Michigan
MICHAEL B. ENZI, Wyoming             MARIA CANTWELL, Washington
JOHN CORNYN, Texas                   ROBERT MENENDEZ, New Jersey
JOHN THUNE, South Dakota             THOMAS R. CARPER, Delaware
RICHARD BURR, North Carolina         BENJAMIN L. CARDIN, Maryland
JOHNNY ISAKSON, Georgia              SHERROD BROWN, Ohio
ROB PORTMAN, Ohio                    MICHAEL F. BENNET, Colorado
PATRICK J. TOOMEY, Pennsylvania      ROBERT P. CASEY, Jr., Pennsylvania
TIM SCOTT, South Carolina            MARK R. WARNER, Virginia
BILL CASSIDY, Louisiana              SHELDON WHITEHOUSE, Rhode Island
JAMES LANKFORD, Oklahoma             MAGGIE HASSAN, New Hampshire
STEVE DAINES, Montana                CATHERINE CORTEZ MASTO, Nevada
TODD YOUNG, Indiana

             Kolan Davis, Staff Director and Chief Counsel

              Joshua Sheinkman, Democratic Staff Director

                                  (ii)
                                  
                                  
                            C O N T E N T S

                              ----------                              

                           OPENING STATEMENTS

                                                                   Page
Grassley, Hon. Chuck, a U.S. Senator from Iowa, chairman, 
  Committee on Finance...........................................     1
Wyden, Hon. Ron, a U.S. Senator from Oregon......................     3

                               WITNESSES

McAneny, Barbara L., M.D., president, American Medical 
  Association, Chicago, IL.......................................     5
Cullen, John S., M.D., FAAFP, president, American Academy of 
  Family Physicians, Leawood, KS.................................     7
Opelka, Frank, M.D., FACS, medical director for quality and 
  health policy, American College of Surgeons, Chicago, IL.......     8
Hines, Scott, M.D., director, American Medical Group Association, 
  Alexandria, VA.................................................    10
Fiedler, Matthew, Ph.D., fellow, USC-Brookings Schaeffer 
  Initiative for Health Policy, Brookings Institution, 
  Washington, DC.................................................    12

               ALPHABETICAL LISTING AND APPENDIX MATERIAL

Cullen, John S., M.D., FAAFP:
    Testimony....................................................     7
    Prepared statement...........................................    37
    Responses to questions from committee members................    41
Fiedler, Matthew, Ph.D.:
    Testimony....................................................    12
    Prepared statement...........................................    54
    Responses to questions from committee members................    65
Grassley, Hon. Chuck:
    Opening statement............................................     1
    Prepared statement...........................................    70
Hines, Scott, M.D.:
    Testimony....................................................    10
    Prepared statement...........................................    71
    Responses to questions from committee members................    75
McAneny, Barbara L., M.D.:
    Testimony....................................................     5
    Prepared statement...........................................    82
    Responses to questions from committee members................    85
Opelka, Frank, M.D., FACS:
    Testimony....................................................     8
    Prepared statement...........................................   105
    Responses to questions from committee members................   110
Wyden, Hon. Ron:
    Opening statement............................................     3
    Prepared statement...........................................   122

                             Communications

Alliance of Specialty Medicine...................................   125
American Academy of Ophthalmology................................   129
American Association of Orthopaedic Surgeons.....................   132
American College of Physicians...................................   133
American Hospital Association....................................   139
American Society of Clinical Oncology............................   142
Center for Fiscal Equity.........................................   146
Healthcare Leadership Council....................................   148
Medical Group Management Association.............................   150
Medicare Payment Advisory Commission (MedPAC)....................   153
National Association of ACOs.....................................   160
Premier Inc......................................................   165
Society of Hospital Medicine.....................................   166
Society of Thoracic Surgeons.....................................   169

 
                   MEDICARE PHYSICIAN PAYMENT REFORM
                    AFTER TWO YEARS: EXAMINING MACRA
                   IMPLEMENTATION AND THE ROAD AHEAD

                              ----------                              


                         WEDNESDAY, MAY 8, 2019

                                       U.S. Senate,
                                      Committee on Finance,
                                                    Washington, DC.
    The hearing was convened, pursuant to notice, at 9:31 a.m., 
in room SD-215, Dirksen Senate Office Building, Hon. Chuck 
Grassley (chairman of the committee) presiding.
    Present: Senators Roberts, Thune, Scott, Cassidy, Daines, 
Young, Wyden, Cantwell, Carper, Cardin, Brown, Casey, Warner, 
Whitehouse, Hassan, and Cortez Masto.
    Also present: Republican staff: Jeffrey Wrase, Deputy Staff 
Director and Chief Economist; Brett Baker, Senior Health Policy 
Advisor; and Karen Summar; Chief Health Policy Advisor. 
Democratic staff: Joshua Sheinkman, Staff Director; Elizabeth 
Jurinka, Chief Health Policy Advisor; Beth Vrabel, Deputy Chief 
Counsel and Senior Health Counsel; and Maura Fitzsimons, 
Professional Staff Member.

 OPENING STATEMENT OF HON. CHUCK GRASSLEY, A U.S. SENATOR FROM 
              IOWA, CHAIRMAN, COMMITTEE ON FINANCE

    The Chairman. The meeting will come to order. And for all 
the members, and particularly for our witnesses who had to work 
so hard to get ready for this hearing, it is going to be kind 
of discombobulated. That is not the right word--it is going to 
be mixed up, you know, because we have five votes at 10 
o'clock. So we are starting a half-hour early, and we are going 
to try to keep the meeting going by different people chairing 
the hearing so we can keep going. So I hope everybody will--I 
know everybody will cooperate, but it is not the best thing for 
a very important subject we have before this hearing to have it 
interrupted in this way.
    I want to thank our witnesses for being here today. We look 
forward to hearing how physician payment reform and the 
Medicare Access and CHIP Reauthorization Act are driving good 
patient outcomes. This law of 4 years ago goes by the acronym 
MACRA. MACRA also took the historic step of getting rid of the 
flawed sustainable growth rate formula which, when it was 
passed, we did not think anything about it was flawed. We 
thought it was an answer to a lot of problems for keeping 
things updated regularly.
    So, let me take a moment to go through the history of SGR, 
as the saga ended with a hopeful message. Congress established 
it in 1997 as a mechanism to control Medicare spending on 
physician services. The formula worked at first, but it was not 
long before it called for large reductions in payments that, 
obviously, we could not tolerate because they threatened access 
to care.
    This then set in motion a perpetual exercise where Congress 
scrambled, usually once a year, sometimes twice a year, to 
prevent physicians from being cut in reimbursement. So 17 times 
that went on over a period of a decade. And each time, we 
kicked the can down the road without solving the underlying 
problem. Finally, 2015 came. Congress came together and passed 
the MACRA law by an overwhelming margin in both chambers. MACRA 
showed that Congress can still work together in a bipartisan 
manner when it is necessary, and we ought to be working more 
when it is not necessary.
    This reminder reinforces my beliefs that the bipartisan 
Finance Committee process to lower prescription drug costs can 
also be successful. That is our present responsibility. It 
bodes well for making changes in Medicare to improve access to 
care for patients in rural and underserved areas. And a little 
bit down the road, that is another goal we are working on. And 
in fact, it is being worked on now. This is something that 
Ranking Member Wyden and I are committed to.
    These bipartisan efforts also provide a glimmer of hope 
that Republicans and Democrats can join together to prevent 
Medicare from going broke. And I would urge people on both 
sides of the aisle to think about putting that high on the 
agenda. This is time better spent than trying to expand 
Medicare for all only for it to, invariably, end up available 
to none.
    MACRA payment reforms established incentives for physicians 
to provide the highest quality of care at the lowest possible 
cost. Physicians can pick from two different paths. They can 
opt to be graded on metrics in a number of different 
categories, or choose to get paid under a different model such 
as single payment for bundled services. This committee held a 
hearing in 2016 on the initial plan by the Centers for Medicare 
and Medicaid Services to implement these reforms. While the CMS 
implementation remains a work in progress, the 2 years of 
experience allows us to take stock of how well these reforms 
are working.
    So that is why we brought together this group of witnesses 
that we have, physicians and other experts who are at the 
forefront of these efforts. Physicians' organizations that 
represent different specialties and practice characteristics 
are at the table. This diversity of physician practice mirrors 
the varying needs of Medicare patients. It also highlights the 
inherent challenge of getting top-notch care to everyone, 
including those in rural areas.
    I am proud that physicians in Iowa provide high-quality 
care while spending less than many other areas. This is a value 
that MACRA payment reform aimed to achieve. I look forward to 
hearing from our witnesses their analysis of it.
    [The prepared statement of Chairman Grassley appears in the 
appendix.]
    The Chairman. Senator Wyden?

             OPENING STATEMENT OF HON. RON WYDEN, 
                   A U.S. SENATOR FROM OREGON

    Senator Wyden. Thank you very much, Mr. Chairman. Mr. 
Chairman, this is another topic where you and I are working 
closely together, as we are on prescription drugs. And with the 
chairman's leave, I am going to make a brief statement on 
behalf of both of us, because there is some particularly sad 
news this morning. The legendary New York Times health reporter 
Robert Pear passed away yesterday.
    And he was the gold standard of health-care reporting. The 
chairman and I were just talking about it. He was fair to 
everybody, Republicans on this committee, the chairman, 
Chairman Hatch. I am sure everyone who has worked on health 
care worked with Robert Pear. He was described as the most 
important reporter in Washington, DC that nobody had ever heard 
of. Also, he did not let anybody get away with anything, 
whether you were a Democrat or Republican.
    And--this is a hard statement to make. Robert Pear probably 
remembered the amendment to the amendment to the amendment of 
some health-care bill 3 decades ago. And it was that commitment 
to professionalism that was so appreciated by Democrats and 
Republicans.
    And I noticed this morning--all over the country for 
decades, everybody waited for a Robert Pear story. He was 
essentially the barometer of what the facts were in health 
care. And The New York Times had a slug called, kind of, 
``Health by Pear,'' something like that. The New York Times 
this morning said they are going to retire the slug.
    And I just think for all of us, and this committee, the 
chairman--and I think about Chairman Hatch who also adored 
Robert Pear--this is a really sad moment, because a really good 
guy who cared passionately about people, and passionately about 
improving health care, and was always trying to appeal to the 
better angels, passed away yesterday, way too young at 69.
    So, Mr. Chairman, thank you. I have a brief statement on 
MACRA, but----
    The Chairman. You spoke for me as well, because he 
interviewed me an awful lot. And I always felt I was treated 
fairly.
    Senator Wyden. Four years ago--Robert Pear covered this 
too--the committee led the effort to revolutionize the way 
doctors are paid under Medicare. And basically what we did back 
then--I think Senator Roberts remembers this too--is we threw 
in the dustbin of history the old way of reimbursing for health 
care. ``We are going to say it is not about quantity. It is 
about quality.'' That was the basic principle in stone that we 
engraved.
    As the chairman noted, the MACRA law has now been in place 
for 2 years. We have been watching its implementation. There 
are a few, kind of key issues that we care about. The chairman 
and I have a strong view with respect to small practices in 
rural and underserved areas. Senator Roberts cares about this 
deeply too. The rural docs are the backbone of communities in a 
lot of ways. You do not have a rural life without rural health 
care.
    So it is absolutely essential that as we reward value in 
health care, we make sure--I have heard Senator Roberts talk 
about this many times; Senator Grassley and I are talking about 
it now. We want to make sure docs in small and rural practices 
are not left behind, otherwise that is going to degrade the 
care rural patients get, and we will have an even bigger gap 
between the cities and suburbs and the little towns.
    Second, when it comes to assessing quality, we want to make 
sure that the docs are not going through bureaucratic water 
torture. They should not be just checking boxes all day long. 
We want to reward doctors for care that really--we want to 
reward all those who practice improved quality, what is 
impactful for patients' health. But we do not want to make this 
some sort of exercise in form-filling and bureaucracy and red 
tape.
    The last point I want to make--I appreciate the chairman 
giving me this extra time--is we want to wring more value out 
of taxpayer dollars in Medicare while coordinating the care 
that seniors need. And we have done that through Accountable 
Care Organizations, medical homes, bundled payments--we have 
used a variety of approaches to do it.
    And last Congress, we passed a historic Medicare bill. If 
you walked on the streets of Kansas, Iowa, Rhode Island, 
Nevada, anywhere you are, I do not think people would know, but 
what we did on a bipartisan basis is we said, you know, the 
Medicare program of 2019 does not resemble the Medicare program 
when I was director of the Gray Panthers, when Robert Pear 
started.
    That program was about acute illness. You broke an ankle, 
you went to the hospital--Part A. You had a bad case of the 
flu, you went to the doc--Part B. That is not Medicare anymore. 
Today it is cancer, diabetes, heart disease, strokes. It is 
chronic illness. That is the whole Medicare budget. So we 
recognized that with our CHRONIC Care bill. It is going to be 
historic.
    So I just want to close by mentioning the next step. The 
next step ought to be to guide countless seniors who are 
getting lost in this blizzard of modern health care-red tape, 
the forms, the prescription requirements, the instructions, the 
pill bottles--it is almost too much for a lot of the seniors 
with these chronic conditions to go through. And, if they are 
in traditional Medicare where we still have well over half the 
seniors, it is twice as bad as if they had coordinated care 
through Medicare Advantage or Accountable Care Organizations.
    So, as a former basketball player, I want to put the next 
step in basketball terms. Every senior with chronic illness 
ought to have what I am calling a chronic care point guard, 
somebody who manages their care and makes sure that the docs 
have all the information and that they can work together. In 
basketball terms it was called having somebody running the 
floor--you know, basically coordinating everything. And whether 
a senior is in traditional Medicare or MA, whatever it is, this 
can avoid a lot of mistakes.
    Mr. Chairman, thank you. I know it was a juggle for you, 
Mr. Chairman, to try to figure out how to do it. And you tried 
to give everybody notice, and we appreciate it.
    And I look forward to working with you on what I will just 
say, again, is a very, very sad day for all of us who watched a 
good man work a lot, sitting right over there at that table. I 
am missing him right now, right at that table for 3 decades. 
Thank you.
    [The prepared statement of Senator Wyden appears in the 
appendix.]
    The Chairman. Thank you for speaking about Mr. Pear, and 
you did accurately say that you spoke for me. And I was glad 
you informed me of it, because I did not know about it.
    I am going to introduce witnesses now. Dr. Barbara McAneny 
just told me a little while ago that she went to Grinnell and 
the University of Iowa. So thank you for being here. She is 
president of the American Medical Association and has served as 
a member of the board of trustees of that organization since 
2010.
    Dr. John Cullen is president of the American Academy of 
Family physicians. He is a practicing physician in Valdez, AK.
    Dr. Frank Opelka is a physician executive, a surgeon, and a 
medical director of quality and health policy at the American 
College of Surgeons.
    Dr. Scott Hines is Crystal Run Healthcare's chief quality 
officer, medical director, and physician leader for Crystal Run 
Healthcare's medical specialties division.
    And Dr. Matthew Fiedler is a fellow with the USC-Brookings 
Schaeffer Initiative for Health Policy. His research is focused 
on health-care economics and policy.
    We are grateful for your taking the time to come and help 
us analyze MACRA. I always tell people you probably have very, 
very long statements that you want to put in the record, and 
they will be put in the record, and you will not have to ask.
    Proceed with your 5 minutes, Dr. McAneny.

  STATEMENT OF BARBARA L. McANENY, M.D., PRESIDENT, AMERICAN 
                MEDICAL ASSOCIATION, CHICAGO, IL

    Dr. McAneny. Thank you very much, Mr. Chairman. I am 
Barbara McAneny. I am an oncologist from New Mexico and 
president of the American Medical Association. Thank you for 
inviting us to this hearing on MACRA. As background, my 
practice is the New Mexico Cancer Center, which used to serve 
in Albuquerque and four rural centers. Recently we have had to 
close three rural cancer clinics.
    Since the enactment of MACRA, the AMA has worked closely 
with Congress and CMS to promote a smooth implementation of the 
Quality Payment Program. We have worked closely with CMS to 
make needed improvements in the MIPS program each year and 
appreciate the technical changes to MACRA that Congress 
included in the BBA18 to simplify and improve the program.
    Our work is not done. To the contrary, the QPP still needs 
significant improvements. Implementation of a new Quality 
Payment Program is a significant undertaking. Congress, CMS, 
and the medical community must continue to work together to 
make the program better for patients and less burdensome for 
their physicians.
    First, we must continue to ensure that small and rural 
practices can succeed. The AMA has strongly supported the 
accommodations that Congress and CMS have made for small 
practices, including the low-volume threshold, which excludes 
numerous practices that see very few Medicare patients. We have 
also supported hardship exemptions from the Promoting 
Interoperability category and technical assistance grants to 
help small and rural practices.
    However, recent scores from the first performance year show 
that small and rural practices scored lower than the average 
for MIPS-eligible clinicians. This is why we need to continue 
to support small and rural practices and make sure all patients 
can succeed in MIPS to preserve the infrastructure for health-
care delivery in rural areas.
    Second, one important goal of MACRA was to provide busy 
physicians with a path to transition into new innovative 
payment models. To facilitate this transition, Congress 
provided a 5-percent incentive for physicians to participate in 
APMs during the first 6 years of the program. These payments 
were intended to allow physicians to invest in changing the way 
we deliver care. The AMA heard from many physician groups that 
are excited to take advantage of this opportunity. 
Unfortunately, during the first 3 years of the program, too few 
APM options were available for physicians. And now only 3 years 
remain, which is not enough time for physicians to transition 
to an APM.
    The AMA is encouraged by our recent discussions with CMS 
Administrator Seema Verma and CMMI Director Adam Boehler and 
their commitment to implement physician-focused payment models 
that give physicians the resources and the flexibility that 
they need to participate in APMs, such as the new Primary Care 
First model announced in April. Therefore, we urge Congress to 
extend the APM incentive for an additional 6 years.
    Third, the AMA is recommending that Congress replace the 
scheduled physician payment freeze beginning in 2020 with 
positive annual updates for physicians. The recent Medicare 
trustee report found that scheduled physician payments are not 
expected to keep pace with physician practice costs. As a 
result, the trustees say access for Medicare patients will be a 
significant issue in the future. Positive payment updates are 
needed to provide physicians a margin to maintain their 
practice as well as transition to more efficient models of care 
delivery. Therefore, we urge Congress to reinstate positive 
payment updates for physicians beginning next year.
    Finally, the AMA urges Congress to continue to make 
technical changes to MACRA to simplify the program and make it 
more clinically significant. The AMA continues to hear from 
physicians that the measures they are required to report are 
taking time away from patient care.
    In conclusion, the AMA thanks the committee for your work 
on this issue. And we remain committed to working with CMS and 
Congress to implement many of these improvements and to ensure 
that the MACRA program is successful.
    Thank you.
    The Chairman. Thank you, Dr. McAneny.
    [The prepared statement of Dr. McAneny appears in the 
appendix.]
    The Chairman. Now, Dr. Cullen.

 STATEMENT OF JOHN S. CULLEN, M.D., FAAFP, PRESIDENT, AMERICAN 
           ACADEMY OF FAMILY PHYSICIANS, LEAWOOD, KS

    Dr. Cullen. Thank you, Chairman Grassley, Ranking Member 
Wyden, and members of the committee. I am honored to be here 
today representing the more than 140,000 members of the 
American Academy of Family Physicians. I am a practicing family 
physician in Valdez, AK, a community of about 4,000 people. 
With my four family medicine colleagues, we staff an 
independent clinic in a critical access hospital 300 miles from 
the nearest tertiary care hospital. Our census area is about 
the size of Ohio.
    Four years ago, the Medicare Access and CHIP 
Reauthorization Act, or MACRA, was signed into law, and today's 
hearing is an appropriate opportunity to step back and evaluate 
how this law is performing. After 4 years, the AAFP still 
considers MACRA an appropriate framework for the physician 
payments in the Medicare program. And while I will outline 
several concerns with how the law is functioning, the 
philosophy and the framework of MACRA remain consistent with 
AAFP policy. We are especially supportive of those policies 
that allow physicians to pursue delivery and payment models 
that support the delivery of comprehensive, continuous, and 
coordinated primary care rather than fee-for-service. We are 
also pleased with the low-volume threshold that has protected 
many rural and independent practices from the negative 
consequences of MIPS. While we strongly support the low-volume 
threshold, we are pleased that CMS has created an optional 
voluntary pathway for small practices to compete within the 
MIPS arena.
    MACRA, through the Advanced Alternative Payment Model 
pathway, created an opportunity for physicians to pursue non 
fee-for-service payment models that support advanced delivery 
models. And MACRA also created an opportunity for physicians to 
create and propose Alternative Payment Models through the 
Physician-
Focused Payment Model Technical Advisory Committee or PTAC.
    On April 22nd, CMS and CMMI announced CMS's Primary Cares 
Initiative, one of two new primary care models that will expand 
opportunity to thousands of family physicians who will be able 
to participate in an APM. And one of those new models, the 
Primary Care First program, is largely reflective of the AAFP's 
proposal submitted to and approved by PTAC in 2017.
    The AAFP continues to have collaborative engagements with 
CMS and CMMI on this important work. And, as previously 
mentioned, the AAFP believes that there are areas where the law 
could be improved. And, in our written testimony, we outline 
five areas of concern, but I am only going to focus on two of 
those. One is creating a culture focused on patient care, and 
the second is eliminating the complexity of MIPS scoring.
    It is well documented that the volume and intensity of 
administrative functions are having a negative impact on 
physicians. And the AAFP is concerned that the complexity and 
the cost of administrative functions are creating practice 
environments that are more focused on administrative tasks than 
on patient care. And we should ask physicians to really focus 
on their patients and not checking boxes. And that is how we 
are going to improve patient satisfaction, outcomes, and 
Medicare costs.
    A study published in the Annals of Internal Medicine found 
that primary care physicians spend 2 hours completing 
administrative tasks for every hour of patient care. We are 
concerned that MIPS has created a burdensome and extremely 
complex program that has increased practice costs and is 
contributing to physician burnout. Understanding the 
requirements and scoring for each MIPS performance category and 
reporting required data to CMS is a complex task and detracts 
from physicians' ability to focus on patients. Many of my 
colleagues are frustrated and angry.
    The AAFP supports CMS's Patients Over Paperwork initiative 
but believes that more must be done to improve patient care 
within the MIPS program by reducing administrative burdens. And 
we urge Congress to work with CMS to reduce the complexity and 
the administrative burden of MIPS. The AAFP has outlined a 
number of technical corrections and policy recommendations in 
our written statement. I would like to highlight three.
    First, MACRA established an annual increase of .5 percent 
in physician payments from July 2015 through 2019. We would 
urge the committee to extend that annual .5-percent payment for 
5 more years.
    Second, the AAFP would recommend that the exceptional 
performance bonus payments be reimagined to reward practices 
that achieve significant year-over-year improvement, versus 
rewarding those practices at the upper levels of annual 
performance.
    And lastly, AAFP recommends that the 5-percent bonus for 
qualifying physicians participating in an APM be extended for 
an additional 3 to 5 years.
    Again, we thank you for holding today's hearing and for 
your continued commitment to ensuring Medicare physician 
payment policies are contributing to the delivery of timely, 
affordable, and high-quality care to beneficiaries.
    [The prepared statement of Dr. Cullen appears in the 
appendix.]
    The Chairman. Dr. Opelka?

  STATEMENT OF FRANK OPELKA, M.D., FACS, MEDICAL DIRECTOR FOR 
   QUALITY AND HEALTH POLICY, AMERICAN COLLEGE OF SURGEONS, 
                          CHICAGO, IL

    Dr. Opelka. Chairman Grassley, Ranking Member Wyden, and 
members of the committee, thank you for inviting the American 
College of Surgeons to testify at this important hearing. The 
College supports MACRA's focus on quality and value. However, 
we are concerned that a hurried CMS implementation has resulted 
in quality metrics that left surgical care as an afterthought. 
We would like to spend our time today discussing how we would 
put quality and value at the forefront of patient care.
    MACRA was intended to move payments away from fee-for-
service in hopes of finding new means for rewarding a care team 
for improving quality and reducing costs for surgery. This 
requires a strategy that defines the surgical care team and 
creates value for the surgical patient. Defining surgical value 
is simply not in the wheelhouse of the insurance industry. 
Thus, CMS continues to struggle, especially when they rely on 
their skills as a payer to retrofit a tired fee-for-service 
payment model with sporadic measures which do not make sense 
for the surgical care teams and outcomes patients seek.
    For many physicians, the Merit-based Incentive Payment 
System has not--and given its current trajectory--will not 
serve as a driver of improvement in quality or reduction of 
cost. The greatest percentage of surgeons participate in 
quality reporting through the CMS Web Interface group reporting 
option, and many are not even aware of the measures reported. 
Measures available in the Web Interface are focused on 
screening, preventive care, and diabetes. In other words, 
surgeons receive credit for how well their group practice 
immunizes a population instead of assuring a patient has safe 
surgical care.
    MACRA states that whenever possible, group measurement 
should reflect the range of items and services furnished by an 
eligible clinician in the group. But that is currently not the 
case. Many believe that other provisions of MACRA, such as the 
emphasis on registries and the pathway for APM creation and 
measured development funding, would create outlets for more 
specialty-specific measure development. But that has not 
materialized.
    ACS has a vision for what we believe meaningful measure of 
surgical quality care looks like. We believe the quality of 
surgical care begins by setting evidence-based standards for 
care and ensuring the right infrastructure and systems are in 
place through measurement and verification, incorporating data 
at the point of care to inform surgeons' and patients' 
decisions. We would propose a surgical quality measurement 
structure that has three components: verification of key 
standards of care, clinical outcome measures, and 
patient-reported outcomes.
    In 2017, the ACS published optimal resources for surgical 
quality and safety, referred to as the Red Book. This framework 
is based on decades of research and implementation of 
verification programs which have proven successful in driving 
better patient outcomes and surgical care. Standards drawn from 
the Red Book are now being used for the verification 
accreditation of hospitals on the basis of surgical quality and 
patient safety. Clinical outcomes and surgery can be measured 
based on a combination of claims-based measures combined with 
rigorous clinical data from programs such as the National 
Surgery Quality Improvement Program.
    Finally, the addition of patient-reported outcome measures 
tailored in an episode of care bring in the patient's voice and 
can assess whether the care achieves the patient's goals, 
including functional status and quality of life.
    While the focus of this testimony is improving incentives 
for quality and value, the American College of Surgeons urges 
Congress to put MACRA implementation in the context of the 
current Medicare reimbursement rates, which have not kept pace 
with inflation and do not adequately cover the costs associated 
with providing care. Furthermore, the ACS has great concerns 
about the structure of payments under MACRA in the years ahead. 
The modest statutory updates included in the law are now 
finished, and we will soon enter a 6-year period with no 
updates. This will likely result in real reductions to payments 
due to inflation and budget neutrality. Physicians will view 
the further implementation of MACRA from this perspective. The 
ACS would welcome the opportunity to further describe the 
physician payment landscape from our perspective and how this 
might affect the future of access to care.
    In closing, what matters most to patients and providers is 
safe, more efficient, high-quality surgical care. ACS believes 
the intent of MACRA is correct. We, as the ACS, remain 
committed to you and look forward to working with Congress and 
the administration to ensure that we can get this right for our 
patients. Congress should encourage CMS to partner with the 
physician community to evaluate and test innovative evidence-
based proposals such as the one we have described. We believe 
CMS has the authority to accomplish this but may benefit from 
additional guidance from Congress.
    CMS would also require additional resources to administer 
the QPP in a way which refocuses the incentives toward higher-
value care and improves the quality of care for Medicare 
patients. This would go a long way toward assuring the long-
term viability and success of the QPP and MACRA programs.
    The Chairman. Thank you, Dr. Opelka.
    [The prepared statement of Dr. Opelka appears in the 
appendix.]
    The Chairman. Now, Dr. Hines.

  STATEMENT OF SCOTT HINES, M.D., DIRECTOR, AMERICAN MEDICAL 
               GROUP ASSOCIATION, ALEXANDRIA, VA

    Dr. Hines. Chairman Grassley, Ranking Member Wyden, and 
distinguished members of the Senate Finance Committee, thank 
you for the opportunity to testify before you today. I am Dr. 
Scott Hines, and I am here on behalf of AMGA, where I serve as 
chair of their public policy committee and member of their 
board of directors. AMGA represents multi-specialty medical 
groups and integrated delivery systems across the United 
States. More than 175,000 physicians practice in AMGA member 
organizations, delivering care to one in three Americans.
    I am board-certified in internal medicine and 
endocrinology, and I am Crystal Run Healthcare's chief quality 
officer. Crystal Run employs over 450 providers across 50 
different specialties in 20 locations throughout the lower 
Hudson Valley of New York State. We are among the first 27 
Accountable Care Organizations to participate in the Medicare 
Shared Savings Program since 2012. In my role as chief quality 
officer, I have helped to develop and implement the clinical 
programs necessary to deliver value-based care to our patients.
    Policy-makers in Congress and the administration have made 
clear their intent to transform the way health care is financed 
and delivered in this country. The need to move Medicare to 
value is evident today more than ever, and I believe Congress 
passed MACRA to drive that transition to value in Medicare Part 
B.
    Our current fee-for-service payment system is not 
sustainable and is not the model best suited to provide 
coordinated, high-
quality, cost-effective care to our patients. AMGA members are 
looking to Congress for a stable, predictable value program 
that creates meaningful and realistic incentives that motivate 
them to make the multimillion-dollar investment to chart a 
course towards value.
    MIPS was designed as a transition tool, an on ramp to 
value-based payment in the Medicare program. However, CMS has 
not implemented MIPS as Congress intended. Under MACRA, MIPS 
providers would have the opportunity for positive or negative 
payment adjustments based on their performance, starting at 
plus or minus 4 percent in 2019 and increasing to plus or minus 
9 percent in 2023. By putting provider reimbursement at risk, 
Congress intended to move Medicare to a value-based payment 
model where high performance was rewarded and poor performers 
were incentivized to improve through lower payment rates. 
Despite the MACRA statute, CMS has excluded nearly half of 
eligible clinicians from MIPS requirements through their MACRA 
regulations.
    Because MIPS is budget-neutral, these exclusions result in 
insignificant payment adjustments to high-performing providers. 
Rather than a 5-percent and 7-percent maximum payment 
adjustment for high performers in 2020 and 2021 respectively, 
these exclusions are resulting in only a 1.5- to 2-percent 
increase. By excluding half of providers from MIPS, the system 
has devolved into an expensive regulatory compliance exercise 
with little impact on quality or cost.
    Now, I understand the concerns for my colleagues, for 
physicians practicing in solo or smaller practices, and that 
the reporting burden on them is at times significant. However, 
we must recall that the MIPS program is a continuation of 
quality programs that have existed for years, where previously 
no one was excluded from participating, let alone half of those 
eligible.
    For Advanced APMs, the other pathway to value under MACRA, 
the system's requirements need to be revised to allow for 
increased APM participation. To qualify for the program, 
providers must meet or exceed minimum revenue thresholds from 
APMs or a minimum number of Medicare beneficiaries in these 
models. These thresholds progressively increase over time, and 
AMGA members feel that these requirements are unrealistic, 
unlikely to be met, and will not attract the number of 
physicians and medical groups necessary to ensure the program's 
success. In fact, these arbitrary thresholds serve as a 
disincentive for AMGA members to make the multimillion-dollar 
investments needed to move to value.
    By eliminating these arbitrary thresholds and extending the 
APM program beyond a 2024 sunset date, Congress would be 
indicating to the health-care community that it is willing to 
offer a stable and predictable risk platform to providers ready 
to move to value. I truly believe Congress passed MACRA to 
drive the transition to value in Medicare Part B. However, we 
have clearly taken a step back from this transition over the 
past 3 years by excluding half of eligible clinicians from MIPS 
and enforcing arbitrary threshold requirements for Advanced 
APMs.
    On behalf of AMGA and Crystal Run Healthcare, we are ready 
to work with Congress and CMS to ensure that MACRA can serve 
its intended purpose in moving our Medicare system towards 
value. Thank you.
    The Chairman. Thank you, Dr. Hines.
    [The prepared statement of Dr. Hines appears in the 
appendix.]
    The Chairman. Now, Dr. Fiedler.

  STATEMENT OF MATTHEW FIEDLER, Ph.D., FELLOW, USC-BROOKINGS 
SCHAEFFER INITIATIVE FOR HEALTH POLICY, BROOKINGS INSTITUTION, 
                         WASHINGTON, DC

    Dr. Fiedler. Chairman Grassley, Ranking Member Wyden, 
members of the Finance Committee, thank you for inviting me to 
testify today. My name is Matthew Fiedler, and I am a fellow at 
the USC-Brookings Schaeffer Initiative for Health Policy, but 
this testimony reflects my personal views.
    I am honored to be here to discuss MACRA's physician 
payment provisions. MACRA made important reforms to the 
structure of Medicare physician payment with the goal of 
improving the quality and efficiency of the care received by 
Medicare beneficiaries. With 2 years' experience behind us, now 
is an opportune time to take stock.
    I will start with what is working well. In my view, MACRA's 
bonuses for participation in Advanced Alternative Payment 
Models, such as Accountable Care Organization models with two-
sided risk, have great potential. Recent research on ACOs, 
which account for most APM and Advanced APM participation in 
Medicare, has found that these models can reduce health-care 
spending while maintaining or improving quality.
    There has been a substantial increase in Advanced APM 
participation as MACRA's bonus payments have been implemented. 
In 2018, around 9 percent of traditional Medicare beneficiaries 
were served by providers and ACOs with two-sided risks, up from 
3 percent in 2016. MACRA's bonuses likely contributed to this 
increase, although other factors likely contributed as well.
    The Advanced APM bonus has also encouraged CMS to be more 
aggressive in deploying APMs that create stronger incentives to 
reduce spending. This includes making needed improvements to 
the calculation of the benchmarks used to judge ACO spending 
performance and increasing how quickly ACOs must transition to 
two-sided risk. While I am optimistic about MACRA's Advanced 
APM bonus, I am pessimistic about MIPS. MIPS's approach of 
adjusting payments based on clinician or practice-level 
performance is ill-suited to creating strong, coherent 
incentives to improve the quality and efficiency of patient 
care.
    One problem is that a given patient's care often involves 
many different providers. Another problem is that clinician- 
and practice-level performance measures can be quite noisy. The 
fact that clinicians can choose the quality measures they 
report under MIPS also prevents MIPS from facilitating 
meaningful quality comparisons across providers. Consistent 
with these concerns, research on programs similar to MIPS, such 
as the Value Modifier program that preceded MIPS, provides 
little evidence that programs like these improve the quality or 
efficiency of patient care. MIPS is, however, creating 
significant administrative costs. CMS estimates that providers 
will spend $482 million reporting to MIPS in 2019. It is hard 
to justify incurring these costs for a program that is unlikely 
to meaningfully improve care.
    Looking to the future, I encourage policy-makers to build 
on what is working in MACRA and discard what is not. A good 
first step would be to make MACRA's Advanced APM bonus 
permanent. Doing so sooner, rather than later, would maximize 
the bonus's impact by encouraging providers to make long-term 
investments in APM participation today.
    But it would be valuable to go further and substantially 
strengthen MACRA's incentives for participation in Advanced 
APMs, both by increasing the size of MACRA's incentive payments 
and by expanding these incentives to new categories of 
providers, like hospitals. These approaches would increase 
participation in Advanced APMs, broaden the types of providers 
with a stake in the deployment and success of these models, and 
enable CMS to go further in deploying versions of APMs that 
create stronger incentives to reduce spending.
    It would be important to structure expanded incentives for 
Advanced APM participation in ways that do not increase Federal 
costs. For example, Congress could implement a budget-neutral 
combination of larger bonuses for Advanced APM participation 
and penalties for non-participation, similar to how Congress 
combined bonuses and penalties under MIPS. Policy-makers may 
also wish to consider eliminating the cliff in the Advanced APM 
bonus eligibility rules, which may soon cause some providers 
with significant engagement in Advanced APMs to miss out on 
bonus payments.
    Turning to MIPS, I agree with MedPAC and a number of other 
experts that the best path forward is to eliminate MIPS. Most 
of MIPS's problems are unavoidable in a program that adjusts 
payments based on clinician- or practice-level performance. So 
even a reformed MIPS would likely struggle to create coherent 
and effective incentives to improve care.
    If MIPS were eliminated, policy-makers could still retain 
targeted incentives for certain activities, like using a 
certified electronic health record or reporting to clinical 
registries. If MIPS continues, there are opportunities for 
improvement, although there are limits to what a reform in its 
program could realistically achieve. Potential improvements 
include standardizing the measures used in the MIPS quality 
category, replacing the MIPS practice improvement category with 
a targeted incentive for reporting to clinical registries, and 
replacing the MIPS Promoting Interoperability category with a 
simpler incentive for using a certified EHR.
    Thank you again for the opportunity to testify. I look 
forward to your questions.
    The Chairman. Let me thank all of you for staying within 
the 5 minutes.
    [The prepared statement of Dr. Fiedler appears in the 
appendix.]
    The Chairman. It is very helpful, particularly on a day 
like today when things are kind of erratic.
    My first question is going to be just to Dr. Opelka, and 
the second one I will have for all of you to answer. The 
statute recognizes the value of data registries as they measure 
physicians on the things that they themselves identify as 
important to their patients. These data registries also provide 
timely feedback that physicians can use to improve. I am 
concerned about the statement in your testimony that these 
registries face challenges that have limited physician uptake.
    Could you elaborate on the problems that have limited 
physicians' use of data registries and provide suggestions for 
how we can knock down these barriers? And if you are not 
prepared to offer suggestions, maybe you can submit those in 
writing. But go ahead and answer as best you can now.
    Dr. Opelka. Thank you, Mr. Chairman. We will give you a 
more detailed response, because this is a very complex subject. 
We do firmly believe in registries. We run seven international 
registries to date. But putting them into the MIPS payment 
program or the MACRA programs is not actually taking full 
advantage of how you would leverage data for better care. And 
that is what we use registries for.
    The biggest challenge we have out there, I can give you in 
a simple analogy. Imagine if every airport had its own air 
traffic control tower with its own data system and they did not 
talk to each other. We would have a mess up in the air. That is 
what we have with all these registries.
    What we need is government guidance about how we actually 
set standards in key areas, how we define the data that enters 
registries, how that data actually is aggregated in a 
consistent manner so it comes in cleanly, how we can normalize 
and analyze that data together, and how we can represent it 
back out to patients and physicians as it is needed.
    Right now, it is the Wild West. Everybody knows this is a 
great way of generating knowledge and helping better care, so 
everyone is doing it, and it becomes a burden on the EHR. It 
becomes a burden on the clinicians trying to use it. And it is 
creating cacophony.
    Your success stories are in registries where there is a 
single source of truth, such as the ophthalmology registry or 
the cardiac surgery registry or the ACC registry where there is 
only one single source of truth. We find we can go there and 
find what we need for patients. When everyone out there creates 
their own version, we have a mess.
    The Chairman. We will look forward to your submitting those 
suggestions. For the others--for all of you, I notice that all 
the witnesses focus on the need for changes to make these 
payment reforms more meaningful to physicians and more relevant 
to the patients they treat. What is the single most important 
change that would have the biggest impact in the effort to get 
patients the best care at the lowest possible cost?
    Let us start with you.
    Dr. McAneny. Thank you, Mr. Chairman, for that question. I 
think the first and most important thing that we could do would 
be to have a continued positive update. If physician practices, 
particularly small and rural practices, are unable to maintain, 
they do not have any additional resources to be able to modify 
their processes and make changes. It is a little like trying to 
drive a car down the freeway and change the tires at the same 
time.
    We are as busy as we can be taking care of patients. Making 
changes requires additional efforts.
    Secondly, we need more opportunities for Advanced 
Alternative Payment Models. We believe that the MIPS APMs are a 
good proving ground to start with some changes and let 
physicians start working with that. So we would like to see 
expansion of that and stability in the program so that we have 
time to make those changes.
    And third, I would say we need to continue the Advanced APM 
updates past the 3 remaining years, because without those 
incentive programs, there is very little reason for people to 
go through the large amount of effort. We could also streamline 
a lot of the reporting processes. Electronic health records are 
not good at sending data off to CMS or anyone else. They are 
adequate, barely, for treating patients one at a time. They are 
not designed for submitting data, and we would appreciate help 
from CMS and from Congress to help the electronic health record 
industry be more responsive to physician needs.
    The Chairman. Thank you. Dr. Cullen?
    Dr. Cullen. And I would actually agree with that as well. 
You know, for the last 2 years, we have been educating our 
members about MIPS and Advanced Alternative Payment Models. We 
have been trying to get everybody into Advanced Alternative 
Payment Models as soon as possible. We have been calling MIPS 
``The Hunger Games.''
    But one of the problems has been that it has just taken so 
long to roll these out that we really have not had any members 
being able to really take advantage of them. We know that with 
advanced primary care, for every dollar you invest in advanced 
primary care, you save $13 at the end. And so if we are looking 
at ways to reduce costs, I think that is important.
    And I would absolutely agree that our electronic records 
really do not do a good job of allowing us to really collate 
the data to be able to send it out. I am actually one of those 
practices that is in the low-volume exclusion, and thank 
goodness, because there is really very little way that our 
electronic record would be able to get the data to send out, 
much less actually perform, under MIPS.
    And besides that, I mean, just the electronic records 
themselves really do not interact with each other. I am in a 
small town of 4,000 people. I have three record systems, none 
of which actually talks to the others. And so all these things 
are making it very complicated.
    The Chairman. Okay. Dr. Opelka?
    Dr. Opelka. So very quickly, there are maybe four key 
areas. One is, create a value expression. Before you put a 
payment model on something, know what it is you are valuing. So 
what is the value expression for trauma care, for cancer care, 
for whatever kind of care you are delivering--create that value 
expression of quality over cost. So you are going to have to 
define both those key elements.
    Second is the concept of asymmetric risk. CMS is stuck on 
this concept of ``risk must be symmetric.'' People do not take 
symmetric risk. They want more upside gain than downside risk. 
It is good to have the risk and upside and downside, but 
asymmetry is how most businesses run.
    The third is a true innovation center. CMS is trying to 
take the entire elephant in one bite, and you cannot implement 
on a broad scale. It needs the ability to do small innovation 
and even tolerance for failure. They are so afraid to fail, 
they will not take the necessary chances they need to truly 
innovate. So we need to change them to a true innovation 
center.
    And last is this whole concept of data. It is not just 
EHRs. It is leveraging data, creating logical models using 
consistency, getting government standards to help us do this so 
that we can move forward.
    The Chairman. Dr. Hines?
    Dr. Hines. Thank you. I believe the best way to move the 
Medicare program toward value and away from fee-for-service is 
to promote the uptake of APMs and incentivize organizations to 
do that. That could be done through: (1) waiving the inclusion 
criteria that are in the statute that make it very difficult 
for organizations to qualify as an APM; (2) making the 5-
percent bonus payment for Advanced APMs permanent, so that 
organizations have a predictable source of revenue to invest in 
the infrastructure, technology, and personnel necessary to 
deliver care using these new competencies; (3) timely access to 
claims data with benchmarking data on that as well, so 
organizations can see how they are doing compared to other 
similar organizations around the country; and lastly and most 
importantly, I would argue that we need to synchronize the 
rules across the various Federal ACO programs.
    Currently, the rules change based on the degree of risk 
that you are taking, and so it makes many of our member 
organizations hesitant to take increasing risk when the rules 
change as you take increasing risk. So imagine you learn to 
play baseball running from first base to second base to third 
base. And then you get to college and they throw you in the 
game and they say, ``Oh well, now we are running from third to 
second to first.'' The rules have completely changed.
    That is the way that it feels and the way that the current 
rules and regulations are around the Federal ACO program.
    The Chairman. Yes.
    Dr. Fiedler, is there anything you want to add?
    Dr. Fiedler. I would just add that I generally agree that I 
think the most promising path forward to encourage more 
efficient and higher-quality care is to build on MACRA's 
incentives for participation in Advanced APMs. I believe that 
making the bonus payment permanent, as well as strengthening 
the incentives that exist, is a promising path forward.
    The Chairman. Senator Wyden?
    Senator Wyden. Thank you very much, Mr. Chairman.
    Dr. Cullen, I am going to ask you a couple of questions 
that Robert Pear would be interested in this morning, because 
they are bipartisan, Democrats and Republicans, about good 
policy. They are about the future, and that is the whole 
chronic care area where he wrote the definitive story, where he 
said Medicare is not about acute illness, it is about chronic 
disease.
    In this committee, Democrats and Republicans--and I would 
like for members, particularly our new members, to know it was 
bipartisan every step of the way, with Senator Isakson, Senator 
Portman leading on the Republican side, caring for people at 
home, advocating for the patient; Senator Warner, who just 
walked in, advocating for people at home, then-Congressman 
Markey, now Senator. But it was always a good policy, where the 
Democrats and Republicans could agree.
    So, Dr. Cullen, I think the staffs talked to you about it. 
Tell me a little bit about your take on how we expand care for 
people at home who have these chronic illnesses, because it 
gives people more of what they want at a lesser price to the 
taxpayer. Portland has a wonderful program, House Call 
Providers.
    My first question is, the Innovation Center has recently 
announced a new Primary Care First model, which I think builds 
on some of the good work that you are doing. I have heard from 
some physicians in Oregon that they think this is a path to 
more home-based primary care.
    I would like to get the old band together again: Senator 
Grassley and I, Senators Portman, Isakson, Senator Warner, 
Senator Markey. I think you guys have some good ideas on it.
    And particularly this morning, I want to hear about people 
working together. That is what Robert Pear was mostly 
interested in. What do you think?
    Dr. Cullen. Well, I absolutely agree with you that people 
would rather be at home and that chronic care management is 
really going to be the most important way, I think, that we can 
reduce costs overall, but also just making sure that people 
remain happy.
    The Primary Care First program, actually, really does 
reward physicians for keeping people at home. And you know the 
reality is that the technologies now really allow us to do a 
lot more for people at home, and keep them at their home. And I 
can tell you that my patients would much rather not be in the 
hospital. I do home visits. As much as possible, I do try to 
keep them within their home, because that is where they feel 
most comfortable.
    I think there is a lot of interest in the seriously ill 
persons' component of Primary Care First, and that is where 
there is actually added money available to really take care of 
people who are sick and keep them in the home. So I think that 
that is--both of those are really important directions to go.
    Senator Wyden. We will hold the record open--the chairman 
has been very generous in working with us--for people to have a 
few days. I would like to see in writing any suggestions you 
all have to make the model work when it comes to home-based 
primary care, what the Center for Innovation is talking about. 
That is the first question.
    One other question, very quickly, Mr. Chairman. Dr. Cullen, 
I think you might have heard this other point I made about the 
chronic care point guard. I am just struck by how, particularly 
people who do not have Medicare Part C, for example, or 
something that coordinates their care--some of the ACOs, of 
course, do that as well--just get lost in this kind of blizzard 
of forms and paper. And as you know, the evidence shows that 
well over half of the Medicare spending is going to go for 
people who have two or more of these conditions, might have 
diabetes, cancer, or something.
    I was teasing the chairman that I want to promote the 
``Grassley Always in Good Health Program,'' because somehow he 
and Barbara have the magic. But we have a lot of people with 
these two or more conditions.
    So I would like to get the band back together again: 
Senator Warner and Senator Markey, and the good work of 
Senators Portman and Isakson, all the members of this 
committee--through the whole chronic care debate, there was not 
one nasty, acrimonious word. People were just trying to figure 
out what the next steps were in terms of transforming Medicare.
    So, what do you think about this chronic care point guard 
and trying to move ahead with a way to help people navigate 
this byzantine system, particularly if they do not have 
Medicare Advantage or some kind of accountable care program 
that pulls it together? What do you think?
    Dr. Cullen. So family physicians see ourselves as that 
point guard.
    Senator Wyden. Good.
    Dr. Cullen. That is exactly where we have positioned 
ourselves. And I have to admit I do not play basketball, but I 
understand the concept. And we do--that is really the whole 
idea because, otherwise, when people are going from specialist 
to specialist to specialist, their care is worse and their 
costs are higher.
    We have found that with the chronic care management program 
that there are some impediments in that that probably need to 
be adjusted, because that has not fulfilled the promise that it 
has, just because it is actually very hard to make that program 
work unless you have a lot of beneficiaries.
    So in my place, we do not have very many. And so just 
getting that program up and running has been difficult because 
of the impediment.
    Senator Wyden. Well, let us do this. My time is up. I would 
like to see anything in writing that you have. We acknowledged 
from day one that that was just the beginning. And particularly 
for the well over half of the patients who are in traditional 
Medicare, the problem you described is very real, and it is 
daily.
    So give us a step-by-step, if you would, because I have 
talked to the chairman about this. And he has been very 
sympathetic to the idea, if there are some bipartisan ideas 
that are cost-effective.
    Our goal is to really go step-by-step on building what is a 
modern Medicare program, as opposed to what we had. And I would 
very much like your specific ideas on exactly the point you 
made.
    Dr. Cullen. We welcome that opportunity.
    Senator Wyden. Thanks. Thank you, Mr. Chairman.
    The Chairman. I am going to go vote. Senator Thune is going 
to lead the committee. Thune is the next one to ask questions. 
And then of the people who are here, it will be Brown and 
Warner. But if other people come back, there would be two or 
three ahead of you.
    Senator Thune [presiding]. Thank you, Mr. Chairman, Senator 
Wyden. Thanks for holding this hearing, and thanks to our 
panelists for being here today. I appreciate the opportunity to 
hear from stakeholders and how they think the shift to value-
based care is going for their members.
    An area that has always been important to me and to my 
State is ensuring that small and rural practices have the 
opportunity to succeed in this transition. The option to form 
virtual groups under MACRA aims to help with that. While it 
took some extra time for CMS to get the program up and running, 
I hope that we will see that it offers a helpful way for 
smaller provider groups to band together and increase their 
chances of success in MIPS.
    Could our provider group panelists, perhaps Dr. Fiedler on 
the academic side of things, briefly share feedback that you 
have received from your members on how implementation of 
virtual groups has gone? Specifically, how do they identify 
fellow providers to work with, and are there any barriers to 
success at CMS that policymakers should consider? Dr. McAneny?
    Dr. McAneny. Thank you very much for that question. The AMA 
shares the disappointment that we have not had much uptake in 
virtual groups. I think one of the things that CMS could help 
us considerably with is to be more transparent about releasing 
the data.
    We have looked at doing virtual groups, with my own 
practice participating in the oncology care model, and we found 
that getting the data a year and a half later makes it 
impossible to actually see how members of that group are doing. 
So having the existing clinically integrated networks work 
together and become some of these pooled groups would be very 
helpful. But we think that there are a lot of infrastructure 
costs that need to be done. So starting with groups that are 
already doing some of that may be helpful.
    One of the concerns that physician practices have in trying 
to integrate with independent practices working together as a 
virtual group is the Stark and anti-kickback laws. We do not 
want to run afoul of those. Yet if we are going to be able to 
conserve resources, we want to be able to work together to 
create processes to have, say, the ancillary services part of 
the virtual group so that they cost less than if we send people 
to the local hospital to get a CT scan or something like that. 
The additional incentives and bonus payments that could be 
provided to help with the increased communication and 
coordination costs across a virtual group would be very useful.
    Thank you.
    Senator Thune. Thank you. Anybody else? Dr. Cullen?
    Dr. Cullen. There was a lot of excitement about the program 
when it was first brought up. I have to say though that it has 
really proven to be very difficult to form these groups. And 
there is--I have not really seen a lot of interest among my 
fellow family physicians, even though, especially for rural 
physicians, this would be a great program.
    I think that there probably needs to be a little bit more 
advertising or communication about them. But there is also a 
lack of multi-payer agreement on what that actually means as 
well.
    Senator Thune. So a year ago, CMS announced its rural 
health strategy with a stated goal of applying a rural lens to 
CMS programs and policies. CMS's willingness to acknowledge 
this issue presents a great opportunity to talk about the 
flexibility that rural providers need in order to overcome the 
challenges associated with taking on risks and implementing 
technology while managing an older and smaller population.
    So, aside from virtual groups, what other suggestions have 
your providers offered in terms of how we can help ensure that 
success of rural providers in delivery system reform?
    Dr. Cullen. Well, first off, I think that paying them more 
would probably be helpful. And I say that because already there 
are many rural practices that are right at the very edge of 
survival, and part of that is because of really the higher 
overhead that is associated with having a small rural practice, 
just because of the cost of actually running a practice.
    And the second is just the complexity of the patients that 
we take care of and the difficulty with referrals, and with 
just being able to afford the IT infrastructure because we do 
not have somebody in town who is able to actually work on that, 
those systems. So I think that if you want rural providers to 
stay in business, I think paying them more is probably the best 
way to do that.
    Secondly, I think reducing the complexity is really 
important. I think that is what we have already been talking 
about with MIPS. But the systems that most rural providers are 
able to afford really are not able to provide the data that we 
can then pass on to CMS. And besides that, a lot of times our 
systems do not communicate with other systems in those 
communities. Like I said, I actually have three different 
systems that do not talk to each other, and they are all 
located in the same building in our community.
    Senator Thune. Anybody else on that? Yes, Doctor?
    Dr. McAneny. Thank you very much. I would like to add to 
that that preserving the small threshold, the small volume 
exemption, would be very helpful because, if you think about 
those physicians and those practices that qualify for that, 
they are treating less than 200 Medicare patients. That is four 
a week.
    So to a previous point that was made, even if you penalized 
all of those physicians by making them participate when they 
cannot make the scores because of all the problems Dr. Cullen 
mentioned, you would not produce very much money to put into 
this pool to give to the ones that are hitting higher scores. 
So, preserve that exception and make that available.
    The second thing is the update. Having a positive update is 
so important, because we know that the cost of providing 
medical practice increases between 2\1/2\ and 3\1/2\ percent 
every year. Yet we are heading into a process where Medicare 
will give us a zero-
percent increase every year. And that simply is not a 
sustainable thing. And the rural practices will be the first to 
feel that problem.
    It is not just primary care. In my oncology practice, we 
have closed several rural clinics for exactly those reasons: 
that we cannot make ends meet because it actually costs more to 
deliver care per patient in a rural area where you have a 
smaller volume.
    Senator Thune. Thank you.
    Senator Brown?
    Senator Brown. Thank you, Senator Thune. And thanks to our 
Senators Wyden and Grassley for this hearing. Thanks so much 
for your testimony and answering questions.
    As you know, we passed MACRA to reward high-value patient-
centered care. While MACRA is about physician payment reform, 
to be sure, our goal should be maximizing patient benefit. I 
know all of you, from your comments, agree with that.
    It is clear we have not done enough to ensure that 
patients' voices are a part of the process and that patients 
are benefiting from these changes. NIH created the Patient-
Focused Therapy Development tools and systems dedicated to 
engaging patients throughout the translational science process. 
FDA has implemented a Patient-Focused Drug Development model to 
help ensure that patients' experiences and perspectives and 
needs and priorities are captured meaningfully during drug 
development and review. My question is for you, Dr. McAneny.
    Two questions: do you believe CMS and Congress are doing 
enough to ensure representation of the patient voice throughout 
the development and the implementation of MACRA, first 
question? And second, what more can your physician 
organizations and CMS do to ensure that patient needs and 
priorities are kept at the center of health-care delivery? If 
you would try to answer those together, thank you.
    Dr. McAneny. Thank you, Senator Brown.
    It is a difficult method to try to collect patient-reported 
outcomes because patients who are sick are too busy being sick. 
I am a cancer doctor. They do not have the energy to fill out 
forms. And for example, in the oncology care model, they send 
out an 84-question document that patients are supposed to fill 
out, which they do not.
    So what we have found works better and what the AMA has 
been proposing with this is to make sure that the patient 
advocacy organizations are heard--and we talk to them and 
convene them in multiple of our sessions--but also to recognize 
what patients need through examples like the patient-centered 
medical home.
    We did this in oncology, and our patient satisfaction 
scores were in the high 90-percent range because you give 
patients the help they need when they need it at the lower cost 
side of service. And in addition, we saved about $2,100 a 
patient, which was pretty good.
    So it is possible to do that, and by incorporating what 
patients want and patients need and their values into this, you 
can direct their care and avoid care they do not particularly 
want. And we continue to work more with that.
    One of the ways that we are trying very hard to involve 
patients from the AMA standpoint is to recognize that there are 
a huge number of Americans who have pre-diabetes and do not 
even know about it, and have other chronic diseases that are 
not well managed, and we recognize that that takes a team of 
people to work on those. So we are focusing on diabetes, pre-
diabetes, and hypertension to try to look at the chronic 
diseases that Americans have said they wanted treatment for.
    We also continue to work for access to care, because what 
we hear from patients is, this is the most important thing for 
them, to have continued access to care.
    Senator Brown. Thank you.
    Dr. Cullen and Dr. Opelka, I will ask you a question 
jointly as my last question. In each of your testimonies you 
mentioned the importance of patient-reported outcomes. We 
obviously should be measuring whether or not we are paying for 
care that is in line with the patient's goals. If you could 
comment, how many of the existing 424 measures in MIPS consider 
the patient voice in their priorities? Dr. Cullen and Dr. 
Opelka?
    Dr. Cullen. I am actually not sure I can answer that. But 
there is a saying in family medicine that it is not patient-
centered until the patients say it is.
    Dr. Opelka. In the surgical space, we do not have any. We, 
ourselves, run our own patient-reported outcomes within our 
database to inform our members. But they are not part of the 
payment program.
    Senator Brown. Okay. Thank you. Thanks, Mr. Chairman.
    Senator Thune. Thank you, Senator Brown.
    Senator Roberts?
    Senator Roberts. Well thank you, Mr. Chairman.
    I would like to echo the sentiment shared by many of our 
witnesses this morning that, while MACRA is not without its 
challenges, it certainly was an improvement over the 
sustainable growth rate payment system and the many doc fixes 
passed by Congress over the years.
    I remember, personally, we would promise the docs and 
everybody else involved in the rural health care delivery 
system, and for that matter, the State of Kansas, ``Yes, we 
will fix it.'' And each month would go by, and finally at the 
11th hour and the 59th minute, we would come up with 
something--never enough, never enough. I never understood why 
we could not do that the first thing in the Congress so we had 
a better system.
    MACRA was a significant step toward improving quality for 
providers and, more importantly, patients going forward. But I 
have several concerns about how the law affects small and rural 
practices. I know that has been emphasized by most of you.
    The Merit-based Incentive Payment System, MIPS, is set up 
to rate providers based on requirements that are often simply 
too burdensome for these practices. And that is probably an 
understatement. These providers already face higher expenses 
and limited resources and lower patient volume, which is often 
not adequately reflected in MIPS. I appreciate the actions that 
have been taken to offer these practices exemption and 
flexibilities from MIPS. However, much more work needs to be 
done in order to make meaningful improvements for these 
providers and their patients.
    It is terribly important to ensure they are not 
overburdened. We should now also aim to incorporate small and 
rural providers and their quality improvement systems by 
accounting for the unique challenges they face. Both providers 
and their patients deserve to be included in Federal efforts to 
improve health-care quality without being penalized by these 
programs simply because of the geography or size of the 
practice.
    As co-chair of the Senate Rural Health Care Caucus, I, 
along with my colleagues on the caucus, sent a letter to the 
National Quality Forum in 2016, back then, requesting that the 
NQF convene a rural Measures Application Partnership--the 
acronym for that is MAP--to develop quality measures that are 
relevant to these rural practices. I was very pleased in August 
when the rural MAP published the first-ever set of rural-
relevant quality measures. But I believe, while this is an 
important step, including all providers into quality programs 
in a way that is both meaningful and appropriate would be the 
best course.
    Dr. McAneny, you have a situation in Iowa. I hope you are 
not underwater where you live, and I hope you can get through 
all of that. We are waiting for that in Kansas. But you 
mentioned in your testimony that rural and small practices, in 
particularly our very small rural communities, tend to have 
lower MIPS scores compared to the national average. How would 
more appropriate quality measures help level the playing field? 
Would other improvements beyond changes to quality reporting be 
necessary? As a tip-off, I think that answer is ``yes.''
    Dr. McAneny. Thank you very much, Senator.
    And I am actually in New Mexico, and we would love to have 
some of that extra water from Iowa. As we look at the very 
specific issues that affect rural patients, what we find is, 
because they have less discretionary income often, we fall into 
the category of the social determinants of health. And holding 
physicians accountable for those social determinants makes 
things incredibly difficult. I know it from my own practice, 
which is rural, that we end up with patients whose outcomes are 
very much affected by food insecurity, by transportation 
issues, and other things that we are not currently allowed to 
help solve.
    If we try to provide transportation through the practices 
to get to care, for example, we are at risk of being guilty of 
inurement and offering something of value. So releasing some of 
the laws that constrain us from being able to band together 
with other rural practices to be able to provide these services 
for patients would be very, very useful.
    Having rural practices, small practices like mine, work to 
try to put the data in for MIPS takes a huge amount of time and 
effort. I decided as AMA president that I would set an example 
for everyone and prove that a rural practice could do this. I 
scored 100 on MIPS. My increase was 1.88 percent. And after the 
adjustment that occurred after that, it lowered that increase 
to where the entire change that I got was $34,000.
    When I added up how much I had to pay my EMR vendor to 
submit that data, when I had added up everything that I had to 
do in terms of paying staff overtime to make sure the data was 
accurate, I lost $100,000 to score that perfect score. So we 
need to modify that. That is, I think, a great example of why 
the lower-volume practices need to be kept out of this process 
so they can continue to use their resources on patient care.
    And we need to streamline this entire process so that we 
can submit the data, hold ourselves accountable for delivering 
the quality of care that our patients deserve, but do it at a 
lower price tag.
    Senator Roberts. Thank you.
    My time has run out, Mr. Chairman. I would only point out 
that when you score 100, it is like all of a sudden the 
referees, the people who wear the stripes in the basketball 
game saying, ``I am sorry. You only scored 80, and you lost the 
game.''
    Dr. McAneny. I lost.
    Senator Roberts. I yield back.
    Senator Thune. Always very perceptive and insightful----
    Senator Roberts. Thank you.
    Senator Thune. Senator Warner?
    Senator Warner. Thank you, Senator Thune. And I guess that 
would be one way to describe Senator Roberts.
    Thank you all for being here. And I think as you heard from 
the chairman and the ranking member and all of our questions, 
this is actually an area where I think we all agree. It feels 
like, while well-intentioned, we may not be getting the results 
we are looking for. I have a lot of small rural providers as 
well.
    I have three questions I want to try to get to, and I 
recognize that we have focused on only part of the panel. I 
think I will start with you, Dr. Cullen.
    You know, I am interested in the Physician-Focused Payment 
Model Technical Advisory Committee, PTAC. It seems like they 
have done some good work. I have been particularly interested 
in some of these physician payment systems, particularly around 
advanced directive, end-of-life, advanced care models.
    It seems like while--again, well-intentioned--CMS has not 
been very good about actually implementing these models. What 
can we do, or is this where we should--do we need legislative 
change here? Do we need haranguing on CMS? I would love to 
hear, again, any of your suggestions. And if we could fairly 
quickly, since I have a couple other questions.
    Dr. Cullen. The big problem with the Advanced Alternative 
Payment Models is that they have taken a really long time to 
roll out. That has not really been the fault of PTAC, because 
we had ours approved back in 2017. Somehow in that process, 
getting it actually rolled out has proven difficult and much 
longer than we expected.
    Dr. McAneny. I would like to add that having the CMMI able 
to do pilot projects might be very useful. And yes, they 
evaluate a lot of good programs that have been submitted to 
them. But if we can get some of the pilots enacted, that would 
be very helpful.
    Dr. Opelka. The PTAC is going through an enormous amount of 
work in the conceptual modeling, and it is fantastic. It then 
fails when it gets to the Innovation Center because it is 
trying to do broad-scale innovation rather than narrowing it 
down. Let us test it. Let us see if we can do this 
implementation.
    And how do we partner? There is really--it goes inside the 
government, and it gets lost in a big swallow. It needs to 
actually be much more nimble if it is truly going to be 
innovative, and it cannot be afraid to fail, and then modify, 
and change, and grow.
    There is a lot of, ``Oh, we just cannot fail with this 
because we are trying to do a big implementation.''
    Senator Warner. It seems, though, that this might be an 
area where you do not necessarily need a legislative change, 
but maybe a group of us from the committee to kind of put the 
pressure on CMS to say, ``We gave you these tools.'' We need to 
try and recognize, and maybe get us on record as saying, ``Try, 
and we realize you may have some failures.'' And if we are then 
on record, then we cannot complain when the failures come back. 
But I think, as a former venture capitalist, you have to have 
that mind-set.
    Dr. Fiedler, on the merit-based incentive program, in your 
testimony you said, ``Let us just eliminate it.'' I am 
reluctant to think that--I know it has been not appropriately 
implemented. But is there--are you fully in that it is not 
worth trying to reform, re-tweak? Do you think elimination is 
the only option?
    Dr. Fiedler. So, I am not optimistic about what can be 
achieved through reform. But I do think there are options to 
improve on the status quo. I think there are improvements we 
can make in the quality domain to ensure that clinicians are 
not incentivized just to select the measures that they think 
they are going to be able to get the highest score on, rather 
than the ones that are most meaningful to their patients.
    I think there are opportunities to simplify the Promoting 
Interoperability category to get what the public--what we sort 
of want out of that category, which is greater take-up and 
anchoring of the certified EHR standards, not a box-checking 
exercise about, you know, are you using the record in this 
particular way that CMS thinks you should?
    And I think we can improve the practice improvement 
category by transforming it into a targeted incentive for 
specific high-value activities, rather than the sort of grab 
bag of 100 activities we have today.
    Senator Warner. I would love to see--perhaps in a written 
response--some of those ideas laid out.
    Let me lay out one last question. I am probably not going 
to get a chance to get all of you to respond. But for the 
record, you know--I failed to mention interoperability.
    I was a telecom guy before I was in politics, and we should 
have seen this train coming in terms of the need for 
interoperability and all of the promise that we so over-
promised on EMRs--and so under-delivered, I think a lot because 
of the lack of interoperability.
    But on a broader basis, everything--so much we are talking 
about in terms of pricing and some of your comments already 
about the requirements to try to get all this data, we are 
going to move towards a more data-centric system.
    But wearing my other intel hat, we are seeing enormous 
vulnerabilities coming from cyber. And I have put out, in a 
sense, a request for ideas and proposals across the health-care 
field. And huge uptake--and Senator Thune plays a leadership 
role on this on the Commerce Committee--huge, huge uptake, but 
the vulnerabilities we have seen, we are already starting to 
see with some of the ransomware against hospitals. But the 
ability to hack into individual docs' systems and others, I 
would hope that you could all come back to me with your 
perspectives on how we continue to take full advantage of this 
data-rich environment, but also not repeat the failure on EMR 
by not having interoperability.
    We may repeat the same if we do not build in basic 
cybersecurity hygiene and standards as we continue to 
accumulate this data. And I just think it is a huge 
vulnerability.
    I know I am over time, so I do not want to--I am over time. 
So maybe you could answer Dr. Cassidy on part of that question.
    Thank you, Senator Thune.
    Senator Thune. Thank you, Senator Warner.
    Senator Cassidy?
    Senator Cassidy. Thank you very much.
    First, I do not want to be pedantic--Dr. McAneny, it is 
nice to see you. I do not want to be pedantic, but let me just 
point out that in your testimony you speak about these small 
practice MIPS having a mean score of 75, but a median of 63. It 
tells me that some practices do very well. It is just that most 
practices do not--that kind of difference between mean and 
median.
    Now I raise that, again not to be pedantic, but are folks 
familiar with the direct contracting model options that were 
released? Dr. Cullen, you would be.
    And so let me just--as quick background, when I was on 
Energy and Commerce on the House side, Mike Burgess and I had 
this concept that small independent practices--small practices 
within an independent practice association--could go to a two-
sided risk directly contracting with CMS.
    Now if we focus on outcomes, not upon measures--so that is 
the good thing about it. And the reason I kind of develop it 
all this way is that Dr. Hines points out that MIPS excludes 
small practices. You make the case that it is probably 
necessary because of increased cost of compliance. But when I 
look at that difference between mean and median, it looks as if 
small practices can do it, it is just that a lot do, but just a 
lot more do not.
    So having said that, Dr. Cullen, to what degree do you 
think that small practices can participate in this direct 
contract model? And do you think this would be a way to 
incentivize that smaller practice to go into a two-sided risk 
arrangement where hopefully they benefit from the upside?
    Dr. Cullen. First off, I am excited to try it because it 
has rolled out in--Alaska is one of the pilot States under 
Primary Care First. So I will be able to tell you a little bit 
more, maybe in a year.
    One thing about the two-sided risk is that I do agree that 
we need to make the downside risk fairly minimal. And I say 
that because, again, a lot of practices in rural areas and 
small practices are really right at the margin at this point.
    And so, if it is a large two-sided risk----
    Senator Cassidy. Now, let me stop you for a second. There 
is a group of physician-run MA plans, and their physicians do 
better financially. They actually have smaller panels than does 
the regular Medicare-focused practice.
    And the guy who runs it says, ``I just go to a small 
practice and I say, `Was there one patient who you hospitalized 
last week that you did not have to?' `Oh yes, I could have 
brought them here instead of the ER, but I was just slammed.' 
''
    If you had not admitted that patient, you would keep the 
savings. So I say that knowing that there are some tight 
margins, but that there are practice decisions that we can make 
as practicing physicians that can lower costs with the benefit 
accruing to us. Would you agree with that?
    Dr. Cullen. Absolutely.
    Senator Cassidy. So it would increase those margins.
    Dr. Hines, any thoughts on all this?
    Dr. Hines. Yes, thank you. I just want to point out, 
because it has been brought up a few times, about small 
practices and MIPS--and I think Dr. McAneny's example of 
scoring 100 is a good example of why we should do away with the 
exclusions and be able to have the funds to be able to reward 
the practices that are doing a good job.
    And let us not forget that there is funding in MIPS for the 
small uninsured and rural support initiative to help these 
smaller practices be able to report on quality and be able to 
have the help that they need. And MIPS is really an on-ramp 
towards value.
    And AMGA's position on this is that we should be expanding 
this so that more and more providers are able to----
    Senator Cassidy. Because I have limited time, can I get you 
back to what I was asking: this direct contracting model in 
which IPAs could go at risk?
    Dr. Hines. So I think that it, in theory, is a great model. 
I think the devil is in the details. This idea of having a per-
capita reimbursement but having patients have total choice of 
care and be able to go anywhere they want----
    Senator Cassidy. It could be a prospective assignment as in 
an MA. It would not be an ACO where, after the fact you decide 
where people got their care. It would be a, no, you are going 
to be my doctor sort of thing.
    Dr. Hines. And I think as long as there are those 
assurances in there, and that there are some limits to the 
network so that you can promote patients to go to physicians 
who have been shown to be high-quality and low-cost, I think it 
has the potential to be successful, yes.
    Senator Cassidy. Dr. McAneny, any comments?
    Dr. McAneny. Yes; thank you for that question.
    First of all, I think that having the prospective payment 
is key, because my practice had the $100,000 to invest to get 
that perfect score, but many small practices do not have that 
resource. And going through the process to get technical 
assistance does not substitute for that. So having a 
prospective payment come out first is great. I also think this 
is a great opportunity for us to do a test for this and see.
    I think we need to scale risk according to what the 
practice can manage. If you are a small practice, promising a 
job to another nurse, a salary with benefits, is a significant 
financial risk. So I think we need to look at that very 
carefully. We do not want to put so much risk on a practice 
that if they do not succeed, we lose the interest----
    Senator Cassidy. I accept that. I am out of time.
    I will make a comment, though. Going back to this 
physician-run MA plan, the paradigm has always been, see as 
many patients as you can to cover your overhead.
    This is a different paradigm: actually give higher-value 
care, and your margins actually rise, even though you see fewer 
patients. And I do think that there is going to be an emotional 
and intellectual adjustment.
    We are out of time, and I will give it back to the 
chairman.
    The Chairman. Senator Whitehouse?
    Senator Whitehouse. Thank you. First, let me thank the 
chairman for having this important hearing. And let me say how 
glad I am that Senator Cassidy is here while I have the chance 
to ask my questions, because we have worked well together in 
this area, and I hope to continue.
    I am going to ask you to answer these questions in writing 
if you care to, because they are fairly complicated. Consider 
them an invitation.
    Before I ask the questions, I just want to make one 
observation, which is that CBO does rolling projections of what 
the total Federal health-care spend is going to be. And their 
most recent projection is down over $4 trillion over 10 years 
from what it was projected to be 10 years ago. So something big 
is happening out there. We do not understand what it is. But $4 
trillion is a lot of money to project in savings.
    So here are my questions. The first has to do with ACOs. 
Rhode Island has two of the best provider ACOs in the country, 
Coastal Medical and Integra. They are doing very well.
    CMS has not always been their best friend. There have been 
a variety of efforts at CMS that frankly would have been very 
damaging to the ACOs. My view is that you feed the lead dogs. 
They should feel rewarded and supported. And very often they 
feel challenged and almost unwelcome. You also invest a little 
bit more than you do in the final product in a prototype. So 
for a whole bunch of reasons, I think we reward the really good 
performers and figure out what they did, and figure out how you 
propagate; that is a better strategy than trying to extract as 
much savings from each one as you can at this early stage while 
we are still developing the prototype.
    One of the problems that the ACOs face is a leveraging 
problem. If they are going to bear risk, they bear risk on the 
entire cost load of their patients. But they only control 10 to 
15 percent of their patient cost. The rest is specialists, 
pharmaceuticals, hospitals--people over whom a provider ACO has 
no control.
    So I think that is something we need to try to figure out: 
how you prevent them from having to not take risk because they 
feel so leveraged. So that was question one, supporting 
provider ACOs, feeding the lead dogs. What can we do better?
    The second has to do with end-of-life care. Whether you 
call it ``end-of-life'' or ``advanced care'' or ``palliative 
care'' or whatever, there is a space in there where--with 
respect to Dr. Opelka's comment that we need microcosms for 
innovation to sort of test the innovation model and move 
forward--I think that ought to be one.
    There is a big group called C-TAC, Coalition to Transform 
Advanced Care, that is working in this space. And I think that 
there is a space there where some of the Medicaid rules, if you 
are actually dealing with this population as a population, 
become counterproductive. And Adam Boehler is being helpful in 
trying to solve that problem, but it would be helpful to have 
your thoughts as well about this population.
    It is the ``2-night, 3-day'' rule. It is the ``patient in 
the hospital for respite care'' rule. It is the ``you cannot 
get home care services unless you are homebound'' rule. There 
are a whole bunch of things that, perhaps in the abstract, make 
sense, but do not once you start managing this population.
    Third, the electronic health record/health information 
exchange interface for doctors. Senator Cassidy and I just had 
to file a bill. We did not need to get it passed to get some of 
these EHR providers to change their behavior about the gag 
rule. So I think there is actually the prospect for pretty 
strong bipartisan signaling out of this committee where there 
are problem areas.
    I think we all understand that the business model of some 
of these providers--not the medical providers, the data 
services--is to try to encourage people to adopt their own 
program by being less interoperable than they should be. They 
actually have a counter-incentive to the interoperability that 
will serve patients. And we need to figure out how to fight our 
way through that.
    Last question, or last point for your response, is that it 
strikes me that one of the areas we have not engaged in very 
effectively yet is at the State level. There was an effort at 
one point by CMS to go and try to impose programs by its 
regions. Nobody cares about its regions. There is nothing real 
about its regions.
    What is real are States. They have Governors. They have 
medical associations. They have health departments. They have 
Medicaid programs. And if we could work together to figure out 
a way to reward States for better outcomes, as well as 
individual practices, I think all of that State-based machinery 
can then be put to work to help solve these problems.
    At this point, other than the Medicaid programs trying to 
reduce cost, I do not think we have engaged the States at that 
level. So if you were to do a Medicare penalty for States that 
are outliers in terms of quality versus cost, I think the 
Governor, the head of the medical society, the health director, 
and the Medicaid program director would all be in the room the 
next day saying, ``How do we avoid this?'' And we need to 
provoke that kind of activity at the State level.
    So those are all for responses in writing. I hope this is a 
healthy dialogue, and I think there is a lot of bipartisan 
interest.
    And thank you, Mr. Chairman, for having this hearing.
    The Chairman. Yes.
    If Senator Hassan is ready--if you are ready, you are up 
next. If you are not ready, I have one question, but I think--
--
    Senator Hassan. Why don't you ask your question, and then I 
would be happy----
    The Chairman. Okay. For any or all of you--but do not take 
a lot of time away from Senator Hassan to get too deeply into 
this--I take special interest in making sure that there are 
physicians to care for people in my rural areas, and there are 
a lot of rural areas more rural than Iowa. But we have plenty 
of them.
    And rural physicians should have an opportunity to 
participate in the Alternative Payment Models. What can be done 
to create such Alternative Payment Model opportunities and give 
physicians in rural areas the best chance to succeed in them?
    Dr. McAneny. Thank you very much. I think the MIPS program 
is a way to start with that, with MIPS Advanced APMs. The 
medical home can be done by very small practices. It is not at 
this point a payment model, but it is a MIPS APM. And so that 
is very useful.
    We are hoping that some of these pooled processes may work 
for that. But the first step has to be to give those practices 
the resources to be able to have the time and flexibility to 
innovate. And that means that will not happen if we have a 
zero-percent update for the next several years for those 
practices that are still in MIPS. It is a process, and they 
cannot stop taking care of the patients of today to think about 
how they are going to manage the patients of tomorrow, and in 
an alternative method.
    We promote the PTAC idea of starting out with, how do you 
want to deliver the care, and then adapting the payment model 
to fit that, instead of the current method of creating a 
payment model and then telling the physicians to adapt their 
practices to that.
    The Chairman. I am just going to hear from Dr. Cullen and 
then go to Senator Hassan--since you are in a rural area.
    Dr. Cullen. Well, the American Academy of Family 
Physicians' Alternative Payment Model I think is really going 
to work in a rural situation. That is something that I have 
been watching really closely, given my situation. But as a 
prospective payment with significant upside risk, I think that 
that is something that will help significantly in rural 
practice.
    The Chairman. Okay.
    Senator Hassan?
    Senator Hassan. Well, thank you very much, Mr. Chairman, 
and thanks to you and the ranking member for having this 
hearing. And to the panel, thank you for your testimony. And to 
say that the Senate's voting practice this morning is 
disruptive is an understatement. So I appreciate your patience 
with that.
    Dr. Cullen, I wanted to just start by following up on what 
I think has been a little bit of your earlier testimony. New 
Hampshire also has its share of rural hospitals, and I am very 
interested in a number of the issues that you have talked 
about.
    But could you speak a little bit more to the specific 
challenges that rural hospitals and providers face complying 
with these reporting requirements, and talk a little bit more 
about how it impacts patient care in rural communities?
    Dr. Cullen. Well, the biggest impact is if the hospital or 
the providers close or leave.
    Senator Hassan. Right.
    Dr. Cullen. And unfortunately, we have lost almost 100 
small rural hospitals in this country in the last 10 years, 
which has had a huge impact on maternal and infant mortality 
and other factors. So this is an enormous impact.
    Senator Hassan. Right.
    Dr. Cullen. As far as why, a lot of it has to do with the 
ability to do the reporting. We just do not have the 
sophisticated systems that allow us to do the reporting or an 
easy way to do that. And part of that is because of the costs 
that are incurred just in buying those systems.
    Part of it is just the support. And then the third thing is 
that oftentimes I see that there is an idea that things are 
easier in rural communities and that they are cheaper. And it 
is just the opposite.
    We take care of a whole range. In my community, we do full 
spectrum OB, which means we deliver babies, we do C-sections, 
we do surgery, we cover the ER; the pace is very intense. But 
being able to find the pool of people to work in the clinic or 
in the hospital is also extremely difficult. And so all of 
those raise costs dramatically.
    Senator Hassan. Okay. Thank you.
    I wanted to ask each of you to comment, if you could, on an 
issue that, again, is near and dear to my State, which is the 
opioid epidemic. MACRA provides an incentive payment for 
providers who improve their tracking and reporting of quality 
measures related to opioid prescribing, treatment agreements, 
follow-up evaluations, and screening of patients who may be at 
risk of opioid misuse.
    The question that I have is for anyone of you who might 
have insight into the issue of substance use disorders. 
Specifically, have these new reporting requirements had an 
impact on reducing opioid misuse, and are there ways we could 
improve the collection and use of this data being reported in 
order to have a greater impact? Anybody want to--Doctor?
    Dr. Cullen. Our clinic does provide medical assisted 
treatment. We do a fair amount of work with the opioid use 
disorder. We would be doing that regardless of the MIPS 
measures, frankly. And that is just our task.
    As far as capturing the data, I think the hard thing is 
that--again, this is an area where it is very hard to distill 
that down to individual data points, because opioid treatment 
disorder is something that really requires a full-court press 
with counseling, physical therapy--we actually use acupuncture 
as well as medication-assisted treatment.
    Senator Hassan. Right.
    Dr. Cullen. It is something that is very labor-intensive.
    Senator Hassan. Thank you. Yes, Doctor?
    Dr. McAneny. Yes, from the AMA standpoint, we have had an 
opioid taskforce looking at this for many years now, since 
2014, because we recognize this. And we have done a lot of 
educational processes that have decreased the amount of 
prescriptions only to see patients then shift to street drugs 
to get their medications that they want.
    Having the opioid use treatment processes as a quality 
measure in MIPS so that people can score for that would be, I 
think, a helpful process for that, and having the prescription 
drug monitoring programs more user-friendly, and also 
recognizing team-based care as opposed to one-physician one-
patient all the time.
    Senator Hassan. Right.
    Dr. McAneny. That is not how we practice anymore. It would 
be very useful along those lines. And having the processes in 
place so that there are more options for treating people who 
have opioid use disorder--many communities, particularly, are 
severely impacted. Rural communities do not have anyone who can 
help with that disorder. It needs a full-court press.
    Senator Hassan. Thank you.
    Dr. Hines?
    Dr. Hines. Yes, I would just add that the opioid epidemic, 
I think, is an area where the model of care that is promoted by 
AMGA can be quite successful, because we are all about 
coordinated, integrated care. And as has been mentioned 
already, in order to treat opioid addiction, just like in order 
to treat chronic diseases, you need to make sure that you have 
the full spectrum of services available for patients. And it is 
often helpful to do that in one place.
    So I think that having measures around opioid use can be 
helpful, but I think it is more just the calling of physicians 
to realize that this is a problem, and the best way to treat 
that is in an integrated, multidisciplinary way.
    Senator Hassan. Thank you. Thank you all very much, again, 
for your testimony, and for your expertise and work.
    Senator Roberts [presiding]. Senator Carper?
    Senator Carper. We apologize for this--the way things are 
being conducted. When Senator Roberts and I are in charge of 
this place, this will not happen. [Laughter.]
    So thanks for bearing with us.
    But thank you for being here. Thanks for your testimony and 
responding to our questions.
    I am interested in hearing about roughly how many 
physicians and health-care providers participate in Medicare, 
but I do not know if you all have any idea about that. Any 
thoughts on that? How many physicians and health-care providers 
actually do participate in Medicare? Anybody want to venture a 
guess?
    Dr. McAneny. I can get you the exact numbers of people who 
do participate in----
    Senator Carper. Can you give me their names and addresses? 
[Laughter.]
    Dr. McAneny. CMS is supposed to have that registry.
    Senator Carper. Okay. Well, we will ask them.
    Dr. McAneny. But I think that the vast majority of 
physicians do, which is always an interesting thing given that 
Medicare does not pay for the full cost of care. It is just 
that as physicians, when you are taking care of a patient, they 
age into Medicare, or your colleague asks you to see a new 
patient who is on Medicare. You think, this is a patient who 
needs me, not, is this patient going to pay their own way, 
because we know that they do not under Medicare.
    Senator Carper. All right.
    Yes? Is it Cullen or Cullens?
    Dr. Cullen. Cullen, thank you.
    Senator Carper. Hi, Dr. Cullen.
    Dr. Cullen. Family physicians, and it is well over 90 
percent, accept Medicare patients.
    Senator Carper. All right. Thank you.
    All right. Anybody else have anything else?
    Dr. Hines. I believe the number is 1.5 million physicians.
    Senator Carper. All right. Thank you. Are you rounding? 
[Laughter.] Okay. All right.
    A follow-up question: what can we on this side of the dais 
be doing in Congress to increase the number of physicians who 
are participating in these Alternative Payment Models, maybe 
more quickly and perhaps even more effectively?
    Dr. Hines. Sure. Maybe I can start with that.
    So I think the best way to do that is to promote APMs. I 
think that the APMS are the best way to move the health-care 
system toward value and away from a fee-for-service system that 
really incentivizes transactional-based care.
    And in order to promote APMs, we need to eliminate the 
thresholds that are preventing many groups from being able to 
become APMs. We need to make the 5-percent Advanced APM bonus 
permanent so that groups have the dependable revenue to be able 
to invest in the personnel, resources, and technology to 
succeed under value, such as the chronic care point guard that 
Senator Wyden was mentioning.
    And also, we need to make sure that we synchronize the 
rules across all of the different ACO programs so that when 
folks learn how to take risk on an upside-only program, those 
same rules apply to the downside risk as well, so you are not 
learning under one set of rules and then performing under 
another.
    Senator Carper. I am not going to ask everybody to go--
anybody agree with anything that he just said?
    Go ahead, Dr. Cullen.
    Dr. Cullen. I think the other thing is that it would be 
better to roll out these programs more quickly and also have 
them available in more geographic areas. One of the problems 
with the rollouts in the past is that they have been actually 
very small areas, and so large parts of the country have not 
been able to take part in any kind of APM, much less an 
Advanced Alternative Payment Model.
    I think that if we could rapidly ramp up those and expand 
them to more geographic areas, that would be useful.
    Senator Carper. Thank you. I appreciate it.
    Dr. Opelka. So thank you very much. For us--as the American 
College of Surgeons--when we look at this, we have been trying 
to actually fit something into a payment model. And what we 
really need to do is define the value of care we want--trauma 
care or cancer care--and then for that value of care, what are 
the elements that we need to afford it? And then, how do we put 
that into a risk model that has asymmetric risks, where there 
is more incentive to take the risk and there is less risk that 
you will go bankrupt if you take that risk? But you need upside 
and downside risk.
    Senator Carper. One last quick question, and that is, what 
Alternative Payment Models are best suited for improving end-
of-life care and treatment for opioid addictions? Any thoughts?
    Dr. Hines. So, perhaps on the end-of-life care, Crystal Run 
Healthcare is involved in the oncology care model. And one of 
the things that we have learned in that model is that we are 
significantly underutilizing end-of-life care.
    And we have really put together a team of experts within 
our organization to have those difficult conversations earlier, 
so that less futile care is provided and less patients are 
dying in ICUs, but rather dying at home with their family 
around them.
    And it is really an opportunity to participate in these 
programs that allows you to see what your data is around that 
and how you can do a better job for your patients and your 
population.
    Senator Carper. Dr. Cullen again--go ahead, ma'am.
    Dr. McAneny. Thank you. I am a medical oncologist, and I am 
participating in that. We also have an oncology medical home 
process as an Innovation Center award. And what we found was 
that, when patients know that you are there for them all the 
way through the course of their illness, and you have that 
continuity of care--and basically oncologists function as the 
primary care doctor for the subset of patients with cancer--
then they trust us.
    And as a byproduct of saving money by keeping them out of 
the hospital and offering those things, we saved a significant 
amount of money on end-of-life care because of the trust and 
the relationship that was established. So I think that is a 
very important part.
    The opioid issue, you know, to have that requires an entire 
team-based effort as well, and I think that is part of the new 
primary care models that are coming out. I will defer that to 
Dr. Cullen.
    Senator Carper. All right. Thanks.
    Dr. Cullen, my time has expired. I am going to ask you to 
respond for the record, if you would.
    And thank you all very much for being here and for your 
testimony. Thanks.
    Senator Wyden [presiding]. Okay.
    I have a question, and then I want to make sure that all 
the bipartisan staff are acceptable with our wrapping up.
    Apropos of rural areas--and this has been a great interest 
of the chairman, of myself, of many Republicans and many 
Democrats. We have a question about how these rural areas are 
going to fit with respect to innovative payment models. In 
other words, everybody talks about them. This is practically a 
gospel of health-care policy. You have a lot of Senators here, 
as I said, both sides of the aisle, who care deeply about small 
practices, rural areas, underserved areas, and we are trying to 
figure out how they are going to fit in this brave new world.
    So I am going to allow any of you to comment on it. And 
then I would like to ask the staffs on both the Democratic side 
and Republican staff to make sure that they are okay after this 
with their members wrapping up, okay?
    Yes, Dr. Cullen?
    Dr. Cullen. So I think the most important thing is making 
sure that these Alternative Payment Models pay adequately for 
the physicians to stay in business, because that is one of the 
big issues. A lot of practices are really at the margins for 
survivability.
    I really am very in favor of Alternative Payment Models. I 
am very excited about the possibility of trying it, but it is 
going to be the--you know, the devil is in the details. It is 
how much is actually going to be part of the prospective 
payment that I think is going to be--and what is going to be 
upside and downside risk is going to be the real key.
    Senator Wyden. Any others? Dr. McAneny?
    Dr. McAneny. Thank you.
    So I think there are several things that can be done for 
this. First, when a small community of physicians wants to get 
together and try to provide services that are less expensive 
and more timely delivered, they are impeded by the Stark and 
anti-kickback rules. They cannot get together and say, ``Gee, 
if we as a group purchased a scanner, we could charge a third 
of what is charged at the local hospital.'' And they cannot get 
together to do those kinds of things. So adjusting the Stark 
and anti-kickback rules would help immensely.
    To recognize that the rural areas often have more of the 
social determinants of health in terms of food insecurity and 
housing insecurity, et cetera, is something that needs to be 
accounted for in the attribution. That may be a part of why a 
lot of rural areas score lower in terms of their hospital 
quality and physician quality, because the social determinants 
are such a major input.
    Then stability and some up-front payments--it takes, 
basically, money to invest in creating a new delivery system, 
to hire a new nurse to do the patient education that is needed 
or the outreach to find that patient who needs an intervention. 
And without the up-front, firm commitment to increased 
resources, you cannot guarantee someone that they will be able 
to do that.
    And third, the other impediment is the data. When we get 
data from CMS, it is a year or a year and a half later. It is 
aggregated data. It is impossible to manage that data in a way 
that I can figure out what I could do differently in my 
practice today so that my next reports come out better. And 
simplifying and clarifying the data that is delivered from CMS 
and making it happen in a more timely manner, would be great.
    And stabilizing the payment system--if you do not know that 
your practice is going to be there next year, it is hard to 
spend a lot of money worrying about innovation.
    Senator Wyden. Anybody else? And then we will probably wrap 
up. Yes?
    Dr. Fiedler. I think there are opportunities to think about 
how we improve measurement in ways to make sure that providers 
in rural areas are being compared against providers that are 
providing care in similar circumstances. So you could think 
about approaches that would compare providers against either 
other providers in their own region, or other providers in 
geographically similar regions.
    The various ACO programs have taken steps in that 
direction, but I think there are opportunities to go further 
beyond ACOs.
    Senator Wyden. This would be another area where I think it 
would be very helpful for you all to use the time the chairman 
allows to get us any responses in writing on this. You know, 
there is no question with respect to, sort of, the nuts and 
bolts of getting from here to there. In other words, you do not 
quickly move a $3.5-trillion health-care system, which, as we 
know, has given short shrift to rural America in many respects 
like this.
    So I am very sympathetic to these kinds of transition 
areas. It is like, Dr. Cullen, when I talked to you about the 
CHRONIC Care bill, we never announced that the legislation was 
the end of the debate. We said, ``This is the beginning. This 
is the beginning.''
    And Robert Pear, on this sad day, was the guy who figured 
that out. So your ideas are welcome. You have Democrats and 
Republicans here aligned with you.
    As you can tell, the members are just juggling. And on 
behalf of the chairman, we just want to say ``thank you'' to 
all of you for your participation. It is hard to get to 
Washington, and the chairman wants to make it clear that he 
appreciates everybody's expertise and coming.
    And on behalf of him, I would ask that any member who 
wishes to submit questions for the record to the Finance 
Committee, please do so by close of business on Wednesday, May 
22nd. And as we have indicated, there is a lot of interest in 
rural health care.
    And chronic care is almost my passion now, because I think 
this is the future of health care. And this committee figured 
that out. So we really thank all of you.
    And with that--and I want to check with both the Republican 
and the Democratic side--I believe that there is a consensus, 
because of the schedule, that we are going to wrap up. And with 
that, the hearing is adjourned.
    [Whereupon, at 11:24 p.m., the hearing was concluded.]

                            A P P E N D I X

              Additional Material Submitted for the Record

                              ----------                              


          Prepared Statement of John S. Cullen, M.D., FAAFP, 
            President, American Academy of Family Physicians
    The American Academy of Family Physicians (AAFP) represents 134,600 
physicians and medical students nationwide. Family physicians conduct 
approximately one in five of the total medical office visits in the 
United States per year--more than any other specialty. They delivery 
care in more than 90 percent of U.S. counties--in frontier, rural, 
suburban and urban areas. They practice in a variety of professional 
arrangements, including privately owned solo practices as well as large 
multi-specialty integrated systems and public health agencies.

    Family physicians provide comprehensive, evidence-based, and cost-
effective primary care dedicated to improving the health of patients, 
families, and communities. Family medicine's cornerstone is an ongoing 
and personal patient-physician relationship where the family physician 
serves as the hub of each patient's integrated care team. More 
Americans depend on family physicians than on any other medical 
specialty.

    The Medicare Access and CHIP Reauthorization Act (MACRA) created a 
major shift in how Medicare compensates physicians for their 
professional services. Congress passed MACRA to move the Medicare 
program away from a system that rewarded volume toward one that 
supports value. Family physicians continue to be among the most 
committed physicians to value-based care and payment--and transitioning 
away from fee-for-service. Our most recent annual survey of members 
found that:

          41 percent practice in Patient-Centered Medical Homes 
        (PCMHs),
          54 percent are in value-based payment models or contracts,
          38 percent of CPC+ participants are AAFP members, and
          Of physicians choosing to practice in an ACO, more than half 
        are in the Medicare Shared Savings program (55 percent).

    Our recommendations on what is working under MACRA--and what must 
be improved--are based on these collective experiences.
                             what's working
    The AAFP continues to support MACRA, most notably because it 
repealed the flawed sustainable growth rate formula, but also because 
emerging alternative payment models catalyzed by MACRA place greater 
emphasis on investments in family medicine and primary care. Fee-for-
service payment is a barrier to many aspects of primary care 
transformation and the kind of primary care-based health system this 
country needs and deserves. The AAFP remains pleased that MACRA places 
a priority on the transition of physician practices from the legacy 
fee-for-service payment model toward alternative payment models that 
promote improved quality and efficiency.

    Through the creation of the Advanced Alternative Payment Model 
pathway, MACRA created an opportunity for physicians to pursue non-fee-
for-service payment. MACRA also created an opportunity for physicians 
to create and propose alternative payment models through the Physician-
Focused Payment Model Technical Advisory Committee (PTAC). The AAFP was 
one of the first organizations to successfully submit a model through 
the PTAC. The AAFP's Advanced Primary Care Alternative Payment Model 
was approved by the PTAC in December 2017, receiving one of the 
strongest recommendations by the PTAC to date. The AAFP remains fully 
supportive of the PTAC's role in evaluating physician-focused payment 
models.

    On April 22nd, the AAFP was pleased to join a CMS Innovation Center 
discussion on primary care. For more than 20 years, the AAFP and our 
primary care colleagues have worked to create a delivery system that 
encourages innovation in primary care delivery and rewards 
comprehensive, continuous, patient-centered care rather than single 
episodes of care. Throughout this time, the AAFP has provided family 
medicine's perspective and input. That effort is ongoing, and we 
continue to work with CMS and the Innovation Center to build a stronger 
foundation for primary care that is patient-centered and focused on 
value and outcomes. The announcement of the Primary Cares Initiative, 
which contains five new models, is a critical step toward recognizing 
the importance of primary care by developing payment models that value 
primary care. We applaud the introduction of new primary care delivery 
and payment models, and we look forward to working with CMS and CMMI on 
testing and developing these models so they are available, attractive 
and workable for all primary care practices, including those that are 
small and/or rural.

    While MACRA's framework is still the right approach, operational 
challenges persist especially for family physicians participating in 
the intricate fee-for-service-based MIPS program.
                           what's not working
    Our recommendations focus on five main issues:

        1.  Correcting the undervaluation of fee-for-service payment 
        for primary care.

        2.  Reducing the complexity in MIPS scoring.

        3.  Eliminating the MIPS APM category.

        4.  Extending the Advanced APM bonus.

        5.  Creating a culture focused on patient care.
(1) Correcting the Undervaluation of Fee-for-Service Payment for 
        Primary Care
    Even though AAFP supports movement away from fee-for-service 
models, the fee schedule is still a critical component of physician 
payment and will continue to be the foundation for future payment. 
Congress should direct CMS to aggressively address inequities in the 
Medicare fee schedule that undervalue primary care services--especially 
the office-based evaluation and management (E/M) codes for new and 
established patients. The MACRA Quality Payment Program (QPP) 
perpetuates the undervaluation of primary care services in the fee 
schedule as part of MIPS. To the extent advanced alternative payment 
models (AAPMs) rely on current relative values assigned to primary care 
services under the fee schedule, the AAPM track of QPP also perpetuates 
these longstanding imbalances in Medicare physician payments.

    Specifically, Congress should urge CMS to increase the relative 
value of ambulatory E/M and other primary care services to rebalance 
the Medicare physician fee schedule. This is not just an AAFP 
perspective. It's also the perspective of Congress's own advisors, the 
Medicare Payment Advisory Commission (MedPAC). In its June 2018 report 
to the Congress, MedPAC stated:

        Ambulatory evaluation and management (E&M) services . . . are 
        essential for a high-quality, coordinated health care delivery 
        system. These visits enable clinicians to diagnose and manage 
        patients' chronic conditions, treat acute illnesses, develop 
        care plans, coordinate care across providers and settings, and 
        discuss patients' preferences. E&M services are critical for 
        both primary care and specialty care. The Commission is 
        concerned that these services are underpriced in the fee 
        schedule for physicians and other health professionals (``the 
        fee schedule'') relative to other services, such as procedures. 
        This mispricing may lead to problems with beneficiary access to 
        these services and, over the longer term, may even influence 
        the pipeline of physicians in specialties that tend to provide 
        a large share of E&M services.\1\
---------------------------------------------------------------------------
    \1\ Medicare Payment Advisory Commission. June 2018 Report to the 
Congress: Medicare and the Health Care Delivery System. P. 65. http://
www.medpac.gov/docs/default-source/reports/
jun18_ch3_medpacreport_sec.pdf?sfvrsn=0. Accessed February 6, 2019.

    We share MedPAC's concern, and like MedPAC, we believe CMS should 
use a budget-neutral approach that would increase payment rates for 
ambulatory E/M services while reducing payment rates for other services 
(e.g., procedures, imaging, and tests). Primary care services must be 
held harmless from any necessary budget-neutrality adjustments 
resulting from an increase in the relative value of primary care 
services. Otherwise, the positive impact of those increases will be 
diluted. Thus such budget neutrality should not occur by adjusting the 
conversion factor but rather reducing the payment rates for non-E/M 
services.
(2) Reducing MIPS Scoring Complexity
    The implementation of MIPS has created a burdensome and extremely 
complex program. Primary care practices' main priority is to remain 
singularly focused on delivering high-quality patient care. However, 
understanding the requirements and scoring for each performance 
category and reporting data to CMS is a complex task and detracts from 
primary care practices' ability to focus on patients. Unfortunately, 
CMS continues to struggle to provide timely and clinically actionable 
data because the MIPS cost category measures are flawed and hold 
primary care physicians more accountable for total cost of care than 
other sub-specialties. We urge Congress to extend CMS's authority to 
weigh the MIPS cost category below 30 percent to allow time to overhaul 
existing measures.

    One of the more concerning portions of MIPS is the Promoting 
Interoperability (PI) category. CMS is hamstrung in PI since the agency 
is bound to Meaningful Use requirements by legislation, including both 
the American Recovery and Reinvestment Act and the Affordable Care Act. 
The AAFP calls on Congress to repeal Meaningful Use requirements and 
allow HHS to remove these requirements from the PI category. We are 
pleased that HHS is pursuing interoperability and stopping information 
blocking through rulemaking and are preparing extensive comments, due 
in early June.

    While the AAFP appreciates the efforts to simplify the PI category, 
we remain extremely concerned and adamantly opposed to the ``all or 
nothing'' nature of the category. CMS believes the category is not 
``all or nothing,'' as an eligible clinician can submit a numerator as 
low as one. However, failure to report one measure results in a 
category score of zero. For all intents and purposes, this is an ``all 
or nothing'' structure.

    CMS should eliminate health IT utilization measures and remove any 
required measures and provide eligible clinicians the flexibility to 
select measures relevant to their practice. All measures within the 
promoting interoperability category should be attestation-based.

    Congress and CMS should work together to improve the implementation 
of the PI category by removing legislative barriers that restrain and 
complicate the category. Congress should encourage CMS to simplify the 
scoring, remove health IT utilization measures and the ``all or 
nothing'' requirement, and hold Health IT vendors accountable for 
interoperability before measuring physicians on EHR use.

    The AAFP is supportive of the industry's move to 2015 edition 
CEHRT. Yet, we have concerns with it being mandated for eligible 
clinicians (ECs). We must also realize that adopting a 2015 edition 
CEHRT does not mean that a practice or hospital will be interoperable. 
Mandates are more beneficial to health information technology (IT) 
developers than to ECs. Mandates relieve market pressures to lower the 
cost of upgrades and increase the value of upgraded versions. The cost 
of EHRs continues to rise, whereas IT cost in every other industry has 
decreased. We strongly encourage CMS to not mandate 2015 edition CEHRT, 
but rather incentivize its adoption through scoring, which benefits 
2015 edition CEHRT users.

    In a letter the AAFP sent HHS early this year, we discussed how 
Health IT and EHR vendors should be more fully regulated to address 
mal-aligned and self-serving behaviors by these vendors. An HHS draft 
report laid out a set of strategies and recommendations and the AAFP 
was largely supportive of them. However, the AAFP strongly urges HHS to 
convert the ``could,'' ``should,'' and ``encourage'' language in the 
report into required actions. Compliance with these mandates by vendors 
will significantly decrease the administrative burdens of physicians. 
It is time for them to be mandates and not suggestions.

    Congress should guide CMS to reduce the complexity and 
administrative burden of MIPS. CMS could accomplish this by providing 
cross-category credit for measures and activities that span multiple 
performance categories. We believe an updated architecture where 
reporting once and receiving credit in multiple categories could 
alleviate significant burden from practices and allow them to focus 
their efforts on better patient care.
(3) Eliminating the MIPS APM Category
    The AAFP remains quite concerned with the MIPS APM option created 
by CMS but not referenced in MACRA's statutory language. The AAFP is 
concerned eligible clinicians may intentionally remain in MIPS APMs, 
given the scoring advantage they have been given, instead of 
progressing toward advanced APMs, which was the congressional intent 
behind MACRA.

    By remaining in MIPS, MIPS APMs will skew the MIPS performance 
threshold. This is already apparent in the 2017 performance period, 
where the performance threshold was three and the exceptional 
performance threshold was 70. MIPS APMs tend to be larger practices 
that are part of an accountable care organization (ACO), which has the 
resources and technology to better support their MIPS participation. In 
the 2017 Quality Payment Program (QPP) Reporting Experience report 
published by CMS, MIPS APMs had a mean final score of 87.64 and median 
final score of 91.76. The MIPS APM final scores are higher than the 
national mean and median final scores which were 74.01 and 88.97. Even 
more disconcerting is the difference between MIPS APM scores and scores 
of small and rural practices. The mean and median final scores for 
small practices were 43.46 and 37.67, respectively. This is a 
significant discrepancy that favors MIPS APMs and compromises the 
integrity of the program.
(4) Extending the Advanced APM Bonus
    Given the limited availability of AAPMs to date, we strongly urge 
Congress to extend the 5 percent Advanced APM bonus for three to 5 
years beyond the current statutory restriction and include language 
giving the Secretary of HHS discretion to extend the bonus further.
(5) Creating a culture focused on patient care
    Feedback we have received is that most family physicians, 
especially those in independent practices, believe that the MIPS 
program has a net-negative impact on their practices. While comfort 
with the existing fee-for-service system may play a role, the feedback 
we have received from family physicians, based on analysis of their 
practice trends, suggest that the MIPS program requirements place 
economic strains on their practices.

    The AAFP strongly supports streamlining MIPS documentation 
requirements and reducing administrative burden in all health care 
programs--both public and private. One of the most onerous 
administrative burdens is prior authorization, which tops the list of 
physician complaints on administrative burden. This uncompensated work 
for physicians and staff translates into increased overhead costs for 
practices, disrupts workflows, and results in inefficiencies and 
reduction in time spent with patients. According to AMA data, 
interactions with insurers cost $82,975 annually per physician. 
Exacerbating this is most family physicians in private practice have 
contractual relationships with seven or more health insurance plans, 
including Medicare and Medicaid. In coalition with 16 other medical 
organizations, the AAFP has called for the reform of prior 
authorization and utilization management requirements that impede 
patient care in Prior Authorization and Utilization Management Reform 
Principles. In addition, the AAFP has published, Principles for 
Administrative Simplification, calling for an immediate reduction in 
the regulatory and administrative requirements family physicians and 
practices must comply with daily.

    Quality measure reporting is another source of administrative 
burden for physicians and their practices. According to a study 
discussed in Health Affairs, physician practices spend, on average, 785 
hours per physician and more than $15.4 billion annually to report 
quality measures. Quality reporting takes considerable time away from 
patient care while causing a considerable financial strain on 
practices, particularly those that are small and/or rural.

    The AAFP strongly supports the CMS Patients Over Paperwork 
initiative but believes more must be done to improve patient care 
within the MIPS program by reducing administrative burdens. So that 
family physicians can devote more time to patient care, we urge 
Congress to influence action by all payers to reduce the administrative 
complexity so that physicians can more fully focus on patient care.
                       additional recommendations
    The AAFP makes the following recommendations to improve Medicare 
payment systems:

        1.  Congress should extend the 0.5-percent baseline conversion 
        factor update until 2026. Doing so would help mitigate budget-
        neutrality cuts required by separate laws such as the 
        Protecting Access to Medicare Act (PAMA) and help adjust for 
        inflation. This rate of increase does not match increase in 
        cost or inflation, but it does provide a minimum level of 
        economic growth.

        2.  Congress should encourage CMS to continue to focus on 
        outcomes and 
        patient-reported outcome measures that are more impactful for a 
        practice and for patients.

        3.  The AAFP asks Congress to reimagine how the exceptional 
        performance positive payment adjustments are applied to reward 
        practices that achieve significant year-over-year improvement 
        versus rewarding those practices at the upper levels of annual 
        performance. In 2019, practices that achieve a final score of 
        75 points are eligible for up to an additional 10 percent 
        positive payment adjustment. While we applaud these high-
        performing practices, it is our belief that additional positive 
        payment adjustments would be better used if they were focused 
        on rewarding the hard work of practices that achieve year-over-
        year improvements.

                               conclusion

    Once again, thank you for the opportunity to discuss with this 
committee the impact of MACRA on family physicians and its potential to 
build a patient-focused health care delivery system built upon a well-
resourced foundation of primary care.

                                 ______
                                 
   Questions Submitted for the Record to John S. Cullen, M.D., FAAFP
                Questions Submitted by Hon. Rob Portman
    Question. I introduced the Medicare Care Coordination Improvement 
Act with Senator Bennet in an effort to reduce some of the barriers 
that providers face when they participate in Alternative Payment 
Models. However, one particular section of my bill focuses on providing 
temporary waivers to practices that are interested in testing their own 
APMs. HHS has been slow to take up new APM concepts, and thus: what can 
we do to incentivize the establishment of new APMs? Has the PTAC 
offered a viable way to propose and test new APMs? If not, what actions 
could be taken to encourage the adoption of PTAC models?

    Answer. Establishing New and Increasing Participation in APMs: The 
AAFP is committed to transforming the Medicare program into one that 
prioritizes the delivery of high-quality, patient-centered, and 
efficient care. As we have previously stated, and literature supports, 
achieving meaningful transformation of our health-care system starts 
with creating a system foundational in primary care--and increased 
investment in primary care to sustain the transformation. 
Unfortunately, a recently released RAND study estimated that only 2-5 
percent of Medicare spending is on primary care. This is despite the 
growing evidence on the positive impacts of primary care on quality, 
lower rates of mortality and overall system spending.

    As a result, we recommend that Congress require CMS to establish 
APMs that significantly increase investments in primary care--andexpand 
existing APMs, such as CPC+ to encourage greater participation among 
primary care practices. AAFP would welcome the opportunity to work with 
Senators and the committee to develop proposals to accomplish these 
objectives.

    Reevaluation of Primary Care Payments in Medicare: The AAFP also 
recommends that the committee support revaluation of ambulatory E&M 
services, which is critical to move physicians into value-based, 
Advanced Alternative Payment Models (AAPMs). As MedPAC observed in its 
June 2018 report, all Advanced APM models use fee-for-service payment 
rates as either the basis of payment or the reference price for setting 
the global or bundled payment amount. If the actuarial basis for E&M 
payment alternatives is the relative values currently assigned to E&M 
services under fee-for-service, then the foundation of the 
corresponding Advanced APM is fundamentally flawed and will undermine 
efforts to create viable APMs for primary care to participate in.

    Like MedPAC, we believe CMS should use a budget-neutral approach 
that would increase payment rates for ambulatory E/M services while 
reducing payment rates for other services (e.g., procedures, imaging, 
and tests). Thus, the committee should support the revaluation of 
ambulatory E&M codes to ensure CMS succeeds in moving physicians into 
value-based, APMs.

    Another way Congress could promote the adoption of APMs is to 
address low Medicaid physician payment rates which have historically 
created a barrier to health-care access for Medicaid enrollees. AAFP 
policy \1\ supports Medicaid payment for primary care services at least 
equal to Medicare's payment rate for those services when provided by a 
primary care physician. Accordingly, we urge Congress to resume Federal 
primary-care payment policy previously found in Medicaid--SSA 
1902(a)(13)(C) and provide Federal funding to ensure a floor of 
Medicare payment rates for primary care services in Medicaid.
---------------------------------------------------------------------------
    \1\ https://www.aafp.org/about/policies/all/medicaid-
principles.html.

    Physician-Focused Payment Model Technical Advisory Committee 
(PTAC): Through the creation of the Advanced APM pathway, MACRA created 
an opportunity for physicians to pursue non-fee-for-service payment. 
MACRA also created an opportunity for physicians to create and propose 
alternative payment models through the Physician-Focused Payment Model 
Technical Advisory Committee (PTAC). The AAFP was one of the first 
organizations to successfully submit a model through the PTAC. The 
AAFP's Advanced Primary Care Alternative Payment Model was approved by 
the PTAC in December 2017, receiving one of the strongest 
recommendations by the PTAC to date. Following approval of the APC-APM, 
the AAFP worked with CMS and the Innovation Center to inform the design 
of the Primary Care First (PCF) model--but unfortunately as currently 
designed it does not in our view represent an increased investment in 
primary care as proposed in the AAFP's APC-APM PTAC approved APM model. 
We continue to advocate for improvements to the model to better align 
with the AAFP's APC-APM proposal. The AAFP remains fully supportive of 
---------------------------------------------------------------------------
the PTAC's role in evaluating physician-focused payment models.

    Question. Per data from CMS, about half of all Medicare providers 
are participating in MIPS, with the majority of these non-participating 
providers being exempt via the low-volume threshold. While we don't 
want to place additional burdens on small and rural providers, we 
should be identifying ways to engage with these practices to help them 
transition towards value-based outcomes.

    What actions should be taken to engage with these providers?

    Answer. Burden of Reporting for Small Practices: The current MIPS 
reporting requirements necessitate an expanded human and technological 
infrastructure that many practices cannot afford, including most small 
rural practices. In the AAFP's 2017 Value-based Payment Study, 70 
percent of respondents indicated lack of staff time as a barrier to 
implementing value-based care, while 41 percent indicated the financial 
investment required for health information technology (HIT) is a 
barrier. Among practice owners, 74 percent cite lack of staff time and 
52 percent cite financial investment as barriers to implementing value-
based care. Further, CMS continues to change program requirements, 
which makes compliance a moving target. Rural practices do not have the 
resources to dedicate staff solely to MIPS reporting as their staff is 
primarily involved in patient care. To reduce reporting burden for all 
MIPS clinicians, Congress should allow CMS to provide scoring 
flexibility through multi-category credit. The AAFP's written testimony 
provides additional details on how this could be implemented.

    There should be a single set of performance measures across all 
payers that are universal, meet the highest standards of validity, 
reliability, feasibility, importance, and risk adjustment. The measures 
should focus on outcomes that matter most to patients and that have the 
greatest overall impact on better health of the population, better 
health care, and lower costs.

    Measures of performance should be derived from data that are 
extracted from multiple data sources rather than self-reported by 
physicians and their teams. Self-reported data are seldom validated for 
accuracy, reliability, missing data, coding variation, and application 
of measure specifications. Elimination of self-reporting will end 
current financial penalties for non-reporting that disproportionately 
impact small practices. Data extraction will reduce administrative 
burden and resolve comparability problems in performance data submitted 
through various mechanisms. Health IT advancements are needed, but 
physicians cannot be expected to continue bearing the burden of data 
collection and reporting while awaiting technological solutions.

    Process measures that rely on self-measurement are best used for 
internal quality improvement efforts to drive changes and improvements 
to achieve higher level outcomes.

    Performance measures should be applied at a system level, as on 
their own individual health-care professional have limited ability to 
drive outcomes and are constrained by the environment and systems in 
which they practice. Performance measures can identify gaps in services 
and outcomes at the entity, community, and population levels, and they 
can be used to direct allocation of public and private resources to 
address unmet needs. Such measures should lead to investment of 
resources to improve equity, access, and socioeconomic factors that 
impact health and health care.

    One of the more concerning portions of MIPS is the promoting 
interoperability (PI) category. CMS is hamstrung in PI since the agency 
is bound to Meaningful Use requirements by legislation, including both 
the American Recovery and Reinvestment Act and the Affordable Care Act. 
The AAFP calls on Congress to repeal Meaningful Use requirements and 
allow HHS to remove these requirements from the PI category.

    Congress and CMS should work together to improve the implementation 
of the PI category by removing legislative barriers that restrain and 
complicate the category. Congress should encourage CMS to simplify the 
scoring, remove health IT utilization measures and the ``all or 
nothing'' requirement, and hold health IT vendors accountable for 
interoperability before measuring physicians on EHR use.

    Electronic Health Records (EHRs) Continue to Pose Significant 
Challenges for Small and Rural Practices:\2\ With fewer resources 
available, some rural practices use less expensive EHRs that have 
limited capabilities, which can make interoperability significantly 
more difficult. Additionally, EHRs often lack adequate technical 
support or may charge for providing basic user support. CMS's mandate 
to implement 2015 Edition certified EHR technology requires additional 
financial investments and staff support further inflate the barriers to 
successful value-based payment participation for rural practices. The 
AAFP welcomes the opportunity to partner with the committee as it 
considers ways to boost clinically meaningful HIT use among small 
practices.
---------------------------------------------------------------------------
    \2\ https://www.gao.gov/assets/700/692179.pdf.

    Allow CMS to Set MIPS Performance Thresholds Based on Practice 
Size: Rural practices, particularly small rural practices, have unique 
challenges as compared to large practices in urban and suburban areas. 
Small, rural practices typically have fewer staff and limited resources 
to manage the Merit-based Incentive Payment System (MIPS) reporting 
requirements that otherwise burden all participants. The challenge to 
participate is demonstrated by the mean and median 2017 MIPS final 
scores for rural practices, which were 63 and 75 respectively. In 
contrast, MIPS Alternative Payment Model (APM) participants, which tend 
to be large practices, had a mean score of 88 and a median score of 92. 
To address this scoring and ultimate payment adjustment disparity, 
Congress should provide CMS additional flexibility to establish 
multiple performance thresholds for practices dependent on size. 
Separate performance thresholds would allow CMS to set thresholds that 
better reflect a practice's ability to meaningfully participate in 
MIPS--potentially narrowing the gap between small and large practices 
and facilitating a move to practice accountability. An inflated 
performance threshold will disproportionately reward large practices 
with more resources while effectively punishing small and rural 
practices that have fewer resources. Without an attainable performance 
threshold for small and rural practices, the program's goal to move 
---------------------------------------------------------------------------
practices to performance accountability is diminished.

    Accommodations for Higher Rural Practice Costs: Rural areas also 
tend to have fewer sub-specialists, resulting in rural patients 
receiving nearly all their health care from their primary care 
physician. When sub-specialists are available, there is a smaller 
network from which to choose. As a result, rural primary care practices 
could have higher costs as compared to urban and suburban practices 
with a larger referral network. Additionally, ensuring patients receive 
timely and appropriate preventive care is difficult for rural 
practices, as patients can be unwilling to travel long distances. 
Higher costs negatively impact rural practices' MIPS performance 
relative to their urban and suburban counterparts and makes them 
potentially less attractive to entities in Advanced Alternative Payment 
Models. Congress should extend CMS's authority to reweight the MIPS 
cost category until such time when valid and reliable cost measures are 
available for all eligible clinicians. The committee should consider 
ways to ensure the MIPS cost category fairly captures and represents 
the costs of care in rural areas where primary care physicians often 
provide a broad range of services to their communities.

                                 ______
                                 
                 Questions Submitted by Hon. Ron Wyden
    Question. The Independence at Home demonstration, which was 
expanded and extended last year through the CHRONIC Care Act, enables 
care teams to deliver high-quality primary care to Medicare 
beneficiaries in the comfort of their own homes. In its third 
performance year, according to the Centers for Medicare and Medicaid 
Services (CMS), Independence at Home saved $16.3 million for the 
Medicare program.\3\ A recent evaluation also found that Independence 
at Home has resulted in fewer emergency department visits leading to 
hospitalization, a lower proportion of beneficiaries with at least one 
unplanned hospital readmission during the year, and a reduced number of 
preventable hospital admissions.\4\ As I mentioned at the hearing, I am 
committed to building on the success of the Independence at Home 
demonstration. As discussed at the hearing, I understand that the new 
Primary Care First model recently announced by CMMI (the Center for 
Medicare and Medicaid Innovation at CMS) may provide an avenue to 
expand access to home-based primary care for more Medicare 
beneficiaries.
---------------------------------------------------------------------------
    \3\ https://innovation.cms.gov/Files/fact-sheet/iah-yr3-fs.pdf.
    \4\ https://innovation.cms.gov/Files/reports/iah-rtc.pdf.

    Based on your members' experience in Independence at Home and other 
Alternative Payment Models, what key components will be necessary in 
order for the Primary Care First model to expand access to home-based 
---------------------------------------------------------------------------
primary care?

    Answer. Home Based Primary Care (HBPC) provides value for 
chronically ill, medically complex, homebound patients in terms of 
quality and overall cost reduction. Payment reform and new models of 
care (including Primary Care First and Direct Contracting) are 
supportive of HBPC. Despite this, attempting to do HBPC as a solo/
independent provider is challenging due to factors such as call 
rotation, establishing/training a care team, community outreach/
referral, uninsured patients, and reduced patient volume. HBPC depends 
on ACO-type goals that allow investment in programs that lead to 
overall reduction in health system costs.

    To expand access to home-based primary care, Medicare payment must 
be based on continuing, comprehensive care and should encourage 
treatment on an ambulatory basis rather than in a costly institutional 
setting. The AAFP advocates for efforts to align payment policies for 
physicians in independent practice with those owned by hospitals. The 
AAFP encourages consideration of site-of-service payment parity polices 
from a broad perspective. Namely, CMS should not pay more for the same 
services in the inpatient, outpatient, or ambulatory surgical center 
setting than in the physician office setting. The AAFP calls for 
incentives for services to be performed in the most cost-effective 
location, such as a physician's office. The AAFP considers the 
artificial distinction between ``inpatient,'' ``outpatient,'' and other 
sites of service as a product of the equally artificial distinction 
between Medicare's Part A and Part B. The AAFP calls for policies that 
progress beyond this silo mentality and instead pay for health-care 
services in a more consistent and equitable manner.

    The AAFP also encourages alignment between alternative payment 
models and the benefit enhancements and payment waivers offered. 
Waivers that would facilitate cost effective home-based primary care 
include the Telehealth Expansion Waiver, Post-Discharge Home Visits 
Rule Waiver, and Care Management Home Visits Rule Waiver. We also 
recommend exploring other waivers that reduce barriers to home-based 
primary care, like extending the ability to certify a patient's 
eligibility for home health services to other members of the care team 
and allowing home health services to be offered to patients who do not 
meet the definition of ``homebound'' but would otherwise benefit from 
receiving some or all of their health care at home.

    Question. What other specific policies would you recommend Congress 
or CMS consider to expand access to home-based primary care for more 
Medicare beneficiaries?

    Answer. As stated above, Medicare payment must be based on 
continuing, comprehensive care and should encourage treatment on an 
ambulatory basis rather than in a costly institutional setting.

    Question. As I mentioned during the hearing, I often hear from 
seniors in Oregon that they don't feel like anyone is in charge of 
managing their health care and helping them navigate the health-care 
system. I am proud of the bipartisan work that this committee did on 
the CHRONIC Care Act last Congress to update the Medicare guarantee. In 
my view, the next step should be making sure that all Medicare 
beneficiaries with chronic illnesses have someone running point on 
their health care--in other words, a chronic care point guard--
regardless of whether they get their care through Medicare Advantage 
(MA), an Accountable Care Organization (ACO) or other Alternative 
Payment Model, or traditional fee-for-service Medicare.

    For beneficiaries in traditional, fee-for-service Medicare, what 
can be done to improve care coordination and make sure their physicians 
and other health-care professionals are all talking to each other and 
working together to provide the best possible care to those 
beneficiaries? What specific policies would you recommend this 
committee pursue toward that end?

    Answer. Data Sharing/EHRs: Family physicians, above all else, seek 
to protect the well-being and health of their patients. Increasingly in 
today's health-care landscape, primary care physicians are accountable 
for safe and effective coordination of care and care management, as an 
integral component of routine business practices. The primary care 
physician should have access to information contained in a 
clearinghouse and be given data (treatment and diagnostic codes, dates, 
medications, provider name/contact information) on all procedures, 
treatments, and diagnoses billed by all other entities to enhance the 
ability of primary care to safely and effectively coordinate care and 
manage costs. This data should be in a standard form that is importable 
into the EHR without special effort by the primary care physician team.

    Patients value the ability to easily access all their health data 
in one place. Access to complete data improves patient ability to 
better engage in care which leads to better outcomes. Patients can be 
extremely effective partners in care coordination when they have easy 
access to all their data and are able to share it with all health-care 
professionals.

    Interoperability is a critical issue. Since Meaningful Use an 
appropriate growth in the exchange of health records occurred. 
Unfortunately, these records are merely in standard formats that allow 
data to be transmitted between EHR systems and not yet in forms that 
allow automated importing into the patient's record in the receiving 
EHR or for authorized applications to extract key patient data. The 
consequences create a tremendous amount of burden placed on the 
physician to scour information for buried key clinical information and 
then ``re-key'' that data into the patient's EHR. Without what is 
called semantic interoperability (i.e., shared meaning), this will 
continue to be a burden to physicians and create patient safety risk. 
While there are pockets of such importable data, there is not 
widespread or expansive in the types of clinical data covered. The AAFP 
believes that HHS has the authority needed to address the current 
issues through MACRA and the 21st Century Cures Act. We ask Congress to 
provide continued oversight of HHS's implementation of these laws.

    Payments for Care Management: Care coordination is also possible 
when practices have resources to support non-face-to-face care 
management. Primary care practices should receive care management fees 
or population-based payments that support consultations across 
providers. This includes reimbursement for non-face-to-face care 
management. The AAFP suggests Congress and CMS consider a care 
management fee or population-based payment for non-face-to-face care 
management that can support consultations and care coordination.

    Question. Please describe the specific steps that Congress and/or 
CMS could take to ensure all Medicare beneficiaries with chronic 
illnesses, including those in traditional fee-for-service Medicare, 
have a chronic care point guard.

    Answer. Access to Primary Care Physicians: All Medicare 
beneficiaries should be attributed to one primary care physician that 
agrees to be responsible for overall care. Waiving co-pays for seeing 
their primary care providers is essential to discourage patients from 
going directly to sub-specialist without seeking primary care first. 
Notification to the PCP of care provided by all other entities should 
be mandatory. Payers should be held accountable for making certain all 
their beneficiaries have a primary care physician that has agreed to be 
responsible for overall care.

    Congress and CMS should only allow physicians specifically trained 
for and skilled in comprehensive first contact and continuing care for 
persons with any undiagnosed sign, symptom, or health concern (the 
``undifferentiated'' patient) not limited by problem origin 
(biological, behavioral, or social), organ system, or diagnosis to bill 
services such as the Chronic Care Management (CCM) code. A primary care 
physician is a specialist in family medicine, internal medicine, or 
pediatrics who provides definitive care to the undifferentiated patient 
at the point of first contact and takes continuing responsibility for 
providing the comprehensive care to the patient. Such a physician must 
be specifically trained to provide comprehensive primary care services 
through residency or fellowship training in acute and chronic care 
settings. Physicians who are not trained in the primary care 
specialties of family medicine, general internal medicine, or general 
pediatrics, at times, may provide some primary care ``services'' that 
are similar to those usually delivered by primary care physicians--but 
this does not constitute primary care. These physicians may focus on 
specific patient care needs related to prevention, health maintenance, 
acute care, chronic care, or rehabilitation. These physicians, however, 
do not offer these services within the context of comprehensive, first 
contact, and continuing care.

    Further, we urge Congress to eliminate the applicability of 
deductible and co-
insurance requirements for the CCM codes. Eliminating CCM cost-sharing 
requirements would facilitate greater utilization of these codes and 
increase coordination of care for those beneficiaries with the greatest 
health-care needs.

    Access to Patient-Centered Medical Homes: In 2018, the AAFP Board 
of Directors approved the ``Health Care for All'' policy, which 
includes a number of guiding principles and considerations for health 
reform. One of these guiding principles is the establishment of a 
primary care-based health system, which include ensuring access to a 
primary care physician and a medical home for all Americans. In an 
annual \5\ review of evidence of the PCMH's impact on cost and quality, 
the Patient-Centered Primary Care Collaborative identifies several PCMH 
programs that have reduced costs and improved quality. Medical homes 
are associated with:
---------------------------------------------------------------------------
    \5\ https://www.pcpcc.org/sites/default/files/resources/
The%20Patient-Centered%20Medical%
20Home%27s%20Impact%20on%20Cost%20and%20Quality%2C%20Annual%20Review%20o
f%20
Evidence%2C%202014-2015.pdf.

          Better coordinated, more comprehensive, and personalized 
        care.
          Improved access to medical care and services.
          Improved health outcomes, especially for patients who have 
        chronic conditions.

    Payment Adjustments for the Social Determinants of Health: The AAFP 
policy on ``Advancing Health Equity: Principles to Address the Social 
Determinants of Health in Alternative Payment Models'' provides 
suggestions for how alternative payment models should account for SDoH 
in their payment methodologies and enable physician practices to 
overcome these barriers. We encourage policymakers to review this 
policy to create similar structures and incentives to motivate and 
enable practices to address social determinants of health.

    Question. Eligible clinicians who receive a certain percentage of 
their payments or see a certain percentage of their patients through 
Advanced APMs are excluded from MIPS and qualify for the 5 percent 
incentive payment for payment years 2019 through 2024. Starting this 
year (performance year 2019), eligible clinicians may also become 
qualifying APM participants (and thus qualify for incentive payments in 
2021) based in part on participation in Other Payer Advanced APMs 
developed by non-Medicare payers, such as private insurers, including 
Medicare Advantage plans, or State Medicaid programs.

    Recognizing that this is the first year in which the All-Payer 
Combination Option is available, how many of your members do you 
anticipate will take advantage of the All-Payer Combination Option this 
year?

    Answer. The AAFP is supportive of the All-Payer Combination Option 
but has not heard substantial feedback from members on it.

    Question. What, if any, challenges have your members faced when 
attempting to take advantage of the All-Payer Combination Option?

    Answer. The AAFP believes the onus of submitting relevant 
information on payer arrangements should fall to the payers. This is 
currently voluntary for payers. While the AAFP believes payers should 
be responsible for submitting information to CMS, we have heard from 
payers that the process is complicated and burdensome.

    We encourage Congress to reduce the qualifying participant 
thresholds since there currently are not many APMs and strongly urge 
Congress to extend the 5-percent Advanced APM bonus for 3 to 5 years 
beyond the current statutory restriction and include language giving 
the Secretary of HHS discretion to extend the bonus further.

    We anticipate challenges in reporting performance data because 
measures are not aligned among payers. Please see our comments above 
regarding the need for a single set of performance measures that are 
universal, meet the highest standards of validity, reliability, 
feasibility, importance, and risk-adjustment. The measures should focus 
on outcomes that matter most to patients and that have the greatest 
overall impact on better health of the population, better health care, 
and lower costs. Measures of performance should be derived from data 
that are extracted from multiple data sources rather than self-reported 
by physicians and their teams.

    Question. In the Medicare Access and CHIP Reauthorization Act of 
2015 (MACRA), Congress provided a total of $100 million over 5 years 
for technical assistance to MIPS-eligible clinicians in practices with 
15 or fewer clinicians, focusing on rural and health professional 
shortage areas.

    To what extent have your members utilized the services of the 
Small, Underserved and Rural Support Initiative, which CMS launched 
using the MACRA funding to provide free, customized technical 
assistance to clinicians in small practices?

    Answer. We promote to our members CMS education services as well as 
AAFP education opportunities. The AAFP encourages Congress to provide 
additional funds for technical assistance and use the $500M bonus pool 
to support small practice transformation.

    Question. What types of technical assistance and support have been 
most helpful to physicians and practices (e.g., understanding program 
requirements, selecting appropriate measures, forming virtual groups)?

    Answer. Congress provided technical assistance funds for CMS to 
support practices in MIPS. CMS created the Small, Rural, and 
Underserved Support (SURS). While these organizations have been 
helpful, they are unable to provide the in-depth and individualized 
support many small and rural practices need. The services provided \6\ 
vary by each organization and may not be available to all practices. 
Additionally, the organizations can provide technical support, but they 
do not provide any financial or permanent human resources for 
practices. Stakeholders interviewed for a recent RAND report \7\ felt 
the QPP support is able to provide high-level support, but much of the 
work cannot be done by outside contractors or office managers. 
Stakeholders also reported that the support providers sometimes lacked 
knowledge in certain areas or were unable to get answers from CMS to 
specific questions. Specifically, funds are needed to pay for IT 
support specific to individual users. Technical assistance providers 
lack specific IT knowledge and funds to implement real solutions.
---------------------------------------------------------------------------
    \6\ https://www.gao.gov/assets/690/681541.pdf.
    \7\ https://www.rand.org/content/dam/rand/pubs/research_reports/
RR2800/RR2882/RAND_
RR2882.pdf.

    Second, the AAFP would recommend the exceptional performance bonus 
payments be reimagined to reward practices that achieve significant 
year-over-year improvement versus rewarding those practices at the 
upper levels of annual performance. While we applaud these high-
performing practices, it is our belief that additional positive payment 
adjustments would be better used if they were focused on rewarding the 
---------------------------------------------------------------------------
hard work of practices that achieve year-over-year improvements.

    The AAFP has not received any feedback from members regarding 
virtual groups and the uptake has been low. In fact, for the 2019 
performance year, CMS estimated that only 80 TINs would form 16 virtual 
groups. While the intentions behind virtual groups were good, the 
implementation and policies have fallen short. For example, those who 
fell below the low-volume threshold but wanted to participate in a 
virtual group could voluntarily report but would not receive a payment 
adjustment. This policy made virtual groups unattractive to those 
practices that virtual groups were designed to help. CMS now offers an 
opt-in pathway for practices that are otherwise excluded to fully 
participate in MIPS. However, this does not alleviate the challenges 
practices face in trying to identify other high performing practices 
with which to form a virtual group. Nor does the opt-in pathway remove 
the administrative and infrastructure barriers presented by virtual 
groups. In addition, CMS does not aggregate data for virtual groups. 
The burden of collecting and reporting data across multiple practices 
(and multiple EHRs) falls solely to the virtual group. Since virtual 
group practices are, by definition, small, it is unlikely they have the 
time or resources to take on such an arduous task. These concerns are 
echoed in the RAND research report ``Perspectives of Physicians in 
Small Rural Practices on the Medicare Quality Payment Program.''\8\
---------------------------------------------------------------------------
    \8\ https://www.rand.org/content/dam/rand/pubs/research_reports/
RR2800/RR2882/RAND_
RR2882.pdf.

    We stand ready to work with Congress and CMS to make virtual group 
---------------------------------------------------------------------------
options more robust for small and rural practices.

                                 ______
                                 
              Questions Submitted by Hon. Debbie Stabenow
    Question. Last time this committee discussed MACRA in 2016, I asked 
Andy Slavitt, then Acting Administrator of CMS, about the agency's 
plans to make it easier for rural physician practices to participate in 
APMs and MIPS. For example, some rural communities lack the required 
technology for electronic health records to participate. As someone who 
has experience with rural communities in your home State of Alaska, 
what changes have you noticed in rural communities and what could be 
improved to better accommodate rural physicians?

    Answer. As committee members have noted, it is also difficult for 
rural practices to participate in Alternative Payment Models (APMs). 
The infrastructure challenges are just as significant in APMs as they 
are in MIPS, and there are simply a limited number of Advanced APMs 
(AAPM) available. Limited financial \9\ resources and reserves make it 
difficult for rural practices to assume financial risk. A key component 
to successful APM and AAPM participation includes the implementation 
the five key functions of a medical home.\10\ The up-front investments 
needed \11\ for participation in value-based models can be significant, 
compounding the difficulties for participating. The AAFP welcomes the 
opportunity to partner with the committee to ensure that the MIPS 
program prepares practices for APM participation, and that CMS and the 
Innovation Center are creating APMs for rural and small practice 
participation.
---------------------------------------------------------------------------
    \9\ https://www.gao.gov/assets/690/681541.pdf.
    \10\ https://www.aafp.org/practice-management/transformation/
pcmh.html.
    \11\ https://www.gao.gov/assets/690/681541.pdf.

    The AAFP strongly encourages Congress to provide additional funds 
for technical assistance and use the $500M bonus pool to support small 
---------------------------------------------------------------------------
practice transformation.

    Question. I am very proud of the work the bipartisan 
accomplishments to address Alzheimer's, including the implementation of 
my HOPE for Alzheimer's Act which required Medicare to pay for new 
individual care plans to support Alzheimer's patients and their 
families. Many of my colleagues are also cosponsors of my Improving 
HOPE for Alzheimer's Act, which will ensure beneficiaries and 
physicians know that they are able to access, and bill for, care 
planning under Medicare. In our last hearing on MACRA implementation, 
my colleagues raised the question of how we should look at quality 
measures in MIPS when it comes to physicians having these conversations 
with beneficiaries and their families and reflecting their priorities. 
Some have mentioned altering MIPS to make the quality measures more 
clinically meaningful. In what ways do you think the system would need 
to change to better incorporate long-term care planning and encourage 
physicians to have these conversations with patients?

    Answer. In general, the AAFP is discouraging the creation of 
numerous additional performance measures that focus on processes. 
Giving in to the temptation to measure everything that can be measured 
drives up cost, adds to administrative burden, contributes to 
professional dissatisfaction and burnout, encourages siloed care, 
undermines professional autonomy, and diverts resources away from the 
most important factors influencing health and health care, such as 
SDoH. Extensive experience with performance measures in various systems 
(e.g., the VA system, the United Kingdom: Quality and Outcomes 
Framework) has shown excessive measurement can cause unexpected harms 
while failing to have an enduring positive impact on health outcomes of 
interest.

    In addition, quality measures under MIPS are voluntary--
professionals choose measures they wish to report, so measures aren't 
consistently selected or applied to all beneficiaries--this leads to a 
minimal impact on outcomes.

    A better solution may be to incorporate a more structured approach 
to screening and paying an additional fee for screening and follow-up.

                                 ______
                                 
               Questions Submitted by Hon. Sherrod Brown
                       the patient voice in macra
    Question. In your testimony, you mention the importance of patient-
reported outcomes. I agree that we should be measuring whether or not 
we are paying for care that is in line with the patient's goals. During 
the hearing I asked you how many of the 424 MIPS measures consider the 
patient voice and their priorities.

    Can you provide that number for me?

    Answer. Seventeen MIPS measures are classified as patient-reported 
outcome measures with 3 additional outcome measures that are not 
classified as such but are in fact patient-reported.

    Question. What more can your physician organization do to ensure 
patient needs and priorities are kept at the center of health-care 
delivery?

    Answer. Physicians could increase their use of patient-reported 
outcome measures (PROMs), but assessment alone is not enough to improve 
outcomes. Adequate community resources and social support systems are 
needed to address what the PROM reveals. Physicians alone cannot meet 
all patient needs but must rely on referral to community resources 
designed to address SDoH and non-clinical needs.

    It is important to clarify that measuring an outcome may not 
translate into good or bad clinician performance. A major challenge of 
using PROMs for performance measurement is demonstrating that the 
outcome is influenced by the care provided, and not attributable to 
other factors, such as social determinants of health. Without such 
evidence, the performance measure would not be considered a valid 
indicator of clinical performance. Like all performance measures, 
patient reported outcome performance measures must also be monitored to 
ensure there are no unintended consequences, such as potential for 
adverse patient selection. In addition, data must be feasible to 
collect, but data standards and integration into the EHR are only 
beginning to evolve.

    Challenges with using patient-reported outcomes in performance 
measurement are substantial. The Massachusetts Medical Society 
concluded that PROMs are a valid tool for internal quality improvement, 
clinical care, and patient engagement, but are still in their infancy 
and ``should not be used to compare providers or outcomes for 
payment.'' The AAFP has taken the position that that many measures 
appropriate for use as quality measures for internal improvement 
purposes may not be appropriate as performance measures.

    Question. What more can and should CMS and Congress do to ensure 
patient needs and priorities are kept at the center of health-care 
delivery?

    Answer. CMS must ensure that performance measure are limited to 
factors that have the greatest impact on health, health care, and 
costs, and are within reasonable control of the entities or 
professionals to which payment adjustments apply to avoid unintended 
consequences of measurement.

    Primary care services should be exempt from cost-sharing 
requirements such as deductibles and co-payments. For instance, the 
establishment of a standard primary care benefit \12\ would guarantee 
connectivity to the health-care system for individuals with high-
deductible health plans and serve as a guardrail against disease 
progression that leads to more costly care. The committee should 
strongly support the Primary Care Patient Protection Act of 2018 (HR 
5858)--a bipartisan bill to make it more affordable for patients with 
HDHPs to access primary care.
---------------------------------------------------------------------------
    \12\ https://www.aafp.org/dam/AAFP/documents/events/fmas/BKG-
StandardPrimaryCare
BenefitHighDeductiplePlans.pdf.

    Ensuring connectivity to a health-care delivery system through 
continuous, comprehensive, primary care is not only solid health 
policy; it also is sound economic policy for individuals and employers. 
A recent study \13\ conducted by the University of Portland found that 
every $1 invested in advanced primary care practices resulted in $13 in 
savings in other health-care services, including specialty, emergency 
room, and inpatient care.
---------------------------------------------------------------------------
    \13\ https://www.oregon.gov/oha/hpa/dsi-pcpch/Pages/index.aspx.

    When patients delay primary or preventive medical care, they often 
end up in an emergency room. According to a poll \14\ conducted by the 
American College of Emergency Physicians, about 80 percent of emergency 
physicians said they are treating insured patients who have sacrificed 
or delayed medical care due to unaffordable out-of-pocket costs, 
coinsurance, or high deductibles. A 2013 study \15\ found that high-
deductible health plans (HDHPs) led to decreased adherence to 
pharmaceutical treatments for patients with chronic conditions. The 
decrease in pharmaceutical adherence contributes to poor control of 
chronic conditions, which leads to the probability of more intensive 
and expensive health-care treatments at some future date.
---------------------------------------------------------------------------
    \14\ https://www.acep.org/uploadedFiles/ACEP/advocacy/
ACEP%20Fair%20Coverage%20
Report.pdf.
    \15\ https://www.ajmc.com/journals/issue/2013/2013-1-vol19-n12/
medication-utilization-and-adherence-in-a-health-savings-
accounteligible-plan.

    These findings further support the need to ensure individuals have 
connectivity with the health-care system through a constant 
relationship with a primary care physician. The cost of not ensuring 
continuous primary care is substantial. For example, the average cost 
of a visit to a primary care physician is $160.\16\ By comparison, the 
median charge for outpatient conditions in the emergency room is $1,233 
\17\ and the average hospital stay is $10,000.\18\ Based on these 
indicators, patients could see their primary care physician 7.7 times 
for the cost of a single visit to the emergency room and 62.5 times for 
a single hospital admission. Furthermore, it is estimated that more 
than $18 billion \19\ could be saved annually if those patients whose 
medical problems are considered ``avoidable'' or ``non-urgent'' were to 
take advantage of primary or preventive health care and not rely on 
emergency rooms for their medical needs. Primary care physicians are in 
the best position to serve as a patient's ``chronic care point guard'' 
and provide the quality and longitudinal care that can improve patient 
outcomes and reduce downstream costs.
---------------------------------------------------------------------------
    \16\ https://www.jhsph.edu/news/news-releases/2015/primary-care-
visits-available-to-most-uninsured-but-at-a-high-price.html.
    \17\ https://journals.plos.org/plosone/article?id=10.1371/
journal.pone.0055491.
    \18\ https://www.hcup-us.ahrq.gov/reports/statbriefs/sb168-
Hospital-Costs-United-States-2011.pdf.
    \19\ https://www.debt.org/medical/emergency-room-urgent-care-
costs/.

    It is well known that the United States, as compared to other 
Organisation for Economic Co-operation and Development (OECD) 
countries, spends a greater percentage of the gross domestic product on 
health care, yet has a significantly lower life expectancy. Many 
researchers have pointed to various reasons why this occurs in the 
United States, but one common finding is the fact that the United 
States spends far less on primary care and prevention than other OECD 
countries. Currently, the United States spends about 6 percent of its 
total health-care resources on primary care. By comparison, the United 
States spends 27 percent on inpatient hospitalization, 28 percent on 
outpatient hospital services, 30 percent on non-
primary care professional procedures, and 16 percent on 
pharmaceuticals.
                    development of metrics in macra
    Question. I have heard from a number of physicians who believe that 
there is no link between many of the MIPS measures they are required to 
report and improving clinical care for their patients. I understand 
that the physician community has engaged with CMS to try and make the 
program more meaningful to physicians and patients through more 
relevant quality measures.

    How are clinicians from your organization involved the creation of 
these measures relevant to their specialties?

    Answer. The AAFP is participating in several CMS efforts to align 
measures and make measurement more meaningful, including the Core 
Quality Measures Collaborative, the Measures Application Partnership, 
the National Quality Forum, and efforts by measure developers to design 
measures applicable to primary care.

    Current measures of primary care are scattered across all diseases, 
conditions, and preventive needs of patients; are generally 
indistinguishable from measures of other specialties; and do not 
adequately assess the quality of primary care. Primary care is much 
more complex than many people understand. Three out of four complaints 
that present are self-limited, and 40 percent of new symptoms do not 
lend themselves to any current coding system (e.g., ICPC, ICD-10). In 
addition, the linear ``assembly line'' model that has resulted in some 
advances (e.g., ventilator care) is not appropriate in primary care. 
Primary care requires a whole-person approach, prioritization of needs, 
a sophisticated primary care team, and consideration of the goals of 
the patient within the context of his or her social system. Additional 
research is needed on how primary care is delivered and how to improve 
and measure care in the primary care setting.

    The AAFP is supportive of research, measure development, and 
measure testing being conducted by the Robert Graham Center and the VCU 
School of Medicine to develop meaningful measures of primary care, 
including measures of continuity, comprehensiveness, and the patient-
centered primary care measure.

    Question. Has CMS been receptive to your feedback when provided?

    How would you assess CMS's collaboration on achieving meaningful 
metrics?

    Answer. CMS along with other payers are collaborating with the Core 
Quality Measures Collaborative, but to date, implementation and 
acceptance by all payers is limited. Performance measures continue to 
be churned-out at high quantity by many organizations and remain 
unaligned and unfocused on the most important factors that impact 
health, health care, and costs, and administrative burden of reporting 
remains unacceptably high.

    Question. Are there any changes in this process you would 
recommend?

    Answer. Eliminate self-reporting of performance measures and rely 
on measures that are extracted from other sources. Please see 
discussion provided earlier. CMS could consider measuring care at a 
geographic area and attributing the measure result to all providers who 
treat patients from the area as a factor in their overall measure score 
(hospitals, clinics, individual physicians, subspecialists, CAH, RHC, 
etc.). Performance metrics derived from existing data sources that are 
most impactful should be calculated and applied as one factor of 
performance to all (e.g., measures of access, SDoH, costs, and other 
factors that have a large impact on health of a population). This would 
support the need for addressing health/health-care needs and costs at 
the system level and reduce silos of care.

    Any single provider, facility, or patient might rightfully belong 
to multiple systems. For greatest impact, all populations and 
geographic areas must be attributed to one or more systems and all 
providers must be included in one or more systems, regardless of 
whether formal arrangements are in place. This is necessary to address 
issues of inequity, access, and cherry-picking, and would ensure that 
someone is responsible for the health, health care, and costs of all 
defined populations. Entities and health-care professionals could find 
themselves in overlapping systems with a competitor, which would 
encourage cooperation and mutual resource allocation to improve factors 
that influence health outcomes. Holding systems responsible for serving 
the needs of a geographic population may prevent the closure of 
clinics, EDs, maternity services, and other essential services in rural 
areas.

                                 ______
                                 
             Questions Submitted by Hon. Sheldon Whitehouse
    Question. Accountable Care Organizations (ACOs) have the potential 
to transform our health care delivery system. While we've seen ACOs 
improve patient care and create shared savings, many provider-led ACOs 
only control a small fraction of total spending, with specialists, 
pharmaceuticals, and hospitals accounting for most of it. This leads to 
ACOs lacking sufficient leverage to bring down costs and can contribute 
to shared losses.

    How can we improve the ACO model to account for this imbalance? How 
can we support successful ACOs and encourage more providers to follow 
their lead?

    Answer. The AAFP supports the creation of more APMs for practices 
of all sizes to participate. We recommended that policymakers increase 
the glide path for new, low-revenue ACOs in the one-sided levels of the 
BASIC track to 3 years. This is supported by a recent study published 
by the New England Journal of Medicine, which found that, after 3 years 
in the MSSP, physician-led ACOs were able to generate shared savings 
that grew over the study period. It is imperative to allow ACOs, 
particularly physician-led and low-revenue ACOs, enough time to 
generate sufficient shared savings to offset startup costs and support 
sustained transformation.

    We also encourage policymakers to maintain the shared savings rate 
at 50 percent for BASIC Levels A-D. We believe that a higher shared 
savings rate is necessary to support ACOs--especially physician-led and 
low-revenue ACOs with more limited capital reserves--in their efforts 
to improve quality and decrease costs.

    Question. Our health-care system is not fully equipped to care for 
an aging population and patients with advanced illness such as late-
stage cancer, Alzheimer's disease or dementia, or congestive heart 
failure. This is an area where we need new models of care that reflect 
these challenges and create a better system for providers, patients, 
and their families. Many of our current Medicare rules in this space 
are counterproductive, such as requiring a two night, three-day stay in 
an inpatient facility to qualify for skilled nursing care, and various 
disincentives to providing respite or palliative care. How are your 
organizations innovating to provide care for these patients, and what 
can Congress and CMS do to support those efforts?

    Answer. The AAFP encourages CMS to continue waivers from its 
previous and existing programs, such as the SNF 3-day, telehealth, and 
home visit waivers. Additionally, CMS should work with Congress to 
create copay waivers. By waiving copays, practices would have more 
freedom to invest in primary care. Further, copays can often create 
barriers for beneficiaries to receive appropriate care and add 
administrative burden to practices as they try to collect copays. A 
copay waiver would reduce this administrative burden and encourage 
beneficiaries to seek the comprehensive and coordinated care provided 
by primary care physicians. Receiving timely, preventive care from 
primary care physicians is vital to improving the health of 
beneficiaries.

    Question. Despite continued investment, electronic health records 
(EHRs) remain difficult to share, challenging for patients to access, 
and a source of frustration to providers and policymakers alike. The 
business models of the EHR venders often leads to perverse incentives 
against sharing patient information.

    What steps can Congress take to make EHRs work better for 
providers? Are the proposed data blocking rules enough to start 
encouraging better data sharing by the vendors?

    Answer. Electronic health records (EHRs) continue to pose 
significant challenges for all physicians and clinicians but especially 
for small and rural practices.\20\ With fewer resources available, some 
rural practices use less expensive EHRs that have limited capabilities, 
which can make interoperability significantly more difficult. 
Additionally, EHRs often lack adequate technical support or may charge 
for providing basic user support. CMS' mandate to implement 2015 
Edition certified EHR technology requires additional financial 
investments and staff support further inflate the barriers to 
successful value-based payment participation for rural practices. The 
AAFP welcomes the opportunity to partner with the committee as it 
considers ways to boost clinically meaningful HIT use among small 
practices.
---------------------------------------------------------------------------
    \20\ https://www.gao.gov/assets/700/692179.pdf.

    The proposed data blocking rules are insufficient to better 
encourage data sharing by vendors. We encourage Senators to review the 
AAFP's response to HHS regarding the Interoperability and Patient 
Access proposed rule. The comment letter \21\ expressed concern with 
proposed changes to drive the adoption of Application Programming 
Interfaces and trusted exchange within the health plan community--
specifically, the requirement to make data available in one business 
day, and the recommendation that health plans amend contracts with 
physicians to require nearly real-time data submission, which would 
increase administrative burden on physicians. We also encourage 
Senators to review the AAFP's letter \22\ on the proposed rule 
regarding interoperability and information blocking. The letter 
cautioned that the proposed framework would add unnecessary complexity 
and uncertainty for family physicians. The AAFP urged HHS to simplify 
the rules with small and medium-sized physician practices in mind.
---------------------------------------------------------------------------
    \21\ https://www.aafp.org/dam/AAFP/documents/advocacy/health_it/
emr/LT-HHS-Interoperability-060319.pdf.
    \22\ https://www.aafp.org/dam/AAFP/documents/advocacy/health_it/
emr/LT-ONC-InfoBlock
ing060319.pdf.

    Question. How can we encourage States to be better innovators on 
health-care spending? The current Medicaid waivers incentivize States 
to keep costs down, but are there ways to encourage both lower costs 
---------------------------------------------------------------------------
and better health-care outcomes?

    Answer. Congress could encourage States to be better innovators on 
health-care spending and promote the adoption of APMs by addressing low 
Medicaid physician payment rates which have historically created a 
barrier to health-care access for Medicaid enrollees. AAFP policy \23\ 
supports Medicaid payment for primary care services at least equal to 
Medicare's payment rate for those services when provided by a primary 
care physician. Accordingly, we urge Congress to resume Federal primary 
care payment policy previously found in Medicaid--SSA 1902(a)(13)(C) 
and provide Federal funding to ensure a floor of Medicare payment rates 
for primary-care services in Medicaid.
---------------------------------------------------------------------------
    \23\ https://www.aafp.org/about/policies/all/medicaid-
principles.html.

                                 ______
                                 
               Questions Submitted by Hon. Maggie Hassan
    Question. We spoke during the hearing about the incentive payment 
for providers to improve tracking and reporting of opioid prescribing, 
treatment agreements, 
follow-up evaluations, and screening of patients who may be at risk of 
opioid misuse under the Medicare Access and Children's Health Insurance 
Program (CHIP) Reauthorization Act of 2015 (MACRA).

    This data has the potential to improve treatment for substance use 
disorder, which is why its collection and reporting is now incentivized 
through increased reimbursement.

    At the hearing, I asked for feedback on the impact this data 
collection and reporting has had on treatment of patients, particularly 
as it relates to any reduction in opioid misuse.

    Based on your response, it seems that there may be additional steps 
the Centers for Medicare and Medicaid Services (CMS) could take so that 
this aggregated, de-identified data can be used to benefit patients and 
improve care.

    Do you have specific suggestions on how CMS can improve the 
collection, use, and dissemination of opioid prescribing and treatment 
data sets in ways that would directly benefit patients at their site of 
care, specifically as it relates to identifying best practices to 
reduce opioid misuse?

    Answer. In the AAFP's ``Chronic Pain Management and Opioid Misuse'' 
position paper,\24\ we call on family physicians to use protocols for 
MAT to address opioid dependence within the clinic population. MAT for 
opioid and heroin dependence has existed for more than 5 decades and 
involves some form of opioid substitution treatment. Originally, only 
methadone (an opioid agonist) was available, but now clinicians have 
buprenorphine (a partial agonist used alone or in combination with 
naloxone) and naltrexone (an opioid antagonist with both oral and 
extended-release injectable formulations) as pharmacologic options for 
MAT. In addition, adjunctive medications such as clonidine, 
nonsteroidal anti-inflammatory medications (NSAIDs), and others are 
used in the treatment of specific opioid withdrawal symptoms.
---------------------------------------------------------------------------
    \24\ https://www.aafp.org/about/policies/all/pain-management-
opioid.html.

    With the increase in opioid misuse, various Federal and State 
authorities and professional organizations have produced guidelines to 
help providers best treat opioid use disorders. The AAFP encourages HHS 
to consult these resources and work toward a nationwide, comprehensive 
---------------------------------------------------------------------------
coverage of drugs used in MAT.

    We applaud policymakers for encouraging health insurance plans to 
provide comprehensive coverage of MAT, opioid misuse and addiction is a 
serious national crisis. The AAFP calls for required, comprehensive 
coverage of MAT and counseling as recommended by the FDA in all public 
and private health insurance plans. Furthermore, the AAFP advocates 
against limits on MAT duration. Both FDA and SAMHSA state that 
treatment with MAT may be life-long, and we urge policymakers to factor 
that into MAT coverage policies.

                                 ______
                                 
           Questions Submitted by Hon. Catherine Cortez Masto
    Question. Nevada has one of the most significant health-care 
workforce shortages in the country. What kind of impact is MACRA having 
on the physician workforce? Are there ways to leverage the law to build 
that work force?

    Answer. By moving Medicare payments away from fee-for-service, 
MACRA has a positive impact on those physicians that are able to 
participate in an APM. However, participation in MIPS continues to be 
burdensome and problematic for small and rural practices. Congress 
should encourage the proliferation of appropriate APMs to increase the 
physician workforce.

    Question. MACRA included $20 million per year through 2020 to 
support the administration of technical assistance to help small and 
rural practices comply with the law's reporting requirements. Almost 
$35 million will be left as of this coming January, to remain available 
until expended. As a contractor, can you explain the process of 
developing technical assistance?

    Answer. The AAFP was not a contractor and did not develop technical 
assistance. Instead, we promoted the SURS to our members for their 
information. Congress provided technical assistance funds for CMS to 
support practices in MIPS. CMS created the Small, Rural, and 
Underserved Support (SURS). While these organizations have been 
helpful, they are unable to provide the in-depth and individualized 
support many small and rural practices need. The services provided \25\ 
vary by each organization and may not be available to all practices. 
Additionally, the organizations can provide technical support, but they 
do not provide any financial or permanent human resources for 
practices. Stakeholders interviewed for a recent RAND report \26\ felt 
the QPP support is able to provide high-level support, but much of the 
work cannot be done by outside contractors or office managers. 
Stakeholders also reported that the support providers sometimes lacked 
knowledge in certain areas or were unable to get answers from CMS to 
specific questions. Specifically, funds are needed to pay for IT 
support specific to individual users. Technical assistance providers 
lack specific IT knowledge and funds to implement real solutions.
---------------------------------------------------------------------------
    \25\ https://www.gao.gov/assets/690/681541.pdf.
    \26\ https://www.rand.org/content/dam/rand/pubs/research_reports/
RR2800/RR2882/RAND
_RR2882.pdf.

    Second, the AAFP would recommend the exceptional performance bonus 
payments be reimagined to reward practices that achieve significant 
year-over-year improvement versus rewarding those practices at the 
upper levels of annual performance. While we applaud these high-
performing practices, it is our belief that additional positive payment 
adjustments would be better used if they were focused on rewarding the 
---------------------------------------------------------------------------
hard work of practices that achieve year-over-year improvements.

                                 ______
                                 
  Prepared Statement of Matthew Fiedler, Ph.D., Fellow, USC-Brookings 
     Schaeffer Initiative for Health Policy, Brookings Institution
    Chairman Grassley, Ranking Member Wyden, members of the Finance 
Committee, thank you for the opportunity to testify today. My name is 
Matthew Fiedler, and I am a fellow with the USC-Brookings Schaeffer 
Initiative for Health Policy, where my research focuses on a range of 
topics in health care economics and health care policy, including 
provider payment policy. Previously, I served as Chief Economist on the 
staff of the Council of Economic Advisers, where I provided economic 
advice on a range of health care policy issues. This testimony reflects 
my personal views and should not be attributed to the staff, officers, 
or trustees of the Brookings Institution.

    I am honored to have the opportunity to speak with you about 
implementation of the Medicare physician payment provisions of the 
Medicare Access and CHIP Reauthorization Act of 2015 (MACRA).\1\ My 
testimony makes four main points:
---------------------------------------------------------------------------
    \1\ Many of the ideas discussed here were developed in joint work 
with several colleagues. See Fiedler, Matthew, Tim Gronniger, Paul B. 
Ginsburg, Kavita Patel, Loren Adler, and Margaret Darling. 2018. 
``Congress Should Replace Medicare's Merit-Based Incentive Payment 
System.'' Health Affairs Blog. https://www.healthaffairs.org/do/
10.1377/hblog20180222.35120/full/. Any errors are my own.

        1.  Research examining the structure of the Merit-based 
        Incentive Payment System (MIPS) and experience with similar 
        programs suggest that MIPS is unlikely to improve the quality 
        or efficiency of patient care. But MIPS is creating substantial 
---------------------------------------------------------------------------
        administrative costs.

        2.  MACRA's bonus payments for clinicians participating in 
        Advanced Alternative Payment Models (APMs) have great potential 
        to increase participation in these models, which recent 
        research has shown can reduce health care spending while 
        maintaining or improving quality. Consistent with this 
        potential, implementation of the bonus has coincided with--and 
        likely helped cause--greater participation in advanced APMs, 
        while also encouraging the Centers for Medicare and Medicaid 
        Services (CMS) to deploy more effective APMs.

        3.  Policy-makers should build on what is working in MACRA and 
        discard what is not by increasing the size of MACRA's 
        incentives for participation in Advanced APMs, creating similar 
        incentives for other categories of providers, and eliminating 
        MIPS.

        4.  In the absence of broader changes to MACRA, several 
        narrower reforms are worth considering. These include making 
        the advanced APM bonus permanent, eliminating the ``cliff'' in 
        the Advanced APM bonus eligibility rules, standardizing the 
        measures used in the MIPS quality category, and replacing the 
        MIPS practice improvement and promoting interoperability 
        categories with more targeted incentives.
                          background on macra
    In addition to reauthorizing the Children's Health Insurance 
Program and repealing the sustainable growth rate formula that 
determined the overall level of Medicare's physician payment rates, 
MACRA made important structural changes to how Medicare pays 
physicians. Under MACRA, clinicians choose between two tracks: (1) 
participating in MIPS; and (2) participating in an Advanced APM.

    Most clinicians are currently participating in MIPS, which adjusts 
clinicians' payment rates upward or downward based on their performance 
in four categories: (1) quality of care; (2) cost of care; (3) 
completion of specified ``practice improvement'' activities; and (4) 
use of certified electronic health records (EHRs), now called the 
Promoting Interoperability category by CMS. In the quality and practice 
improvement categories, clinicians have broad flexibility to select the 
measures or activities they are evaluated on. With the exception of the 
cost category, clinicians are generally responsible for collecting the 
information used to evaluate their performance and submitting that 
information to CMS. The first ``performance year'' under MIPS was 2017; 
payment adjustments for the 2017 performance year are occurring during 
2019.

    Clinicians are permitted to opt out of MIPS if they participate to 
a sufficient degree in an Advanced APM, as measured by the share of a 
clinician's payments or patient volume connected with an Advanced 
APM.\2\ Importantly, clinicians with sufficient participation in 
Advanced APMs are also eligible for a bonus payment equal to 5 percent 
of their physician fee schedule revenue. Paralleling MIPS, the first 
performance year for the Advanced APM bonus was 2017, and the first 
bonus payments are occurring in 2019. The bonus for Advanced APM 
participation will expire after the 2022 performance year.\3\
---------------------------------------------------------------------------
    \2\ For the current performance year, a clinician must serve at 
least 35 percent of its patients or receive at least 50 percent of its 
payments in connection with an Advanced APM. For 2021 and later 
performance years, those thresholds rise to 50 percent and 75 percent, 
respectively. Clinicians with somewhat lesser engagement with Advanced 
APMs are eligible to opt out of MIPS but are not eligible for bonus 
payments.
    \3\ MACRA provides that payment rates for clinicians participating 
in Advanced APMs will grow 0.5 percentage points per year more quickly 
than those for non-participants starting with the 2024 performance 
year, which will gradually re-create an incentive for participation in 
Advanced APMs. However, it will take more than a decade after 2022 
before incentives for participation in Advanced APMs return to the 
level of the current bonus.

    To be considered an Advanced APM, a payment model must make 
participants financially liable if spending exceeds an expected level. 
Advanced APMs must also must base payment in part on participants' 
quality performance and require participants to use an EHR that meets 
the certification criteria promulgated by the Department of Health and 
Human Services (HHS). The most prominent examples of Advanced APMs are 
Accountable Care Organization (ACO) models that include ``two-sided'' 
risk (that is, ACO models that require participants to bear a portion 
of the costs if spending by their beneficiaries exceeds the 
``benchmark'' spending level under the model). However, some episode 
(or ``bundled'') payment models, as well as some medical home models, 
also qualify as Advanced APMs.
      mips appears unlikely to meaningfully improve patient care, 
                         but is creating burden
    There is limited direct evidence on MIPS's effects to date because 
data on the program's first year were only recently released and 
because decisions CMS made to ease the transition to MIPS make this 
early experience a poor guide to how MIPS will perform in the long run. 
However, analyses of MIPS's structure, as well as research examining 
prior similar programs, suggest that MIPS is unlikely to achieve its 
goals of reducing costs or improving quality. Nevertheless, MIPS is 
creating significant administrative costs for providers.
Structural Problems Limit MIPS's Ability to Improve the Quality or 
        Efficiency of Patient Care
    MIPS has several structural problems that limit the program's 
ability to improve the quality or efficiency of the care Medicare 
beneficiaries receive. I focus on three that are particularly 
significant. Other experts and the Medicare Payment Advisory Commission 
(MedPAC) have expressed similar concerns about MIPS's architecture.\4\
---------------------------------------------------------------------------
    \4\ See, for example, Schneider, Eric C. and Cornelia J. Hall. 
2017. ``Improve Quality, Control Spending, Maintain Access--Can the 
Merit-based Incentive Payment System Deliver?'' New England Journal of 
Medicine 376(8): 708-710; Medicare Payment Advisory Commission. 2018. 
``Moving Beyond the Merit-based Incentive Payment System.'' http://
www.medpac.gov/docs/default-source/reports/
mar18_medpac_ch15_sec.pdf?sfvrsn=0; Rathi, Vinay K. and J. Michael 
McWilliams. 2019 ``First-Year Report Cards From the Merit-Based 
Incentive Payment System (MIPS): What Will Be Learned and What Next?'' 
Journal of the American Medical Association.
---------------------------------------------------------------------------
Problem #1: Orienting Payment Incentives Around Clinicians, Rather Than 
        Patients
    MIPS aims to improve the quality and efficiency of patient care by 
adjusting payments for individual clinicians or practices. But a given 
patient's care often involves multiple different clinicians, each 
playing a different role. Ensuring that the payment incentives MIPS 
creates for individual clinicians or practices add up to a coherent set 
of incentives for the management of each patient's care is at best 
difficult and, as a practical matter, probably impossible.

    For example, under the MIPS cost category as currently implemented, 
the need to measure cost performance at the clinician or practice level 
has led CMS to create multiple different cost measures, score each 
clinician or practice on all measures for which minimum sample size 
requirements are met, and then compute a final category score as an 
equally weighted average of the scored measures. This approach creates 
an unpredictable and haphazard overall set of incentives to reduce 
spending since a given dollar of spending may factor into zero, one, or 
more than one of the cost measures that end up being scored for any 
given provider.
Problem #2: Limited Panel Sizes at the Practice Level
    It is difficult to reliably measure cost or quality performance at 
the level of an individual clinician or practice because of the 
relatively small number of Medicare beneficiaries involved. This 
problem is particularly acute when measuring cost performance since 
health care spending varies so widely across individuals. As a result, 
at least once MIPS is fully implemented, chance will play a large role 
in determining where a clinician falls on the spectrum of possible 
payment adjustments under MIPS, which weakens the incentives those 
payment adjustments create for clinicians to improve performance. 
Incentives could, of course, be strengthened by making the MIPS payment 
adjustments larger, but clinicians would have legitimate concerns about 
basing large payment adjustments on performance measures influenced so 
strongly by random chance.
Problem #3: Clinician Choice of Quality Measures
    Clinicians' ability to choose the quality measures they are 
evaluated on undermines the effectiveness of the MIPS quality category. 
Allowing clinicians to choose quality measures was a well-intended 
effort to allow clinicians to tailor the measures they report to the 
nature of the care they provide. However, the lack of common measures 
makes comparing the performance of different clinicians--even 
clinicians providing similar services--difficult or impossible. That, 
in turn, makes it hard to determine which clinicians are, in fact, high 
or low performers for the purposes of MIPS payment adjustments. The 
lack of common measures will also make it difficult or impossible for 
patients to use the data generated by MIPS to compare providers.

    Allowing choice also creates strong incentives for clinicians to 
selectively report quality measures on which they perform well while 
declining to report measures on which they perform poorly. Indeed, due 
to the financial stakes under MIPS, it is hard for clinicians to avoid 
doing this, even if that would be their preference. This type of 
selective reporting causes the data collected under MIPS to provide a 
skewed picture of each clinician's performance, making it even more 
difficult for patients or CMS to use the data to evaluate clinicians. 
These incentives for selective reporting likely also increase 
administrative costs by requiring providers to invest time and effort 
(or hire consultants) to identify the measures they are likely to 
perform best on, or, alternatively, to collect data on many more 
measures than they are required to report and submit only the best 
ones.

    The MIPS practice improvement activities category suffers from 
similar problems. Practices are permitted to select from a list of more 
than 100 practice improvement activities and can achieve a maximum 
score by completing at most four (and sometimes fewer) activities.\5\ 
The list is sufficiently broad that, at least in many instances, 
clinicians can achieve the maximum score for the practice improvement 
category by reporting on activities that they had already planned to 
complete. In those instances, the practice improvement category creates 
reporting costs for providers, but no benefit to patients. Even when 
the category does induce providers to take action they would not 
otherwise have taken, the benefit to patients is uncertain. While many 
of the included activities are at least superficially appealing, the 
evidence base supporting them is not always clear, nor is it clear that 
the level of engagement with these activities required to gain credit 
under MIPS is sufficient to generate meaningful changes in care.
---------------------------------------------------------------------------
    \5\ Practice improvement activities include items like reporting to 
clinical registries, conducting a survey on patient satisfaction, 
participating in specific trainings, or integrating recommended 
clinician screenings into routine practice.
---------------------------------------------------------------------------
Research on Programs Similar to MIPS Has Found Discouraging Results
    MIPS is not the first instance in which Medicare has sought to 
improve the quality or reduce the cost of patient care by adjusting 
providers' fee-for-service payment rates upward or downward based on 
performance on a broad set of cost and quality measures. Research on 
these similar programs has found little evidence that such programs 
have achieved their objectives, and there is little reason to believe 
that a different result should be expected under MIPS.

    A recent study examining the Value-Based Payment Modifier (Value 
Modifier), a predecessor to MIPS that adjusted Medicare payment rates 
for physician groups based on cost and quality performance, provides 
particularly relevant and compelling evidence.\6\ This research draws 
on the fact that practices with 100 or more clinicians could receive 
either bonuses or penalties under the Value Modifier, while practices 
with between 10 and 99 clinicians could receive only bonuses and 
smaller practices were excluded entirely. The researchers were thus 
able to isolate the effect of the Value Modifier by looking for sharp 
changes in cost or quality performance at these practice size 
thresholds. The authors found no evidence that the Value Modifier had 
any effect on potentially avoidable hospitalizations, hospital 
readmissions, Medicare spending, or mortality.
---------------------------------------------------------------------------
    \6\ Roberts, Eric T., Alan M. Zaslavsky, and J. Michael McWilliams. 
2018. ``The Value-Based Payment Modifier: Program Outcomes and 
Implications for Disparities.'' Annals of Internal Medicine 168(4): 
255-265.

    Research examining the Hospital Value-Based Purchasing Program 
(HVBP), which adjusts Medicare hospital payments upward and downward 
based on a similarly broad set of measures, has reached similar 
discouraging conclusions.\7\ The same is true of research on the 
Premier Hospital Demonstration, a demonstration project that was a 
predecessor of the HVBP.\8\ It is notable that these hospital-
focused programs avoid at least some of MIPS's shortcomings since most 
hospitals have much higher patient volumes than individual clinicians 
or practices and these programs do not allow hospitals to choose which 
measures they are evaluated on.
---------------------------------------------------------------------------
    \7\ Ryan, Andrew M., Sam Krinsky, Kristin A. Maurer, and Justin B. 
Dimick. 2017. ``Changes in Hospital Quality Associated With Hospital 
Value-Based Purchasing.'' New England Journal of Medicine 376(24): 
2358-2366; Figueroa, Jose F., Yusuke Tsugawa, Jie Zheng, E. John Orav, 
and Ashish K. Jha. 2016. ``Association between the Value-Based 
Purchasing pay for performance program and patient mortality in US 
hospitals: observational study.'' British Medical Journal 353: i2214.
    \8\ Jha, Ashish K., Karen E. Joynt, E. John Orav, and Arnold M. 
Epstein. 2012. ``The Long-Term Effect of Premier Pay for Performance on 
Patient Outcomes.'' New England Journal of Medicine 366(17): 1605-1615.

    Before proceeding, I note two caveats on this evidence. First, the 
estimates from these studies are subject to some uncertainty. Thus, 
while this evidence largely rules out the possibility that these 
programs caused large improvements in patient care, these programs 
could have caused smaller improvements in patient care that these 
---------------------------------------------------------------------------
studies were unable to detect.

    Second, this evidence should not be interpreted as showing that 
adjusting payments based on particular outcomes within a fee-for-
service structure can never be successful. Notably, research on the 
Hospital Readmission Reduction Program (HRRP), which penalizes 
hospitals at which a large share of patients are readmitted soon after 
discharge finds that it substantially reduced hospital readmission 
rates.\9\ Moreover, while there has been some recent controversy on 
this point, there is, in my view, some evidence that the HRRP reduced 
post-discharge mortality rates and no compelling evidence that the HRRP 
increased mortality.\10\ One plausible explanation for why the HRRP has 
been more successful than the Value Modifier or HVBP is that the HRRP 
is a much more targeted program that attaches relatively strong 
incentives to a narrow set of outcomes.
---------------------------------------------------------------------------
    \9\ Zuckerman, Rachael B., Steven H. Sheingold, E. John Orav, Joel 
Ruhter, and Arnold M. Epstein. 2016. ``Readmissions, Observation, and 
the Hospital Readmission Reduction Program.'' New England Journal of 
Medicine 374: 1543-1551; Medicare Payment Advisory Commission. 2018. 
``Mandated report: The effects of the Hospital Readmissions Reduction 
Program.'' http://www.medpac.gov/docs/default-source/reports/
jun18_ch1_medpacreport_sec.pdf; Atul Gupta. 2017. ``Impact of 
performance pay for hospitals: The Readmissions Reduction Program.'' 
Working Paper. https://www.dropbox.com/s/rfwok9en2c5812j/
Gupta_HRRP.pdf.
    \10\ Ibid.
---------------------------------------------------------------------------
Providers Incur Significant Costs to Comply With MIPS
    While MIPS, at least in its current form, appears unlikely to 
substantially improve patient care, it is creating substantial 
compliance costs. For the 2019 performance year, CMS estimates that 
providers will incur $482 million in reporting costs related to MIPS, 
with the MIPS quality category accounting for the majority of those 
costs.\11\ Notably, this figure does not include the costs providers 
incur to develop a strategy for complying with MIPS, including deciding 
which quality measures it is most advantageous to collect and report. 
These activities are likely to require providers to invest substantial 
staff time, hire outside consultants, or both.
---------------------------------------------------------------------------
    \11\ See Table 91 in Centers for Medicare and Medicaid Services. 
2018. ``Medicare Program; Revisions to Payment Policies Under the 
Physician Fee Schedule and Other Revisions to Part B for CY 2019.'' 
Federal Register 83(226): 59452. https://www.govinfo.gov/content/pkg/
FR-2018-11-23/pdf/2018-24170.pdf.

    Of course, the fact that complying with MIPS creates administrative 
costs is not, in itself, evidence of a problem. If MIPS was improving 
the quality or efficiency of patient care, then these costs could be 
worth incurring. Indeed, the $482 million in estimated reporting costs 
cited above constitute only around 0.5 percent of projected spending on 
services under the physician fee schedule during 2019, so even modest 
improvements in care could suffice. But it is hard to justify requiring 
clinicians to incur these costs in service of an ineffective program.
        research finds apms can be effective, and participation 
                       in advanced apms is rising
    While I am pessimistic about MIPS, I am optimistic about MACRA's 
bonus payments for participation in Advanced APMs. Recent research has 
shown that well-designed APMs can reduce health-care spending while 
maintaining or improving quality. Furthermore, implementation of 
MACRA's bonus payments has coincided with--and likely helped cause--an 
increase in participation in these models, while also facilitating the 
deployment of more effective APMs.
Evidence on APMs' Effectiveness
    Recent research indicates that APMs can be effective tools for 
reducing health-care spending. I focus on the evidence on ACO models 
since they account for the large majority of participation in APMs and 
advanced APMs in Medicare. The best such research has focused on the 
Medicare Shared Savings Program (MSSP), which is by far the largest 
Medicare ACO program.\12\ This research has found that MSSP ACOs reduce 
average spending per beneficiary by between 0 and 5 percent, with the 
size of the spending reduction depending on an ACO's composition and 
how long it has participated in the MSSP. On average, physician-group 
ACOs that have a few years of experience in the MSSP have performed at 
the high end of this range, while ACOs containing a hospital have 
performed at the low end of this range. Research examining the Center 
for Medicare and Medicaid Innovation's Pioneer ACO model has also found 
evidence that the model reduced spending, as has research examining a 
commercial ACO-like contract operated by Blue Cross Blue Shield of 
Massachusetts.\13\
---------------------------------------------------------------------------
    \12\ McWilliams, J. Michael, Laura A. Hatfield, Bruce E. Landon, 
Pasha Hamed, and Michael E. Chernew. 2018 ``Medicare Spending After 3 
Years of the Medicare Shared Savings Program.'' New England Journal of 
Medicine 379(12): 1139-1149.
    \13\ McWilliams, J. Michael, Michael E. Chernew, Bruce E. Landon, 
and Aaron L. Schwartz. 2015. ``Performance Differences in Year 1 of 
Pioneer Accountable Care Organizations.'' New England Journal of 
Medicine 372(20): 1927-1936; Nyweide, David J., Woolton Lee, Timothy T. 
Cuerdon, Hoangmai H. Pham, Megan Cox, Rahul Rajkumar, Patrick H. 
Conway. 2015. ``Association of Pioneer Accountable Care Organizations 
vs Traditional Medicare Fee for Service With Spending, Utilization, and 
Patient Experience.'' Journal of the American Medical Association 
313(21): 2152-2161; Song, Zirui, Sherri Rose, Dana G. Safran, Bruce E. 
Landon, Matthew P. Day, and Michael E. Chernew. 2014. ``Changes in 
Health Care Spending and Quality 4 Years Into Global Payment.'' New 
England Journal of Medicine 371(18): 1704-14.

    For a few reasons, I suspect these findings may understate the 
overall savings that should be expected from ACO models, at least over 
the long run. First, the research cited above provides some evidence 
that providers perform better in these models as they gain experience. 
Second, the research on MSSP examines years in which essentially all 
ACOs were participating in one-sided models under the program's 
original benchmarking methodology; as discussed below, CMS has made 
changes in both these areas that will likely cause MSSP ACOs to have 
stronger incentives to reduce spending in the future than they have in 
the past. Third, these models may reduce spending through a variety of 
channels that were not examined in these studies. Most directly, 
reductions in traditional Medicare spending reduce payments to plans 
under the Medicare Advantage program.\14\ Medicare's deployment of 
these models also appears to have coincided with--and plausibly helped 
cause--increased use of these models by private insurers.\15\ Providers 
participating in ACOs may also change the way they treat patients 
covered by other payers or play a role in reshaping the practice norms 
adhered to by other providers.\16\
---------------------------------------------------------------------------
    \14\ Centers for Medicare and Medicaid Services. 2018. ``Medicare 
Program; Medicare Shared Savings Program; Accountable Care 
Organizations--Pathways to Success and Extreme and Uncontrollable 
Circumstances Policies for Performance Year 2017.'' Federal Register 
83(249): 67816; McWilliams, J. Michael. 2016. ``Savings From ACOs--
Building on Early Success.'' Annals of Internal Medicine 165(12): 873-
875.
    \15\ Muhlestein, David, Robert S. Saunders, Robert Richards, and 
Mark B. McClellan. 2018. ``Recent Progress in the Value Journey: Growth 
of ACOs and Value-Based Payment Models in 2018.'' Health Affairs Blog. 
https://www.healthaffairs.org/do/10.1377/hblog20180810.
481968/full/.
    \16\ Baicker, Katherine, Michael E. Chernew, and Jacob A. Robbins. 
2013. ``The spillover effects of Medicare managed care: Medicare 
Advantage and hospital utilization.'' Journal of Health Economics 
32(6): 1289-1300; Glied, Sherry and Joshua Graff Zivin. 2002. ``How do 
doctors behave when some (but not all) of their patients are in managed 
care?'' Journal of Health Economics 21(2): 337-353; McWilliams, J. 
Michael, Bruce E. Landon, Michael E. Chernew. 2013. ``Changes in Health 
Care Spending and Quality for Medicare Beneficiaries Associated With a 
Commercial ACO Contract.'' Journal of the American Medical Association 
310(8): 829-836.

    It is less clear how ACOs have affected quality of care, in part 
because measuring changes in quality of care is more difficult. There 
is reasonably persuasive evidence that the savings achieved under 
Medicare's ACO models have not come at the cost of worse health 
outcomes.\17\ What is less clear is whether ACO models have actually 
improved quality of care and, if so, by how much. There is some 
evidence that ACOs have improved patients' experience of care.\18\ Some 
research has also suggested that ACOs have increased receipt of certain 
recommended screenings services, but this finding has been 
inconsistent.\19\ More research on this question would be valuable.
---------------------------------------------------------------------------
    \17\ Herrel, Lindsey A., Edward C. Norton, Scott R. Hawken, Zaojun 
Ye, Brent K. Hollenbeck, and David C. Miller. 2016. ``Early Impact of 
Medicare Accountable Care Organization Cancer Surgery Outcomes.'' 
Cancer 122(17); 2739-2746; McWilliams, J. Michael, Lauren G. Gilstrap, 
David G. Stevenson, Michael E. Chernew, Haiden A. Huskamp, and David C. 
Grabowski. 2017. ``Changes in Post-acute Care in the Medicare Shared 
Savings Program.'' JAMA Internal Medicine 177(4): 518-526.
    \18\ McWilliams, J. Michael, Bruce E. Landon, Michael E. Chernew, 
and Alan M. Zaslavsky. 2014. ``Changes in Patients' Experiences in 
Medicare Accountable Care Organizations.'' New England Journal of 
Medicine 371(18): 1715-1724.
    \19\ McWilliams et al. (2015); McWilliams, J. Michael, Laura A. 
Hatfield, Michael E. Chernew, Bruce E. Landon, and Aaron L. Schwartz. 
2016. ``Early Performance of Accountable Care Organizations in 
Medicare.'' New England Journal of Medicine 374(24): 2357-2366.

    An important question is why ACOs have performed better than pay-
for-
performance programs like MIPS, at least with respect to the cost of 
care. I suspect two factors are important. First, an ACO serves many 
more patients than an individual clinician or practice. That larger 
size makes it much easier to produce statistically reliable measures of 
providers' performance, which in turn allows ACOs to use payment 
designs that create much stronger incentives to reduce spending than 
programs like MIPS. Second, ACOs make one provider (or group of 
providers) accountable for the overall cost and quality of a patient's 
care. That allows ACOs to create much more coherent--and 
comprehensible--incentives to improve patient care than programs like 
MIPS that make disconnected payment adjustments for each individual 
provider.
Advanced APM Participation Has Risen Markedly in Recent Years
    Participation in APMs that meet the Advanced APM criteria has 
increased markedly since MACRA's enactment. Figure 1 presents data on 
participation in ACOs, which, as noted above, account for the large 
majority of APM and Advanced APM participation in Medicare.\20\ The 
share of Medicare beneficiaries served by providers that participate in 
an ACO that involves ``two-sided'' risk--the types of ACO models that 
qualify as Advanced APMs--stood at 9 percent in 2018, up from 3 percent 
in 2016, the last year before the Advanced APM bonus became available. 
Advanced APM participation also increased from 2015 to 2016, from 1 
percent to 3 percent, and it is possible that a portion of this 
increase occurred because providers were anticipating the fact that 
bonuses for Advanced APM participation would become available in 2017.
---------------------------------------------------------------------------
    \20\ These estimates include beneficiaries assigned to ACOs 
participating in the Medicare Shared Savings Program or the Center for 
Medicare and Medicaid Innovation's Pioneer and Next Generation ACO 
models. Estimates use the MSSP public use files produced by CMS, as 
well as the published financial results for the Pioneer and Next 
Generation models. Enrollment data are not yet available for 2018, but 
the number of ACOs participating in each program is available, so I 
have assumed that the number of beneficiaries assigned to each type of 
ACO grew in proportion to the number of ACOs of that type. Track 1+ did 
not exist as an MSSP participation option until 2018, so I assume that 
the average number of beneficiaries assigned to each Track 1+ ACO in 
2018 was the same as the average number of beneficiaries assigned to 
each Track 1 ACO in 2017.

[GRAPHIC] [TIFF OMITTED] T5819.001


    Additional research on why participation in two-sided ACO models 
has risen in recent years would be valuable, but I suspect that the 
Advanced APM bonus has played an important role. That said, the bonus 
payment is likely not the only factor. Notably, CMS has recently been 
expanding its portfolio of two-sided ACO models: in 2016, CMS 
introduced the Track 3 participation option under the MSSP and 
introduced the Next Generation ACO model under the auspices of the 
Center for Medicare and Medicaid Innovation; and, in 2018, CMS 
introduced the Track 1+ participation option under the MSSP, an option 
that includes ``two-sided'' risk, but in a more limited form than prior 
models. Providers have also gained experience with ACO models over 
time, which may make them more willing to take on two-sided risk.
MACRA's Advanced APM Bonus Has Supported Deployment of More Effective 
        APMs
    The existence of the Advanced APM bonus has also encouraged CMS to 
be more aggressive in deploying ACO models that create stronger 
incentives for providers to reduce health-care spending. This is the 
case in at least two areas.

    First, in 2016, CMS finalized changes to the rules for calculating 
the spending ``benchmarks'' used to evaluate MSSP ACOs' spending 
performance. Prior to this change, benchmarks for MSSP ACOs were set 
based on each ACO's own spending over the 3 years preceding each 
agreement period. This methodology greatly weakened ACOs' incentives to 
reduce spending since success in reducing spending during an ACO's 
current agreement period was penalized by a dollar-for-dollar reduction 
in the ACO's benchmark for the subsequent agreement period.

    To ameliorate this problem, CMS changed the benchmark calculation 
so that each ACO's benchmark equaled a blend of the ACO's own past 
spending and average spending in the ACO's region.\21\ The revised 
methodology has the downside, however, of making MSSP participation 
less attractive for ACOs with high spending relative to their regions. 
The upward pressure on ACO participation from implementation of the 
Advanced APM bonus helped counteract the downward pressure on 
participation among high-cost ACOs from the benchmarking change and 
likely made CMS more willing to implement these improvements to the 
benchmarking methodology.
---------------------------------------------------------------------------
    \21\ Centers for Medicare and Medicaid Services. 2016. ``Medicare 
Program; Medicare Shared Savings Program; Accountable Care 
Organizations--Revised Benchmark Rebasing Methodology, Facilitating 
Transition to Performance-Based Risk, and Administrative Finality of 
Financial Calculations.'' Federal Register 81(112): 37950.

    Second, in late 2018, CMS finalized rules that will require all 
ACOs to shift into models that include two-sided risk more quickly than 
had been required under prior rules.\22\ Like the benchmarking change, 
this policy change involves a tradeoff. Models that include two-sided 
risk create stronger incentives for providers to reduce spending and, 
even holding underlying health care spending constant, directly 
generate larger savings for the Medicare program. Models with two-sided 
risk are also, however, less attractive to providers (all else being 
equal), so requiring two-sided risk is likely to put downward pressure 
on ACO participation. The existence of the Advanced APM bonus appears 
to have shaped how CMS weighed these tradeoffs and made it more willing 
to move ahead, which was, in my view, the right decision, although it 
was a close call.\23\
---------------------------------------------------------------------------
    \22\ Centers for Medicare and Medicaid Services. 2018. ``Medicare 
Program; Medicare Shared Savings Program; Accountable Care 
Organizations--Pathways to Success and Extreme and Uncontrollable 
Circumstances Policies for Performance Year 2017.'' Federal Register 
83(249): 67816.
    \23\ For additional discussion of my views on these changes, see 
Fiedler, Matthew. 2018. ``Comments on CMS's Proposed Rule, `Medicare 
Shared Savings Program; Accountable Care Organizations--Pathways to 
Success.' '' https://www.brookings.edu/opinions/comments-on-cmss-
medicare-shared-savings-program-accountable-care-organizations-
pathways-to-success/. For a thoughtful opposing view, see McWilliams, 
J. Michael, Michael Chernew, and Bruce Landon. 2018. ``Comment Letter 
on MSSP Proposed Rule.'' https://hmrlab.hcp.med.harvard.edu/mcwilliams-
chernew-and-landon-comment-mssp-proposed-rule.
---------------------------------------------------------------------------
               the best path forward: eliminate mips and 
                   strengthen advanced apm incentives
    Policymakers should seek to build on the parts of MACRA that are 
working well, while discarding the parts that are not. To that end, I 
believe that the best path forward is to eliminate MIPS, but expand 
incentives for participation in Advanced APMs. I will discuss each 
recommendation in turn.
Recommendation #1: Eliminate MIPS
    In light of the problems with MIPS discussed earlier, I agree with 
MedPAC and other experts that eliminating MIPS is the best path 
forward.\24\ Some of MIPS's problems--particularly those stemming from 
clinicians' ability to choose the quality measures they are evaluated 
on--could be addressed while retaining MIPS's basic structure. However, 
many of MIPS's issues are more fundamental. In particular, generating 
statistically reliable measures of cost and quality performance at the 
practice level is likely effectively impossible, as is creating 
coherent overall incentives to improve patient care by adjusting 
payments to individual physician practices.
---------------------------------------------------------------------------
    \24\ See, for example, Medicare Payment Advisory Commission. 2018. 
``Moving Beyond the Merit-based Incentive Payment System.'' http://
www.medpac.gov/docs/default-source/reports/
mar18_medpac_ch15_sec.pdf?sfvrsn=0; Rathi, Vinay K. and J. Michael 
McWilliams. 2019 ``First-Year Report Cards From the Merit-based 
Incentive Payment System (MIPS): What Will Be Learned and What Next?'' 
Journal of the American Medical Association.

    These challenges, together with the evidence that prior programs 
similar to MIPS have not been effective, lead me to believe that a 
reformed MIPS would still fail to generate improvements in the quality 
or efficiency of patient care sufficient to justify its administrative 
costs. I thus view eliminating MIPS as the best path forward. If MIPS 
were eliminated, policymakers should consider creating targeted 
incentives for use of certified EHRs and reporting to clinical 
registries; I discuss such incentives later in this testimony in the 
section on potential incremental changes to MIPS.
Recommendation #2: Strengthen Incentives for Advanced APM Participation
    In contrast to MIPS, MACRA's incentive for participation in 
Advanced APMs appears to be achieving its main goal of increasing 
participation in effective alternative payment models. Policymakers 
should seek to build on the success of this component of MACRA by 
strengthening incentives for participation in Advanced APMs.

    Creating stronger incentives for participation in Advanced APMs 
would have two benefits. First, stronger incentives for Advanced APM 
participation would directly increase participation in these models, 
which the research reviewed earlier indicates would increase the 
efficiency of Medicare spending while maintaining or improving the 
quality of the care Medicare beneficiaries receive. Second, stronger 
incentives for participation in Advanced APMs would allow CMS to make 
further progress in deploying versions of APMs that create stronger 
incentives to reduce spending. In particular, it will likely ultimately 
be desirable for CMS to go further in requiring ACOs to take on two-
sided risk and in basing ACOs' ``benchmarks'' on regional average 
spending rather than ACOs' own historical costs. However, as noted 
earlier, changes like these make ACO participation less attractive for 
some categories of providers. Sufficiently strong incentives for 
Advanced APM participation could mitigate or eliminate this tradeoff.

    A good first step to strengthen incentives for participation in 
Advanced APMs would be to make MACRA's bonus for participation in 
Advanced APMs permanent, a point I return to in the next section of my 
testimony. However, more significant enhancements are warranted:

          Increase the size of the incentive for Advanced APM 
        participation: One worthwhile step would be to increase the 
        size of MACRA's incentives for participation in Advanced APMs.

       Determining the appropriate magnitude of the increase would 
require additional modeling and analysis, but creating an incentive for 
Advanced APM participation that is at least twice as large as the 
current incentive could easily be appropriate.

       Since a major objective of promoting greater participation in 
Advanced APMs is to reduce Medicare spending, additional incentives for 
Advanced APM participation should be structured in a way that does not 
increase Federal costs. To that end, Congress could implement a budget-
neutral combination of larger bonuses for Advanced APM participation 
and penalties for providers that decline to participate in an Advanced 
APM. This approach of using penalties from poor performers to fund 
bonus payments to high performers is similar to the approach Congress 
has taken under MIPS and many other programs.

          Create incentives for other categories of providers to 
        participate in Advanced APMs or collaborate with participants 
        in Advanced APMs: An additional worthwhile step would be to 
        create incentives for other categories of providers, 
        particularly hospitals, to participate in Advanced APMs or 
        collaborate with providers who participate in Advanced APMs. 
        Providers could qualify for incentive payments in essentially 
        the same way that clinicians can qualify under MACRA, with the 
        exception that providers could count services or patients 
        associated with an Advanced APM in which the provider was not 
        itself participating if the provider had a written 
        collaboration agreement with participants in that Advanced APM. 
        This approach would, for example, allow a hospital to earn the 
        incentive payment by collaborating with one or more physician-
        only ACOs in its community rather than setting up its own ACO. 
        Allowing hospitals to take this approach is particularly 
        important in light of the evidence noted above that physician-
        only ACOs have been more successful in reducing spending than 
        those containing a hospital as a participant.

       There are two reasons to extend Advanced APM incentives to non-
physician providers. First, it would give these providers a greater 
stake in the deployment and success of Advanced APMs, which may be 
necessary to fully realize these models' potential to improve the 
quality and efficiency of patient care. Second, there are likely limits 
on how low payment rates for clinicians not participating in Advanced 
APMs can be set, which limits the overall size of the incentives that 
can be created for Advanced APM participation if the physician fee 
schedule is the sole vehicle for creating those incentives. Extending 
incentives for Advanced APM participation for other providers relaxes 
this constraint.

       As above, it would be important that additional incentives for 
Advanced APM participation be structured in a way that would not 
increase Federal costs. To this end, any incentive for hospitals or 
other categories of providers could be structured as a budget-neutral 
combination of bonuses for participants and penalties for non-
participants.
           incremental steps: extend the advanced apm bonus 
                     and make targeted mips changes
    While eliminating MIPS and expanding MACRA's Advanced APM 
incentives is the best path forward in my view, there are also 
opportunities to make incremental improvements in both areas.
Permanently Extend the Advanced APM Bonus and Eliminate the Eligibility 
        ``Cliff''
    There are at least two incremental changes that could be made to 
the Advanced APM bonus:

          Permanently extend the Advanced APM bonus: One important 
        step Congress can take is to permanently extend the Advanced 
        APM bonus, which is currently scheduled to expire after the 
        2022 performance year. It would be best to enact an extension 
        well before the bonus expires. Many of the investments 
        providers need to make to be successful under Advanced APMs are 
        only likely to be attractive to providers that expect to 
        continue participating in Advanced APMs in the future, and the 
        likelihood that the Advanced APM bonus will continue is one 
        major factor shaping providers' plans about future APM 
        participation. Waiting until the last minute to extend the 
        bonus would thus likely reduce Advanced APM participation in 
        the near term and forfeit a portion of the bonus's potential 
        benefits.

       The Advanced APM bonus can and should be extended in a way that 
does not increase overall Medicare spending. One approach to achieving 
this objective, discussed above, would be to replace the current bonus 
payment with a budget-neutral combination of bonuses for Advanced APM 
participation and penalties for non-participation. Another approach 
would be to pair the extension with offsetting changes to Medicare 
payments.

          Smooth out the ``cliff'' in the Advanced APM bonus 
        eligibility criteria: A clinician's eligibility for the 
        Advanced APM bonus depends on whether a sufficient share of its 
        payments or patient volume is connected with an Advanced APM. 
        Clinicians that exceed the threshold are eligible for the full 
        bonus, while clinicians that fall short, even by a very small 
        amount, are eligible for no bonus payments at all.

       This ``all or nothing'' structure is hard to justify. The 
Medicare program frequently benefits from clinician engagement with 
Advanced APMs even when that engagement falls short of the eligibility 
thresholds; that will be particularly true under the relatively high 
eligibility thresholds that will apply over the long run. Additionally, 
the Medicare program would sometimes benefit if clinicians that meet 
the current thresholds had incentives to further increase their 
engagement with Advanced APMs.

       Thus, it would be desirable to replace the current ``all or 
nothing'' structure with a structure in which a clinician's bonus 
phased up gradually once a clinician's engagement with Advanced APMs 
crossed a threshold level. Under such an approach, it would be 
important that the bonus payment phase in rapidly enough to ensure that 
clinicians currently receiving bonuses generally received bonuses 
comparable to those they receive today. This approach has similarities 
to a proposal included in the administration's fiscal year 2020 budget, 
but there are two important differences.\25\ First, the 
administration's proposal appears to reduce bonuses for many current 
recipients, which would be a step in the wrong direction. Second, the 
administration's proposal would pay bonuses to some providers with very 
limited Advanced APM engagement, which is likely a low-priority use of 
bonus funds.
---------------------------------------------------------------------------
    \25\ Department of Health and Human Services. 2019. ``Fiscal Year 
2020 Budget-in-Brief.'' https://www.hhs.gov/sites/default/files/fy-
2020-budget-in-brief.pdf.
---------------------------------------------------------------------------
Make Targeted Improvements to MIPS
    As noted earlier, I believe there are limits to what a reformed 
MIPS program could realistically achieve. But there are three changes 
that I believe would improve MIPS's performance:

          Standardize quality measures: The problems that arise from 
        clinicians' ability to choose quality measures under MIPS could 
        be addressed by directing CMS to establish standardized measure 
        sets for each specialty (or subspecialty) and requiring 
        clinicians to report those standardized measure sets. The 
        applicable measure set could be determined from claims data 
        based on the mix of services a clinician delivered.\26\
---------------------------------------------------------------------------
    \26\ Multi-specialty groups could be required to report on all 
measure sets that applied to more than a specified share of their 
clinicians.

       Particularly initially, it is likely that some clinicians would 
lack a standardized measure set appropriate to their practice. For 
these clinicians, the quality category could be excluded from scoring 
under MIPS. Excluding the quality category would be preferable to 
requiring clinicians to incur the costs necessary to continue reporting 
under the current system since such reporting appears unlikely to 
---------------------------------------------------------------------------
meaningfully benefit Medicare beneficiaries.

       CMS could be directed to collaborate with other payers in 
constructing these specialty-specific standardized measure sets, to the 
extent feasible, in order to reduce administrative burden for 
providers. CMS is already engaged in such a process via the Core 
Quality Measures Collaborative operating under the auspices of the 
National Quality Forum.

       An alternative approach to reforming the MIPS quality category 
would be to eliminate the requirement that clinicians report quality 
measures and instead rely on measures derived from claims records or 
beneficiary surveys. The administration's fiscal year 2020 budget and 
MedPAC have both put forward proposals in this vein.\27\ This approach 
would generate large reductions in clinicians' reporting burdens and is 
worth considering. However, even with this change, I expect that MIPS 
would remain an ineffective tool for improving the quality and 
efficiency patient care, so if Congress is willing to consider changes 
this large, I would encourage it to consider eliminating MIPS entirely.
---------------------------------------------------------------------------
    \27\ Ibid.; Medicare Payment Advisory Commission. 2018. ``Moving 
Beyond the Merit-based Incentive Payment System.'' http://
www.medpac.gov/docs/default-source/reports/mar18_medpac
_ch15_sec.pdf?sfvrsn=0.

          Eliminate the practice improvement category and create a 
        targeted incentive for reporting to clinical data registries: 
        The MIPS practice improvement category is essentially a ``box 
        checking'' exercise that is doing little to improve patient 
        care but is creating reporting costs for clinicians. I 
---------------------------------------------------------------------------
        recommend eliminating this category.

       That said, there may be some specific activities currently 
included on the list of practice improvement activities that are worth 
encouraging. Notably, clinician reporting to clinical data registries 
has features of a ``public good.'' Reporting to registries generates 
benefits for the health care system as a whole by facilitating research 
on ways to improve patient care and allowing clinicians to compare 
themselves to their peers.

       To encourage registry reporting, Congress could create a small, 
targeted incentive for clinicians to report to registries that meet 
rigorous criteria. The appropriate size of such an incentive merits 
further research, but a reasonable starting point would be 0.5 percent 
of clinicians' payments. The incentive could be structured as a budget-
neutral combination of bonuses for compliance and penalties for non-
compliance, similar to the existing payment adjustments under MIPS. 
Congress could consider applying this incentive to clinicians 
participating in Advanced APMs in addition to those participating in 
MIPS, as reporting by Advanced APM participants generates similar 
systemic benefits.

          Eliminate the Promoting Interoperability category and create 
        a targeted incentive for use of a certified EHR: Encouraging 
        clinicians to use EHRs that meet the certification standards 
        promulgated by HHS generates substantial benefits for the 
        health-care system by facilitating interoperability. It is much 
        less clear, however, that there is a rationale for requiring 
        providers to use these tools in particular ways, rather than 
        allowing providers to use these tools in whatever way generates 
        the greatest value for their patients.

       For that reason, I recommend eliminating the MIPS Promoting 
Interoperability category and replacing it with a small, targeted 
incentive for having an EHR that meets the HHS certification standards. 
Practices could earn the incentive merely by showing that they have a 
suitable EHR installed and in active use, similar to the requirements 
currently in place for Advanced APMs. Clinicians would not be required 
to perform any specific activities with that EHR, unlike under MIPS. 
CMS has moved a significant distance in this direction in creating the 
requirements for the current Promoting Interoperability category, but 
it would be possible to at least modestly reduce burden by simplifying 
further. Like the incentive for registry reporting, the appropriate 
size of such an incentive merits further research, but a reasonable 
starting point would be 0.5 percent of clinicians' payments, structured 
as a budget-neutral combination of bonuses and penalties.

                                 ______
                                 
      Questions Submitted for the Record to Matthew Fiedler, Ph.D.
                Questions Submitted by Hon. Rob Portman
    Question. I introduced the Medicare Care Coordination Improvement 
Act with Senator Bennet in an effort to reduce some of the barriers 
that providers face when they participate in Alternative Payment 
Models. However, one particular section of my bill focuses on providing 
temporary waivers to practices that are interested in testing their own 
APMs. HHS has been slow to take up new APM concepts, and thus: what can 
we do to incentivize the establishment of new APMs? Has the PTAC 
offered a viable way to propose and test new APMs? If not, what actions 
could be taken to encourage the adoption of PTAC models?

    Answer. In my view, focusing on expanding the portfolio of APMs 
clinicians can choose is a poor strategy for improving the quality and 
efficiency of Medicare beneficiaries' care. A proliferation of APMs 
would create opportunities for clinicians to choose among APMs based on 
which APM would be most financially advantageous to them, not which APM 
would generate the largest improvements in the quality and efficiency 
of patient care. This type of strategic APM selection could have 
various downsides, including increased costs for the Medicare program.

    As discussed in my testimony, I do believe that expanding 
participation in Advanced APMs is an important objective. However, 
rather than achieving that objective by increasing the number of APMs 
clinicians can choose among, I would recommend: (1) increasing 
incentives for participation in existing Advanced APMs, notably 
accountable care organization models; and (2) testing and deploying 
additional episode and bundled payment models on a mandatory basis.

    Question. Per data from CMS, about half of all Medicare providers 
are participating in MIPS, with the majority of these non-participating 
providers being exempt via the low-volume threshold. While we don't 
want to place additional burdens on small and rural providers, we 
should be identifying ways to engage with these practices to help them 
transition towards value-based outcomes.

    What actions should be taken to engage with these providers?

    Answer. Ensuring that all providers, including small and rural 
providers, deliver efficient, high-quality care is an important 
objective. However, due to the broader shortcomings of MIPS, which are 
discussed at length in my testimony, expanding these providers' 
engagement with MIPS is unlikely to pay major dividends. A more 
promising strategy for improving the quality and efficiency of patient 
care is to create stronger, more effective incentives to participate in 
Advanced APMs. As discussed in my response to the next question, while 
small and rural providers do face special barriers to engaging with 
such models, the existence of incentives to participate in Advanced 
APMs is spurring the private sector to develop approaches that make 
participating in these models feasible for many types of providers.

    Question. I'd like to ask about your proposals to improve 
participation in APMs. I appreciate your proposal to ``smooth out the 
cliff'' for participating in APMs, but I want to get your perspective 
on whether this may be enough to incentivize small and rural practices 
to participate in APMs. Your proposal would help move providers towards 
APMs if they are already able to bear risk, but some of the smaller and 
rural practices may not be ready yet to do that.

    What actions could Congress take to help these practices start to 
take on risk?

    Answer. Small and rural providers face barriers to participation in 
Advanced APMs that other providers do not. However, even for these 
providers, I believe that strengthening and improving incentives for 
participation in Advanced APMs--including eliminating the cliff in the 
Advanced APM bonus eligibility rules and, more importantly, 
strengthening the overall size of the incentives for Advanced APM 
participation--is the best path to encouraging greater Advanced APM 
participation for all types of providers.

    If strong, predictable incentives for Advanced APM participation 
are in place, I expect that the private sector will develop solutions 
that facilitate Advanced APM participation for all types of providers. 
Indeed, spurred in part by the existing incentives for Advanced APM 
participation, a range of private firms now offer services aimed at 
helping providers of all types participate successfully in Advanced 
APMs. These firms frequently take on a portion of the downside risk 
involved in participating in an Advanced APM and give providers tools 
designed to help them be successful under the APM, including analytic 
and programmatic support.

                                 ______
                                 
                 Questions Submitted by Hon. Ron Wyden
    Question. The Independence at Home demonstration, which was 
expanded and extended last year through the CHRONIC Care Act, enables 
care teams to deliver high-quality primary care to Medicare 
beneficiaries in the comfort of their own homes. In its third 
performance year, according to the Centers for Medicare and Medicaid 
Services (CMS), Independence at Home saved $16.3 million for the 
Medicare program.\1\ A recent evaluation also found that Independence 
at Home has resulted in fewer emergency department visits leading to 
hospitalization, a lower proportion of beneficiaries with at least one 
unplanned hospital readmission during the year, and a reduced number of 
preventable hospital admissions.\2\
---------------------------------------------------------------------------
    \1\ https://innovation.cms.gov/Files/fact-sheet/iah-yr3-fs.pdf.
    \2\ https://innovation.cms.gov/Files/reports/iah-rtc.pdf.

    As I mentioned at the hearing, I am committed to building on the 
success of the Independence at Home demonstration. As discussed at the 
hearing, I understand that the new Primary Care First model recently 
announced by CMMI (the Center for Medicare and Medicaid Innovation at 
CMS) may provide an avenue to expand access to home-based primary care 
---------------------------------------------------------------------------
for more Medicare beneficiaries.

    What key components will be necessary in order for the Primary Care 
First model to expand access to home-based primary care?

    Answer. The performance-based payments available under the Primary 
Care First model are based primarily on providers' success in reducing 
hospitalizations. Thus, two things are likely to be required for the 
model to expand delivery of these services. First, providers must 
believe that home-based primary care services are a cost-effective 
means of reducing hospitalizations. Second, providers must be attentive 
to the financial incentives created under the model. Experience with 
CMMI's prior medical home models (the Comprehensive Primary Care 
Initiative and Comprehensive Primary Care Plus models) has been 
somewhat discouraging in this regard, but the payment methodology under 
the Primary Care First model is sufficiently different to merit 
additional testing.

    Question. What other specific policies would you recommend Congress 
or CMS consider to expand access to home-based primary care for more 
Medicare beneficiaries?

    Answer. In general, I would encourage Congress and CMS to focus on 
creating broad-based incentives for providers to improve the quality 
and efficiency of patient care. As discussed in my testimony, one 
promising way to do so would be to improve and strengthen incentives 
for providers to participate in Advanced APMs. This approach would 
reward greater provision of home-based primary care services in 
settings where those services are likely to improve the quality and 
efficiency of patient care, while ensuring that the Medicare program 
does not bear the cost if these services are deployed in settings where 
they are not appropriate or effective.

    Question. As I mentioned during the hearing, I often hear from 
seniors in Oregon that they don't feel like anyone is in charge of 
managing their health care and helping them navigate the health-care 
system. I am proud of the bipartisan work that this committee did on 
the CHRONIC Care Act last Congress to update the Medicare guarantee. In 
my view, the next step should be making sure that all Medicare 
beneficiaries with chronic illnesses have someone running point on 
their health care--in other words, a chronic care point guard--
regardless of whether they get their care through Medicare Advantage 
(MA), an Accountable Care Organization (ACO) or other Alternative 
Payment Model, or traditional fee-for-service Medicare.

    For beneficiaries in traditional, fee-for-service Medicare, what 
can be done to improve care coordination and make sure their physicians 
and other health-care professionals are all talking to each other and 
working together to provide the best possible care to those 
beneficiaries? What specific policies would you recommend this 
committee pursue toward that end?

    Answer. Please see the response under the next question.

    Question. Please describe the specific steps that Congress and/or 
CMS could take to ensure all Medicare beneficiaries with chronic 
illnesses, including those in traditional fee-for-service Medicare, 
have a chronic care point guard.

    Answer. One worthwhile step would be to increase payments for 
evaluation and management services under the physician fee schedule, 
financed by a reduction in payments for other services. Such a step 
would likely expand the supply of primary care services and facilitate 
improvement in the quality of those services. This type of change would 
benefit all enrollees in traditional Medicare, including those cared 
for by providers not affiliated with an ACO. It might also benefit 
people covered by private insurers since Medicare's fee schedule 
frequently serves as a template for private insurers' payments.

    However, there are likely limits to the improvements in care 
coordination that can be achieved in the context of fee-for-service 
payment models. Improving provider participation in ACOs and similar 
models is thus another important objective. As discussed in my 
testimony, one way to do so would be to improve and strengthen 
incentives for providers to participate in Advanced APMs.

                                 ______
                                 
               Question Submitted by Hon. Debbie Stabenow
    Question. I am very proud of the work the bipartisan 
accomplishments to address Alzheimer's, including the implementation of 
my HOPE for Alzheimer's Act which required Medicare to pay for new 
individual care plans to support Alzheimer's patients and their 
families. Many of my colleagues are also cosponsors of my Improving 
HOPE for Alzheimer's Act, which will ensure beneficiaries and 
physicians know that they are able to access, and bill for, care 
planning under Medicare. In our last hearing on MACRA implementation, 
my colleagues raised the question of how we should look at quality 
measures in MIPS when it comes to physicians having these conversations 
with beneficiaries and their families and reflecting their priorities. 
Some have mentioned altering MIPS to make the quality measures more 
clinically meaningful. In what ways do you think the system would need 
to change to better incorporate long-term care planning and encourage 
physicians to have these conversations with patients?

    Answer. As I discussed in my testimony, in light of the 
discouraging results from research on pay-for-performance systems 
similar to MIPS, I am pessimistic that even a reformed MIPS program 
could produce substantial improvements in the quality of the care 
Medicare beneficiaries receive, including with respect to long-term 
care planning.

    However, some improvement might be possible by standardizing the 
performance measures used in the MIPS quality category. As discussed in 
my testimony, clinicians' ability to choose the measures they are 
evaluated on under MIPS makes it difficult for CMS to use MIPS data to 
distinguish between high and low performers for payment purposes. It 
also makes it difficult for patients to use those data to choose a 
provider. These shortcomings, in turn, keep MIPS from creating strong 
incentives to improve quality performance. Standardizing the quality 
measures used under MIPS would give MIPS a fighting chance to improve 
care on the dimensions of quality that policymakers prioritized. Those 
could, if desired, include long-term care planning.

                                 ______
                                 
               Questions Submitted by Hon. Sherrod Brown
                       the patient voice in macra
    Question. As I mentioned in my hearing questions, we passed MACRA 
to incentivize and reward high-value, patient-centered care. While 
MACRA is all about physician payment reform, our goal should be 
maximizing patient benefit. It is clear to me that we have not done 
enough to ensure the patient's voice is a part of the process, and that 
patients are benefitting from these changes. The NIH has created 
Patient-Focused Therapy Development tools and systems dedicated to 
engaging the patient community throughout the translational science 
process. The FDA has implemented a Patient-Focused Drug Development 
model to help ensure patients' experiences, perspectives, needs, and 
priorities are captured meaningfully during drug development and 
review.

    Are you aware of any efforts to monitor MACRA's impact on patient 
satisfaction?

    Answer. I am not aware of any ongoing research to estimate MACRA's 
effect on patient satisfaction.

    Question. What is the best way to evaluate patient benefit across 
MACRA's programs?

    Answer. Quantifying the effects of any policy intervention, 
including MACRA, requires determining what would have happened in the 
policy's absence. Researchers have a range of tools for doing this, but 
they are not universally applicable and must be carefully tailored to 
the particular setting in which they are applied. Thus, the best 
approach is likely to vary across MACRA's components, and it is not 
possible to identify a single best research design.

    However, it is important that any comprehensive evaluation of 
MACRA's effects on Medicare beneficiaries account for the fact that 
these effects may be multi-
faceted. MACRA may affect ``objective'' measures of health status like 
longevity, as well as ``subjective'' measures of well-being like 
patient satisfaction. Reductions in the cost of care could also improve 
beneficiaries' financial security by reducing their premiums and cost-
sharing. Obtaining a complete picture of MACRA's effects on Medicare 
beneficiaries requires taking account of--and appropriately weighing--
all of these various effects.

                                 ______
                                 
             Questions Submitted by Hon. Sheldon Whitehouse
    Question. Accountable Care Organizations (ACOs) have the potential 
to transform our health care delivery system. While we've seen ACOs 
improve patient care and create shared savings, many provider-led ACOs 
only control a small fraction of total spending, with specialists, 
pharmaceuticals, and hospitals accounting for most of it. This leads to 
ACOs lacking sufficient leverage to bring down costs and can contribute 
to shared losses.

    How can we improve the ACO model to account for this imbalance? How 
can we support successful ACOs and encourage more providers to follow 
their lead?

    Answer. Interestingly, the best research on the effect of the 
Medicare shared savings program has suggested that ACOs that do not 
include a hospital have had the greatest success in reducing Medicare 
spending.\3\ Indeed, small ACOs may have one important advantage: 
unlike an ACO that includes a hospital, a physician-only ACO does not 
need to worry that reducing unnecessary hospitalizations will reduce 
its inpatient volume.
---------------------------------------------------------------------------
    \3\ McWilliams, J. Michael, Laura A. Hatfield, Bruce E. Landon, 
Pasha Hamed, and Michael E. Chernew. 2018 ``Medicare Spending after 3 
Years of the Medicare Shared Savings Program.'' New England Journal of 
Medicine 379(12): 1139-1149.

    Nevertheless, the relatively small fraction of total spending 
accounted for by 
physician-led and, particularly, primary-care-led ACOs does present two 
special obstacles: (1) shared savings/shared losses calculated on the 
total cost of care can be large relative to these ACOs' revenue; and 
(2) these ACOs can have difficulty eliciting cooperation from other 
---------------------------------------------------------------------------
providers.

    In my view, both problems can be ameliorated by improving the 
financial incentives for participation in Advanced APMs along the lines 
I recommended in my testimony. The first problem can be ameliorated by 
increasing the overall size of incentive for participation in Advanced 
APMs, which will make taking on significant financial risk to 
participate in such models more palatable for these types of providers.

    The second problem can be addressed by creating incentives for non-
physician providers to engage with Advanced APMs that parallel MACRA's 
incentives for physicians. For example, a hospital (or other category 
of provider) could receive an incentive payment based on the share of 
its volume received through ACOs with whom it had a formal 
collaboration agreement. Since the hospital would need the ACO's sign-
off to receive the incentive payment, this would give the ACO leverage 
over the hospital's behavior that it lacks today.

    It would be important to structure enhanced incentives for Advanced 
APM participation in ways that would not increase overall spending. 
That could be done by implementing a budget-neutral combination of 
bonuses for engaging with an Advanced APM and penalties for failing to 
do so, akin to how Congress combined bonuses and penalties under MIPS.

    Question. Our health-care system is not fully equipped to care for 
an aging population and patients with advanced illness such as late-
stage cancer, Alzheimer's disease or dementia, or congestive heart 
failure. This is an area where we need new models of care that reflect 
these challenges and create a better system for providers, patients, 
and their families. Many of our current Medicare rules in this space 
are counterproductive, such as requiring a 2-night, 3-day stay in an 
inpatient facility to qualify for skilled nursing care, and various 
disincentives to providing respite or palliative care. How are your 
organizations innovating to provide care for these patients, and what 
can Congress and CMS do to support those efforts?

    Answer. Congress could facilitate the relaxation or removal of some 
of the Medicare rules you are concerned about by encouraging greater 
participation in Advanced APMs. Some of these rules, including the 
skilled nursing facility (SNF) 3-day rule, are motivated by concerns 
that providers have incentives to encourage inappropriate use of the 
relevant services in order to increase their Medicare payments. Those 
concerns largely do not exist when providers are at risk for a 
sufficient fraction of the cost of a beneficiary's care, as is the case 
under Advanced APMs. Because of this fact, CMS has issued partial 
waivers of the SNF 3-day rule for beneficiaries assigned to certain ACO 
models that involve two-sided risk. Broader participation in Advanced 
APMs would expand eligibility for these and similar waivers, as well as 
facilitate the creation of waivers in other similar areas.

    Question. Despite continued investment, electronic health records 
(EHRs) remain difficult to share, challenging for patients to access, 
and a source of frustration to providers and policymakers alike. The 
business models of the EHR venders often leads to perverse incentives 
against sharing patient information.

    What steps can Congress take to make EHRs work better for 
providers? Are the proposed data blocking rules enough to start 
encouraging better data sharing by the vendors?

    Answer. I have not studied the EHR market carefully enough to make 
recommendations about how to improve EHR functionality. I have also not 
studied the proposed data blocking rules carefully enough to render a 
judgement. However, as I described in my testimony, there are 
opportunities to make Medicare's EHR requirements less burdensome for 
clinicians without compromising efforts to improve usability and 
interoperability. The MIPS promoting interoperability category could be 
replaced by a small payment incentive for having an EHR that meets 
Federal certification standards installed and in active use. Unlike 
under MIPS, clinicians would not be required to perform any specific 
activities with that EHR, which would limit compliance costs for 
providers. The incentive could be structured as a budget-neutral 
combination of payment bonuses and penalties.

    Question. How can we encourage States to be better innovators on 
health-care spending? The current Medicaid waivers incentivize States 
to keep costs down, but are there ways to encourage both lower costs 
and better health-care outcomes?

    Answer. Starting with Medicaid, because provider payment rates 
under State Medicaid programs are generally already relatively low, 
efforts to reduce the cost of delivering Medicaid coverage should focus 
on encouraging more efficient utilization of health-care services. Just 
like for the Federal Government, one promising strategy for States is 
to make greater use of non-fee-for-service payment mechanisms that 
reward efficient, high-quality care.

    States are already engaged in a variety of efforts in this area 
(and frequently can do so without a waiver from CMS), but the Federal 
Government can support them in a variety of ways. First, the Federal 
Government should continue its efforts to develop and deploy APMs. 
Federal payment reform efforts provide templates that other payers, 
including State Medicaid programs, can use in their own payment reform 
efforts. Second, where possible, the Federal Government should partner 
with State Medicaid programs to deploy APMs that are harmonized across 
Medicare, Medicaid, and private payers. CMS has already done this in 
some instances, but it should look for additional opportunities to do 
so in the future.

    Looking beyond Medicaid, States should also seek to reduce the cost 
of health care in the private insurance market. In particular, States 
should seek to foster robust competition in health care provider 
markets and health insurance markets. That could include robustly 
enforcing antitrust laws with respect to mergers and anti-competitive 
conduct, as well as repealing State laws that inhibit competition, such 
as so-called ``any willing provider'' laws. The Federal Government 
could encourage activities like these by providing grant funding to 
States that act in these areas. The Federal Government should also 
remove barriers that keep States from getting a comprehensive picture 
of their health-care markets; notably, Congress should address 
limitations on States' ability to construct all-payer claims databases 
that were created by the Supreme Court's decision in Gobeille vs. 
Liberty Mutual Insurance Company.

                                 ______
                                 
           Questions Submitted by Hon. Catherine Cortez Masto
    Question. Early on, with Meaningful Use, Congress heard a lot from 
providers about the complexity and reporting burden; we are hearing 
less but concerns remain.

    Should the EHR vendors be responsible for ensuring use and 
workability rather than the doctors? How would that work?

    Answer. As I discussed in my testimony, there are opportunities to 
make Medicare's EHR requirements less burdensome for clinicians. In 
particular, the MIPS promoting interoperability category could be 
replaced with a small payment incentive for having an EHR that meets 
Federal certification requirements installed and in active use. Unlike 
under MIPS, clinicians would not be required to perform any specific 
activities with that EHR, which would limit clinicians' compliance 
burdens. The incentive could be structured as a budget-neutral 
combination of payment bonuses and penalties.

    It is important, however, to retain some direct incentive for 
providers to install and use certified EHRs since the Federal 
certification standards are an important tool for promoting 
interoperability. While vendors could be encouraged to market EHRs that 
meet these standards using other policy tools, some incentive for 
providers is likely necessary to ensure that providers actually adopt 
those EHRs.

    Question. How do we bring the rest of the health-care workforce 
online--ambulances, mental health providers, etc.?

    Answer. As with physicians and hospitals, encouraging other types 
of providers to use EHRs that meet Federal certification standards has 
the potential to benefit the health-care system as a whole by 
facilitating interoperability. Creating a modest payment incentive for 
having a certified EHR installed and in active use, similar to the 
incentive my testimony proposes for clinicians, would be one approach 
to this problem worth considering.

                                 ______
                                 
              Prepared Statement of Hon. Chuck Grassley, 
                        a U.S. Senator From Iowa
    I want to thank the witnesses for being here today. We look forward 
to hearing how physician payment reforms in the Medicare Access and 
CHIP Reauthorization Act are driving good patient outcomes. The MACRA 
law also took the historic step of getting rid of the flawed 
sustainable growth rate formula.

    Let me take a moment to go through the history of the SGR as the 
saga ended with a hopeful message. Congress established the SGR in 1997 
as a mechanism to control Medicare spending on physician services. The 
formula worked at first, but it wasn't long before it called for large 
reductions in payments that threatened access to care. This set in 
motion a perpetual exercise where Congress scrambled to prevent the 
cuts.

    Congress acted 17 times over more than a decade--each time kicking 
the can down the road without solving the underlying problem. Then, in 
2015, Congress finally came together and passed the MACRA law by an 
overwhelming margin in both chambers. MACRA showed that Congress can 
still work together in a bipartisan manner to address big problems.

    This reminder reinforces my belief in the current bipartisan 
Finance Committee process to lower prescription drug costs. It bodes 
well for making changes in Medicare to improve access to care for 
patients in rural and underserved areas. This is another project to 
which Ranking Member Wyden and I are committed.

    These bipartisan efforts also provide a glimmer of hope that 
Republicans and Democrats can join together to prevent Medicare from 
going broke. I urge my colleagues on the other side of the aisle to 
focus on shoring up Medicare's finances. This is time better spent than 
trying to expand Medicare for all only for it to invariably end up 
available to none.

    The MACRA payment reforms established incentives for physicians to 
provide the highest quality of care at the lowest possible cost. 
Physicians can pick from two different paths. They can opt to be graded 
on metrics in a number of different categories, or choose to get paid 
under a different model, such as a single payment for a bundle of 
services.

    This committee held a hearing in 2016 on the initial plan by the 
Centers for Medicare and Medicaid Services to implement these reforms. 
While the CMS implementation remains a work-in-progress, the 2 years of 
experience allow us to take stock of how well these reforms are 
working. That's why we brought in physicians and other experts who are 
at the forefront of these efforts.

    The witnesses are from physician organizations that represent 
different specialties and practice characteristics. This diversity of 
physician practice mirrors the varying needs of Medicare patients. It 
also highlights the inherent challenge in getting top-notch care to 
everyone, including those in rural areas.

    I am proud that physicians in Iowa provide high-quality care while 
spending less than in many other areas. This is the value that the 
MACRA payment reforms aim to achieve.

    I look forward to hearing from the witnesses about their experience 
and what Congress should consider for the road ahead.

                                 ______
                                 
          Prepared Statement of Scott Hines, M.D., Director, 
                   American Medical Group Association
    Chairman Grassley, Ranking Member Wyden, and distinguished members 
of the Senate Finance Committee, thank you for the opportunity to 
testify on behalf of AMGA, where I serve as chair of its Public Policy 
Committee and member of their board of directors. AMGA represents 450 
multispecialty medical groups and integrated delivery systems across 
the United States. More than 175,000 physicians practice in AMGA member 
organizations, delivering care to one in three Americans.

    I am board-certified in internal medicine, endocrinology, diabetes, 
and metabolism, and am Crystal Run Healthcare's chief quality officer, 
as well as medical director and physician leader for our medical 
specialties division. Crystal Run Healthcare employs more than 450 
providers across 50 different primary care, medical, and surgical 
specialties in 20 locations throughout the lower Hudson Valley of New 
York State. We were among the first 27 Accountable Care Organizations 
(ACOs) to participate in the Medicare Shared Savings Program (MSSP) 
since 2012. In my role as chief quality officer, I have helped develop 
and implement the clinical programs necessary to deliver value-based 
care to our patients.

    I want to thank Congress for eliminating the sustainable growth 
rate (SGR) formula in its attempt to bring more stability to the 
Medicare Part B program. The SGR formula necessitated continuous fixes 
every year, forcing policymakers to think in the short term, and we 
appreciate that we now have the opportunity and ability to plan for the 
future. Congress's passage of the Medicare Access and CHIP 
Reauthorization Act (MACRA) of 2015 represents an opportunity for 
providers to move away from the current fee-for-service reimbursement 
model and transition towards value-based care by adjusting payments 
based on quality and other key factors.

    The Centers for Medicare and Medicaid Services (CMS) envisioned 
that MACRA would help achieve three goals for the health-care system--
better care, smarter spending, and healthier people. The law and 
regulations would achieve this by rewarding physicians who performed 
well in three key areas: payment incentives, care delivery, and 
information sharing.

    Policymakers in Congress and the administration have made clear 
their intent to transform the way health care is financed and delivered 
in this country. The need to move Medicare to value is evident today, 
more than ever, and I believe Congress passed MACRA to drive that 
transition to value in Medicare Part B. Our current fee-for-service 
payment system is not sustainable and is not the model best suited to 
provide coordinated, high quality, cost effective care to our patients. 
AMGA members are looking to Congress for a stable, predictable value 
program that creates meaningful and realistic incentives that motivates 
them to make the multimillion-dollar investments needed to chart a 
course to value.

    Congressional passage of MACRA aimed to bring more stability to 
Medicare physician reimbursement by granting providers predictable 
payments until this year, when two new systems would be fully 
implemented: the Merit-based Incentive Payment System (MIPS) and 
Advanced Alternative Payment Models (APMs). AMGA members, like Crystal 
Run Healthcare, have invested considerable time and resources to 
deliver the best possible care while embarking on this pathway to 
value, and have concerns with the implementation of these two systems.
               what it takes to deliver value-based care
    The competencies necessary to deliver coordinated, value-based care 
are not incentivized in a fee-for-service system. Over the past decade, 
Crystal Run Healthcare has invested tens of millions of dollars in the 
infrastructure, personnel, and technology needed to deliver care that 
improves quality and lowers cost. Crystal Run care managers, for 
example, act as liaisons and points of contact between visits to ensure 
that our patients understand and comply with their personalized care 
plans. Our technology solutions risk stratify the population to 
identify the most vulnerable patients under our care. Homegrown 
analyses evaluate variations in care to increase awareness of, and 
adherence to, evidence-based practice guidelines. A Care Optimization 
Team reaches out to patients identified to have gaps in care in an 
effort to reengage them and get them the care that they need. None of 
this is rewarded in a transactional, fee-for-service system. Provider 
groups like Crystal Run rely on dependable, value-oriented payment 
models from CMS in order to continue to provide such services.

    These services have a direct, positive impact on our patients. In 
the MSSP program in 2017, which is the most recent year for which we 
have finalized data, we reduced inpatient admissions per 1,000 patients 
by 3.4 percent when compared to 2016. We reduced our readmission rate 
from 16.3 percent to 14.25 percent, we reduced our emergency room (ER) 
utilization by 4.9 percent, and we reduced our per member per month 
spend on skilled nursing facilities by 9 percent. In total, we saved 
CMS $5.6 million on the nearly 15,000 beneficiaries we were accountable 
for that year. As significant as this may be on a population level, it 
is more impactful to understand how care is different, and better, on 
an individual patient level.

    Take patient A as an example. Patient A is a Medicare beneficiary 
in the MSSP program who was referred to the endocrinology clinic for 
uncontrolled diabetes. During the history and examination it was 
discovered that her blood sugar was four times normal and she was 
significantly dehydrated. Intravenous fluids and subcutaneous insulin 
were administered immediately in the clinic and the patient started to 
feel better. Upon further questioning, she said that she had not been 
exercising of late due to developing chest tightness and shortness of 
breath whenever she walked up an incline. A cardiology consult was 
immediately sought and the patient was transported across the hall to 
the cardiology clinic. There she had an EKG and echocardiogram that 
suggested she had unstable angina. An interventional cardiologist was 
called and advised his colleague to send Patient A to the local ER 
where he would admit her for a cardiac catheterization. That study 
revealed two blockages that were able to be stented and the patient was 
admitted for observation and discharged the next day. The series of 
events from office visit to catheterization occurred over the course of 
less than twelve hours because care was coordinated and provided in a 
multispecialty setting.

    Contrast Patient A with one of my relatives (Patient B) who obtains 
his medical care in a typical community setting. Patient B called his 
primary care physician complaining of worsening back pain. He was told 
to go to the ER because he had no open appointments that day. Upon 
arrival in the ER, he was given one dose of intravenous pain medication 
and waited 4 hours to see a physician. That physician did a cursory 
examination and told Patient B that he needed to make a follow-up with 
the on call orthopedic surgeon. The first available appointment was in 
2 weeks. At that appointment, the nurse told Patient B that the surgeon 
he was scheduled to see was a shoulder specialist, not a back 
specialist so he needed to reschedule his appointment since the back 
surgeon was not in the office that day. Two weeks later, Patient B 
finally saw the back specialist and was told that he needed surgery 
pending medical clearance. Since Patient B's primary care physician and 
cardiologist were in different practices from the orthopedic surgeon, 
it took nearly 6 weeks to obtain the necessary clearance for surgery. 
Luckily, the surgery went smoothly but Patient B was forced to remain 
in the hospital an extra day because there was confusion on who was 
supposed to discharge him. That extra time in the hospital resulted in 
a urinary tract infection that worsened Patient B's dementia and 
required an additional two days in the hospital and a brief stay in a 
skilled nursing facility (SNF) after discharge. Given the experiences 
of Patient A and Patient B, in which setting would you like your 
children or parents to receive care?
                  merit-based incentive payment system
    MIPS was designed as a transition tool--an on-ramp to value-based 
payment in the Medicare program. However, CMS has not implemented MIPS 
as Congress intended. Under MACRA, MIPS providers would have the 
opportunity to earn positive or negative payment adjustments based on 
their performance, starting at +/-4 percent in 2019 and increasing to 
+/-9 percent in 2023. By putting provider reimbursements at risk, 
Congress intended to move Medicare to a value-based payment model where 
high performance was rewarded and poor performers were incentivized to 
improve with lower payment rates.

    Despite Congress's goals, CMS has excluded nearly half of eligible 
clinicians from MIPS requirements through its MACRA regulations. 
Because MIPS is budget neutral, these exclusions result in 
insignificant payment adjustments to high-
performing providers. For example, in 2020, CMS expects a 1.5-percent 
payment adjustment for high performers, compared to a potential 5-
percent adjustment provided for in the law. And in 2021, CMS expects a 
2-percent payment adjustment for high performers, but the statute 
allows for a potential 7-percent adjustment. By excluding half of 
providers from MIPS, the system has devolved into an expensive 
regulatory compliance exercise with little impact on quality or cost.

    I understand my colleagues' concerns for physicians practicing in 
solo or smaller practices, and that the reporting burden on them is at 
times significant. However, we must recall that the MIPS program is a 
continuation of quality programs that have existed for years, namely 
the Physician Quality Reporting System (PQRS), the Value-Based Payment 
Modifier (VBM), and the Meaningful Use (MU) programs, where previously 
no one was excluded from participating--especially not half of eligible 
clinicians. In fact, under prior law, combined penalties for failure to 
participate in PQRS, VBM, and MU could be up to negative 11 percent.\1\ 
Additionally, there is an opportunity for bonus points for high 
performers under MIPS.
---------------------------------------------------------------------------
    \1\ Statement of the American Medical Association to the U.S. House 
of Representatives Committee on Energy and Commerce Subcommittee on 
Health, Re: ``MACRA and MIPS: An Update on the Merit-based Incentive 
Payment System,'' July 26, 2018, https://energycommerce.
house.gov/sites/democrats.energycommerce.house.gov/files/documents/
Testimony-Barbe-%20HE
-MACRA-and-MIPS-An-Update-on-the-Merit-based-Incentive-Payment-System-
2018-07-26.pdf.

    Congress correctly anticipated that small and rural providers may 
need extra assistance and authorized funding in MACRA to provide that 
help. With this funding CMS created the Small, Underserved, and Rural 
Support initiative to provide free, customized technical assistance to 
clinicians in small practices. This serves both the small clinicians 
and the overall Medicare program better than simply excusing them from 
participation. If we want to be successful in moving our health-care 
system to value, policymakers should no longer exclude providers from 
participating in MIPS.
               advanced alternative payment model program
    For Advanced APMs, the other pathway to value under MACRA, the 
system's requirements need to be revised to allow for increased APM 
participation. To qualify for the program, providers must meet or 
exceed minimum revenue thresholds from APMs, or minimum numbers of 
Medicare beneficiaries in these models. For example, for performance 
year 2019, in order to become a qualified participant, a provider must 
receive at least 50 percent of their Medicare Part B payments, or see 
at least 35 percent of Medicare patients through Advanced APMs. The 
threshold increases to 75 percent of revenue for performance year 2021. 
However, AMGA members report APM requirements are unrealistic, unlikely 
to be met, and will not attract the numbers of physicians and medical 
groups necessary to ensure the program's success.

    In order for more providers to transition to value, there is a need 
for Congress to offer meaningful incentives so providers will make the 
multimillion-dollar investments to build a value-based platform. By 
eliminating or revising these arbitrary thresholds, and extending the 
APM program beyond its 2024 sunset date, Congress would strongly 
demonstrate to the health-care community its commitment to offering a 
stable and predictable risk platform to providers ready to move to 
value.
Accountable Care Organizations
    Participants in the Federal ACO program, like Crystal Run 
Healthcare, have been moving towards value while making improvements in 
care processes and the delivery of high-quality care, all while 
reducing healthcare utilization. However, ACOs have encountered 
significant obstacles in program design that threaten not only their 
own success, but also the future sustainability of the program. AMGA 
members have invested considerable financial, clinical, operational, 
and leadership resources to establish sophisticated care management 
infrastructures and organizational cultures necessary to support the 
goals of the ACO program. ACOs need a workable financing and 
operational structure that adequately incentivizes their move to value. 
In order to maintain the viability and structure of the ACO program, 
AMGA has several recommendations.

    Providers that willingly assume financial risk for a patient 
population require a consistent regulatory framework. In the ACO 
program, rules that shift depending on what level of risk is accepted 
is counterproductive, as the care delivery processes must change to 
adapt to new program rules. Lessons learned under one set of rules may 
not apply to a care process that must account for a different set of 
requirements or options. For example, rather than use payment waivers 
or beneficiary incentive programs as an incentive to take on risk, 
Congress should synchronize rules across all Federal ACO levels. This 
will allow providers who participate in the program to create delivery 
models that incorporate payment waivers such as the 3-day qualifying 
inpatient stay for SNF care and other post-discharge home-visit 
supervision requirements. Limiting these waivers or any beneficiary 
incentives to a subset of ACOs creates a situation that requires 
providers to adjust how they deliver care with no benefit to patients. 
Indeed, why patients should be required to stay in a hospital for three 
days or more before they are discharged to a SNF penalizes the patient 
for no other reason than a provider is in a different ACO level than 
another. The only meaningful difference in ACOs should be the level of 
financial risk a provider is willing to accept as an ACO moves up the 
risk continuum.

    Appropriate and accurate risk adjustment is a vital aspect of any 
performance-based program. When determining the risk adjustment factor, 
CMS has become overly concerned about coding efforts. Instead, the risk 
adjustment methodology should be chiefly concerned with the health 
status of the population assigned to the ACO. CMS uses Hierarchical 
Condition Category (HCC) prospective risk scores to account for changes 
in severity and case mix. It is possible that year-over-year the 
population's health status may improve. Conversely, it may worsen. As 
such, a risk adjustment factor should be concerned with just that: the 
health status of the ACO's beneficiaries.

    CMS's recent decision to set a 40-percent shared savings rate for 
ACO Basic Levels A and B only weakens financial incentives to move 
providers to risk. This level is insufficient and less than what was 
originally included in the MSSP. The levels of shared savings need to 
be increased to encourage participation and recognize the investments 
ACOs make.

    We should adjust ACO regional benchmarking so that they are not 
competing against themselves. Currently, CMS incorporates historical 
spending when resetting subsequent agreement period benchmarks. 
Historical spending should factor into a reset benchmark for those ACOs 
that are spending more than their region. These ACOs will then have the 
incentive to address their spending and align their costs to that of 
their region. However, those ACOs that have demonstrated an ability to 
deliver care below the regional cost should be evaluated against their 
region, as it would be increasingly difficult for an ACO to 
consistently perform better than its historical costs.

    Lastly, new repayment mechanisms should be provided for ACOs. As of 
2015, CMS no longer allows ACOs to purchase reinsurance policies as a 
repayment mechanism. Allowing for ACOs in two-sided risk-based 
contracts to purchase a reinsurance policy would allow them to mitigate 
significant financial losses.

    I truly believe Congress passed MACRA to drive the transition to 
value in Medicare Part B. However, since 2017, the first performance 
year for MIPS, we have clearly taken a step back from this transition, 
by excluding half of eligible clinicians from MIPS and enforcing 
arbitrary threshold requirements for Advanced APMs. Additionally, 
providers in the MSSP need one, and only one set of rules to follow. 
Creating different programmatic rules depending on which track a 
provide is on requires ACOs to develop new care processes based not on 
what is best for the patient, but rather by what CMS requires. On 
behalf of AMGA and Crystal Run Healthcare, we are ready to work with 
Congress and CMS to ensure that MACRA can serve its intended purpose in 
moving our Medicare system to value.

                                 ______
                                 
        Questions Submitted for the Record to Scott Hines, M.D.
                Questions Submitted by Hon. Rob Portman
    Question. I introduced the Medicare Care Coordination Improvement 
Act with Senator Bennet in an effort to reduce some of the barriers 
that providers face when they participate in alternative payment 
models. However, one particular section of my bill focuses on providing 
temporary waivers to practices that are interested in testing their own 
APMs. HHS has been slow to take up new APM concepts, and thus: what can 
we do to incentivize the establishment of new APMs? Has the PTAC 
offered a viable way to propose and test new APMs? If not, what actions 
could be taken to encourage the adoption of PTAC models?

    Answer. In order to establish new APMs, Congress must offer 
meaningful incentives so providers will make the multimillion-dollar 
investments to build a value-based platform. By eliminating or revising 
the arbitrary thresholds, and extending the APM program beyond its 2024 
sunset date, Congress would strongly demonstrate to the health-care 
community its commitment to offering a stable and predictable risk 
platform to providers ready to move to value. Synchronizing rules 
across all APMs would also incentivize their establishment.

    Current APM participants, like those in the Federal Accountable 
Care Organization (ACO) program, have made significant improvements in 
care processes and the delivery of high-quality care, while reducing 
health-care utilization. Although many ACOs have improved the quality 
of care and saved Medicare dollars, program results have been uneven at 
best. ACOs have encountered significant obstacles in program design 
that threaten not only their own success, but also the future viability 
of this program.

    AMGA members have invested significant financial, clinical, 
operational, and leadership resources to establish sophisticated care 
management infrastructures and organizational cultures necessary to 
support the goals of the ACO program. They have done so because it is 
the right thing to do for their patients and they want to assist 
Congress, the Centers for Medicare and Medicaid Services (CMS), and 
other payers to create the new payment models that reward coordinated, 
patient-centered care with measurable outcome improvements. To achieve 
that goal, ACOs need a workable financing and operational structure 
that adequately incentivizes this important work.

    Question. Per data from CMS, about half of all Medicare providers 
are participating in MIPS, with the majority of these non-participating 
providers being exempt via the low-volume threshold. While we don't 
want to place additional burdens on small and rural providers, we 
should be identifying ways to engage with these practices to help them 
transition towards value-based outcomes.

    What actions should be taken to engage with these providers?

    Answer. We understand the concerns for physicians practicing in 
rural or small practices that the reporting burden on them is at times 
significant. However, the MIPS program is a continuation of quality 
programs that have existed for years, namely the Physician Quality 
Reporting System (PQRS), the Value-Based Payment Modifier (VBM), and 
the Meaningful Use (MU) programs, where previously no one was excluded 
from participating--especially not half of eligible clinicians. In 
fact, under prior law, combined penalties for failure to participate in 
PQRS, VBM, and MU could be up to negative 11 percent. In addition to 
these legacy quality programs that have been around for 10 years, when 
MACRA passed in 2015 it gave doctors 4 years of 0.5 percent automatic 
updates to get ready to participate. There is also an opportunity for 
bonus points for high performers under MIPS.

    Congress correctly anticipated that small and rural providers may 
need extra assistance and authorized funding in MACRA to provide that 
help. With this funding, CMS created the Small, Underserved, and Rural 
Support initiative to provide free, customized technical assistance to 
clinicians in small practices. This serves both the small clinicians 
and the overall Medicare program better than simply excusing them from 
participation. MACRA should be implemented as the statute requires and 
policymakers should no longer exclude providers from participating in 
MIPS.

                                 ______
                                 
                 Questions Submitted by Hon. Ron Wyden
    Question. The Independence at Home demonstration, which was 
expanded and extended last year through the CHRONIC Care Act, enables 
care teams to deliver high-quality primary care to Medicare 
beneficiaries in the comfort of their own homes. In its third 
performance year, according to the Centers for Medicare and Medicaid 
Services (CMS), Independence at Home saved $16.3 million for the 
Medicare program.\1\ A recent evaluation also found that Independence 
at Home has resulted in fewer emergency department visits leading to 
hospitalization, a lower proportion of beneficiaries with at least one 
unplanned hospital readmission during the year, and a reduced number of 
preventable hospital admissions.\2\
---------------------------------------------------------------------------
    \1\ https://innovation.cms.gov/Files/fact-sheet/iah-yr3-fs.pdf.
    \2\ https://innovation.cms.gov/Files/reports/iah-rtc.pdf.

    As I mentioned at the hearing, I am committed to building on the 
success of the Independence at Home demonstration. As discussed at the 
hearing, I understand that the new Primary Care First model recently 
announced by CMMI (the Center for Medicare and Medicaid Innovation at 
CMS) may provide an avenue to expand access to home-based primary care 
---------------------------------------------------------------------------
for more Medicare beneficiaries.

    Based on your members' experience in Independence at Home and other 
alternative payment models, what key components will be necessary in 
order for the Primary Care First model to expand access to home-based 
primary care?

    Answer. We are looking forward to reviewing the details of the 
Primary Care First model when the Centers for Medicare and Medicaid 
Services issues its Request for Applications later this year. In any 
value-based model of care, however, there are some key features that 
providers will need to have the best opportunity to succeed. In order 
for the Primary Care First model to expand access to home-based primary 
care, incentives for providers must exist. I also would recommend that 
Congress eliminate the arbitrary APM threshold requirements so that 
more providers will qualify as an Advanced Alternative Payment Model 
under the Quality Payment Program. In addition, the APM program should 
be extended beyond 2024.

    Lack of access to administrative claims data also is a barrier to 
the success of these payment models. AMGA members report that while 
some payers share this data with them, the majority of payers do not. 
Without this data, it is challenging to manage the cost and quality of 
a population of patients, which is a goal of moving to value-based 
care. Congress should require Federal and commercial payers to provide 
accurate, timely access to all administrative claims data to health-
care providers in value-based arrangements.

    Question. What other specific policies would you recommend Congress 
or CMS consider to expand access to home-based primary care for more 
Medicare beneficiaries?

    Answer. Additionally, we recommend Congress or CMS consider 
expanding telehealth, eliminating the 20 percent Chronic Care 
Management cost-sharing requirement, and decreasing administrative 
burden and providing regulatory relief for participants in these 
models.

    Question. As I mentioned during the hearing, I often hear from 
seniors in Oregon that they don't feel like anyone is in charge of 
managing their health care and helping them navigate the health-care 
system. I am proud of the bipartisan work that this committee did on 
the CHRONIC Care Act last Congress to update the Medicare guarantee. In 
my view, the next step should be making sure that all Medicare 
beneficiaries with chronic illnesses have someone running point on 
their health care--in other words, a chronic care point guard--
regardless of whether they get their care through Medicare Advantage 
(MA), an accountable care organization (ACO) or other alternative 
payment model, or traditional fee-for-service Medicare.

    For beneficiaries in traditional, fee-for-service Medicare, what 
can be done to improve care coordination and make sure their physicians 
and other health-care professionals are all talking to each other and 
working together to provide the best possible care to those 
beneficiaries? What specific policies would you recommend this 
committee pursue toward that end?

    Answer. To improve care coordination, we recommend continued 
efforts by Congress to reduce Medicare's regulatory burden by linking 
regulatory reform efforts to providers participating in value-based 
payment models. For example, Federal legislation and regulations 
governing physician self-referral, collectively termed the ``Stark 
Law,'' were intended to prevent financial conflicts of interest around 
physician self-referrals in fee-for-service (FFS) settings. As Medicare 
transitions to value-based arrangements, the need for these protections 
and related self-referral and anti-kickback regulations lessen, as 
incentives to over-utilize health-care services diminish.

    Participants in the MSSP or ACO program often have to receive 
several fraud and abuse waivers since the financial incentives push 
providers to improve the continuity, coordination, and continuum of 
care for assigned ACO beneficiaries. The Stark Law's prohibitions, 
which were drafted 30 years ago, impede the physician-hospital 
relationships necessary to address overuse of services. The Stark Law 
was drafted to address volume of service increases in FFS Medicare. It 
has virtually no application in value models, which incentivize 
appropriate use of services. This law should be updated to account for 
changes in care models that have led to more integrated care delivery.

    Question. Please describe the specific steps that Congress and/or 
CMS could take to ensure all Medicare beneficiaries with chronic 
illnesses, including those in traditional fee-for-service Medicare, 
have a chronic care point guard.

    Answer. The recent legislation to waive the cost-sharing 
requirements of Medicare's Chronic Care Management (CCM) code is a 
great example of putting the idea of a chronic care point guard into 
practice. CCM is a critical part of coordinated care, and as a result, 
Medicare began reimbursing physicians for CCM under a separate code in 
the Medicare Physician Fee Schedule. As you are aware, this code is 
designed to reimburse providers for non-face-to-face care management. 
We support this initiative to further manage chronic care conditions to 
improve the health of patients.

    The creation of a separately billable code, however, created a 
beneficiary cost-sharing obligation for care management services. Under 
current policy, Medicare beneficiaries are subject to a 20 percent 
coinsurance requirement to receive the service. This cost-sharing 
requirement creates a barrier to care, as beneficiaries are not 
accustomed to sharing the cost for care management services. 
Consequently, only 684,000 out of 35 million Medicare beneficiaries 
with two or more chronic conditions benefited from CCM services over 
the first 2 years of the payment policy.

    AMGA supports the legislation to waive the beneficiary coinsurance 
amount to facilitate further appropriate management of chronic care 
conditions to improve the health of patients. Providers and care 
managers, who would fulfill the role of the chronic care point guard, 
report many positive outcomes for beneficiaries who receive CCM 
services, including improved patient satisfaction and adherence to 
recommended therapies, improved clinician efficiency, and decreased 
hospitalizations and emergency department visits.

    Question. Eligible clinicians who receive a certain percentage of 
their payments or see a certain percentage of their patients through 
Advanced APMs are excluded from MIPS and qualify for the 5 percent 
incentive payment for payment years 2019 through 2024. Starting this 
year (performance year 2019), eligible clinicians may also become 
qualifying APM participants (and thus qualify for incentive payments in 
2021) based in part on participation in Other Payer Advanced APMs 
developed by non-Medicare payers, such as private insurers, including 
Medicare Advantage plans, or State Medicaid programs.

    Recognizing that this is the first year in which the All-Payer 
Combination Option is available, how many of your members do you 
anticipate will take advantage of the All-Payer Combination Option this 
year?

    Answer. We do not have the data available to answer at this time 
but we would expect that very few of our members are able to take 
advantage of this because, based on our risk surveys, commercial payers 
are not offering an adequate amount of risk based contracts in many 
markets.

    Question. What, if any, challenges have your members faced when 
attempting to take advantage of the All-Payer Combination Option?

    Answer. Not applicable.

    Question. In the Medicare Access and CHIP Reauthorization Act of 
2015 (MACRA), Congress provided a total of $100 million over 5 years 
for technical assistance to MIPS-eligible clinicians in practices with 
15 or fewer clinicians, focusing on rural and health professional 
shortage areas.

    To what extent have your members utilized the services of the 
Small, Underserved, and Rural Support Initiative, which CMS launched 
using the MACRA funding to provide free, customized technical 
assistance to clinicians in small practices?

    Answer. AMGA members have been preparing for the transition to 
value so we did not require additional assistance from the government 
to follow the MACRA statute.

    Question. What types of technical assistance and support have been 
most helpful to physicians and practices (e.g., understanding program 
requirements, selecting appropriate measures, forming virtual groups)?

    Answer. Not applicable.

    Question. As physicians continue to gain experience with the 
Quality Payment Program, what additional types of technical assistance 
would be most helpful to solo practitioners and physicians in small 
practices and/or to those practicing medicine in rural or underserved 
areas?

    Answer. Additional technical assistance that would be helpful to 
solo practitioners and physicians in small practices or rural areas 
would be incentives to report quality measures while participating in 
the MIPS program.

                                 ______
                                 
              Questions Submitted by Hon. Debbie Stabenow
    Question. You mentioned the Small, Underserved, and Rural Support 
Initiative in your testimony. What have you heard from your members and 
colleagues about the effectiveness of this funding for assisting rural 
practices, and how do you think it could be improved?

    Answer. Not applicable.

    Question. I am very proud of the work the bipartisan 
accomplishments to address Alzheimer's, including the implementation of 
my HOPE for Alzheimer's Act which required Medicare to pay for new 
individual care plans to support Alzheimer's patients and their 
families. Many of my colleagues are also cosponsors of my Improving 
HOPE for Alzheimer's Act, which will ensure beneficiaries and 
physicians know that they are able to access, and bill for, care 
planning under Medicare. In our last hearing on MACRA implementation, 
my colleagues raised the question of how we should look at quality 
measures in MIPS when it comes to physicians having these conversations 
with beneficiaries and their families and reflecting their priorities. 
Some have mentioned altering MIPS to make the quality measures more 
clinically meaningful. In what ways do you think the system would need 
to change to better incorporate long-term care planning and encourage 
physicians to have these conversations with patients?

    Answer. To begin, over 50 percent of eligible clinicians should not 
be excluded from participation in MIPS. For the quality measures to 
truly be more clinically meaningful, patients must receive care from 
providers that actually report these measures.

    In addition, AMGA has endorsed a set of value measures designed to 
simplify the reporting process and limit the burden on providers and 
group practices, while still reporting clinically relevant and 
actionable data. The 14 measures were selected to address the flaws 
with the current quality measurement and reporting system, which 
suffers from duplicative measures and a lack of data standardization. 
AMGA believes that the use of this set of core measures will ultimately 
save providers' time and reduce costs while improving care.

    The 14 measures are:

         1.  Emergency Department use per 1,000.
         2.  SNF admissions per 1,000.
         3.  30-day all cause hospital readmission.
         4.  Admissions for acute ambulatory sensitive conditions 
        composite.
         5.  HbA1C poor control > 9 percent.
         6.  Depression screening.
         7.  Diabetes eye exam.
         8.  Hypertension (HTN)/high blood pressure control.
         9.  CAHPS/health status/functional status.
        10.  Breast cancer screening.
        11.  Colorectal cancer screening.
        12.  Cervical cancer screening.
        13.  Pneumonia vaccination rate.
        14.  Pediatric well child visits (0-15 months).

                                 ______
                                 
               Questions Submitted by Hon. Sherrod Brown
                       the patient voice in macra
    Question. As I mentioned in my hearing questions, we passed MACRA 
to incentivize and reward high-value, patient-centered care. While 
MACRA is all about physician payment reform, our goal should be 
maximizing patient benefit. It is clear to me that we have not done 
enough to ensure the patient's voice is a part of the process, and that 
patients are benefiting from these changes. The NIH has created 
Patient-Focused Therapy Development tools and systems dedicated to 
engaging the patient community throughout the translational science 
process. The FDA has implemented a Patient-Focused Drug Development 
model to help ensure patients' experiences, perspectives, needs, and 
priorities are captured meaningfully during drug development and 
review.

    In your testimony, you shared the story of a relative who got 
caught in the health-care system's inefficiencies. Unfortunately, I 
hear similar stories from Ohioans far too often. What more can and 
should we do to ensure both MIPS and APM programs prioritize and value 
patient satisfaction?

    Answer. MACRA must be allowed the chance to work by being 
implemented as originally intended. You will never move the needle 
towards a value-based health-care system that values patient 
satisfaction when half of eligible clinicians are excluded from 
participation in MIPS. The APM system's requirements need to be revised 
to allow for increased APM participation as well, such as eliminating 
the arbitrary threshold requirements.
                    development of metrics in macra
    Question. I have heard from a number of physicians who believe that 
there is no link between many of the MIPS measures they are required to 
report and improving clinical care for their patients. I understand 
that the physician community has engaged with CMS to try and make the 
program more meaningful to physicians and patients through more 
relevant quality measures.

    How are clinicians from your organization involved the creation of 
these measures relevant to their specialties?

    Has CMS been receptive to your feedback when provided?

    How would you assess CMS's collaboration on achieving meaningful 
metrics?

    Are there any changes in this process you would recommend?

    Answer. We are encouraged by CMS's efforts with the meaningful 
measures initiative. To help with this effort, AMGA endorsed a set of 
value measures designed to simplify the reporting process and limit the 
burden on providers and group practices, while still reporting 
clinically relevant and actionable data.

    The 14 measures were selected to address the flaws with the current 
quality measurement and reporting system, which suffers from 
duplicative measures and a lack of data standardization. AMGA members 
report hundreds of different quality measures to various public and 
private payers, the vast majority of which are not useful in evaluating 
or improving the quality of care provided. There is a significant cost 
to measure reporting. Research has indicated that, on average, U.S. 
physician practices across four common specialties annually spend more 
than $15.4 billion and 785 hours per physician to report quality 
measures.

    AMGA believes that the use of this set of 14 core measures will 
ultimately save providers' time and reduce costs while improving care. 
By offering a standard set of measures for value-based contracts with 
payers, the AMGA measure set will reduce the variation in the measures 
that are reported and help eliminate unnecessary confusion and 
administrative burden. The measurement set includes both process 
measures, such as cancer screening and immunization rates, which focus 
attention on quality improvement, and outcome measures, which emphasize 
the need to evaluate how care is provided to best drive quality 
improvement.

                                 ______
                                 
             Questions Submitted by Hon. Sheldon Whitehouse
    Question. Accountable Care Organizations (ACOs) have the potential 
to transform our health care delivery system. While we've seen ACOs 
improve patient care and create shared savings, many provider-led ACOs 
only control a small fraction of total spending, with specialists, 
pharmaceuticals, and hospitals accounting for most of it. This leads to 
ACOs lacking sufficient leverage to bring down costs and can contribute 
to shared losses.

    How can we improve the ACO model to account for this imbalance? How 
can we support successful ACOs and encourage more providers to follow 
their lead?

    Answer. In order to improve the ACO model and support successful 
ACOs, AMGA recommends the following: synchronize rules across all 
Federal ACO levels; reduce regulatory burdens on ACOs; increase the 
Shared Savings Rate to incentivize participation in the program; adjust 
MSSP ACO regional benchmarking so that they are not competing against 
themselves; and provide for new repayment mechanisms for ACOs.

    Question. Our health-care system is not fully equipped to care for 
an aging population and patients with advanced illness such as late-
stage cancer, Alzheimer's disease or dementia, or congestive heart 
failure. This is an area where we need new models of care that reflect 
these challenges and create a better system for providers, patients, 
and their families. Many of our current Medicare rules in this space 
are counterproductive, such as requiring a two night, three-day stay in 
an inpatient facility to qualify for skilled nursing care, and various 
disincentives to providing respite or palliative care. How are your 
organizations innovating to provide care for these patients, and what 
can Congress and CMS do to support those efforts?

    Answer. Policy-makers should waive the 3-day qualifying inpatient 
stay for skilled nursing facility (SNF) care and implement policies 
that encourage providers to work with their patients to provide 
services in the most clinically appropriate location.

    The Social Security Act requires Medicare beneficiaries to have an 
inpatient hospital stay of no fewer than 3 consecutive days to be 
eligible for Medicare coverage of SNF care. This rule dates back to the 
inception of the Medicare program, and is referred to simply as the SNF 
3-Day Rule. The 3-day stay is not required for other forms of post-
acute care, including home health care or inpatient rehabilitation 
facility stays. Today, under pay-for-value arrangements, the 3-Day Rule 
has become, as the Medicare Payment Advisory Commission (MedPAC) 
previously noted, ``antiquated.''

    Question. Despite continued investment, electronic health records 
(EHRs) remain difficult to share, challenging for patients to access, 
and a source of frustration to providers and policymakers alike. The 
business models of the EHR venders often leads to perverse incentives 
against sharing patient information.

    What steps can Congress take to make EHRs work better for 
providers? Are the proposed data blocking rules enough to start 
encouraging better data sharing by the vendors?

    Answer. In our May 2016 principles for interoperability, AMGA 
stressed the need to help providers share a patient's health 
information between each other and the patient and not block the 
exchange of electronic health information. As we strive for a health-
care system that rewards value over volume, the need to ensure this 
information is freely exchanged becomes even more important. 
Information-blocking practices are contrary to a desired well-
coordinated healthcare delivery system because sharing information 
seamlessly across the care continuum is fundamental to moving toward a 
patient-centered, high-performing delivery system. As such, the 
exceptions to the information-blocking provisions outlined in the 
recent ONC interoperability proposed rule are adequate and no 
additional exceptions are warranted.

    Question. How can we encourage States to be better innovators on 
health-care spending? The current Medicaid waivers incentivize States 
to keep costs down, but are there ways to encourage both lower costs 
and better health-care outcomes?

    Answer. A shift toward a value-based approach and away from the 
fee-for-service system is the most effective way to lower overall costs 
while encouraging better health-care outcomes. We need to align 
payments with the goals of the health-care system, and the best way to 
do this is to reduce the barriers to success in value-based care 
arrangements. If it were simpler for practices to participate and 
succeed in risk, more would adopt the models that incentivize 
outcomes--better care quality, improved patient experience, and lower 
costs--rather than volume of services provided.

                                 ______
                                 
               Questions Submitted by Hon. Maggie Hassan
    Question. We spoke during the hearing about the incentive payment 
for providers to improve tracking and reporting of opioid prescribing, 
treatment agreements, 
follow-up evaluations, and screening of patients who may be at risk of 
opioid misuse under the Medicare Access and Children's Health Insurance 
Program (CHIP) Reauthorization Act of 2015 (MACRA).

    This data has the potential to improve treatment for substance use 
disorder, which is why its collection and reporting is now incentivized 
through increased reimbursement.

    At the hearing, I asked for feedback on the impact this data 
collection and reporting has had on treatment of patients, particularly 
as it relates to any reduction in opioid misuse.

    Based on your response, it seems that there may be additional steps 
the Centers for Medicare and Medicaid Services (CMS) could take so that 
this aggregated, de-identified data can be used to benefit patients and 
improve care.

    Do you have specific suggestions on how CMS can improve the 
collection, use, and dissemination of opioid prescribing and treatment 
data sets in ways that would directly benefit patients at their site of 
care, specifically as it relates to identifying best practices to 
reduce opioid misuse?

    Answer. CMS can improve the collection, use, and dissemination of 
opioid prescribing and treatment data sets in ways that would directly 
benefit patients at their site of care, specifically as it relates to 
identifying best practices to reduce opioid misuse, by supporting 42 
CFR part 2 reform efforts.

    42 CFR part 2 requires limiting the use and disclosure of patients' 
substance use records from certain substance use programs. Under 
current law, a patient must provide written authorization permitting 
each individual provider access to their substance use disorder 
records. A lack of access to the full scope of medical information for 
each patient can result in the inability of providers and organizations 
to deliver safe, high-quality treatment and care coordination. The 
Health Insurance Portability and Accountability Act (HIPAA) grants 
providers access to a wide range of patient data to manage population 
health, while still maintaining patient privacy protections. AMGA 
requests that Congress align the 42 CFR part 2 law with HIPPA to alter 
access to patients' substance use information. This policy proposal 
would grant providers access to this data to manage population health, 
while still maintaining patient privacy protections, such as 
identifying opioid misuse.

                                 ______
                                 
           Questions Submitted by Hon. Catherine Cortez Masto
    Question. In 2011, REMSA, an EMS provider in Northern Nevada, 
received innovation grant funding from CMMI. The program was incredibly 
successful--they avoided re-hospitalizations, and improved county-wide 
health outcomes. In addition, they saved $9 million for the Medicare 
program. In 2020, CMS will launch ET3, a national model based on the 
REMSA program.

    Do we have an adequate process to transition demonstrations from 
innovation grantees to national models?

    Answer. At this time, I am not certain that we do have an adequate 
process.

    One example is participants in the Federal Accountable Care 
Organization (ACO) program, which has made significant improvements in 
care processes and the delivery of high-quality care, while reducing 
health-care utilization. Although many ACOs have improved the quality 
of care and saved Medicare dollars, program results have been uneven at 
best. ACOs have encountered significant obstacles in program design 
that threaten not only their own success, but also the future viability 
of this program.

    Question. What are some of the lessons from the success of your 
larger practices in complying with MIPS or transitioning to APMS? Are 
they applicable to small and rural groups that are eligible for 
technical assistance? If so, how can we share them with those groups?

    Answer. Crystal Run Healthcare was founded in 1996 in Orange County 
New York, which is three counties north and west of New York City. This 
is a fairly rural region, but in 2002, we expanded one county north to 
Sullivan County, which is rural and underserved. We recruited 40 
providers and built a 60,000 square foot facility that houses physician 
offices, a lab, radiology and urgent care. Those rural and underserved 
patients were able to experience the benefits of coordinated care in an 
integrated model similar to that of most AMGA member organizations.

    With the proper incentives, such as eliminating MIPS exclusions and 
eliminating arbitrary APM thresholds and possibly others, providers in 
rural areas could work with larger organizations to be able to tap into 
this model of care. Rather than preserving the status quo (a broken, 
uncoordinated, expensive fee-for-service system), we should be 
incentivizing rural providers to collaborate with organizations that 
have experience delivering care in this new manner. This is not to say 
that rural providers need to join larger entities. Each provider can 
decide for themselves what the nature of that relationship should be. 
However, if the incentives are adequate integration will occur.

                                 ______
                                 
            Prepared Statement of Barbara L. McAneny, M.D., 
                President, American Medical Association
    The American Medical Association (AMA) appreciates the opportunity 
to present our views to the U.S. Senate Committee on Finance. As the 
largest professional association for physicians and the umbrella 
organization for State and national specialty medical societies, the 
AMA has invested heavily in efforts to achieve successful 
implementation of the Medicare Access and CHIP Reauthorization Act of 
2015 (MACRA).

    Since the enactment of MACRA, the AMA has worked closely with both 
Congress and the Centers for Medicare and Medicaid Services (CMS) to 
promote a smooth implementation of the Merit-Based Incentive Payment 
System (MIPS) and Alternative Payment Models (APMs) under the Quality 
Payment Program (QPP). We continue to believe that MACRA represents an 
improvement over the flawed sustainable growth rate (SGR) payment 
methodology. However, the implementation of a new Medicare quality and 
payment program for CMS and physicians has been a significant 
undertaking, and further refinements are still needed to improve the 
program and reduce administrative burden for physicians.

    MACRA included modest positive payment updates in the Medicare 
Physician Fee Schedule, but it left a 6-year gap from 2020--next year--
through 2025 during which there are no updates at all. Following this 
6-year freeze, the law specifies physician payment rate updates of 0.75 
percent or 0.25 percent for physicians participating in APMs or MIPS, 
respectively. By contrast, other Medicare providers will continue to 
receive regular, more stable updates.

    The recent ``2019 Annual Report of the Board of Trustees of the 
Federal Hospital Insurance and Federal Supplementary Medical Insurance 
Trust Funds'' (``Medicare Trustees Report'') found that scheduled 
physician payment amounts are not expected to keep pace with the 
average rate of physician cost increases, which are forecast to average 
2.2 percent per year in the long range. The Medicare Trustees Report 
also found that ``absent a change in the delivery system or level of 
update by subsequent legislation, the Trustees expect access to 
Medicare-participating physicians to become a significant issue in the 
long term.''\1\ The AMA agrees and urges Congress to replace the 
upcoming physician payment freeze with annual positive payment updates 
over the next several years to provide physicians with a stable and 
sustainable revenue source that allows them a margin to invest in 
practice improvements in order to transition to more efficient models 
of care delivery to better serve Medicare patients.
---------------------------------------------------------------------------
    \1\ U.S. Department of Health and Human Services, Centers for 
Medicare and Medicaid Services. (April 22, 2019). ``2019 Annual Report 
of the Board of Trustees of the Federal Hospital Insurance and Federal 
Supplementary Medical Insurance Trust Funds.'' Retrieved from https://
www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-
Reports/Reports
TrustFunds/Trustees-Reports-Items/2016-2019.html.

    One goal of MACRA was to provide physicians with a glide path to 
transition into APMs. To help facilitate this transition, Congress 
provided a 5-percent bonus for physicians who participate in Advanced 
APMs during the first 6 years of the program. Unfortunately, through 
the first 3 participation years--half the time this bonus was to be 
available--few physicians have had the opportunity to participate in 
Advanced APMs. Consequently, the AMA is urging Congress to extend the 
Advanced APM bonus payments to fulfill Congress's original intent and 
---------------------------------------------------------------------------
provide support to physicians as they transition to new payment models.

    In addition to a sustained glide path to allow physicians to 
transition to APMs, the AMA urges Congress and CMS to continue to make 
MIPS more meaningful for physicians. We hear from our physician members 
that there is no link between many of the MIPS measures they are 
required to report and improving clinical care for their patients. The 
AMA has engaged the physician community through workgroups to develop 
creative solutions to simplify and streamline the QPP, while making it 
more meaningful for physicians. We look forward to working with 
Congress and CMS to implement some of these creative solutions and 
continue to improve MIPS.
                    improvement over legacy programs
    The AMA was supportive when Congress replaced the flawed, target-
based SGR formula with a new payment system under MACRA in 2015. 
Scheduled payment cuts prior to the implementation of MACRA exceeded 20 
percent. Those cuts would have had a devastating impact on physician 
practices and patient access to care. Under MACRA, the SGR formula was 
replaced with specified payment updates for 2015 through 2019 and for 
2026 and beyond. MACRA also created an opportunity to address problems 
found in existing physician reporting programs. In addition, the law 
sought to promote innovation by encouraging new ways of providing care 
through APMs.
Support for Technical Corrections
    The AMA strongly supported the changes to MACRA in the Bipartisan 
Budget Act of 2018 (BBA18). These technical changes helped many 
practices avoid penalties that they likely would otherwise have 
incurred under the MIPS program. Specifically, we commend Congress for 
excluding Medicare Part B drug costs from MIPS payment adjustments, as 
including these additional items and services created significant 
inequities in the administration of the MIPS program. In addition, we 
appreciate the flexibility given to CMS to reweight the Cost 
performance category to not less than 10 percent for the 3rd, 4th, and 
5th years of MIPS, and to set the performance threshold for 3 
additional years. As Congress intended, we believe the goal of the 
program should be to help physicians succeed, not to cause physicians 
to fail, and we believe these technical changes, along with other 
changes, will allow CMS to increase the program requirements gradually 
and transition to a more meaningful program over time.

    We also appreciated the BBA18 provision that allowed the Physician-
focused Payment Model Technical Advisory Committee (PTAC) to provide 
initial feedback to proposal submitters. Unfortunately, the PTAC has 
indicated that it is still not able to provide technical assistance and 
data analyses to stakeholders who are developing proposals for its 
review. Additional technical corrections may be needed to provide the 
PTAC with more flexibility in this regard.
Support for Small and Rural Practices
    The AMA appreciates the accommodations for small practices that are 
included MIPS. Specifically, the low-volume threshold exemption 
excludes numerous small practices or physicians who see very few 
Medicare patients. In 2018, physicians with annual Medicare allowed 
charges of $90,000 or less or 200 or fewer Medicare patients were 
exempt from the QPP altogether. In 2019, CMS extended the low-
volume threshold to physicians who provide 200 or fewer covered 
professional services to Medicare Part B beneficiaries. The AMA has 
also supported reduced reporting requirements for small practices, 
hardship exemptions from the Promoting Interoperability MIPS 
performance category for qualifying small practices, bonus points for 
small practices, and technical assistance grants to help small and 
rural practices succeed in the program.

    Despite these improvements, the AMA and our physician members still 
have significant concerns regarding the ability for small and rural 
practices to succeed in the MIPS program. In 2017, the national mean 
and median scores for all MIPS eligible clinicians were 74.01 and 88.97 
points. However, the mean and median scores for rural and small 
practices were 43.46 and 37.67, and 63.08 and 75.29, respectively. 
Given the lower scores achieved by small and rural practices compared 
to all MIPS eligible clinicians, the AMA urges Congress and CMS to 
continue to implement policies that help small and rural physician 
practices succeed in MIPS.
                          glide path into apms
Extend the Advanced APM Bonus
    MACRA was intended to create a gradual glide path to move 
physicians into more innovative value-based care payment models. 
Changing the way physicians deliver care requires significant 
investment into new technologies and workflow systems. In order to help 
physicians implement these changes, MACRA provided a 5-percent bonus 
for the first 6 years of the program for physicians who participate in 
an Advanced APM. These bonus payments were intended to create a margin 
for physicians to invest in changing the way they deliver care. We 
heard from many physician groups who were excited to take advantage of 
the opportunity to move to an Advanced APM.

    Unfortunately, there were a limited number of Advanced APMs in 
which physicians could participate during the first 3 MACRA performance 
years, and there are only 3 years left in the program for physicians to 
receive an APM bonus. The dearth of Advanced APMs available for 
physicians limited their ability to take advantage of the APM bonus 
that Congress provided to assist physicians with moving to new, 
innovative payment models.

    The AMA is greatly encouraged by the recent steps taken by 
Department of Health and Human Services Secretary Azar, CMS 
Administrator Verma, and Center for Medicare and Medicaid Innovation 
(CMMI) Director Boehler. They are working to implement and further 
develop new models based on stakeholder proposals to the PTAC. We 
believe there will be increased opportunities for physicians in various 
practice group sizes and specialties to participate in Advanced APMs as 
CMMI continues to release new models. However, given the small number 
of physicians who have been eligible to receive the APM Qualified 
participant (QP) bonus to date, the AMA strongly urges Congress to 
extend the APM bonus for an additional 6 years to provide physicians a 
realistic onramp to participation in value-based care. As CMMI 
continues to test and develop new models, the AMA hopes that physicians 
will have access to APMs that give them the resources and flexibility 
to redesign the delivery of patient care and support their efforts to 
achieve good health outcomes.
Modify Thresholds to Achieve QP Status
    In addition to extending the period of time that the QP bonus 
payments are available to APM participants, the AMA recommends that 
Congress revisit the payment thresholds set by MACRA. Under current 
law, these thresholds escalate from 25 percent to 75 percent of APM 
participant revenues over a 5-year period. Many APM participants are 
concerned that these thresholds are too high, especially for episode-
based APMs. MACRA set the payment thresholds but gave limited authority 
to CMS to set patient thresholds to achieve QP status. The AMA 
recommends that CMS' statutory authority be expanded so it can set both 
the payment and patient thresholds for QP status and could set 
different thresholds for different types of APMs.
Further Improvements Are Needed
    The AMA urges Congress to make additional technical changes to 
MACRA to simplify the program and make reporting more clinically 
meaningful for physicians. We were pleased CMS established transition 
policies for the first year of MIPS and, as a result, 93 percent of 
eligible clinicians received a modest positive payment adjustment and 
nearly three-quarters qualified for an additional exceptional 
performance bonus. However, we continue to hear from physicians that 
the program needs to be streamlined and more clinically relevant. To 
assist Congress and CMS in making the program cohesive and meaningful 
to physicians and patients, the AMA convenes MIPS and APM workgroups 
made up of representatives from across the physician community, which 
have developed creative solutions to improve the QPP. These solutions 
include ways to simplify scoring, create more integrated approaches to 
reporting across performance categories, and improve the physician 
reporting experience.

    For example, Congress and CMS can make MIPS more cohesive and 
meaningful to physicians and patients by allowing physicians to focus 
their participation around a specific procedure, condition, or public 
health priority. By allowing physicians to focus on activities that fit 
within their workflow and address their patient population needs, 
rather than focusing on segregated activities that fit into the four 
disparate MIPS categories, the program could improve the quality of 
care and be more meaningful and less burdensome for physicians. The AMA 
has worked closely with the physician community to develop a 
streamlined MIPS participation option that would hold physicians 
accountable for the cost and quality of care around a specific episode. 
For instance, a cardiologist could participate in a MIPS episode 
evaluating cost and quality using valid and reliable measures, as well 
as health IT use, around Percutaneous Coronary Intervention procedures 
and primary care physicians could focus on lowering costs and improving 
quality by maximizing patient engagement through a Patient-Centered 
Medical Homes. This participation option in MIPS would also be a bridge 
to APMs by giving physicians an opportunity to gain experience and see 
their data before taking on financial risk in a bundled payment or 
advanced primary care model.

    Additional suggestions for technical changes to improve MACRA from 
the work groups include:

          Updating the Promoting Interoperability performance category 
        to allow physicians to use certified electronic health record 
        technology (CEHRT) in more clinically relevant ways;
          Developing a separate threshold for small and rural 
        practices to ensure a level playing field for all physicians;
          Prioritizing cost measures that are valid and actionable and 
        that have stronger correlation between costs and the 
        physicians' influence over those costs;
          Incentivizing reporting on new quality measures, especially 
        specialty developed and recommended measures;
          Eliminating the requirement to set the performance threshold 
        at the mean or median so CMS, rather than a pre-set formula, 
        can determine whether physicians are ready to move to an 
        increased threshold based on available data; and
          Aligning and improving the methodologies of MIPS 
        calculations and Physician Compare. Currently, physicians 
        receive two different scores and reports, which is confusing to 
        physicians and patients and does not lead to quality 
        improvement.

    The QPP is a complex program that remains complicated for CMS to 
implement and difficult for physicians to understand; however, the AMA 
is confident that if Congress, CMS, and the medical community continue 
to work together to improve the program, we can ensure physicians have 
the opportunity to be successful and provide high-value care to 
patients.

    The AMA remains committed to ensuring that the MACRA program is 
successful. We appreciate the opportunity to provide our comments on 
the current MACRA program, and look forward to continuing to work with 
the committee and CMS to make further refinements to the program.

                                 ______
                                 
     Questions Submitted for the Record to Barbara L. McAneny, M.D.
                Questions Submitted by Hon. Rob Portman
    Question. I introduced the Medicare Care Coordination Improvement 
Act with Senator Bennet in an effort to reduce some of the barriers 
that providers face when they participate in alternative payment 
models. However, one particular section of my bill focuses on providing 
temporary waivers to practices that are interested in testing their own 
APMs. HHS has been slow to take up new APM concepts, and thus: what can 
we do to incentivize the establishment of new APMs? Has the PTAC 
offered a viable way to propose and test new APMs? If not, what actions 
could be taken to encourage the adoption of PTAC models?

    Answer. First, the AMA strongly supports the Medicare Care 
Coordination Improvement Act of 2019 because it would increase care 
coordination for patients, improve health outcomes, and reduce spending 
by allowing physicians to participate and succeed in APMs. The vision 
of greater APM adoption can only be achieved if antiquated laws like 
Stark, which are based on outdated treatment delivery schemes, are 
modernized; the Act would help advance this vision.

    Tying compensation to the value of care provided, equipping 
providers with tools to improve care especially when that involves 
development of lower cost imaging centers or labs that are imbedded in 
the APM structure, and investing in software and care coordination 
tools to clinically and financially integrate, may run afoul of the 
Stark law. Specifically, in certain circumstances, it prohibits 
physicians from providing innovative services such as transportation or 
other services of value to their patients. Instead, the patient, in 
addition to dealing with the physical and emotional aspects of a 
disease or condition, must also attempt to coordinate their own care in 
a fragmented and siloed system. Accordingly, the AMA has urged Congress 
to create a Stark exception and anti-kickback safe harbor to facilitate 
coordinated care and promote well-designed APMs. This exception should 
be broad, covering both the development and operation of a model to 
allow physicians to transition to an APM model, and provide adequate 
protection for the entire care delivery process to include downstream 
care partners, entities, and manufacturers who are linking outcomes and 
value to the services or products provided.

    Second, AMA has also strongly supported the PTAC since its creation 
in MACRA. The PTAC was designed to allow physicians to develop and 
implement new payment models that would support the services physicians 
feel are necessary and provide accountability focused on aspects of 
quality and cost that physicians can control.

    There continue to be a limited number of APMs in which physicians 
can participate during the first 3 MACRA performance years. However, 
the AMA has recently been greatly encouraged by steps taken by the 
Center for Medicare and Medicaid Innovation (CMMI) that illustrate it 
is working to implement and further develop new models based on PTAC 
proposals.

    In order to ensure that physicians continue to be incentivized to 
develop APMs, we urge Congress to extend the APM bonus for an 
additional 6 years, which would allow physicians more of a realistic 
onramp to develop and move into new payment models. Given the limited 
number of APMs tested and approved to date, physicians need an 
extension of the APM bonus to allow them to experiment with new models 
and change the way they deliver care.

    We also recommend that Congress make technical corrections to MACRA 
that would give the PTAC explicit authority to provide data analyses 
and technical assistance to stakeholders developing physician-focused 
APM proposals. A provision of the Bipartisan Budget Act of 2018 allows 
PTAC to provide initial feedback to proposal submitters, but PTAC has 
been barred from providing the types of data analyses and technical 
assistance that could help stakeholders develop proposals that CMMI 
would be more readily able to implement.

    We appreciate Congress's continued efforts to work with CMS and the 
physician community to ensure there are sufficient numbers of APMs for 
physicians to choose from.

    Question. Per data from CMS, about half of all Medicare providers 
are participating in MIPS, with the majority of these non-participating 
providers being exempt via the low-volume threshold. While we don't 
want to place additional burdens on small and rural providers, we 
should be identifying ways to engage with these practices to help them 
transition towards value-based outcomes.

    What actions should be taken to engage with these providers?

    Answer. The AMA continues to believe the simplest way to ensure 
small and rural practices remain viable is to maintain the low-volume 
threshold. To eliminate or reduce the threshold, and force physicians 
to participate in MIPS, when they see such few Medicare patients, could 
cause small and rural practices to close.

    If Congress's goal is to help these small practices transition into 
value-based outcomes, it should focus on ensuring the development and 
implementation of APMs are realistic for small practices to implement. 
This may require multiple small pilot models to determine what will 
best meet the goals of patients and CMS. In addition, the extension of 
the APM bonus payments, as mentioned above would provide a more 
realistic onramp for small practices to start implementing APMs.

    Finally, Congress should revisit the APM Qualifying Participant 
(QP) payment thresholds set by MACRA. It is unrealistic for many small 
practices to escalate from 25 to 75 percent of APM participant revenues 
over a 5-year period. These thresholds are especially difficult to 
achieve for practices that implement episode-based APMs. Therefore, the 
AMA has recommended that CMS' statutory authority be expanded so it can 
set both the payment and patient thresholds for QP status and set 
different thresholds for different types of APMs.

    In addition, the costs of compliance with MIPS reporting criteria 
need to be addressed. As I mentioned in my testimony, my practice 
scored 100 percent on MIPS but the increase in payments was $104,000 
less than the cost of achieving that score.

                                 ______
                                 
                 Questions Submitted by Hon. Ron Wyden
    Question. The Independence at Home demonstration, which was 
expanded and extended last year through the CHRONIC Care Act, enables 
care teams to deliver high-quality primary care to Medicare 
beneficiaries in the comfort of their own homes. In its third 
performance year, according to the Centers for Medicare and Medicaid 
Services (CMS), Independence at Home saved $16.3 million for the 
Medicare program.\1\ A recent evaluation also found that Independence 
at Home has resulted in fewer emergency department visits leading to 
hospitalization, a lower proportion of beneficiaries with at least one 
unplanned hospital readmission during the year, and a reduced number of 
preventable hospital admissions.\2\
---------------------------------------------------------------------------
    \1\ https://innovation.cms.gov/Files/fact-sheet/iah-yr3-fs.pdf.
    \2\ https://innovation.cms.gov/Files/reports/iah-rtc.pdf.

    As I mentioned at the hearing, I am committed to building on the 
success of the Independence at Home demonstration. As discussed at the 
hearing, I understand that the new Primary Care First model recently 
announced by CMMI (the Center for Medicare and Medicaid Innovation at 
CMS) may provide an avenue to expand access to home-based primary care 
---------------------------------------------------------------------------
for more Medicare beneficiaries.

    Based on your members' experience in Independence at Home and other 
Alternative Payment Models, what key components will be necessary in 
order for the Primary Care First model to expand access to home-based 
primary care?

    Answer. The AMA is happy to work with you and your colleagues to 
expand access to home-based primary care. The AMA continues to support 
the Independence at Home (IAH) Demonstration Program, which has already 
produced savings to the Medicare program as well as improved health 
outcomes among a beneficiary population that is medically fragile with 
high acuity. The comprehensive approach and flexibilities provided by 
the IAH Demonstration have established a proven method for providing 
care in less costly settings that enhance the quality of patient care. 
Notably, IAH teams that include a physician and have an established 
relationship with a hospital are able to provide the most 
comprehensive, coordinated care, particularly for patients with complex 
comorbidities.

    Question. What other specific policies would you recommend Congress 
or CMS consider to expand access to home-based primary care for more 
Medicare beneficiaries?

    Answer. In order to improve home-based primary care and access to 
timely medical treatment for Medicare's most vulnerable and high acuity 
beneficiaries, the AMA strongly urges Congress to provide access to 
medically necessary and timely clinical services by lifting statutory 
restrictions on telehealth. The AMA recommends that Congress amend 
section 1834(m) of the Social Security Act to waive the geographic and 
originating site limitations for such services for home-based primary 
care. Currently, most Medicare beneficiaries are not eligible to 
receive telehealth services. A limited subset of Medicare beneficiaries 
are eligible for telehealth services that CMS has determined are 
clinically appropriate to be delivered via telehealth. The beneficiary 
must reside in a qualifying rural geographic location. Furthermore, 
even those who reside in a qualifying geographic location in most 
instances are precluded from receiving such services in their home. 
Counter-
intuitively, a Medicare beneficiary must travel to a qualifying 
facility such as their physician's office or the hospital in order to 
receive telehealth services.

    Section 1834(m) was fashioned at a time when telehealth was 
primarily used to provide access to medical specialty services in rural 
underserved communities and the technology to enable reliable, high 
quality two-way audio-visual real time communications was limited to 
health facilities. The dramatic advances in digital technology and 
rapid dispersion of such technologies obviate the concerns that 
initially prompted Congress to prescribe the section 1834(m) 
limitations. The restrictions have chilled the uptake and use of 
telehealth services as part of continuum of services a medical practice 
may offer to high acuity and medically complex beneficiaries, 
particularly those who receive home-based primary care. The limited 
Medicare coverage is in sharp contrast to commercial insurers and other 
Federal health-care programs like the Veterans Health Administration 
and Department of Defense that have moved forward to expand coverage of 
telehealth services. These Federal health-care programs moved forward 
to expand coverage because the evidence base has grown demonstrating 
both clinical efficacy for various telehealth services as well as 
overall reduction in costs through improved triage, reduction in 
emergency department visits, and reductions in hospitalization along 
with improved care coordination and communication.

    Coordination of care between primary and specialty care is an 
essential part of keeping complex Medicare patients out of the 
hospital. Removing the restriction on telemedicine for both primary and 
specialty care would facilitate multidisciplinary care and extend the 
effective reach of the primary care physician.

    For the past several years, the AMA has urged CMS to undertake 
telehealth demonstrations that waive these restrictions to evaluate 
whether expansion is warranted under CMMI authority. We have 
recommended a request for proposal(s) for demonstrations to evaluate 
the telehealth services Medicare currently covers (albeit with 
restrictions) by waiving those statutory geographic and/or originating 
site restrictions. Also, the demonstrations should be sufficiently 
large (e.g., several regions or multiple States) to provide sufficient 
claims data to evaluate whether telehealth is cost saving or cost 
neutral without the restrictions. At a minimum, we urge Congress to 
require CMS to undertake a demonstration to waive the originating site 
restrictions for Medicare beneficiaries who live in an eligible 
geographic location to assess cost savings or neutrality of delivering 
such services while beneficiaries are at home. This will provide 
increased access for beneficiaries in qualifying rural locations. CMS 
would not only be able to expand coverage where such services are cost 
neutral or cost saving while maintaining or improving clinical care, 
but this would also generate essential claims data needed by Congress 
and the Congressional Budget Office to develop more accurate cost 
estimates based on the Medicare patient population that will be 
informative for other services.

    We strongly urge Congress, however, to lift the geographic and 
originating site restrictions for Medicare beneficiaries receiving 
home-based primary care when received as part of a continuum of 
services (both in-person and virtual) in a coordinated manner with an 
established medical home. This patient population is the most likely to 
benefit from enhanced access to care. Telehealth provides the care team 
and caregivers additional options to ensure that these medically 
complex patients have access to the right care, at the right time.

    In addition to IAH and other primary care models, we also need to 
better support specialists who work with primary care physicians to 
manage patients with chronic conditions. For example, the American 
College of Physicians developed a ``medical neighborhood'' model to 
help support the teams of primary care physicians and specialists who 
are often needed to manage patients with chronic diseases. A model was 
also submitted to the PTAC recently that would support teams of primary 
care physicians and pulmonary or allergy specialists in managing 
patients with asthma.

    Question. As I mentioned during the hearing, I often hear from 
seniors in Oregon that they don't feel like anyone is in charge of 
managing their health care and helping them navigate the health-care 
system. I am proud of the bipartisan work that this committee did on 
the CHRONIC Care Act last Congress to update the Medicare guarantee. In 
my view, the next step should be making sure that all Medicare 
beneficiaries with chronic illnesses have someone running point on 
their health care--in other words, a chronic care point guard--
regardless of whether they get their care through Medicare Advantage 
(MA), an accountable care organization (ACO) or other alternative 
payment model, or traditional fee-for-service Medicare.

    For beneficiaries in traditional, fee-for-service Medicare, what 
can be done to improve care coordination and make sure their physicians 
and other health-care professionals are all talking to each other and 
working together to provide the best possible care to those 
beneficiaries? What specific policies would you recommend this 
committee pursue toward that end?

    Answer. The health-care system is moving to a world that pays 
health professionals to manage episodes of patient care in a more 
comprehensive way. However, this approach to payment can run afoul of 
the fraud and abuse laws. For example, even if the primary purpose of 
an arrangement is to improve patients' health outcomes, as long as one 
purpose of the arrangement's payments is to induce future referrals, 
the fraud and abuse laws are implicated (e.g., an arrangement that pays 
for a nurse coordinator to coordinate a recently discharged patient's 
care among a hospital, physician specialists, and a primary care 
physician may induce future referrals to the primary care physician to 
avoid an unnecessary readmission to the hospital).

    Fostering the shift to APMs has necessitated reviewing and, in some 
situations, updating fraud and abuse laws to ensure that they do not 
unduly impede the development of value-based payment. Through specific 
statutory authority, both the CMS and the Office of Inspector General 
(OIG) have deemed it necessary to waive the requirements of certain 
fraud and abuse laws to test the viability of innovative models that 
reward value and outcomes.

    Outside of those models, however, the fraud and abuse laws may 
still pose barriers to initiatives that align payment with quality and 
improve care coordination. Tying compensation to the value of care 
provided, equipping providers with tools to improve care, and investing 
in tools to clinically and financially integrate all may run afoul of 
these laws. For example, the Stark law impedes sharing needed resources 
between multiple physicians caring for the patient which prohibits 
physicians from coordinating care on behalf of their patients. Instead, 
the patient, in addition to dealing with the physical and emotional 
aspects of a disease or condition, must also attempt to coordinate 
their own care in a fragmented and siloed system. Placing the 
obligation on the patient to know how to properly manage follow-up care 
without the assistance of their physician or care coordinator may have 
a negative impact on patient care and the physician-patient 
relationship.

    Accordingly, the AMA has urged Congress and the administration to 
create a Stark exception and anti-kickback safe harbor to facilitate 
coordinated care and promote well-designed APMs. This exception should 
be broad, covering both the development and operation of a model to 
allow physicians to transition to an APM model, and provide adequate 
protection for the entire care delivery process to include downstream 
care partners, entities, and manufacturers who are linking outcomes and 
value to the services or products provided.

    Successfully navigating health care will also require consistent 
access to the right information at the right time about the right 
individual. This is an overarching need by both patients and 
physicians. Often the term interoperability is used which makes this 
seem a purely technical issue. In actuality, physicians want 
information that is pertinent to their clinical needs and that they can 
trust is accurate. Patients want to ensure that their physicians have 
access to their medical records and have assurances that their medical 
information is safe, private, and secure.

    The AMA supports several proposals by HHS to address technical 
aspects of EHR interoperability issues. Yet, both patients and 
physicians are concerned that the recent information blocking proposals 
will not improve the access, use, and exchange of information. Rather, 
as proposed, HHS's rules may ultimately compromise patient privacy, 
increase the likelihood of cyber-attacks in health care, overwhelm 
patients with information that may not be useful, and undermine 
physician clinical decision-making. The AMA urges Congress to take a 
close look at the unintended consequences of HHS's information blocking 
and interoperability proposals and recommends Congress use its 
oversight role to ensure the goal of care coordination is achieved 
without sacrificing patients' rights in the process.

    Furthermore, to improve utilization of chronic care management 
(CCM), transitional care management (TCM), and other care management 
services by Medicare patients, the AMA recommends that Congress 
eliminate the cost-sharing requirements for these services. Although 
utilization of CCM and TCM has been increasing in recent years, patient 
cost-sharing remains a barrier. Trying to promote patient participation 
in a care management program, and then having to talk about patients' 
cost-sharing obligations, puts physicians in an uncomfortable position. 
As a result, patients are reluctant to consent to participate in care 
management programs, and if they do, they frequently complain about the 
cost. These concerns often lead to them withdrawing from the program. 
By removing the cost-sharing obligations from the care management 
codes, more Medicare beneficiaries will benefit from the care 
coordination and case management services these codes support.

    Question. Please describe the specific steps that Congress and/or 
CMS could take to ensure all Medicare beneficiaries with chronic 
illnesses, including those in traditional fee-for-service Medicare, 
have a chronic care point guard.

    Answer. Congress or the administration can take the following steps 
to ensure a chronic care point guard:

        1.  Update the fraud and abuse laws so that a chronic care 
        point guard is not considered remuneration.

        2.  Make meeting the requirements of the promoting access to 
        care exception under the Civil Monetary Penalties (CMP) be a 
        permissible activity that would not be subject to the anti-
        kickback statute liability.

        3.  Allow for the waiver of cost-sharing amounts for chronic 
        care management services and when the amount to collect the 
        cost-sharing amount is less than reasonable collection efforts.

    With Medicare beneficiaries with chronic illnesses, the AMA has 
concerns about the ability of financial arrangements to satisfy anti-
kickback safe harbors that involve shared savings or incentive payments 
being distributed based on the value of care provided by physicians 
either in a group or independent practice. For example, a financial 
arrangement that is based on managing patients with a chronic disease 
rewards an individual physician for properly coordinating care with a 
chronic care point guard or nursing staff and intervening proactively 
with a patient to prevent unnecessary hospitalization. This reward can 
be interpreted as running afoul of the anti-kickback statute as 
remuneration in return for referring an individual for an item or 
service that is payable under a Federal health-care program (i.e., 
referral for a follow-up primary care visit in lieu of an unnecessary 
hospitalization).

    The AMA is also concerned about potential anti-kickback statute 
liability for arrangements and activities that fall within the 
exceptions from the definition of remuneration under the CMP law. 
Specifically, the exception from the beneficiary inducement CMP for 
remuneration that promotes access to care and poses a low risk of harm 
could implicate anti-kickback statute liability. This means that 
although a physician meets the requirements of an exception under the 
CMP law, the physician is still liable under the anti-kickback statute. 
For example, beneficiaries being provided a dedicated mobile treatment 
plan app that allows for daily engagement with the physician and 
ensures greater compliance with agreed to evidence-based treatment 
plans so that early intervention can be taken to avoid unnecessary 
hospitalizations and emergency room visits fits within the exception 
from remuneration because it helps beneficiaries access care by 
improved future care-planning by their physician. However, the 
arrangement is still subject to anti-kickback statute liability.

    The promoting access to care exception from remuneration already 
includes the concept of posing a low risk of harm to patients and the 
Federal health-care programs, OIG has already placed the burden of 
demonstrating low risk of harm under the CMP onto health-care 
providers,\3\ and using the Advisory Opinion process for a case-by-case 
determination for every instance of a beneficiary incentive is an 
impracticable solution. Moreover, these incentives help deliver higher 
quality, better coordinated care; enhance value; and improve the 
overall health of patients and should not be subject to the anti-
kickback statute when posing a low risk of harm to patients. Thus, 
Congress should consider legislation that meeting the requirements of 
the promoting access to care exception from remuneration would be a 
permissible activity that would not be subject to the anti-kickback 
statute.
---------------------------------------------------------------------------
    \3\ See 81 Fed. Reg. 88368, 88391 (December 7, 2016).

    Cost-sharing obligations are particularly problematic with chronic 
care management (CCM) services. Patients may be discouraged from taking 
advantage of this high-value service due to the cost-sharing amounts. 
Congress should create a safe harbor to waive cost-sharing amounts for 
CCM and other high-value services that may save money through better 
care coordination, improved patient outcomes, and avoiding unnecessary 
hospitalizations. This safe harbor could be tied to APMs that are 
focused on managing chronic conditions where the cost-sharing amount 
may discourage a patient from seeking primary care. Removing this 
unnecessary impediment to the physician-patient relationship could 
return impressive results. Regular appointments allow providers to more 
closely monitor patients and identify complications before they require 
hospitalization and to establish a more regular, wellness-based 
relationship between physician and patient. This can encourage the 
patient to reach out to a physician before resorting to more costly 
---------------------------------------------------------------------------
options such as calling an ambulance.

    Additionally, cost-sharing obligations are also problematic when 
the costs associated with reasonable collection efforts exceeds the 
cost-sharing amount that would be potentially collected. Thus, Congress 
should clarify that an exception exists from the definition of 
remuneration under the CMP to allow for the waiver of cost-
sharing amounts when the cost-sharing amount is nominal. For example, 
CMS expanded Medicare coverage to include services like virtual care 
visits. CMS pays approximately $15 for a virtual check-in service.\4\ 
With a 20-percent cost-sharing amount, a beneficiary would pay 
approximately $3. As defined by CMS and OIG, the costs of any 
``reasonable collection effort'' would far exceed the $3 collected.\5\ 
Requiring such efforts creates waste, adds unnecessary administrative 
burdens, and inappropriately increases costs to physician practices. 
Thus, Congress should clarify that the ``reasonable collection 
efforts'' under section 1128A(i)(6)(A)(iii)(II) of the Social Security 
Act do not include situations where the costs of the collection efforts 
by the provider exceeds the cost-sharing amount that would be 
potentially collected.
---------------------------------------------------------------------------
    \4\ 83 Fed. Reg. 35704, 35723, and 35786 (July 27, 2018).
    \5\ OIG has stated that ``reasonable collection efforts'' are those 
efforts that a reasonable provider would undertake to collect amounts 
owed for items and services provided to patients. 65 Fed. Reg. 24400, 
24404 (April 26, 2000). In 2016, OIG cited the CMS Provider 
Reimbursement Manual's description of reasonable collection efforts 
including requiring ``providers to issue a bill for the patient's 
financial obligation'' and ``other actions such as subsequent billings, 
collection letters, and telephone calls or personal contacts with this 
party which constitute a genuine, rather than a token, collection 
effort.'' 81 Fed. Reg. 88368, 88374 (December 7, 2016) (citing CMS, 
Provider Reimbursement Manual, CMS Pub. 15-1, Sec. 310).

    In addition, Congress and CMS have several opportunities to refine 
the Medicare Access and CHIP Reauthorization Act (MACRA) to promote 
care coordination for Medicare beneficiaries. In a recent letter to 
congressional leaders, the AMA and 120 national specialty and State 
---------------------------------------------------------------------------
medical societies outlined several refinements, including:

          Replace the upcoming Medicare physician pay freeze with a 
        stable and sustainable revenue source that allows physicians to 
        sustain their practice and provides a margin to invest in the 
        practice improvements needed to transition to more efficient 
        models of care delivery and better serve Medicare patients;
          Extend the Advanced APM payments for an additional 6 years 
        to provide physicians with an onramp to move to APMs once they 
        become available, as intended in the original legislation; and
          Simplify the MIPS by allowing physicians to focus their 
        participation around a specific episode of care, condition, or 
        public health priority to address the needs of their patient 
        population.

    Question. Eligible clinicians who receive a certain percentage of 
their payments or see a certain percentage of their patients through 
Advanced APMs are excluded from MIPS and qualify for the 5-percent 
incentive payment for payment years 2019 through 2024. Starting this 
year (performance year 2019), eligible clinicians may also become 
qualifying APM participants (and thus qualify for incentive payments in 
2021) based in part on participation in Other Payer Advanced APMs 
developed by non-Medicare payers, such as private insurers, including 
Medicare Advantage plans, or State Medicaid programs.

    Recognizing that this is the first year in which the All-Payer 
Combination Option is available, how many of your members do you 
anticipate will take advantage of the All-Payer Combination Option this 
year?

    Answer. As currently implemented, the All-Payer Combination Option 
hurts more than helps physicians in achieving Qualifying Participant 
(QP) status. Under this option, participation in APMs is measured as a 
percent of nearly all payers, including Medicaid, Medicare Advantage, 
commercial payers, and others, rather than as a percent of payers with 
value-based care programs that meet CMS's definition of an Advanced 
APM. We urge Congress to change this so that participating in Other 
Payer APMs adds to Medicare Part B APM participation and helps 
physicians reach the QP thresholds.

    Question. What, if any, challenges have your members faced when 
attempting to take advantage of the All-Payer Combination Option?

    Answer. Many payers do not offer value-based care programs that 
meet CMS's definition of an Advanced APM. Because of this constraint, 
many physicians who are participating in such programs with payers, in 
addition to Medicare Part B Advanced APMs, are not permitted credit 
under CMS's rules for such participation. This is contrary to the goal 
of Congress to encourage physician participation in value-based models 
across multiple payers. We believe Congress should modify the All-Payer 
Combination Option so that participating in Other Payer APMs adds to 
Medicare Part B APM participation and helps physicians reach the QP 
thresholds.

    Question. In the Medicare Access and CHIP Reauthorization Act of 
2015 (MACRA), Congress provided a total of $100 million over 5 years 
for technical assistance to MIPS-eligible clinicians in practices with 
15 or fewer clinicians, focusing on rural and health professional 
shortage areas.

    To what extent have your members utilized the services of the 
Small, Underserved, and Rural Support Initiative, which CMS launched 
using the MACRA funding to provide free, customized technical 
assistance to clinicians in small practices?

    Answer. The AMA strongly supports the free technical assistance 
available for clinicians in small practices and has heard that the 
assistance has been helpful, but more must be done to continue to 
support small and rural practices. In 2017, the national mean and 
median scores for all MIPS eligible clinicians were 74.01 and 88.97 
points. However, the mean and median scores for small practices were 
43.46 and 37.67. The lower scores achieved by small practices 
illustrate the need for Congress to work with the CMS and the physician 
community to continue to support and make changes that will help small 
practices and solo practitioners succeed in the program. Costs for 
reporting must be kept low, so that the value of a high score is more 
than the cost to achieve it.

    Question. What types of technical assistance and support have been 
most helpful to physicians and practices (e.g., understanding program 
requirements, selecting appropriate measures, forming virtual groups)?

    Answer. While continued technical assistance for small practices is 
important, the simplest way to ensure small and rural practices remain 
viable is to maintain the low volume threshold. To eliminate or reduce 
the threshold and force physicians to participate in MIPS would kill 
small practices. Financially, it just doesn't make sense for these 
practices with limited resources to invest in MACRA compliance when 
they have such a small Medicare patient population--less than four 
Medicare patients a week.

    In addition, for those small practices that treat larger Medicare 
patient populations and participate in the MIPS program, the most 
helpful assistance comes in shaping the MIPS program to allow practices 
of all sizes to be successful. For example, the reduced reporting 
requirements for small practices in several of the MIPS reporting 
categories, hardship exemptions from the Promoting Interoperability 
performance category for qualifying small practices, or bonus points 
for small practices greatly help small practices succeed in MIPS.

    EHR vendors often do not have data reporting tools that correspond 
to the MIPS requirements, which makes reporting very difficult and 
expensive. The measures need to be meaningful to the practices, which 
will differ depending on the practice type.

    Question. As physicians continue to gain experience with the 
Quality Payment Program, what additional types of technical assistance 
would be most helpful to solo practitioners and physicians in small 
practices and/or to those practicing medicine in rural or underserved 
areas?

    Answer. The AMA believes that Congress and CMS should continue to 
structure the Quality Payment Program so that physicians in practices 
of all sizes have the opportunity to succeed. Some ideas that the AMA 
has suggested to even the playing field between small and large 
practices include developing a separate performance threshold for small 
practices which would allow practices to be compared to other groups of 
a similar size with more analogous resources. The AMA has also provided 
detailed suggestions on how to improve virtual groups to make 
participation in a virtual group a viable option for small practices, 
including allowing groups to leverage Clinically Integrated Networks 
(CINs) and Independent Practice Associations (IPAs), providing 
protection from Stark and anti-kickback violations for virtual groups, 
and offering an additional incentive or bonus payment to practices 
participating in virtual groups until the model is tested and refined.

                                 ______
                                 
               Question Submitted by Hon. Debbie Stabenow
    Question. I am very proud of the work the bipartisan 
accomplishments to address Alzheimer's, including the implementation of 
my HOPE for Alzheimer's Act, which required Medicare to pay for new 
individual care plans to support Alzheimer's patients and their 
families. Many of my colleagues are also cosponsors of my Improving 
HOPE for Alzheimer's Act, which will ensure beneficiaries and 
physicians know that they are able to access, and bill for, care 
planning under Medicare. In our last hearing on MACRA implementation, 
my colleagues raised the question of how we should look at quality 
measures in MIPS when it comes to physicians having these conversations 
with beneficiaries and their families and reflecting their priorities. 
Some have mentioned altering MIPS to make the quality measures more 
clinically meaningful. In what ways do you think the system would need 
to change to better incorporate long-term care planning and encourage 
physicians to have these conversations with patients?

    Answer. Under the current MIPS quality structure, CMS utilizes 
specialty measure sets and requires reporting on a minimum set number 
of measures (six), which forces physicians to pick random individual 
measures and lumps a specialty together, regardless of sub-
specialization. In addition, when quality measures are tied to cost or 
an episode of care, it does not necessarily ensure that the quality 
measures match up with the episode and can appropriately evaluate 
potential for stinting on care to appear low cost. We believe allowing 
physicians to focus on activities that fit within their workflow and 
address their patient population needs--and providing them with credit 
for those activities that span across MIPS categories--will increase 
participation in MIPS, allow physicians to report on measures that are 
more meaningful to their practice, and drive continued improvement 
across performance categories.

                                 ______
                                 
               Questions Submitted by Hon. Sherrod Brown
                    development of metrics in macra
    Question. In your testimony, you mentioned that your physician 
members believe that there is no link between many of the MIPS measures 
they are required to report and improving clinical care for their 
patients. I understand that the physician community has engaged with 
CMS to try and make the program more meaningful to physicians and 
patients through more relevant quality measures.

    How are clinicians from your organization involved the creation of 
these measures relevant to their specialties?

    Answer. The American Society of Clinical Oncology (ASCO), along 
with many other medical specialty societies have a measure development 
process in place which leverages the expertise of their members on 
expert panels. They also provide input on the feasibility of data 
collection and participate in measure testing. CMS also develops MIPS 
quality measures through its various contractors. While the contractors 
may include specialists to participate on the technical expert panels, 
the contractors are often not very receptive to specialty feedback and 
the AMA urges CMS to include more specialty input throughout the 
measure development process.
MIPS cost measure development
    The AMA appreciated the flexibility in the Bipartisan Budget Act of 
2018 for CMS to gradually increase the weight of the cost category 
while the agency develops new episode-based measures. Over the past 2 
years, CMS has taken several important steps to improve its ability to 
fairly and accurately measure and compare physician resource use. The 
AMA greatly appreciates the agency's efforts to increase clinical input 
into the development of new measurement tools such as patient 
relationship categories and episode-based cost measures.

    The AMA has worked with national specialty, State and other 
physician groups to ensure this process involves as many physician 
perspectives as possible and to develop recommendations for 
improvements that have broad support across the profession. The AMA 
also works closely with a smaller set of specialty and State medical 
societies as part of its MIPS workgroup to provide CMS and its 
contractor with detailed suggestions to improve the cost measure 
development and refinement process.

    Finally, AMA members, including a current member of the AMA Board 
of Trustees, have devoted substantial hours volunteering on the cost 
measure technical expert panels to provide clinical input about how to 
accurately and fairly attribute episode of care costs to physicians. As 
discussed in detail below, however, CMS has retained problematic 
population level measures that have been developed outside of this 
process and with less clinical input, including the total per capita 
cost measure. Total cost of care is a very complex issue that cannot 
easily be attributed, and physicians are frustrated at being held 
accountable for issues beyond their control.

    Question. Has CMS been receptive to your feedback when provided?

    Answer. Many medical specialty societies are developing tools such 
as Qualified Clinical Data Registries (QCDRs), to help physicians 
incorporate systems of learning into their practice to improve quality 
of care, provider workflow, patient safety, and efficiency. For 
improvements to be made to quality measurement we must move beyond 
snapshots of care which focus on random individual measures to a 
learning system with a broad focus. Utilizing specialty-led QCDRs 
provides an opportunity to evaluate care within an entire specialty, as 
well as at the individual physician level. Unfortunately, CMS has not 
been very receptive to specialty developed measures, especially ones 
developed for use within a QCDR, which was the intent of the QCDR 
pathway in the MACRA statue. CMS' MIPS requirements and benchmark 
methodologies also discourage practices from reporting through a QCDR. 
Therefore, specialty societies have begun to stop supporting their 
QCDRs and developing quality measures due to the escalating burden and 
arbitrary nature of the vetting process and MIPS requirements that 
often lacks evidence and operates on unrealistic timelines and 
expectations. We believe the key to achieving MACRA's goals is the 
availability of an adequate portfolio of appropriate quality measures 
that allows for all physicians, regardless of specialty or subspecialty 
to meaningfully participate in the program.
Streamlining MIPS
    Further refinements are also needed to make MIPS clinically 
relevant for physicians and patients. The AMA urges Congress and CMS to 
continue to make MIPS more meaningful for physicians. We hear from our 
physician members that there is no link between many of the MIPS 
measures they are required to report and improving clinical care for 
their patients. The AMA has engaged the physician community through 
workgroups to develop creative solutions to simplify and streamline the 
QPP, while making it more meaningful for physicians.

    In a recent letter to congressional leaders, the AMA and 120 
national specialty and State medical societies outlined several 
refinements to the Medicare Access and CHIP Reauthorization Act 
including recommendations to simplify MIPS and make reporting more 
clinically meaningful for physicians. For example, Congress and CMS 
could make the program more cohesive by allowing physicians to focus 
their participation around a specific episode of care, condition, or 
public health priority. By allowing physicians to focus on activities 
that fit within their workflow and address their patient population's 
needs, rather than segregated measures divided into four disparate MIPS 
categories, the program would be more likely to improve quality of care 
for patients, reduce Medicare spending, and be more meaningful and less 
burdensome for physicians.

    CMS should also have explicit flexibility to base scoring on multi-
category measures to make MIPS more clinically meaningful, reduce silos 
between each of the four MIPS categories, and create a more unified 
program. This provision could also allow CMS to award bonus points at 
the composite score level, which would allow for a simplified scoring 
methodology. The primary goal of this approach is to allow physicians 
to spend less time on reporting and more time with patients and on 
improving care, and to create a more sustainable MIPS program. It also 
creates a glide path towards participation in APMs by encouraging 
physicians to focus on more clinically relevant measures and 
activities, improvement, and providing better value care to patients. 
We look forward to working with Congress and CMS to implement some of 
these creative solutions and continue to improve MIPS.

    Question. How would you assess CMS's collaboration on achieving 
meaningful metrics?

    Answer. The AMA was instrumental in ensuring MACRA included funding 
authorization for quality measure development, and we appreciate CMS's 
efforts to streamline measures and eliminate duplication. However, we 
have concerns with the way CMS allocated the funding for measure 
development. We were hopeful that CMS would have funded small projects 
over multiple years to several physician-led organizations to allow for 
maximum participation. Instead CMS issued a single announcement in 2018 
(3 years after the passage of MACRA), funding only seven projects. We 
were also disappointed that some of the awards were given to large 
provider systems, rather than physician-led organizations, and that 
much of the work involved re-specifying and/or re-tooling existing 
measures, which is traditionally work handled by CMS's Measure and 
Instrument Development and Support contractors. There also does not 
appear to be a requirement in the cooperative agreements to require 
contractors to seek feedback and coordinate with specialty societies 
and practicing physicians.

    We believe the MACRA statute intended ``organizations with quality 
measure development expertise'' to be physician-led organizations, 
specifically medical specialty societies and PCPI that have devoted 
substantial time and resources to developing and refining quality 
improvement and/or measure development activities. Partnering with 
specialty societies and PCPI would have ensured the measures aligned 
with specialty guideline development, quality improvement efforts, QCDR 
activities and alternative payment models.

    We appreciate CMS's efforts to streamline regulations with the goal 
to reduce unnecessary cost and burden on physicians, as well as the 
initial efforts to identify the highest priority areas for quality 
measurement and improvement to improve patient outcomes through the 
Meaningful Measures Initiative. We also recognize the need to move to 
more measures focused on outcomes; however, absent true reforms to the 
quality category, benchmark methodology and overall MIPS program we do 
not believe the Meaningful Measure Initiative is truly a reduction of 
administrative burden. At a minimum, if CMS would like to see immediate 
reduction and return on Patients Over Paperwork, we strongly urge CMS 
to reduce the number of quality measures a physician must report and 
adopt our recommendations to simplify MIPS and make the program more 
meaningful.

    MACRA requires all physicians to participate, regardless of 
specialty so there must be a sufficient number of meaningful measures 
that all physicians can report to satisfy the quality category. Under 
the current MIPS quality structure, CMS utilizes specialty measure sets 
and requires reporting on a minimum set number of measures (six), which 
still forces physicians to pick random individual measures and lumps a 
specialty together, regardless of sub-specialization. When you tie this 
to cost/an episode it does not ensure that the specialty set matches up 
with the episode and would seem to encourage physicians to stint on 
care to appear low cost. No measure should ever penalize a physician 
for doing the right thing for patients or suggest that avoiding needed 
care is a good idea.

    We believe allowing physicians to focus on activities that fit 
within their workflow and address their patient population needs--and 
providing them with credit for those activities that span across MIPS 
categories--will encourage increased participation and drive continued 
improvement across categories.

    Question. Are there any changes in this process you would 
recommend?
MIPS quality category
    We request that CMS ensure that current and future projects are 
coordinated with specialty societies and that practicing physicians are 
actively involved during the development, specification and testing of 
the measures, which follows the intent of the law. We also request that 
CMS require that the relevant specialty societies have a seat at the 
table during the measure development process, including at the time of 
concept. This involvement is critical across the majority of funded 
projects, as it is not clear the degree to which these academic 
institutions and others can leverage clinical expertise available to 
specialty societies.

    To improve the QCDR process, CMS must recognize that changes to 
QCDRs, registries or EHRs require significant financial resources and 
time to plan, incorporate, and test. This time-lag limitation becomes 
very challenging when CMS makes annual changes to quality requirements, 
measure specifications or technology functionality. Absent a reduction 
in the number of measures a physician must satisfactorily report, the 
AMA does not support immediate removal of measures from the program, 
but would support a phased approach. Without such a process, it is 
extremely hard for specialty QCDR stewards to plan and fails to 
consider the length of time it takes to develop a measure. It is also 
extremely difficult for physicians to create historic benchmarks if CMS 
changes or removes measures on an annual basis. It is the AMA's belief 
that the only way to truly measure improvement and track data over time 
is to have a process in place that allows for longitudinal data 
collection and tracking.
MIPS cost category
    To improve the cost category of MIPS, CMS should focus on 
developing episode-based cost measures with high variability and 
potential high impact for change at the physician level and Congress 
should remove the requirement that episode-based cost measures account 
for half of all expenditures under Parts A and B in MACRA.

    In addition, we recommend removing the total cost of care measure 
requirement. The original Total Per Capita Cost (TPCC) measure did not 
receive endorsement by the National Quality Forum in 2013 for use in 
physician cost measurement. Problems with the measure were linked to 
validity, patient attribution, and holding physicians accountable for 
costs over which the physician has no control. Moreover, the measure 
holds physicians responsible for total Medicare Part A and B 
expenditures, including costs over which the physician has no control. 
In recognition of the issues with the existing TPCC measure, CMS 
recently pursued revisions to the measure's attribution methodology and 
measurement period, among other changes.

    At a time when cost measurement is an immature science, the AMA 
appreciates CMS's willingness to revisit and refine existing cost 
measures. We believe, however, that the revisions to the TPCC measure 
do not address underlying concerns about the measure's validity and 
raise new problems with the attribution methodology. The revised TPCC 
measure retains the flawed concept of holding physicians responsible 
for total costs of care even for services delivered after the patient 
was no longer in their care and assumes that data regarding services 
provided by other physicians is readily available and therefore 
actionable by the attributed physician. The revisions to the measure 
also increased the risk of inappropriate attributions. For example, 
while certain specialists who provide specific types of services (e.g., 
chemotherapy, radiation therapy, surgery, and anesthesia) would be 
exempt, a practice comprised of exempt specialists might still be 
subject to the measure if a physician assistant or nurse practitioner 
provides an office visit and has the beneficiary attributed to them as 
a result. We believe CMS should score physicians on episode-based cost 
measures that have a stronger correlation with costs that are within 
physicians' control and remove the TPCC measure from MIPS.

    While we continue to believe that appropriately designed episode 
cost measures have the potential to measure costs more accurately, 
these measures represent a significant shift in the measurement of 
resource use. CMS should put in place safeguards against unintended 
consequences. These include:

          Phasing in new measures over several performance periods to 
        give physicians an opportunity to understand how they will be 
        evaluated on their resource utilization during episodes;
          Increasing the case minimums for measures to create better 
        physician buy-in, promote more accurate benchmarks, and ensure 
        individual physicians and small groups are not disadvantaged by 
        a small number of outliers;
          Lowering or at least maintaining the current cost category 
        weight at 15 percent for the next 3 years while new episode 
        measures are developed, tested, and used in MIPS;
          Releasing more detailed analyses about how the new measures 
        will impact physicians and groups, particularly based on group 
        size; and
          Conducting extensive education and outreach about the new 
        measures.

    Finally, the point of the MIPS cost category is to show physicians 
where there are opportunities for their practice to be more efficient. 
However, initial MIPS feedback reports did not include the detailed 
patient level information that was available in the predecessor Quality 
and Resource Use Reports (QRUR). Physicians tell us that the QRURs were 
much more useful and that the QRUR drop down data should be restored in 
the feedback reports. It is our understanding that CMS intends to add 
this data in the future and we hope that the next round of feedback 
reports will contain additional data.
                     macra and the addiction crisis
    Question. During the hearing, Senator Hassan asked some important 
questions around the MACRA incentive payments for those who improve 
tracking and reporting of quality measures related to opioid 
prescribing and treatment. You mentioned that recognizing team-based 
care in the treatment of substance use disorder would be useful in the 
MACRA program.

    Can you please elaborate on your comments during the hearing 
related to this issue? How can MACRA be improved to take into account 
team-based care more effectively and how would this improve treatment 
for substance use disorder?

    Answer. On the APM side, the AMA and the American Society of 
Addiction Medicine developed a framework for an APM focused on 
treatment of opioid use disorder that Congress included in the SUPPORT 
Act last year as the basis for a federally mandated demonstration 
project. The AMA and American Society of Addiction Medicine talked with 
physicians who wanted to deliver treatment for patients with opioid use 
disorder but could not do so because of the problems in the current 
payment system, and so we designed an APM that would correct those 
problems.

    The AMA believes that the current approach to address the opioid 
crisis through quality measurement has been too narrowly focused on 
preventing and/or reducing opioid use in the absence of addressing the 
larger clinical issue--ensuring adequate pain control while minimizing 
the risk of opioid addiction. Quality measurement must focus on how 
well patients' pain is controlled, whether functional improvement goals 
are met, and what therapies are being used to manage pain. We recommend 
that CMS develop measures that examine adequate pain control with 
appropriate therapies of which opioids may be an option. Until such 
time that these broadly applicable measures are available, we do not 
support continued inclusion of the narrowly focused measures CMS has 
proposed in its quality programs.

    The AMA has also recommended that CMS adopt measures in the 
Improvement Activities part of MIPS focused specifically on physician 
efforts to end the opioid epidemic, such as taking the training needed 
to be able to prescribe buprenorphine to treat opioid use disorder.
                               stark law
    Question. The goal of the Stark Law is to protect Medicare 
beneficiaries from unnecessary utilization and fraud. However, there 
are concerns from stakeholders that Stark Law hinders care coordination 
and does not align with value-based care by posing barriers to 
participation of physician group practices in APMs.

    During the hearing, in response to one of Senator Wyden's 
questions, you mentioned that changes to Stark Law are necessary 
because it prevents small community physicians from working together to 
offer less expensive services to patients.

    Can you please elaborate on your comments during the hearing 
related to this issue?

    Answer. As it relates to small community practices, one issue with 
Stark is virtual groups. To encourage broader MIPS participation for 
solo practitioners and groups with 10 or fewer eligible clinicians, CMS 
created a virtual group option. Many solo practitioners and groups of 
10 or fewer MIPS eligible clinicians have limited resources and 
technical capabilities. Virtual groups will involve preparation of 
health information technology systems and training staff to be ready 
for implementation, sharing and aggregating data, and coordinating 
workflows. While these are necessary steps to ensure the success of 
virtual groups, these steps could raise concerns involving Stark.

    By pooling resources together to participate in MIPS, individual 
physicians may receive an ownership interest in the virtual group or 
other compensation arrangement from the virtual group (e.g., 
disbursement of any incentive payments). Moreover, physicians may 
prefer to refer patients within their own virtual group to control 
unnecessary costs and provide higher quality care because each 
physicians' performance is tied to the same virtual group's MIPS score. 
Any of these referrals within the virtual group between physicians 
could violate Stark. This outcome is different from a normal ``group 
practice'' where some of these referrals are protected from Stark 
through exceptions.

    ``Virtual groups,'' by definition, are not ``group practices'' as 
that term is specifically defined under Stark because virtual groups do 
not constitute a ``single legal entity.'' Virtual groups consist of at 
least two legal entities. Thus, because virtual groups do not meet this 
definition, the Stark in-office ancillary services exception and the 
physician services exception do not apply. Furthermore, the anti-
kickback safe harbor for investments in group practices also does not 
apply. Accordingly, physicians in a virtual group with a financial 
relationship with such a virtual group may not be eligible to make 
referrals for designated health services payable by Medicare to the 
virtual group.

    More broadly, significant changes in health-care payment and 
delivery have occurred since the enactment of Stark. Numerous 
initiatives are attempting to align payment and coordinate care to 
improve the quality and value of care delivered. The delivery of care 
is going through a digital transformation. However, Stark--in its 
almost 30 years of existence--has not commensurably changed.

    Stark was enacted in a fee-for-service world that paid for services 
on a piecemeal basis. The fraud and abuse laws act as a deterrent 
against overutilization, inappropriate patient steering, and 
compromised medical judgment with heavy civil and criminal penalties 
like treble damages, exclusion from participation in Federal health-
care programs, and potential jail time.

    The health-care system is moving to a world that pays health 
professionals to manage episodes of patient care in a more 
comprehensive way. However, this approach to payment can run afoul of 
the fraud and abuse laws. For example, even if the primary purpose of 
an arrangement is to improve patients' health outcomes, as long as one 
purpose of the arrangement's payments is to induce future referrals, 
the fraud and abuse laws are implicated (e.g., an arrangement that pays 
for a nurse coordinator to coordinate a recently discharged patient's 
care among a hospital, physician specialists, and a primary care 
physician may induce future referrals to the primary care physician to 
avoid an unnecessary readmission to the hospital).

    Fostering the shift to APMs has necessitated reviewing and, in some 
situations, updating fraud and abuse laws to ensure that they do not 
unduly impede the development of value-based payment. Through specific 
statutory authority, both the CMS and the OIG have deemed it necessary 
to waive the requirements of certain fraud and abuse laws to test the 
viability of innovative models that reward value and outcomes.

    Outside of those models, however, the fraud and abuse laws may 
still pose barriers to initiatives that align payment with quality and 
improve care coordination. Tying compensation to the value of care 
provided, equipping providers with tools to improve care, and investing 
in tools to clinically and financially integrate all may run afoul of 
these laws. For example, the Stark law impedes care coordination by 
prohibiting physician groups from banding together to provide needed 
services. Specifically, in certain circumstances, it prohibits 
physicians from coordinating care on behalf of their patients. Instead, 
the patient, in addition to dealing with the physical and emotional 
aspects of a disease or condition, must also attempt to coordinate 
their own care in a fragmented and siloed system. Placing the 
obligation on the patient to know how to properly manage follow-up on 
care without the assistance of their physician or care coordinator may 
have a negative impact on patient care and the physician-patient 
relationship.

    Accordingly, the AMA has urged Congress and the administration to 
create a Stark exception to facilitate coordinated care and promote 
well-designed APMs. This exception should be broad, covering both the 
development and operation of a model to allow physicians to transition 
to an APM model, and provide adequate protection for the entire care 
delivery process to include downstream care partners, entities, and 
manufacturers who are linking outcomes and value to the services or 
products provided.

    Question. Congress and CMS have been considering modifying the 
Stark Law to promote more robust participation in APMs. If CMS waives 
Stark law for groups developing or operating APMs, what tools and 
guardrails would you recommend to ensure that the APMs developed by 
these groups reach 2-sided risk in a timely manner?

    Answer. Congress should create a Stark exception to facilitate 
coordinated care and promote well-designed APMs. The financial 
arrangement that fits within the exception should be for the purposes 
of operating and developing an APM. Protecting the development of the 
APM is a key to help shift physicians from transitioning from MIPS to 
APMs. The development should cover start-up and infrastructure costs. 
The exception should cover any arrangement between the APM, one or more 
of the APM's participants, downstream care partners, entities, and 
manufacturers who are linking outcomes and value to the services or 
products provided, or a combination thereof.

    Flexibility is important for innovation. Yet flexibility in a new 
payment system also may raise fraud and abuse concerns. To help address 
these concerns, the Stark exception could incorporate provisions that 
increased transparency and accountability through a board of director's 
approval; require the arrangement to be tied to the goals of the APM; 
and allow freedom of choice for patients by prohibiting stinting on 
medically necessary care. The exception should also ensure that 
referrals for designated health services are not being steered for 
market dominance or financial gain rather than for coordination of 
care.

    While participation agreements work well in the context of specific 
payments models, the AMA believes they would likely be impractical for 
Medicare generally. As an alternative, the parties to the arrangement 
could set forth in writing the arrangement, their goals for patient 
care quality, utilization, and costs, and the items and services 
covered under the arrangement.

                                 ______
                                 
             Questions Submitted by Hon. Sheldon Whitehouse
    Question. Accountable Care Organizations (ACOs) have the potential 
to transform our health care delivery system. While we've seen ACOs 
improve patient care and create shared savings, many provider-led ACOs 
only control a small fraction of total spending, with specialists, 
pharmaceuticals, and hospitals accounting for most of it. This leads to 
ACOs lacking sufficient leverage to bring down costs and can contribute 
to shared losses.

    How can we improve the ACO model to account for this imbalance? How 
can we support successful ACOs and encourage more providers to follow 
their lead?

    Answer. Under the new ``Pathways to Success'' regulation, new ACOs 
will only have two to 3 years in a shared savings model before they 
have to take on downside risk. The AMA is concerned that this policy 
will prevent ACOs that may have been successful in improving quality of 
care for Medicare patients and in saving money for the Medicare program 
from continuing to participate.

    In addition, it is important to note that physicians who 
participate in ACOs are paid the same way as other physicians. They do 
not receive any upfront or monthly payments to support better care 
management services, team-based care, clinical decision support 
systems, or after-hours access. Without being provided any additional 
resources, they are asked to take financial risk for the total cost of 
care for thousands of patients. Changes that would help more ACOs 
successful include: develop better payment models for ACOs (and 
physicians who are part of ACOs) that provide them with the resources 
and flexibility needed to redesign patient care; limit downside risk to 
the types of costs that ACOs can actually influence or control, such as 
preventing avoidable hospital admissions, achieving good surgical 
outcomes with low complication rates, or managing chronic conditions so 
they do not get worse; extend the MACRA APM incentive payments for an 
additional 6 years; and give CMS authority to modify the thresholds for 
being a qualified APM participant.

    Question. Our health-care system is not fully equipped to care for 
an aging population and patients with advanced illness such as late-
stage cancer, Alzheimer's disease or dementia, or congestive heart 
failure. This is an area where we need new models of care that reflect 
these challenges and create a better system for providers, patients, 
and their families. Many of our current Medicare rules in this space 
are counterproductive, such as requiring a 2-night, 3-day stay in an 
inpatient facility to qualify for skilled nursing care, and various 
disincentives to providing respite or palliative care. How are your 
organizations innovating to provide care for these patients, and what 
can Congress and CMS do to support those efforts?

    Answer. Congress and CMS should support APMs that focus on 
preventing hospitalizations and preventing exacerbations of these 
chronic conditions. Many of the PTAC proposals do this, as does the 
recently announced Primary Care First model. The PTAC proposal from the 
Renal Physicians Association is another good example. It focuses on the 
6-month period when patients transition from chronic to end-stage 
kidney disease, a very sick population. My PTAC proposal, MASON is an 
attempt to improve the Oncology Care Model so that more oncology 
practices will be able to continue the work of aggressively managing 
the side effects of cancer and its treatment to lower hospitalization 
rates, but with an accurate target price for the parts of oncology care 
that the physician can control.

    Congress can provide CMS with broader program waiver authority to 
support organizations that are innovating to provide care. Currently, 
CMS only has the authority to waive program waivers--like the skilled 
nursing facility 3-day rule--for the Medicare Shared Savings Program or 
for models operating under CMMI.

    We recognize that the most expensive part of the health care 
delivery system is the hospital inpatient arena, and encouraging 
chronic disease management to keep patients healthy enough to remain 
outpatients has great potential to save money as well as manage the 
increasing number of elderly with multiple chronic diseases. Yet the 
savings currently accrues to the insurer--Medicare in this case--but 
the expense accrues to the practices.

    Question. Despite continued investment, electronic health records 
(EHRs) remain difficult to share, challenging for patients to access, 
and a source of frustration to providers and policymakers alike. The 
business models of the EHR venders often leads to perverse incentives 
against sharing patient information.

    What steps can Congress take to make EHRs work better for 
providers?

    Answer. Four steps that Congress can take to make EHRs work better 
for providers:

        1.  Use of health information technology (health IT) beyond 
        CEHRT for the Promoting Interoperability performance category;
        2.  Permit reporting by attestation to move to a more outcome-
        focused care;
        3.  Leverage EHR vendor-generated information to reduce 
        physician burden and to meet the Federal Government's needs to 
        collect data on EHR usage; and
        4.  Consider the capabilities of EHRs when developing quality 
        measures.
                        use of hit beyond cehrt
    Question. Federal policy is a major driver in EHR system design. 
The AMA continues to highlight that Federal reporting requirements 
(e.g., the Quality Payment Program's Promoting Interoperability 
measures) are significant determinations in how EHRs look and feel to 
physicians. Simply put, EHR design is based on Federal reporting 
demands. Program requirements are too focused on physicians reporting 
use of EHRs as opposed to whether EHRs are useful to physicians and the 
care they provide to their patients. Unless changes are made, EHRs will 
continue to burden physicians.

    Answer. As an initial step to improve physicians' experience with 
health IT, physicians should be allowed to use certified EHR technology 
(CEHRT), technology that interacts with CEHRT, and/or a qualified 
clinical data registry to participate in Promoting Interoperability and 
to be considered a meaningful user. This will reduce the demand on EHRs 
having to be a ``one size fits all'' tool. Because increased 
interoperability and patient access will require new combinations of 
technologies and services, we continue to urge HHS to reevaluate 
regulations that prioritize the use of CEHRT over other non-certified 
digital health tools. Patients, physicians, and other care team members 
should be empowered to make decisions based on what works best for 
their needs, and not what regulatory boxes must be checked. Any new 
Promoting Interoperability measures should allow clinicians to utilize 
not only CEHRT but also health IT that ``builds on'' CEHRT--a concept 
taken directly from CMS's priorities in its call for new Promoting 
Interoperability measures. It would not only reward doctors who seek to 
utilize emerging health IT for patient care or contribute data for 
aggregation and quality analysis purposes, but also allow additional 
clinicians to participate in the Promoting Interoperability category 
since some currently seek an exclusion because they do not use CEHRT 
(e.g., non-patient facing clinicians such as radiologists). This would 
require a new clause in 1848(o)(2)(A):

        (iv) ADDITIONAL TECHNOLOGY--The eligible professional may 
        choose whether to use certified EHR technology, technology that 
        interacts with certified EHR technology, or may participate in 
        a qualified clinical data registry (or a combination of all 
        three technologies), to be considered a meaningful EHR user.
                        reporting by attestation
    Congress should direct CMS to utilize the authority it granted to 
the Secretary through HITECH to permit reporting in PI through yes/no 
attestation. Each ``yes'' would be worth a certain amount of points. In 
addition to relieving the reporting burden, an attestation-based 
approach would help facilitate EHR development to be more responsive to 
real-world patient and physician needs, rather than designed simply to 
measure, track, and report, and could help prioritize both existing and 
future gaps in health IT functionality. This can be accomplished by 
adding the following to 1848(q)(2)(B)(iv): ``For the performance 
category described in (A)(iv), the requirements shall be met via 
attestation or other less burdensome means.''
  leverage ehr vendor-generated information to reduce physician burden
    Congress should work with ONC and CMS to leverage EHR data 
generated as a byproduct of PI participation. EHR vendors already track 
and record many data points used for PI reporting, so there is no need 
to continue to use physicians as reporting intermediaries. For 
instance, CMS's ``Support Electronic Referral Loops by Receiving and 
Incorporating Health Information'' PI measure groups summary of care 
records received and the reconciliation of clinical information into 
one process. Physicians are required to manage and report both the 
acceptance of summary documents and the reconciliation process. This 
tasks physicians with juggling the technical aspect of 
interoperability, i.e., digital document capture and incorporation, and 
the laborious process of reconciliation. In fact, our members view 
information reconciliation in an EHR as ``overwhelming'' and adding ``a 
lot of non-meaningful noise'' to their patients' charts.

    Instead of focusing on EHRs as a tool for measuring physician 
actions, more clarity is needed on whether the EHR was able to use the 
summary of care document without burdening the physician, whether the 
EHR was able to provide the physician with usable and actionable 
clinical information in a format that supports clinical decision 
making, and if the EHR enabled a closed-loop referral. Essentially, 
more needs to be done to understand how EHRs actually function and 
should function in the real world. This type and level of information 
is far more meaningful and valuable to physicians, CMS, and ONC, and 
should be what Federal EHR reporting programs promote. Analyzing this 
information would expose the usefulness of the EHR, if the EHR could 
accommodate the needs of the physician, whether the EHR contributed to 
or detracted from patient care, and whether the EHR supported the goal 
of health information exchange. Knowing this will also help EHR vendors 
build better products. Opportunely, because EHRs already track what 
functionalities are used to perform tasks, EHR vendors should directly 
provide such information to CMS and ONC. This data capture mechanism 
also conveniently provides an audit trail for CMS.

    Congress should work with ONC and CMS to implement a ``record once, 
reuse multiple times'' approach, leveraging EHR-captured data for 
multiple needs--including CMS's Promoting Interoperability programs and 
to inform EHR development going forward. To be clear, the intent is to 
reduce the reporting requirements on physicians by using EHR-captured 
data--provided by the EHR vendor--as an alternative, supplement, or 
direct replacement for physician reporting in programs like Promoting 
Interoperability. Ideally, EHR vendors would report on how a measure 
was achieved and physicians would attest (as discussed in the previous 
section) to their experience in meeting that measure. This not only 
reduces physician reporting burden, but also creates a feedback loop to 
EHR vendors--allowing them to improve EHR use based on physician need. 
The AMA strongly suggests Congress work with ONC and CMS to identify a 
plan to operationalize this concept. We offer our assistance in further 
reducing physician burden through this and other novel approaches.
        encourage coordination when developing quality measures
    Congress should encourage CMS and ONC to coordinate with health IT 
developers and measure stewards, including national medical societies, 
to ensure optimal development of electronic quality measures. Medical 
specialties should not be required to dilute measure development due to 
delinquencies in EHR data capture or reporting capabilities. EHR 
development continues to be shaped by Federal reporting requirements--
not the needs of patients and physicians--which severely limits their 
ability to support actual patient care and improvement. Disconnecting 
the linkage between EHR development and Federal reporting requirements 
is also a crucial step in improving physician satisfaction.

    Question. Are the proposed data blocking rules enough to start 
encouraging better data sharing by the vendors?

    Answer. The proposed data blocking rules are one method to 
encourage data sharing. While the AMA supports several aspects of the 
proposed rules (e.g., promoting patient access, certifying APIs, and 
removing EHR vendor gag clauses), ONC's and CMS's broad interpretation 
of legislative language, compressed development and adoption timelines, 
complex regulatory requirements, and a misplaced emphasis on data 
quantity will dramatically impact patient privacy and safety, data 
security, and further exacerbate physician burden and concerns with 
health IT. Without addressing these issues, the U.S. Department of 
Health and Human Services (HHS) may fail at meeting the goals set out 
by Congress in the 21st Century Cures Act (Cures).
                                privacy
    The problem: In the proposed rule, ONC did not indicate that it 
will create policy to help ensure patient privacy protections through 
the API. In other words, it is promoting API usage, but not requiring 
that the API technology include privacy and security controls. The 
technological capability to implement these controls exists, so if ONC 
doesn't implement controls, they are making a policy decision to not 
prioritize privacy. This is particularly concerning given ONC's 
information blocking proposal is more focused on requiring that data be 
shared.

    Why this is important: Mobile apps typically require a consumer to 
consent to all terms or not use the app at all. However, we've all read 
stories and studies about how smartphone apps share sensitive health 
information with third-parties, often without the knowledge of an 
individual.\6\ If patients access their and their family's health 
data--some of which is likely sensitive--through a smartphone, a 
patient must have a clear understanding of the potential uses of that 
data by app developers. Most patients will not be aware of who has 
access to their medical information, how and why they received it, and 
how it is being used (for example, an app may collect or use 
information for its own purposes, such as an insurer using health 
information to limit/exclude coverage for certain services, or may sell 
information to clients such as to an employer or a landlord). The 
downstream consequences of data being used in this way may ultimately 
erode a patient's privacy and willingness to disclose information to 
his or her physician.
---------------------------------------------------------------------------
    \6\ Examples: (1) The Wall Street Journal reported that Facebook 
collected sensitive health and demographic data from a user's cellphone 
apps, regardless of whether the individual had the Facebook app on his 
or her phone, and even if the individual had never signed up for 
Facebook. (2) Studies reported in the BMJ and JAMA have demonstrated 
that most apps do not share privacy policies with patients, and when 
they do, sometimes do not adhere to them. (3) The Washington Post 
reported that a workplace wellness pregnancy-tracking app reports data 
to a woman's employer, including the woman's average age, number of 
children, and current trimester; the average time it took her to get 
pregnant; whether the pregnancy is high-risk, conceived after a stretch 
of infertility, a C-section or premature birth; and her return-to-work 
timing. The app's privacy notice is 6,000 words.

    How Congress can address the issue: Congress could encourage ONC in 
the final rule to require an EHR vendor's API to check for these three 
``yes/no'' adoption and implementation attestations as a part of the 
---------------------------------------------------------------------------
EHR vendor's certification requirements:

        (1)  Industry-recognized development guidance (e.g., Xcertia's 
        Privacy Guidelines);

        (2)  Transparency statements and best practices (e.g., Mobile 
        Health App Developers: FTC Best Practices and CARIN Alliance 
        Code of Conduct); and

        (3)  A model notice to patients (e.g., ONC's Model Privacy 
        Notice).

    These could be viewed as ``value-add services'' as proposed by ONC. 
The app could be acknowledged or listed by the health IT developer 
(e.g., in an ``app store,'' ``verified app'' list). EHR vendors could 
also publicize app developers' attestations. This shouldn't be a 
significant burden on EHR vendors since it's only requiring that an API 
check for an app developer's attestation. We also recognize this 
wouldn't ensure apps implement or conform to their attestations. 
However, we believe this will provide a needed level of assurance to 
patients and physicians, and would be greatly welcomed by users. CMS 
should require app developers to attest ``yes'' to each of these items 
before listing an app on its BlueButton 2.0 website.
    presumption of guilt will result in significant physician burden
    The problem: Physicians may have a valid, reasonable reason to 
restrict the exchange of information. Yet ONC's interpretation of Cures 
creates an assumption that any physician who withholds data is guilty 
of information blocking. To counter this assumption and to justify 
withholding information for any reason, physicians must divert time and 
resources away from patient care to dissecting incredibly complex 
exceptions that are riddled with subjective terminology. Once a 
physician does so (potentially by hiring attorneys or consultants at 
great expense to the practice), he or she must create new policies and 
procedures, train staff, and adjust workflows. Furthermore, physicians 
may need to document the justification for applying those exceptions 
for every single request of information.

    Why this is important: The inherent presumption of guilt, complex 
sub-exceptions, and substantial added burdens of ONC's proposal exceed 
the scope of Cures' intent. ONC should create policies that identify 
bad actors without placing considerable burden on the rest of the 
health-care system. Otherwise physicians will be tasked, time and time 
again, with the chore of documenting decisions that should be left to 
the physician's best judgement. Or, alternatively, they will just share 
whatever information they are asked for, regardless of whether the 
requestor has valid reasons for doing so, and the physician risks 
penalties for that, too. In either scenario, physicians and patients 
lose.

    How Congress can address the issue: Congress can encourage ONC to 
clarify that a physician exercising his or her best judgement when 
providing information to a requestor will not be considered an 
information blocker. ONC should also remove onerous requirements for 
physician to document their decision-making associated with qualifying 
for information blocking exceptions or sub-exceptions.

    The AMA shares the administration's continued focus on improving 
interoperability and patient access across the U.S. Physicians and 
patients must be provided better access to needed clinical information 
while at the same time being assured privacy and security are 
strengthened. We look forward to continuing our work with Congress and 
administration to secure long-lasting revisions to health IT policy and 
implement the provisions in Cures.

    Question. How can we encourage States to be better innovators on 
health-care spending? The current Medicaid waivers incentivize States 
to keep costs down, but are there ways to encourage both lower costs 
and better health-care outcomes?

    Answer. MACRA was enacted almost 4 years ago, but most physicians 
still do not have opportunities to participate in APMs that meet the 
criteria for the bonus payments authorized by Congress. Congress 
authorized these payments not just as an incentive to participate in 
APMs, but because it recognized the time and costs physicians will face 
in transitioning to APMs. MACRA only authorized 6 years of APM bonus 
payments, and the current 2019 performance period is halfway through 
the available time to earn them. We urge Congress to extend this time 
period for more years so that physicians will have the opportunity to 
receive all of the support intended. Additionally, Congress can 
encourage APMs to control spending and improve quality in Medicaid by 
modifying the ``all payer'' requirement for a physician to become a 
qualified APM participant under MACRA. The rules for becoming qualified 
should encourage Medicaid and multi-payer APMs, but the current rules 
can actually discourage physicians from participating in Medicaid APMs 
because they would then need to meet an ``all-payer'' threshold of APM 
participation to qualify for the MACRA incentive payment.

                                 ______
                                 
           Questions Submitted by Hon. Catherine Cortez Masto
    Question. Nevada has one of the most significant health-care 
workforce shortages in the country. What kind of impact is MACRA having 
on the physician workforce? Are there ways to leverage the law to build 
that work force?

    Answer. In order to prevent health-care workforce shortages around 
the country, the AMA has urged Congress to replace the upcoming 
physician payment freeze with annual positive payment updates over the 
next several years. MACRA included modest positive payment updates in 
the Medicare Physician Fee Schedule, but it left a 6-year gap from 
2020--next year--through 2025 during which there are no updates at all. 
Following this 6-year freeze, the law specifies physician payment rate 
updates of 0.75 percent or 0.25 percent for physicians participating in 
APMs or MIPS, respectively. By contrast, other Medicare providers will 
continue to receive regular, more stable updates. As physician practice 
payments fall increasingly below their costs, patient access issues 
would arise. Rural health care will be more affected than other areas 
because increasing costs are spread across fewer patients, and many 
health-care employees can demand higher salaries that in urban areas 
where more applicants reside.

    The recent ``2019 Annual Report of the Board of Trustees of the 
Federal Hospital Insurance and Federal Supplementary Medical Insurance 
Trust Funds'' (``Medicare Trustees Report'') found that scheduled 
physician payment amounts are not expected to keep pace with the 
average rate of physician cost increases, which are forecast to average 
2.2 percent per year in the long range. The Medicare Trustees Report 
also found that ``absent a change in the delivery system or level of 
update by subsequent legislation, the Trustees expect access to 
Medicare-participating physicians to become a significant issue in the 
long term.'' Therefore, to ensure the health-care workforce shortage 
does not increase and to provide physicians with a stable and 
sustainable revenue source that allows them a margin to invest in 
practice improvements and transition to more efficient models of care 
delivery, the AMA urges Congress to replace the upcoming physician pay 
freeze with annual positive payment updates.

    MACRA included $20 million per year through 2020 to support the 
administration of technical assistance to help small and rural 
practices comply with the law's reporting requirements. Almost $35 
million will be left as of this coming January, to remain available 
until expended.

    Question. In your experience, has that assistance been helpful or 
successful?

    Answer. While the AMA has strongly supported the provision of 
technical assistance to small and rural practices, and believes it is 
an important tool to make available to these physician groups, this 
technical assistance is not enough. Congress, CMS and the physician 
community must continue to work together to help small and rural 
practices succeed in the Quality Payment Program.

    Question. Are practices aware of the availability of technical 
assistance? If not, what should we be doing to make them aware?

    Answer. The AMA has worked with CMS to try and make physicians in 
all practices sizes and all specialties aware of the technical 
assistance that is offered by the agency.

    Question. Looking forward, do you see that $35 million as 
sufficient to meet the needs of providers who are struggling to comply 
with MIPS?

    Answer. The AMA encourages Congress to continue to fund technical 
assistance to help small and rural practices comply with the Quality 
Payment Program. In 2017, the national mean and median scores for all 
MIPS eligible clinicians were 74.01 and 88.97 points. However, the mean 
and median scores for small practices were 43.46 and 37.67. The lower 
scores achieved by small practices illustrate the need for Congress to 
work with the CMS and the physician community to continue to make 
changes that will help small practices and solo practitioners succeed 
in the program.

    While continued technical assistance for small practices is 
important, the simplest way to ensure small and rural practices remain 
viable is to maintain the low volume threshold. To eliminate or reduce 
the threshold and force physicians to participate in MIPS would kill 
small practices. Financially, it just does not make sense for these 
practices with limited resources to invest in MACRA compliance when 
they have such a small Medicare patient population.

    In addition, for those small practices that treat larger Medicare 
patient populations and participate in the MIPS program, the most 
helpful assistance comes in shaping the MIPS program to allow practices 
of all sizes to be successful. For example, the reduced reporting 
requirements for small practices in several of the MIPS reporting 
categories, hardship exemptions from the Promoting Interoperability 
performance category for qualifying small practices, or bonus points 
for small practices greatly help small practices succeed in MIPS.

    Question. Are grantees able to use that technical assistance 
funding to help practitioners develop admissions to PTAC? If not, 
should we consider such authority? Should that be under the same 
program or developed as a separate program?

    Answer. We agree more can be done to help physicians develop APM 
proposals. Having spent a year developing a proposal for PTAC, I can 
attest to the fact that the process is not easy and requires resources 
beyond the capability of most practices. Feedback from PTAC was very 
useful but PTAC was very concerned that it not overstep its limits, but 
more feedback would have been helpful. The AMA appreciated the 
Bipartisan Budget Act of 2018 provision that allowed the PTAC to 
provide initial feedback to proposal submitters. Unfortunately, the 
PTAC has indicated that it is still not able to provide technical 
assistance and data analyses to stakeholders who are developing 
proposals for its review. Additional technical corrections may be 
needed to provide the PTAC with more flexibility in this regard. In 
particular, the Bipartisan Budget Act of 2018 language stated that the 
PTAC can provide ``initial feedback'' on ``proposals.'' HHS, which 
provides staff support to PTAC, has determined that this means no 
feedback can be provided until a complete proposal is submitted. In 
addition, HHS has determined that PTAC's feedback cannot involve ``data 
or analyses whose only purpose is to aid further development of a 
proposal,'' ``technical assistance in the development of the proposed 
model,'' or ``instructions on how to remedy or fix any identified 
shortcoming(s).'' (These prohibitions are stated on page 14 of the PTAC 
``Proposal Submission Instructions.'')

    Question. What portion of these providers do you think will never 
make it to an APM? Should we be concerned about that?

    Answer. Physicians understand MACRA implementation is evolving and 
they are regularly reevaluating their participation options to 
determine which pathway best supports them in providing high value care 
to their patients. There are many variables that influence a 
physician's participation decision, and most notable is the 
availability of APMs and their readiness to move to financial risk. 
Risk is a major impediment for many practices, as by definition, risk 
implies that the results will not always be positive. Practices 
generally don't have reserves to pay for a year where they must pay 
money back to CMS and they don't have the data analytic capabilities to 
determine how much risk they are taking on. For small practices, hiring 
a nurse educator to provide services for which there are no fees is a 
significant economic risk. To ensure a glide path to Advanced APMs, the 
AMA is urging Congress to extend the Advanced APM bonus payment to 
allow physicians a reasonable time period to transition to new payment 
models once they are made available. An APM should only put a physician 
at risk for the items they can control and never for so much risk that 
it could bankrupt the practice and destroy the infrastructure of care 
delivery.

    Additionally, the best way to increase physician participation in 
APMs is to give physicians a major role in designing and implementing 
new payment models so the payments support the services physicians feel 
are necessary and accountability is focused on aspects of quality and 
cost that physicians can control.

    Traditionally, APMs have been designed by payers in a top-down way. 
Physicians often feel that these models fail to provide the resources 
needed for high-value services or penalize them for delivering services 
their patients need. With the recent Primary Cares Initiative, CMMI is 
using proposals submitted to the PTAC by physicians to design its APMs 
and we welcome this change.

    The AMA supports a bottom-up approach that starts by having 
physicians identify the opportunities to reduce spending through 
improving patient care and then designing APMs that will support the 
appropriate changes in care delivery.

    Finally, many specialists simply do not fit into any of the current 
Advanced APMs. Often ACOs do not want to include them because their 
services are not needed frequently enough. Others have tried to develop 
models and submit them to PTAC, but CMS has not accepted them for 
further testing. There are signs now that CMS is more prepared to start 
testing PTAC recommended models, which is a very positive development. 
But this longer-than-expected ramp up period is why we are asking that 
the five percent incentive payments provided to early Advanced APM 
participants be extended in future legislation.

                                 ______
                                 
 Prepared Statement of Frank Opelka, M.D., FACS, Medical Director for 
        Quality and Health Policy, American College of Surgeons
    The American College of Surgeons (ACS) thanks the Senate Finance 
Committee for convening a hearing on the implementation of the Medicare 
Access and CHIP Reauthorization Act (MACRA). ACS has a longstanding 
commitment to improving the quality of surgical care and we are 
grateful to Congress for making quality a focus of the MACRA law. 
However, ACS has concerns that this focus may have been obscured as the 
priorities and ideas of Congress and the broader stakeholder community 
who partnered in developing MACRA met the constraints of a hurried 
implementation. We welcome the opportunity to continue partnering with 
Congress and the administration to ensure that the goal of improving 
the value of care to the surgical patient stays at the forefront.
            acs supports the congressional intent of macra 
                   but implementation misses the mark
    MACRA was intended to replace the failed cost containment strategy 
of the sustainable growth rate formula (SGR) by implementing payment 
incentives that rewarded physicians for improving quality and keeping 
down cost. In other words, the idea was to tie payment more closely to 
the value of care provided to the patient. Achieving this congressional 
intent in the area of surgery requires the establishment of a strategy 
for expressing what constitutes value in surgical care. This is not 
achievable using legacy Physician Quality Reporting System (PQRS) and 
Value-Based Payment Modifier (VM) measures. The Centers for Medicare 
and Medicaid Services (CMS) relied on their skills as a payer to 
retrofit their payment models with sporadic, disaggregated quality 
metrics. The end result has been disruption of the care teams and a 
disconnect from real quality of care. For many physicians, the Merit-
based Incentive Payment System (MIPS) has not, and given its current 
trajectory will not, serve as a driver of improvement in quality or 
reduction of cost.

    In addition to these implementation issues, we also have great 
concerns about the structure of payments under MACRA in the years 
ahead. The modest statutory updates included in the law are now 
finished, and we will soon enter a 6-year period with no updates. This 
will likely result in real reductions to payments due to inflation and 
budget neutrality requirements. Additional incentives for high 
performers and qualified Alternative Payment Model (APM) participants 
also disappear during this time, which will be experienced as 
reductions by many of the highest performing physicians in Medicare. 
While the focus of the testimony today is improving incentives for 
quality and value, the ACS urges Congress to consider these factors as 
well. The ACS would welcome the opportunity to further describe the 
physician payment landscape from our perspective and how this might 
affect access to care in the future.
                  quality measurement in mips and apms
ACS Vision for Meaningful Measurement Models
    ACS continues to welcome and celebrate the congressional focus on 
quality and value built into MACRA, including the concept of rewarding 
those who provide high-quality surgical care while holding down costs. 
However, CMS as a payer does not have the resources or knowledge to 
generate the master plan for quality for a surgical team working toward 
a patient outcome in a particular episode of surgical care and 
therefore must first fully collaborate with the surgical community. 
This collaboration would include (1) defining the patient-centered care 
model, (2) identifying the structure and processes required to deliver 
quality in surgical care, and (3) assigning quality metrics and 
attaching an incentive payment program to achieve care goals.

    Expressing value in surgical care requires appreciation of the 
specific condition and its care model, consideration for clinicians and 
their unique roles as team members in providing surgical care to the 
patient, and the ultimate outcome of that care. With this 
understanding, it is possible to define the critical data and 
measurement elements across the care model for the team, which is 
essential in driving improvement. What follows then is agnostic to the 
payment system; it is possible for CMS to use the various tools of 
MACRA to design a payment model either within Medicare fee-for-service 
(FFS) or within some form of APM.

    More specifically, by designing a master quality care plan for 
surgical care as the first step, these value-based models can be 
tailored to a broad range of payment models such as FFS in MIPS, 
Accountable Care Organizations (ACOs), bundled payments such as the 
Bundled Payment for Care Improvement--Advanced (BPCI-A) model, or other 
APMs. This master quality care plan would be used to measure quality 
across all payment programs so that the care team has one valid and 
meaningful quality target to define value for surgical care. Such an 
effort will also greatly reduce burden.

    The ACS developed a model formula that could serve as the 
foundation for quality in surgical care. The ACS model formula for 
expressing value in care does not differ from those found in other 
industries. ACS believes that quality of care begins by setting 
evidence-based standards for care, ensuring that the right 
infrastructure and systems are in place through measurement and 
verification, and incorporating data at the point of care to inform 
surgeons' and patients' decisions. The patient should have a voice to 
determine whether the treatment met his/her goals. We define the 
episodes for a given domain such as trauma care, cancer care, or 
complex gastrointestinal care as examples and assign a surgeon 
champion. Within each of these domains, evidence-based, common 
standards are applied for areas that affect all surgical patients. 
Specific standards can also be applied for each individual surgical 
episode or condition. With the proper standards, infrastructure, data, 
and verification we can greatly improve outcomes and patient safety 
while simultaneously reducing complications and other unnecessary 
costs. If implemented correctly, the data generated helps to feed 
research into which interventions and care are most effective, creating 
a beneficial cycle of quality improvement. This marriage of quality and 
cost for a given treatment, condition, or episode of care is a true 
representation of value.
QPP Incentivizes Check-the-Box Compliance Instead of Striving for 
        Quality Improvement
    An increasing number of surgeons recognize that CMS efforts are not 
contributing to higher quality surgical care. The rational response is 
for surgeons and/or health care administrators to simplify their 
engagement in MIPS by taking the necessary steps to assure payment 
rather than to focus on quality. The figure below illustrates that the 
Quality Payment Program (QPP) is designed around how services are paid 
for, using aspects of claims transaction as a proxy for quality and 
measurement of ``success,'' at the level of the tax identification 
number (TIN). The current measurement system does not consider the 
patient's care journey and does not represent a patient's experience. 
For example, an ever-greater percent of surgeons are participating in 
quality reporting through the CMS Web Interface group reporting option. 
This translates into reports based on large groups of physicians 
(frequently providing care for very different patients and conditions) 
gathered under one TIN. It does not translate down to the care a 
surgical patient receives. In other words, surgeons receive credit for 
how well their group immunizes a population instead of assuring 
patients have safe surgical care.

[GRAPHIC] [TIFF OMITTED] T5819.002


    Currently, much QPP reporting takes place in the CMS Web Interface 
option, which allows groups of at least 25 eligible clinicians with the 
same TIN or participants in certain ACOs to submit data together and be 
measured as a single unit. The Web Interface is a stable, known program 
to administrators. They know what their scores are likely to be, and it 
is built into the workflow for their organization. While easy for 
physicians to comply with, the ten measures available in the Web 
Interface are focused on screening, preventive care, and diabetes 
control. These measures are important to a patient's overall health but 
provide absolutely no information on the quality of surgical care 
received by patients of surgeons in these groups and therefore are not 
relevant to efforts to improve surgical quality.

    MIPS participants can choose to report both as part of a group and 
as an individual, but the majority of surgeons are unlikely or unable 
to do so due to financial implications. Administrators and the C-Suite 
often decide the most cost-effective way for the TIN to report in MIPS, 
and specialty specific reporting may result in a lower MIPS score. In 
fact, performance data from the first year of MIPS shows that the 
median score of groups was more than 50 percent higher than that of 
those who participated as individuals. For clinicians who still choose 
to report specialty-specific measures, those available are not patient 
focused, frequently dating back to the PQRS program, and are designed 
for an exclusively FFS world. Furthermore, new measures without a 
benchmark can only receive the lowest amount of points. These problems 
stem from how CMS has set up reporting incentives, favoring large group 
reporting on primary care.

    Many believed that Qualified Clinical Data Registries (QCDRs) which 
are referenced more than 20 times in MACRA, would be a key pathway for 
stakeholders to influence quality measures. However, roadblocks emerged 
that impeded the ability of specialty societies to measure quality 
based on what matters most to their patients. There is a huge 
disincentive to use QCDRs for many specialties, such as the constant 
annual removal of measures, and very low opportunities for earning 
points. New measures without a benchmark receive the lowest point 
value. This has greatly limited the value and uptake of these 
registries.

    Data rigor and aggregation standards are also crucial to registry 
success. As a payer, CMS has little ability and expertise to utilize 
these registry elements and value these tools within their current 
measurement systems, resulting in a cacophony of reports that are 
meaningless to the end user. Only when registries have standardized 
data, aggregation, normalization, and reporting from a single source of 
truth are they of value. This is evident in registries maintained by 
ACS. Registries and the information they provide are best implemented 
within an overall care plan where a team of experts use the knowledge 
imparted to inform the patients and the team members about clinical 
care based on rigorous data. The ACS continues to work to demonstrate 
how to structure data models for care improvement.

    In sum, CMS's implementation of MACRA has fostered a payment model 
rather than first focusing on quality. As a result, surgeons currently 
lack confidence in CMS as a source of quality reporting. Thus, we 
expect more surgeons will be reporting through the group reporting 
options, which constitutes the path of least resistance. This is 
unfortunate since it may have the additional consequence of crowding 
out other efforts aimed at improving quality in surgical care and areas 
that are not incentivized. It also seems counter to the intent of MACRA 
which encouraged CMS to seek comprehensive measurement of groups. The 
statute notes that to the extent practicable, group measurement should 
reflect the range of items and services furnished by the eligible 
clinicians in the group. This is not currently the reality in the CMS 
Web Interface.
A Way Forward in the QPP: Proposed ACS Measurement Framework for Value-
        Based Care
    The ACS proposes alternate quality measurement structures for the 
QPP based on our more than a century of experience in surgical quality 
improvement. This focus on quality resulted in the publication in 2017 
of ``Optimal Resources for Surgical Quality and Safety,'' referred to 
as the Red Book. This comprehensive volume serves as a manual for those 
seeking to build a learning environment designed to provide patient-
centered, high-quality care. Standards drawn from the Red Book are now 
being used for the verification and accreditation of hospitals on the 
basis of surgical quality and patient safety.

    The ACS alternative framework for surgical quality measurement is 
comprised of three components:

        1.  Verification of Key Standards of Care: Since the inception 
        of the ACS, we have sought to build standards for clinical 
        domains with the expectation to improve overall outcomes of 
        surgical care. While implementing these standards, we have 
        gained over a half-century of experience in building clinical 
        verification programs in specific clinical domains to drive 
        quality, improvement, and excellence in care. The success of 
        verification programs are well-established in the peer-reviewed 
        literature. Each of the major surgical domains contain a set of 
        standards for inclusion in a renewable, triennial verification 
        program. The long-term goal is to scale these verification 
        programs initially through pilot testing, then as a 
        foundational component to building a national quality system in 
        surgical care.

        2.  Clinical Outcome Measures: We envision the use of 
        administrative claims measures for surgical procedures that 
        have a low event rate of care for poor outcomes (readmissions, 
        mortality, reoperation, etc.), and propose using programs such 
        as the National Surgical Quality Improvement Program (NSQIP), 
        for complex, high risk care that have variation in outcomes and 
        require risk adjusted, clinical outcome measurement with a high 
        level of rigor. This would require pilot testing before large-
        scale implementation.

        3.  Patient-Reported Outcomes: In addition to standards-based 
        verification programs and clinical outcome measures, we propose 
        inclusion of patient-
        reported outcomes measures (PROMs) based on an episode of care. 
        Episode-based PROMs are inclusive of the patient's voice and 
        can assess whether care achieves the patient's goals, including 
        functional outcomes and quality of life. We have begun early 
        testing and development of enriched PROMs, focused on surgical 
        outcomes. This model is designed to recognize the complexity of 
        modern medicine and demonstrate that it exceeds the ability of 
        a single physician to provide all of the care.

    This framework, which is illustrated in the figure below, is based 
on decades of research and implementation of verification programs, 
which have proven successful in driving better outcomes in surgical 
care. It is applicable across various clinical domains, particularly in 
surgery where robust verification programs exist in areas such as 
cancer care, trauma care, bariatric care, and care for frail geriatric 
patients. Such programs depend on triennial surveys, and already exist 
in thousands of delivery systems today with demonstrated success. As an 
example, measurement of cancer care spans the entire care journey 
experienced by patients and includes areas such as prevention, 
screening, early diagnosis, treatment, post treatment surveillance, and 
end-of-life care. A surgical resection for cancer may involve debulking 
and staging the disease, while also including a method for tracking 
quality through verification of key standards, PROMs, and clinical 
outcomes. Furthermore, if such a quality framework were combined with 
the ongoing cost measurement work that formed the core of the ACS-
Brandeis Advanced APM described below, then this would constitute 
quality and cost measurement across standardized episodes of care 
representing true value to the patient.

[GRAPHIC] [TIFF OMITTED] T5819.003


           ptac recommendations to pilot apms not actualized
    In addition to MIPS, MACRA created a separate option for 
participation through APMs. Since quality measurement in APMs is 
required only to be ``comparable'' to that in MIPS, APMs were 
considered an attractive option to propose innovative measures and new 
concepts. The inclusion of the Physician-focused Payment Model 
Technical Advisory Committee (PTAC) in MACRA was seen by many in the 
physician community as a positive step. MACRA payment incentives and 
the establishment of PTAC encouraged the development of physician led 
models, creating a clear pathway for the transition from FFS to APMs.

    ACS recognized the importance of the value transformation in 
healthcare through APMs and partnered with experts in episode-based 
cost measurement at Brandeis University to develop the first proposal 
received, evaluated, and ultimately recommended by the PTAC in April 
2017. The ACS-Brandeis Advanced APM proposal incorporated cutting edge 
cost and quality measurement beyond that currently required by CMS in 
the FFS world into a new value expression. The PTAC thoroughly vetted 
the model both through written requests for information and at an in-
person meeting. PTAC ultimately agreed that the proposal satisfied 
their quality criteria. Unfortunately, the ACS model and many other 
models recommended for testing or implementation in the QPP have not 
been acted upon, closing another door for truly meaningful quality 
measurement.
                                summary
    MACRA promotes innovative quality and cost measures as well as the 
development of alternative payment models. We welcomed the legislative 
intent to improve care and have been hopeful the implementation of the 
law would promote meaningful surgical quality over the burdensome, 
insignificant measures used in many of the previous payment programs. 
Without real meaningful quality measurement, MACRA will fall short of 
achieving the aspirations of patient-centered quality care. The QPP as 
it currently stands fails to provide meaningful quality measurement and 
is in need of a course correction.

    ACS holds that what matters most to patients and providers is 
safer, more efficient, and higher-quality care. It is with these goals 
in mind that we designed our proposed measurement framework for value-
based surgical care. Congress should encourage CMS to partner with 
clinical stakeholders to evaluate and test innovative, evidence-based 
proposals such as the one we have described. We believe CMS has the 
authority to accomplish this but may benefit from additional guidance 
from Congress. CMS may require additional resources to increase their 
ability to accept meaningful data and administer the QPP in a way that 
supplies participants with the tools and data they need to improve 
value, and patients with the information they need to make the best 
possible choices for their care. Creation of a formal process for 
partnerships with the physician community on efforts to improve value 
for patients could help improve the quality of care for Medicare 
patients and truly refocus the incentives in MIPS toward higher value 
care. This would go a long way toward ensuring the long-term viability 
and success of the QPP and MACRA.

                                 ______
                                 
     Questions Submitted for the Record to Frank Opelka, M.D., FACS
                Questions Submitted by Hon. Rob Portman
    Question. I introduced the Medicare Care Coordination Improvement 
Act with Senator Bennet in an effort to reduce some of the barriers 
that providers face when they participate in alternative payment 
models. However, one particular section of my bill focuses on providing 
temporary waivers to practices that are interested in testing their own 
APMs. HHS has been slow to take up new APM concepts, and thus: what can 
we do to incentivize the establishment of new APMs? Has the PTAC 
offered a viable way to propose and test new APMs? If not, what actions 
could be taken to encourage the adoption of PTAC models?

    Answer. The American College of Surgeons (ACS) thanks Senator 
Portman for the opportunity to provide feedback on ways to incentivize 
new Alternative Payment Model (APM) development. The ACS is supportive 
of the Medicare Care Coordination Improvement Act, as it will likely 
help to spur more APM development. However, it is imperative that CMS 
has the tools and commitment to implement new and innovative payment 
models.

    Because quality measurement in APMs is required only to be 
``comparable'' to that in the Merit-based Incentive Payment System 
(MIPS), APMs were considered an attractive option to propose innovative 
measures and new concepts. The inclusion of the Physician-focused 
Payment Model Technical Advisory Committee (PTAC) in Medicare Access 
and CHIP Reauthorization Act (MACRA) was seen by many in the physician 
community as a positive step. MACRA payment incentives and the 
establishment of PTAC encouraged the development of physician led 
models, creating a clear pathway for the transition from fee-for-
service (FFS) to APMs.

    ACS recognized the importance of the value transformation in health 
care through APMs and partnered with experts in episode-based cost 
measurement at Brandeis University to develop the first proposal 
received, evaluated, and ultimately recommended by the PTAC in April 
2017. The ACS-Brandeis Advanced APM proposal incorporated cutting edge 
cost and quality measurement--beyond that currently required by CMS in 
the FFS world--into a new value expression. The PTAC thoroughly vetted 
the model both through written requests for information and at an in-
person meeting. PTAC ultimately agreed that the proposal satisfied 
their quality criteria. Unfortunately, the ACS model and many other 
models recommended for testing or implementation in the Quality Payment 
Program (QPP) have not been acted upon, closing another door for truly 
meaningful quality measurement.

    Question. Per data from CMS, about half of all Medicare providers 
are participating in MIPS, with the majority of these non-participating 
providers being exempt via the low-volume threshold. While we don't 
want to place additional burdens on small and rural providers, we 
should be identifying ways to engage with these practices to help them 
transition towards value-based outcomes.

    What actions should be taken to engage with these providers?

    Answer. The ACS shares your concern for small and rural physicians, 
but believes it is fortunate that they are currently exempted from 
MIPS. Until there are meaningful measures, these physicians should 
remain focused on properly treating patients rather than complying with 
burdensome meaningless activities.

                                 ______
                                 
                 Questions Submitted by Hon. Ron Wyden
    Question. As I mentioned during the hearing, I often hear from 
seniors in Oregon that they don't feel like anyone is in charge of 
managing their health care and helping them navigate the health-care 
system. I am proud of the bipartisan work that this committee did on 
the CHRONIC Care Act last Congress to update the Medicare guarantee. In 
my view, the next step should be making sure that all Medicare 
beneficiaries with chronic illnesses have someone running point on 
their health care--in other words, a chronic care point guard--
regardless of whether they get their care through Medicare Advantage 
(MA), an accountable care organization (ACO) or other alternative 
payment model, or traditional fee-for-service Medicare.

    For beneficiaries in traditional fee-for-service Medicare, what can 
be done to improve care coordination and make sure their physicians and 
other health-care professionals are all talking to each other and 
working together to provide the best possible care to those 
beneficiaries? What specific policies would you recommend this 
committee pursue toward that end?

    Please describe the specific steps that Congress and/or CMS could 
take to ensure all Medicare beneficiaries with chronic illnesses, 
including those in traditional fee-for-service Medicare, have a chronic 
care point guard.

    Answer. The ACS thanks Senator Wyden for the opportunity to provide 
feedback on improving care coordination for patients with chronic 
illnesses. The ACS represents surgeons and their patients, many of whom 
are faced with chronic conditions which tend to complicate their 
surgical care. It is important that the Congress and the Centers for 
Medicare and Medicaid Services (CMS) begin to recognize that the 
health-care sector is no longer represented by cottage industries in a 
simple transactional business, with one stop shopping for care. 
Instead, the current system utilizes a continuum of care which is 
extraordinarily complex. Modern care models have advanced to team-based 
care with the patient in the center.

    The ACS understands the concerns of Senator Wyden's constituents 
regarding their need for a ``point guard.'' This analogy is quite 
fitting. The point guard is an active participant as well as the in-
the-game coach guiding her team. Modern day treatments are too complex 
for any one physician or surgeon to assume all responsibility for 
optimal care. Care occurs in teams of clinicians working together to 
optimize the outcome and meet the goals of the patients.

    Yet, the actions of fee-for-service and CMS have been detrimental 
to the modern-day care models. No point guard operates alone or can win 
the game by herself. It takes all of the team members working in 
concert to accomplish the complex outcomes patients seek. While the 
care models have advanced to team-based care, with the patient in the 
center, the business models and payment models are lagging. Physicians 
are still competing to be the source of care which is paid, rather than 
optimally serving the patients as a team. The over-emphasis on one 
member of the team and not on the entire team is detrimental to the 
overall goal. If the only member of the team is the point guard, what 
would you expect the reaction to be from all the other team members who 
are so essential in assuring the best outcome?

    Everyone has a role to play and everyone is essential to lift up 
all their teammates in their roles. As exuberance builds for the point 
guards, let us not forget how to build the entire team toward the 
excellence in outcomes we seek.

    In order to make this actionable, there are several aspects of 
modern care which need to be rewired in order to create sustainable 
transformation of care. First, the most important focus has to move 
from payment models and an electronic health record (EHR) focus to 
center attention on the actual care model. Care models are now team-
based care models with the point guards as primary care physicians 
(PCPs) coordinating with patients and a broad array of specialty 
medicine, including surgeons. Operationalizing the care models are 
business models which refer to how clinical practices pull together the 
essential resources to optimal practice (staff, equipment, information 
services, inter office communication, finance etc.). Once the care 
model and business models have taken shape, the practice revenue models 
or payment models have to match the care model with a payment model. 
Some conditions are self-limited, with brief care models which may be 
simply managed by one physician, the care model will be narrow and 
brief making fee for service a rational choice. Other aspects of care 
are far more complex and require team-based revenue models. Payers need 
to think about how to ultimately drive the best care models and 
resources for business models in rethinking payment and not simply 
tweak around the edges of fee-for-service.

    Beyond these three aspects of care models, business models and 
payment models are the actual physician compensation models. Physicians 
are primarily compensated based on relative work units and not on how 
patients feel about achieving their outcomes making it rational for a 
physician to drive toward more work units for compensation. This is 
driving volume of services to higher levels and not always for the 
right reason. In order to move away from volume-based payment, 
compensation plans need to become linked to value, and be designed with 
team-based care in mind.

    In order to achieve the goals of care coordination, more needs to 
be done to ensure that digital health information services are not 
heavily siloed by EHRs. Patients not uncommonly have different parts of 
their health in different EHRs. So their health information becomes 
siloed. To move towards breaking down silos, Congress should envision a 
digital information health system as a service to patients, Software as 
a Service (SaaS). This can be achieved by building an open standard, 
patient cloud and requiring every EHR to conform to providing data to 
clouds which conform to the standard. By doing so, this will ensure 
that patients, point guards (PCPs), and all other medical specialties 
are able to see the entire patient record and not just one site's EHR 
view of a patient. Patients' data live in more than one EHR and more 
than EHRs can talk to clouds in today's world of the Internet of Things 
(IoT). To fully enable the care model, the business model, the payment 
and compensation model, and to create a complete team for 
accountability requires a digital ecosystem well beyond the constraints 
of an EHR. This ecosystem is struggling to emerge because of the 
constraints by EHR vendors, by an over emphasis of EHR solutions rather 
than cloud solutions, and by the lack of a personal medical 
identification number which is essential for creating a unique patient 
record in the cloud. The care patients would receive for having such an 
open source cloud architecture would take digital health services to a 
new level. Congress needs to reduce the complexity surrounding digital 
health services and expand the opportunity by empowering Federal 
agencies to work collaboratively within the government and with the 
private sector.

    Question. Eligible clinicians who receive a certain percentage of 
their payments or see a certain percentage of their patients through 
Advanced APMs are excluded from MIPS and qualify for the 5-percent 
incentive payment for payment years 2019 through 2024. Starting this 
year (performance year 2019), eligible clinicians may also become 
qualifying APM participants (and thus qualify for incentive payments in 
2021) based in part on participation in Other Payer Advanced APMs 
developed by non-Medicare payers, such as private insurers, including 
Medicare Advantage plans, or State Medicaid programs.

    Recognizing that this is the first year in which the All-Payer 
Combination Option is available, how many of your members do you 
anticipate will take advantage of the All-Payer Combination Option this 
year?

    What, if any, challenges have your members faced when attempting to 
take advantage of the All-Payer Combination Option?

    Answer. We appreciate the Congress's efforts to expand eligibility 
for inclusion in incentives for payment through the Advanced APM (A-
APM) and recognizing All-Payer Combination options. Our members are 
divided into two broad classes when thinking of payment in A-APMs. One 
group includes our employed surgeons and the other group includes the 
self-employed surgeons. The employed surgeons are typically part of 
larger contract groups and are pulled into commercial models based on 
enterprise contracting. The self-employed surgeons struggle more with 
complex risk-based contracting and would prefer to remain in fee-for-
service MIPS programs. The self-employed are smaller group practices 
which lack the ability to assume much in terms of risk, do not have the 
data infrastructure for risk based contracting, and cannot manage risk 
in general.

    In addition, the current CMS implementations for A-APMs are 
typically payment models based on fee-for-service, but are not 
necessarily built on a care model. As such, care remains fragmented 
even while in bundles which contain fragments of fees for various 
services provided. If the intent of MACRA is to truly focus on 
improving quality and reducing costly waste by using risk-based payment 
models to affect real change, consideration has to begin with building 
care models which are suited for all types of patients, their 
conditions, and a broad array of practice types. Thoughtful design of 
APMs requires input from the physician community in order to appreciate 
the interrelationships of how care is delivered. This will require a 
means for bringing teams together for patient care, with shared risks 
through aligned incentives, openly shared common data dashboards. This 
will need to be consumable by small group practices in rural America as 
well as in large delivery systems.

    For now, all-payer activities are not standardized, with each payer 
creating their own iteration of the various aspects of an APM. This 
creates chaos at the point of care. It is difficult for a team of 
clinicians to understand the nuances of various payment models between 
insurers, when the real focus should be on a patient. For the 
government to promote all-payer models, first we need the government to 
realize all the aspects of care and business practices which need to be 
standardized.

    Just imagine a single procedure such as a lung resection or a 
cardiac bypass. If ten payers each had their own prior authorization 
rules, their own data elements, variation in their applications of risk 
based contracting, and different quality metrics, then these ten payers 
multiplied by four sets of variables would create forty variables; 
which are too burdensome for a system to manage. This is for only one 
procedure and it has already reached the level of being an unmanageable 
burden. Ultimately, surgeons would end up chasing after payment rules 
and differences between payers rather than clinical care, with a 
significant impact on both patients and surgeons.

                                 ______
                                 
               Question Submitted by Hon. Debbie Stabenow
    Question. I am very proud of the work the bipartisan 
accomplishments to address Alzheimer's, including the implementation of 
my HOPE for Alzheimer's Act which required Medicare to pay for new 
individual care plans to support Alzheimer's patients and their 
families. Many of my colleagues are also cosponsors of my Improving 
HOPE for Alzheimer's Act, which will ensure beneficiaries and 
physicians know that they are able to access, and bill for, care 
planning under Medicare. In our last hearing on MACRA implementation, 
my colleagues raised the question of how we should look at quality 
measures in MIPS when it comes to physicians having these conversations 
with beneficiaries and their families and reflecting their priorities. 
Some have mentioned altering MIPS to make the quality measures more 
clinically meaningful. In what ways do you think the system would need 
to change to better incorporate long-term care planning and encourage 
physicians to have these conversations with patients?

    Answer. The American College of Surgeons (ACS) thanks Senator 
Stabenow for the opportunity to provide feedback on meaningful quality 
measurement under the MIPs program. While most surgeons do not engage 
in long-term care planning, the ACS maintains that CMS should work with 
stakeholders to develop measures that are more meaningful to providers, 
with the goal of improving the value of care.

                                 ______
                                 
               Questions Submitted by Hon. Sherrod Brown
                       the patient voice in macra
    Question. In your testimony, you mention the importance of patient-
reported outcomes. I agree that we should be measuring whether or not 
we are paying for care that is in line with the patient's goals. During 
the hearing I asked you how many of the 424 MIPS measures consider the 
patient voice and their priorities. You told me that zero of the 
surgical measures in the payment program are patient reported outcomes.

    What more can your physician organization do to ensure patient 
needs and priorities are kept at the center of health-care delivery?

    What more can and should CMS and Congress do to ensure patient 
needs and priorities are kept at the center of health-care delivery?

    Answer. The American College of Surgeons (ACS) thanks Senator Brown 
for the opportunity to provide feedback related to the inclusion of 
patient needs and priorities in care delivery. Ensuring patient needs 
and priorities are communicated and met is especially critical in the 
delivery of surgical care because most surgical procedures are elective 
and performed with the goal of improving a patient's well-being. 
Therefore patient reported outcomes (PROs) are the best determinant of 
whether an operation was successful. Some examples of PROs include 
measurement of functional goal attainment, severity of symptoms, 
quality of life, etc.

    To be inclusive of the patient's voice, we have to move away from 
collecting patient reported data in the form of long surveys 
administered after a hospital stay or procedure, such as the Clinician 
and Group Consumer Assessment of Healthcare Providers and Systems 
(CAHPS) surveys (currently part of the MIPS program). These 
retrospective PROs do not provide an opportunity to address patient 
needs during their care journey.

    We believe that the integration of the patient experiences and 
milestones within the clinician workflow, including the collection of 
PROs in more frequent, but brief, occurrences throughout their episode 
of care, can provide meaningful information to physicians. Information 
such as progress on care goals, post-surgical recovery, pain 
management, and rehab and therapy are critical to ensuring meaningful 
care delivery. This will enable a more patient-centric approach to 
surgery while facilitating shared decision making and increased 
communication with the patient and surgical team.

    To scale PROs nationally, patient portals and third-party 
applications connected to EHRs through application programming 
interfaces (APIs) could create additional options for the patient's 
voice become a part of clinical decision-making. This would create a 
simple interface for users to respond to questions and share data back 
to their physicians. There is a great opportunity through the 
implementation of 21st Century Cures to leverage technology to achieve 
these goals.

    In the short term, CMS should leverage current resources to 
prioritize outcomes that matter to patients with the use of the PROs to 
receive frequent patient feedback across a patient's care journey, as 
described above. One immediate action CMS should take is to immediately 
distribute the funding available through the MACRA Measurement 
Development for the QPP to develop, test, and implement PROs to measure 
care across the care continuum fit for value-based payment models.

    In the longer term, we urge CMS to build a value framework based on 
what matters most to patients--safer, efficient and high-quality care. 
To do so, payers need to think about how to ultimately drive the best 
care models and resources for business models instead of designing 
quality measures based on fee-for-service transactions without measures 
that map to the care a patient experiences. True patient-centric 
quality should measure the patient outcome and have shared 
accountability for the entire team while ensuring the appropriate 
resources and risk-adjusted clinical data are available for quality 
improvement and patient safety. Below is a figure that details how to 
achieve patient-centric value and improvement across an episode of care 
by the use of:

        1.  Verification of key standards of care (such as the ACS 
        trauma verification program).
        2.  Patient-reported outcome measures.
        3.  Clinical outcome measures.

        [GRAPHIC] [TIFF OMITTED] T5819.004
        

    This framework is based on decades of research and implementation 
in verification programs, which have proven successful in driving 
better surgical outcomes, and is supported by over 2,000 publications 
in the literature. The proposed framework includes patient-reported 
outcomes, which will need to be tested. Our proposal is based on the 
simple tenet that patient-centric quality should measure the patient 
outcome and incorporate shared accountability for the entire team.

    This model relies on validation of successes by measuring outcomes 
using clinical data analytics, which partially depend on bi-directional 
automated interoperability for data exchanges to and from registries. 
Our proposal is simultaneously integrated into surgical workflows, 
while reducing burden by measuring compliance with standards through 
triennial surveys, rather than measures linked to CPT or diagnosis-
related group (DRG) codes. Such surveys exist in thousands of delivery 
systems today, with demonstrated success in trauma, cancer, and 
bariatric surgery.
                    development of metrics in macra
    Question. I have heard from a number of physicians who believe that 
there is no link between many of the MIPS measures they are required to 
report and improving clinical care for their patients. I understand 
that the physician community has engaged with CMS to try and make the 
program more meaningful to physicians and patients through more 
relevant quality measures.

    How are clinicians from your organization involved the creation of 
these measures relevant to their specialties?

    Has CMS been receptive to your feedback when provided?

    How would you assess CMS's collaboration on achieving meaningful 
metrics?

    Are there any changes in this process you would recommend?

    Answer. A Majority of Surgeons Are Measured for Complying With 
Primary Care Measures: We do not believe that CMS has been receptive to 
our feedback because the majority of surgical care is not measured in 
the QPP. The program uses metrics broadly applied across physicians 
without a real appreciation for the details involved in surgical 
quality and improvement, despite suggestions from ACS and other 
specialties to design the program as such. Instead, most surgeons 
required to participate in the QPP are ranked based on measures in the 
CMS Web Interface or the Accountable Care Organization (ACO) Web 
Interface, which evaluate large group practices' compliance with 
primary care services, such as immunizations, blood pressure control, 
diabetes control, and tobacco cessation. These measures do not provide 
the information surgeons need to improve care, including critical 
patient safety indicators, or information patients seek when looking 
for a surgeon. Instead, compliance with these measures leads to added 
administrative burden and detracts resources away from highly 
successful quality improvement programs.

    This is a result of CMS developing the MIPS measure framework based 
on clinical services billed to Medicare based on a surgeon's TIN, not 
episodes of care. The measures are reported using a submission process 
that does not consider the care delivery model. The result is 
fragmented metrics that do not always map to the patient and the care 
model, as illustrated below:

[GRAPHIC] [TIFF OMITTED] T5819.005


    CMS Does Not Value Conformance With Key Process Measures: Since the 
inception of the ACS, we have built standards for clinical domains with 
the expectation of improving overall outcomes of surgical care. Through 
this work, we have gained over a half-century of experience in building 
clinical verification programs for specific clinical domains. Each of 
the major surgical domains contains a set of standards as part of a 
renewable, triennial verification program. These programs have proven 
to drive quality, improvement, and excellence in care. Compliance with 
ACS verified standards (such as the ACS Trauma verification program) 
confirm appropriate structure and resources are in place for optimal 
care.

    However, the CMS ``topped out'' measure policy devalues these 
critical process measures by removing measures with a high performance 
rate. An example of a process measure that CMS has determined is topped 
out and plans to phase out of the program is use of the American 
College of Surgeons National Surgical Quality Improvement Program (ACS 
NSQIP) Surgical Risk Calculator measure. CMS policy does not value this 
measure, but the College maintains that every patient undergoing an 
operation should have access to a risk calculator that predicts the 
likelihood of a positive outcome. This step in preoperative planning 
provides an opportunity for the surgeon and the patient to engage in 
shared decision making, including whether an operation is the ideal 
form of treatment. Shared decision making does not occur commonly 
enough, but most patients consider it an essential part of care 
planning.

    CMS Is Reluctant to Test Innovative Physician-developed Models: 
MACRA payment policies and the establishment of Physician-focused 
Payment Model Technical Advisory Committee (PTAC) clearly incentivize 
the development of, and participation in, Alternative Payment Models 
(APMs). ACS and others have recognized the value of creating such 
models and have expended significant time, effort, and resources in 
doing so. The ACS-Brandeis Advanced Alternative Payment Model (A-APM), 
which was recommended by the PTAC but not implemented, would allow for 
the use of episode-based surgical measures meaningful to surgeons and 
surgical patients. The health-care community has rallied to meet 
Congress's challenge to develop new physician-focused models but the 
disconnect between the PTAC recommendation process and the testing of 
new models by CMS poses a significant barrier to innovation. Instead of 
testing new models developed by physicians, we continue to see 
variations on existing CMS models such as the Bundled Payments for Care 
Improvement (BPCI) Advanced or the ACO Track 1+. While we believe there 
is great merit in the move toward A-APMs and plan to continue work on 
developing core concepts of the ACS-Brandeis A-APM, it is unfortunate 
that the input from the broader health-care community has not led to 
the implementation of physician-built APMs by CMS.

    Additionally, MACRA allocated $15 million a year for 5 years 
starting in 2015 to incentivize the development of innovative quality 
measures. This money has been slow to flow to new measure development. 
This money was intended to be used to help fill gaps where measures 
fail to meaningfully measure care delivery, including surgical PROs. 
ACS submitted a proposal to CMS fund the development of a value-based 
measurement framework to measure surgical care, but funding was not 
granted.

                                 ______
                                 
             Questions Submitted by Hon. Sheldon Whitehouse
    Question. Accountable Care Organizations (ACOs) have the potential 
to transform our health care delivery system. While we've seen ACOs 
improve patient care and create shared savings, many provider-led ACOs 
only control a small fraction of total spending, with specialists, 
pharmaceuticals, and hospitals accounting for most of it. This leads to 
ACOs lacking sufficient leverage to bring down costs and can contribute 
to shared losses.

    How can we improve the ACO model to account for this imbalance? How 
can we support successful ACOs and encourage more providers to follow 
their lead?

    Answer. The American College of Surgeons (ACS) thanks Senator 
Whitehouse for the opportunity to provide feedback on ways to improve 
Accountable Care Organization (ACO) models. The early wins in ACOs have 
come from the ``low-hanging fruit'' typically found in pharmacy costs, 
site of service differentials, excessive imaging usage, and excessive 
visits for patients with chronic conditions. These are common, 
recurring costs which are easily controlled by simple cost saving 
efforts.

    Taking ACOs to another level with the goal of transforming care, 
with the addition of medical specialties to the action plan, will 
involve a major redesign of care. Much has been made of primary care as 
the major source of savings without realizing the complexity of care 
today far exceeds the single-transactional mind-set of past care 
delivery. The science of medicine has outstripped the ability of a 
cottage industry for a single professional to remain current and 
practice the best care once the care required becomes complex. Modern 
care models have advanced to team-based care with the patient in the 
center. While basics in prevention and maintenance of care are still 
delivered between a patient and their doctor, once care becomes more 
complex, it takes a team to deliver the type of care needed to stay 
ahead of a condition or disease.

    Currently, most specialty-based medicine continues to be incented 
by fee-for-
service revenues and volume-based compensation. To change their 
direction means taking steps to redesign the care models and their 
associated underlying business models. Underneath the care models and 
business models are needed complex data infrastructure to inform the 
entire care team of a patient's journey. These remain fragmented and 
difficult to manage in an ACO. Fee-for-service revenue models and 
compensation plans for physicians still predominate medical specialties 
even within ACOs. The infrastructure to craft the sort of change needed 
is taking shape but needs directional guidance and incentives from the 
government in order to accelerate the change for true health-care 
transformation. Total cost of care (TCOC) for an episode would provide 
patients and their medical teams the ability to understand the price of 
the medical goods and services incurred by patients and payers. 
However, if each payer performs their own cost of care model, the 
impact for patients and clinicians will be chaotic. A single standard 
is needed to apply all-payer claims data and determine the standard 
method for providing costs. The ACS has worked with the Centers for 
Medicare and Medicaid Services (CMS) to promote the CMS Episode Grouper 
Methodology and through our work with Remedy Health, Cerner, and 
Brandeis University, we have stepped up to create a TCOC system as a 
public utility for all to use in a new non-profit entity referred to as 
PACES--the Patient-Centered Episode System.

    The unit of analysis of specialty medicine, particularly surgical 
care, should expand to consider team-based episodes of care. These can 
be viewed as separate from an ACO or may reside as a bundle within an 
ACO population. To date, CMS has elected to carve out these episodes or 
bundles from the ACO and incent them as separate risk-based payment 
events. It may be easier to implement episode-based care as a carve-out 
from the ACO. This would leave more chronic care models within the ACOs 
where population-based care plans are better suited to population-based 
payments.

    Question. Our health-care system is not fully equipped to care for 
an aging population and patients with advanced illness such as late-
stage cancer, Alzheimer's disease or dementia, or congestive heart 
failure. This is an area where we need new models of care that reflect 
these challenges and create a better system for providers, patients, 
and their families. Many of our current Medicare rules in this space 
are counterproductive, such as requiring a 2-night, 3-day stay in an 
inpatient facility to qualify for skilled nursing care, and various 
disincentives to providing respite or palliative care. How are your 
organizations innovating to provide care for these patients, and what 
can Congress and CMS do to support those efforts?

    Answer. The ACS would ask that Congress urge CMS to reconsider the 
rule that does not allow time spent as a hospital outpatient to count 
toward the 3-day qualifying inpatient stay for Medicare Part A coverage 
of care in a skilled nursing facility (SNF). Not only can services 
provided in the outpatient setting be similar to services provided in 
the inpatient setting, often the beds used for both sites of service 
are the same and indistinguishable to the patient and sometimes even to 
the clinicians. As such, a Medicare patient may not know whether he/she 
is admitted as an inpatient or on observation as an outpatient. In 
these situations, a patient could be surprised by a large medical bill 
when transferred to a SNF after a 3-day stay in the hospital that the 
patient thought was an inpatient stay.

    Question. Despite continued investment, electronic health records 
(EHRs) remain difficult to share, challenging for patients to access, 
and a source of frustration to providers and policymakers alike. The 
business models of the EHR venders often leads to perverse incentives 
against sharing patient information.

    What steps can Congress take to make EHRs work better for 
providers? Are the proposed data blocking rules enough to start 
encouraging better data sharing by the vendors?

    Answer. Congress has been extraordinarily supportive in the 
implementation of digital health services through EHRs and the 
subsequent efforts in 21st Century Cures regarding unleashing data. 
This move towards standards for data models and data exchange are a 
necessary first step in easing interoperability and increasing patient 
and provider access to the complete patient record.

    We believe it is time to move a layer above EHRs and begin the 
conversation about the semantically interoperable, digital information 
system as a service in an open-standard, patient cloud. Patients do not 
live in one health system or one EHR, they live in five, six, or more 
EHRs. Patient data also lives in third-party applications (Apps), in 
wearable devices, and in claims. The next generation of digital health 
services has to create the unified patient record in a patient cloud. 
The patient cloud should be an industry open standard based 
architecture that any digital system could use. A simple example of 
open industry standards are the railheads for railroads. Similarly, the 
electric grid is on one standard. The free market can then exploit 
these standards and avoid overbearing, inefficient, and costly 
duplicative services. Similarly, the United States needs an open 
standard for the architecture of a patient cloud so that any digital 
information company can apply the standard and create a semantically 
interoperable cloud. Upon these clouds, digital services like Apps can 
accelerate the role of the Internet of Things (IoT) in health care for 
all patients and clinicians.

    The EHR data models are constructs from decades past and are no 
longer going to serve as the digital architecture of tomorrow. Building 
a Linux-like architecture as an open standard cloud architecture which 
anyone can standup and use is critical to ensuring a modern 
interoperable system. This open standard cloud architecture would hold 
a patient unified record in a cloud upon which all EHRs could provide 
data, all smartphones could interact, all Application programming 
interface (API) developers could drop in their services for patients 
and clinicians. The ACS is working with cloud architects who support an 
open standards environment so that we do not repeat the mistakes we 
made with EHRs by providing perverse incentives. These efforts do not 
void the EHRs. The EHRs remain a point of data entry at a care site 
just as a smartphone or a desktop computer could also serve to enter 
data.

    In this emerging digital information system, all patient privacy 
and security rights need to remain. The care patients would receive for 
having an open source cloud architecture would take digital health 
services to a new level. Congress needs to reduce the complexity 
surrounding digital health services and expand the opportunity by 
empowering Federal agencies to work collaboratively within the 
government and with the private sector. For now, having separate 
activities which lack strategic alignment between CMS, the Office of 
the National Coordinator of Health Information Technology (ONC), the 
Centers for Disease Control and Prevention, the Agency for Healthcare 
Research and Quality, and the Food and Drug Administration create 
enough confusion. Adding in the commercial activity and the desires of 
the EHR vendors to continue their dominance and the end result will 
hinder innovation in one of the most important futures for health care.

    The ONC proposed rule as part of 21st Century Cures Act begins to 
address some of the EHR and data exchange challenges through requiring 
Fast Healthcare Interoperability Resources (FHIR) based APIs and U.S. 
Core Data for Interoperability (USCDI) data standards. We encouraged 
the ONC to work with vendors and specialty societies to define the data 
elements that are part of data exchange, and ensure that the included 
data are relevant and meaningful. This will help to avoid sending large 
amounts of irrelevant data into a new architecture. With clearly 
defined and reasonable standards, data exchange between EHRs to other 
vendors and third party applications will be manageable. We are 
concerned, however, that without incentives or an adjustment in 
reimbursement methodology, that the vendor development costs will be 
passed on to providers and health systems. Further, encouraging open 
source platforms that minimize the number of one-off connections needed 
for providers and health systems to share data with other entities and 
third party applications would ease the burden of data exchange and 
encourage innovation from health information technology (HIT) vendors.

    While many benefits come from increased interoperability, the 
challenge of patient matching is heightened as data sources increase. 
Today, there is no consistent and accurate way of linking a patient to 
their health information as they seek care across the continuum. If 
physicians cannot ensure that we have the right patient at the point of 
care, we cannot properly utilize the enormous promise of the 
portability and interoperability of health records. We continue to 
encourage a universal patient identifier to minimize this burden, and 
to work with the industry to develop algorithms in the interim that use 
demographic data points to determine patient identity.

    ACS is supportive of legislative efforts that would remove a 20-
year mandate that prevented the U.S. Department of Health and Human 
Services (HHS) from spending Federal dollars to adopt a unique patient 
identifier. Removing the ban on unique patient identifier would help to 
ensure that surgeons have a more accurate and consistent way of linking 
patients to their health information across the continuum of care by 
providing HHS with the authority to evaluate a full range of patient 
matching solutions. It would also enable HHS to work with the private 
sector to identify a solution that is cost-effective, scalable, secure 
and one that protects patient privacy.

    Question. How can we encourage States to be better innovators on 
health-care spending? The current Medicaid waivers incentivize States 
to keep costs down, but are there ways to encourage both lower costs 
and better health-care outcomes?

    Answer. In order to identify how we can encourage States to be 
better innovators on health-care spending, Congress must understand the 
current landscape in the health insurance coverage space. States lack 
the resources to think in large scalable terms and across the landscape 
of uninsured, minimally insured, commercially insured, and those 
covered by Employee Retirement Income and Security Act of 1974 (ERISA) 
plans. The States react mostly to their budgets and the payment 
obligations, and struggle to consume a problem as complex as designing 
and transforming health care, one of the largest business sectors in 
the Nation. While we think of health care as a cottage industry which 
States should be empowered and able to manage, the long history of 
failed attempts should attest to the low level of expectations from 
States. The magnitude and complexity of the challenge leave most States 
in a quandary.

    This leaves two possibilities. First, States could await a Federal 
solution. Secondly, Congress could consider the States as testbeds for 
Federal solutions and provide States with Federal guidance containing 
well controlled swim lanes within which they can locally innovate. If 
States then wish to add-on to federally guided aspects of the business 
and payment models in health care, these additions would come at their 
individual State expense.

    Relying on States to take action on health care involves the 
commercially insured, which are mostly small businesses within a State. 
The larger corporations have been spared State regulations by providing 
health coverage under ERISA, which is regulated at the Federal level. 
Because of this, any actions taken by the States to test new ideas in 
health care are built on the backs of the small businesses that are 
unable to sustain themselves in the face of major health care redesign. 
This allows larger employers in the State to escape State-based 
regulations under ERISA plans even though larger corporations are more 
able to tolerate innovation efforts than small businesses. In order to 
increase voluntary uptake in testing new ideas in health care, Federal 
agencies overseeing ERISA plans could enact or incent innovation in 
health-care payments using rules and regulations.

                                 ______
                                 
               Questions Submitted by Hon. Maggie Hassan
    Question. We spoke during the hearing about the incentive payment 
for providers to improve tracking and reporting of opioid prescribing, 
treatment agreements, 
follow-up evaluations, and screening of patients who may be at risk of 
opioid misuse under the Medicare Access and Children's Health Insurance 
Program (CHIP) Reauthorization Act of 2015 (MACRA).

    This data has the potential to improve treatment for substance use 
disorder, which is why its collection and reporting is now incentivized 
through increased reimbursement.

    At the hearing, I asked for feedback on the impact this data 
collection and reporting has had on treatment of patients, particularly 
as it relates to any reduction in opioid misuse.

    Based on your response, it seems that there may be additional steps 
the Centers for Medicare and Medicaid Services (CMS) could take so that 
this aggregated, de-identified data can be used to benefit patients and 
improve care.

    Do you have specific suggestions on how CMS can improve the 
collection, use, and dissemination of opioid prescribing and treatment 
data sets in ways that would directly benefit patients at their site of 
care, specifically as it relates to identifying best practices to 
reduce opioid misuse?

    Answer. The American College of Surgeons (ACS) thanks Senator 
Hassan for the opportunity to provide feedback, specifically as it 
relates to the opioid crisis and the data collection behind prescribing 
and treatment. Your question was reviewed by the ACS Opioid Taskforce 
\1\ which is dedicated to helping prevent opioid abuse and addiction in 
surgical patients. Please find the College's official statement on the 
opioid epidemic and guiding principles here: https://www.facs.org/
about-acs/statements/100-opioid-abuse.
---------------------------------------------------------------------------
    \1\ https://www.facs.org/education/patient-education/safe-pain-
control/taskforce.

    Prescribing guidelines should be evidence based and written using 
actual data. There is a concern that a 200 morphine milligram 
equivalents (MME) cutoff or 7-day limit will hurt patients, increase 
readmissions, emergency department visits, and increase costs. Detailed 
articles outlining the harm of hard limits can be found here: https://
www.ncbi.nlm.nih.gov/pubmed/28697049 and here: https://www.
---------------------------------------------------------------------------
ncbi.nlm.nih.gov/pubmed/30004924.

    ACS would encourage the Center for Medicare and Medicaid Services 
(CMS) to develop evidence-based guidelines to reduce over prescribing 
and misuse. ACS suggests referencing guidelines like the ones released 
by the Mayo Clinic: https://advancingthescience.mayo.edu/2018/04/16/
new-mayo-guidelines-cut-some-opioid-prescriptions-by-half/ (Study 
attached).

    More generally, data collection should be mobile and easily 
accessible at the point of care. Data collection should be focused at 
the population level. Narcan for example, is distributed by police, 
fire, emergency medical technicians (EMTs), physicians and the patients 
themselves. This community data should be shared with the databases of 
physician offices, hospitals and clinics. In order to fully understand 
the scope of the epidemic data should be as granular as possible.

    Furthermore, ACS supports the use of fully-functioning prescription 
drug monitoring programs (PDMPs) as a health-care and research tool to 
assist physicians and other prescribers. Currently, there is wide 
variability between the functionality and accuracy of PDMPs from State 
to State. ACS strongly supports the utilization of governmental grant 
funding to enhance these programs and make them accessible to 
appropriate members of the health-care team. ACS also believes PDMPs 
should integrate into a clinician's natural workflow.

    Patient education is also a key component to reducing opioid 
misuse. The ACS has developed and discriminates a wide variety of tools 
for physicians to use in order to education and inform their patients: 
https://www.facs.org/education/opioids/patient-ed. Public awareness 
campaigns such as ``Change the Script''\2\ led by the State of 
Connecticut connects ``town leaders, health-care professionals, 
treatment professionals and everyday people with the resources they 
need to face prescription opioid misuse.''
---------------------------------------------------------------------------
    \2\ https://portal.ct.gov/DMHAS/Prevention-Unit/Prevention-Files/
Change-the-Script.

    The ACS is committed to addressing the societal imperative to avoid 
the overprescribing of opioids through both patient and provider 
education, as well as through continued research into non-opioid pain 
treatments and other alternative remedies. We stand ready as a resource 
to Senator Hassan and the members of the Health, Education, Labor and 
---------------------------------------------------------------------------
Pensions (HELP) Committee as discussions continue on this topic.

[GRAPHIC] [TIFF OMITTED] T5819.006

[GRAPHIC] [TIFF OMITTED] T5819.007


                                 ______
                                 
                 Prepared Statement of Hon. Ron Wyden, 
                       a U.S. Senator From Oregon
    Four years ago, this committee led the effort to revolutionize the 
way doctors are paid under Medicare. Into the dustbin of history went 
the out-of-date system known as the sustainable growth rate--a system 
that had inflicted more than a decade of uncertainty on doctors and 
seniors.

    The new system that replaced it engraved a basic principle in 
stone: Medicare is going to reward the quality of care rather than the 
quantity of care. That's the direction that health care is headed in 
across the country, and Medicare ought to lead the way.

    That new system established by the bipartisan MACRA law has now 
been in place for 2 years, and this committee has kept a close eye on 
its implementation. So today, the committee will hear from the doctors 
who operate under this system about what's working and what's not. 
There are a few key issues to focus on this morning.

    First, all doctors should have a meaningful opportunity to succeed 
under the new payment system--including those in small practices and in 
rural and underserved areas. Oftentimes those rural physicians are the 
backbone of their communities, and they're relied on for a broad range 
of care. It's absolutely essential, as there's a greater focus on 
rewarding value in health care, that doctors in small and rural 
practices aren't left behind. Otherwise that'll degrade the care rural 
patients get, and it'll cause an even bigger health-care gap between 
big cities and small towns.

    Second, when it comes to assessing quality, the goal of 
implementing this new system is not to have doctors checking boxes all 
day long. Our system needs to measure and reward the care that is most 
impactful for patients' health. When you're all about rewarding value, 
that's what matters.

    Third, the system needs to continue wringing more value out of 
taxpayer dollars in Medicare while coordinating the care seniors need. 
You can do that, for example, by encouraging more doctors to provide 
care through Accountable Care Organizations, medical homes, and bundled 
payments.

    One final point on the topic of physician payments as I wrap up. 
Last year the Congress passed a historic Medicare bill, the CHRONIC 
Care Act. It marked a major shift for Medicare away from being an acute 
care program treating broken ankles and bouts of the flu. It recognized 
that modern medicine for seniors in America is about treating cancer, 
diabetes, Alzheimer's, and other chronic illnesses. After that 
progress, it's time to think about what's next.

    In my view, the next step ought to be helping to guide the 
countless seniors who get lost in the blizzard of modern health care. 
Forms and prescriptions and instructions and pill bottles--it can be 
too much and too complicated for any one person to manage on their own.

    As a former basketball player, I put the solution in basketball 
terms. Every senior with chronic illness ought to have what I call a 
chronic care point guard managing their care and making sure their 
doctors work together. To extend the metaphor, it's about having 
somebody out there running the floor. The truth is, regardless of 
whether an older person is enrolled in traditional Medicare or a 
Medicare Advantage plan, that kind of assistance could help improve 
care and avoid a lot of mistakes.

    As for today, I want to hear from those on the ground about how the 
new physician payment system is working and what can be done to improve 
it. I want to thank all of our witnesses for joining us today, and I 
look forward to questions.

                                 ______
                                 

                             Communications

                              ----------                              


                     Alliance of Specialty Medicine

                         3823 Fordham Road, NW

                          Washington, DC 20016

    The Alliance of Specialty Medicine (``Alliance'') is a coalition of 
fifteen medical specialty societies representing more than 100,000 
physicians and surgeons from specialty and subspecialty societies 
dedicated to the development of sound federal health care policy that 
fosters patient access to the highest quality specialty care. As 
patient and physician advocates, the Alliance welcomes the opportunity 
to provide input in the formulation of healthcare and Medicare policy. 
This hearing is an important step toward continuing the promise of the 
Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) and 
associated programs established under the Centers for Medicare and 
Medicaid Services' (CMS) Quality Payment Program (QPP)--the Merit-based 
Incentive Payment System (MIPS) and Advanced Alternative Payment Models 
(A-APMs)--as it was intended by the Congress.

    The Alliance of Specialty Medicine believes:
          Congress should continue to make adjustments to the programs 
        created under MACRA;
          Congress should maintain a viable fee-for-service option for 
        providers under the Medicare program;
          Congress must safeguard beneficiaries' access to care by 
        eliminating the 0% payment update applied to the Medicare 
        conversion factor from 2020-2025 and replacing it with an 
        update factor that better recognizes the Medicare Physician Fee 
        Schedule conversion factor has failed to keep with inflation 
        and in some instances has been reduced.
          Congress should acknowledge the slow pace of implementation 
        of APMs by altering the timelines for bonuses embedded in 
        statute. This includes:
              Extending the availability of the Advanced 
        APM 5% Incentive Payment in acknowledgement of the snail's pace 
        of APM implementation by Medicare; and
              Re-evaluating the qualifying participation 
        thresholds for the A-APM incentive payment in light of the lack 
        of implementation by CMS of qualifying APMs.

Background on Physician Engagement in MACRA

    We first would like to take the opportunity to again commend 
Congress for enacting MACRA. This important step removed the constant 
threat brought to Medicare payments by the Sustainable Growth Rate 
(SGR). With the SGR, a destabilizing force for Medicare beneficiaries 
and the system overall, out of the way, Congress has provided the 
opportunity for all stakeholders to engage in a more meaningful 
discussion about how best to update Medicare payments and recognize the 
value of services that are provided by physicians, including 
specialists. We would also like to thank Congress for ``technical 
corrections'' included as part of the Balanced Budget Act of 2018, 
which significantly improved the ability of physicians--namely 
specialists--in their ability to participate in MACRA programs, and 
especially MIPS.

    Through MACRA, Congress sought to provide flexible options for 
clinicians to meaningfully engage in quality improvement and value-
based payment under Medicare. Members of this committee heard our 
concerns about legacy quality improvement programs in Medicare--the 
Physician Quality Reporting System (PQRS), Physician Value-Based 
Payment Modifier (VM) and the Medicare and Medicaid Electronic Health 
Record Incentive Program, or ``Meaningful Use''--and in response sought 
to remove disparate reporting requirements, overlapping measures, and 
most of the ``all-or-nothing'' aspects of these programs and to create 
a streamlined system that allows physicians to focus on the measures 
and activities that most closely align with their practices. As a key 
example of that, Congress included clinical practice improvement 
activities under MIPS, giving physicians MIPS credit under Medicare's 
payment methodology for activities designed to improve care--further 
encouraging physicians' ongoing engagement in quality improvement 
activities. More importantly, Congressional leaders understood that a 
viable fee-for-service option was essential to the Medicare program for 
those physicians, including many specialty and subspecialty providers 
that may never find a place in alternative payment and delivery models. 
While MIPS serves as an ``on-ramp'' for many clinicians, it serves as 
the ongoing value-based payment system for clinicians who must remain 
in a fee-for-service reimbursement construct. Under MIPS, specialists 
and subspecialists have a fair opportunity to remain in fee-for-service 
while continuing to measure, report, and improve performance on key 
areas of clinical quality that matter to their practice and their 
patients.

    The Alliance recognizes that MIPS has challenges, although the 
first year of the program showed significant participation by 
physicians. According to CMS' 2017 Quality Payment Program Experience 
Report, 95 percent of eligible clinicians participated in MIPS (54 
percent as groups, 12 percent as individuals, and 34 percent through 
MIPS APMs), exceeding the agency's goal of having 90 percent of MIPS 
eligible clinicians participate during the first performance year. This 
success can be attributed to CMS' efforts to ease clinicians into the 
program through a transition, which began with a ``Pick Your Pace'' 
engagement strategy and determined efforts by medical professional 
societies to educate physicians on successful participation. For those 
who participated, 93 percent earned a positive payment adjustment and 2 
percent got a neutral adjustment. Of note, the majority of clinicians 
across all payment categories chose to report data for 90 days or 
longer.

    Despite calls by the Alliance and other medical and healthcare 
professional organizations, a detailed breakdown of QPP performance by 
physician specialty is not available nor reporting option utilization 
rates by physician specialty. We contend that such data should be 
routinely included as part of CMS' regulatory impact analyses included 
in annual rulemaking for the QPP. In order for medical healthcare 
profession associations to better educate and motivate members, it is 
also important for CMS to begin sharing payment adjustment data by 
physician specialty.

    With respect to A-APMs, engagement is more challenging, 
particularly for specialists. First, CMS has implemented so few APMs 
since the passage of MACRA that meaningful opportunities to participate 
in APMs for most specialists does not exist. MACRA contemplated an 
expansion of available models with the creation of the Physician 
Focused Payment Model Technical Advisory Committee (PTAC). While CMS 
recently announced the Primary Care First model, a single model largely 
focused on primary care that incorporates a few elements from several 
different models recommended for limited-scale testing by PTAC, CMS has 
otherwise failed to implement models recommended by the PTAC that have 
addressed a broad range of physician specialties.

    Existing A-APMs, such as qualifying Medicare Accountable Care 
Organizations (ACOs), do not fairly measure or account for the quality 
and costs of specialty medical care. For example, the measure sets used 
by current ACO models focus on measures reported by primary care 
providers rather than specialty care providers, making it difficult for 
specialists to meaningfully engage. Without measures of specialty care, 
ACOs seem to struggle with specialist engagement. Perhaps more 
concerning, and similar to health insurers, Medicare ACOs have 
seemingly adopted ``narrow networks'' as a strategy to control costs, 
severely limiting the participation of specialists. Other models that 
have been identified as Advanced APMs, such as medical home models like 
Comprehensive Primary Care Plus (CPC+), are also difficult for 
specialty care physicians to engage in, as these models are designed 
for primary care physicians. CMS recently announced its Primary Cares 
Initiative, which again, will be largely limited to primary care 
providers.

    While a few models focus on specialty medical conditions and engage 
specialty physicians, these only cover a paucity of physician specialty 
domains. The MACRA vision of moving clinicians from fee-for-service 
into alternative payment models can only materialize if those models 
are actually implemented by CMS for potential participation. This 
currently leaves MIPS as the only track of the QPP for most specialists 
to meaningfully engage in MACRA's reforms. More importantly, some 
specialists may never find an appropriate A-APM given their specialty 
or practice size. To that end, MIPS must be enhanced for long-term 
viability and the timelines contemplated under the original passage of 
MACRA must be re-evaluated to account for the fact that so few APMs are 
available and in recognition of the fact that many physicians, and 
specialists in particular, will continue to have payment updates based 
on MIPS because of this and because current APMs are not designed to 
account for the type of care provided by certain specialists.

MACRA and Specialists: Considerations for the Future

    The Alliance appreciates the Congress' and CMS' efforts to improve 
the QPP and reduce the burden of participation, as well as minimize the 
number of clinicians subject to negative payment adjustments. 
Nevertheless, specialty physicians continue to face unique challenges 
as they attempt to engage. For example, CMS' ``Meaningful Measures'' 
initiative, which is aimed at reducing the number of measures in its 
quality programs, has limited the ability of specialists to 
meaningfully participate in MIPS as relevant measures have been 
eliminated. Specialty societies have made considerable investments in 
specialty-specific measure development, only to find CMS implementing 
an overly aggressive policy to eliminate what it deems are ``topped 
out'' measures. We believe that while it might be appropriate to place 
less of a priority on these measures from a MIPS scoring stand point, 
the current policy eliminates these measures when there is still 
measurement value, and the aggressive timeframe leaves societies with 
inadequate time to develop new quality measures to ensure that every 
specialty has a MIPS quality score based on measures meaningful to that 
specialty. Contrary to CMS' efforts to reduce administrative burden, 
this policy actually increases the burden of MIPS on those specialties 
that no longer have relevant measures in the program.

    The Alliance and its member organizations continue to work with the 
agency to improve MIPS and the availability of A-APMs. To that end, the 
Alliance makes the following recommendations to Congress, many of which 
have been previously shared with CMS:
MIPS
          Eliminate the 0% payment update applied to the Medicare 
        conversion factor from 2020-2025 and replace with positive 
        annual updates that recognize the Medicare Physician Fee 
        Schedule conversion factor has in the past failed to keep up 
        with inflation and in some instances has even been reduced, 
        provides reimbursements that keep up with the escalating costs 
        of providing care, and supports practice efforts to invest in 
        models of care and reimbursement based on value;
          Provide participation data in MIPS, by specialty, as part of 
        the annual notice and comment rulemaking for the QPP;
          Remove the ``all-or-nothing'' aspect of the Promoting 
        Interoperability (Pl) category by allowing eligible clinicians 
        to select from a menu of measures that are most appropriate for 
        their practice and patient population and gives full credit for 
        this category for those practices that participate in a 
        qualified clinical data registry (QCDR); and
          Simplify MIPS scoring so eligible clinicians and practice 
        staff can have a more accurate understanding of how success can 
        be achieved given various levels of participation.
A-APMs
          Provide participation data in A-APMs, by specialty, as part 
        of the annual notice and comment rulemaking for the QPP;
          Extend the availability of the A-APM incentive payment 
        (i.e., the 5% APM incentive payment) beyond the 2024 payment 
        year/2022 performance year;
          Re-evaluate the qualifying participation thresholds for the 
        A-APM incentive payment in light of the lack of implementation 
        by CMS of qualifying APMs;
          Provide CMS with directives on implementation of physician-
        focused payment models (PFPMs) and, in particular, specialty-
        developed PFPMs; and
          For Medicare's ACO program:
              Establish pathways for specialists to 
        meaningfully engage in the ACO program;
              Provide ACOs with technical assistance that 
        would allow them to appropriately analyze clinical and 
        administrative data, improving their understanding of the role 
        specialists could play in addressing complex health conditions, 
        such as preventing acute exacerbations of comorbid conditions 
        associated with chronic disease;
              Establish requirements that prohibit ACOs 
        from restricting specialist participation;
              Closely examine the referral patterns of ACOs 
        and establish benchmarks that will foster an appropriate level 
        of access to and care coordination with specialists, in 
        addition to collecting feedback from beneficiaries on access to 
        specialty care;
              Develop an ACO quality measure that would 
        capture the percentage of physicians reporting to specialty-
        focused clinical data registries; and
              Adopt specialty designations for non-
        physician practitioners to ensure specialty practices are not 
        inadvertently forced into exclusivity.

MedPAC Recommendation to Eliminate MIPS

    In 2018, the Medicare Payment Advisory Commission (MedPAC) 
recommended the elimination of MIPS based on its conclusion that the 
basic design of MIPS is fundamentally flawed. The Commission contends 
that MIPS will not succeed in helping beneficiaries choose clinicians, 
in helping clinicians change practice patterns to improve value, or in 
helping the Medicare program reward clinicians based on the value of 
the care they provide. To address these concerns, Med PAC further 
recommended implementing a voluntary value program (VVP) that would 
measure large groups of physicians on population, outcome, and patient 
experience measures. Details about the VVP are anticipated in future 
Commission work; however, the concept at its broadest level ensures 
that most specialists will be unable to meaningfully engage as the 
measures MedPAC has suggested are those CMS uses in its other quality 
programs and focus on primary care activities and population health.

    The Alliance strongly opposes MedPAC's recommendations for the 
reasons cited below:

          There is a significant lack of A-APMs in which specialists 
        can meaningfully engage;
          The measures contemplated for use under a VVP will be 
        limited in their ability to determine quality and cost of 
        specialty medical care;
          Specialty providers have very little control over the 
        activities that affect performance on the measures contemplated 
        for use under a VVP; and
          MACRA very clearly intended to promote the development of 
        clinically relevant, specialty-based quality measures. MIPS, 
        and fee-for-service, remain a viable reimbursement structure 
        for many specialists and subspecialists and must be maintained.

    Instead of the MedPAC recommendation to scrap the progress that has 
been made thus far on the implementation of MACRA, in addition to the 
provisions suggested above, we believe the following steps, many of 
which can be taken by CMS, will help make the QPP a better system on 
which to base physician payment updates than what is suggested by 
MedPAC under the VVP:

          Streamline the program to avoid the siloed scoring of the 
        current four performance categories;
          Condense the amount of time between performance and payment 
        years in order to provide more meaningful feedback and 
        incentives;
          Reduce the reporting periods to an amount of time that 
        provides reliable data but reduces the administrative reporting 
        burden placed on practices; and
          Promote the inclusion of measures that recognize the value 
        of specialty care rather than broad primary care-focused 
        measures that only apply to a subset of services provided in 
        the context of the Medicare Physician Fee Schedule.

Conclusion

    Specialists are an essential and needed component of the healthcare 
system. Specialists use their deep knowledge and expertise to reach a 
precise medical diagnosis, present the full array of available 
interventions, collaborate closely with their patients to determine 
which treatment options are most appropriate based on their preferences 
and values, and coordinate and manage patients' specialty and related 
care until treatment is complete. No other clinician, provider or 
health care professional can replace the value offered by specialty 
physicians. At the same time, specialty physicians have had limited 
opportunity to engage in value-based transformation through available 
A-APMs that are targeted to their specialties, and the likelihood of 
widespread future models tailored to their expertise remain low. To 
that end, MIPS must continue to be improved for long-term viability 
since it will be the only option for many of these specialists to 
engage in value-based payment given they will have no other option than 
to remain in fee-for-service.

    Finally, while we are confident that successful implementation of 
the idea cited above will make strides in developing a more meaningful 
QPP for patients, physicians, and for Medicare as a payer, we also 
believe that it will be important to begin having a larger conversation 
about the siloed payment systems in Medicare that fail to recognize the 
impact that specialists have on inpatient and outpatient hospital 
spending. Physicians have been asked to bear the brunt of Medicare 
spending increases with payments that are sometimes cut, certainly fail 
to keep pace with inflation, and fail to even measure up to the payment 
increases included in MACRA. For instance, in 2016, the first year that 
the MACRA 0.5% base payment update was implemented, the Medicare 
Physician Fee Schedule conversion factor actually decreased by -0.34% 
going from $35.9335 in 2015 down to $35.8043 in 2016. In no subsequent 
year did the actual conversion factor increase match the 0.5% 
contemplated in statute, and 5 years later we stand at a Medicare 
Physician Fee Schedule conversion factor of $36.0391, only nominally 
above the 2015 conversion factor. During this time, hospitals continue 
to get significant across-the-board Medicare payment increases based on 
an inflationary update in addition to their value-based purchasing 
program updates. CMS has proposed a general fiscal year (FY) 2020 
payment increase for inpatient hospitals of 2.7%. The inequity between 
these payment systems will continue to exacerbate issues in our health 
care delivery system, undermine the value of the services physicians 
provide to their patients while throwing money at brick-and-mortar 
investments, and fail to recognize that patients are best supported 
when the payment systems reflect the actual care delivery system.

    The Alliance of Specialty Medicine is committed to the successful 
and timely implementation of the law while still providing 
practitioners time and opportunities to succeed. We look forward to 
working with the committee to ensure MACRA continues to be successful, 
and we would be happy to discuss any other questions you may have going 
forward.

                                 ______
                                 
                   American Academy of Ophthalmology

                       20 F Street, NW, Suite 400

                       Washington, DC 20001-6701

                           T: +1 202-737-6662

                          https://www.aao.org/

Thank you for holding an important oversight hearing on implementation 
of the Medicare Access and CHIP Reauthorization Act (MACRA) of 2015. 
The American Academy of Ophthalmology appreciates the opportunity to 
submit a statement for the record. As the world's largest association 
of eye physicians and surgeons, the Academy seeks to protect sight and 
empower lives by setting the standards for ophthalmic education and 
advocating for our patients and the public.

The Academy, along with most of the healthcare community, supported 
MACRA and the repeal of the Sustainable Growth Rate formula. Moving to 
a new payment system that works to reward quality patient care, improve 
outcomes, and ensure cost effectiveness in the Medicare program is 
important to the Academy. While a small specialty, the fact that the 
majority of ophthalmology's patients are Medicare beneficiaries makes 
us vital to the new Medicare physician payment program.

The best way to achieve MACRA's aims is with continuous quality 
improvement; this is the driving force for our implementation of the 
Academy's IRIS' Registry (Intelligent Research in Sight)--
the nation's first comprehensive eye disease clinical registry.

CMS's slow ramp up (Pick your Pace) allowed practitioners and their 
specialty organizations needed time to prepare to meet the requirements 
of the new Quality Payment Program (QPP). Because of this necessary 
ramp up, there is naturally a delay in seeing evidence of significant 
improvement for beneficiaries and patient outcomes.

The IRIS Registry:

Just 5 years since its launch, IRIS Registry is the world's largest 
single specialty clinical data registry. Today, nearly 18,000 
physicians are contracted with the IRIS Registry, and nearly 15,000 of 
these physicians are integrated with IRIS Registry through their 
electronic health record (EHR). This integration allows seamless 
transmission of quality data points from the patient records into the 
registry each night, easing the reporting burden for clinicians. This 
works to level the playing field, facilitating participation of small 
and rural practices in MIPS. More than 70 percent of U.S. actively 
practicing ophthalmologists participate in the IRIS Registry. This high 
participation rate is bolstered by two factors:

      The high percentage of our ophthalmologists that must 
participate in MIPS; and
      Actionable information provided in a timely fashion that allows 
our members to implement effective quality improvement measures of 
direct benefit to patients independent of the QPP.

More than 20 other specialties have initiated similar EHR integrated 
clinical data registries that, like IRIS Registry, have been recognized 
as a qualified clinical data registry (QCDR) under MIPS. The Academy 
made the major commitment to develop a clinical data registry to 
advance true improvement in quality of care and patient outcomes, 
devoting significant resources and investing more than $13 million. 
Participation is free for member ophthalmologists which has helped 
foster a collaborative and inclusive program. The Academy is committed 
to making MIPS work for Medicare and ophthalmology because there is 
little opportunity on the horizon for non-hospital-based specialties to 
participate in and achieve status as Advanced Alternative Payment 
Models (AAPMs).

For 2019 MIPS, CMS approved 28 QCDR measures for the IRIS Registry 
developed by the Academy with our subspecialties. The vast majority of 
these measures are outcome measures. Our goal is to provide at least 
two outcome measures of quality that effectively represent relevant 
performance and outcomes for each of ophthalmology's nine 
subspecialties.

Areas for Improvement Under MIPS:

Low Volume Threshold--MIPS has not been without controversy. Under the 
significant low volume exclusion threshold established by CMS, two-
thirds of practitioners are not required to participate in the QPP. 
This appears to be contrary to Congress' commitment to value-based care 
under Medicare. Ophthalmology, and a few other specialties, have the 
highest percentage of clinicians required to participate in MIPS. This 
means that our members are at a higher risk for significant penalties 
under MIPS/MACRA than other specialties, and we do not believe that 
Congress intended this risk inequity when the law was enacted. In 
addition, the limited participation overall in the QPP hampers the 
health system transformation that Congress envisioned from MACRA.

Web Interface Reporting Option--The low-volume threshold is not the 
only policy in CMS's QPP that introduces inequities among MIPS 
participants. For example, the web interface reporting option is only 
an option for very large practices. Under this reporting option, very 
large groups report on 10 primary/general care measures for a subset of 
248 patients. No specialty outcome measures are included. Therefore, 
specialty care in these groups essentially goes unevaluated, leaving 
CMS and patients with no insight into the quality of care provided by 
the large volume of specialty practitioners in these very large groups. 
In stark contrast, physicians who do not practice in these very large 
groups are held individually accountable for outcomes pertinent to 
their specialty. This introduces a bias where a higher bar is set for 
physicians in smaller practices. In other words, this is a double-edge 
sword. The CMS Web Interface reporting policies result in the 
following: (1) a higher reporting burden on small practices than on the 
very large practices; (2) limit the potential quality care improvement 
in very large practices; and (3) reduce the public's ability to select 
specialists on the basis of quality metrics.

Healthcare Consolidation--Furthermore, the Web Interface reporting 
option for very large groups may incentivize a trend in healthcare that 
both HHS and Congress have been trying to stem--consolidation. 
Consolidation has been shown to contribute to increased healthcare 
costs.

Small Practices--In addition to the large practice bias introduced by 
the Web Interface reporting policies, a recent article in Health 
Affairs highlighted the challenges small practices face complying with 
QPP/MIPS. Specifically, small and rural practices had significantly 
lower MIPS scores. We recommend that CMS reinstate the small practice 5 
percent differential/bonus on the total score. In addition, score 
improvements for small practices continue to be needed in the Quality 
Component and current differentials should be retained.

Expanding QCDR Credit--In the MACRA legislation, Congress foresaw the 
difficulty in creating germane and more dynamic measurements of quality 
performance among specialists and specifically instructed CMS to 
incentivize the use of QCDRs. However, CMS has indicated its intention 
to remove these even limited or small incentives altogether. Recently, 
the Brookings Institute raised concern about the outlook for MIPS but 
called for a standalone bonus/recognition for clinical data registries 
that are clearly improving care. To help achieve the goals of the law 
and improve quality of care, patient outcomes and costs, CMS should 
follow congressional intent and increase its credit for practitioners 
that participate in proven quality improvement initiatives such as 
certain clinical data registries.

Ways that Medicare is benefiting from incentivizing QCDRs/Clinical Data 
Registries:

Quality Improvement--Registries have been demonstrated to improve 
quality of care and outcomes. A study published in Ophthalmology 
documented improvement on quality measure performance as a result of 
the feedback provided by the IRIS Registry.\1\ This includes 
improvements in lowering high risk medications for the elderly, and 
improvement in lowering the complications after cataract surgery. While 
one of the most successful procedures, cataract is also one of the most 
frequently performed procedures under Medicare. Even a small reduction 
in cataract complications has a substantial impact for Medicare.
---------------------------------------------------------------------------
    \1\ Rich WL 3rd, Chiang MF, Lum F et al. ``Performance Rates 
Measured in the American Academy of Ophthalmology IRIS Registry 
(Intelligent Research in Sight).'' Ophthalmology. 2018; 125:782-4.

Value Improvements--At a time when there was much public concern about 
the risks of compounded pharmaceuticals, IRIS Registry data has been 
used to show that there is no statistical difference in the rates of 
endophthalmitis in age-related macular degeneration (AMD) patients by 
anti-vascular endothelial growth factor (VEGF) agent, helping to 
preserve practitioner and beneficiary confidence in repackaged, off-
label treatments for AMD and diabetic retinopathy. Studies using 
registry data could bring significant cost savings to Medicare. For 
example, preserving the option to use Bevacizumab for AMD treatment is 
estimated to save the Medicare program and patients in the billions.\2\
---------------------------------------------------------------------------
    \2\ Rosenfeld PJ, Windsor MA, Feuer WG et al. ``Estimating Medicare 
and Patient Savings From the Use of Bevacizumab for the Treatment of 
Exudative Age-related Macular Degeneration.'' Am J Ophthalmology 2018; 
191:135-139.

Real World Evidence--The IRIS Registry has also helped to demonstrate 
the safety of commonly performed procedures. One study showed that in 
real-world usage, anti-VEGF intravitreal injections are associated with 
a small decrease in intraocular pressure, and not an increase in 
intraocular pressure.\3\ Another study demonstrated that cataract 
surgery is associated with a very low rate of endophthalmitis, a 
vision-threatening complication, at 0.08%.\4\
---------------------------------------------------------------------------
    \3\ Atchison E, Wood K et al. ``The Real World Effect of 
Intravitreous Anti-VEGF Drugs on IOP: An Analysis Using the IRIS 
Registry.'' Ophthalmology, 2018; 125:676-82.
    \4\ Coleman AL. ``How Big Data Informs Us About Cataract Surgery: 
The LXXII Edward Jackson Memorial Lecture.'' Am J Ophthalmology 2015; 
160:1091-1103.
---------------------------------------------------------------------------

Conclusion:

The Academy applauds the Committee for conducting its oversight hearing 
on the implementation of the Medicare Access and CHIP Reauthorization 
Act. As implementation of the law continues, we look forward to working 
with the Committee to improve both the QPP and MIPS to ensure that 
participating physicians have opportunities to succeed and the push for 
a quality-driven healthcare system continues.

When Congress enacted the MACRA, it created the QPP to streamline 
Medicare's existing quality improvement programs and reduce the 
regulatory and administrative burdens on physicians. Congress 
envisioned QCDRs like the Academy's IRIS Registry to be a meaningful 
solution to achieving the QPP's goals and directed the HHS Secretary to 
encourage clinical data registries in the law's implementation.

Therefore, Academy recommend that Congress reiterate its support for 
specialty-led clinical data registries and strongly encourage CMS to 
increase credit under the QPP/MIPS to eligible practitioners who 
voluntarily participate in registries. For example, a highly valuable 
move and important step would be to create a pathway through which EHR-
integrated registry participants could fully qualify for the Promoting 
Interoperability (PI) category of MIPS. PI is the most onerous category 
of the MIPS program, and a registry pathway would significantly reduce 
practitioner burdens and improve participation in specialty-led 
registries.
               disclosure of federal grants or contracts
Between 2013 and 2015, the American Academy of Ophthalmology (AAO) 
received funding from the Agency for Healthcare Research and Quality 
(AHRQ) under the Developing Evidence to Inform Decisions about 
Effectiveness (DEcIDE) Program, to disseminate the Registry for 
Glaucoma Outcomes Research (RiGOR) study findings through the use of 
social media tools.

The American Academy of Ophthalmology is a 501c(6) educational 
membership association.

                                 ______
                                 
              American Association of Orthopaedic Surgeons

                317 Massachusetts Avenue, NE, Suite 100

                       Washington, DC 20002-5701

                           PHONE 202-546-4430

                            www.aaos.org/dc

May 7, 2019

The Honorable Chuck Grassley        The Honorable Ron Wyden
U.S. Senate                         U.S. Senate
135 Hart Senate Office Building     221 Dirksen Senate Office Building
Washington, DC 20510                Washington, DC 20510

Dear Chairman Grassley and Ranking Member Wyden,

On behalf of the American Association of Orthopaedic Surgeons (AAOS), 
we would like to express our appreciation for holding a hearing on 
Medicare physician payment reform and the Medicare and CHIP 
Reauthorization Act (MACRA). This is a high priority issue for our 
members, and we have closely been monitoring MACRA's progress and 
effects on the AAOS membership. AAOS represents over 34,000 orthopaedic 
surgeons and residents, as well as musculoskeletal patients nationwide.

The AAOS commends Congress on its efforts to improve access to high 
quality, high value health care. We hope the opportunity to provide 
input on MACRA, as well as other proposals and policies impacting 
physician quality measurement and reporting practices, will shape the 
continued development and improvement of these programs. We have 
provided our comments below.

MACRA Implementation and Progress

We are pleased that the Center's for Medicare and Medicaid Services 
(CMS) agreed to our request for a gradual buildup of penalties starting 
in 2018. With the implementation of MACRA under CMS' Quality Payment 
Program (QPP), as well as numerous other regulatory changes, physicians 
are navigating a complex new reporting system. Indeed, many are still 
working to understand the new requirements and prepare necessary 
infrastructure and education.Congress should continue to make program 
reforms that allow physicians to adequately prepare for the 
increasingly complex and ever-changing regulatory environment.

Additionally, AAOS encourages removal of the requirement to report on 
all patients going forward. It is widely known that orthopaedic 
medicine lacks validated patient reported outcome-based performance 
measures (PRO-PM) and has few process measures. AAOS suggests that in 
areas where there are no validated clinical-level quality measures, and 
until the time these are developed, physicians be allowed to 
participate in the Merit-based Incentive Payment System (MIPS) 
voluntarily.

For payment year 2019, for an eligible clinician to become a qualifying 
participant they must receive 50 percent of their Medicare part B 
payments or see at least 35 percent of Medicare patients through an 
Advanced APM entity to receive the 5 percent Advanced APM bonus. These 
thresholds are almost impossible even for our high-volume surgeons who 
participate in BPCI Advanced. AAOS urges Congress to provide reasonable 
thresholds so that surgical clinicians can adequately participate and 
become a qualifying program participant.

Clinical Data Registry Participation and Incentives

AAOS has invested significantly in our family of clinical data registry 
programs, including quality collection measurement functionality and 
components. Within orthopaedics, a growing number of AAOS members 
participate in these registries such as the American Joint Replacement 
Registry (AJRR), which collects data that would be useful in quality 
reporting. Many other medical and specialty societies operate 
registries of various scopes and sizes, and the vast majority of these 
registries contain relevant data on quality. Other entities operating 
registries include integrated health care systems (e.g., Kaiser, 
Geisinger), Accountable Care Organizations, and Independent Physician 
Associations.

If registries or other existing quality reporting programs report to 
CMS, a common set of variables should be required across all reporting 
entities. The list of required common variables should be developed in 
collaboration with medical specialty societies. Additionally, data must 
be appropriately risk-adjusted for each physician's particular case 
mix, including co-morbid conditions, to facilitate meaningful and 
relevant comparisons among physicians. Lastly, physicians should have 
the opportunity to request audits of their quality data and have due 
process to address any errors.

Quality reporting systems also need to become more user-friendly and 
more tailored to specific specialties, particularly surgical 
specialties. Significant progress needs to be made in developing valid, 
relevant, patient-centered measures of physicians' quality of care. 
These measures should be expanded to include patient outcomes, patient 
safety measures, and experience of care.

There is also not currently a path for registries to participate as an 
Alternative Payment Model (APM). AAOS strongly advocates for the 
opportunity to allow physicians to qualify for payment updates under 
MACRA for participation in a qualified clinical data registry (QCDR).

Alternative Payment Models (APMs)

We strongly urge Congress to discourage the mandatory nature of the 
proposals coming out of CMS and instead create incentives for 
interested participants that would reward innovation and high-quality 
patient care. We believe the programs should be voluntary for any set 
of surgeons, facilities, and providers who seek to collaborate in 
innovative ways to bring higher quality, coordinated, and lower costs 
for musculoskeletal care and who have the infrastructure necessary to 
carry out an episode of care approach to payment and delivery. 
Specifically, we recommend that CMS require that any participating 
entity have verifiable interoperability, infrastructure, and agreements 
between all necessary entities.

Conclusion

The AAOS has committed considerable member and financial resources to 
developing and analyzing evidence-based process and outcome measures 
and encouraging the adoption of evidence-based practice guidelines for 
the prevention, diagnosis, and management of musculoskeletal diseases. 
We invite CMS to call on us as an involved partner and subject matter 
expert in evidence-based performance and quality measurement in 
musculoskeletal care.

We look forward to working with you and other stakeholders to ensure 
the continued success of MACRA and other related physician payment 
programs. Please feel free to contact Madeline Kroll, Manager of 
Government Relations ([email protected]), if you have any questions or if 
the AAOS can further serve as a resource to you.

Sincerely,

Wilford Gibson, MD
Council on Advocacy Chair, American Association of Orthopaedic Surgeons

                                 ______
                                 
                     American College of Physicians

                 25 Massachusetts Avenue, NW, Suite 700

                       Washington, DC 20001-7401

                              202-261-4500

                              800-338-2746

                           www.acponline.org

The American College of Physicians (ACP) appreciates the opportunity to 
share our views regarding Medicare physician payment reform under 
MACRA, the implementation of this law after two years, and the road 
ahead for physicians to ensure a health care delivery system that 
rewards the value and quality of care provided to patients. We thank 
Senate Finance Chairman Grassley and Ranking Member Wyden for hosting 
this hearing to hear the view of physicians concerning MACRA in order 
to ensure that it is implemented successfully and as intended by 
Congress. As Congress considers oversight or potential legislative 
changes to MACRA, we urge you to take steps to improve Medicare payment 
policies in ways that better align payments with the value of care 
provided to patients, reduce unnecessary administrative burdens that 
divert physicians away from patient care, ensure that performance 
measures used for payment or public accountability are evidence-based, 
clinically relevant, and appropriate, and create more opportunities for 
physicians to lead and participate in alternative payment models.

ACP is the largest medical specialty organization and the second 
largest physician group in the United States. ACP members include 
154,000 internal medicine physicians (internists), related 
subspecialists, and medical students. Internal medicine physicians are 
specialists who apply scientific knowledge and clinical expertise to 
the diagnosis, treatment, and compassionate care of adults across the 
spectrum from health to complex illness.

Overview of the First Two Years of MACRA

In order to provide an accurate assessment of whether the new payment 
systems under MACRA have provided adequate support and reimbursement 
for physicians to continue to provide high quality value-based care for 
their patients, it is essential to examine how physicians fared during 
the first two years of MACRA implementation. ACP has examined the 
results of the Quality Payment Program (QPP) Experience Report based on 
the 2017 participation rate in Merit-based Incentive Payment System 
(MIPS) and Advanced Alternative Payment Models (APMs). There are 
several positive results from this survey that acknowledge in some 
degree that MACRA is working as it intended. The 2017 results show that 
the participation rate of physicians in MACRA was 95 percent and that 
only five percent of the physicians received a penalty. However, the 
bar for entry into MACRA was set very low, by design, to ensure that in 
the first year physicians could adequately transition into MIPS or 
Advanced APMs. In the 2017 Quality Payment Program, known as Pick Your 
Pace, physicians could avoid a penalty by submitting only three points, 
which could have been as easy as submitting one quality measure on one 
patient for the entire year. We may find a more accurate reading of how 
well physicians fared under MACRA by looking at the 2018 data, when it 
is released, where physicians were required to submit 15 points to 
avoid a penalty. The performance standard for physicians is even higher 
in 2019, as they are now required to submit 30 points to avoid a 
penalty.

The 2017 QPP results also show that small practices lagged behind 
larger practices in their overall performance rating for the QPP. The 
average score for small practices was more than 30 points lower than 
the average overall score, and rural groups also lagged 11 points 
behind. Small practices were almost 20 percent less likely to earn a 
bonus and 14 percent more likely to get a penalty than the average 
across all practices. One factor that may prohibit smaller practices 
from succeeding in the QPP is that they often do not have the capital 
to build the office infrastructure necessary to make investments in 
their practices so that they may meet the requirements of the QPP 
program.

Small practices were also less likely to report more than 90 days of 
quality data which was optional in 2017 but became mandatory in 2018. 
The data show that while 74 percent of all practices reported quality 
data for a full year only 67 percent of rural and 44.5 percent of small 
practices reported a full year of QPP data.

ACP is disappointed that despite repeated objections from the vast 
majority of stakeholders including the College, CMS continues to 
require a full year of quality and cost data. We ask the Senate Finance 
Committee to weigh in with CMS in the strongest possible terms to urge 
the agency to reconsider this policy and reconsider instituting a 
consistent, minimum 90 consecutive day minimum reporting period across 
all MIPS performance categories. Lowering the minimum reporting period 
to 90 consecutive days would drastically reduce reporting burden, allow 
time to implement EHRs or other innovative technologies without risk of 
compromising MIPS reporting or performance, allow for more timely 
performance feedback, and reduce the two-year lag between performance 
and payment. Moreover, 90 days would be a minimum; while 90 days is a 
sufficient length of time to capture reliable data for the majority of 
measures, individual measures could have their own separate minimums so 
that data accuracy would not be compromised.

THE MIPS PROGRAM

The majority of physicians participate in the QPP through the MIPS 
track, which builds on traditional fee-for-service payments by 
adjusting them based on a physician's performance. The MIPS program 
measures physicians' performance based on a scoring structure that 
requires physicians to report performance data to CMS in four weighted 
categories: Quality Measurement (45 percent-weight), Improvement 
Activities (15 percent), Promoting Interoperability (25 percent), and 
Cost (15 percent). Physicians receive a score based on how well they 
perform in each of these categories, which then determines their 
Medicare payment. This scoring structure is unnecessarily complex 
because each category has its own unique scoring methodology and 
because the value of any measure or activity is scored out of an 
arbitrary number of points that has no correlation to its weight 
relative to the final MIPS score. Moreover, the categories are siloed, 
preventing any cross-category credit, and the measures on which 
physicians must report are overly burdensome and do not measure what 
matters.

The MIPS program was intended to create a more streamlined approach for 
physicians to report performance measures through a unified program 
rather than through several different performance measurement programs 
as required prior to the authorization of MACRA. This program has not 
worked as Congress intended. We urge the Senate Finance Committee to 
exercise their oversight authority to urge CMS to simplify the scoring 
structure and reporting requirements under MIPS in order to fulfill 
Congress' intent of a more streamlined program that reduces burdens on 
physicians.

MIPS Scoring

The College reiterates our previous concerns that the separate 
reporting requirements and scoring methodologies for each category are 
confusing for clinicians and counter to CMS' efforts to minimize burden 
and create a unified program. One simple solution would be to assign 
point values for each measure proportionate to their overall value 
relative to the MIPS composite score. The total points in the Pl 
Category would total 25 for example, and so on. This methodology has 
the support of a number of physician groups, and also would allow CMS 
to continue distinguishing high-priority measures and categories with 
more value while creating a more intuitive, streamlined scoring 
approach. We encourage CMS to take every opportunity to award cross 
category credit. Doing so will create synergy between the various 
performance categories and align incentives to drive meaningful 
improvement in critical priority areas, rather than spreading practices 
too thin across too many metrics. This will lead to better patient 
outcomes and less burden on clinicians and practice staff.

Quality Category

This category, and MIPS in general, needs more relevant, accurate, and 
effective quality measurement, particularly measures based on patient 
outcomes. We urge the Finance Committee to weigh in with CMS to reduce 
the number of measures required for full participation in this category 
from six to three measures. ACP's Performance Measurement Committee 
(PMC) conducted a study of many of the performance measures included in 
the MIPS program, applicable to internal medicine, and found that only 
37 percent were rated as valid, 35 percent as not valid, and 28 percent 
as of uncertain validity. Measures should be evaluated against four 
critically important criteria: importance to measure, scientifically 
acceptable, usable and relevant, and feasible to collect. CMS should 
collaborate with specialty societies, frontline clinicians, patients, 
and EHR vendors in the development, testing, and implementation of new 
quality measures with a focus on integrating performance measurement 
and reporting within existing care delivery protocols to maximize 
clinical improvement while decreasing clinician burden. A majority of 
new MIPS measures finalized for 2019 have received only conditional 
support from the Measure Application Partnership (MAP), and previously 
adopted measures remain despite being recommended for ``continued 
development'' by the MAP, a designation reserved for measures that lack 
evidence of strong feasibility and/or validity. MAP is a multi-
stakeholder partnership that guides the U.S. Department of Health and 
Human Services (HHS) on the selection of performance measures for 
federal health programs.

It is imperative CMS ensure that a transparent, multi-stakeholder 
process is used to evaluate all measures used in its programs. The 
National Quality Forum (NQF), for instance, evaluates measures against 
four critically important criteria: importance to measure 
scientificallyacceptable, usable and relevant, and feasible to collect. 
CMS should also collaborate with 8 specialty societies, frontline 
clinicians, patients, and EHR vendors in the development, testing, and 
implementation of new quality measures with a focus on integrating 
performance measurement and reporting within existing care delivery 
protocols to maximize clinical improvement while decreasing clinician 
burden. Further, the criteria and processes CMS uses to make its final 
decisions regarding which measures to remove from the program and which 
to continue using should also be fully transparent. This would allow 
stakeholders to better plan their efforts in terms of measure 
development and review and provide more meaningful feedback to the 
Agency in the future.

Cost Category

Under current statute, MACRA will require CMS to increase the weight of 
the cost category to 30 percent by performance year 2022, but we urge 
Congress to revise the timeline to afford CMS additional flexibility 
just as it did with the Bipartisan Budget Act. The problem with 
maintaining the current timeline for an increase in the weight of the 
cost category is that the measures used to evaluate the cost of care 
are not adequately reliable and accurate. We appreciate CMS' repeated 
efforts to engage stakeholders in the measure development process. 
However, we have serious concerns about moving forward with eight new 
episode-based cost measures that have low average reliability and have 
not been given an adequate opportunity to be fully vetted by 
stakeholders. ACP shares the goal of the cost category to reward 
physicians who are delivering high quality, efficient care, but this 
only works with accurate cost and quality measurement. Otherwise, a 
host of unintended consequences could ensue, such as clinicians being 
penalized for treating sicker or older patients that may require more 
expensive care.

Promoting Interoperability (PI) Category

ACP continues to call for the PI Category to be re-conceptualized into 
a performance category that promotes the use of health IT to improve 
patient care and support practical interoperability. While we 
appreciate CMS's attempt to simplify and streamline the PI category in 
the 2019 QPP final rule, the Agency continues to use the same ``EHR-
functional-use'' measures that clinicians have found to be cumbersome 
and inappropriate and do little to help clinicians move forward in 
using their health IT to improve the value of patient care. CMS should 
further update the PI performance category such that the current ``EHR-
functional-use'' measures (e.g., e-prescribing and health information 
exchange [HIE] measures) are not scored on an ``all-or-nothing'' basis 
and that one minor misstep by a clinician could result in a score of 
zero for the entire category. CMS should then add in optional measures 
and activities (similar to the Improvement Activities component of 
MIPS) where clinicians can choose and attest to health IT activities 
that leverage health IT to improve patient care and better fit certain 
specialties and scopes of practice.

ALTERNATIVE PAYMENT MODELS

Although we are pleased that CMS recently announced the creation of two 
new APMs (Primary Care First and Direct Contracting) that will be 
available for physicians to join in the future, we are disappointed 
that to date, there are only eight active distinct types of Advanced 
APMs. The number of available models falls well short of the robust 
pathway to value-based reform that Congress had envisioned for APMs and 
does not support the Agency's own stated goal of shifting physicians 
into APMs.

We encourage the Senate Finance Committee to use their oversight 
authority over CMS to encourage the agency to leverage the Physician-
focused Payment Model Technical Advisory Committee (PTAC) which could 
be an invaluable tool to facilitating the implementation of innovative 
new physician-led APMs but to date has unfortunately been 
underutilized. Few of the now 11 models recommended for limited scale 
testing or full-scale implementation have been adopted by CMS. Many of 
these models have a proven track record of working in the private 
sector; it is to CMS' benefit to capitalize on the substantial 
investment and testing that has already gone into these models. 
Moreover, we have already seen a decline in the number of submissions 
to PTAC. The longer CMS goes without adopting any models, what could be 
a great launching pad for a variety of innovative new payment models 
could cease to serve any practical purpose as enthusiasm wanes and 
developers cease to invest the resources and time into developing 
models without a realistic chance of those models ever being adopted.

Physicians who qualify to deliver care in an Advanced APM also receive 
a five percent bonus if they meet certain metrics and use certified 
Electronic Health Record Technology, which then excludes them from MIPS 
reporting requirements, a huge incentive. Unfortunately this 5 percent 
bonus is set to expire in 2022 unless Congress approves legislation to 
extend it. We are concerned that if physicians are not assured that 
this five percent bonus will be available in the future, they would be 
less inclined to invest in the necessary infrastructure transformation 
in their practices to deliver care in an Advanced APM. Because one of 
the goals of MACRA was to encourage physicians to transform their 
practices into Advanced APM's, we urge Congress to extend the 5 percent 
bonus beyond 2022 to continue to provide the necessary incentives for 
physicians to deliver care in this model.

An additional barrier that prevents physicians from transforming their 
practices into Advanced Alternative Payment Models is that physicians 
are required to bear significant financial risk, either 3 percent of 
estimated expenditures or 8 percent of average estimated Medicare Parts 
A and B revenue in order to participate in an APM. CMS intended for 
this threshold of participation as the standard for ``nominal'' risk so 
that additional practices to transform into APM's but this threshold is 
simply too high to be considered a nominal financial risk. CMS should 
also consider that physicians have to invest a significant amount of 
capital in order to afford the infrastructure improvements and practice 
transformation required to participate in an Advanced APM. This 
threshold is especially difficult for smaller and rural practices who 
desire to participate in APMs but often lack the sophisticated 
infrastructure, financial reserves to purchase technologies required 
for interoperability or quality improvement, and ability to take on 
risk that immediately puts them on uneven ground when it comes to 
participating in Advanced APMs. We encourage the Finance Committee to 
support a separate, lower Advanced APM nominal amount standard to 
encourage additional participation in Advanced APMs especially for 
small and/or rural practices.

NEW PAYMENT MODELS ANNOUNCED BY CMS

ACP is encouraged that CMS is testing new delivery and payment models 
to support the role of care provided by primary care physicians. Last 
month, the Department of Health and Human Services announced the 
creation of two new payment models, known as Primary Care First and 
Direct Contracting. These models are intended to recognize the value of 
primary care physicians in our health care system by offering 
sustainable and predictable prospective monthly payments to practices, 
to reduce administrative burdens for clinicians, to increase the 
quality of care for patients, and to allow practices and their 
physicians to share in savings from keeping patients healthy and out of 
the hospital whenever possible.

Internal medicine specialists are uniquely trained to provide adult 
patients with primary and comprehensive care throughout their 
lifetimes, and ACP is supportive of new primary care models that 
recognize and support their contributions to bringing greater value to 
their patients. The new models are important steps in this direction. 
Specifically, ACP is pleased that CMS has considered our 
recommendations to provide a variety of payment and delivery models 
that support internal medicine and primary care practices, from smaller 
and independent practices to larger integrated ones. Of note, ACP is 
optimistic that the new models will emphasize the important role 
primary care plays in value-based care delivery, that models are 
voluntary and have a range of risk options, and that practices should 
use population health management data to reap potential benefits. 
Additionally, ACP is supportive of the fact that the new models aim to 
reduce administrative burdens-potentially allowing physicians to spend 
more time with their patients.

We are especially interested in the Primary Care First Model that 
``will focus on advanced primary care practices ready to assume 
financial risk in exchange for reduced administrative burdens and 
performance based payments.'' As noted in the CMS fact sheet on this 
model:

      Primary Care First Model--to be eligible to participate in the 
PCF model, a practice must include ``primary care practitioners (MD, 
DO, CNS, NP and PA), certified in internal medicine, general medicine, 
geriatric medicine, family medicine and hospice and palliative 
medicine.'' It must have 125 attributed Medicare beneficiaries at a 
particular location, have primary care services account for at least 
70% of the practices' collective billing based on revenue, and in the 
case of a multi-specialty practice, 70% of the practice's eligible 
primary care practitioners' combined revenue must come from primary 
care services. It must also ``have experience with value-based payment 
arrangements or payments based on cost, quality, and/or utilization 
performance such as shared savings, performance-based incentive 
payments, and episode-based payments, and/or alternative to fee-for-
service payments such as full or partial capitation.''

There are elements of the PCF model that suggest that CMS is on the 
right track to building models that will improve patient care and that 
will support the work of primary care physicians. It provides a variety 
of payment models that will support internal medicine and primary care 
practices, from smaller and independent practices to larger integrated 
ones; it includes a range of risk options available to practices, and 
it could potentially reduce administrative burdens that would allow 
physicians to spend more time with their patients.

However, a lot of details related to risk adjustment, attribution, and 
financial benchmarking are still missing that may determine how many 
physicians and practices will seek to participate. Also, unless other 
payers join Medicare in supporting the PCF model, practices may not 
experience the reduction in administrative burdens and predictable 
revenue that CMS anticipates. Presumably, CMS will be releasing such 
information soon, prior to the enrollment period it intends to begin 
this fall. As CMS moves forward with the development of new care 
models, we urge the continued creation of new Advanced APMs that 
include multiple payers so that all patients, not just Medicare 
beneficiaries, may benefit from the innovations and improvements to 
patient care that these models may provide. This will also allow those 
practices that voluntarily support these innovative care delivery 
system reform models to focus on a unified set of metrics and goals, 
allowing them to focus on truly improving patient care in key strategic 
areas and get back to delivering patient care, rather than juggling 
dozens of sets of varying reporting metrics.

Although there is great potential that these models will reinvigorate 
the practice of primary care physicians, we believe the success and 
viability of these models will depend on the extent that they are 
supported by payers in addition to Medicare and Medicaid, are 
adequately adjusted for differences in the risk and health status of 
patients seen by each practice, are provided predictable and adequate 
payments to support and sustain practices (especially smaller 
independent ones), are appropriately scaled for the financial risk 
expected of a practice, are provided meaningful and timely data to 
support improvement, and are truly able to reduce administrative tasks 
and costs, among other things. ACP will continue to evaluate the new 
payment and delivery models based on such considerations, and we look 
forward to working with CMS and to continue advocating for ways to 
support the value of primary care for physicians and for all patients 
across the health care system.''

THE FUTURE OF MACRA

After MACRA was passed in 2015, the law established a period of 
positive Medicare payment updates of .5 percent until the end of 2019, 
which are then adjusted upward or downward based on reporting on 
performance measures. After this year, physicians will receive a zero 
percent Medicare baseline payment update from 2020-2025. We remain 
concerned that a zero percent update from 2020-2025 does not provide 
adequate support for physicians to continue to make the necessary 
adjustments to perform at a high level on standards set by MACRA to 
measure quality, clinical improvement, interoperability, and cost data 
related to their practices. As noted in the testimony concerning this 
hearing submitted by the American Medical Association, the recent 2019 
Annual Medicare Trustees Report found that scheduled physician's 
payment amounts are not expected to keep pace with average rate of 
physician cost increases, which are forecast to average 2.2 percent per 
year in the long range. The Medicare Trustees Report also found that 
absent a change in the delivery system or level of update by subsequent 
legislation, the Trustees expect access to Medicare-participating 
physicians to become a significant issue in the long term. We encourage 
members of the Senate Finance Committee to introduce and pass 
legislation that would replace the zero percent baseline payment 
updates under Medicare, scheduled to take effect in 2020, with positive 
updates.

SUMMARY OF ACP KEY RECOMMENDATIONS

As the Senate Finance Committee conducts oversight over CMS 
implementation of the Quality Payment Program under MACRA and also 
considers legislative changes to this law, we offer the following key 
recommendations to ensure that MACRA is implemented successfully and as 
intended by Congress.

Members of the Senate Finance Committee should encourage and provide 
incentives to physicians who transform their practices into Advanced 
APMs and continue to provide stability for physicians in the MIPS 
program by introducing and passing legislation that would do the 
following:

      Extend the five percent Qualified APM participant bonus beyond 
the 2022 performance year.

      Replace the zero percent baseline payment updates under 
Medicare, scheduled to take effect in 2020, with positive updates.

      Revise the timeline to afford CMS with additional flexibility to 
determine the weight of the cost category within MIPS. It is scheduled 
to be 30 percent by performance year 2022.

Members of the Senate Finance Committee should exercise their oversight 
authority over CMS and urge it to implement the following 
recommendations:

      Expedite approval of more Advanced Alternative Payment models 
(APMS), particularly those that work for small and specialty practices.

      Provide a separate, lower Advanced APM nominal amount to 
encourage participation in Advanced APMs by small and/or rural 
practices.

      Simplify the scoring structure and reporting requirements under 
the Merit-based Incentive Payment System (MIPS) in order to fulfill 
Congress' intent of a more streamlined program that reduces burdens on 
physicians.

      Institute a consistent 90 consecutive day minimum reporting 
period across all MIPS performance categories.

      Reduce the number of measures required for full participation in 
the MIPS quality category from six to three measures.

      Restructure the Promoting Interoperability Category within MIPS 
to remove the ``all-or-nothing'' scoring component and provide more 
flexibility and options for clinicians to use their health IT to 
improve value-based care.

CONCLUSION

ACP appreciates the Senate Finance Committee's convening this hearing 
to examine the implementation of MACRA and chart the road ahead for 
this law in the future. We look forward to working with you to ensure 
that MACRA works to improve the value and quality of care delivered to 
patients, provides support for physicians to continue to meet 
performance standards measured by this new law, and additional pathways 
for physicians to transition into Advanced APMs.

                                 ______
                                 
                     American Hospital Association

                          800 10th Street, NW

                       Two CityCenter, Suite 400

                       Washington, DC 20001-4956

                             (202) 638-1100

On behalf of our nearly 5,000 member hospitals, health systems and 
other health care organizations, and our clinician partners--including 
more than 270,000 affiliated physicians, 2 million nurses and other 
caregivers--and the 43,000 health care leaders who belong to our 
professional membership groups, the American Hospital Association (AHA) 
appreciates the opportunity to submit comments on the implementation of 
the Quality Payment Program (QPP) created by the Medicare Access and 
CHIP Reauthorization Act of 2015 (MACRA).

Three years into its implementation, the QPP continues to have a 
significant impact, not only on physicians and other clinicians, but 
also on the hospitals and health systems with whom they partner to 
deliver care. There remains strong interest from the field in 
participating in advanced alternative payment models (APMs) to support 
new models of care, and to qualify for the bonus payment and exemption 
from the QPP's Merit-based Incentive Payment System (MIPS). However, 
opportunities to access the Advanced APM track remain significantly 
constrained. In the calendar year (CY) 2019 Physician Fee Schedule 
final rule, the Centers for Medicare and Medicaid Services (CMS) 
estimated that as few as 16 percent of eligible clinicians will qualify 
for the Advanced APM track in 2021.

The AHA urges Congress to continue working with CMS to provide greater 
opportunity to participate in Advanced APMs. In addition, we urge 
Congress to consider changes to the fraud and abuse laws to allow 
hospitals and physicians to work together to achieve the important 
goals of the new payment models--improving quality, outcomes and 
efficiency in the delivery of patient care. Finally, opportunities 
remain to improve fairness and reduce burden under the MIPS.

Our detailed comments follow.

Broadening Opportunities for Advanced APM Participation

The AHA supports accelerating the development and use of alternative 
payment and delivery models to reward better, more efficient, 
coordinated and seamless care for patients. Many hospitals, health 
systems and payers are adopting such initiatives with the goal of 
better aligning provider incentives to achieve the Triple Aim of 
improving the patient experience of care (including quality and 
satisfaction), improving the health of populations and reducing the per 
capita cost of health care. These initiatives include forming 
accountable care organizations (ACOs), bundling services and payments 
for episodes of care, developing new incentives to engage physicians in 
improving quality and efficiency, and testing payment alternatives for 
vulnerable populations and underpaid services.

Despite the progress made to date, the field as a whole is still 
learning how to effectively transform care delivery. There have been a 
limited number of Medicare APMs introduced thus far, and existing 
models have not provided participation opportunities evenly across 
physician specialties. Therefore, many physicians are still exploring 
APMs for the first time or at only the early stages of transforming 
care under APM arrangements. As a general principle, the AHA believes 
the APM provisions of MACRA should be implemented in a broad manner 
that provides the greatest opportunity for physicians who so choose to 
become qualifying APM participants. CMS should take an expansive 
approach that encourages and rewards physicians who demonstrate 
movement toward APMs. The agency also should ensure that it designs 
APMs with a fair balance of risk and reward, standardized and targeted 
quality measures and risk adjustment methodologies, physician 
engagement strategies, and readily available data and feedback loops 
between CMS and participants.

While we acknowledge and appreciate CMS's development and 
implementation of more APMs that qualify as Advanced APMs, we continue 
to be concerned that these existing and announced APMs offer too few 
opportunities for certain types of providers that serve more dispersed 
and vulnerable populations. For example, rural providers often lack the 
access or ability to make investments needed to participate in new 
models, among the many other challenges they face given their 
geographic location, low patient volumes, aging infrastructure in which 
they practice, workforce shortages and other factors. High-risk APMs 
are not accessible to these providers, even those that wish to 
participate in them. Similarly, post-acute and behavioral health 
providers serve particularly challenging and unique populations and 
thus are in need of APM options tailored to the degree of risk they can 
manage given their patient populations. CMS should consider these and 
other providers when designing APMs and expand opportunities for them 
to participate in Advanced APMs that offer them targeted resources and 
a manageable amount of risk.

Legal Impediments to Implementation of New Payment Models

By tying a portion of most physicians' Medicare payments to performance 
on specified metrics and encouraging physician participation in APMs, 
MACRA marks another step in the health care field's movement to a 
value-based paradigm from a volume-based approach. To achieve the 
efficiencies and care improvement goals of the new payment models, 
hospitals, physicians and other health care providers must break out of 
the silos of the past and work as teams. Of increasing importance is 
the ability to align performance objectives and financial incentives 
among providers across the care continuum.

Outdated fraud and abuse laws, however, are standing in the way of 
achieving the goals of the new payment systems, specifically, the 
physician self-referral (Stark) law and anti-kickback statute. These 
statutes and their complex regulatory framework are designed to keep 
hospitals and physicians apart--the antithesis of the new value-based 
delivery system models. A 2016 AHA report, Legal (Fraud and Abuse) 
Barriers to Care Transformation and How to Address Them (Wayne's 
World), examines the types of collaborative arrangements between 
hospital and physicians that are being impeded by these laws and 
recommends specific legislative changes.

Congress should create a clear and comprehensive safe harbor under the 
anti-kickback law for arrangements designed to foster collaboration in 
the delivery of health care and incentivize and reward efficiencies and 
improvement in care. Arrangements protected under the safe harbor would 
be protected from financial penalties under the anti-kickback civil 
monetary penalty law. In addition, the Stark law should be reformed to 
focus exclusively on ownership arrangements. Compensation arrangements 
should be subject to oversight solely under the anti-kickback law.

Addressing MIPS Policy Priorities

The AHA has urged that CMS implement the MIPS in a way that measures 
providers accurately and fairly; minimizes unnecessary data collection 
and reporting burden; focuses on high-priority quality issues; and 
fosters collaboration across the silos of the health care delivery 
system. To achieve this desired state, we have recommended that CMS 
prioritize the following policy approaches:

      Adopt gradual, flexible increases in MIPS reporting requirements 
in the initial years of the program to allow the field sufficient time 
to plan and adapt.

      Streamline and focus the MIPS quality and cost measures to 
reflect the measures that matter the most to improving outcomes.

      Allow facility-based clinicians the option to use their 
facility's CMS quality reporting and pay-for-performance results in the 
MIPS.

      Employ risk adjustment rigorously--including sociodemographic 
adjustment, where appropriate--to ensure providers do not perform 
poorly in the MIPS because of differences in clinical severity and 
communities they serve.

      Align the requirements for eligible clinicians in the Promoting 
Interoperability (formerly known as advancing care information) 
performance category with the requirements for eligible hospitals and 
critical access hospitals (CAHs).

The AHA is pleased that CMS has made important progress in addressing 
the above priorities. For example, in the first three MIPS performance 
years (calendar years (CY) 2017 through 2019), CMS has adopted gradual 
increases to the length of reporting periods, data standards and the 
performance threshold for receiving positive or negative payment 
adjustments. The AHA also commends CMS for using its new ``Meaningful 
Measures'' initiative to remove 26 measures from the MIPS program in 
the CY 2019 physician fee schedule final rule. CMS also has brought the 
Promoting Interoperability programs for clinicians and hospitals into 
far greater alignment. We offer our perspective on other MIPS policy 
priorities below.

Facility-based Measurement. The AHA applauds CMS for responding to our 
long standing request to develop a facility-based measurement option 
for the MIPS that is available starting this year. We believe the 
option ultimately will help clinicians and hospitals alike spend less 
time collecting data, and more time improving care. Under this 
approach, clinicians that spend 75 percent or more of their time in a 
hospital inpatient, emergency department (ED) setting or on-campus 
hospital outpatient setting can use their hospital's CMS hospital 
value-based purchasing program performance in the MIPS without having 
to report separate quality or cost data. In short, it means those 
clinicians and hospitals can focus their efforts on the same set of 
priorities, and see their performance rewarded in a consistent fashion.

Congress can help make facility-based measurement even more beneficial 
and effective by encouraging CMS to consider future expansion of the 
option to a broader array of facility types, such as post-acute care 
and inpatient psychiatric care providers. In last year's rulemaking 
process, CMS signaled an openness to expanding the option.

MIPS Cost Category. We urge Congress to work with CMS to take a more 
gradual approach to increasing the weight of the MIPS cost category, as 
well as adding measures to the cost category. Hospitals and clinicians 
alike are focused on improving the value of care and need well-designed 
measures of cost and resource use to help inform their efforts. 
However, we believe CMS's recent decision to increase the weight of the 
cost category to 15 percent of the total MIPS score and to adopt eight 
new episode-based cost measures should be delayed until CY 2022 at the 
very earliest.

Serious questions remain about the accuracy and reliability of all of 
the measures in the MIPS cost category, making it problematic to 
increase the weight beyond the 10 percent weight adopted for CY 2020 
payments. CMS's recent changes to the Medicare spending per beneficiary 
(MSPB) measure underscore this point. In the CY 2017 QPP final rule, 
CMS chose to remove specialty adjustment from the MSPB measure, and 
lower the MSPB minimum volume threshold from 125 cases to just 20 
cases. Yet neither of these changes had strong data or analysis to 
support them. Specialty adjustment in MSPB is intended to account for 
differences in specialty mix that can affect the costs of care. 
Furthermore, the MSPB measure once had a minimum case threshold of 125 
cases because CMS's analyses suggested that many cases were necessary 
to get a statistically reliable result. We do not believe the measure 
materially changed in such a way that it achieves reliable results 
without the higher case threshold. Taken together, we worry that these 
measure changes will result in rewards or penalties based on 
differences in patient population or statistical noise, and not real 
performance differences.

The AHA also remains concerned that the basic performance attribution 
approach for the MSPB and cost per capita measures in the MIPS lacks a 
``line of sight'' from clinician actions to measure performance. The 
measures do not reflect the performance of just the clinician or group 
practice. Rather, the measures attribute all of the Medicare Parts A 
and B costs for a beneficiary during a defined episode (three days 
prior to 30 days after an inpatient admission for MSPB, and a full year 
for total cost per capita). Yet, these costs reflect the actions of a 
multitude of health care entities--hospitals, physicians, post-acute 
providers, etc. The ability for any clinician or group to influence 
overall measure performance will vary significantly depending on local 
market factors, including the prevalence of clinically integrated 
networks.

Lastly, while we appreciate the concept behind the episode-based 
measures, we are concerned that clinicians have had limited time to 
understand their baseline performance and implement changes to improve 
performance. In contrast to the two total cost measures, the episode-
based measures include only the items and services related to the 
episode of care for a particular treatment or condition. This 
measurement approach can result in a more clinically coherent set of 
information about cost. However, this approach also necessitates the 
use of algorithms for identifying costs relevant to an episode, and a 
multi-step approach for attributing measure performance. This 
methodology adds necessary rigor, but also complexity. Yet, clinicians 
only had information from a ``dry run'' of the episode measures that 
CMS conducted using data from 2016 before CMS added the measures to the 
program.

Enhancing Risk Adjustment. Congress should encourage CMS to continue 
refining its approach to accounting for both clinical and social risk 
factors in measuring performance outcomes. CMS took an important step 
toward recognizing the impact of sociodemographic and other risk 
factors on outcomes by adopting a ``complex patient bonus'' in the MIPS 
in 2018. Clinicians receive up to five bonus points on their MIPS Final 
Scores based on a Medicare claims-derived proxy for patient complexity 
(Hierarchical Condition Categories, or HCCs), as well as the number of 
patients dually eligible for Medicare and Medicaid that a clinician or 
group treats. Dual-eligible status is a proxy for sociodemographic 
factors.

However, experience from the use of HCC scores in the value-based 
payment modifier (VM) raises questions about its adequacy in accounting 
for patient risk. CMS used HCC scores to provide modest increases to 
performance scores to groups treating significant numbers of high-risk 
patients. Unfortunately, the results of the 2016 VM program show that 
group practices caring for patients with more clinical risk factors 
were still significantly more likely to receive negative VM 
adjustments. Furthermore, while dual eligibility is an established 
proxy for sociodemographic status, there are others--such as income and 
education--that may be more accurate adjusters for particular measures. 
We urge that the patient complexity bonus be viewed as an interim step 
while methodologies for accounting for social and clinical risk 
continue to evolve.

Evolving MIPS in the Future

As with any significant policy change, the QPP and MIPS will need 
ongoing refinements to ensure it meets its goals. Indeed, that is why 
Congress used the Bipartisan Budget Act of 2018 to make several welcome 
technical amendments to the MIPS, such as allowing CMS more time to 
increase the weight of the MIPS cost category and applying payment 
adjustments to only covered professional services. These changes give 
providers and CMS greater flexibility, and improve the program's 
fairness.

Indeed, the AHA believes that future changes to MIPS policy should 
continue to be informed by data, experience and input from this field. 
That is why we believe the Medicare Payment Advisory Commission 
(MedPAC) recommendation in its March 2018 Report to Congress to replace 
the MIPS with a new voluntary value program (WP) is premature. We refer 
the Committee to our March 2018 statement to the committee for 
additional information.

CONCLUSION

Thank you for the opportunity to share our views on the implementation 
of the MACRA's QPP. The AHA looks forward to working with Congress, CMS 
and all other stakeholders to ensure MACRA enhances the ability of 
hospitals and physicians to deliver quality care to patients and 
communities, and advance health in America.

                                 ______
                                 
                 American Society of Clinical Oncology

                       2318 Mill Road, Suite 800

                          Alexandria, VA 22314

            T: 571-483-1300 / F: 571-366-9530 / www.asco.org

May 6, 2019

Hon. Chuck Grassley
Chair
U.S. Senate
Committee on Finance
Washington, DC 20510

Hon. Ron Wyden
Ranking Member
U.S. Senate
Committee on Finance
Washington, DC 20510

Dear Chairman Grassley and Ranking Member Wyden,

The American Society of Clinical Oncology (ASCO) is pleased to submit 
comments for the Committee's hearing, ``Medicare Physician Payment 
Reform After Two Years: Examining MACRA Implementation and the Road 
Ahead.''

ASCO is the national organization representing more than 45,000 
physicians and other health care professionals specializing in cancer 
treatment, diagnosis, and prevention. We are committed to ensuring that 
evidence-based practices for the treatment of cancer are available to 
all Americans.

ASCO supported the passage of the Medicare Access and CHIP 
Reauthorization Act of 2015 (MACRA) as a replacement to the flawed 
Sustainable Growth Rate. Since its enactment, ASCO has educated its 
members on MACRA and how to make it work for both their practices and 
the Medicare beneficiaries they serve. We have extensive MACRA-related 
practice tools, webinars, and other resources readily available for our 
members on asco.org/MACRA.

We appreciate the Committee's shared commitment to MACRA's success, and 
we offer the following ideas for how Congress and the Centers for 
Medicare and Medicaid Services (CMS) can strengthen MACRA and the 
Medicare program.

Encourage the Creation of Value-Based Incentives That Increase Quality 
                    and Lower Cost

ASCO members practice in diverse settings, including community-based 
physician practices, outpatient cancer centers, teaching hospitals, and 
large cancer treatment centers. Our members participate in a variety of 
value-based payment models, including the Merit-based Incentive Payment 
System (MIPS), Alternative Payment Models (APMs) with private payers, 
the Center for Medicare and Medicaid Innovation (CMMI) sponsored 
Oncology Care Model (OCM) and other CMMI sponsored models. As strong 
advocates of high-quality, high-value care, ASCO has supported 
development of new payment models that include the full scope of 
services needed by patients facing a cancer diagnosis. We do not agree 
with piecemeal reforms based on cost alone.

A key component of OCM is the sharing of Medicare claims data, which 
provides physicians the information necessary to understand the total 
cost of care borne by Medicare and patients. Analysis of these data has 
highlighted opportunities to reduce health care costs. We have heard 
from participating practices that oncology-specific care management 
payments, such as OCM's monthly-enhanced oncology service (MEOS) 
payments, provide funding to support resources such as navigators, 
triage nurses, and palliative care specialists. This helps to mitigate 
some of the costs for these previously uncovered services that are 
critical to quality care in oncology. We note that, for many practices, 
a large portion of the MEOS payment has been consumed by administrative 
support needed to comply with required reporting and analysis of data. 
This has drawn MEOS payments away from the intended patient services 
support and is an area where ongoing discussion will be important.

Practices participating in APMs continue to undergo transformation. 
Many have reported hiring clinical and financial navigators to improve 
coordination of care and proactively manage symptoms that would 
otherwise lead to acute care admissions or other long-term expenses. 
Practices have also employed value-based decision support tools, such 
as treatment and triage pathways.

Overall, participation in these payment models have resulted in reduced 
admissions, improved end-of-life quality measure performance, and 
increased patient satisfaction.

Adopt the Patient-Centered Oncology Payment Model (PCOP)

Medicare coding and payment for outpatient cancer treatment should be 
transformed by adopting proposals such as ASCO's ``Patient-Centered 
Oncology Payment Model'' (PCOP) and implementing policies that are 
consistent with that model. Originally published in 2015, ASCO has 
recently convened a diverse team of clinicians, payer and employer 
representatives to update the PCOP model and incorporate learnings from 
OCM and multiple commercial payer models.

The updated PCOP incorporates a community-centric oncology medical home 
structure, that encourages a true multi-payer approach. The use of 
evidence-based clinical treatment pathways is a cornerstone of the PCOP 
model, along with measurement and rewards for high-quality, high-value 
care.

A draft of the updated PCOP model has been provided to the CMMI and 
will be submitted to the Physician Focused Payment Model Technical 
Advisory Committee later this year. Should the PTAC recommend 
acceptance, Congressional support will be imperative for CMMI approval. 
ASCO is already in discussions with states and local communities who 
are interested in the PCOP model to advance cancer care for their 
population.

Test Multiple Oncology-focused Alternative Payment Models

ASCO urges Congress to work with CMMI to create and adapt a multi-step 
process for developing and implementing APMs--one that begins with 
limited-scale testing and then refinement or expansion of promising 
APMs over time. ASCO believes that by utilizing small-scale testing of 
multiple oncology-focused APMs, CMS can highlight potentially 
successful strategies for the broader community of cancer patients and 
oncology professionals.

For cancer, ASCO urges Congress and CMS to encourage the approval of 
multiple APMs because of the varied needs of cancer populations and 
providers. Oncology practices exist in numerous forms, and a ``one size 
fits all'' approach to payment models fails to take advantage of the 
strength of each of these practice structures. In this context, care 
should be taken not to disadvantage small and rural practices, which 
fulfill a crucial role in oncology care. While CMS has taken concrete 
steps to assist small practices participating in MIPS, such as freely 
available technical assistance and special considerations related to 
their scoring in the MIPS framework, small and rural practices fared 
less well under MIPS in the first performance year (2017): while the 
overall national mean score for a clinician was 74 points, clinicians 
in small and rural practices had national means of 43 points and 63 
points, respectively. CMMI should embrace oncology-focused APMs that 
differ from the existing OCM, as well as from other existing models 
that are not specifically focused on cancer.

Exclude Medicare Drug Cost From Resource Use in Cancer Care

ASCO has urged CMS to exclude all Medicare Part Band D drug costs from 
the assessment of cost performance and refrain from increasing the 
weight of cost performance category in the MIPS scoring methodology 
until it implements a cost measurement methodology that fairly and 
accurately assesses resource use in cancer care.

The current cost measurement methodologies are inadequate for measuring 
cost performance for oncology focused providers and practices due to 
several unique characteristics of cancer care. Cancer is a complex 
disease state with multiple forms. Treatment decisions are highly 
dependent upon a patient's unique medical characteristics, including 
their cancer morphology, cancer stage, genetic characteristics, 
mutation status, comorbidities and preferences. Individual physicians 
often specialize in treating specific types of cancer that may be 
especially complex or expensive to treat. Protecting the most 
vulnerable Medicare beneficiaries will require CMS to account for these 
considerations without threatening the viability of subspecialties that 
focus on treating certain cancers.

Promote Interoperability

Interoperability and the free exchange of health care information are 
core components to realizing the potential of a value-based health care 
system.

ASCO commends CMS for reforming the Promoting Interoperability (Pl) 
performance category measures to emphasize the exchange of health 
information, but we remain concerned that the scoring for this category 
remains essentially ``all or nothing,'' which places a heavy penalty on 
practices which fail to meet one of the criteria. We understand that 
CMS is exploring potential options to move toward more customized 
scoring of this category through incentives for innovative use of HIT, 
and ASCO would be eager to discuss our ideas for how this could be 
accomplished with CMS.

Despite our many steps forward in this area, oncology practitioners are 
still plagued by a lack of interoperability between different types of 
electronic medical records (EMRs) in addition to a lack of 
interoperability between EMRs and other forms of health information 
technology including electronic systems such as registries, genomic 
testing laboratories, and hospital laboratory information systems. 
These types of technology hold great promise for improving and 
enhancing patient care, especially in the realm of care coordination 
and quality improvement. To further enhance healthcare quality, we 
should move with urgency towards realizing the vision of seamlessly 
integrated health information, easily and securely accessible to all 
patients.

A basic need in the field of oncology is a common, shared set of data 
elements used to exchange information between providers and patients. 
Under our CancerlinQ (CLQ') subsidiary, ASCO is currently 
developing a set of ``Minimal Common Oncology Data Elements'' 
(mCODETM), an effort designed to result in a parsimonious 
set of consensus-developed oncology data elements necessary for 
critical information exchange between EHRs, for clinical care, quality 
reporting, and other use cases. This set of oncology data elements is 
envisioned by ASCO to form the basis of an initial parsimonious set of 
necessary data that should populate all electronic health records 
(EHRs) serving patients with cancer. Adoption of these data elements, 
which are being developed by experts in the fields of oncology and 
informatics, would greatly streamline the exchange of basic needed data 
necessary for oncologists. The National Cancer Institute (NCI) is 
engaged with this project, and we look forward to collaborating with 
agencies such as ONC wherever possible to encourage consideration and 
adoption of these elements when they are finalized. We have previously 
provided ONC with our description of this work and will continue to 
keep the agency abreast of our efforts; we are currently engaged in a 
pilot project with a large healthcare system as proof of concept in 
anticipation of wider adoption of these oncology data elements, which 
we believe would streamline communication between care providers and 
positively impact patient care.

Encourage Adoption of High-Quality Clinical Pathways

ASCO strongly supports the utilization of high-quality value-based 
oncology clinical pathways. As health care payment models continue to 
advance, private insurers have already embraced the use of oncology 
clinical pathways that incorporate both evolving scientific evidence 
and considerations of cost and value. We have encouraged the Medicare 
program to adopt high-quality value-base d pathways as a mechanism to 
assure high-quality and high-value care for the Medicare population.

Clinical pathways are regularly updated treatment protocols that map 
care based on current scientific evidence. When used appropriately, 
high-quality pathways can reduce unwarranted variations in care and 
focus resources on the most appropriate and valuable therapies while 
still allowing for justifiable individualized decision-making. Placing 
adherence to clinical pathways at the center of an oncology-based care 
model can improve quality, efficiency, and value of medical oncology 
services for Medicare beneficiaries, and would align Medicare policy 
with ongoing pathway initiatives in use by commercial payers.

ASCO has done extensive work examining pathways in oncology and has 
developed robust criteria for the development and implementation of 
pathway programs. ASCO has used these criteria to assess clinical 
pathway vendors. For more information on clinical pathways please 
visit: https://www.asco.org/practice-guidelines/cancer-care-
initiatives/clinical-pathways.

Improve Access to Claims Data

MACRA required CMS to make its data easier to access, especially for 
the purpose of linking clinical registries to CMS claims data. CMS is 
using its existing ResDAC process instead, which is cumbersome, time 
consuming to navigate, and strictly limits use of the data. CMS should 
allow much easier access to its data, as intended by Congress in the 
MACRA legislation. Congress should work with CMS to ensure these 
changes are made.

Thank you for your commitment to improving the Medicare program. If you 
have questions on any issue involving the care of individuals with 
cancer or would like to be directed to ASCO's thoughts on a specific 
issue related to drug pricing, please contact Jennifer Brunelle at 
[email protected].

Sincerely,

Monica M. Bertagnolli, MD, FACS, FASCO
President, American Society of Clinical Oncology

                                 ______
                                 
                        Center for Fiscal Equity

                        14448 Parkvale Road, #6

                       Rockville, Maryland 20853

                      [email protected]

                      Statement of Michael Bindner

Chairman Grassley and Ranking Member Wyden, thank you for the 
opportunity to comment on this issue. We will leave it to the 
Administration witnesses to address MACRA Implementation and confine 
ours comments to the Road Ahead, specifically the how Medicare for All 
will impact these reforms

Under Medicare for All proposals, it is assumed that insurance rates 
and copayments will be reduced to Medicare levels. Payments to 
Physicians will continue under Medicare rates, presumably relying on 
current reforms, such as MACRA, to help control the funding gap, with 
some kind of payroll or value added tax replacing premium payments, 
regulation of monopolistic hospital chains as public utilities, 
including negotiations to control both hospital and drug prices.

Monopoly and monopsony power already control costs to increase profit 
to shareholders. Negotiation will aim to reduce these profit margins. 
Please see our attachment which excerpts previous comments from last 
year on Medicare Advantage, including a more detailed exploration of 
Medicare for All.

Thank you for the opportunity to address the committee. We are, of 
course, available for direct testimony or to answer questions by 
members and staff.

Attachment One--Hearing on the Medicare Advantage Program

Medicare for All, Do We Already Have It?

Medicare for All is a really good slogan, at least to mobilize the 
base. One would think it would attract the support of even the Tea 
Partiers who held up signs saying ``Don't let the government touch my 
Medicare!'' Alas, it has not. This has been a conversation on the left 
and it has not gotten beyond shouting slogans either. We need to decide 
what we want and whether it really is Medicare for All. If we want to 
go to any doctor we wish, pay nothing and have no premiums, then that 
is not Medicare.

There are essentially two Medicares, a high option and a low one. One 
option has Part A at no cost (funded by the Hospital Insurance Payroll 
Tax and part of Obamacare's high unearned income tax as well as the 
general fund), Medicare Part B, with a 20% copay and a $135 per month 
premium and Medicare Part D, which has both premiums and copays and is 
run through private providers. Parts A and B also are contracted out to 
insurance companies for case management.

The other option is the Medicare Advantage (Part C) HMO. You pay a 
premium and copays, but there is much more certainty, while ABD are 
more like a PPO, but costs can go much higher. So much higher that some 
seniors and the disabled get Medicap coverage for the copays. Which is 
high and which low, I am not sure. They are both now managed care.

Medicaid lingers in the background and the foreground. It covers the 
disabled in their first two years (and probably while they are seeking 
disability and unable to work). It covers non-workers and the working 
poor (who are too poor for Obamacare) and it covers seniors and the 
disabled who are confined to a long-term care facility and who have run 
out their assets. It also has the long term portion which should be 
federalized, but for the poor, it takes the form of an HMO, but with no 
premiums and zero copays.

Obamacare has premiums with income-based supports (one of those facts 
the Republicans hate) and copays. It may have a high option, like the 
Federal Employee Health Benefits Program (which also covers Congress) 
on which it is modeled, a standard option that puts you into an HMO. 
The HMO drug copays for Obamacare are higher than for Medicare Part C, 
but the office visit prices are exactly the same.

What does it mean, then, to want Medicare for All? If it means we want 
everyone who can afford it to get Medicare Advantage Coverage, we 
already have that. It is Obamacare. The reality is that Senator Sanders 
wants to reduce Medicare copays and premiums to Medicaid levels and 
then slowly reduce eligibility levels until everyone is covered. Of 
course, this will still likely give us HMO coverage for everyone except 
the very rich, unless he adds a high-option PPO or reimbursable plan.

Either Medicare for All or a real single payer would require a very 
large payroll tax (and would eliminate the HI tax) or an employer paid 
subtraction value-added tax (so it would not appear on receipts nor 
would it be zero rated at the border, since there would be no evading 
it), which we discuss below, because the Health Care Reform debate is 
ultimately a tax reform debate. Too much money is at stake for it to be 
otherwise, although we may do just as well to call Obamacare Medicare 
for All and agree to leave it alone.

Social Insurance

It is always important to note that the whole purpose of social 
insurance, including Medicare, is to prevent the imposition of unearned 
costs and payment of unearned benefits for not only the beneficiaries, 
but also their families. Cuts which cause patients to pick up the slack 
favor richer patients, richer children and grandchildren, patients with 
larger families and families whose parents and grandparents are already 
deceased, given that the alternative is higher taxes on each working 
member. Such cuts would be an undue burden on poorer retirees without 
savings, poor families, small families with fewer children or with 
surviving parents, grandparents and (to add insult to injury) in laws.

Recent history shows what happens when benefit levels are cut too 
drastically. Prior to the passage of Medicare Part D, provider cuts did 
take place in Medicare Advantage (as they have recently). Utilization 
went down until the act made providers whole and went a bit too far the 
other way by adding bonuses (which were reversed in the Affordable Care 
Act).

Funding Levels and Premium Increases

Shifting to more public funding of health care in response to future 
events is neither good nor bad. Rather, the success of such funding 
depends upon its adequacy and its impact on the quality of care--with 
inadequate funding and quality being related. One form of increased 
funding could very well be higher Part B and Part D premiums (or Part 
C). This has been suggested by both the Fiscal Commission and the 
Bipartisan Policy Center. In order to accomplish this, however, a 
higher base premium in Social Security would be necessary. Our proposal 
is that to do this, the employee income cap on contributions should 
actually be lowered to decrease the entitlement for richer retirees 
while the employer income cap is eliminated, the employer and employee 
payroll taxes are decoupled and the employer contribution credited 
equally to each employee at some average which takes in all income. If 
a payroll tax is abandoned in favor of some kind of consumption tax, 
all income, both wage and non-wage, would be taxed and the tax rate may 
actually be lowered.

Ultimately, fixing health care reform will require more funding, 
probably some kind of employer payroll or net business receipts tax--
which would also fund the shortfall in Medicare and Medicaid (and take 
over most of their public revenue funding), regardless of whether Part 
B and D premiums are adjusted. If the same consumption tax pays both 
retirement income and government health plans, the impact on the 
taxpayer is exactly nil in the long term.

Funding Options Through Tax Reform

We will now move to an analysis of funding options and their impact on 
patient care and cost control.

The committee well understands the ins and outs of increasing the 
payroll tax, so we will confine our remarks to a fuller explanation of 
Net Business Receipts Taxes (NBRT). Its base is similar to a 
Subtraction Value-Added Tax (VAT).

Unlike a VAT, an NBRT would not be visible on receipts and should not 
be zero rated at the border--nor should it be applied to imports. While 
both collect from consumers, the unit of analysis for the NBRT should 
be the business rather than the transaction. As such, its application 
should be universal--covering both public companies who currently file 
business income taxes and private companies who currently file their 
business expenses on individual returns.

If employer-provided care to retirees is not included, the best funding 
mechanism is a Value-Added Tax with border adjustment, but at a higher 
rate to cover the loss. The key difference between the two taxes is 
that the NBRT should be the vehicle for distributing tax benefits for 
families, particularly the Child Tax Credit, the Dependent Care Credit 
and the Health Insurance Exclusion, as well as any recently enacted 
credits or subsidies under the ACA. In the event the ACA is reformed, 
any additional subsidies or taxes should be taken against this tax (to 
pay for a public option or provide for catastrophic care and Health 
Savings Accounts and/or Flexible Spending Accounts).

The NBRT can provide an incentive for cost savings if we allow 
employers to offer services privately to both employees and retirees in 
exchange for a substantial tax benefit, either by providing insurance 
or hiring health care workers directly and building their own 
facilities. Employers who fund catastrophic care or operate nursing 
care facilities would get an even higher benefit, with the proviso that 
any care so provided be superior to the care available through 
Medicaid. Making employers responsible for most costs and for all cost 
savings allows them to use some market power to get lower rates, but no 
so much that the free market is destroyed.

This proposal is probably the most promising way to arrest health care 
costs from their current upward spiral--as employers who would be 
financially responsible for this care through taxes would have a real 
incentive to limit spending in a way that individual taxpayers simply 
do not have the means or incentive to exercise. While not all employers 
would participate, those who do would dramatically alter the market. In 
addition, a kind of beneficiary exchange could be established so that 
participating employers might trade credits for the funding of former 
employees who retired elsewhere, so that no one must pay unduly for the 
medical costs of workers who spent the majority of their careers in the 
service of other employers.

The NBRT would replace disability insurance, hospital insurance, the 
corporate income tax, business income taxation through the personal 
income tax and the mid-range of personal income tax collection, 
effectively lowering personal income taxes by 25% in most brackets.

Note that collection of this tax would lead to a reduction of gross 
wages, but not necessarily net wages--although larger families would 
receive a large wage bump, while wealthier families and childless 
families would likely receive a somewhat lower net wage due to loss of 
some tax subsidies and because reductions in income to make up for an 
increased tax benefit for families will likely be skewed to higher 
incomes. For this reason, a higher minimum wage is necessary so that 
lower wage workers are compensated with more than just their child tax 
benefits.

                                 ______
                                 
                     Healthcare Leadership Council
May 8, 2019

The Honorable Chuck Grassley        The Honorable Ron Wyden
Chairman                            Ranking Member
U.S. Senate                         U.S. Senate
Committee on Finance                Committee on Finance
219 Dirksen Senate Office Building  219 Dirksen Senate Office Building
Washington, DC 20510                Washington, DC 20510

Dear Chairman Grassley and Ranking Member Wyden:

As the Senate Committee on Finance holds a hearing on, ``Medicare 
Physician Payment Reform After Two Years: Examining MACRA 
Implementation and the Road Ahead,'' the Healthcare Leadership Council 
(HLC) welcomes the opportunity to share its perspectives with you.

HLC is a coalition of chief executives from all disciplines within 
American healthcare. It is the exclusive forum for the nation's 
healthcare leaders to jointly develop policies, plans, and programs to 
achieve their vision of a 21st century healthcare system that makes 
affordable high-quality care accessible to all Americans. Members of 
HLC--hospitals, academic health centers, health plans, pharmaceutical 
companies, medical device manufacturers, laboratories, biotech firms, 
health product distributors, post-acute care providers, home care 
providers, and information technology companies--advocate for measures 
to increase the quality and efficiency of healthcare through a patient-
centered approach.

HLC has long supported a shift away from fee-for-service healthcare 
toward a system based on providing better value for healthcare 
consumers. Our member organizations have been proponents of delivery 
system innovations that are value-based, patient-centered and reward 
improved quality and cost-effective care.

HLC strongly supported the ``Medicare Access and CHIP Reauthorization 
Act (MACRA) of 2015'' and is pleased to provide feedback that we expect 
will strengthen the broader transition to a payment system that 
emphasizes value. As providers in the delivery system transition to a 
new payment system that emphasizes value, we encourage prioritizing 
consumer feedback and outreach, provider feasibility and minimizing new 
administrative burdens. We have been pleased to see significant action 
on key recommendations provided by HLC in previous years.

In particular:

      HLC supports CMS's recognition of Medicare Advantage (MA) as an 
advanced alternative payment model. In payment years 2019 and 2020, the 
participation criteria for Advanced APMs were only for traditional 
Medicare payments or patients. Starting in payment year 2021, the 
participation requirements for Advanced APMs may include MA plans. The 
demonstration would allow physicians that participate in value-based 
arrangements with MA plans to see the same payment benefits as 
physicians participating in one of the CMS designated Advanced 
Alternative Payment Models (AAPMs).

      HLC encourages Congress and the Administration to continue to 
push forward with its efforts to facilitate the movement of 
organizations to pay-for-performance and AAPMs. A critical element of 
this effort will be incorporating complementary value-based 
arrangements (such as Medicare Advantage) into AAPM MACRA thresholds as 
soon as possible.

      HLC strongly supports efforts to reduce the quality measure 
reporting burden on clinicians. HLC continues to emphasize that this 
flexibility is necessary as it may be difficult--particularly in the 
initial years--to design APMs that are attractive to a variety of 
providers. The federal government must ensure, however, that these 
flexibilities do not lessen important incentives for provider 
participation.

      HLC supports the creation of a new improvement activity for 
clinician leadership in clinical trials, research alliances, or 
community-based participatory research (CBPR)--especially around 
minimizing disparities in healthcare access. HLC supports this effort 
to improve clinical trial enrollment and encourages the federal 
government to consider including other physicians or even a counseling 
service payment to incentivize providers to provide information on 
clinical trials.

As shared in previous correspondence, HLC continues to emphasize 
several broader priorities that we believe are critical for the overall 
success of value-based care programs.

Congress should adopt changes to modernize the federal fraud and abuse 
legal framework to facilitate stronger provider performance in the 
Merit-based Incentive Payment System (MIPS) measurement categories and 
facilitate growth into full AAPMs. Modernization of the current legal 
framework is needed to make it more compatible with healthcare delivery 
system transformation while retaining appropriate protections against 
fraud and abuse. Congress should amend the Anti-Kickback Statute and 
Stark Law to allow waivers for stakeholders engaged in alternative 
payment arrangements (both AAPMs and MIPS reporting APMs) that meet 
certain conditions. The current unpredictable and burdensome system of 
``one-off'' waivers is not sufficient for alternative payment goals. 
Congress should also extend existing Anti-Kickback Statute and Stark 
Law exceptions for donation and financial support of electronic health 
information products that facilitate care coordination, cybersecurity 
protection, and compliance with systems' interoperability goals.

Quality measurement and coding updates should better incorporate 
socioeconomic status adjustments to incentivize alternative payment 
arrangements in areas of high need. It is critical that all efforts to 
move to outcome-based payment properly account for complexities of 
patients as well as the socioeconomic challenges that providers face in 
caring for patients. Without these adjustments, efforts to reward 
higher performing providers may result in lower funding for those 
serving the most vulnerable. To ensure appropriate payment and risk-
adjustment, quality programs under MACRA should include a reasonable 
number of measures that effectively capture variance in patient 
populations. We support the use of a limited number of standard, vetted 
measures and urge CMS to synchronize measures, expectations, and 
reporting requirements with existing efforts in the private sector. By 
working closely with experts in the private sector, a system that 
appropriately reflects health system challenges--such as the social and 
economic status of consumers--can create a more accurate payment 
system.

Traditionally, ICD-10 codes are used to document diagnoses, symptoms, 
treatment, and procedures into the patient medical record. The 
expansion of these codes to include social determinants of health, 
including socioeconomic status, education, geographic location, home 
environment, functional limitation, employment, access to healthcare, 
transportation, food and nutrition, social isolation and many more 
broad categories would allow physicians to better assess the whole 
patient. Further, healthcare providers would be able to use these codes 
to document when a patient may benefit from a social service such as 
better access to transportation or access to nutrition services. For 
example, if a patient does not have a means of transportation or cannot 
afford to pay for transportation to a breast cancer screening center, 
the probability is high that this screening will not occur. The 
implementation of new ICD-10 codes for social determinants of health 
would help manage these types of situations to drive better patient 
engagement, care, and outcomes.

It is imperative that Congress and CMS continue to work closely with 
private-sector health leaders during MACRA implementation. The law 
provides CMS with an unprecedented ability to transform healthcare 
delivery through incentives. These changes, which will have far-
reaching and significant effects on consumers nationwide, should be 
validated by healthcare experts across the healthcare system. These 
changes must be deliberate, transparent, and allow for meaningful 
collaborative efforts. Similarly, we urge the federal government to 
provide clear, concise, and actionable feedback on a timely and regular 
basis to allow providers to improve the quality of care delivered to 
patients and enhance program performance.

Thank you for examining this important issue and please feel free to 
reach out to Tina Grande, Senior Vice President for Policy, at (202) 
449-3433 or [email protected] with any questions.

Sincerely,

Mary R. Grealy
President

                                 ______
                                 
                  Medical Group Management Association
The Medical Group Management Association (MGMA) commends the Senate 
Finance Committee for convening this hearing on ``Medicare Physician 
Payment Reform After Two Years: Examining MACRA Implementation and the 
Road Ahead.'' MGMA is the premier association for professionals who 
lead medical practices. Since 1926, through data, people, insights, and 
advocacy, MGMA empowers medical group practices to innovate and create 
meaningful change in healthcare. With a membership of more than 45,000 
medical practice administrators, executives, and leaders, MGMA 
represents more than 12,500 practices of all sizes, types, structures, 
and specialties that deliver almost half of the healthcare in the 
United States.

Through repealing the problematic sustainable growth rate and retiring 
an overly complex and duplicative hodgepodge of quality reporting 
programs, the Medicare Access and CHIP Reauthorization Act (MACRA) 
charted a value-based trajectory for the Medicare payment system by 
valuing innovative, patient-centric, and efficient care delivery over 
check-the-box bureaucracy.

We appreciate this Committee's oversight efforts to ensure successful 
implementation of MACRA's sweeping payment reforms. We also applaud 
Congress for making technical corrections to MACRA through the 
Bipartisan Budget Act of 2018, another example of its continued support 
for the innovative care delivery improvements taking place in physician 
group practices across the country.

Since MACRA passed, MGMA has partnered with Congress and the 
Administration to help practices succeed in the Quality Payment Program 
(QPP). We have hosted numerous educational events that connect our 
members directly with Centers for Medicare and Medicaid Services (CMS) 
staff, developed informational and educational resources related to the 
Merit-based Incentive Payment System (MIPS) and alternative payment 
models (APMs), and provided suggestions on how to improve the current 
program to policymakers based on feedback from our members.

At this critical juncture in Medicare's transition from fee-for-service 
toward value-based reimbursement, Congress has an opportunity to make 
refinements to the program that would align it more closely with the 
original intent of MACRA. We hope these comments will help guide the 
Committee as it seeks to improve the QPP, align it more closely with 
congressional intent in MACRA to improve physician payment, and ensure 
a successful transition to a new Medicare payment system centered 
around high-value care.

Continue the 0.5 Percent Medicare Payment Update Beyond CY 2019

MACRA stabilized annual updates under the Physician Fee Schedule (PFS) 
and is a vast improvement to the previous, draconian sustainable growth 
rate methodology. Under MACRA, PFS payment updates increased by 0.5 
percent between 2015-2018, 0.25 percent in 2019, and then will be 
frozen for 6 years between 2020-2025.

As the healthcare community transitions toward a value-based payment 
environment, fee-for-service does not need to be abandoned entirely, 
but it does need to be updated appropriately. Physician practices face 
a challenging environment with escalating costs, flat reimbursement 
updates, and an increasingly complex regulatory environment. To 
continue supporting these practices as they implement the changes 
necessary to ensure success in new delivery models, MGMA urges Congress 
to continue the stability in physician payments by extending the 0.5 
percent adjustment to the conversion factor beyond CY 2019.

Encourage the Development and Availability of Physician-Focused APMs

MGMA strongly supports efforts to advance value-based care delivery 
through APMs that reward high quality and efficient care delivery. MGMA 
agrees with Congress that the APM pathway is a promising door to value-
based reimbursement without imposing undue administrative burden. We 
are encouraged by CMS' recent efforts to implement new primary care 
APMs through the Primary Care First and Direct Contracting models.\1\
---------------------------------------------------------------------------
    \1\ ``HHS to Deliver Value-Based Transformation in Primary Care,'' 
HHS Newsroom (April 22, 2019).

Despite this progress, however, the healthcare system is still learning 
how to effectively transform care delivery. We are now past the 3-year 
mark for implementation of MACRA, yet there are still limited 
opportunities for physician practices to participate in an APM, 
particularly those that qualify as ``advanced'' under CMS regulations. 
CMS estimates that less than 220,000 clinicians will become qualifying 
participants in Advanced APMs this year, compared to the 798,000 
clinicians expected to participate in MIPS.\2\ Many practices are 
interested in joining an APM, but are unable to do so because there are 
not viable options for practices of their size, specialty, or location. 
In a 2018 survey of MGMA members, 55% of over 400 respondents reported 
that Medicare does not offer an Advanced APM that is clinically 
relevant to their practice.\3\
---------------------------------------------------------------------------
    \2\ 83 Fed. Reg. 59452, 59721 (November 23, 2018).
    \3\ ``MGMA 2018 Regulatory Burden Survey'' (October 2018).

Congress established the Physician-focused Payment Model Technical 
Advisory Committee (PTAC) to leverage private sector development and 
expedite the availability and implementation of APMs. Dozens of APMs 
have been submitted to PTAC, however CMS has yet to implement or test 
on a limited scale any of the models recommended by PTAC. We urge 
Congress to direct the Administration to be more collaborative with 
PTAC, including testing and adopting new physician-
focused payment models.

Extend the APM Bonus Beyond CY 2024 When it Currently Expires

MGMA appreciates Congress' work to support physician practices 
transitioning to value-based payment in Medicare by providing 
incentives to participate in APMs, including a five percent bonus 
payment for significant participation in APMs. This five percent bonus 
is a powerful incentive for practices to participate in APMs, but it is 
set to end in 2024. Momentum toward practice participation in these 
value-based models could be lost without this support. We urge Congress 
to consider extending the availability of the five percent payment to 
continue incentivizing practices to participate in APMs as more models 
are developed that may offer practices an opportunity to participate in 
an APM for the first time.

Furthermore, the five percent bonus is not only an incentive to 
participate in an APM, it also lends financial support to practices 
incurring extra expenses when making the transition into a new care 
delivery model, which may include start-up costs, hiring and training 
additional support staff, making technology upgrades, and the use of 
time and resources for high-value, yet non-covered, services.

We share Congress and the Administration's goal of expediting the 
process for physician practices to participate in APMs and believe an 
important step to achieving this goal is to extend the availability of 
the five percent incentive payment beyond 2024 when it is currently set 
to expire, so that group practices have the opportunity to receive the 
support Congress intended.

Modify the APM Risk Standard

We recommend modifying the APM financial risk standard to account for 
start-up costs as well as ongoing expenses incurred by a group practice 
as they participate in an APM. Start-up costs alone can easily exceed 
millions of dollars by CMS' own estimates, and these amounts should be 
counted towards an APM's nominal amount standard. Incorporating these 
financial risks could lead to many more APMs entering this track of 
MACRA and additional APMs finally being recognized for the very 
tangible risk they are assuming.

Modernize Antiquated Fee-for-Service Policies That Undercut Value-Based 
                    Transformation

As practices explore new payment models, they face outdated payment 
requirements and fraud and abuse rules that hinder their ability to 
coordinate care. To allow for greater care coordination within the 
construct of APMs, MGMA recommends that Congress assess and modify the 
existing physician self-referral (Stark Law) prohibition and/or create 
new waivers for APM participants from certain fraud and abuse rules and 
payment requirements.

There is a growing consensus supporting the expeditious modernization 
of existing fraud and abuse rules, such as the Stark Law and Anti-
Kickback Statute (AKS). While well-intended, the Stark Law and AKS are 
broadly construed such that they effectively prohibit or introduce 
uncertainties regarding clinical and financial integration arrangements 
that have the potential to improve care for patients.

Congress has recognized the incongruity between the current fraud and 
abuse framework and the development and implementation of APMs and 
other value-based payment arrangements. Congress authorized the 
Administration to issue waivers for select programs, such as those 
created through the Center for Medicare and Medicaid Innovation (CMMI) 
and for accountable care organizations in the Medicare Shared Savings 
Program. Waivers do not offer sufficient protection, however, as they 
are issued on a case-by-case basis, are limited in duration, and only 
protect arrangements within specific programs. Uncertainty about the 
application of fraud and abuse rules, and potential for severe 
penalties for any violation, have had a chilling effect on innovation 
and slowed the progression toward cost-efficient, 
quality-driven models.

As the healthcare industry transitions to a value-driven payment 
environment, we urge Congress to enact legislation that modernizes 
these outdated rules and creates flexible waivers for APMs, which are 
already held accountable for utilization and quality of care as 
inherent aspects of model design. Congress should pass the Medicare 
Care Coordination Improvement Act (S. 966/H.R. 2282), which would 
expand the Secretary's fraud and abuse exception and waiver authority 
and remove the ``volume or value'' prohibition in Stark Law to 
facilitate the development and operation of APMs. Additionally, we 
support broader reforms, such as eliminating the compensation prong 
from the Stark Law to return its focus to governing ownership 
arrangements.

Lastly, we recommend the Committee reevaluate the usefulness of out-of-
date billing requirements for telehealth and other high value services. 
This is particularly important for APMs, which are held accountable for 
total cost of care and should not be subject to a duplicative set of 
requirements.

Streamline and Simplify MIPS Reporting Requirements

As medical group practices transition to value-based payment to improve 
the delivery of health care, they are hamstrung by burdensome and 
outdated government mandates that impede innovation, drive up costs, 
and ultimately redirect resources away from patients. Through its 
oversight authority, Congress should ensure CMS does more to streamline 
and significantly simplify reporting requirements and scoring for MIPS. 
CMS should reduce the overall number of measures required for full 
participation in MIPS and use a flexible set of measures that are 
proven to be statistically reliable, clinically valid, outcomes-
focused, and, most importantly, patient-centered. Furthermore, CMS 
should base MIPS point values for individual measures on their relative 
value to the total MIPS score.

Minimizing regulatory burden to the greatest extent possible, such as 
burdens related to quality reporting requirements, allows physician 
practices to allocate more time toward improving patient care. To 
assist CMS in resetting its approach and achieving its stated goals of 
reducing clinician burden in MIPS and enhancing patient care, MGMA 
encourages Congress to instruct CMS to make the following high-impact 
improvements to MIPS:

      Decrease the number of measures across MIPS. Physician group 
practices' finite resources are spread across a minimum of nearly 20 
measures required to meet MIPS requirements. CMS should structure MIPS 
to allow practices to prioritize effective and impactful improvements 
to patient care, rather than comply with sprawling reporting mandates.

      Significantly simplify the scoring scheme. CMS should simplify 
the overall MIPS scoring structure by basing point values for 
individual measures on their relative value to the total MIPS score.

      Increase CMS' flexibility to appropriately score MIPS 
performance. On top of simplifying the overarching scoring scheme of 
MIPS, Congress should add legislative language to MACRA to increase 
flexibility in MIPS scoring methodology to expressly allow CMS to 
provide clinicians and group practices with credit across categories 
for performing certain activities that touch on multiple MIPS 
categories. For instance, reporting quality measures via certified EHR 
technology should count toward fully meeting the promoting 
interoperability category, rather than merely toward bonus points.

      Do not prematurely measure cost. Many features of the cost 
performance category are still unfinished. Currently, CMS is 
overhauling two MIPS cost measures to address longstanding, significant 
concerns related to flawed attribution and insufficient risk adjustment 
methodologies; adding new condition-based measures; and testing patient 
relationship codes. Group practices should not be evaluated on measures 
with unresolved methodological flaws. While CMS continues to fine-tune 
the cost component of MIPS, Congress should encourage the agency to 
weight the cost category to ten percent to allow sufficient time to 
significantly overhaul existing cost measures. CMS' own data has shown 
that the current methodology discriminates against physicians who treat 
the sickest patients. The agency needs time to develop better risk 
adjustment and attribution methodologies. It is crucial for CMS to 
understand the complexities of patient attribution and take this 
opportunity to fully test any new code set, such as the patient 
relationship codes required under MACRA, to ensure the agency achieves 
the desired outcome of appropriately assigning costs to providers who 
have control over the care.

      Provide clear and actionable feedback about MIPS performance at 
least every calendar quarter, as recommended by the statute. Without 
timely feedback, MIPS is essentially a reporting exercise that enters 
data into a ``black box'' only understood by CMS, rather than a useful 
barometer practices can leverage to drive clinical improvement.

Conclusion

Thank you for the opportunity to share our comments regarding 
implementation of MACRA. MGMA stands ready to work with Congress, the 
Administration, and other stakeholders in ensuring MACRA supports 
physician practices' transition to value-based care delivery models by 
reducing administrative burden, improving the clinical relevance of 
MIPS, increasing opportunities to move into APMs, and modernizing 
outdated federal rules impeding care coordination. Should you have any 
questions, please contact Mollie Gelburd at [email protected] or 202-
293-3450.

                                 ______
                                 
             Medicare Payment Advisory Commission (MedPAC)

                      425 I Street, NW, Suite 701

                          Washington, DC 20001

                              202-220-3700

                           Fax: 202-220-3759

                             www.medpac.gov

The Medicare Payment Advisory Commission (MedPAC) is a small 
congressional support agency established by the Balanced Budget Act of 
1997 (Pub. L. 105-33) to provide independent, nonpartisan policy and 
technical advice to the Congress on issues affecting the Medicare 
program. The Commission's goal is a Medicare program that ensures 
beneficiary access to high-quality, well-coordinated care; pays health 
care providers and health plans fairly, rewarding efficiency and 
quality; and spends taxpayer and beneficiary dollars responsibly. The 
Commission thanks Chairman Grassley and Ranking Member Wyden for the 
opportunity to submit a statement for the record today.

Background

Physicians and other health professionals billing under Medicare's fee 
schedule deliver a wide range of services--office visits, surgical 
procedures, and diagnostic and therapeutic services--in a variety of 
settings. The Medicare program paid $69.1 billion for physician and 
other health professional services in 2017, or 14 percent of benefit 
spending in Medicare's traditional fee-for-service (FFS) program. In 
2017, about 985,000 health professionals billed Medicare through the 
fee schedule--roughly 596,000 physicians and 389,000 nurse 
practitioners, physician assistants, therapists, chiropractors, and 
other practitioners (Medicare Payment Advisory Commission 2019).

Medicare's fee schedule payment rates are based on the clinician work 
required to provide the service, expenses related to maintaining a 
practice, and expenses related to professional liability insurance. 
From 1999 to 2015, updates to these payment rates were governed by the 
sustainable growth rate (SGR) system, which set updates so that total 
spending would not increase faster than a target--a function of input 
costs, FFS enrollment, gross domestic product (GDP), and changes in law 
and regulation. Because annual spending generally exceeded these 
parameters, payments to clinicians were scheduled to be reduced by 
ever-growing amounts starting in 2002. The Congress overrode these 
negative cuts in all but the first year they were scheduled. Because of 
these overrides and volume growing in excess of per capita GDP, the 
resulting scheduled payment rate reduction was expected to be 21 
percent in 2015, creating considerable tension for clinicians and the 
Medicare program. The Medicare Access and CHIP Reauthorization Act of 
2015 (MACRA) repealed the SGR system and created a fixed set of 
statutory updates for clinicians.

MACRA also included two other major provisions--an incentive payment 
for qualifying participants in advanced alternative payment models (A-
APMs) and the Merit-based Incentive Payment System (MIPS). From 2019 
through 2024, clinicians who are qualifying participants in an A-APM 
receive incentive payments of 5 percent of their Medicare-covered 
professional services revenue each year that they qualify. MACRA's 
incentive payments for clinicians participating in A-APMs were intended 
to encourage clinicians to move toward these models. A-APMs generally 
require participating entities to assume financial risk for their 
patients, which creates incentives for providers to improve care 
coordination and quality while controlling cost growth. Unless 
otherwise exempted, clinicians who are not qualifying participants in 
an A-APM and meet certain thresholds for Medicare participation are 
required to participate in MIPS. MIPS is a system that calculates 
individual clinician-level or group-level payment adjustments based on 
four areas: (1) quality and advancing care information, (2) meaningful 
use of electronic health records, (3) clinical practice improvement 
activities, and (4) cost. Based on the clinicians' performance in these 
four areas, the payments they receive from Medicare can be increased or 
decreased by varying amounts over time. The basic MIPS payment 
adjustments are budget neutral, but MACRA also appropriated an 
additional $500 million in bonuses for exceptional performance in MIPS 
each year from 2019 to 2024.

(The Commission has commented extensively on A-APMs and MIPS. For more 
background on these topics, see the Commission's annual reports and 
comment letters referenced at the end of this document).

The Commission Supports Repeal of the Sustainable Growth Rate System

The Commission had long supported repealing the SGR and commends the 
Congress for doing so (Medicare Payment Advisory Commission 2011, 
Medicare Payment Advisory Commission 2018b). The SGR failed to restrain 
volume growth under the fee schedule and, in fact, may have exacerbated 
it. Although the pressure of the SGR likely minimized fee increases 
while in effect, it disproportionally affected clinicians who have less 
ability to increase volume, such as primary care providers. 
Additionally, both the magnitude of the threatened cuts and the 
temporary policies to override the SGR engendered uncertainty among 
clinicians, which in turn may have caused anxiety among beneficiaries. 
For these reasons, the Commission believes that repealing the volume-
based approach to clinician payment was warranted. The MACRA approach 
of tying payments to clinicians' performance, through comprehensive, 
patient-centered care delivery models, provides better incentives for 
clinicians and could ideally result in better care and outcomes for 
Medicare beneficiaries.

Implementing Advanced-Alternative Payment Models

MACRA established the A-APM incentive payment to spur reform in the 
delivery of health care by encouraging clinicians to move toward these 
models, in which providers take accountability for health care spending 
and quality. A-APMs are defined in statute based on three criteria:

    1.  The model requires use of certified electronic health record 
technology.

    2.  The model makes payments based on a set of quality measures 
comparable with MIPS.

    3.  The model requires the entity to bear financial risk under such 
alternative payment model in excess of a nominal amount or to be a 
medical home expanded under Section 1115A(c) (Medicare Payment Advisory 
Commission 2016b).

The Commission generally supports the establishment of A-APMs and other 
elements of MACRA that are designed to move clinicians toward 
comprehensive, 
patient-centered care delivery models. These models can help counter 
the incentives in traditional FFS, which reward volume and thus can 
lead to higher spending for the Medicare program and for beneficiaries. 
The Commission holds that it is important to encourage providers to 
take accountability for the cost of health care and for quality 
outcomes, and it has long recognized the limitations of traditional 
FFS.

Effective A-APMs should encourage delivery system reform that results 
in beneficiaries having access to high-quality health care services and 
a sustainable Medicare program. To help the Centers for Medicare and 
Medicaid Services (CMS) implement A-APMs in a way that achieves that 
goal, in June 2016 the Commission established the following set of 
principles to help inform how A-APMs should be defined (Medicare 
Payment Advisory Commission 2016b):

      Clinicians should receive an incentive payment only if the A-APM 
entity in which they participate (e.g., an accountable care 
organization (ACO)) is successful in controlling cost, improving 
quality, or both.\1\
---------------------------------------------------------------------------
    \1\ Clinicians are participants in A-APM entities. The A-APM entity 
is a participant in a qualifying model.

      The A-APM entity should be at financial risk for total Part A 
---------------------------------------------------------------------------
and Part B spending.

      The A-APM entity should be responsible for a beneficiary 
population sufficiently large to detect changes in spending and 
quality.

      The A-APM entity should have the ability to share savings with 
beneficiaries.

      CMS should give A-APM entities certain regulatory relief.

      Each A-APM entity should assume financial risk and enroll 
clinicians.

While the statute contains some guidance for the models CMS should 
consider as A-APMs for purposes of the 5 percent incentive payment, the 
agency has considerable flexibility in making that determination. CMS 
began deciding which models qualified as A-APMs beginning in 2017, and 
the number has increased each year to 13 models in 2019 (Centers for 
Medicare and Medicaid Services 2018a).

Some A-APMs align relatively well with the Commission's principles for 
A-APMs. One type of A-APM that the Commission has generally supported 
is an ACO model that features two-sided financial risk, meaning that 
providers share in savings or losses based on beneficiaries' actual 
spending relative to what was expected. The Next Generation 
(``NextGen'') ACO model is an example. It began in 2017, and 
participating providers agree to take responsibility for the overall 
cost and quality of medical care for a population of beneficiaries. 
This model has strong incentives for providers to improve quality and 
control the overall cost of care for attributed beneficiaries, and it 
generally aligns with our principles. The most recent evaluation of the 
program found that in its first year the NextGen program reduced 
Medicare spending for beneficiaries by 1.7 percent before taking into 
account shared savings paid to the ACOs (and losses paid to Medicare by 
ACOs) (NORC at the University of Chicago 2018). After shared savings 
and losses are taken into account, the NextGen demonstration saved 1.1 
percent. Most quality measures did not show statistically significant 
changes.

Recently the Commission conducted an analysis to measure the 
performance through 2016 of the Medicare Shared Savings Program (MSSP), 
the largest ACO program in Medicare. Almost all of the ACOs in the MSSP 
during this time did not face two-sided financial risk, and thus had 
weaker incentives than ACOs in the NextGen program. We concluded that 
the MSSP resulted in spending growth from 2012 to 2016 that was 1 or 2 
percentage points lower than spending growth would have been without 
the program. However, that was before payments to ACOs for shared 
savings, and actual savings realized by the Medicare program were thus 
lower. Models incorporating two-sided risk, like NextGen, have stronger 
incentives for achieving better cost and quality outcomes and align 
most closely with our principles.

In contrast, some A-APMs do not align well with our principles. For 
example, the Commission has expressed concerns about the Comprehensive 
Primary Care Plus (CPC+) model being designated as an A-APM, in part 
because providers could join without assuming enough financial risk to 
change incentives for delivering care (Medicare Payment Advisory 
Commission 2016a). In CPC+, providers get additional payments in the 
form of monthly fees and awards based on performance. These additional 
dollars are intended to help primary care practices coordinate care to 
improve quality and reduce spending. However, participants in CPC+ only 
face financial risk for these additional payments, and not on their FFS 
revenue. The Commission has expressed concern that A-APMs with low 
standards for financial risk may attract providers interested in 
gaining the incentive payment and not in changing care delivery.

In April 2019, CMS posted performance results from the first year of 
CPC+. Overall, the evaluation found that practices participating in 
CPC+ tended to have FFS spending that was 2 to 3 percent higher than 
comparison practices, after accounting for enhanced payments. These 
results illustrate the risks to the Medicare program and taxpayers of 
having A-APMs that are not designed with robust incentives (Centers for 
Medicare and Medicaid Services 2019).

Ideas for Improving A-APMs

A key policy choice is whether to have more A-APM participants in 
models with weaker incentives, or fewer A-APM participants in models 
with stronger incentives. The Commission's goal is for Medicare to 
design efficient A-APMs that create real value for beneficiaries, the 
Medicare program, and taxpayers, not to maximize the number of 
providers that can join A-APMs. Thus, it is important for policymakers 
to continue improving A-APMs in order to increase their likelihood of 
success. To help in that effort, the Commission has discussed several 
policies that could improve A-APMs. These policies are focused on 
strengthening incentives for providers to change practice patterns, 
reducing burden and uncertainty, and sending consistent signals 
throughout the Medicare program for how providers and other entities 
will be measured on cost and quality.

Maintain High Standards for Financial Risk

CMS should only approve A-APMs with high standards for financial risk. 
As noted above, without high standards for financial risk, A-APMs may 
attract providers who see the model primarily as a means for gaining 
incentive payments, and who may be less focused on changing care 
delivery. This would increase spending for the Medicare program and 
beneficiaries, without providing real value.

Use Prospective Attribution in ACOs

Starting in June 2019, MSSP ACOs (some of which are A-APMs) will be 
given the ability to choose, each year, whether to have their 
beneficiaries assigned prospectively or retrospectively. This creates 
risk for the program because it could encourage patient selection. 
Prospective assignment means that beneficiaries are assigned to an ACO 
based on which providers they saw in the previous year. Retrospective 
assignment means that beneficiaries are assigned to an ACO based on the 
providers they saw in the current year. There are strengths and 
weaknesses to both approaches, but, on balance, prospective assignment 
has several advantages. ACOs know with certainty who their assigned 
beneficiaries are at the beginning of the year, and thus can better 
target their efforts to improve care. Also, when an ACO knows in 
advance who its beneficiaries are, the program is able to relax 
regulations and give greater flexibility to the ACO (e.g., by allowing 
a waiver from the requirement that a beneficiary have a 3-day hospital 
stay before being admitted to a SNF). Prospective assignment also 
reduces problems of patient selection that may arise through 
retrospective assignment. Under retrospective assignment, ACOs can take 
actions during a performance year to influence which patients are 
assigned to them. For example, toward the end of the year, an ACO could 
encourage patients with little service use to have an annual wellness 
visit (AWV) with an ACO clinician so that low-spending patients would 
be assigned to the ACO. Alternatively, an ACO could encourage patients 
to see non-ACO doctors if they have an anticipated need for an 
expensive procedure such as a knee replacement. These selection issues 
are less of a problem under prospective assignment because it is more 
difficult to predict a patient's spending in a future year than in the 
current year, and the ACO is responsible for the patient's spending 
during the entire year regardless of where the patient gets care.

Measure Quality Consistently Across Medicare

To reward accountable entities and providers for offering high-quality 
care to beneficiaries, A-APMs should be designed to link payment to 
quality of care. However, the ACO program used 32 quality measures in 
2018, including some process measures with an unclear link to patient 
health outcomes. Using so many measures is burdensome to ACO 
participants and makes it difficult to draw comparisons with providers 
in other parts of Medicare that use different quality measures. The 
Commission asserts that Medicare quality incentive programs should use 
a small set of outcomes, patient experience, and value measures to 
assess the quality of care across different populations, such as 
beneficiaries enrolled in Medicare Advantage (MA) plans, ACOs, and FFS 
in defined market areas, as well as those cared for by specified 
hospitals, groups of clinicians, and other providers (Medicare Payment 
Advisory Commission 2018a).

A consistent set of population-based measures will allow policymakers 
to compare quality across different accountable entities and providers 
in the Medicare program. This would also provide information to the 
program to better reward high-quality providers, and to beneficiaries 
to inform decisions of where to get care. Sending consistent signals 
across the program could also help providers focus their quality 
improvement activities on improving patient outcomes.

Continue Improving FFS

Although A-APMs represent a significant opportunity to encourage 
delivery system reform and to move the Medicare program to paying for 
value, it is important to remember that these payment models largely 
rely on the Medicare FFS system to operate underneath them. That is, in 
most A-APMs, providers still submit FFS claims and are paid FFS rates. 
Therefore, it is crucial that the FFS payment systems be continually 
maintained and improved so that they function smoothly and, to the 
extent possible, do not create conflicting incentives.

Moving Beyond the Merit-based Incentive System (MIPS)

MedPAC shares Congress's goal, expressed in MIPS, of having a value 
component for clinician services in traditional Medicare that promotes 
high-quality care. However, MedPAC believes that MIPS, as currently 
structured, cannot achieve this goal and, therefore, should be replaced 
with a better quality payment program (Medicare Payment Advisory 
Commission 2018b). The Commission did not reach this conclusion 
hastily. We first examined options for improving MIPS as it was 
implemented, and we have provided feedback as CMS established rules for 
the first three years of the program (Medicare Payment Advisory 
Commission 2016a, Medicare Payment Advisory Commission 2017). However, 
as we continued to explore MIPS in a deliberative process laid out in 
several Commission reports to the Congress, we came to the conclusion 
that the basic design of MIPS is fundamentally flawed. For a number of 
reasons, MIPS will not succeed in helping beneficiaries choose 
clinicians, in helping clinicians change practice patterns to improve 
value, or in helping the Medicare program reward clinicians based on 
the value of the care they provide.

First, information collected under MIPS is unlikely to be meaningful 
because the MIPS measures are variable in application, clinical 
appropriateness, and association with meaningful outcomes. Under MIPS, 
each clinician's quality score is based on six measures chosen by the 
clinician from a set of several hundred predominantly process measures. 
To measure all or most medical and surgical specialties at the 
individual level, as the MIPS program is designed, there needs to be a 
wide variety of clinical process measures, including those relevant to 
each specialty. Therefore, when clinicians are compared with each other 
nationally to determine Medicare payments, the comparison is on wholly 
different measures. This will likely lead to substantial inequities 
over time and to the ultimate rejection of the program as unfair. The 
Commission supports providers using additional measures, such as care 
process measures, to manage their own quality improvement. However, 
these measures should not be tied to Medicare payments through quality 
incentive programs.

Second, few individual clinicians manage a sufficient number of 
discrete beneficiary medical issues and resultant processes of care 
during a year to produce reliable, statistically significant 
comparative results (the ``small numbers'' problem). Although some 
clinicians may furnish services at volumes large enough to be 
accurately measured, they are too few to build a comprehensive program 
that is broadly accurate and equitable across clinicians. In the third 
year of the program, CMS plans to exclude about 45 percent of 
clinicians from the MIPS program because they do not meet group 
eligibility or fall below the low-volume threshold (Centers for 
Medicare and Medicaid Services 2018b).

Third, adjusting payment based on quality and efficiency measured at 
the individual clinician level belies the reality of modern medicine. 
Medicine is increasingly provided by care teams. Although there are 
clearly examples of how the actions of one clinician alone are 
critically important to quality outcomes, the preponderance of care 
experienced by most Medicare beneficiaries is the result of the actions 
of multiple clinicians and institutions. The Commission believes that 
coordinating care over time and across settings is one important key to 
a more effective and efficient Medicare program of the future. 
Measuring clinicians individually and on their own chosen measures 
undermines incentives to coordinate care broadly across the Medicare 
program.

Fourth, requiring clinicians to report annually multiple measures to 
CMS is burdensome, complex, and expensive. For 2017 (the first year of 
reporting under MIPS), CMS estimated that the cost for providers to 
comply with MIPS was more than $1.3 billion (Centers for Medicare and 
Medicaid Services 2016). CMS estimated that MIPS would require 
approximately $700 million in reporting costs in 2018 (Centers for 
Medicare and Medicaid Services 2017). For 2019, CMS did not provide a 
summary estimate for reporting costs (Centers for Medicare and Medicaid 
Services 2018b). Clinicians have already spent a substantial amount of 
financial resources and time to implement MIPS, and they will continue 
to do so. This is time and money that could be better devoted to 
patient care.

MIPS Is Not Succeeding

Based on the flaws in the design of MIPS, we expected that MIPS-based 
payment adjustments would be small in the first years of the program, 
providing little incentive for clinicians to improve. This expectation 
was confirmed by CMS's first year MIPS performance data, which showed 
that the maximum MIPS bonus a clinician receives in 2019 is 0.22 
percent. When the exceptional performance bonus is added, the maximum 
total bonus is 1.88 percent.

Almost all (93 percent) of clinicians who participated in MIPS are 
receiving a small positive adjustment in 2019 based on their 2017 
performance (Medicare Payment Advisory Commission 2019). Seventy-one 
percent of the clinicians qualified for a positive adjustment plus an 
exceptional performance bonus. CMS estimates that this trend will 
continue in payment year 2021, with about 90 percent of participating 
clinicians receiving a MIPS bonus and about 60 percent receiving an 
additional exceptional performance bonus (Centers for Medicare and 
Medicaid Services 2018b). Most participating clinicians receive a 
positive payment because of a number of policy decisions CMS has made 
to reflect a phased approach to MIPS implementation, which CMS refers 
to as ``Pick Your Pace.'' Specifically, CMS used its regulatory 
authority to:

      Set the MIPS performance threshold at 3 points (out of 100) for 
payment year 2019. Clinicians with a score above 3 are to receive a 
neutral or positive payment adjustment, and clinicians with a score of 
3 or below are to receive a negative payment adjustment. For payment 
year 2021, CMS has changed the performance threshold from 3 to 30 
points.

      Set the MIPS exceptional performance bonus threshold at 70 
points (out of 100) for payment year 2019 and 75 points for payment 
year 2021.

      Permit clinicians to meet the 3-point MIPS performance threshold 
by reporting minimal information on one quality measure (or attesting 
to one performance activity) in 2019.

      Weight the cost component at 0 points, so costs (i.e., resource 
use) do not affect MIPS payment adjustments in the first year. Costs 
account for 15 percent of the total performance score in year 3.

Because clinicians could choose which measures to report, most 
clinicians had very high performance scores overall in the first year 
of the program. Specifically, the mean performance score was 74 points, 
and the median performance score was 89 points, well in excess of the 
3-point threshold for a positive adjustment and the 70-point threshold 
for the exceptional performance bonus.

Under the statute, performance thresholds will eventually be set at the 
mean or median of clinician performance, and payment adjustments will 
increase substantially to 9 percent. Because clinicians will still be 
able to select the measures on which they expect to perform well, MIPS 
scores will continue to be very high and compressed around a high 
average. This means that small changes in scores will result in very 
large and unpredictable swings in payment adjustments, creating greater 
uncertainty and inequity, and potential rejection of the program by 
large numbers of clinicians.

The MIPS program is not succeeding in its goals of rewarding and 
penalizing clinicians based on performance. Subsequent legislation has 
delayed implementation of the higher performance thresholds to 2022. 
The Commission urges policymakers to use the intervening years to begin 
developing an alternative approach to measuring and rewarding value in 
clinician payment.

A New Direction for Rewarding Clinician Quality: A Voluntary Value 
Program

While the Commission believes MIPS is fundamentally flawed, we do 
believe that traditional Medicare FFS clinician payment should have a 
value-based payment component. Thus, we also recommended creating a new 
clinician value-based purchasing program--a voluntary value program, or 
VVP--to take its place (Medicare Payment Advisory Commission 2018b). 
The VVP recommendation reflects a conceptual direction (not yet a 
detailed design) for rewarding clinician quality in FFS Medicare 
according to the core quality principles developed by the Commission; 
future Commission work will explore more detailed specifications for a 
VVP.

The VVP would incorporate the Commission's quality measurement 
principles by measuring groups of clinicians (rather than individual 
clinicians, to address the ``small numbers'' problem) on a small set of 
population-based metrics--that would include measures such as 
readmission to the hospital and patient experience--that are important 
to the program and its beneficiaries, can be measured reliably, and can 
be applied across payment models and providers (Medicare Payment 
Advisory Commission 2018a). These types of measures would recognize 
that all clinicians have a role in affecting the health outcomes of 
their patients. The data required to calculate the measures would be 
generated from claims or surveys, substantially reducing clinicians' 
reporting burden. Moreover, this approach aims to align measures for 
clinicians with measures we have suggested CMS use in its other quality 
programs, creating the potential to send clear, transparent, and 
consistent signals to providers in all sectors. Participation in the 
program would be voluntary, and clinicians would elect their own group 
(e.g., independent practice associations, organized hospital medical 
staffs, or local medical societies), which could include specialists as 
well as primary care clinicians.

The VVP would encourage clinicians to think about how the care they 
provide contributes to the overall health outcomes of their patients, 
while also providing a transition for those who want to join A-APMs. 
This new direction would encourage care coordination among clinicians, 
focus quality improvement efforts on measures that are important to 
beneficiaries and Medicare, and relieve individual providers of the 
significant reporting burdens they face today and in the future. The 
VVP would also make quality measurement more equitable across different 
types of clinicians and improve the transparency of clinician quality 
of care for both the Medicare program and its beneficiaries.

Conclusion

MACRA made important improvements in how Medicare pays for clinician 
services. The Commission commends the Congress for repealing the SGR, 
which created uncertainty in Medicare payment for many years and 
contained poor incentives that rewarded volume of services. The 
Commission supports the elements of MACRA that move toward 
comprehensive, patient-centered care, including the establishment of A-
APMs. However, the Commission urges the Congress to move past MIPS, as 
it will not accomplish the shared goal of motivating providers to 
improve performance on cost and quality. The Commission looks forward 
to continuing to be a resource for the Committee as it deliberates on 
policies to promote high-quality clinician care at lower costs to 
beneficiaries and the program.

References

Centers for Medicare and Medicaid Services, Department of Health and 
Human Services. 2016. Medicare program; Merit-based Incentive Payment 
System (MIPS) and Alternative Payment Model (APM) Incentive under the 
physician fee schedule, and criteria for physician-focused payment 
models. Final rule. Federal Register 81, no. 214 (November 4): 77008-
77831.

Centers for Medicare and Medicaid Services, Department of Health and 
Human Services. 2017. Medicare program; CY 2018 updates to the quality 
payment program; and quality payment program: Extreme and 
uncontrollable circumstance policy for transition year. Final rule with 
comment period. Federal Register 82, no. 220 (November 16): 53568-
54229.

Centers for Medicare and Medicaid Services, Department of Health and 
Human Services. 2018a. Advanced alternative payment models (APMs). 
https://qpp.cms.gov/apms/advanced-apms?py=2019.

Centers for Medicare and Medicaid Services, Department of Health and 
Human Services. 2018b. Medicare program; revisions to payment policies 
under the physician fee schedule and other revisions to Part B for CY 
2019; Medicare Shared Savings Program requirements; Quality Payment 
Program; Medicaid Promoting Interoperability Program; Quality Payment 
Program--Extreme and Uncontrollable Circumstance Policy for the 2019 
MIPS payment year; provisions from the Medicare Shared Savings 
Program--Accountable Care Organizations--Pathways to Success; and 
expanding the use of telehealth services for the treatment of opioid 
use disorder under the Substance Use-Disorder Prevention That Promotes 
Opioid Recovery and Treatment (SUPPORT) for Patients and Communities 
Act Final rules and interim final rules. Federal Register 83, no. 226 
(November 23): 59452-60294.

Centers for Medicare and Medicaid Services. 2019. Independent 
evaluation of Comprehensive Primary Care Plus (CPC+): First annual 
report. Report prepared by Mathematica for the Centers for Medicare and 
Medicaid Services. Baltimore, MD: CMS.

Medicare Payment Advisory Commission. 2011. Moving forward from the 
sustainable growth rate (SGR) system. Letter to the Congress. October 
14.

Medicare Payment Advisory Commission. 2016a. Comment on CMS's proposed 
rule on the Merit-based Incentive Payment System and alternative 
payment models, June 15. http://www.medpac.gov/docs/default-source/
comment-letters/medpac-comment-on-cms-s-proposed-rule-on-the-merit-
based-incentive-payment-system-and-alternative-pa.pdf?sfvrsn=0.

Medicare Payment Advisory Commission. 2016b. Report to the Congress: 
Medicare and the health care delivery system. Washington, DC: MedPAC.

Medicare Payment Advisory Commission. 2017. MedPAC comment on CMS's 
proposed rule on CY 2018 updates to the Quality Payment Program, August 
18.

Medicare Payment Advisory Commission. 2018a. Report to the Congress: 
Medicare and the health care delivery system. Washington, DC: MedPAC.

Medicare Payment Advisory Commission. 2018b. Report to the Congress: 
Medicare payment policy. Washington, DC: MedPAC.

Medicare Payment Advisory Commission. 2019. Report to the Congress: 
Medicare payment policy. Washington, DC: MedPAC.

NORC at the University of Chicago. 2018. First annual report: Next 
Generation Accountable Care Organization (NGACO) Model evaluation. 
Report prepared by staff from NORC at the University of Chicago for the 
Center for Medicare and Medicaid Innovation. Bethesda, MD: NORC.

                                 ______
                                 
                      National Association of ACOs

                  601 13th Street, NW, Suite 900 South

                          Washington, DC 20005

We thank the committee for their work on the Medicare Access and CHIP 
Reauthorization Act of 2015 (MACRA) and for continuing to ensure the 
proper implementation of this landmark legislation. We appreciate the 
opportunity to provide comments on the recent Committee on Finance 
hearing, ``Medicare Physician Payment Reform After Two Years: Examining 
MACRA Implementation and the Road Ahead.''

The National Association of ACOs (NAACOS) is the largest association of 
accountable care organizations (ACOs), representing more than 5 million 
beneficiary lives through 330 Medicare Shared Savings Program (MSSP), 
Next Generation Model, and commercial ACOs. NAACOS is an ACO member-led 
and member-owned nonprofit working on behalf of ACOs across the nation 
to improve the quality of Medicare, population health, outcomes, and 
healthcare cost efficiency. Our members want to see an effective, 
coordinated, patient-centric care process.

The ACO model is a market-based solution to fragmented and costly care 
that empowers local physicians, hospitals, and other providers to work 
together and take responsibility for improving quality, enhancing 
patient experience, and reducing waste. The number of ACOs in Medicare 
has grown considerably in recent years and included nearly 650 ACOs in 
2018, covering 12.3 million beneficiaries. ACOs have been instrumental 
in the shift to value-based care and utilize cost-saving tools like 
telehealth to better reach their patient populations.

Therefore, we feel it is critical that Congress continue to guide the 
effective implementation of MACRA and the Quality Payment Program (QPP) 
by strengthening the role of Alternative Payment Models (APMs) as a key 
piece of the transition to a value-based payment system. As the premier 
APM, ACOs are focused on population health for the totality of patients 
they serve. We therefore urge Congress and the Centers for Medicare and 
Medicaid Services (CMS) take steps to ensure that the ACO program 
remains a robust, successful participation option for Medicare 
providers navigating both value-based care and MACRA. Our specific 
recommendations are as follows:
Quality Payment Program Recommendations

1. Extend the Advanced APM 5% Bonus for an Additional 6 Years

Eligible clinicians who participate in an Advanced APM \1\ and meet 
certain Qualifying APM Participant (QP) criteria will receive a 5% 
annual lump sum bonus from 2019-2024. Under the current statute, after 
2024, that bonus expires and QPs will instead only receive a 0.75% 
increase in Medicare Part B payments.\2\
---------------------------------------------------------------------------
    \1\ CMS identifies qualifying Advanced APMs annually. In 2019, CMS 
has identified 13 AAPMs. See CMS, ``Advanced Alternative Payment Models 
(APMs),'' available at https://qpp.cms.gov/apms/overview.
    \2\ The Medicare Access and CHIP Reauthorization Act of 2015 
(MACRA), Pub. L. 114-10(a)(2)(C)(20), enacted April 16, 2015.

While CMS projections of the number of eligible clinicians that meet 
the QP criteria have increased with each year of the program, the 
number remains low. In fact, the number is lower than Congress 
envisioned in 2015 when MACRA was passed; in a 2015 CMS Office of the 
Actuary report, published shortly prior to the passage of MACRA; that 
office asserted that 60 percent of physician payment would be through 
Advanced APMs by 2019. The reality has been much slower: in the first 
year of the QPP, CY 2017, CMS predicted between 9-16% of all eligible 
clinicians to become QPs. For the third year of the QPP, CY 2019, CMS 
estimates that between 17-21% of eligible clinicians will be QPs. Given 
the slow implementation of Advanced APMs, we urge the extension of the 
5 percent Advanced APM bonus for an additional 6 years to encourage 
adoption.

2. Lower or Remove the QP Thresholds

To become a QP, an eligible clinician must receive at least SO percent 
of their Medicare Part B payments or see at least 35 percent of 
Medicare patients through an Advanced APM entity at one of three 
determination snapshots during the year. In addition, 75 percent of 
practices need to be using certified EHR Technology within the Advanced 
APM entity. While certain eligible clinicians may also become a QP 
through the ``All-Payer and Other Payer Option,'' which is a 
combination of Medicare and non-Medicare payer arrangements such as 
private payers and Medicaid, this option has not been widely utilized. 
The current and future QP thresholds are challenging for providers to 
meet, resulting in less participation in Advanced APMs. Many providers 
already have difficulty meeting the current percentage threshold, which 
increased in performance year 2019. The 75 percent threshold that goes 
into effect for performance year 2021 is far too high for continued 
widespread and meaningful participation and will undoubtedly preclude 
many providers from obtaining QP status. To continue to increase 
participation in Advanced APMs, we urge Congress to modify the 
statutory QP thresholds such that CMS has discretion to set thresholds 
OR modify the payment amount threshold to be set at a lower level.

3. Address APM Overlap

As more APMs are rolled out, APM overlap within markets and provider 
organizations has occurred more frequently, and we have observed 
confusion in the marketplace regarding which APMs providers may 
participate, and when. While some APMs can complement one another when 
it comes to improved quality and other outcome-based goals, 
participation in more than one APM can result in conflicting financial 
incentives that undermine the objectives of those already in existence. 
APM overlap also adds administrative complexity and dilutes the savings 
opportunities for those already on the forefront of care redesign.

To address APM overlap, we recommend:

      i.  An independent review of all CMS APMs and how they overlap 
with one another, and a subsequent report back to Congress about APM 
overlap and how the agency is mitigating concerns related to overlap 
such that APMs support one another rather than conflict.

      ii.  CMS should be required to address how model overlap will 
work with each release of a new model. A market-driven approach should 
be prioritized, establishing methods for APMs to work together.

     iii.  CMS should be permitted to allow multiple program 
participants to keep the shared savings they have earned regardless of 
the existence of program overlap in instances where at least one of the 
programs is being tested by the Center for Medicare and Medicaid 
Innovation, under 1115A of the Social Security Act.

4. Modify the All-Payer Combination Option

The All-Payer Combination Option takes into account an eligible 
clinician's participation in Advanced APMs both with Medicare and other 
payers (including Medicare Advantage, Medicaid, and other commercial 
plans) when determining whether the eligible clinician meets the QP 
threshold. The All Payer Combination Option allows eligible clinicians 
to become QPs through participation in a combination of Advanced APMs 
and Other Payer Advanced APMs starting in the 2019 QP Performance 
Period. We recommend modifying the All-Payer Combination Option to be a 
Multi-Payer Combination Option to allow for increased participation of 
this option.

As currently structured, CMS requires providers to submit detailed 
information on all payers with which they have contracts. While there 
are an increasing number of opportunities to work with payers outside 
of Medicare on value-based arrangements, many payers do not yet offer 
APMs that meet CMS's definition of an Advanced APM. Accordingly, 
providers do not have ample opportunity to receive additional credit 
for their participation with those payers that do offer Advanced APMs. 
Effectively, being required to submit information on all payers, 
regardless of whether they offer Advanced APM opportunities, waters 
down Advanced APM participation with those that do offer Advanced APMs. 
We do not believe Congress's intent was to structure the All-Payer 
Combination Option in this manner, which does not meaningfully reward 
Advanced APM participation outside of Medicare. CMS has explained that 
the statutory language does not allow them to provide credit for 
Advanced APM participation with some payers while not factoring in 
payers that do not offer Advanced APM arrangements.

To remedy this problem, we urge Congress to modify the statute to base 
the All-Payer Combination Option on multiple payers without making 
providers have to meet a more difficult ``All-Payer'' threshold. This 
modification would change the All-Payer Combination Option to be 
additive in a way that it could only help APM entities meet QP 
thresholds when the entity is unable to do so strictly through Medicare 
APM participation.

5. Exclude MIPS Payment Adjustments From ACO Expenditures

NAACOS also continues to oppose the unfair policy whereby CMS counts 
MIPS payment adjustments as ACO expenditures. The current framework CMS 
has established will punish ACOs for their high performance in MIPS. 
NAACOS believes CMS should recognize all ACOs, including those in BASIC 
tracks, as Advanced APMs. However, because CMS continues to subject 
BASIC track Level A, B, C, and D ACOs to MIPS, these ACOs have no 
choice but to be evaluated under MIPS while continuing their focus on 
the ACO program goals. Most ACOs will perform very well under the 
established MIPS performance criteria and therefore earn bonuses under 
the program. These bonuses will then count against the ACO when 
expenditures are calculated for purposes of MSSP calculations. 
Therefore, the better an ACO and its clinicians perform in MIPS, the 
more they will be penalized when calculating shared savings for the 
ACO. This is an unfair and untenable policy, and CMS must modify its 
position to exempt MIPS payment adjustments as expenditures in the ACO 
program. CMS does make claim level adjustments by adding sequestration 
costs back to paid amounts when calculating ACO expenditures, therefore 
the Administration has the technical ability to make such a change. It 
was not the intent of Congress to penalize ACOs in MIPS, and therefore 
CMS must alter this policy to continue encouraging provider 
participation in the BASIC track of the ACO program. Therefore, we urge 
Congress to work with CMS to revise this flawed policy.

6. Discontinue Delays to MIPS Implementation

NAACOS is concerned that Congress and the Administration continue to 
make changes to MACRA to further dilute accountability for quality and 
cost performance for Medicare beneficiaries. In the Bipartisan Budget 
Act (BBA) of 2018, Congress provided CMS with additional flexibility to 
implement the performance standard for which clinicians were intended 
to be evaluated against. Additionally, the BBA included a provision 
allowing for CMS to further delay the incorporation of cost measurement 
in MIPS. Congress originally intended for cost to be a component of 
MIPS scores by 2021. CMS has already delayed incorporating cost in MIPS 
scores in 2019 and 2020 to provide clinicians with additional time to 
prepare. Further, for the 2018 performance year, CMS made the decision 
to exempt an additional 585,560 clinicians from the program, exempting 
an unprecedented number of clinicians from the performance requirement 
s altogether.

NAACOS fears that continuing to dilute performance requirements and 
exempting nearly half of providers will discourage those clinicians who 
have already made a commitment to value-based care and invested time 
and resources towards making the shift to value-based care. Instead, 
Congress and CMS should reward high-
performing clinicians who have invested heavily in performance 
improvement and should therefore be rewarded for this investment, time, 
and effort. While we support providing a phased-in approach to value-
based payments for Medicare, it should be noted that the Agency's 
legacy programs, from which the MIPS program was developed, have been 
in existence for years and therefore these clinicians have had ample 
time to prepare for these changes. It is critical that Congress and CMS 
continue their commitment to transition providers toward value-based 
payments to improve the experience of care and the health of 
populations and reduce per capita costs of health care.
Medicare Shared Savings Program Recommendations

7. Increase MSSP BASIC Track Shared Savings Rates

Current rates shared savings rates finalized under the Pathways rules 
are: Basic Levels A and B: 40%; Levels C, D and E: 50%. We urge 
Congress to focus its efforts on not only making models with downside 
financial risk more attractive, but also continuing to support shared 
savings-only models. It is essential that Congress structure the 
program such that it includes a business model attractive enough to 
retain current participants while bringing in new ACOs to create a 
pipeline for ACOs to advance on the path to value-based care.

We urge Congress to provide sufficient shared savings rates to MSSP 
ACOs to ensure an adequate return on investment and their continued 
participation in the program. Specifically, increase the shared savings 
rates to at least the following: Basic Levels A and B: 50%; Levels C 
and D: 55%; Level E: 60%.

8. Eliminate the MSSP High-Low Revenue Distinction

Under the Pathways to Success Final Rule, CMS created a new distinction 
between ``high revenue'' and ``low revenue'' ACOs. This distinction 
determines program specifics, including the timing for when an ACO must 
move to downside risk. Low revenue ACOs are allowed additional time 
under lower-risk options within the Basic track, while ACOs identified 
as high revenue are required to transition to the Enhanced track more 
quickly.

We urge Congress to eliminate this distinction for the following 
reasons. First, the distinctions are arbitrary--being ``high'' or 
``low'' revenue does not determine when an ACO is ready to take on risk 
or how much risk they are able to assume. As previously described, 
significant investments are needed in population health platforms and 
care process changes for ACOs to bear risk. The financial position and 
backing of a particular ACO, as well as the ability to assume risk 
depends on a variety of factors, including local market dynamics, 
culture, leadership, financial status, previous program success, and 
the resources required to address social determinants of health that 
influence care and outcomes for patients.

Second, the high and low revenue distinctions create unnecessary 
program complexity. Furthermore, the move creates uncertainty for ACOs 
who may have a difficult time predicting the category in which they 
would fall. This distinction may also change over time as ACO 
participant composition changes, adding more complexity and making 
long-term planning very difficult. Removing the distinction would 
minimize some of the complexity and uncertainty.

9. Provide More Time in Shared Savings-only Models and Keep the 
Enhanced Track Voluntary

Currently, CMS only allows ACOs entering the program on the Basic Track 
to be in a one-sided risk contract for two to three years. ACOs 
previously in the program can only be in a one-sided risk model for one 
year. CMS also expects Basic Track ACOs to eventually transition to the 
Enhanced Track and therefore take on the most downside risk.

While there should be movement towards risk, ACOs need more time to 
produce positive financial results and such a movement should be 
appropriate and reasonable to encourage participation in the MSSP which 
is a voluntary program. The levels of risk required in two-sided models 
such as the Enhanced Track are much higher than what many ACOs can bear 
and are not viable options for most ACOs. The decision to take on risk 
is critical to an ACO's choice about which model to select and having 
to potentially pay millions of dollars to Medicare is not feasible for 
many of these organizations. Requiring ACOs to assume downside risk may 
result in many ACOs dropping out of the MSSP, which is an unintended 
consequence and will immediately reduce incentives to help bend the 
cost curve in Medicare.

We urge Congress to allow MSSP ACOs to remain in a shared savings-only 
model for at least three years before being required to assume any risk 
and to not require any ACOs to participate in the Enhanced track. This 
increased timeline and enhanced flexibility related to risk will help 
ACOs better prepare to take on downside risk, increase participation, 
and lead to more successful outcomes.

10. Update the MSSP Risk Adjustment Methodology

CMS uses the CMS Hierarchical Condition Category (CMS-HCC) prospective 
risk adjustment models to calculate beneficiary risk scores, adjust the 
benchmark years used for the historical benchmark, and compute the 
rebased historical benchmark. Accurate risk adjustment is imperative to 
assess ACO performance, as risk adjustment should remove or minimize 
differences in health and other risk factors that impact performance 
but are outside the ACO's control. The risk adjustment cap finalized in 
the Pathways to Success rule allows up to a 3 percent increase over 
five years and should be increased. A risk adjustment methodology that 
allows risk adjustment scores to increase even more will give ACOs a 
better ability to meet their financial benchmarks. A downward cap 
should also be used, thus controlling for outliers on both ends of the 
spectrum. Further, Congress should require CMS to provide additional 
transparency on the risk adjustment methodology, which would allow ACOs 
to better understand the process and provide more certainty.

Specifically, Congress should:

      i.  Implement a risk adjustment methodology that allows risk 
adjustment scores to increase at least 5% over 5-year agreement period 
and apply a cap of up to -5% on downward adjustments.

     ii.  Require CMS to provide full transparency on the methodology 
(ex. algorithms) used in risk adjustment.

     iii.  Provide funding for an independent study comparing Medicare 
risk adjustment approaches across Medicare programs (including APMs and 
Medicare Advantage).

11. Modify the MSSP Benchmarking Methodology

There remain a number of flaws with the MSSP benchmarking methodology 
which must be addressed. Benchmarking is of the utmost importance to 
ACOs; it is a fundamental program methodology which determines how ACOs 
perform individually and is one of the ways CMS evaluates the overall 
success of the program.

Under the regional benchmarking methodology, CMS uses all ``assignable 
beneficiaries,'' including ACO assigned beneficiaries, in determining 
expenditures for the ACO's region. The determination of which 
beneficiaries are included in the regional population is very important 
as this population is the basis for calculating the regional 
expenditure data that is factored into benchmarks that include a 
regional component. Rather than comparing ACOs to themselves and other 
ACOs, CMS should compare ACO performance relative to fee for service 
(FFS) Medicare by defining the regional reference population as 
assignable beneficiaries without ACO-assigned beneficiaries for all 
ACOs in the region. At the very least, Congress should exclude the ACO 
itself from the region to prevent an otherwise tautological comparison 
that essentially double counts those ACO-assigned beneficiaries.

12. Allow NPI-level Participation in the MSSP

Currently, MSSP ACO participation is limited to participation at the 
Tax Identification Number (TIN) level (i.e., acute care hospitals, 
group practice, solo practice, long term care hospitals, skilled 
nursing facilities, etc.). Participants in MSSP ACOs are identified by 
their TIN number. Consequently, there is no option for MSSP ACO 
participation at the National Provider Identifier (NPI) level.

This limitation presents challenges for individuals who wish to 
participate in an ACO and practice in a group setting that does not 
participate in an ACO under its TIN. Because providers cannot 
participate at the TIN level as an individual unless engaged in solo 
practice, they cannot participate in the program. We recommend Congress 
allows NPI-level participation in the MSSP to increase opportunities 
for participation and provide greater flexibility across a wider range 
of providers.

13. Provide Upfront Payments to Help ACOs Get Started and Assist 
Providers That Have Difficulty Moving to Risk

Congress recognized the principle from the ACO authorizing statute that 
one of the purposes of creating ACOs is to ``encourage investment in 
infrastructure and redesigned care processes for high quality and 
efficient service delivery.'' ACOs require a significant amount of 
investment to develop the necessary infrastructure and effectively 
adjust to a different approach to care. These investments are for 
clinical and care management, health IT/population analytics/reporting, 
and ACO management and administration. Not only do such investments 
require a significant amount of time and money, but they also require 
organizations to incur a substantial amount of risk apart from any risk 
associated with strictly providing care. The cost of the necessary 
infrastructure and operating expenses may deter ACOs from starting up 
in the first place or continuing on the path to value, as there is no 
guarantee that the ACOs will earn back the expenses associated with 
such investments.

We urge Congress to provide greater support to ACOs by providing 
upfront and ongoing payments to assist with such investments and 
operating costs. CMS previously offered programs to help fund ACOs up 
front, with those payments later recouped via shared savings. These 
programs, such as the ACO Investment Model (AIM), should be reinstated 
to help ACOs fund activities and transformations early on in ACOs' 
development.

14. Increase the MSSP BASIC Track Shared Savings Rates Based on Quality 
Performance

Currently, an ACO that achieves CMS's established quality performance 
levels is not rewarded and is instead merely prevented from forfeiting 
the shared savings payments it has earned. There is no direct financial 
reward for improving quality of care and no penalty for poor quality 
unless the ACO has generated savings. This lack of reward can be a 
strong disincentive for ACOs to invest in quality improvement. Many 
efforts to improve the quality of care consume ACO resources and 
increase spending relative to the ACO's financial benchmark in the 
short term, even if they decrease Medicare spending over the long term. 
The more an ACO strives to improve quality performance, the more it 
often needs to spend. If the services used to improve quality are 
billable services, they will increase the ACO's spending and reduce the 
probability of beating its benchmark.

To emphasize and reward above average quality performance or 
improvement, we urge Congress to provide on a sliding scale up to 10 
percentage points of additional shared savings to ACOs scoring in the 
top half of total ACO quality performance or quality improvement. 
Additionally, we urge Congress to add a bonus opportunity for ACOs 
whose quality performance is exceptional, but did not meet criteria for 
shared savings. Adding this bonus opportunity will more appropriately 
incentivize quality improvement.
Conclusion
In closing, we appreciate the committee's attention to the important 
issue of monitoring implementation of MACRA. We hope you will consider 
these comments as you continue in your efforts to ensure a successful 
implementation of this critical law which has the power to truly 
transform Medicare payments to pay for value over volume of services 
provided to beneficiaries.

                                 ______
                                 
                              Premier Inc.

                444 North Capitol Street, NW, Suite 625

                          Washington, DC 20001

                             T 202-393-0860

                             F 202-393-6499

                      https://www.premierinc.com/

The Premier healthcare alliance appreciates the opportunity--to submit 
a statement for the record on the Senate Judiciary Committee's hearing 
titled ``Medicare Physician Payment Reform After Two Years: Examining 
MACRA Implementation and the Road Ahead'' scheduled for May 8, 2019. We 
applaud the leadership of Chairman Grassley, Ranking Member Wyden and 
members of the Committee for holding this hearing to examine the 
Medicare Access and CHIP Reauthorization Act (MACRA) of 2015 and assess 
how well that reform legislation is meeting its goals of improving 
quality of care and value for taxpayers.

Premier strongly supports the intent of MACRA's Quality Payment Program 
(QPP) to help fix the misaligned incentives in our traditional fee-for-
service Medicare program. Premier is an ardent supporter of the 
transition toward models where providers are accountable and rewarded 
for high-quality, cost-effective care.

Physician Incentives: Extending the AAPM Bonus

MACRA is designed to encourage clinicians to participate in alternative 
payment models (APMs) as a way to move from a volume-based healthcare 
system to a value-based system where healthcare providers organize to 
collaborate to deliver better outcomes. The Advanced APM (AAPM) bonus 
that was established by MACRA to accelerate this movement to value-
based care expires in 2024 (payment year 2022). This means that new 
accountable care organizations (ACOs) entering the Medicare Shared 
Savings Program (MSSP) Pathways to Success in July 2019 or January 2020 
do not have an opportunity to receive the AAPM bonus. MACRA was written 
with the assumption of the availability of additional AAPMs that would 
be eligible for the 5 percent bonus in OPP. While Premier is encouraged 
by the recent new models announced by the Center for Medicare and 
Medicaid Innovation, the rollout of new APMs, particularly models in 
which specialists can participate, has been slow.

To allow MACRA to work as intended, Premier urges Congress to extend 
the AAPM bonus at least six additional years, through payment year 2030 
(performance year 2028).

Giving CMS Authority to Adjust the QP Thresholds

Under MACRA; eligible professionals (EP) who meet certain revenue 
thresholds for participation in an APM are considered qualified 
participants. (QP) or partial qualified participants. QPs receive 5 
percent bonus payment on their services billed under the physician fee 
schedule and are exempt from MIPS; partial QPs do not receive a bonus 
but are exempt from MIPS unless they participate in MIPS. The 
thresholds to qualify for the AAPM bonus (QP thresholds) are set in 
statute for the payment threshold, but CMS has the authority to set the 
patient threshold. The thresholds increase every other year. Due to the 
lack of availability of AAPMs and the structure of these models, it 
will be increasingly difficult to meet the QP threshold. In the patient 
count method, CMS has adjusted the thresholds in response to MPM 
penetration and the type of models available. We urge Congress to also 
grant CMS the authority to adjust the payment thresholds.

In closing, the Premier healthcare alliance appreciates the opportunity 
to submit a statement for the record on the Senate Finance Committee 
hearing on MACRA. As an established leader in pay for performance, 
bundled payment and accountable care organization (ACO) models, Premier 
is available as a resource and looks forward to working with Congress 
as it considers policy options to address this very important issue.

If you have any questions regarding our comments or need more 
information, please contact Aisha Pittman, Senior Director of, at 
[email protected] or 202-879-8013.

                                 ______
                                 
                      Society of Hospital Medicine

                  1500 Spring Garden Street, Suite 501

                         Philadelphia, PA 19130

                           Phone 800-843-3360

                        www.hospitalmedicine.org

Dear Chairman Grassley, Ranking Member Wyden, and Members of the 
Committee, the Society of Hospital Medicine (SHM), on behalf of the 
nation's hospitalists, is pleased to offer our comments to the Senate 
Finance Committee regarding the recent hearing entitled, ``Medicare 
Physician Payment Reform After Two Years: Examining MACRA 
Implementation and the Road Ahead.''

Hospitalists are front-line clinicians in America's acute care 
hospitals whose professional focus is the general medical care of 
hospitalized patients. Their unique position in the healthcare system 
affords hospitalists a distinct perspective and systems-based approach 
to confronting and solving challenges at the individual provider- and 
overall institutional-level of the hospital. In this capacity, 
hospitalists not only manage the inpatient clinical care of their 
patients, but also work to enhance the performance of their hospitals 
and health systems. They provide care for millions of patients each 
year, including a large majority of hospitalized Medicare 
beneficiaries, and are national leaders in quality improvement, 
resource stewardship and care coordination.

Since the inception of the specialty of hospital medicine and the 
founding of SHM in the 1990s, hospitalists have been at the forefront 
of delivery and payment system reform. They are integral leaders in 
helping the healthcare system move from volume to value. Hospitalists 
from across the country are engaged in driving innovation aimed at 
achieving higher quality and lower cost care for their patients. As 
such, they are key leaders and partners in alternative payment model 
(APM) adoption, including bundled payments, the Medicare Shared Savings 
Program Accountable Care Organizations (ACOs), and managed care.

The Medicare Access and CHIP Reauthorization Act (MACRA) created two 
pathways to encourage providers to move away from Medicare fee-for-
service (FFS) billing: Alternative Payment Models (APMs) and the Merit-
based Incentive Payment System (MIPS). MACRA seeks to incentivize 
providers to utilize payment structures that focus on value, rather 
than volume, of care. We are very supportive of Congress' efforts to 
reform the FFS payment system and believe more must be done to drive 
innovation and align incentives for lower-cost, high quality care. 
Through our members' experiences in the first few years of the program, 
we have identified several concerns and provide suggestions below.

Barriers to Alternative Payment Model (APM) Adoption

MACRA seeks to incentivize providers to move away from fee-for-service 
(FFS) Medicare towards APMs. Qualified participation in an APM provides 
an exemption from the MIPS and a 5 percent lump sum incentive payment 
through 2024. In order to determine whether a provider qualifies for 
the APM pathway of MACRA, the law established thresholds of payment or 
patients. In 2019 and 2020, the thresholds are set at 25 percent of 
Medicare payments; 2021 and 2022 at 50 percent; 2023 and beyond at 75 
percent. For patient count, providers must meet generally similar 
thresholds in each year. Starting in 2021, the thresholds may be met 
through an all-payer analysis, though providers must still reach a 
minimum threshold of Medicare payments or patients. We understand the 
law specified these thresholds to ensure that providers are 
meaningfully engaged with the APM and have moved significantly away 
from FFS Medicare.

SHM believes that encouraging providers to move into APMs is the most 
important aspect of MACRA. We see APMs as the only pathway away from 
the costly FFS system. APMs are also important because they return a 
significant amount of control directly to providers. That said, the 
threshold model of APM participation creates a major barrier for many 
providers, leaving them stuck in traditional fee-for-service Medicare 
and the MIPS. Small fluctuations in patient mix can result in providers 
qualifying as APM participants one year and not the next. In addition, 
some of the APM models, such as Bundled Payments for Care Improvement 
(BPCI) Advanced, are condition-based, meaning generalists like 
hospitalists will be unable to collect enough payments or patients to 
meet the threshold. In the original BPCI, hospitalist participants that 
engaged with 12 different condition bundles in the model were unable to 
meet even the lowest thresholds set for the program.

We believe the thresholds serve as an impediment to meeting the intent 
of MACRA and, importantly, as a barrier to cost containment. Well-
designed APMs have the potential to save a significant amount of money 
for the Medicare Trust Fund, while the budget-neutral MIPS does not 
share the same potential. To save money, we must move more providers 
off of fee-for-service and onto APMs.

Rethinking Exclusions Under the MIPS

The Merit-based Incentive Payment System (MIPS) was developed to 
transition the traditional Medicare fee-for-service payment system into 
value-based payments. We have serious concerns about the effectiveness 
of the program, as nearly 60 percent of providers are completely exempt 
from the program under current Medicare policies. Since the MIPS is a 
budget-neutral program, the money used to incentivize high performers 
is taken from underperforming providers who are penalized. As more 
providers are exempted from the program, the pool of potential payments 
for high performing providers has decreased significantly. To ensure 
compliance in the MIPS, providers that are not exempt have had to 
invest significantly in data infrastructure, administration and 
reporting under the program. However, with such large numbers of exempt 
providers, the potential return on those investments are negligible. 
With so many providers exempt from the program, we also have serious 
concerns about the relevance and accuracy of data reflected by measures 
that are being reported in the MIPS.

CMS has indicated through rulemaking that they believe exemptions from 
the program are necessary because of concerns about the validity of 
data in measures with small case volumes and the financial burdens 
placed on providers for reporting. We believe these exemptions and the 
reasoning for them are evidence of serious structural flaws within the 
program. Policymakers should focus on refinements aimed at achieving a 
meaningful program that yields simple and actionable feedback for all 
Medicare providers.

Pay for Performance: Are We Measuring the Right Things?

Measurement has become a central feature of the Medicare system. The 
use of measurement in pay-for-performance programs is built around an 
assumption that measurement can lead to improvements in quality and 
reductions in cost. SHM agrees that well-designed measures have the 
potential to yield these outcomes and may be worth the time, work, and 
cost to implement. Looking at the MIPS, current policies create a 
complicated program with measures that give providers very little 
meaningful and actionable feedback. Providers spend a significant 
amount of time and money on reporting quality measures that may not be 
reflective of their entire practice or even report on most of their 
Medicare patients. Instead, they are participating in the MIPS as a 
compliance effort to avoid significant penalties.

We believe there is an ample opportunity to step back from siloed and 
micromanaged quality and cost measures and focus on developing 
indicators for the quality and safety of healthcare and on the general 
health and well-being of communities. Shared accountability between 
providers on these broad indicators will lead to the proliferation of 
local-level quality improvement and cost-reduction efforts. This 
systems-based approach, while it does not contain the most narrowly 
tailored measures to specific specialties or individual clinicians, is 
how patients view the healthcare system and is ultimately how providers 
must work together to improve quality and decrease costs. We believe 
the goal of the MIPS should be to point providers in the right 
direction by aligning incentives and having simple and clear markers 
that are shared across providers and specialties.

Policy and Definitions That Are Inconsistent With Practice Realities

Often, MIPS/MACRA definitions and policy does not align with practice 
realities. A clear example of this is an issue that facility-based 
providers, including hospitalists, are facing with the definition of 
hospital based group in the Promoting Interoperability (formerly 
Advancing Care Information) category of the Merit-based Incentive 
Payment System (MIPS).

Hospital-based providers are meant to be exempt from the Promoting 
Interoperability (PI) category in the MIPS. This policy acknowledges 
that these providers are working in settings that use Certified 
Electronic Health Record Technology (CEHRT) and participate as 
providers working in eligible hospitals in the Promoting 
Interoperability Program (formerly EHR Incentive Program). It prevents 
unnecessary duplication and excessive administrative burden practices 
that work primarily in the hospital. We note the policy is meant to 
account for how hospital-based providers are already doing work for 
their hospitals to meet similar or identical requirements in the 
eligible hospital Promoting Interoperability Program. Furthermore, it 
protects hospital-based providers from being penalized for factors 
outside of their control, since they do not always have full access to 
or influence over the CEHRT used in their facilities.

To determine whether a MIPS eligible clinician (defined as a unique 
Taxpayer Identification Number National Provider Identifier (TIN-NPI) 
combination) is exempt from PI as a hospital-based provider, the 
Centers for Medicare and Medicaid Services (CMS) uses a threshold of 75 
percent of covered professional services in Place of Service (POS) 
codes for off-campus outpatient hospital (POS 19), inpatient hospital 
(POS 21), on-campus outpatient hospital (POS 22), or emergency room 
(POS 23) during a 12-month determination period. If a MIPS eligible 
clinician meets or exceeds this threshold, they are exempt from the PI 
category and the category weighting is reallocated to the MIPS Quality 
category.

To determine whether a group is exempt as a hospital-based group, CMS 
has indicated that 100 percent of the eligible clinicians associated 
with the group must be designated as hospital-based during the same 12-
month determination period. This extremely restrictive definition is 
inconsistent with the overarching intent of the hospital-based PI 
exemption as it requires groups that have only a single provider whose 
billing deviates from the exemption to participate in PI. This does not 
only make sense in the real world of medical practice but is also 
resulting in many hospital-based providers being subject to unfair 
penalties that are not of their making and have nothing to do with 
their performance.

It is imperative that the MIPS policies and definitions reflect 
practice realities in order to make the program as relevant as possible 
to providers. We encourage the Committee to work with CMS and with 
stakeholders to identify areas where policy changes must be made to 
ensure practices are accurately represented and assessed under pay for 
performance programs.

Conclusion

The Society of Hospital Medicine looks forward to working with the 
Committee as it looks to achieve the shared goals of MACRA: higher 
quality care at lower cost. We stand ready to help craft policies that 
are not only easier for providers to understand, but also aim toward 
better accomplishing the stated intent of MACRA.

                                 ______
                                 
                      Society of Thoracic Surgeons

                   633 N. Saint Clair St., Suite 2100

                         Chicago, IL 60611-3658

                             (312) 202-5800

                          https://www.sts.org/

May 21, 2019

The Honorable Chuck Grassley        The Honorable Ron Wyden
Chairman                            Ranking Member
U.S. Senate                         U.S. Senate
Committee on Finance                Committee on Finance
219 Dirksen Senate Office Building  219 Dirksen Senate Office Building
Washington, DC 20510                Washington, DC 20510

Dear Senators Grassley and Wyden,

On behalf of The Society of Thoracic Surgeons, I write to thank you for 
hosting the May 8, 2019 hearing titled, ``Medicare Physician Payment 
Reform After Two Years: Examining MACRA Implementation and the Road 
Ahead.'' We appreciate your continued oversight on the implementation 
of the Medicare Access and CHIP Reauthorization Act (MACRA).

Founded in 1964, STS is an international not-for-profit organization 
representing more than 7,000 cardiothoracic surgeons, researchers, and 
allied health care professionals in 90 countries who are dedicated to 
ensuring the best surgical care for patients with diseases of the 
heart, lungs, and other organs in the chest. The mission of the Society 
is to enhance the ability of cardiothoracic surgeons to provide the 
highest quality patient care through education, research, and advocacy.

Merit-based Incentive Payment System (MIPS)

MACRA was designed to promote value (quality/cost) rather than simply 
rewarding physicians for the volume of service they provide. This means 
the Centers for Medicare and Medicaid Services (CMS) must be able to 
effectively measure quality. STS has been a pioneer in this space with 
the STS National Database (the Database) that recently received the 
John M. Eisenberg Patient Safety and Quality award from the National 
Quality Forum (NQF) and The Joint Commission. The Database, established 
in 1989, includes subspecialty registries for adult and pediatric 
cardiac surgery, mechanical circulatory support, and general thoracic 
surgery. Using data from the registry, STS has developed risk models 
and NQF-endorsed composite performance measures for all of its 
subspecialties and major procedures to help providers guide their 
improvement initiatives. These measures are the basis for the Society's 
highly successful voluntary public reporting program.

Unfortunately, none of this expertise is being utilized in the Merit-
Based Incentive Payment System (MIPS). As practices continue to 
consolidate, an increasing number of surgeons work under larger, multi-
specialty and often facility-based groups. Since these groups often opt 
to participate in federal quality reporting programs at the hospital or 
group practice level (i.e., at the Taxpayer Identification Number 
level), the individual clinicians in these practices are increasingly 
losing autonomy over the selection of measures and reporting mechanisms 
that are most relevant to their specific specialty and patient 
population. This arrangement means that cardiothoracic surgeons are not 
able to influence their own personal quality scores as their hospitals 
or groups may elect to report on quality measures that are 
insignificant or irrelevant to cardiothoracic surgery. This will result 
in a number of problems for physicians, patients, and the Medicare 
program:

    a.  MACRA was founded on the principles of promoting and 
incentivizing quality care throughout health care. However, without 
utilizing cardiothoracic surgery specific quality measures, CMS fails 
to incentivize quality in one of the specialties that has the largest 
impact on Medicare beneficiaries and is one of the largest cost centers 
in the Medicare program.

    b.  Without utilizing measures specific to cardiothoracic surgery, 
cardiothoracic surgeons are not able to quantify their value to their 
employers and may have their contribution to the overall performance of 
the hospital diminished.

STS has urged CMS to ensure that specialists, including physicians 
employed by hospitals or group practices, have the option to report on 
quality metrics that are germane to their practice. CMS has adopted a 
policy whereby physicians can report via multiple mechanisms and have 
their MIPS scores calculated based on the highest reported score. This 
policy fails to give adequate incentive for physicians to report on the 
quality measures that are most relevant to them. Until CMS levels the 
playing field and recognizes the value of true quality measurement, the 
MIPS program will fail to realize its purpose of incentivizing high 
value care.

Alternative Payment Models (APMs)

Medicare Claims Data
The Quality Payment Program (QPP) that was derived from the MACRA 
statute was intended to create value in health care. Indeed, the most 
valuable tool for patients who are interested in making proactive 
choices about their health care is value transparency. Fortunately, the 
Database already provides for quality transparency through STS Public 
Reporting online. If CMS were to adequately implement Section 105(b) of 
MACRA (Pub. L. 114-10), we would have access to Medicare claims data, 
or the cost denominator of the value equation. These datasets would 
also help us to develop and adequately benchmark novel APM concepts and 
advance the value proposition throughout the Medicare program. 
Unfortunately, the programs CMS has offered to implement that section 
of statute are not working.

Section 105(b) of MACRA requires CMS to provide Qualified Clinical Data 
Registries (QCDRs) with access to Medicare data for purposes of linking 
such data with clinical outcomes data and performing risk-adjusted, 
scientifically valid analyses and research to support quality 
improvement or patient safety. CMS initially decided not to issue 
rulemaking on this section of the law based on its assertion that QCDRs 
currently can request Medicare claims data through the Research Data 
Assistance Center (ResDAC) data request process. This position ignored 
the fact that Section 105(b) is intended to provide QCDRs with access 
to Medicare data for quality improvement purposes, not just clinical 
research, and that the broad and continuous access needed for quality 
improvement purposes is fundamentally different than the access to 
Medicare data for research purposes provided by ResDAC. In subsequent 
rulemaking, CMS decided to treat QCDRs as ``quasi-qualified entities'' 
for purposes of obtaining access to Medicare claims data for quality 
improvement, but maintained that QCDRs should use the ResDAC 
application process for research.

While we appreciate that CMS has made some effort to provide QCDRs with 
an alternative means of accessing Medicare data, treating QCDRs as 
quasi-qualified entities does not allow the type of access contemplated 
by Section 105(b) of MACRA. To perform data analysis for quality 
improvement purposes and patient safety, QCDRs require long-term and 
continuous access to large Medicare datasets so that they can better 
track clinical outcomes longitudinally. In drafting Section 105(b) of 
MACRA, Congress was aware of this need and, as such, specifically 
directed CMS to provide QCDRs with Medicare claims data. Qualified 
entity status lasts for only three years and continued participation in 
the program requires re-application by submitting documentation of any 
changes to the original application. If the re-application is denied, 
CMS will terminate its relationship with the qualified entity. In 
addition, Medicare fee-for-service files are released quarterly on an 
approximate 5.5 month lag. Qualified entities must pay for each set of 
data they receive, which can become cost prohibitive over time.

Further, the quasi-qualified entity program covers only the ``quality 
improvement'' portion of a QCDR's access to claims data. If the same 
QCDR wanted to facilitate research combining cost and claims 
information, that QCDR would have to submit a separate application to 
ResDAC. In fact, if the QCDR already had the claims data in question 
through the quasi-qualified entity program, it would still need to 
apply and pay ResDAC for the same data. The ResDAC application is 
duplicative, time-consuming, and costly, with a significant lag between 
application approval and delivery of data.

At the same time, every new payment model released by CMS and the 
Center for Medicare and Medicaid Innovation (the Innovation Center) 
includes a provision that hospitals and qualified participants should 
be able to access their own claims information and any additional 
information deemed necessary by the participant. Clearly, CMS 
understands the value of price transparency in health care, yet it is 
failing to implement statute that speaks to that purpose. If CMS is 
truly interested in using its existing authority to provide information 
on the value of health care to the Medicare population, it will take 
another look at how it is implementing Section 105(b) of MACRA. Absent 
that ideal scenario, CMS should provide claims data to the providers 
with a straightforward breakdown of inpatient costs, provider costs, 
post-acute care costs, home health costs, readmission rates, and costs. 
Given these data and local or regional (not necessarily national) 
benchmarks, providers (and patients) will have an idea where care can 
improve and where there are opportunities to improve efficiency. If 
benchmark prices from big data are created, the methodology employed 
should be clear and include relevant stakeholders in the development.
Physician-focused Payment Model Technical Advisory Committee (PTAC)
MACRA was founded on the principles of incentivizing value over volume. 
As such, considerable emphasis was placed within MACRA on development 
of and participation in alternative payment models (APMs). 
Specifically, Congress created the physician-focused payment model 
technical advisory committee (PTAC) to both improve transparency at the 
Innovation Center and increase the variety, efficacy and number of 
APMs, in hopes of maximizing the number of physicians and medical 
specialties able to participate. STS was prepared to offer a physician 
focused payment model (PFPM) to both the PTAC and the Innovation Center 
for consideration and implementation. Because of our unique resource--
the Database--we believed that we would be able to demonstrate to CMS a 
payment model capable of rewarding physicians for increasing the 
quality of care they provide and reducing resource use. Unfortunately, 
the APM pathway has become extremely complicated and difficult to 
navigate. According to legal review by the office of the Assistant 
Secretary for Planning and Evaluation, under current statute, PTAC is 
not able to provide technical assistance to stakeholders during APM 
development. Without this assistance, APMs eventually fail to navigate 
the complexities of getting a proposed APM from development through 
PTAC review and on to Innovation Center implementation. Although 
Congress attempted to address this concern with language added to the 
Balanced Budget Act of 2018, PTAC has indicated that it is still not 
able to provide technical assistance and data analyses to stakeholders 
who are developing proposals for its review. Additional technical 
corrections may be needed to provide the PTAC with more flexibility in 
this regard.
Bundled Payment for Care Improvement--Advanced (BPCI-A)
A notable success of MACRA implementation has been our recent 
collaboration with the Innovation Center on the development of quality 
measures for two episodes of care contained in BPCI-A. Unlike our 
experience with other APMs, staff from the Innovation Center 
proactively sought, and utilized feedback from stakeholders on how to 
adequately measure quality within a payment bundle. The result is that 
the Innovation Center is looking to implement episodes under BPCI-A 
that rely on clinical data registries for true quality reporting.

The failed mandatory Coronary Artery Bypass Graft (CABG) episode 
payment model (EPM) provides a perfect example of why this is so 
important. Under the proposed CABG EPM, CMS intended to use two quality 
measures: a patient assessment of care and all-cause mortality. It is 
understandable that CMS would identify these measures because they are 
easy to quantify with the tools they have available. However, they do 
not paint an adequate picture of quality. The mortality rate for CABG 
is already at 2%. We questioned how CMS planned to distinguish among 
EPM participants if 98% of them were already hitting the prescribed 
quality benchmark.

The proposed CABG episode under BPCI-A intends to offer a far more 
robust quality measure: the STS-developed CABG Composite Score. The STS 
CABG Composite Score is calculated using a combination of 11 measures 
of quality divided into four broad categories or domains. Importantly, 
the 11 individual measures and the overall composite measure 
methodology are all endorsed by the NQF and have undergone careful 
scrutiny by quality measure experts. The four domains are:

      Risk-adjusted mortality.
      Risk-adjusted major morbidity, which represents the percentage 
of patients who leave the hospital with none of the five most serious 
complications (often referred to as morbidities) of CABG-reoperation, 
stroke, kidney failure, infection of the chest wound, or prolonged need 
to be supported by a breathing machine, or ventilator. Some of these 
complications, such as stroke or kidney failure, are just as important 
to many patients as whether they survive the surgery, as these outcomes 
profoundly impact quality of life. Overall, based on data from the 
Database, about 85 percent of patients are discharged with no such 
complications.
      The percentage of CABG procedures that include the use of at 
least one of the arteries from the underside of the chest wall--the 
internal mammary (or internal thoracic) artery--for bypass grafting. 
This artery has been shown to function much longer than vein grafts, 
which can become blocked over time.
      How often all of the four medications believed to improve a 
patient's immediate and long-term outcomes were prescribed. These 
medications include beta-blocking drugs prescribed pre-operatively, as 
well as aspirin (or similar drugs to prevent graft clotting), and 
additional beta-blockers and cholesterol-lowering medicines prescribed 
at discharge.

Without registries, CMS did not have a way to effectively measure 
quality for CABG, one of the most common procedures performed in the 
Medicare population and therefore one of the major Medicare cost 
centers. By working together, we have been able to design an episode 
that should be able to more effectively demonstrate value.

Other

Electronic Health Records (EHR)
Data-blocking by electronic health records (EHR) vendors remains a 
significant barrier to the provision of high quality health care. 
Additional provisions included in the 21st Century Cures Act address 
lack of interoperability among EHRs but also between EHRs and clinical 
data registries. The recent proposed rules on interoperability did not 
provide great detail on how these data-sharing concerns will be 
addressed. We urge Congress to continue to carefully monitor this 
implementation, with special interest in how the practice of data-
blocking is inhibiting success under the QPP.
MIPS Payment Adjustments and APM Glide Path
We agree with many of the panelists who testified about their concerns 
that Medicare payments have failed to keep up with inflation. We are 
also concerned that, due to the way MACRA has been implemented, many 
physicians have not had an APM available to them so they could not 
benefit from the statutory bonus Congress created to facilitate 
physicians' transition to APMs. We agree that Congress should intervene 
to replace the upcoming physician payment freeze with positive payment 
updates under MIPS and extend the APM bonus so more physicians have the 
opportunity to transition to APMs.

We strongly disagree with the testimony that CMS should use a budget-
neutral approach that would increase payment rates for ambulatory E/M 
services while reducing payment rates for other services (e.g., 
procedures, imaging, and tests). We support the proposed E/M payment 
rate changes as proposed by the RVS Update Committee (RUC). As with any 
other rate changes, budget neutrality adjustments are required. We 
strongly urge the Senate Finance Committee to apply any budget 
neutrality adjustments across all specialties. Recent policy has 
continually favored primary care over other specialists (e.g., surgery, 
imaging and testing) to the detriment of these specialists. Our 
specialty society worked with primary care and others to help correct 
payment changes related to the work of all physicians. To favor primary 
care over other specialties in this circumstance would impact the 
integrity of the process. While we support primary care physicians and 
initiatives supporting them and their work, we do not support it at the 
expense of other specialists.

STS remains fully committed to improving the quality, safety, and 
efficiency of care for all patients. We had hoped that MACRA would help 
to move our healthcare system toward a value based system. However, we 
remain frustrated with the implementation of MACRA. We hope that 
Congress and CMS can work together to truly measure quality and allow 
for more alternative payment models that reimagine how health care is 
delivered. We look forward to working with you on this issue. Please 
contact Courtney Yohe Savage, STS Director of Government Relations, at 
[email protected] or 202-787-1230 should you need additional information or 
clarification.

Sincerely,

Robert S.D. Higgins, MD
President

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