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87–877—PDF 2013

S. HRG. 113–272 

REFORMING THE DELIVERY SYSTEM: THE CENTER 

FOR MEDICARE AND MEDICAID INNOVATION 

HEARING 

BEFORE THE

COMMITTEE ON FINANCE 

UNITED STATES SENATE 

ONE HUNDRED THIRTEENTH CONGRESS 

FIRST SESSION 

MARCH 20, 2013 

( 

Printed for the use of the Committee on Finance 

COMMITTEE ON FINANCE 

MAX BAUCUS, Montana, Chairman 

JOHN D. ROCKEFELLER IV, West Virginia 

RON WYDEN, Oregon 

CHARLES E. SCHUMER, New York 

DEBBIE STABENOW, Michigan 

MARIA CANTWELL, Washington 

BILL NELSON, Florida 

ROBERT MENENDEZ, New Jersey 

THOMAS R. CARPER, Delaware 

BENJAMIN L. CARDIN, Maryland 

SHERROD BROWN, Ohio 

MICHAEL F. BENNET, Colorado 

ROBERT P. CASEY, Jr., Pennsylvania 

ORRIN G. HATCH, Utah 

CHUCK GRASSLEY, Iowa 

MIKE CRAPO, Idaho 

PAT ROBERTS, Kansas 

MICHAEL B. ENZI, Wyoming 

JOHN CORNYN, Texas 

JOHN THUNE, South Dakota 

RICHARD BURR, North Carolina 

JOHNNY ISAKSON, Georgia 

ROB PORTMAN, Ohio 

PATRICK J. TOOMEY, Pennsylvania 

AMBER COTTLE, Staff Director 

CHRIS CAMPBELL, Republican Staff Director 

(II) 

(III) 

C O N T E N T S 

OPENING STATEMENTS 

Page 

Baucus, Hon. Max, a U.S. Senator from Montana, chairman, Committee 

on Finance ............................................................................................................ 1 

Hatch, Hon. Orrin G., a U.S. Senator from Utah ................................................. 16 

WITNESS 

Gilfillan, Richard J., M.D., Director, Center for Medicare and Medicaid Innovation, Centers for Medicare and Medicaid Services, Baltimore, MD ............. 3 

ALPHABETICAL LISTING AND APPENDIX MATERIAL 

Baucus, Hon. Max: 

Opening statement ........................................................................................... 1 

Prepared statement .......................................................................................... 23 

Gilfillan, Richard J., M.D.: 

Testimony .......................................................................................................... 3 

Prepared statement .......................................................................................... 25 

Responses to questions from committee members ......................................... 38 

Hatch, Hon. Orrin G.: 

Opening statement ........................................................................................... 16 

Prepared statement .......................................................................................... 56 

COMMUNICATIONS

Roundtable on Critical Care Policy ........................................................................ 59 

Wilson, Brandon G. ................................................................................................. 62 

(1) 

REFORMING THE DELIVERY SYSTEM: 

THE CENTER FOR MEDICARE AND 

MEDICAID INNOVATION 

WEDNESDAY, MARCH 20, 2013 

U.S. SENATE, 

COMMITTEE ON FINANCE, 

Washington, DC. 

The hearing was convened, pursuant to notice, at 9:35 a.m., in 

room SD–215, Dirksen Senate Office Building, Hon. Max Baucus 

(chairman of the committee) presiding. 

Present: Senators Carper, Casey, Hatch, Grassley, Crapo, Roberts, Thune, and Isakson. 

Also present: Democratic Staff: Mac Campbell, General Counsel; 

David Schwartz, Chief Health Counsel; Tony Clapsis, Professional 

Staff; and Karen Fisher, Professional Staff. Republican Staff: Kimberly Brandt, Chief Healthcare Investigative Counsel. 

OPENING STATEMENT OF HON. MAX BAUCUS, A U.S. SENATOR 

FROM MONTANA, CHAIRMAN, COMMITTEE ON FINANCE 

The CHAIRMAN. The committee will come to order. 

The great American inventor Thomas Edison often liked to challenge his colleagues by saying, ‘‘There is a way to do it better: find 

it.’’ Edison always looked to inspire fresh ideas to overcome any 

challenge. 

Today we are in need of new and innovative ideas for America’s 

health care system. We know there is a better way to deliver 

health care and to lower costs. We created the Center for Medicare 

and Medicaid Innovation to find it. 

Known simply as the Innovation Center, the Affordable Care Act 

established a national facility to inject government health care programs with some of the flexibility and creativity that the private 

sector enjoys. 

The Center comes with a simple mission: lower costs and improve quality. It does so by testing new payment incentives and 

employing creative methods of delivering care. If the Center develops a successful idea, Medicare and Medicaid work to quickly replicate it nationwide. If an idea is not successful, they go back to the 

drawing board and develop something different. 

In just a short time, the Innovation Center has produced results. 

According to the Congressional Budget Office, the investments in 

the Innovation Center are expected to generate a 13-percent return 

through 2019, and, in the decade after, the Center is expected to 

save taxpayers tens of billions of dollars. 

2 

The Innovation Center is already testing many promising ideas. 

These include Pioneer Accountable Care Organizations, groups of 

doctors across the United States who work together and coordinate 

their care to reduce costs. 

From Minneapolis to Maine, from Nevada to New York, these 

doctors are sharing lessons learned and best practices in an effort 

to provide better patient care. This is just one of the more than 30 

new programs that the Innovation Center has already introduced, 

impacting the lives of 5 million beneficiaries across all 50 States. 

Health reform included specific ideas for the Innovation Center 

to test. We also knew that tapping into Americans’ ingenuity and 

entrepreneurship could lead to ground-breaking ideas on how to 

improve the health care delivery system. 

So we told the Center to ask Americans for their ideas on how 

to improve the quality of care without increasing costs, and, as an 

incentive, the Center would provide grants to test the most promising models. One company that answered the call is the online 

clinic, Health Link Now. 

Recognizing the challenges that rural communities face in accessing mental health care, Health Link Now will partner with local 

hospitals and doctors in Montana and in Wyoming. They will provide mental health care through secure video-conferencing and 

interactive technology. 

Patients in even the most rural areas, like Troy, MT, population 

933, can now access quality care if needed. This initiative is expected to lower costs through reduced hospital admissions and 

emergency room visits while increasing access to care in rural communities. If proven successful, it will likely be replicated across 

rural America. 

This is just one example of the type of revolutionary ideas the 

Innovation Center is supporting. Some of the tested models will be 

successful, others will not, but we cannot be afraid of missteps. We 

must continue trying new ideas, learning from mistakes, building 

on our successes. That is how we find what works. 

We also need Medicare and Medicaid to develop programs faster 

than they have in the past. In 2003, Medicare partnered to create 

a demonstration project in which hospitals in 26 States, including 

St. James Healthcare in Butte, St. Vincent Healthcare in Billings, 

and Holy Rosary Healthcare in Miles City, MT, would receive 

bonus payments based on the quality of care delivered. From 2003 

to 2009, the demonstration project is estimated to have saved thousands of lives, including 8,500 heart attack patients. 

Seeing the success of this demonstration project, Congress used 

it as a model to create a program where Medicare rewards all hospitals across the Nation for high-quality care. It also penalizes hospitals that produce poor outcomes. That program began this year. 

In many ways, the 2003 demonstration project set a new standard. It was developed in stages, with close public/private collaboration, but it took too long. We cannot wait a decade to develop a 

model and then implement it nationally. We need to cut through 

red tape much more quickly. 

We need to allow proven ideas to ramp up and spread rapidly 

without waiting for Congress to act. That is what the vision of the 

3 

Center’s task is. It can broadly deploy demonstration projects that 

are proven to reduce spending or increase quality. 

This will allow us to test, evaluate, and then integrate new ideas 

nationwide in only a few years instead of a decade. I look forward 

to examining the progress that the Center has made. We are here 

to ask questions. We want to hear about different models tested, 

we want to hear which projects are the most promising, and we 

want to know when we are going to see results. 

We are going to need a bold vision if we are going to get health 

care costs under control, so let us act boldly. Let us realize there 

is a way to do it better when it comes to health care costs, and, 

as Thomas Edison said, let us find it. 

[The prepared statement of Chairman Baucus appears in the appendix.] 

The CHAIRMAN. Senator Hatch is not here yet, so I will just introduce you, Dr. Gilfillan. Why don’t you proceed? As most people 

know, you are the Director for the Center for Medicare and Medicaid Innovation. Doctor, your full statement will be in the record, 

and I would urge you to summarize and get to the point in about 

5 minutes. We look forward to hearing from you. 

I might say, I think you are doing great work. I would just encourage you to keep at it. 

STATEMENT OF RICHARD J. GILFILLAN, M.D., DIRECTOR, CENTER FOR MEDICARE AND MEDICAID INNOVATION, CENTERS 

FOR MEDICARE AND MEDICAID SERVICES, BALTIMORE, MD 

Dr. GILFILLAN. Chairman Baucus, Ranking Member Hatch, committee members, thank you for the opportunity to discuss the Innovation Center’s progress. I am a family physician by background, 

and I practiced in rural Massachusetts and urban New Jersey. Before joining CMS, I was an executive at the Geisinger Health System in Pennsylvania. While there, I worked with colleagues to develop new primary care and episode-based payment models and 

tools for ACO development. 

During that experience, I saw how innovative approaches to delivering high-quality care at a lower cost can make a real difference 

for patients and their families. Marie, a high-risk patient in a medical home program there, had previously been hospitalized frequently. Through that model, Marie gained access to a case manager who helped her better manage her medical conditions and 

avoid frequent trips to the ER. 

Marie described the program simply by saying, ‘‘The idea of the 

program is to keep me healthy, keep me out of the hospital, and 

keep costs down. I don’t think I would still be here without this 

program. It has been my lifeline.’’ 

Care like this is the promise of delivery system reform and the 

potential answer to the challenging problems we face in our health 

care system. In all of our work at the Center, we are focused on 

creating care models that improve outcomes, as this one did for 

Marie, because that is the way to make care more affordable and 

accessible for all Americans. 

We must find new care and payment models that reward and 

support providers in delivering high-quality, coordinated, and efficient care, not simply for providing more services. Today, I am 

4 

pleased to report on our progress at the Center for Medicare and 

Medicaid Innovation. 

Our job is to test new models of care delivery and payment that 

reduce costs and improve quality by changing the incentive structure of our payment systems to emphasize care coordination, improved quality outcomes, and reduced total cost of care. 

In short, to accelerate our movement to a health care system 

with better outcomes and lower costs, we must accelerate the 

movement of CMS, and indirectly other payers, from being fee-forservice payers to becoming value-based purchasers of health care 

through the new models we are testing. 

The resources provided in the Affordable Care Act have allowed 

us to build on the excellent existing CMS capabilities to test more 

models on a larger scale to get more rapid results. Right now we 

are working on three dozen models that support 50,000 health care 

providers who are serving more than 1 million Medicare, Medicaid, 

and CHIP beneficiaries, as well as many private patients. We believe these models will result in better coordinated care, improved 

quality outcomes, and reduced total costs of care. 

Examples of these new service and payment models that reward 

providers for delivering high-quality, coordinated care and improved outcomes include our Comprehensive Primary Care Initiative, a multi-payer test of care management expenses to primary 

care physicians; our Pioneer Accountable Care Organization model, 

a multi-payer test also testing advanced Shared Savings incentives 

for larger, experienced groups of providers; and our Bundled Payments for Care Improvement Initiative, which is a model to test 

payment of a global episode fee instead of fee-for-service payments 

for specific procedures and conditions. Each of these models is directly supporting the re-designing and the re-engineering of care to 

deliver these outcomes. 

From our work on these and other models, we have already 

learned that providers and other stakeholders are eager to redesign care and participate in models that reward quality and coordination and decrease costs. States and private payers are committed to working with us as well. 

We also know that there is no one simple solution. We must test 

a broad range of models. Of course we are all eager to see the results of these models, but we need to be realistic. This change is 

difficult. Some models will work, and some will not. It will take 

time to see the improvements we are after. 

We will see signs of change in some metrics early on, but measures of broader impacts, such as the total cost of care, will take 

longer. To get accurate information, we must give each project sufficient time for claims to come in and quality outcomes to emerge. 

We are currently analyzing the first year of data from two primary care projects, the Multi-Payer Advanced Primary Care Practice and the Federally Qualified Health Center Advanced Primary 

Care Practice Demonstration. We will also see first-tier results 

from the Pioneer ACO model this summer. We will be able to start 

sharing interim results with Congress within the year and start 

giving recommendations for payment or care changes within the 

next 2 years. 

5 

The good news is that providers are responding positively to the 

many portions of the Affordable Care Act that support these efforts 

to improve care, such as value-based purchasing. Delivery system 

transformation to a more sustainable, higher-quality system is 

clearly under way across the Nation, and it is coming from grassroots providers in their communities who understand the need, the 

imperative, to improve our system. 

More than 250 ACOs, including the 32 ACOs in models developed by the Innovation Center, are now operating in the Medicare 

fee-for-service program, serving more than 4 million Medicare 

beneficiaries. Early national data is starting to show the effects of 

this focus on improving care coordination, improved quality of care, 

and the total cost of care. 

After more than 5 years of holding steady, the rate of all-cause 

hospital readmissions is starting to trend downwards. In addition, 

the rate of growth in per capita Medicare spending has been at historic lows for 3 years in a row. We look forward to seeing which 

models and demonstrations will provide the results our health care 

system and the people we serve need. I am happy to answer your 

questions. 

The CHAIRMAN. Thank you, Doctor. 

[The prepared statement of Dr. Gilfillan appears in the appendix.] 

The CHAIRMAN. The bottom line is, I think most of us—at least 

I am—are concerned about making sure we are getting value for 

our buck in terms of the Act, that is, that the Center actually does 

produce results. You mentioned that it takes time. That is true, it 

does take time. 

But at the same time, people, at least in Congress, are going to 

be a little bit impatient. They are going to want results that are 

quantifiable, demonstrable, that you can identify, put your finger 

on, and see, not just grand goals and platitudes. So what can you 

tell us? You mentioned you would have some results in a year, 

other results in a couple of years. 

What can you tell us here that kind of makes us more comfortable that we are actually going to get demonstrable results so 

this whole effort is worthwhile? It sounded good when we put it together in the Act, but now we are trying to find out whether in 

practice it makes sense. So give us some numbers that make us a 

little more comfortable that you can actually get the work done 

where these proposals will produce results. 

Dr. GILFILLAN. Certainly, Chairman Baucus. We are, as I said, 

now looking at some of the first-year results from some of our early 

programs in primary care. It takes time for all of these programs 

to—number one, programs have to start putting new care models 

in place, then they need to start measuring results. We need to see 

results over time so that the information we receive and analyze 

is complete. 

Typically, for models like this, it will take us 12 months of experience with the new model operating, and then 3 months after that 

12-month period to get the claims in-house into the system so we 

can analyze them. That is what we are doing right now with the 

two models that I mentioned for primary care. We are starting to 

see some signs, and I can share with you a couple of data points. 

6 

We want to make sure though that, as we do this analysis, it 

produces complete and accurate, dependable information. We can 

see now, as we look at data from the State of Vermont, that it appears that the trend, the rate of increase in cost for the total cost 

of care, looks like it is below what was expected. So it does appear 

that there is some early evidence of bending the cost trend from 

the medical home program that we have there. 

In the State of North Carolina, we are seeing some improvement 

in the rates of hospitalization, that is, the frequency with which 

Medicare beneficiaries are being admitted to the hospital and the 

frequency with which they are visiting the emergency room. 

These are two types of data that we are looking at very closely 

in all of our models: high-level data looking at the total cost of care 

and looking at quality measures and outcomes, and then more 

granular, more detailed measures of the actual experience, such as 

how often people go to the emergency room of the hospital. 

We are working hard. In each of our models, we have established 

a rapid-cycle evaluation group, Senator, that allows us to watch 

these results on a quarterly basis. As they become complete, as we 

get that data to a point where we feel it is accurate and complete, 

then we will share those results with you. 

The CHAIRMAN. I appreciate that. I have another question that 

I am curious about. The premise behind the ACA was to move 

away from volume-based services, fee-for-service, and push toward 

reimbursement based more on quality. 

One question is, do you think that, based upon your work, that 

premise, that assumption, is still valid, and should we still work 

in that direction? The second is, as you, I am sure, know, Time 

magazine published an article that is getting a lot of currency. I 

read it last weekend. 

I am just curious of the degree to which some of these delivery 

system reforms and some of your work at the Center can get at 

some of the problems pointed out in that article, namely how 

charges are based on this Charge Master in hospitals, and how, at 

least according to the author, many people are over-paying because 

the Charge Master sets rates much higher than the actual costs of 

the devices, the Durable Medical Equipment, or whatnot. So the 

question is the degree to which your work will get at some of those 

problems mentioned in that article. 

Dr. GILFILLAN. Thank you for that question, Chairman Baucus. 

It was quite an interesting and revealing article that talked about 

many of the issues those of us who have been in health care for 

a long time have been concerned about. 

To your first question, we believe that the underlying ideas in 

the Affordable Care Act regarding the need to transition from feefor-service-based payment approaches to more value-based payment approaches is still correct, and I think it has gained greater 

acceptance throughout the country. I think what we are seeing is 

a real commitment from providers to engage with CMS and with 

their private payers to pursue these alternative approaches to reimbursement. 

The article in Time spoke largely about the effect of charges on 

either commercial payers and rates of premium that people end up 

7 

paying through private payers or, even more unfortunately, the impact that they have on individuals who may not have coverage. 

I think we are seeing in our models, where we are working closely with other payers, that there is a real opportunity to change the 

way private payers are paying providers as well, and some engagement from providers and being willing to engage with them on 

that. 

So, I would be hopeful that, with the increased coverage that we 

are likely to see in 2014, the ability for more people to access negotiated rates that are paid by commercial payers, or the rates paid 

by government payers, we will see less impact from charges and we 

will see the gradual move on the private sector side from payments 

based on charges, such as were referred to in the article, to payments based on value produced, as you have stated. 

The CHAIRMAN. Thank you. My time has expired. 

Senator CARPER. Mr. Chairman? Mr. Chairman? I need to go 

chair a hearing on Sandy recovery in Homeland Security and Governmental Affairs. Could I have just 30 seconds to say something 

very briefly? 

The CHAIRMAN. Absolutely. 

Senator CARPER. Would my colleagues indulge me? 

The CHAIRMAN. I am sure they will for 30 seconds. 

Senator CARPER. Dr. Gilfillan, thank you so much for assuming 

these responsibilities for our country. The work that you are doing, 

the work at the Innovation Center, is just so important. It is exciting, it is essential. We are going to be debating in the next 36 to 

48 hours how to get better health care results for less money, especially with respect to Medicare and Medicaid, and what you and 

other folks are working on across the country is just critical. 

Our neighbor to the north is Pennsylvania. You ran Geisinger up 

there. I have been up to visit your facility and was just really impressed with what you are doing there and some of the lessons that 

we can learn, so thank you for doing this work. 

The chairman is trying to impart a sense of urgency, and that 

is a sense of urgency that I think we all share. Thank you. 

Dr. GILFILLAN. Thank you, Senator. I think I can say for all of 

our team, it is a real honor and a privilege to be involved in the 

work here at CMS and throughout the administration and the 

health care system to build on the work that was done in the Affordable Care Act. 

The CHAIRMAN. Thank you. 

Senator Crapo? 

Senator CRAPO. Thank you, Mr. Chairman. 

Dr. Gilfillan, I appreciate your work and appreciate you being 

here. I also appreciate hearing that CMS is taking an innovative 

approach to dealing with our Medicare issues. As the chairman referenced, we regularly are told from many different sources that we 

have to get away from focusing on volume and on to focusing on 

quality. The problem is, how do we do that? You are here to give 

us those answers. 

Physicians should be able to manage the care of their beneficiaries in a way that rewards them for quality, which is why I 

supported things like—well, various programs that promote flexiVerDate Nov 24 2008 17:27 May 16, 2014 Jkt 000000 PO 00000 Frm 00011 Fmt 6633 Sfmt 6633 R:\DOCS\87877.000 TIMD
8 

bility and quality rewards for health care experts, like the Accountable Care Organizations. 

I was also pleased to see that the dialysis community also accessed this integrated care program with the new End-Stage Renal 

Disease Care Initiative formation. I am told that, under this model, 

the dialysis clinics and nephrologists can access more expensive patients, those with multiple diseases and co-morbidities, and the 

care in the Medicare program. 

My question is, can you explain to me how these two models, the 

Accountable Care Organization on the one hand and the new 

ESRD Care Initiative, will work together and how new patients are 

attributed to each? 

Dr. GILFILLAN. Senator, thank you for that question. Yes, that is 

a great question. One of the things that we are working on at CMS 

in pursuit of all these models is to build the operational infrastructure that is needed to operate in this new way, needed to operate 

in a value-based world. 

This goes right to the heart of that question, and we have built 

the operational capacity and ability to distinguish patients who 

were aligned with one ACO or one program versus another. It has 

been something we have worked hard on over the past 2 years. 

There are rules that we will use to decide who the most likely provider of care to a particular patient is and, as were laid out actually in the Shared Savings regulations, we look at the experience 

of that patient to see who has provided the most care. 

In this case, while some patients were aligned with Pioneer 

ACOs or Shared Savings ACOs, the vast majority of ESRD patients, End-Stage Renal Disease patients, were not aligned with 

those ACOs. We expect that we will be able to use our computer 

systems that we have built to actually identify a distinct set of patients for the ACOs and a distinct set of patients who will be obtaining most of their care from their dialysis provider or their 

nephrologist and actually align them appropriately with the provider of their care. 

Senator CRAPO. Thank you. Will the beneficiaries with ESRD be 

assigned first to the new ESRD-specific program and then to the 

primary care ACOs? 

Dr. GILFILLAN. Senator, they will not be. They will not be assigned to two of the programs; they will only be assigned to one. 

Those who are assigned already to the Pioneer or Shared Savings 

ACOs will remain with those. Those who will be aligned through 

our analysis with the dialysis provider will be assigned there and 

will not be eligible for assignment into ACOs. 

Senator CRAPO. All right. Thank you. 

Thank you, Mr. Chairman. 

The CHAIRMAN. Thank you, Senator. 

Senator Isakson? 

Senator ISAKSON. Thank you, Mr. Chairman. 

Thank you for your work, Dr. Gilfillan. I appreciate it very much. 

I have a question that actually popped into my head while you 

were talking. I am one who talks about fee-for-service all the time, 

and I commend the movement away from that and the movement 

towards reimbursement based on quality. But it seems to me, in 

the debate on the Accountable Care Organizations and in some deVerDate Nov 24 2008 17:27 May 16, 2014 Jkt 000000 PO 00000 Frm 00012 Fmt 6633 Sfmt 6633 R:\DOCS\87877.000 TIMD
9 

cisions that have been made by CMS, there has been a total move 

away from home health care to drive people more to hospitals than 

home health care services. 

I represent a State that has a major metropolitan area, Atlanta, 

but we also have a huge rural area where there is not a physician 

in the county, much less a hospital. Home health care, particularly 

for the elderly, but in long-term recovery, is a better environment 

and a less expensive environment for a patient to be healed in than 

a hospital is. Have you all done any analysis of some of the decisions that have been made to drive the reimbursement rates on 

fee-for-service for home health care way down to move people into 

hospitals, which are far more expensive? 

Dr. GILFILLAN. Senator Isakson, thank you for that question. We 

could not agree more with you that it is always better for a patient 

to obtain care in the least restrictive, least clinical, intense setting 

as possible. So, whenever care can be provided in a home, we think 

that is a good thing to do, assuming it can be done safely and effectively. 

We have established some models that emphasize more, we 

think, home care, certainly our ACO programs, our Comprehensive 

Primary Care Initiatives. All of our primary care initiatives are 

very much oriented to using home care services as much as possible, avoiding unnecessary hospital services, so there is great incentive to do that. 

We also, in our Bundled Payments for Care Improvement Initiative, through the use of episode-based payments, have created conditions in which hospitals, other providers working closely with 

home care providers, and other post-acute providers, can design 

care in a way that is most effective and delivers the best outcomes. 

So we think, more and more, we will see services provided in the 

home as a result of the models that we are testing. 

Senator ISAKSON. Well, I am glad to hear you say that, because 

I have had a personal experience with one of my children many 

years ago where they were recovering over an extensive period of 

time, and the home health care, from the standpoint of the mental 

health of the patient, is far superior to long-term hospitalization in 

many recoveries. 

I think there are some people—some people; I am not speaking 

about you—who are driving people away from home health care 

and into hospitalization, which is less good for the patient’s mental 

health and much more expensive in terms of reimbursement. So, 

thank you for that answer. 

The second question. Ten billion dollars is a lot of money. That 

is your authorization over a decade. Last November, GAO reported 

that several programs funded through CMMI were potentially duplicative or overlapping with other initiatives that CMS is currently undertaking. What specific steps are you taking to ensure 

that work is coordinated and that duplication does not take place? 

Dr. GILFILLAN. Thank you, Senator. The GAO report did speak 

to, I think, three areas where there may have been duplication, or 

they thought that it was possible. They identified the specific activities that we had put in place to ensure that there was coordination, and they ranged from daily interactions with the Innovation 

Center team, with the Centers for Medicare and Medicaid Services, 

10 

and with the Center for Clinical Quality Standards. So we are 

working throughout CMS to ensure that we coordinate well. The 

other area that was identified in the GAO report was the potential 

overlap with activities of the Quality Improvement Organizations, 

the QIO program. We have reviewed all of the potential overlap situations between our QIOs and the hospital engagement networks 

from our Partnership for Patients Program. 

We have created plans for any hospital where both organizations 

could potentially overlap so that they are coordinating and ensuring that there is no duplication of services or payments. So it is 

something we pay attention to regularly. We meet at the highest 

levels of CMS to review potential duplication and avoid that and 

ensure that the programs are synergistic and complementary. 

Senator ISAKSON. Well, that is very important. Quite frankly, 

Congress is guilty of the same type thing. We have far too many 

duplicative appropriations in different departments where we could 

find a lot of savings if we would take time to look, so I am glad 

you paid attention to that report and are taking a look at it. Thank 

you for your service. 

Dr. GILFILLAN. Thank you, Senator. 

Senator ISAKSON. Thank you, Mr. Chairman. 

The CHAIRMAN. Thank you, Senator. 

Senator Grassley, you are next. 

Senator GRASSLEY. Thank you very much. 

I am sorry I did not hear your testimony. I had to be at another 

place. 

I have a question about the GAO’s November report raising questions about CMMI activity overlapping with the CMS offices. Specifically, the GAO identified three key examples of overlap between 

the 17 Innovation Center models and the efforts of other CMS offices. CMS’s response to this overlap was calling the work complementary to each other. At the same time, CMMI has a designated funding stream of $10 billion between 2010 and 2019. 

So, as everyone is acutely aware, we are in the middle of sequestration. Agencies have been told to scale back and be smarter with 

the dollars. So my first question to you is, do you think it is appropriate for CMMI to be operating models that clearly overlap with 

existing programs at CMS, and was there a good policy reason for 

choosing models that overlapped so closely with existing CMS initiatives? 

Dr. GILFILLAN. Thank you, Senator Grassley. The GAO report 

identified those three areas to include ACO activity, possible overlaps with Medicaid activities, and possible overlap between the 

Quality Improvement Organizations and the Partnership for Patients’ Hospital Engagement Networks. 

As they pointed out in the report, we have established mechanisms to ensure that there is not duplication in each of those programs. We did improve the coordination and address the specifics 

of overlap in the QIO and Partnership for Patients programs, and 

completed the work that they suggested in December. 

One of the things we have learned, Senator—and we have heard 

loud and clear from stakeholders around the country—is that not 

one model works for everyone, that there are provider organizations that are experienced in delivering more coordinated care, havVerDate Nov 24 2008 17:27 May 16, 2014 Jkt 000000 PO 00000 Frm 00014 Fmt 6633 Sfmt 6633 R:\DOCS\87877.000 TIMD
11 

ing done it for years in Medicare Advantage programs, and they 

were interested in having a more advanced program. The Pioneer 

program was the result of that. 

We had people from around the country come to us in the earliest days of the Innovation Center, asking for a more advanced, 

higher opportunity program for ACOs. So we developed that program specifically for that segment of the delivery system that was 

more advanced and was requesting it. 

Similarly, we had heard input from other physicians in rural 

communities about their concerns about being able to participate in 

the Shared Savings Accountable Care Organization program, because they were concerned they did not have sufficient capital to 

make the investments. 

So we established the Advanced Payment ACO program, which 

supports small physician Accountable Care Organizations and Accountable Care Organizations from rural communities. As a result 

of those activities, we ended up with 40 Advanced Payment ACOs, 

seven of which are actually from rural communities and 33 that 

are physician-based Accountable Care Organizations. 

So, Senator, we think there is good reason for developing programs that sound initially like they might be overlapping or duplicative but really represent the attempt to mix or match the richness, the diversity of the delivery system, and the requests we have 

had from stakeholders to create paths to this new care model for 

all different types of providers. 

Senator GRASSLEY. All right. Well, put me down for being a little 

cynical about it. I think that you have answered in good faith, so 

I do not question your intent. But, in 3 to 5 years, when you might 

be called back here to testify during an evaluation phase, are you 

comfortable that you will be able to justify that those $10 billion 

were spent in truly separable projects, because that is going to be 

a lot of taxpayers’ money that we are wagering? 

Dr. GILFILLAN. Senator, we take financial accountability very seriously. I spent a career in the private sector, where I learned how 

important it is to be accountable for, and responsible in, the handling of financial resources. 

We appreciate the resources we have. We know there is a great 

deal of work to be done. We think every day about what the ultimate return on the investments will be, and we are confident that 

we will come back to you at some future time and be able to demonstrate that to you. 

Senator GRASSLEY. All right. Thank you. 

Senator Roberts, you are next. The chairman just handed me the 

gavel, and I am going to give it to you, because I have to go to the 

Judiciary. 

Senator ROBERTS. That is a very dangerous proposition. [Laughter.] 

Senator GRASSLEY. Yes. Do not abuse the privilege. 

Senator ROBERTS. I could ask unanimous consent and then say 

‘‘without objection.’’ [Laughter.] 

I hate to tell you this, but you may not have a job, just repeal 

and—never mind. [Laughter.] 

We will go on from there. You will note that they really did not 

hand me the gavel. 

12 

Thank you very much for coming and taking time out of your 

schedule to come up. I do not think it comes as any surprise to anybody on the committee, and perhaps you, that I have some strong 

concerns with many of the provisions of the Affordable Health Care 

Act, what some call AHA or PPACA, or whatever way you want to 

describe it, most especially, those provisions that I believe gave the 

Department, and more especially CMS, authority—as I have determined in talking to many of my providers out in the rural health 

care delivery system, both in Kansas and all across the country— 

to ration care. Now, those are their words, not mine, but I think 

they are mine as well after listening to many of their concerns. 

You stated in your testimony that Congress provided the Secretary with the authority to expand the scope and duration of a 

model being tested through rulemaking, including—and this is very 

important—the option of expanding on a nationwide basis. 

I do not think I would have ever been comfortable with this, and 

we did not get an opportunity at the time, although we had many 

hearings in the HELP Committee and here in this committee, but 

the final product, we did not have much access to, so I could not 

offer an amendment. 

But I have talked about this a lot on the floor of the Senate and 

every chance that I get, but I do not think I would have been very 

comfortable with allowing officials who are not elected the ability 

to bypass the Congress to implement policies that could impact 

Americans in every State, every region of the United States. But 

I can tell you that I have become even more alarmed watching the 

implementation. 

Right off the bat, the Department and CMS began implementing 

the major portions through IFRs, interim final rules. I have a big 

problem with this in regards to—I remember the days when CMS 

actually went out and asked people if in fact a regulation made 

sense, if in fact it could be tweaked, changed, or many different 

kinds of suggestions. If enough people really complained about it 

during a 90-day period, 60-day period, there would be an additional 

60 days. Well, you gave 30 days. 

Basically, the stakeholders do not really have an opportunity to 

weigh in. We have seen regulations, even economically significant 

regulations—and that is a term that is hard to really define—implemented with, I think, little or no quantitative cost/benefit analysis, despite the fact that it is required by the President’s executive 

order. 

Then—and this is the one that has really got me riled most recently—regulations are being implemented with what we call subregulatory guidances. This was a problem for me in that I had a 

heck of a time trying to remember that sub-regulatory guidance is 

just the name of it to begin with, but we are talking about such 

things as FAQs—FAQs is Frequently Asked Questions—and then 

bulletins, then postings to the website, then guidances. 

Now, aside from the fact that stakeholders can barely keep up 

with all the regulations now coming out of CMS, we cannot even 

guarantee that these folks know about sub-regulatory guidances, 

because no one ever let them know. I am talking about everybody 

within the provider system who is involved with Medicare payments. 

13 

Then, when actually implementing the regulations through notice and comment, the Department is giving stakeholders a minimum amount of time, 30 days, to review hundreds of pages of regulations, sometimes with multiple regulations being issued in the 

same day. 

Throw in the holidays, and you have a perfect recipe to assure 

stakeholders will not be able to engage constructively, if at all. I 

do not know how many hospital administrators—or for that matter 

doctors, nurses, whatever—are overwhelmed with the regulatory 

situation. They just do not have time to pay attention to subregulatory guidance. They do not even know it is there to begin 

with. 

Then you are going to have to have somebody whom they hire— 

I think it is a new growth industry: regulatory overkill 101, 102, 

103—but our universities and others in the private sector just cannot really have people available to do that. There are not that 

many people to help out. Do not tell me to call a 1–800 number 

that does not answer or where somebody does not have the answer. 

Some representatives from the administration have come before 

this committee, and I thank them for this. They have suggested 

that 60 days is a more appropriate time frame in regards to subregulatory guidance, again, if they even have the ability to know 

what that is. 

I would tell my distinguished friend and colleague and the ranking member that I am over my time 10 seconds, but I am on a roll, 

so I am going to keep going, if you do not mind. 

Senator HATCH [presiding]. Keep rolling if you want to. 

Senator ROBERTS. All right. Thank you. 

I ask unanimous consent to proceed for another 5 minutes, if I 

might. 

Senator HATCH. Without objection. 

Senator ROBERTS. And I know that I want to give the good doctor 

an opportunity to respond. 

I think this attempt to circumvent the traditional regulatory 

process—again, what CMS used to do, not what they do now because there is an agenda out there with all the regulations—I know 

that there is a time frame here that the administration wants to 

follow, but you cannot just leave the entire health care delivery 

system behind in a fog of regulations. 

At any rate, this becomes especially alarming when coupled with 

new authorities to allow CMS to expand the policies nationwide 

without accountability through any congressional review, which is 

what we are having today. I think there is a big storm coming. I 

am concerned, because whatever chance we have for this to really 

succeed, I think, is being endangered by a storm of regulatory overkill. I call it a Katrina of regulations; perhaps that is an overstatement. 

The traditional regulatory process, as described in both statute 

and executive order, calls for notice, it calls for comment, it calls 

for review, and it calls for consideration of comments, and the 

issuing then of a final rule. 

Again, I do not think I will ever be comfortable with the way this 

was done, but here is my question, finally, after this speech, or 

rant, or whatever you want to call it. Can you assure me today that 

14 

any policies CMMI expands, especially those that go nationwide, 

will be done through the traditional rulemaking process, including 

the notice, 60-day comment period, review and consideration of 

comments, clear and quantitative cost/benefit analysis, and issuance then of a final rule? I suppose you could say ‘‘yes’’ and that 

would be the end of it, but would you please comment? 

Dr. GILFILLAN. Senator, as you point out, the Affordable Care 

Act, section 3021, does speak to the potential for the Secretary expanding the scope or duration of a particular model even to a national level, assuming that we can demonstrate to the satisfaction 

of the actuaries at CMS that there are cost savings, or at least the 

same costs and quality getting better and quality always being better—the same, or better. So there is that provision, and it is stated 

through regulations. 

We have not gotten to that point at this time. We have not 

issued any regulations. I understand and hear your concerns about 

regulations. We have not confronted that, but our expectation is 

that we would follow the usual regulatory pathways and all of their 

levels, but we have not gotten to that point with any of our models 

at this point. 

I would say that—— 

Senator ROBERTS. But you intend to do that, of course? 

Dr. GILFILLAN. We certainly are expecting to find models that are 

successful that we would like to expand the duration and the scope 

of, and ideally some of them nationally, as we demonstrate the results of these different models. I would say that we have not been 

involved in regulation other than in the regulations for the Medicare Shared Savings Program for Accountable Care Organizations. 

That was, I think, a remarkable example of how we put an initial—— 

Senator ROBERTS. All right. Now, I am going to do something I 

do not like to do, and I do not want to interrupt you, but you mentioned it, and that gets to my next question. And I am still over 

time. Again, I will ask for another 5 minutes if I have to. 

But the Advanced Payment ACOs, that is what you are talking 

about, the Accountable Care Organizations. One question is, what 

percentage of these are rural? My answer to that is, I have heard 

back from many rural providers that, due to the structural limitations of the ACOs, it is difficult, if not impossible, for a rural community or provider to initiate an ACO. 

We just do not have the doctors, we do not have the professionals. Many times you have to drive 60 miles, 120 miles, whatever, to see a doctor or a nurse clinician, and maybe there is only 

one doctor. That doctor may circulate around in many different 

hospitals. We do have regional centers that provide very good care. 

But can you speak to how many rural providers have initiated 

ACOs versus any participation in an ACO initiated by a health system for a more urban community? I think there is a tremendous 

bias here to have ACOs succeed in urban settings, but the criteria 

for the rural providers I think are such that it just does not match 

up. 

Dr. GILFILLAN. Certainly, Senator, that is an excellent question, 

confronting the real challenges that we know providers in rural 

communities face. That is why, for our Pioneer ACO model, we creVerDate Nov 24 2008 17:27 May 16, 2014 Jkt 000000 PO 00000 Frm 00018 Fmt 6633 Sfmt 6633 R:\DOCS\87877.000 TIMD
15 

ated a specific set of criteria for rural entities to participate, and 

it resulted in us having a rural ACO in Ft. Dodge, IA, at Trinity 

Health. 

In our Advanced Payment program, we put additional funding in 

place for rural providers for small physician organizations or for 

hospitals in rural areas who lacked capital to become Accountable 

Care Organizations. We have seven of our 40 Advanced Payment 

Accountable Care Organizations that are from rural areas. One of 

them includes a hospital, but the others are physician-based. 

We have also worked hard across our other activities to ensure 

that we get good representation and good opportunities for rural 

providers, Senator. About 16 percent of our health care innovation 

awards are specifically for providers, rural providers, and are getting at some of those difficulties you have mentioned. 

Senator ROBERTS. All right. I am out of time, and I am taking 

way too much time, and I apologize to my colleagues. I am going 

to ask one more question if I might, and I apologize to Senator 

Casey and to the ranking member. 

You addressed efforts to reduce inappropriate hospital admissions. Now, I do not know of anybody on the committee or anybody 

anywhere who is supportive of continuing to allow for inappropriate hospital readmissions, and I know that you have done a lot 

of work for CMS, HHS, and have certainly done a lot of work to 

cut down on hospital readmissions. It comes under the heading of 

cost savings and even fraud and abuse prevention. 

However, can you speak to me about what work is being done to 

look into the unintended consequences of these policies? Specifically, I am referring to anecdotal examples I am being given that 

make this a real problem in rural areas with patients who need to 

be readmitted but are not because of this policy. 

In rural areas, there is no other place to go. I know of a particular case of a very good friend of mine—and I am not going to 

mention the hospital or the area—but whose mother was in her 90s 

and had a sprained ankle. She went in to see the doctor and went 

out to the parking lot and had apparently, later, as we have determined, a stroke, but she could not get readmitted back in the hospital except to the emergency room. 

The person there who gave the treatment indicated she was fine 

and went home. It was obvious that her son knew something was 

terribly wrong but could not get her readmitted back into the hospital. Now, I am not going to go into the details of what happened 

later, but unfortunately she died. 

Now, that is just one anecdotal example that I am personally 

aware of and was involved with, and I could not believe it. In talking to the hospital administrator, he said, well, this is what we are 

operating under. Now, that is a problem. I hope—I hope—that that 

is not a common theme, but I think you have to really take a look 

at the rural areas and hospital admissions. Have you done that on 

the other side of it? You always wonder what lurks under the banner of reform and what you are trying to do, and the real world 

out there is something entirely different if we are not careful. 

Dr. GILFILLAN. Thank you, Senator. We would be happy to work 

with your folks and with CMS to look into any specific concerns 

you have, certainly, but we know we have to ultimately—every hosVerDate Nov 24 2008 17:27 May 16, 2014 Jkt 000000 PO 00000 Frm 00019 Fmt 6633 Sfmt 6633 R:\DOCS\87877.000 TIMD
16 

pital, every doctor makes decisions about the right way to care for 

a patient, and there is nothing in the Affordable Care Act that says 

that people cannot do things, it just asks them to exercise judgment about whether the patients need to be in the hospital or can 

be cared for at home or in other settings. 

So we will monitor patient satisfaction rates, patient concerns, 

hospital complications. The whole intent of value-based purchasing, 

of course, is to look at the combination of quality of care outcomes, 

whether they be for admissions to the hospital or readmissions to 

the hospital. 

Senator ROBERTS. So you are going to take a look at the readmission policy and look at the law of unintended consequences and 

what really happens out in a rural health care delivery system, and 

that that hospital administrator who tells me that, well, it says 

right here under subsection C, paragraph 2, I am sorry, I cannot 

do this. Something is wrong here somewhere. There is a disconnect. 

Dr. GILFILLAN. Senator, we would be happy to follow up on that 

directly. 

Senator ROBERTS. I do not mean to target anybody individually. 

The last thing they want is for me to call them and say, guess 

what, I am going to have CMS or you folks give them a call and 

figure out what is wrong. They do not want to do that. I mean, nobody wants to get into that kind of situation. 

To my distinguished ranking member and Senator Casey, I 

apologize for taking so much time, but these are concerns that are 

very real, and I appreciate the doctor answering to the best of his 

ability. Thank you, sir. 

Senator HATCH. Well, thank you, Senator. 

Senator Casey, I have not made my opening statement. I will 

make that and I will hold my questions, and then I will turn to 

you. Is that all right? 

Senator CASEY. Yes. 

Senator HATCH. All right. 

OPENING STATEMENT OF HON. ORRIN G. HATCH, 

A U.S. SENATOR FROM UTAH 

Senator HATCH. I want to thank Senator Baucus for convening 

this timely and much-needed hearing this morning. It is no secret 

that for many reasons—and we want to welcome you, Dr. Gilfillan, 

and appreciate you being here—I did not support the President’s 

health reform bill. 

Despite my long-term interest in reforming our Nation’s health 

care delivery system to reduce costs and of course improve quality, 

I was concerned with the creation of a new bureaucracy known as 

the Center for Medicare and Medicaid Innovation, CMMI, and giving them $10 billion in taxpayer funds with no strings attached. 

We have now held two hearings in the committee where we have 

heard from the public and private sectors about interesting ways 

they are working to improve the delivery of care. I for one wholly 

support the private sector, working among payers, providers, and 

patients, to come up with solutions that best fit their communities 

in order to achieve more efficient and higher quality results. 

I have heard repeatedly from my Democratic colleagues that 

CMMI is tasked with letting ‘‘a thousand flowers bloom.’’ What I 

17 

really wonder is if this is simply a euphemism for ‘‘barely controlled chaos.’’ Dr. Gilfillan, I do not envy you your job. The administration expects you and your staff to overhaul the way health 

care is delivered in this country and to do it quickly so that people 

begin to believe their claims that Obamacare will save money. 

I will make a prediction: come the first part of next year, this is 

going to be utter chaos, and people are going to realize what a tragic mess we are in because of Obamacare. However, despite the 

claims that Obamacare will save money, I am quite confident that 

Obamacare will only increase the costs of health care in this country. 

I believe the evidence overwhelmingly supports my position, and 

we will all find out at the beginning of next year when all of these 

things trigger, including 20,000 pages of regulations. 

With that said, I do think there is merit to trying to change the 

delivery of care and to focus on greater coordination of care, reducing hospital admissions, and providing better outcomes to patients. 

I am concerned, though, that there is confusion and a clear lack of 

focus at CMMI. 

The Government Accountability Office, GAO, reported in November of last year that, while you have taken steps to coordinate with 

other offices at CMS, more work needs to be done to make coordination more systemic. It seems to me that CMMI would function 

best if it would pick a few initiatives, such as Accountable Care Organizations or Bundled Payments and really devote the time to 

those initiatives to make sure they actually work and have the intended consequences of lowering costs and increasing quality and 

efficiency. 

Instead, I hate to say this, but I fear that you are trying to do 

too much at one time. Coordination among initiatives that have 

similar goals is something the GAO has highlighted as a concern. 

For example, the Innovation Center’s Partnership for Patients 

model and CMS’s Quality Improvement Program have a similar 

goal: to reduce the rate of preventable hospital-acquired conditions 

and 30-day hospital readmissions. Both models contract with organizations to disseminate interventions to hospitals and perform virtually identical functions. That sounds like something that could be 

consolidated. 

I hope that CMMI takes the time to really study the impact of 

initiatives, both while they are going on and at the end of demonstrations, so we know if they work and how well they work before the initiatives are offered to more providers and patients. 

Since the GAO report indicated that, in most cases, it would be 

3 to 5 years before CMMI and the taxpayers know if these initiatives achieved their anticipated savings, it is critical that they be 

reviewed to determine whether they meet their stated goals. As 

you know, in the past, the Congressional Budget Office has shown 

us that most demonstrations do not actually save the taxpayers 

any money. 

Finally, I wanted to raise concerns about the number of highsalary staff who are employed by CMMI. In addition to spending 

billions on the CMMI projects, GAO noted that nearly half of the 

184-plus members of the CMMI staff are paid at the highest levels 

of the Federal pay scale, which stands in stark contrast to other 

18 

areas within CMS. I have also heard that CMMI staffers have 

state-of-the-art workspaces, including very expensive treadmill 

desks. 

In a post-sequester world where White House tours are being 

canceled and Easter egg hunts are being threatened, you can imagine why the American people would take a very cynical view about 

Federal employees being furnished with $1,000 treadmill desks. 

The Federal Government absolutely cannot afford to pour money 

into things that do not work. Our priority must be very clear. We 

need to make government as efficient as possible, and we do not 

need bloated bureaucracies, we do not need duplication of efforts, 

and we do not need an increased morass of regulations and platitudes. 

We do not need taxpayer dollars being spent so that staff can 

work at treadmill desks. What we do need is a clear strategic plan 

to improve quality and reduce costs. We need specific goals with 

specific direction to achieve those goals. We need the right people 

with expertise in these areas to develop targeted approaches that 

can be tried quickly, studied, and assessed for measures of success. 

Now, Dr. Gilfillan, you know that last year I sent you a letter 

asking for an accounting of what your office has been working on, 

how much money has been spent and, more importantly, how that 

money was spent. It took you more than 6 months to reply to my 

request. Now, let me repeat that again: 6 months. That is, to me, 

entirely unacceptable. I hope I will have your commitment today 

that that type of behavior will not be repeated, and all members 

of this committee will be given timely and complete responses. I 

would hope that you would do that. Can I get a commitment on 

that? 

Dr. GILFILLAN. Senator, we deeply regret the length of time it 

took to respond to your letter. It was the first such letter we received. It took us time to develop what we felt was an adequately 

comprehensive report addressing your questions. It certainly is our 

intent to be much more—— 

Senator HATCH. Then call me and say, ‘‘Look, we need a little 

more time here; we will be happy to give you a step-by-step approach in accordance with what we have worked on.’’ But do not 

let us sit there for 6 months without having a response. We are 

getting too much of that in this administration, where they just ignore what people up here ask them to give. It is too pervasive in 

this administration, and we have to stop that or there is going to 

be just unholy war up here. 

Well, as you can see, I have a number of concerns that I do not 

have time enough to go into right now, but I do want to thank the 

chairman for convening this hearing. 

[The prepared statement of Senator Hatch appears in the appendix.] 

Senator HATCH. Let me turn to Senator Casey at this point. 

Senator CASEY. I want to thank the ranking member. Doctor, I 

appreciate you being here, for your testimony and for your service. 

I know you have fond memories of Pennsylvania, and we appreciate your work that you did in our State. 

Doctor, I want to ask you one question that relates to the work 

that has been done to date—with regard to the work of the InnovaVerDate Nov 24 2008 17:27 May 16, 2014 Jkt 000000 PO 00000 Frm 00022 Fmt 6633 Sfmt 6633 R:\DOCS\87877.000 TIMD
19 

tion Center. I know a lot of the focus, attention, and work has been 

on payment or delivery system reforms as it relates to Medicare 

and Medicaid, and appropriately so. We need to find more and better ways to deliver good care, good quality care, and also save 

money. 

My concern, though, is, I am not sure we are doing enough in 

terms of using those same approaches or strategies as it relates to 

children. I guess the basic question I would have is, can we, or how 

can we, and how does CMMI plan to invest in strategies for children that we can prove over time will result in better outcomes, 

and especially with regard to children that have the kind of complex medical needs. 

You have heard the child advocates often say that, when it comes 

to children’s health insurance—and you know this better than I do 

as a medical doctor and a practitioner—children are not small 

adults, and you cannot just impose health care strategies or approaches on them that you would on an adult. So, can you talk a 

little bit about that and whether or not there might be more opportunities to focus those same reforms on children? 

Dr. GILFILLAN. Certainly, Senator. Thank you for that question. 

We are working closely with our colleagues at the Centers for Medicaid and CHIP Services on a variety of programs intended to improve care for all Medicaid and CHIP beneficiaries, and of course 

most particularly focusing on issues that affect children. 

One of those programs, of course, is the Strong Start initiative, 

where we are working hard with the private sector, the March of 

Dimes, the American Congress of Obstetricians and Gynecologists, 

to find new ways to deliver prenatal care to give kids the best 

start, to get them off on the right foot by decreasing the incidences 

of prematurity. So, from a program standpoint, that program is certainly well-focused on children at the very beginning. 

In our health care innovation awards, we have a number of 

projects focused directly on the needs of children, specifically the 

children with complex needs. We have, I believe, four different 

models actually looking at systems of care intended to address the 

needs of those patients. We have a program in Cleveland, a program in Akron, a program in Texas, and a program in North Carolina focused directly on that population and investigating new systems. 

Now, these are innovation awards, small programs. We are 

learning a lot. We have the option as we learn to expand them, 

make them broader model tests, and we have met with the stakeholders from the Pediatric Hospital Association several times to 

talk about that. We are also focused on what is probably the most 

significant health problem, chronic health problem, for children in 

the treatment of asthma. 

We have a number of initiatives that we are working on, again, 

in the health care innovation award space, to look at new ways of 

treating children with asthma to decrease exacerbations or complications and limit or decrease the frequency that they have to go 

to the emergency room. 

Then we are working with States through our State Innovation 

Model, where we are asking them to work with us, work with the 

Centers for Medicaid and CHIP Services, work with the Innovation 

20 

Center, to design programs that will improve care for all of their 

populations, and these will include the pediatric populations as 

well. 

So it is an important area. We are committed to working through 

it, to learning from the initial models, and looking for broader opportunities, Senator, to test in a more broad-based way new care 

systems for children across the country. 

Senator CASEY. And I appreciate that. I am glad you mentioned 

Strong Start, because I was noting in your testimony at page 7 the 

description, and quoting the second sentence of that section in your 

testimony, ‘‘The first is a public/private partnership, an awareness 

campaign to reduce the rate of early elective delivery prior to 39 

weeks for all populations.’’ You then go on and talk about, ‘‘It is 

a persistent problem.’’ You highlight the Strong Start awards, 27 

of them most recently, and two of them, by the way, in Pennsylvania. We are happy whenever that occurs. 

But what are you seeing with regard to the larger challenge of 

making sure that we are learning through these programs to deliver care better? I know it is early, but have any conclusions as 

to that been yielded from Strong Start? 

Dr. GILFILLAN. Well, yes, Senator. The Strong Start strategy is 

one we have been working on for almost a year now. This is an initiative to work across the delivery system with private sector colleagues, the March of Dimes, the American Congress of OB–GYNs, 

and other private sector interested parties, to help support the enactment of policies across hospitals that are consistent with what 

the American Congress of Obstetricians and Gynecologists has advocated for 20 years. That is, that there should not be elective deliveries performed prior to 39 weeks gestation. 

Now what that means, elective deliveries mean, is there is no 

medical reason for doing it, so it may be done for the convenience 

of the practice, the physician. At times people have said patients 

are interested, moms are interested in having early elective deliveries. 

What we have learned is that, while people think the baby may 

be at-term, the reality is there is a great deal of development that 

goes on between 37 and 39 weeks, so it is important. About 8 percent of the time, babies who are delivered at that time actually end 

up being admitted to the NICU, the Neonatal Intensive Care Unit, 

for complications. 

Senator CASEY. Before 39 weeks? 

Dr. GILFILLAN. Before 39 weeks, even though people think it is 

at-term. So the experts have long supported avoiding doing that 

and not delivering babies early like that. So, through the Partnership for Patients, we have engaged their hospital network to talk 

with hospitals about putting policies in place that prevent that 

from happening, and we have seen remarkable improvement in the 

hospitals that are doing that. 

Some hospitals had already started doing that themselves, but 

many—the vast majority of hospitals around the country—had not 

put a policy like that in place. Through our private/public partnership with the March of Dimes, the American Congress of Obstetricians and Gynecologists, hospital associations, and through the relationships we have in our Partnership for Patients, we have been 

21 

really, I think, able to raise the consciousness, the awareness of 

this problem nationally, and we are seeing major changes across 

health systems, across State hospital associations, in hospitals putting that in place. 

What happens very dramatically is, we see early elective deliveries going from a rate that could be as high as 15, and in some 

cases over 20 percent, going down to 2, 3, or 4 percent with better 

outcomes, because babies are not being admitted to the Neonatal 

Intensive Care Unit. We think, but we do not have definite evidence of this, we are beginning to see a decreased frequency in use 

of Neonatal Intensive Care Units as a result of this. More to come 

on that as that information and data become more complete and 

mature. 

Senator CASEY. Thanks very much. I now owe the ranking member 3 minutes and 47 seconds. 

Senator HATCH. Well, I was happy to give that to you, especially 

after giving the distinguished Senator from Kansas 10 minutes. 

And, we were interested in your questions besides. 

Senator Thune, you will be our last questioner. 

Senator THUNE. Thank you, Mr. Chairman. 

Dr. Gilfillan, thank you for being here today. On page 31 of the 

November 2012 GAO report on the early implementation efforts of 

the CMS Center for Innovation, GAO talked about how a centralization database would hep the Innovation Center make coordination of the new models more systematic. 

One of the biggest goals of such a database would be to prevent 

duplicative payments to providers that participate in CMS efforts 

involving incentive payments for meeting quality and cost measures. At the time, CMS officials said that such a database would 

ensure that beneficiaries are not counted twice for the purposes of 

calculating incentive payments and that the database would be 

fully functional in September of 2012. Is that database operational? 

Dr. GILFILLAN. Yes, Senator, it is operational. 

Senator THUNE. And can you explain what happens when the 

database discovers a beneficiary is being counted twice? 

Dr. GILFILLAN. Certainly, Senator. That is a great question. It 

goes to how we have had to build new operating capabilities within 

CMS to track patients in the different initiatives that we have, not 

just within the Innovation Center, but across CMS and the Shared 

Savings Program as well. 

So we had to build the capability for our information systems to 

only align a patient once with any of these programs, and that is 

exactly what the system does. We have a series of dates where different programs present their physicians to the IS folks. They run 

the data through this database. 

They look at all the visits a patient has had to a particular provider, and, as a result of that, they align a patient with only one 

set of providers so that we do not have any duplication. So that 

system has been operating now since last year. It is refined and 

continually upgraded, and it becomes faster to operate, frankly, as 

they refine it. But it is operating and producing the result that we 

were after: namely, avoiding duplicated payments for patients. 

Senator THUNE. Thank you. 

22 

My understanding is that, in mid-2012, CMMI had started to 

work on 17 new models designed to test different approaches to 

health care delivery and payment in Medicare and Medicaid, and 

it has assumed responsibility for another 20 demonstration programs that were already in progress when the Center was created. 

GAO’s report, again, from November of 2012, provided some valuable insight into how those 17 new models were functioning. Since 

the GAO report, has CMMI initiated any new models? 

Dr. GILFILLAN. Since the final report, we have announced awardees for our Strong Start program, and we have announced our upcoming comprehensive End-Stage Renal Disease program that we 

are just in the solicitation phase for right now. 

We also have announced awardees for our State Innovation 

Model program and have identified six States that are testing their 

innovation plan, and another 19 States that are testing or have received grants, awards, to do design work. I think those are the 

major additions we have had since then. 

Senator THUNE. What was the review process for those models? 

Dr. GILFILLAN. Sure. Well, we follow the standard CMS review 

processes for consideration of applications, and we convene typically panels of reviewers to look at applications to rate them according to the criteria that we have. Then we go through a standard review and approval process that is consistent with the overall 

grant and corporate agreement-making policy of CMS. 

Senator THUNE. And is that process that you just described any 

different from the process that was noted in the GAO report? 

Dr. GILFILLAN. No, I do not believe it is, Senator. We followed the 

standard grant-making and corporate agreement-making processes 

that other Federal agencies follow. So I would have to go back and 

look at the exact language, but I do not think it is different. 

Senator THUNE. If it is not, if the review process has not changed 

from what was noted in their report, how then can you be sure that 

you do not end up repeating the same mistakes that were noted in 

their report, in the GAO report? 

Dr. GILFILLAN. Well, Senator, we have continually improved our 

approach. We are exquisitely conscious of potential duplication in 

all of our models. We are working carefully to coordinate across 

CMS and across the Innovation Center with different models. I 

think we have been very conscious of the importance of avoiding 

overlap where there is no added advantage to starting another program. 

Senator THUNE. All right. My time is up, Mr. Chairman. Thank 

you. 

Senator HATCH. Well, thank you. 

Dr. GILFILLAN. Thank you, sir. 

Senator HATCH. Dr. Gilfillan, we appreciate you taking the time 

to be with us, and we look forward to working with you in the future. Hopefully, we can get some of these conflicts resolved. But 

thank you for being here. 

With that, we will recess until further notice. 

Dr. GILFILLAN. Thank you very much, Senator Hatch. 

[Whereupon, at 10:49 a.m., the hearing was concluded.] 

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