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Collaboration of Health IT Policy and Standards Committees, December 6, 2016 1

Collaboration of the Health IT Policy and Standards Committees

Final Transcript December 6, 2016

Presentation

Operator All lines are now bridged.

Michelle Consolazio, MPA – Federal Advisory Committee Program Lead – Office of the National Coordinator for Health Information Technology Thank you, good morning everyone, this is Michelle Consolazio with the Office of the National Coordinator. This is a joint meeting of the Health IT Policy and the Health IT Standards Committee. This is a public call and there will be time for public comment at the end of today’s call. As a reminder, please state your name before speaking as this meeting is being transcribed and recorded and I will now take roll. Arien Malec?

Arien Malec – Vice President, Clinical Solutions Strategy- RelayHealth Corporation I’m here.

Michelle Consolazio, MPA – Federal Advisory Committee Program Lead – Office of the National Coordinator for Health Information Technology Hi, Arien. Lisa Gallagher?

Lisa Gallagher, BSEE, CISM, CPHIMS – Managing Director – Pricewaterhouse Coopers (PwC) Here. Hi, Michelle.

Michelle Consolazio, MPA – Federal Advisory Committee Program Lead – Office of the National Coordinator for Health Information Technology Hi, Lisa.

Michelle Consolazio, MPA – Federal Advisory Committee Program Lead – Office of the National Coordinator for Health Information Technology Kathy Blake?

Kathleen Blake, MD, MPH – Vice President – AMA-Convened Physician Consortium for Performance Improvement – American Medical Association Here.

Michelle Consolazio, MPA – Federal Advisory Committee Program Lead – Office of the National Coordinator for Health Information Technology Hi, Kathy and Paul Tang?

Paul Tang, MD, MS – Vice President & Chief Health Transformation Officer – IBM Watson Health Here.


Michelle Consolazio, MPA – Federal Advisory Committee Program Lead – Office of the National Coordinator for Health Information Technology Hi, Paul. Aaron Miri I think is going to be running a few minutes late. Andy Wiesenthal? I know Andy was there.

Andrew M. Wiesenthal, MD, SM – Director, Health Care Practice – Deloitte Consulting, LLP – International Health Terminology Standards Development (SNOMED) Here.

Michelle Consolazio, MPA – Federal Advisory Committee Program Lead – Office of the National Coordinator for Health Information Technology Hi, Andy.

Andrew M. Wiesenthal, MD, SM – Director, Health Care Practice – Deloitte Consulting, LLP – International Health Terminology Standards Development (SNOMED) I’m here, I’m here, I’m here.

Michelle Consolazio, MPA – Federal Advisory Committee Program Lead – Office of the National Coordinator for Health Information Technology Angela Kennedy is not able to join. Anjum Khurshid? Anne LeMaistre?

Anne LeMaistre, MD – Senior Director Clinical Information Systems & Chief Medical Information Officer – Ascension Health Present.

Michelle Consolazio, MPA – Federal Advisory Committee Program Lead – Office of the National Coordinator for Health Information Technology Hi, Anne.

Anne LeMaistre, MD – Senior Director Clinical Information Systems & Chief Medical Information Officer – Ascension Health Hi.

Michelle Consolazio, MPA – Federal Advisory Committee Program Lead – Office of the National Coordinator for Health Information Technology Aury Nagy? Brent Snyder? Carolyn Petersen?

Carolyn Petersen, MBI, MS – Senior Editor – Mayo Clinic Global Business Solutions Here.

Michelle Consolazio, MPA – Federal Advisory Committee Program Lead – Office of the National Coordinator for Health Information Technology Hi, Carolyn. Chesley Richards?

Chesley Richards, MD, MPH, FACP – Director, Office of Public Health Scientific Services – Centers for Disease Control and Prevention Here.


Michelle Consolazio, MPA – Federal Advisory Committee Program Lead – Office of the National Coordinator for Health Information Technology Hi, Chesley. Chris Lehmann? Dale Nordenberg? David Kotz? Devin Mann? Donna Cryer? Eric Rose is here. Floyd Eisenberg?

Floyd Eisenberg, MD, MPH, FACP – President – iParsimony, LLC Here.

Michelle Consolazio, MPA – Federal Advisory Committee Program Lead – Office of the National Coordinator for Health Information Technology Hi, Floyd. Gayle Harrell? Jamie Ferguson?

Jamie Ferguson – President, Health Information Technology Strategy & Policy, Fellow, Institute for Health Policy – Kaiser Permanente Institute for Health Policy Good morning.

Michelle Consolazio, MPA – Federal Advisory Committee Program Lead – Office of the National Coordinator for Health Information Technology Hi, Jamie. Jitin Asnaani?

Jitin Asnaani, MBA – Executive Director – CommonWell Health Alliance Here.

Michelle Consolazio, MPA – Federal Advisory Committee Program Lead – Office of the National Coordinator for Health Information Technology Hi, Jitin. John Scott? John…

W He will not be here this morning.

Michelle Consolazio, MPA – Federal Advisory Committee Program Lead – Office of the National Coordinator for Health Information Technology Thank you. Jon White?

P. Jonathan White, MD – Deputy National Coordinator – Office of the National Coordinator for Health Information Technology Here.

Michelle Consolazio, MPA – Federal Advisory Committee Program Lead – Office of the National Coordinator for Health Information Technology Hi, Jon. Jonathan Nebeker? Josh Mandel?

Joshua C. Mandel, MD, SB – Research Faculty – Harvard Medical School I’m here, good morning.

Michelle Consolazio, MPA – Federal Advisory Committee Program Lead – Office of the National Coordinator for Health Information Technology Good morning Josh. Karen van Caulil?


Karen van Caulil, PhD – President and Chief Executive Officer – Florida Health Care Coalition Karen van Caulil, yes, here.

Michelle Consolazio, MPA – Federal Advisory Committee Program Lead – Office of the National Coordinator for Health Information Technology I’m sorry, I always get it wrong.

Karen van Caulil, PhD – President and Chief Executive Officer – Florida Health Care Coalition That’s okay, that’s all right.

Michelle Consolazio, MPA – Federal Advisory Committee Program Lead – Office of the National Coordinator for Health Information Technology Kay Eron?

Kay Eron, MBA – General Manager Health IT & Medical Device – Intel Corporation Here.

Michelle Consolazio, MPA – Federal Advisory Committee Program Lead – Office of the National Coordinator for Health Information Technology Hi, Kay. Kevin Johnson?

Kevin B. Johnson, MD, MS – Professor & Chair of Biomedical Informatics – Vanderbilt University Medical Center Here.

Michelle Consolazio, MPA – Federal Advisory Committee Program Lead – Office of the National Coordinator for Health Information Technology Hi, Kevin. Kim Nolen?

Kim Nolen, PharmD – Clinical Informatics Medical Outcomes Specialist – Pfizer, Inc. Hey, Michelle, I’m here.

Michelle Consolazio, MPA – Federal Advisory Committee Program Lead – Office of the National Coordinator for Health Information Technology Hi, Kim. Kim Schofield?

Kim J. Schofield – Advocacy Chair – Lupus Foundation of America Here. Hi, Michelle.

Michelle Consolazio, MPA – Federal Advisory Committee Program Lead – Office of the National Coordinator for Health Information Technology Hi, Kim. Kyle Meadors?

Kyle Meadors – President – Chart Luz Consulting Here.

Michelle Consolazio, MPA – Federal Advisory Committee Program Lead – Office of the National Coordinator for Health Information Technology Hi, Kyle. Larry Wolf? I know Larry is here. Leslie Kelly Hall?


Larry Wolf, MS – Principal – Strategic Health Network Here, sorry.

Leslie Kelly Hall – Senior Vice President of Policy – Healthwise Here. I’m here, this is Leslie.

Michelle Consolazio, MPA – Federal Advisory Committee Program Lead – Office of the National Coordinator for Health Information Technology Hi, Leslie. Lisa…I’m sorry we already got Lisa. Lorraine Doo?

Lorraine Doo, MSWA, MPH – Senior Policy Advisor – Centers for Medicare & Medicaid Services – Health and Human Services Hi, good morning, I’m here.

Michelle Consolazio, MPA – Federal Advisory Committee Program Lead – Office of the National Coordinator for Health Information Technology Good morning, Lorraine. Nancy Orvis?

Nancy J. Orvis, MHA, CPHIMS – Director, Business Architecture & Interoperability – Department of Defense Here.

Michelle Consolazio, MPA – Federal Advisory Committee Program Lead – Office of the National Coordinator for Health Information Technology Hi, Nancy. Patty Sengstack? Paul Egerman? Peter Johnson?

Peter Johnson, MBA – Senior Vice President & Chief Information Officer – Dartmouth Hitchcock Health Care System Here.

Michelle Consolazio, MPA – Federal Advisory Committee Program Lead – Office of the National Coordinator for Health Information Technology Hi, Peter. Raj Dash?

Rajesh C. Dash, MD, FCAP – Director of Laboratory Informatics Strategy, Office of CIO – Duke University Health System Here.

Michelle Consolazio, MPA – Federal Advisory Committee Program Lead – Office of the National Coordinator for Health Information Technology Good morning.

Rajesh C. Dash, MD, FCAP – Director of Laboratory Informatics Strategy, Office of CIO – Duke University Health System Good morning.

Michelle Consolazio, MPA – Federal Advisory Committee Program Lead – Office of the National Coordinator for Health Information Technology Ram Sriram? I believe Ram is here. Rich Elmore?


Ram Sriram, PhD – Chief, Software & Systems Division – National Institute of Standards and Technology Yeah, Ram is here, Ram is here, yeah, I’m here.

Michelle Consolazio, MPA – Federal Advisory Committee Program Lead – Office of the National Coordinator for Health Information Technology Hi, Ram. I thought I heard Rich Elmore earlier too?

Richard Elmore, MA – President, Strategic Initiatives – Allscripts Yeah, good morning, Michelle.

Michelle Consolazio, MPA – Federal Advisory Committee Program Lead – Office of the National Coordinator for Health Information Technology Scott Gottlieb? Hi, Rich. Steve Brown? Terry O’Malley?

Terrence (Terry) O’Malley, MD – Medical Director for Non-Acute Care Services, Partners Healthcare System – Massachusetts General Hospital Here.

Michelle Consolazio, MPA – Federal Advisory Committee Program Lead – Office of the National Coordinator for Health Information Technology Hi, Terry. Troy Seagondollar?

Troy Seagondollar, RN-BC, MSN, UNAC/UHCP – Regional Technology Nursing Liaison – Informatics Nurse – Kaiser Permanente I’m here.

Michelle Consolazio, MPA – Federal Advisory Committee Program Lead – Office of the National Coordinator for Health Information Technology Wanmei Ou? Hi, Troy.

Troy Seagondollar, RN-BC, MSN, UNAC/UHCP – Regional Technology Nursing Liaison – Informatics Nurse – Kaiser Permanente Hi.

Michelle Consolazio, MPA – Federal Advisory Committee Program Lead – Office of the National Coordinator for Health Information Technology Okay, after that long roll call has anyone else joined since we went through roll call?

Dale Nordenberg, MD – Chief Executive Officer – Novasano Health & Science Hey, Michelle…

Wanmei Ou, PhD – Director, Precision Medicine and Data Science – Merck Hi Wanmei is here.

Dale Nordenberg, MD – Chief Executive Officer – Novasano Health & Science It’s Dale Nordenberg.


Michelle Consolazio, MPA – Federal Advisory Committee Program Lead – Office of the National Coordinator for Health Information Technology Hi, Dale and I heard a female voice as well?

Wanmei Ou, PhD – Director, Precision Medicine and Data Science – Merck Hi, Wanmei is here.

Michelle Consolazio, MPA – Federal Advisory Committee Program Lead – Office of the National Coordinator for Health Information Technology Hi, Wanmei. Okay with that I am going to turn it over to Jon White to make a few introductory remarks.

P. Jonathan White, MD – Deputy National Coordinator – Office of the National Coordinator for Health Information Technology All right, thank you so much, Michelle. Wonderful to hear everybody’s name and voices as we went through the roll. Just a few kinds of brief opening remarks for you all. It’s been a nice quiet fall in Washington DC not much is happening here so we’ll get you caught up pretty quickly.

Two main things that I just wanted to address for you all that you have may been thinking about. There is an upcoming change in administration that is going to be happening and I just want to reinforce a couple of things to you all. The first is that, you know, ONC has a statutory mission. You know prior to 2009 ONC existed through executive order but since 2009 ONC has existed under statute and our statutory mission which is to improve the health and the well-being of individuals and communities through the use of technology and health information that is accessible where and when it matters most is going to continue.

I am very pleased to be able to tell you that we have several senior career leaders beyond myself and Lisa Lewis we’ve also…you’re well acquainted with Steve Posnack and with Elise Anthony, and of course the one who all of us obeys, Michelle Consolazio, and all of these folks are in place and will ensure that there’s a smooth transition through to the next administration and beyond that we’re probably not going to speculate a whole lot on the future that’s…the future is going to hold what it’s going to hold and we’re going to go forward bravely into it.

The other thing that I’ll mention to you all that’s probably of interest to this group in particular is the 21st Century Cures Bill. Normally I do not…some of you may have, you know, asked me before at advisory committee meetings, I normally don’t comment on pending legislation, however, this particular bill has passed the House, Senate. The Senate has invoked cloture on it and by a fairly, you know, broad margin and the administration has issued a fairly strong statement of support.

So, I am going to just offer you a few quick comments on the 21st Century Cures Bill. If Cures is enacted we’re going to look forward to working to implement the provisions of the bill and for this group in particular I want you to know that we’re going to work to ensure an orderly transition from the current committee set up to the Health IT Advisory Committee that is described in the bill. If it’s enacted we’ll be as transparent as possible regarding the next steps for committee members and in the transition from the current structure to the new structure.

You know this is important for me to say to you because, you know, this is going to sound a little glib for me to say, but I’m genuinely inspired by the work that you all do with us and for us every day so many smart, talented, hard-working people who give so much to be able to, you know, give us the best support and advice that we can get from you all as we go about our mission.


So, you know, I just wanted to emphasize that we really value the feedback from advisories, from our advisory committees both on our current work and our past work and the workgroups, and committees that put forth and, you know, I look back across the past seven or eight years and, you know, I think that, you know, these committees have a tremendous amount to be proud of. You have advanced the health IT policy and standards landscape in ways that may not have been fathomable to me seven years ago. So, without your time and contribution none of what we’ve done would have been possible.

So, on behalf of everybody at ONC I am grateful for the work that you do and as I said we will be as transparent with you as we can be if this bill gets passed about how we transition over to the new committee. So, thank you I’ve taken up enough of your time. Michelle the floor is yours again.

Michelle Consolazio, MPA – Federal Advisory Committee Program Lead – Office of the National Coordinator for Health Information Technology Thank you, Jon. I’m going to turn it over to Kathy Blake to review the agenda and approve the minutes from the last meeting.

Kathleen Blake, MD, MPH – Vice President – AMA-Convened Physician Consortium for Performance Improvement – American Medical Association Thank you Michelle and also thank you to Jon and I think I echo and really state the thanks of the entire Health IT Policy as well as the Standards Committee because it has been I think our privilege as well as our great honor to be able to work with all of you and thank you for reminding all of us of how much has been accomplished in the last seven years.

So, our agenda today focuses on two major topics. First, we will hear from Dr. Kate Goodrich with CMS on the Quality Payment Program review and certainly that is I think front and center on the minds of many involved, many stakeholders all across healthcare and then following that we’ll hear from Elise Anthony and Mike Lipinski from ONC about the Enhanced Oversight and Accountability review and with no further ado, I will ask for a motion and for seconds to approve the minutes of our most recent meeting.

Arien Malec – Vice President, Clinical Solutions Strategy- RelayHealth Corporation Move to accept.

Paul Tang, MD, MS – Vice President & Chief Health Transformation Officer – IBM Watson Health Second.

Kathleen Blake, MD, MPH – Vice President – AMA-Convened Physician Consortium for Performance Improvement – American Medical Association Thank you and are there any…is there any discussion or changes that need to be made before we vote for approval?

Hearing none, I will ask people to affirm their votes just verbally say “yes” and then will ask for nays and if there are no nays the minutes will be approved. So, all in favor?

Multiple Yes/Aye.


Kathleen Blake, MD, MPH – Vice President – AMA-Convened Physician Consortium for Performance Improvement – American Medical Association Any opposed? So, the minutes are adopted and I will now turn things over to Arien to introduce our next topic.

Arien Malec – Vice President, Clinical Solutions Strategy- RelayHealth Corporation Excellent…

Paul Tang, MD, MS – Vice President & Chief Health Transformation Officer – IBM Watson Health I think it’s me…

Arien Malec – Vice President, Clinical Solutions Strategy- RelayHealth Corporation I think it’s to Paul actually.

Michelle Consolazio, MPA – Federal Advisory Committee Program Lead – Office of the National Coordinator for Health Information Technology I think it’s actually Paul Tang.

Kathleen Blake, MD, MPH – Vice President – AMA-Convened Physician Consortium for Performance Improvement – American Medical Association Oh, my apologies.

Paul Tang, MD, MS – Vice President & Chief Health Transformation Officer – IBM Watson Health Okay.

Kathleen Blake, MD, MPH – Vice President – AMA-Convened Physician Consortium for Performance Improvement – American Medical Association Paul Tang.

Paul Tang, MD, MS – Vice President & Chief Health Transformation Officer – IBM Watson Health No worries.

Kathleen Blake, MD, MPH – Vice President – AMA-Convened Physician Consortium for Performance Improvement – American Medical Association Please.

Paul Tang, MD, MS – Vice President & Chief Health Transformation Officer – IBM Watson Health No worries. This is Paul Tang. I also want to thank ONC for the tremendous work they’ve done, not that we’re in our final stages, but the tremendous work they’ve done in implementing HITECH and creating the result that we’ve had. So, a special thanks to Karen and Vindell, Jon, the entire office, it’s just been a pleasure to work with you all and see the great work it’s been a joint effort in terms of getting this…accomplishing the things that have been done in the past seven years and also to Michelle who keeps us from going astray and really keeps us on track. So, thanks, Michelle and thanks, Jon.

Our first speaker is going to be Kate Goodrich from CMS on a really important topic, Kate’s going to present an overview of the final rule for the Quality Payment Program as part of MACRA and as you know MACRA is really a major milestone in the country’s move from pay for volume to pay for value.

We also all recognize in the many pages there it’s a complex rule but one, as we’ve pointed out in the NPRM, that demonstrates how attentively CMS has taken the time to listen to the various stakeholders


in healthcare and try to accommodate the needs and the concerns while balancing the needs of the country.

Our country is remarkably and wonderfully diverse so major policies like MACRA are complex but the good news is that once again Kate has done an exceptional job that summarizes the rule in really a crystal clear language in the presentation we’re about to receive. So, look forward to hearing your summary, Kate.

Kate Goodrich, MD, MHS – Director, Center for Clinical Standards & Quality – Centers for Medicare & Medicaid Services Great, thank you, Paul. Can you all hear me okay?

Paul Tang, MD, MS – Vice President & Chief Health Transformation Officer – IBM Watson Health Yes.

Kate Goodrich, MD, MHS – Director, Center for Clinical Standards & Quality – Centers for Medicare & Medicaid Services Okay, terrific.

Michelle Consolazio, MPA – Federal Advisory Committee Program Lead – Office of the National Coordinator for Health Information Technology Yes.

Kate Goodrich, MD, MHS – Director, Center for Clinical Standards & Quality – Centers for Medicare & Medicaid Services And I have to say credit goes entirely to our communications team for these slides they have done an amazing job starting even with the proposed rule with trying to get our policies and messages out in a way that’s easier for folks to understand both in slide format as well as our website that many of you have probably visited and I encourage you to visit to get whatever information you need.

So, I am going to do an overview of the Quality Payment Program, many of you are probably already quite familiar with it or have seen other presentations, so I’m going to take a little bit of a deeper dive in this presentation into the advancing care information category and a little bit more also about the improvement activities because we took sort of a first step to try to better align those two categories based upon comments we received asking us to do exactly that as part of the proposed rule.

And then I’ll talk a little bit about the information blocking and I’ll just briefly talk about that and the attestation and the surveillance but certainly would invite my colleagues from ONC to weigh in on the surveillance piece as well.

So, moving to the next slide, as you all undoubtedly know very well the Quality Payment Program is the biggest reform to clinician payments under Medicare Part B pretty much in our…just about in our history and it will reform Part B payments for about 600,000 clinicians and the reason that number is 600,000 and not 1.3 million, which is the number of clinicians that participate in Medicare Part B, has to do with the various exclusions for who is able to participate at least certainly in the first year. There are two tracks, the Merit-based Incentive Payment System or MIPS as well as Advanced APMs. Next slide.

When we first started designing the program and thinking about the policies the very first thing that we did was we developed, with input from our colleagues from ONC certainly but also from clinicians and


patients, a strategic plan and we defined very clear strategic goals for the program and we actually do have metrics underneath these goals that we are tracking to some of which we are still developing.

So, of course the first goal is to improve beneficiary outcomes that is true for all of the work in HHS that we do and certainly within the CMS programs as well so that’s always going to be number one.

We knew, based upon our experience from the first…from the legacy programs, if you will, Meaningful Use, PQRS and so forth, that clinicians had really variable levels of experiences and that many of them felt they didn’t have a very good experience and so we really needed to focus very strongly on the clinician experience with the program so that it’s meaningful to them, that it actually helps them to improve the work they do every day to take care of patients and that we could reduce burdens as much as we can over time.

One primary goal of the legislation, and therefore a goal of our program, is to increase adoption of advanced APMs to help people transition into alternative methods of payment. We want to of course maximize participation in the programs as much as possible. Very importantly what we’ve heard from clinicians in particular is the need to improve the data that we’re asking them to report on as well as what we feed back to them and improve the information sharing between CMS and clinicians but also between clinicians and clinicians and patients.

And then underpinning all of this is ensuring operational excellence for program implementation within CMS and that is I think absolutely foundational to the success of this program. We launched a website at the same time that we launched the final rule on October 14th hopefully you visited it, qpp.cms.gov, I think you’ll notice it’s very different from other CMS websites. It was developed with a tremendous amount of user experience testing in ways we have not done previously that has directly informed not only what goes on the site but the look and feel so always interested in your feedback on that. Next slide.

So, what is the MIPS Program, we’ll start with MIPS. Most of this presentation will be about MIPS. There are four performance categories as you see here. One of the things we really tried hard to do in the final rule was to provide clinicians with flexibility to choose the activities and measures that are most meaningful to their practice really across all four of these categories.

The legacy programs for many clinicians have really felt very much sort of one-size-fits-all and part of that was the way the programs were designed, part of it was statutory constraints but certainly we felt like we had flexibility under the MACRA legislation to provide more flexibility.

I will say you’ll see this, especially as I start talking about the advancing care information category there are some trade-offs that we definitely had to make in the development of the final policies and one of those trade-offs sometimes was balancing flexibility, which clinicians overwhelmingly asked for, with simplicity.

So, I would say that probably our most complicated to understand of these categories is the advancing care information category but that was in part in an effort to reduce burden and to provide some flexibility so we’ll talk to that. Okay, next slide.

So, first let’s start talking about who participates in the program?


So, going onto slide six, eligible clinicians include the boxes that you see that are on the bottom, physicians, PAs, nurse practitioners, clinical nurse specialists and certified registered nurse anesthetists. These are the clinicians that are eligible to participate for the first two years of the program.

For the third and future years we can expand those categories and include occupational therapists, physical therapists, social workers, dietitians and so forth. Certainly those clinicians can voluntarily report to MIPS in the first two years if they like and we would give them feedback reports and everything else we just would not adjust their payments based upon their performance.

And so based upon the low-volume threshold exclusions that we finalized that eligible clinicians are those who are in those categories but also who bill more than $30,000 a year under Medicare Part B, Medicare Part B allowed charges and who provide care for more than 100 Medicare patients a year. So, if you know anything about Boolean logic the opposite of that is our low-volume threshold exclusion which is that clinicians who bill less than $30,000 a year or they provide care for fewer than 100 patients, Medicare patients a year, are excluded from the program. So, next slide.

So that gets to that here with the middle box here about the low-volume threshold. We proposed $10,000 and 100 patients but we got feedback pretty consistently that folks felt like $30,000 was a better threshold so that’s what we ended up finalizing. So, that’s going to exclude a fair number of clinicians and in particular probably clinicians who are solo practitioners and in small practices, we’ll exclude a fair number of those.

Clinicians who are in their first year of Medicare are excluded, that’s by statute, and then clinicians who are significantly participating in an advanced APM. So, to be a qualified participant which gets you out of the MIPS Program you have to first of all be participating in an advanced APM and I’m going to get to that a little bit later, but to be a qualified participant you must receive 25% of your Medicare payments through that advanced APM or see 20% of your Medicare patients through that advanced APM. And that 25% threshold actually was set in statute we really didn’t have any flexibility there. We certainly did have some flexibility around the patient threshold. So, those are the three categories of folks who would be excluded from MIPS.

A little bit about non-patient-facing clinicians, so these tend to be certainly your radiologists, pathologists and so forth. There were some exceptions within the MACRA law around non-patient-facing clinicians understanding that they are in some ways somewhat different from other clinicians in terms of their ability to be able to be successful with certain of the categories.

So, non-patient-facing clinicians certainly can participate in MIPS as long as they don’t meet those three categories I just described. Now there are certainly groups of clinicians that have a fair number of non-patient-facing clinicians and we know that some groups report as a group. So, a group is considered non-patient-facing if greater than 75% of the NPIs or clinicians in that group are labeled as non-patient-facing.

And then there are some more flexible reporting requirements for non-patient-facing clinicians. For example, they are exempt from the ACI category and they have to do…or can do a fewer number of improvement activities in order to get the full credit for that category. We will be posting our list of patient-facing codes by the end of the year, we get asked that a lot we are working hard on that. So, that will go up by the end of this month. Next slide.

So, how do clinicians participate in MIPS? So going onto slide 10, about a month before we finalized the final rule we announced pick your pace because we heard overwhelmingly from clinicians that they did


not feel ready, or many of them, did not feel ready to begin participating in 2017 which was what we had proposed that 2017 be the first performance year.

Certainly there are many clinicians out there who have been participating in PQRS and Meaningful Use for years and they clearly did feel ready and wanted to begin in 2017 but in particular we heard from small practices, rural practices and folks who represented them that they needed more time to understand the program and they needed more time to really get their systems ready to partner with an EHR vendor, to partner with a registry in order to be able to participate in the program.

So, we worked very hard to figure out how we could design a transition year that would allow people who are ready to be able to participate fully but also allow sort of an on-ramp for those who really felt like they needed more time and so we announced pick your pace.

So, there are really four ways you can participate under pick your pace. You can either…if you’re participating in an advanced APM or you’re ready to participate in an advanced APM that’s obviously one method.

Then there’s test pace which is where we allow you to submit a minimal amount of data, a partial year where you can report for about 90 days which is a timeframe that folks are obviously very used to because of Meaningful Use or you can participate for a full year and if you…especially we think that folks who have been doing this for a long time will feel comfortable with that. Next slide, slide 11.

So, I’m just going to walk through what each of these mean. So, for testing, so choosing to test for 2017, you can essentially submit the minimum amount of data to avoid a downward adjustment. Essentially the only way to get a downward adjustment, the -4% for 2017 performance year, which will affect 2019 payment, is to do nothing.

But if you submit one quality measure or one improvement activity or the required ACI measures, and there are five of those, then you can avoid the downward adjustment. You can certainly submit, you know, two or three of each if you want but you only have to submit one to avoid a penalty. You probably won’t get much of a bonus either, you may have actually a neutral adjustment, you know, you’ll just be…you’ll just get reimbursed based upon the physician fee schedule with no upward adjustment or you’ll get a very, very minimal upward adjustment.

The reason that we had to finalize the five required ACI measures instead of allowing for one measure really has to do with the requirements under the original HITECH legislation for the measures that are required to say that somebody is essentially a Meaningful User if you will. So that’s why we have to require those five.

Going onto the next slide, partial participation, so clinicians for partial participation can choose to report for a period of time less than a full performance year but we are suggesting that people can report for 90 days because again that’s a period that they’re very used to.

They would have to report more than one quality measure and more than one improvement activity but they certainly would avoid a payment penalty and might even be able to earn a positive payment adjustment. So, they can begin collecting data and reporting any time from January 1st through October 2nd to meet those 90 days. The time period, during which you actually submit data to CMS is what it has always been, it is January through March of the following year. So that’s why this slide says you would send in performance data by March 31st of 2018.


And moving onto the next slide, for full participation for 2017, you’d submit a full year of data essentially just like you do for the current programs. We anticipate that folks who do that because it would be a greater amount of data and they’d probably have an easier time reporting on measures that were incentivizing like outcome measures and other high-value measures that may be more difficult to report with just a 90 day period that folks who do a full year would probably earn the largest payment adjustment although if you do report 90 days and you’re a high performer you certainly could receive the largest, you know, a higher payment adjustment.

There’s nothing inherent about reporting 90 days that would get you a smaller bonus than if you reported a year based upon the amount of data that you send in or the amount of time, amount of information or the length of time submitted but we just are anticipating that because of reliability of data and the ability to report more outcome measures if you’re doing a year that those folks are more likely to receive a higher payment adjustment but that’s not certainly set in stone or guaranteed by any means.

Okay, moving to the next slide, slide 14. Again, just sort of reinforcing what I said, you know, we’ve gotten this question a lot, you know, are we going to somehow…people who report 90 days are guaranteed to get, you know, a lower bonus that’s certainly not the case here and people really should pick what is best for their practice.

Moving onto slide 15, so we also proposed the ability for clinicians to report either as an individual or as a group just like they do in PQRS. I think what’s important to note here is what’s asterisk there on the bottom, if clinicians participate as a group they are assessed as a group across all four performance categories. So, you can’t participate as an individual for quality but as a group for the other three categories. You do it all as an individual or all as a group. So, next slide.

So, I’m going to just walk through each of the categories but certainly focusing for the most part on the ACI category. So, next slide, slide 17.

These are the performance categories and their weights and the weights are assigned to each category based upon 100 point scale as is required under the legislation. So, a couple of things to note here, the big changes from the proposed rule were around quality and cost. So, we got, again, sort of really overwhelming feedback from folks that they really wanted us, during the first year, to not score clinicians on cost and the reason for this was twofold.

Number one, we had proposed a number of measures, episode-based resource use measures that had been available in feedback reports but had not been used to tie to payment previously and so people wanted a little bit more experience with those.

Also the 2015 performance year was the first year that even individual clinicians were subject to the physician value modifier which includes cost measures and so particularly for clinicians that were in groups of nine or less, or individual practitioners they really felt like they did not have enough experience with the resource use or cost category and wanted more time to understand those measures and get feedback on those measures before we start applying it as part of the composite performance score that could affect their payment and we thought that was reasonable and we did finalize that we’re going to be weighting the cost category I think at 10% in the second year and by the third year statutorily we had to weight it at 30%.

So, for the first year cost will be at zero but we will still be calculating cost measures for clinicians and giving them feedback on that so they will have the opportunity to see how they’re doing.


Okay, moving onto the next slide under quality. So this really replaces the PQRS and the quality portion of the value modifier. It will comprise 60% of the final score. Each clinician will be able to select six measures which is a reduction from what is required under PQRS where it’s nine measures across three national quality strategy domains.

Within MIPS there is no requirement that clinicians have to choose measures that cover a certain number of domains but they are encouraged to choose measures that span as many domains as possible and we did build in some incentives for them to choose measures that are what we call high value so certainly outcome measures as well as, you know, appropriate use, patient safety, care coordination and so forth.

So, of these six measures one must be an outcome measure or a high priority measure if an outcome measure really isn’t available to them or relevant for their practice and you see the different types of high priority measures what I just said, outcomes, appropriate use, patient experience and so forth.

Clinicians may elect instead of choosing six measures out of the portfolio of about 300 measures we also finalized a number of specialty measure sets. We worked with specialty societies to define these sets and so they can elect to just choose a set and report that set. Some of the sets are more than six measures. They can report all the measures in that set or they can only report six. And there are one or two sets that are only four measures I believe because that specialty only has four measures and so they would just report those four measures and wouldn’t be penalized for not reporting six.

One other very important thing to note here is that there are different requirements for group practices that are reporting via the CMS web interface or those that are reporting in APMs. So, the web interface is a method that’s really used primarily by groups of 100 clinicians or more, it’s available to groups of 25 or more but is mostly by far used with much larger groups. They still would have to report all of the measures within that web interface and I believe there’s about 15 or 16 measures in that web interface and the reason for that is we have to do assignment and sampling ahead of time for those groups for all of those measures and plus these do tend to be groups that have been participating for quite some time.

If a group has been participating in a web interface and, you know, wants to either, you know, choose through pick your pace 90 days or something else then they can choose to report through another mechanism like a registry.

Okay, moving onto slide 19, I’ve pretty much already covered cost, it will be zero percent of the score but we will still be giving feedback on this category in 2017.

Moving onto slide 20, this is the improvement activity category. We will be asking clinicians, at least in the first year or two of this program, to simply attest to participation in activities that improve clinical practice. There are about nine different subcategories that you see listed here. Six of these categories, I believe the first six, that you see here are the categories that were required under legislation but we did have the flexibility to propose more categories so we proposed the ones you see at the bottom health equity, integrating behavioral and mental health and emergency preparedness and response and got very positive feedback on those so we did finalized them and then underneath each of these nine there are specific improvement activities. We will be releasing more information with more detail around each of these categories. So, again clinicians choose from about 90 plus activities under each of these categories. Moving onto the next slide.


No clinician or group has to attest to more than four activities. We also did give special consideration for small and rural practices as well as non-patient-facing clinicians so they…in order to get full credit for this category they have to report I believe on two activities. And then if you’re an APM or a certified medical home essentially you get full credit for this category automatically. Moving onto the next slide.

Now the next series of slides is around advancing care information. So, what we did with this is we really wanted to focus our efforts here on promoting patient engagement and electronic exchange of information. This category ends and replaces the EHR Incentive Program from Medicare clinicians. We did allow for much more flexibility in choosing measures but there…and also this category is not necessarily just exclusive to physicians I think that’s important to note as well. It basically applies to all eligible clinicians participating in the MIPS Program either as an individual or as a group. There are some ways to of course apply for exceptions which I’ll get to in just a little bit.

So, what we’ve done is we’ve essentially removed the all or nothing reporting criteria that was under the EHR Incentive Program and, again, replaced it with a greater degree of flexibility. So there are no longer the thresholds that a clinician must hit in order to be successful in this category.

So, there are two sets of measures and I’m going to just go to the next slide to talk about this. So, first of all of course clinicians must use certified EHR technology to report. For those who are using the 2015 Edition, so in 2017 if clinicians have upgraded to 2015 technology they have two options. They can either report to the advancing care information objectives and measures that are finalized for the 2015 Edition or we know that some clinicians may want to report a combination of the 2015 Edition and the 2014 Edition objectives and measures.

If you’re using…if you haven’t upgraded by 2017 and you’re waiting until 2018 to upgrade to 2015 Edition technology you can use your 2014 Edition technology and we have a set of measures that are specific to the 2014 technology and you can, again, use a combination of the two measures sets if you like. Moving onto the next slide.

So, for the transition year, what does it mean for this particular category? Test pace means submitting 4 or 5 base score measures and that depends upon which edition of technology you have. Reporting all of the required measures in the base score you have to report all of the required measures in the base score to earn any credit in this category. And then partial or full participation means submitting more than just the base score in year one and I am going to walk through this in just a bit. Moving onto the next slide.

Again, there are two sets of objectives and measures. There is the 2017 transition objectives and measures because again we know not everybody will have upgraded to 2015 Edition technology and there of course is what would be sort of the 2015 Edition technology objectives and measures that will be required for everybody starting in 2018.

Moving onto the next slide this just walks you through, I’m not going to read through this, but you should be able to, you know, keep these slides or have these slides available to you. This just walks through what all of the different performance score measures are.

Okay, so there is some flexibility built into this category generally. So, CMS will automatically re-weight this performance category to zero for certain clinicians. So, for hospital-based clinicians, clinicians with a lack of face-to-face patient interaction, so those who are considered non-patient-facing clinicians, nurse practitioners, PAs, CRNAs and clinical nurse anesthetists or clinical nurse specialists, excuse me, they can


report in this category if they want to but we are not going to require them to do it and we will automatically re-weight folks to zero and give that weight back in the quality category.

Also if the clinician faces a significant hardship and is unable to report measures they can apply to have their performance category score weighted to zero. This of course mirrors the hardship exception rules we have in place currently.

Okay, moving onto slide 28. So, this is how this particular category works and again I do want to acknowledge that this does…that this is somewhat complex, we do understand that but this is…what we were I think able to…the policy that we put forward to be able to again give that flexibility to clinicians to be able to choose the measures that are most relevant for them while basically adhering to the statutory requirement that certain measures must be reported in order to be successful under advancing care information because that piece of the HITECH legislation did carry over into the MACRA Program.

So, there’s a base score that you’ll be scored on or clinicians will be scored on plus a performance score where you can actually get more points and do better under this category, plus we provided opportunities for getting bonus points under this category. Actually, the total number of points that are available under this category under this scheme is actually more than 100 but we would, you know, obviously just cap you out 100 points in order to get the full 25% for the ACI category. So, I will walk through each of these.

So, moving onto slide 29 let’s start with the base score. So, under the base score clinicians must submit a numerator and denominator or a yes/no response for each of the required measures and again there are two sets of measures depending upon the edition of technology that you have. Failure to meet the reporting requirements will result in a base score of zero and therefore a performance score of zero under this category.

The measures that are required under this category include protecting patient health information or the security risk analysis, ePrescribing, patient electronic access and then two health information exchange measures at least for the 2015 Edition technology, sending a summary of care and requesting or accepting a summary of care.

Moving onto the next slide. So, for the performance score, this is worth up to 90% of the full total amount of points for this category. You can report up to nine advancing care information measures for 2015 Edition technology or up to seven advancing care information measures if you have 2014 Edition technology. And basically each measure is worth a total of 10 to 20% and the percentage score is based upon the performance rate or really the…which really translates into the amount of data that are sent in for each category, for each measure, excuse me. I apologize somebody is trying to call me on another line that’s the ringing you’re hearing.

So, this is just…so basically you get a base score that is worth 50% but you can actually get higher than 50% by reporting more information on each of the base score measures plus the additional measures such as clinical information reconciliation, public health and clinical data registry option reporting and so forth.

Moving onto the next slide, slide 31, we do also provide opportunities for getting bonuses. So, you get a 5% bonus for reporting on any additional public health and clinical data registry so to incentivize use of registry reporting you see those here. You also get a potential 10% bonus for using certified technology to report certain improvement activities. So, this gets to what I mentioned early on where we were


trying to start down the pathway of aligning the improvement activity category with the advancing care information category. So, if you’re a clinician and you choose improvement activities that leverage the use of certified technology you can receive a 10% bonus and we would know that from the improvement activities that you report to us.

So, moving onto the next slide, this is very busy, I’m certainly not going to read through it. Essentially, these are the improvement activities that we worked with ONC but also took feedback from the proposed rule to identify the improvement activities that leverage certified technology that could be used to get bonus points.

You know thinking about the future we really are interested in further aligning really all of the categories certainly is the ultimate goal for MIPS where, you know, if you’re a practicing clinician and you treat mostly diabetic patients that the quality measures that you submit to us related to the diabetes care you use you select improvement activities that go towards improving care for diabetic patients that you leverage your health IT system to help you care for those patients and that you’re assessed on cost for diabetes care, that they really should all be seamlessly integrated.

We know there’s still quite a bit more work that we need to do, you know, with input from these committees as well as from our colleagues at ONC and the clinician and patient community to think about how we can move more toward measuring sort of the outcomes of care related to use of health information technology that really can be accounted for and scored for both the advancing care information and the improvement activities category.

So, slide 33 just sort of again reiterates how this category works again it’s 25% of the final score and it is comprised of a base score, a performance score and a bonus score for those that choose to either select those activities that are aligned with certified technology or report to additional registries and again the maximum score, despite the number of points, is greater than 100, the maximum score of course would be 100%.

Okay, moving on to surveillance and information blocking attestations, so moving onto slide 35. So, there is a section of the MACRA legislation that requires clinicians to demonstrate that they have not knowingly and willfully limited or restricted interoperability of certified technology. So, we finalized a new required attestation for healthcare providers using technology in the MIPS Program as well as the other EHR Incentive Programs that are still in place for hospitals and Medicaid providers in order to support the prevention of information blocking. So, we have requirements around prevention of information blocking and there also are some requirements that ONC has finalized around participating in health IT surveillance.

So, next slide, prevention of information blocking, basically they just have to attest that they did not knowingly or willfully limit or restrict interoperability and they respond to requests to retrieve or exchange information that they may receive from another provider or from patients and that they’ve implemented appropriate standards and processes to ensure their technology is in accordance with, you know, the applicable laws and standards, they’ve allowed patients access to their information and supported electronic health information exchange with other healthcare providers.

So, we’re envisioning being able to implement this again through a simple attestation that would be through our portal which ultimately we envision being part of the website sort of a one-stop shop, if you will, that we released in October. So, just like they would be attesting for improvement activities they would also attest to this as well.


Under supporting providers with performance of certified EHR technology these…we are asking clinicians, along with ONC, to engage in activities related to ONC direct review as well as accrediting body surveillance of certified health IT.

We finalized, again, sort of a two-part attestation for providers as you see there on the slide. If there are questions about this I’m probably going to defer to my ONC colleagues and I’m also going to have someone from my team who can talk through this one just a little bit more if there are questions about this at the end of the presentation.

Okay, I’m going to just talk a little bit about APMs and we’re getting towards the end and then we’ll have time for questions. So, moving onto slide 39, I think you all know what an APM is; it’s a payment approach that provides additional incentives to clinicians to provide high-value care.

APMs can be sort of more broad like an ACO construct or they can apply to a specific condition, care episode or population such as some of the bundled payment models that we have. Advanced APMs are a subset of all of the APMs.

So, the next slide goes through the Advanced APMs that we finalized for 2017. They are listed here. We do encourage people to check back with us through the QPP website periodically as the final list of Advanced APMs for the first performance year will be posted by January 1st of 2017. But you see the ones that we certainly know or we finalized that are available now.

Now one of the things that we heard from the clinician community in particular is concern that there may not be an Advanced APM available for them because they are a specialist or a subspecialist or maybe there’s not one available to them in their geographic area at this point.

So, moving onto the next slide, we have been thinking about how we can look at the existing APMs that we have that would meet Advanced APM criteria and potentially retrofit some of those to meet Advanced APM criteria for the first performance year if possible but certainly for 2018.

So, a couple of things to note about future APM opportunities, Advanced APM opportunities, first of all, as you’re undoubtedly aware there is a Physician-Focused Payment Model Technical Advisory Committee that’s been empaneled that already started to meet that their purpose is to review and assess physician-focused payment models based upon proposals that are submitted by external stakeholders to the committee and then they can make recommendations to HHS as to whether or not we should implement those models and we know from many conversations we’ve had with the clinician community there’s a lot of work going on out there right now to develop these payment models, certainly many of them from specialty societies but others as well.

So, we are very excited to see what comes through the pipeline. We know a lot of folks out there are working very hard on getting models together to be able to submit to the committee for consideration. So, we’re very excited about that.

But for the 2018 performance year we also anticipate that some of our existing models and a new model that we’re calling ACO Track 1+ will be available for clinicians to participate in. We heard from the clinician community that, you know, I think a lot of folks were disappointed that we were not able to make Track 1 ACO work as an Advanced APM. We felt like we just weren’t able to do that based upon the statutory requirements around financial risk for that track but they didn’t feel ready to jump into Track 2 or 3, and that there were probably some ways that we could have an ACO model that would meet the requirements to be an Advanced APM, particularly the financial risk requirements, but might


be a little bit easier for people to transition into then tracks 2 or 3. So, we are at work now on a new track that we’re calling ACO Track 1+ so more to come on that soon.

Moving onto slide 42, the benefits of being in an Advanced APM and being a qualified participant, so meeting that 25% allowed charges, threshold or the 20% patient threshold is that qualified participants are excluded from MIPS but they also receive a 5% lump sum bonus if they are a qualified participant and then starting in 2026 they receive a higher physician fee schedule update. Starting in 2026 qualified participants in Advanced APMs receives a 0.75% update and everybody else receives a 0.25% annual update.

Okay, moving onto the next slide, I want to talk a little bit about concerns we heard from the clinician community but I would say also just more broadly around the ability of fellow practitioners and small practices, rural practices to be able to be successful in the program. So, as we were designing our final policies and certainly one of the things that led us to the transition year in the first place was concern around this clinician population.

So, moving onto the next slide, we believe that based upon what we finalized that there will be easier access to being able to participate, at least in the MIPS Program, to be successful in the quality payment program by small practices, rural practitioners and those in health professional shortage areas. So, we’ve reduced the time and cost to participate not only because of pick your pace but also because we’ve reduced the number of measures that are required to be successful. With pick your pace of course there’s now an on-ramp to participation.

We also are increasing the opportunities to participate in Advanced APMs and we included a practice-based model for participation in Advanced APMs as an alternative to a total cost-based option which is something we heard from the clinician community would make things easier for them.

And then the MACRA legislation actually provided about $100 million to CMS to provide technical support and outreach specifically geared toward small practices, rural and underserved practices as well. So, we have those, that procurement action is well underway. We hope to be able to make an announcement about that sometime early in 2017 so working very hard on that but we’re really excited about that and we think that that’s going to be tremendously helpful for people to be able to get that frontline technical support to help them participate in the program.

And then through our current transforming clinical practice initiative, which has been up and running now for over a year, we actually have recruitment targets for small, rural and underserved practices of about, I think, 20% and we’ve been meeting this target. So, there’s direct technical support already out there available for these practices under TCPI. Next slide.

There are also certain exceptions that we created in the final rule for these practices. So, we established a low-volume threshold in part with these practices in mind so we have already talked about that. For the improvement activity category these clinicians in these practices essentially need to…the requirements are essentially half of what they are for everybody else so they can choose one high weighted activity which would get them 20 points or two medium weighted activities each one being worth 10 points for a total of 20. And 20 points for these practices would get them the full credit of or 50% for that category.

And then we also increased the ability for clinicians in certain types of settings FQHCs, rural health clinics and CAHs to qualify as a qualifying APM participate.


So, I’m going to talk a little bit more about the technical assistance and support that’s currently available so moving onto the next two slides. So, slide 47, there are three ways that we are providing or funding the provision of technical assistance now. So, first is what I just mentioned TCPI which is designed to support really up to or more than 140,000 clinician practices over the next four years. These are intended to target practices that are ready or want to get ready to make the transition into an Advanced APM environment and so really ready to engage in system redesign and practice redesign.

We also have assistance from our existing Quality Innovation Networks and QIOs who traditionally have supported hospitals and nursing homes but now are also there and available to support, you know, frontline clinicians. So these will really be targeted more towards little bit larger practices.

And then we have, if you’re in an APM, the Innovation Center’s Learning Systems can help you find specialized information about what you need to do to be successful. So, each of our APMs has a learning collaborative associated with it where participants in the APM come together to share stories and best practices and document best practices. There is usually a faculty that’s associated with each of these learning collaboratives and the feedback we’ve gotten has been that the participants find them incredibly valuable to help them learn what works so they can apply it to their practices.

So, finally, on slide 48, we finalized this rule in a similar fashion to what we did last year with the combined Meaningful Use Stage 2 and Stage 3 rules where we finalized it with comments and what that means is that all of the policies that are in the rule are final but there are some things, for example virtual groups, that we did not implement in the first year that we’re seeking more comment on and there are additional areas, including around the advancing care information category and further alignment with improvement activities and so forth, that we are seeking additional comment on to inform the future years of the program.

So, comments are due by December 19th. They should be submitted in the usual fashion to us through the Federal Register. So, we haven’t gone over what we’re seeking comment on but certainly happy to talk to that if that’s helpful.

And then finally, going onto the second to last slide this is our website qpp.cms.gov I’ve referenced it numerous times throughout the talk. I hope some of you have gone to it while I’ve been talking. The content that we put up on that site is really driven by what we’re hearing from our stakeholders that they want and that they need and that’s really the approach that we’ve been trying to take for everything including the policy. You saw that a couple of weeks ago we released our first API related to the QPP around our quality measures, actually it’s all of our measures not just our quality measures.

Our intent is to develop and release more APIs that will be useful to clinicians, to vendors and to other stakeholders eventually patients as well and the development of those will again be driven by what we are hearing from our stakeholders that they want and need and that would be useful to them.

And so, certainly very open to feedback on how we can make this website better or any of our tools. And this is also where you would want to go to learn about what technical assistance is available to you in your area and which of the three and soon four, with the technical assistance available to small and rural practices which will be available soon, which of these is most appropriate for your practice.

And I think that is it. I want to let you know that I have two of my colleagues here in the room with me, Jayne Hammen and Alex Mugge who run our Division of Health IT and have been instrumental in the development of not only the Quality Payment Program policies but also the EHR Incentive Program


policies who are here to help answer any questions that you all may have. So, I will stop and happy to take questions.

Paul Tang, MD, MS – Vice President & Chief Health Transformation Officer – IBM Watson Health Well, thank you very much Kate and once again, thanks to you and the communications team that put together these slides for really an exceptionally clear presentation. It’s much easier to read then the rule, but, thanks.

So, if the committee members would raise their hand on the tool I’ll call you in order. The first came in from Kevin Johnson from Vanderbilt having a question of has there been any consideration given to aligning the MIPS improvement activities, as you know we have maintenance of certification, with the medical specialty boards MOC, Maintenance Certification Practices, so that you could…in the end it could fit in with your desire to have the improvement activities reported through the certified EHRs?

Kate Goodrich, MD, MHS – Director, Center for Clinical Standards & Quality – Centers for Medicare & Medicaid Services Yes. So, we do have maintenance and certification and I forget the details around it, forgive me, as one of the improvement activities that is available to clinicians now. We actually have started some discussions with the ABMS an some of the individual boards about how we can strengthen that and part of those discussions have been around how we could further align that particular improvement activity with the use of certified EHRs.

So, we are in ongoing conversations with the ABMS but some of the individual boards that have…that are maybe a little bit more sophisticated in their development of registries for example and being able to abstract data from EHRs for their registries. So, we’re definitely open to how we can further align that and have already been thinking about it but, you know, certainly open to feedback from folks here, you know, either here or off line about thoughts you may have about how we can do that for future years.

Paul Tang, MD, MS – Vice President & Chief Health Transformation Officer – IBM Watson Health Okay, thank you, very much. And Eric Rose?

Eric Rose, MD, FAAFP – Director of Clinical Terminology – Intelligent Medical Objects Good morning. Thanks for the presentation and kudos for making it through, it was a marathon. I represent practicing physicians, the statutory physician…for practicing physicians on the Standards Committee and I’d be remiss if I didn’t ask, what is CMS doing to ensure that the data entry burden on the practicing clinician during the patient encounter that results from MIPS doesn’t have a deleterious effect on the quality of care provided at that encounter because we hear a lot about, you know, these days the doctor just had his or her head pointed toward the computer, didn’t look at me at all, a lot of anecdotal evidence that said that we’re introducing risk.

So, with this, you know, consolidated large program I think it is incumbent upon CMS to do something to measure that. So, how is CMS going to address it and it’s not just about the small, rural and underserved practices I think this applies in all practices. So, what’s CMS’s plan to assess that?

Kate Goodrich, MD, MHS – Director, Center for Clinical Standards & Quality – Centers for Medicare & Medicaid Services Yeah, so we have absolutely heard that loud and clear, you know, I’m a practicing physician, I can tell you it’s a real issue, you know, we definitely do keep our noses pointed at the computers and I think some clinicians do find it challenging to have that more meaningful patient encounter that they want to have when they are required to document for a variety of purposes not just for this program, right.


So, I think that this issue goes beyond just the Quality Payment Program although I think we definitely have things we can do within the Quality Payment Program to reduce that burden to some degree and what I will say is I can’t tell you exactly how we would do that. I think we tried to start that with the first year by not only, you know, having pick your pace but by reducing the requirements around the advancing care information category so people aren’t necessarily so focused on meeting some of these thresholds that may be just really not meaningful at all for their practice, so providing that flexibility around ACIs so people can really choose the measures that actually, you know, add value to the program.

And then thinking ahead over time, you know, even beyond the measures that we just have now but how do we capture sort of, again getting to the patient outcomes of care that are supported by the use of technology and how do we capture that in a way that’s less about sort of just counting things which is the feedback that we hear now that is frustrating to clinicians with the way some of the measurement is set up now. I also think…

Eric Rose, MD, FAAFP – Director of Clinical Terminology – Intelligent Medical Objects So…

Kate Goodrich, MD, MHS – Director, Center for Clinical Standards & Quality – Centers for Medicare & Medicaid Services Like I said this is bigger than just the MIPS Program or the ACI or the, sorry, Quality Payment Program, this goes to, you know, documentation writ large that, you know, is required by CMS and other payers and so one of the things that we announced at the time…around the time of the final rule was sort of a new focus with, you know, resources dedicated to it within CMS around sort of, you know, reducing documentation burden or burden generally for providers, again, sort of more writ large so that work is sort of just getting underway but I think we have to look at that in addition to what’s required for the Quality Payment Program.

Eric Rose, MD, FAAFP – Director of Clinical Terminology – Intelligent Medical Objects So, thank you, so it sounds like…I mean, there are some areas that touch on this, but there really isn’t a…CMS doesn’t have a specific plan to determine the impact of MIPS data entry burdens on the quality of the physician patient encounter and so I guess my follow-up would be, are you open to input from the Standards and Policy Committees as to what CMS could do to assess and maybe mitigate that risk?

Kate Goodrich, MD, MHS – Director, Center for Clinical Standards & Quality – Centers for Medicare & Medicaid Services Yes. I apologize I didn’t directly answer your question now I see what you were asking. You’re right we don’t have a specific plan like a specific measure around that. That is true. We are very open to that.

I think we certainly strongly believe that it is an issue and that’s why we, you know, started to try to address it but certainly if the committee has thoughts about how we could either measure it or certainly I think even more importantly additional thoughts about how we can further advance this category and what’s required for this and quality measurement I would say to reduce burden we would be very interested in that as well.

Eric Rose, MD, FAAFP – Director of Clinical Terminology – Intelligent Medical Objects Thank you.

Paul Tang, MD, MS – Vice President & Chief Health Transformation Officer – IBM Watson Health Thank you. Next is Leslie Kelly Hall.


Leslie Kelly Hall – Senior Vice President of Policy – Healthwise Thank you very much and I would echo the compliments on the presentation but also the work that you’ve done in creating websites and explanations online for MACRA and MIPS has been really exceptional, easy to understand and very approachable so thank you for that.

I am confused by one area and that’s the requirement for certified use of technology it seems that that’s pervasive throughout but then there was a section you mentioned that there was bonus if you did use the certified technology. So, is it an opportunity for a bonus as optional or is it a requirement?

Kate Goodrich, MD, MHS – Director, Center for Clinical Standards & Quality – Centers for Medicare & Medicaid Services Okay, I think what you’re referencing, but tell me if I got this right, I mean, certainly for the advancing care information category you have to use certified technology to do that. I think maybe what you’re talking about is around the improvement activity category, do I have that right?

Leslie Kelly Hall – Senior Vice President of Policy – Healthwise Yes, there is a place where you said there was a 10% bonus for…

Kate Goodrich, MD, MHS – Director, Center for Clinical Standards & Quality – Centers for Medicare & Medicaid Services Ah.

Leslie Kelly Hall – Senior Vice President of Policy – Healthwise Including use of that and so I’m wondering where is it optional, where is it not?

Kate Goodrich, MD, MHS – Director, Center for Clinical Standards & Quality – Centers for Medicare & Medicaid Services Okay, got you. So under the improvement activity category we identified I think about 18 improvement activities that directly leverage use of certified technology to accomplish those activities. Those are the ones that are optional for clinicians to choose those and remember there are like about 95 improvement activities overall but if, as a clinician, you choose to attest to one of those 18 then you would get the bonus points that cross over into the advancing care information activities.

So, let’s say that you pick, you know, one of those 18 and let’s say anticoagulant management improvements and I know that’s very general, but there’s more detail behind that, but let’s say you pick that one as a clinician and you attest to it. We will see that you’ve attested to that and automatically give you the bonus points under the ACI category for having picked an improvement activity that uses certified technology. Does that help?

Leslie Kelly Hall – Senior Vice President of Policy – Healthwise So, what you’re saying of the 90 plus activities that are available to choose from only 18 require the use of advancing information and certified or require the use of certified technology?

Kate Goodrich, MD, MHS – Director, Center for Clinical Standards & Quality – Centers for Medicare & Medicaid Services They don’t require the use of certified technology.

Leslie Kelly Hall – Senior Vice President of Policy – Healthwise Okay.


Kate Goodrich, MD, MHS – Director, Center for Clinical Standards & Quality – Centers for Medicare & Medicaid Services Maybe I can have one of my colleagues here explain it, I’m sorry, they’re more steeped in the details than I am.

Leslie Kelly Hall – Senior Vice President of Policy – Healthwise Okay, thank you.

W Sure, so those 18 do not require the use of certified EHR technology, however, if you complete the activities using certified EHR technology there will be an attestation to say, I used CEHRT to complete this activity which will earn you the bonus points in the advancing care information performance category.

You can also complete the improvement activity without the use of CEHRT however you would not qualify for that bonus.

Leslie Kelly Hall – Senior Vice President of Policy – Healthwise And in the advancing payment model area is it all required for CEHRT or not?

Kate Goodrich, MD, MHS – Director, Center for Clinical Standards & Quality – Centers for Medicare & Medicaid Services So, to be an Advanced APM you have to…there are requirements around the use of certified technology that’s one of the statutory requirements to be an Advanced APM is the use of certified technology. Each APM has their own improvement activities that are separate from MIPS, what I’ve presented here.

So, and if you basically…if you are in an APM, if you’re a doctor that’s in an APM but you’re participating in MIPS because you either don’t meet the 25% reimbursement threshold or your APM isn’t an Advanced APM because the improvement activity requirements are really robust within each of the APMs you automatically get full credit for the improvement activity category under MIPS.

So, I think one really important thing about the APMs to remember nothing about the MACRA legislation changes the requirement of each individual APM. So, they have their own set of quality measures that are…you know they have to be comparable to the MIPS quality measures but they have their own set of quality measures that are assessed on cost for total cost of care so they are not subject to the resource use measures we have. For improvement activities they get full credit because that’s inherent in participating in an APM and also as required by law they have to use certified technology.

Leslie Kelly Hall – Senior Vice President of Policy – Healthwise Okay, thank you very much. I’d encourage some…in future documentation to be really clear about that because as we think about standards in the future we want to make sure we’re focusing our efforts on those standards that advance information use that are under requirements of the MIPS/MACRA.

Kate Goodrich, MD, MHS – Director, Center for Clinical Standards & Quality – Centers for Medicare & Medicaid Services Yes that makes a lot of sense. The slide deck we have here is part of about a 90 slide deck that does have that information in there plus we have certain fact sheets on it on our website. So, I didn’t include it here, but it is out there for folks to see.


Leslie Kelly Hall – Senior Vice President of Policy – Healthwise Super, perhaps the committee could get those slides, thank you.

Kate Goodrich, MD, MHS – Director, Center for Clinical Standards & Quality – Centers for Medicare & Medicaid Services Yes, oh, sure. I think they’re on our website so anybody can get them, but we can certainly make sure you get them.

Paul Tang, MD, MS – Vice President & Chief Health Transformation Officer – IBM Watson Health Thank you. Next is Rich Elmore. Anybody else who wants to raise their hand please add yourself to the list.

Richard Elmore, MA – President, Strategic Initiatives – Allscripts Kate, great presentation thanks a lot. Question about patient safety organizations and whether or not there’s any defined role for them as it relates to the Quality Payment Program?

Kate Goodrich, MD, MHS – Director, Center for Clinical Standards & Quality – Centers for Medicare & Medicaid Services So, these are the PSOs that are I guess, you know, more tied to hospital quality reporting, is that what you’re referring to?

Richard Elmore, MA – President, Strategic Initiatives – Allscripts Yeah, it’s also relevant to providers. So, but, yes, so the AHRQ kind of…

Kate Goodrich, MD, MHS – Director, Center for Clinical Standards & Quality – Centers for Medicare & Medicaid Services Right.

Richard Elmore, MA – President, Strategic Initiatives – Allscripts Yeah.

Kate Goodrich, MD, MHS – Director, Center for Clinical Standards & Quality – Centers for Medicare & Medicaid Services So AHRQ PSOs, right, right, right. You know off the top I don’t have all of the 90 plus improvement activities memorized but I don’t believe we have that as part of the improvement activities currently. So, like for example if you’re a hospital-based clinician and you participate in reporting adverse events to a PSO or something like that is that sort of how you’re envisioning how they could be included or did you have something else in mind?

Richard Elmore, MA – President, Strategic Initiatives – Allscripts Well, so it was a general question whether or not there was a, you know, kind of a formalized role defined for them. It seemed like there was an alignment opportunity I just didn’t know if…

Kate Goodrich, MD, MHS – Director, Center for Clinical Standards & Quality – Centers for Medicare & Medicaid Services Yeah, there is not yet, obviously, but certainly open to that. You know we’re familiar with that work and we actually, in development of the improvement activity portfolio, worked very closely with AHRQ on that.


We’ve established a call for improvement activities just like we do a call for measures every year, for quality measures, so that people can submit to us ideas around how we could…you know improvement activities that we could add to the program and maybe improvement activities may not be the only way to leverage PSOs but it’s sort of the first thing that comes to mind. So, certainly open to it, but at this point in time there’s not a specific role for them.

Richard Elmore, MA – President, Strategic Initiatives – Allscripts Thank you very much.

Paul Tang, MD, MS – Vice President & Chief Health Transformation Officer – IBM Watson Health Thank you. Leslie, did you have another question?

Leslie Kelly Hall – Senior Vice President of Policy – Healthwise I did, just a quick one. So, for instance in MACRA and MIPS you talk a lot about shared decision-making and the use of technology to support that and in previous…I think a year or two ago we started talking about how to incorporate cost information and had put that aside but it seems to be that is very important how we reconcile decision-making with cost of drugs and so forth which leads me to the question is, how do we then see going forward any sort of how we ramp up the technology and standards advice needed to support MACRA and MIPS?

Kate Goodrich, MD, MHS – Director, Center for Clinical Standards & Quality – Centers for Medicare & Medicaid Services Yeah, so that’s a really interesting question and I know there is some work and forgive me, I forget now the name of the organization but extensive work I think even with some of the folks in the vendor community to develop the technology to be able to make cost information about…in particular this is focused on drugs available and transparent sort of at the point of care so that as clinicians are seeing patients and prescribing new medications they will be able to know and have available to them right then and there what the cost of…not only just the cost of the drug but the cost to that patient based upon their insurance and their co-pays and all that kind of stuff.

And it is very exciting and intriguing technology to think about how we could leverage within the Quality Payment Program I think it’s something that we would be very interested in and have had some discussions with a number of folks who are developing and also just interested in using this technology so I would love to find a way that we could be able to incentivize the use of that technology within the Quality Payment Program because I think that would just add a tremendous amount of value.

Leslie Kelly Hall – Senior Vice President of Policy – Healthwise Thank you.

Paul Tang, MD, MS – Vice President & Chief Health Transformation Officer – IBM Watson Health Thank you and then finally, Kathy Blake.

Kathleen Blake, MD, MPH – Vice President – AMA-Convened Physician Consortium for Performance Improvement – American Medical Association Yes, thank you Paul and thank you Kate and to your entire team. So, the question that I have really goes to the quality portion of MIPS and the availability of quality measures now at about 300 measures and I’d like you to use this opportunity, if you can, to update us on the progress being made by the Core Measures Collaborative and what your thoughts are about being able to have that measure set, which is being developed or identified in collaboration with private payers, become an increasingly large component of the measures for the Quality Payment Program because it certainly has been our view


that having as much harmonization between the federal and the private payers would lessen clinician burden, health system burden for the kinds of reporting we’re talking about. Thank you.

Kate Goodrich, MD, MHS – Director, Center for Clinical Standards & Quality – Centers for Medicare & Medicaid Services Sure. So, for those who may not be as familiar with what Kathy is referring to, CMS and America’s health insurance plans convened the Core Quality Measures Collaborative starting a little over two years ago, it basically included commercial payers, obviously CMS, specialty societies, clinicians, patient and consumer organizations and purchasers to develop consensus around core sets of measures for primary care, cardiology, oncology, OB-GYN, GI, pediatrics, I’m probably forgetting one, and the idea being that CMS and commercial payers would implement these core sets for us in our regulations and for commercial payers in their contracts with clinician groups and health systems so that we have as much harmonization as possible across payers for what clinicians have to report really focus, you know, where we want to focus on quality improvement and also to reduce some of the burden that clinicians are feeling so really for both purposes.

Within our final rule we did finalize the vast majority of the measures that were in those core sets. So, they’re currently in the Quality Payment Program. So, in some ways, because we had to go through an annual rulemaking cycle we can implement those core sets at a little bit quicker pace than some of the commercial payers maybe able to at least initially, just because they, you know, have to go through their contracting cycles which are sometimes on an every three to five year basis.

So, you know, we had about 80% of the major payers around the table and agreeing to these core sets and they continue to be committed to this work to, you know, update and refine the core sets as we have better, you know, outcome and patient reported outcomes measures and as we develop new core sets with the additional clinical areas that we haven’t tackled yet. So, we do think that this is a fundamental part of the program.

Again, I think under Quality Payment Program and in particular under MIPS, you know, clinicians can choose the measures that they wish to report. So, we did highlight in the rule, and I think are working towards being able to highlight on the QPP site, exactly what those core sets are so that they’re easy for clinicians to access and know what they are and we’d imagine and hope that clinicians would select if those measures are relevant for them that they would select those core sets to report.

So, we do think it continues to be fundamental to the program to work with the commercial sector to align, in fact that’s called out in the MACRA legislation. So, as we’re going forward with our measure development work our goal is to work very, very closely with certainly all of our stakeholders but, you know, prospectively with the commercial payer community so that we’re not just sort of retrospectively aligning measures based upon the portfolio we have now but that as we’re developing measures that we are prospectively aligning, you know, in order to, you know, achieve those two goals of focusing the quality signal to really drive quicker improvement for patients and also to reduce burden for clinicians.

Paul Tang, MD, MS – Vice President & Chief Health Transformation Officer – IBM Watson Health All right, thank you. Any other questions? Well, I want to thank you again Kate for really such a clear presentation but also it just reflects how much effort CMS put into accommodating the feedback and working with all of the stakeholders in designing something that moves us forward so thanks very much.

Kate Goodrich, MD, MHS – Director, Center for Clinical Standards & Quality – Centers for Medicare & Medicaid Services Well, thank you.


Paul Tang, MD, MS – Vice President & Chief Health Transformation Officer – IBM Watson Health Okay, turning it over to Arien for the next section.

Arien Malec – Vice President, Clinical Solutions Strategy- RelayHealth Corporation Good morning, so we are here to discuss, and I think Kate mentioned this in her summary on her QPP, but at the same time that the finalized MACRA Enablement QPP rule came out ONC issued a companion rule for Enhanced Oversight and Accountability just to bring people up-to-speed this was a rule that ONC put out in response to physician perspectives that sometimes the performance of EHRs in the field did not match the stated performance in certification so this an attempt to provide additional means for providing better verification of EHRs in practice at the same time the rule had some folks commenting that there was potentially too much oversight in ways that were inappropriate relative to the appropriate rule of government oversight and so CMS or sorry so ONC published the finalized rule that responded to much of that input with a finalized Oversight and Accountability Program and here to discuss it are Elise and Mike. Thank you.

Elise Sweeney Anthony, Esq. – Director, Office of Policy – Office of the National Coordinator for Health Information Technology Good morning everyone, thank you so much. Elise Anthony, Director of Policy here at ONC and also presenting with me today will be Mike Lipinski who leads our Division on Regulatory Affairs and federal policy so he, for those who don’t know him, has an amazing regulatory mind and lead drafter for this regulation in particular.

So, what I thought we would do is we’d start with a little bit of an overview of the rule and why we put this together and the process to get to finalizing it.

There are three key parts to this rule that we’ll talk about today, one is the direct review of Certified

Health IT and that sets up a regulatory process around how we look, as ONC, would look at technology that we’ve certified once it’s in the field.

The second key provision is around setting up authorized testing laboratories which in many ways align the ONC ATL process with what we have in place for the accredited certification bodies.

And the last provision relates, additionally, to transparency which obviously you see a theme across our work lately around transparency and the availability of surveillance results. So, those are the three key sections in the EOA rule, the Enhanced Oversight and Accountability Rule.

When we first started putting together this rule we took a lot of time to think about what we’ve heard from stakeholders and put together a rule that we really wanted to get public comment on obviously and to hear the different views and view-points of stakeholders.

So, first I want to really thank all of those who contributed to that process through submitting public comment. As always we review every single comment that comes in and respond to them in the final rule but having those view-points expressed and shared really helped us to think through how best to put together the final rule and we did take much of that into consideration as we put together the final rule in terms of the different ideas and components of how health IT has operated on the ground that was shared with us.

So, we thank you for all of those comments and I think you’ll see a fair amount of that reflected in the final policy that we’ve also included language in the rule explaining where we did not accept some of the


comments we received as well so as, always, we encourage folks to read the rule. The rule is actually fairly short this time around unlike some of the other certification criteria rules that we put together which are longer due to the type of information that they cover. So, next slide.

So, let’s talk first about what the rule does not do and that’s pretty important because this rule is a little bit different from the last rule that we released. The 2015 Edition rule focused on certification criteria. It did include a section to update the certification program as well but usually when people think about ONC releasing a rule there’s some type of certification criteria element or section that’s included in it.

In this rule it’s different. There was actually no new certification criterion that’s included in this rule and there’s no new requirement that providers would be required to do. Now we get this question a lot which is a little bit of an interesting question because, as you know, ONC works on the rules that apply to certified heath IT products whereas ONC, I’m sorry, whereas CMS sets the behavior that’s required for providers regarding the use of certified health IT and just in general for payment but we did get a number of questions and we still do get questions about whether this new rule, this new ONC rule affects providers and I just want to be clear that this rule is actually focused on the products, the health IT products, so really impacts how the developers are developing the products for purposes of certification as Kate Goodrich did mentioned in her presentation, however, there is some cross work between ONC and CMS as always we try to work together very closely.

And one of the things that CMS wanted to do was to…in recognition of what they’ve heard as well in terms of supporting the effectiveness of the product once it’s out in the field is that there is a requirement in the CMS program, in the QPP Program, that a provider would be required to participate in the direct review should ONC be leading it. So, there is a corollary there but that sits in the CMS rule not in the ONC rule.

What else doesn’t this rule do? So, it doesn’t establish a means for ONC to directly test certified health IT. This actually was another area where we got a lot of questions on. What we’re looking at through this rule, in terms of direct review, is the review of the product once it has been certified. So, once it’s certified by the certification body when it goes out in the field we want to make sure that we are doing as much as possible to make sure that the product is operating as it should once it’s in the field.

We recognize that certified health IT not only has to do what it’s supposed to do and what it’s certified to do in the testing environment but also really has to support the needs of providers once it’s on the ground. So, it also does not establish a regular or routine auditing process for certified health IT.

So, now to what it does do. How is this rule set up? So, in terms of the direct review component what this rule does is it sets up a regulatory framework for ONC to directly review certified health IT that’s already been certified and that’s the key part there and then it increases oversight around health IT testing bodies and it also increases the transparency and accountability for the surveillance results, we’ll talk a little bit about those later but hopefully what you’re seeing through this rule is a continued commitment by ONC to make sure that the process associated with certified health IT and it’s use, once it’s on the ground, is very transparent, that providers and other users are aware of how the technology is supposed to operate and that this actually is how it operates once it’s out and released and then implemented.

And then you also see transparency as it relates to ONC, making sure that we are releasing as much information as possible so that providers and other users of certified health IT can make as an informed choice as possible in terms of what the technology does whether it’s…obviously whether it’s been certified but also whether it’s been surveilled and what those results where whether positive or


negative in some ways and negative I mean that maybe there was a correction action plan that had to be addressed and a lot of that information sits on our CHPL, our Certified Health IT Products List, but we are very committed to the transparency of the process and doing what we can to encourage that. Now there’s a lot happening in the private sector in that field and we’re really excited about that as well but in terms of us doing as much as we can I think you see that thread woven through this rule. So next slide, and one more, okay.

So, let’s talk a little bit about the components of direct review and then I’m going to turn it over to Mike to talk specifically about the processes and the procedures that we’ve included in this rule. So, what is the focus of direct review and why are we doing the rule and that’s a question that we get a fair amount of and the goal is really, you know, when we think about health IT adoption we’ve come a long way as a country and a lot of that was due to the work through MU and through the earlier rules that ONC released.

So, health IT adoption as it increases and as the use of certified health IT advances across different programs, across more settings as we encourage interoperability we want to make sure that we are supporting the best amount of accountability we can by health IT developers to make sure that the products, again, are…and you’re going to hear me say numerous times during the presentation, doing what it’s supposed to do once the product hits the ground. So, that’s one of the key reasons.

The other component is thinking about the confidence that purchasers and users have in health IT, there’s a role that ONC plays in that. A lot of that comes through tangibly through the CHPL as it were but there’s a lot of background work that happens in terms of the operation of the testing labs, working with the certification bodies and now through the direct review process we are extending that through a regulatory framework that allows us to actually step in as ONC and look at the product to see how it’s operating and we have some different ways that we can do that that Mike will talk about a little bit later.

The last is setting up a process and I think that’s a lot of what we heard in the proposed rule and you will see there are some additional processes around what termination would look like for example, what the process would be for receiving notification that there’s a concern about the product that is causing a direct review to possibly begin.

But we recognize that the effectiveness of this process hinges not just on ONC it hinges on developers and it hinges on the provider community to let us know if there is a concern with the product and what we want to make sure is that when we’re looking at this we’re looking at it from a holistic perspective and it’s not…our focus is on resolving the problem or the nonconformity, as we call it in the rule, that might have surfaced and the process that we set up helps to manage that to make sure that there is a recognizable process that is set in regulation in terms of how we would look at the direct review and when we would step in and that’s a great segue to the next slide.

So, a couple of things about the direct review process and what that looks like, one it is an independent process. Many folks who are aware of ACB surveillance would know that this process, as it states in the rule, will continue and the ACBs continue to play a really important role in the operation of the certification program here at ONC. The direct review process would be independent of that and in some ways it may be in addition to the ACB process but really the goal here is for ONC to have a way to step in two very specific scenarios that we finalized in the rule.

So, if you look at the last bullet on that slide that really captures that. So, one, ONC would focus stepping in in circumstances where there is a risk to public health or safety, or where there are practical


challenges. So, what do we mean by that? Practical challenges are scenarios that would prevent the ACB from carrying out their surveillance responsibilities and would make it more effective for ONC to do that.

Just to jump back to the middle bullet, which I know was a lot of the questions that we got in terms of the rule and a lot of the comments on the rule as well as amongst stakeholders, was around the focus of the capabilities and what aspects of health IT would we be looking at through the direct review process.

So, we’ve included a lot of language on this in the rule itself, but just to provide a quick summary, we would be focused on capabilities that are certified under the program that takes into consideration that there are other functionalities within a product that may not be certified that we would look at to the extent it would be necessary to determine whether the certified health IT is functioning as it should. The focus however is on the certified health IT within the product. Next slide.

So, let’s talk a little bit about the two scenarios. So we have the public health or safety scenario and then we have the practical challenges or as is noted on this slide, impediments to ACB oversight. So, on the serious risk to public health or safety we focused the final rule in that area. In the proposed rule we put out a number of different scenarios where ONC could step in based upon our authority structure and in the final rule we decided to focus on these particular ones.

For public health and safety it’s a focus on whether there is a reasonable belief that certified health IT may not conform to program requirements and that could be because the certified health IT may be causing or contributing to conditions that present a serious risk to public health or safety.

Some of things we would consider in determining whether there is such a risk is the nature or the severity and the extent of the suspected conditions. We’d also look at whether an immediate response is needed by the government to address it.

And then another scenario we would step in would be whether information that is called into question…that the information presented calls into question the certification of the product itself and this again goes to the reliability that we want to support within the certified health IT community amongst providers who are looking at the product that they continue to have confidence in the products that they are using that are certified.

The other area is practical challenges, right, the impediments to ACB oversight. So, ONC would initiate direct review in some cases where there’s a reasonable belief that the certified health IT doesn’t conform to the requirements and some examples of where the practical challenge may exist with the ACB is one if the information presented or the situation involved confidential or other information that is unavailable to the ACB but is available to ONC or where there’s concurrent or overlapping review between multiple ACBs.

So, for example if there’s a product that has certified health IT and certified health IT functionality A for example was certified by one ACB and functionality B was certified by another but they’re included in a singular product it might be more effective for ONC to step in and do the direct review in that process.

And the other issue that we would consider would be resources or expertise in terms of what ONC has at its disposal versus what an ACB has at its disposal. There are a number of examples that we include in the rule, six to be specific, that outline different scenarios and how we would consider them. Of course it’s a case by case basis when we look at direct review but we thought that this would be helpful to the stakeholder community so we encourage folks to take a look at those. We even included the page


numbers so please do take a look at them because they do give some insight into how ONC is thinking about direct review and some of the scenarios that are laid out in this slide in particular.

So, going onto the next slide I’m actually going to turn it over to Mike and the goal here is hopefully to see a couple of things, one that there’s a strong process in place to address and effect a direct review should one be…should one commence and also that our focus is on the fix. Our focus is on how to fix the nonconformity that’s found.

Our goal is not to terminate products as soon as we find that there’s a problem. What we want to do is make sure that this product is operating as it should for the user community that uses these on a daily basis to provide patient care.

So, once the nonconformity is fixed making sure that this product is out there and that the fix is available to providers is really where our focus is on this rule. So, we think that to be as effective as possible this rule will require everyone to come to table to address the problem and get it fixed and that involves the vendor community. So, we look forward to working with them very much as we move forward and with that let me turn it over to Mike Lipinski.

Mike L. Lipinski, Esq. – Director, Division of Federal Policy & Regulatory Affairs – Office of the National Coordinator for Health Information Technology Thanks, Elise. So, good morning everyone, I’m going to talk, as Elise noted, about the processes that we finalized for direct review. I’m also going to talk a little bit about, you know, how they were, you know, impacted by the comments received through the notice and comment rulemaking process and I’ll just say I’m going to talk about those two other main parts of the rule that we finalized which is the ONC-ATLs and the publication of identifiable surveillance results.

So, let’s start talking about how the whole process itself starts and a little bit how we weaved transparency throughout the whole process as that’s a value we hold dear.

So, it will start with either a notice of potential nonconformity or notice of nonconformity that kicks off the regulatory direct review of a developer’s product and this slide here shows a little…tries to illuminate the distinction between a notice of potential nonconformity and notice of nonconformity, and I guess the information used to make a determination really is what the distinction is between the two of them.

So, obviously within the potential nonconformity there may be a nonconformity versus a notice of nonconformity there is an actual nonconformity but there’s also…and this lays it out here some of, you know, what would happen under each notice a key being under the notice of nonconformity. The developer has to respond with a opposed corrective action plan.

So, what I notice a nonconformity obviously does is allows ONC to immediately address the matter and go to correction. In a potential nonconformity the information isn’t as clear as to what…you know where if there is a nonconformity which is within the developer’s control and therefore we need to take some more steps to look into the issue.

They are two distinct notices. They can both be issued and each have their own time period and a notice of potential nonconformity does not have to precede a notice of nonconformity. So, again back to the fact that it’s based on the information available and we could…ONC could proceed directly to a notice of nonconformity particularly in instances where immediacy is a concern in public health or safety is a concern.


So, let’s move to the next slide where we focus, as Elise said, on the fix and some of the provisions that we finalized in the rule related to that. So, obviously, one of the biggest provisions in the rule in terms of addressing the fix is a corrective action plan and what you have here on this slide highlighted are three key provisions. They’re by no means the only provisions of a corrective action plan. There are…we have…hello? Can everyone still hear me? I was hearing a ringing, a phone ringing?

Michelle Consolazio, MPA – Federal Advisory Committee Program Lead – Office of the National Coordinator for Health Information Technology Mike if you can hang on a second so that the operator can try and pull that line. I’m sorry.

Mike L. Lipinski, Esq. – Director, Division of Federal Policy & Regulatory Affairs – Office of the National Coordinator for Health Information Technology Okay. Okay I wasn’t sure if it was me. Okay, so I’ll continue. So, as I was saying there are multiple requirements of the CAP such as the timeframe in which it will be addressed, assessment of the severity of the nonconformity but what I’m highlighting here or what we’re highlighting here are three key provisions that we think help providers and the market as a whole related, and even the developer, and I’ll explain how.

So, what you have here is that they would have to notify all potentially affected customers of nonconformity and then the plan for resolution. They’d also have to attest and provide documentation that the nonconformity and all issues are resolved in the specified timeframe.

So, this gives us information, ONC, that, you know, they’ve addressed the problem and they’ve addressed the problem for all affected customers as well and then they’re going to provide documentation that supports that not just the attestation itself.

And then a key provision also is they have to explain and agree to execute steps that would prevent the nonconformity from reoccurring. So we think this is good both for the providers obviously but also the developer because what it’s saying is the developer can point back and say not only did I fix it but I’ve got in place a means for making sure this doesn’t recur so you can trust the product going forward and not have to worry about that nonconformity reoccurring again.

So, we’re hoping through the corrective action plan when we identify a nonconformity we can have that quickly addressed and corrected for all affected customers and, again, as I said, not have that issue recur in the future.

And before I move onto the next slide I want to say that in the spirit of transparency we’ve also…and this goes back to the prior two notices I guess I should have mentioned on that slide, we’ve specified ONC actions these weren’t specified in the proposed rule but what we’ve done is said, if we issue a notice of nonconformity or, you know, you send us a corrective action, your proposed corrective action plan or we send you a notice of potential nonconformity here’s what we will do in response.

So, for example, just to give a quick example of the…notice of potential nonconformity what we will say we’ll do is we may end review based on the information provided, we may ask for additional information, we may, based on information we have at that point, proceed to the notice of nonconformity and request a corrective action plan or if there…as required under regulation the developer isn’t cooperating despite multiple efforts to get them to cooperate we can issue a notice of proposed termination, I’ll talk a little more about that in a couple of slides, but I just wanted to point out that transparency piece where we’ve outlined how we’re going to respond to a CAP as well so when we get a proposed CAP the process that takes place before that CAP is finalized and put in place we’ve


outlined in the rule. And so for any…we’ve done the same for proposed termination as well in the interest of making everything as transparent as possible for the developers and all stakeholders.

So, moving onto the next slide talks a little more about the fix and that communication I just mentioned with developers. So, that’s clearly a key component to make…to correct this because we want to see the product stay certified, we want to see it stay on the market and we want to see it being used by providers to facilitate patient care and exchange of health information that supports patient care.

So, you know, the process is set up for that back-and-forth with developers and to, like I said with the corrective action plan, address the problem and there are notices, there are opportunities to respond to all those notices in the CAP as I mentioned as well and then again what we’ll do in response to that.

And if we can move to the next slide this is how we keep all the other stakeholders informed as well. So, developers are required, as I mentioned with the CAP, obviously to notify all potentially affected customers of the nonconformity and the plan for resolution and then they also have to notify them, them being the customers, if the product is suspended or terminated we’re going to make that information also available on the CHPL, the Certified Health IT Products List.

We will also use other means as necessary or as appropriate to provide information to stakeholders such as our LISTSERV to announce any suspensions or terminations. And then, as noted here and as noted in the rule, we will obviously coordinate within the department, we care just as much about, you know, the developer, the product and the providers equally in terms of the impact of a direct review and a potential termination and so we will be coordinating within the department with programs and the agencies that run those programs if the product is terminated to identify…to make that information available to all participants in the program using that product as well to identify and make available appropriate remedies for providers under those programs.

So, let’s move now into talking a little more about the different processes. So, can we move to the next slide?

Suspension, so the suspension was a process that was proposed based on comment and based on how we finalized direct review. It has been narrowed, the scope of suspension, to those situations where the nonconformity with the Health IT…we have a reason to believe that it presents a serious risk to the public health and safety and just as with the direct review itself we would look at the nature, extent and severity of the risk and again we could also do the same if there was a question about the validity of the certification so obviously when we are talking about validity it’s what was done to have the product tested and certified before it was even implemented.

And then just as the opposite would be in terms of lifting that suspension if we no longer had that reasonable belief based on either actions taken by the developer or the circumstances itself resolved we could lift that suspension.

So, let’s move and talk about another part of the process. So, proposed termination. This was a new step in the direct review process based on public comment that we received. So, this gives the developer another opportunity to explain why, you know, maybe they weren’t cooperating if that was a reason for…the basis for proposed termination or instead of just going directly to termination as we proposed in the proposed rule. So, again, another step to communicate and work with the developer has been finalized in the final rule.


Moving on to the next slide, so, the appeals process, also a process in which we received a lot of comment particularly from developers, understandably, their interest in the process and, you know, being able to again provide information and communicate their position. So, based on that we finalized a two-step process so initially we gave them a period of time to appeal but now the final rule finalized the process where they would file an intent to appeal and then they would file their appeal.

Further in the proposed rule we said that ONC could provide additional information beyond the written records of the hearing officer. We received comments on that, the developer wanted to be able to respond to that information or review it.

So, what we’ve done in the final rule is said that if ONC decides to file an additional statement in support of the written record and the decision to terminate or suspend they must provide that to the developer within 15 days of the filing of an intent to appeal this would give the developer then time to review it and provide any additional information or statement as part of their appeal that has to be filed within 30 days of the intent to appeal filing so again another making sure that we have transparent processes in place that provide every opportunity for the developer to provide their side of the story and information. Moving onto the next slide.

So, the certification ban, this was proposed in the proposed rule and finalized. What we did when we finalized this we did provide some clarification and some more flexibility for health IT developers. So, what does this do? It prohibits the certification of any health IT of a developer if a product of theirs is terminated under direct review or if it’s called withdrawal under ONC ACB review. Withdrawal is just a term of art used under the accreditation processes for certification bodies but it means the same thing essentially as terminate.

So, I want to make clear that this only comes into play after we’ve gone through all of those processes I just spent some time talking with you about where they had opportunities, you know, to put forth a corrective action plan to address the issue, an opportunity, you know, if we were at termination, you know, a proposed termination to maybe again address the issue if they weren’t able to in the time, you know, in all that other time provided with the corrective action plan or even through the appeals process there are opportunities there to stop the process and go back and try and fix it before we get to an effective termination.

So after all of that takes place and we actually get to termination that’s when the certification ban is in place and as it says here on the slide our goal here is to incentivize that developer if they haven’t been incentivized yet to correct that nonconformity for those…with that product and for those affected consumers, providers in most cases, before they’re allowed to go forward and test and certify other products.

And what this slide makes clear is that…and like I said it would apply to ACB actions as well but if a product is terminated and a ban is in place…let me be clear what the ACB product, ACB action is only regarding certified capabilities so it isn’t for example the requirements that apply but aren’t certification criteria such as the mandatory disclosure requirements and making those available that would not be a reason for instituting a certification ban.

However, if a ban is instituted ONC makes all determinations regarding the lifting of a ban whether the termination, called a withdrawal, is done by the ACB or if the termination was done by ONC.


And lastly, I want to hit on the appropriate remediation. So, what we say here is that all providers that are effected or excuse me customers that are effected by the terminated certification need to be provided with appropriate remediation.

In the proposed rule we said they had to correct the nonconformity with the product and that was the only way to lift the ban but I think we recognized, and based on comment, that sometimes you may not be able to cure the product or there are other means that may be suitable to the consumer besides correcting that particular product such as an upgraded version of that product that addresses the issue or maybe they’ve decided, the developer and consumer, to part ways and a potential financial settlement or a customer…as a customer releases as a result of a financial settlement could be the appropriate remediation for that particular customer.

So, what we’ve said in the rule that it is not just fixing the product but as long as what we care about is all customers that purchased or licensed that product under the auspices that it was a certified product that would work in the field we want to make sure they are provided with the appropriate remediation and lastly noted here, as with all provisions in the final rule they become effective on December 19th of this year.

So, let’s move on and talk quickly about the other two parts to the rule. So, the ONC authorized testing labs, and as Elise mentioned early on in the presentation, this is going to establish a process that is parallel to the process we already have in place for our ONC ACBs and what it provides ONC with is the ability to…if there are issues to provide an immediate direct and precise guidance if necessary or resolution to the matter and like I said, and we’ll see on the next slide, we can just go to the next slide which shows you kind of the parallel with the ACBs, this is really nothing…not new cloth other than applying a process in place that we have already for ABCs. So, on the next slide, please. Next slide.

Okay, there we are. So, here again, a quick comparison of the ONC ATL processes with the ONC ACB process. As you can see very similar, similar application process, similar need to be accredited as noted on the prior slide there is no new accreditation requirement for the testing labs it’s still NVLAP accreditation.

There is a distinct, principles of proper, conduct for ATLs so they are going to be more specific to testing issues versus the principles of proper conduct for ACBs are focused on certification issues.

And so let’s move to the next slide, which I believe will be our transparency and availability of identifiable surveillance results. Another…which I didn’t mention just recently, but with the other part of the rule the ATLs, this too just like that proposal received a lot of support almost unanimous support even for the publication of these surveillance results including from developers and to get to that I guess unanimous support it was how we finalized the process.

So, what it’s going to do is going to require the ABCs to make these results publicly available but they’re going to make it available on the CHPL on a quarterly basis. We had proposed that they should do it on each of their own websites and, you know, based on comments and consideration of that comment there’s a realization that this is not as easy for providers or other stakeholders to capture all that information it’s easier to have it all in one place than for them to go to various ACB sites, which may change throughout the program as we’ve seen in the past, so you have that issue like if one certification body went out, you know, left the program or a new one came in what happened to those prior results, this way they’ll all be in one place, you’ll have the history of the results now from, you know, the start of this provision going forward all in one place easier for stakeholders to access and it releases the burden on the certification bodies in terms of hosting this information on their websites.


So, as you see here on the slide based on public comment this is the additional data that would be available. So, it’s obviously the identifiable information regarding the product and the developer, but also what criteria or program requirements are under surveillance, how it was done, was it part of the randomized surveillance and to be clear, again, this is an ACB surveillance, this is not direct review that we’re talking about, the proposal was regarding ACB surveillance.

Reactive which could be information provided to the ACB through ONC, the accreditor or from complaints. So that would be a form of reactive surveillance so that’s going to tell you what type of surveillance was conducted, the dates obviously and the number of sites not where, so I want to be clear about that, we’re not making available where that surveillance…what potential provider location but how many sites if it was randomized.

And then obviously the results, you know, did the product continue to perform in the field as it was originally certified for that particular criteria or functionality and if it didn’t, you know, was there a corrective action plan in place. And so that’s information that you see as this balanced view of surveillance result, that is information that’s currently already provided, you know, if there is a nonconformity and a corrective action plan that information is on the CHPL already.

So, with this finalization, and this would not begin until April, and that’s because it’s on a quarterly basis, so the beginning this year we will expect ACBs to collect this information and then early April will be the first posting of this information but it will be…based on what we have to date the information we have to date you’ll begin some see some positive results. So you’ll begin to see for providers…that the product that they purchased, you know, continues to function in the field and is passing surveillance and so you’ll have a history of a product now or you’ll know if your product has ever been surveilled at all because the absence of this information would be an indication that it was not surveilled.

And I should say lastly, based on comments, that the fact that a product goes under surveillance isn’t a bad thing or should not be seen a negative light because as noted there is randomized surveillance and what it says is, you know, that we’re going to check to make sure it continues to function as it was certified and in a lot of cases that will be the case and now you’ll know that because that information will be available on the CHPL.

So, I think with that this concludes our presentation. On the Enhanced Accountability, oh, excuse me, Enhanced Oversight and Accountability final rule and I think Elise and I are available for some questions at this point if there are any.

Arien Malec – Vice President, Clinical Solutions Strategy- RelayHealth Corporation Excellent, so we will open it up for questions. Again, if you want to ask a question, enter yourself in the queue by raising your hand and Michelle can you walk us through…

Michelle Consolazio, MPA – Federal Advisory Committee Program Lead – Office of the National Coordinator for Health Information Technology Yes.

Arien Malec – Vice President, Clinical Solutions Strategy- RelayHealth Corporation The folks on the queue?

Michelle Consolazio, MPA – Federal Advisory Committee Program Lead – Office of the National Coordinator for Health Information Technology Yes. Paul Tang?


Paul Tang, MD, MS – Vice President & Chief Health Transformation Officer – IBM Watson Health Okay, thank you. I have two questions. Thank you, one, for the presentation, like the CMS presentation this was very clear. I do have two questions though and it relates to the public health and safety risks.

So, one, does the plan here invoke anything like the “HIT Safety Center” that was recommended by the IOM? So, for example, you do have the ability to go follow-up on complaints from the field. Is there any requirement that a vendor report adverse events that its customers may report to it? And it sounds like you can request additional information from the vendor. Do you have the wherewithal to do analysis sort of more in aggregate about this particular topic across the certified EHRs? So, that’s question one.

And question two, is having to do with the appeals process. I just wanted to make sure…so if ONC has a reason to believe that there’s a serious risk to public health and safety does the appeals process and the added appeals that you…in the final rule does that only apply to termination or do you also have this appeals process go through for even suspending or notifying the customers of this potential safety hazard?

What I was concerned…I wasn’t clear whether you had to go through all those multiple appeals before actually you could stop preventing harm or potential harm occurring from a vendor’s product.

Mike L. Lipinski, Esq. – Director, Division of Federal Policy & Regulatory Affairs – Office of the National Coordinator for Health Information Technology Well, I can take the last…the second…Paul I can take the second question first because it’s the one I remember most right now.

Paul Tang, MD, MS – Vice President & Chief Health Transformation Officer – IBM Watson Health Sure.

Mike L. Lipinski, Esq. – Director, Division of Federal Policy & Regulatory Affairs – Office of the National Coordinator for Health Information Technology So, I’ll start there and it’s probably the easier one too. So, let’s…so the appeals process, okay, it’s only for a suspension or termination, okay, so there is no proposed suspension process per se in regulation. ONC could issue a suspension…so it’s a reasonable belief of that risk to public health and safety.

Would we always…if that was a prong we used to…under the regulatory process for direct review would we always issue a suspension notice? No that’s not always the case but it could come with the notice of nonconformity and there may be, you know, this is…here’s the basis of why we’re doing this and here’s why we’re suspending your product at this time and then that becomes public so there is notification that goes out, they have to make notification as well.

Can they…they can appeal that suspension so that would be, you know, they could file the intent to appeal immediately. They can file their appeal they don’t have to wait 30 days after they file their intent to appeal they can…that could move quickly. The…I believe its 30 days, up to 30 days for the hearing officer to make a final decision on that.

And then if the suspension was upheld, so let’s just use that one, where there’s a serious, you know, risk to public health and safety, that stays in place, that suspension stays in place until we…ONC determines otherwise if it’s upheld by the hearing officer.

The only two things that they can appeal under the regulation are the suspension and the termination. They can’t appeal the notice of nonconformity or the proposed termination under the administrative


process we’ve laid out in regulation. It’s just the termination and the suspension. So, does that answer that second question?

Paul Tang, MD, MS – Vice President & Chief Health Transformation Officer – IBM Watson Health I think it does. It sounds like there’s up to a 30 day delay. I was thinking if I were to make up an example, so the product accidentally adds an extra zero to drug dosing and you would want to stop that right away but in theory they have up to 30 days before you can…

Mike L. Lipinski, Esq. – Director, Division of Federal Policy & Regulatory Affairs – Office of the National Coordinator for Health Information Technology No, no not if we suspend it. So, take the…

Paul Tang, MD, MS – Vice President & Chief Health Transformation Officer – IBM Watson Health Oh, you can suspend immediately, okay.

Mike L. Lipinski, Esq. – Director, Division of Federal Policy & Regulatory Affairs – Office of the National Coordinator for Health Information Technology Yeah, yeah.

Paul Tang, MD, MS – Vice President & Chief Health Transformation Officer – IBM Watson Health That answers the question.

Mike L. Lipinski, Esq. – Director, Division of Federal Policy & Regulatory Affairs – Office of the National Coordinator for Health Information Technology That…yeah, so if we really think this is a, you know, serious risk to public health and safety we have the ability to suspend that product. It doesn’t eliminate the certification, I want to make clear and we made that clear in the rule, so if you’re participating in an HHS program that requires certified products, if your product is suspended that doesn’t…it’s still certified. So we tried to make that kind of clear, it doesn’t impact your ability to participate in the program until it’s actually terminated…

Paul Tang, MD, MS – Vice President & Chief Health Transformation Officer – IBM Watson Health Okay.

Mike L. Lipinski, Esq. – Director, Division of Federal Policy & Regulatory Affairs – Office of the National Coordinator for Health Information Technology Then you don’t have a certified product anymore, you just have a suspended certified product at that time but it’s still a certified product.

However, that notice has to go out to everyone that the product has been suspended. The developer can’t certify other products until it addresses that safety risk under the regulation. So, if we suspend a product we definitely are concerned obviously about the risks to public health or safety and we expect…

Paul Tang, MD, MS – Vice President & Chief Health Transformation Officer – IBM Watson Health Okay now…

Mike L. Lipinski, Esq. – Director, Division of Federal Policy & Regulatory Affairs – Office of the National Coordinator for Health Information Technology Immediate action at that point.


Paul Tang, MD, MS – Vice President & Chief Health Transformation Officer – IBM Watson Health I’ll restate the first question since it was a while ago.

Mike L. Lipinski, Esq. – Director, Division of Federal Policy & Regulatory Affairs – Office of the National Coordinator for Health Information Technology Sure.

Paul Tang, MD, MS – Vice President & Chief Health Transformation Officer – IBM Watson Health So one it’s in relation to the IOM recommendation for an HIT safety Center which has a number of…

Mike L. Lipinski, Esq. – Director, Division of Federal Policy & Regulatory Affairs – Office of the National Coordinator for Health Information Technology Right.

Paul Tang, MD, MS – Vice President & Chief Health Transformation Officer – IBM Watson Health Attributes, one is that you can require vendors to report adverse events that they hear about from their customers. Two, you can get information from multiple vendors let’s say if there’s something that could be more pervasive in these systems so that you can do an analysis and then potentially affect future certifications.

Mike L. Lipinski, Esq. – Director, Division of Federal Policy & Regulatory Affairs – Office of the National Coordinator for Health Information Technology So…

Paul Tang, MD, MS – Vice President & Chief Health Transformation Officer – IBM Watson Health Do you have those capabilities…

Mike L. Lipinski, Esq. – Director, Division of Federal Policy & Regulatory Affairs – Office of the National Coordinator for Health Information Technology I’ll say a few things about that and then…

Paul Tang, MD, MS – Vice President & Chief Health Transformation Officer – IBM Watson Health That really…

Mike L. Lipinski, Esq. – Director, Division of Federal Policy & Regulatory Affairs – Office of the National Coordinator for Health Information Technology I can say a few things about that and Elise, you know, can add to that. So these are the thoughts that come to mind on that point, so, no, not particularly it’s definitely independent of our work related or proposal related to the safety center, safety collaborative I should say.

And a vendor can always, a developer that is, you know, self-report a nonconformity. It happens this day to ACBs and then they work to correct it. They may correct it even before they report it but they let them know. So that happens and, you know, they can work with their ACB to correct it if they’ve identified it and they may, depending on the circumstances, lead to a corrective action plan that’s on the CHPL as well and that has happened.

Another point to make is that when we determine whether or not, you know, we have a reasonable belief going back to what Elise mentioned about, you know, the severity and so forth, so it could be one really good complaint, you know, use that whistleblower paradigm where they have a lot of information they’ve worked on it and that may be all we need to institute it but as we talk in the rule, you know, it


may be multiple complaints and we’re seeing the same issue at different sites and that would lead to direct review and it’s direct review of the products, it would the product at all those sites as well and those would all be potentially affected customers.

The other point I think I want to make is that if developers get complaints they’re supposed to have a log of those complaints and make those available to the ACBs. So there’s that information and then obviously there’s the healthit.gov complaint site were other complaints can be also submitted which could serve as a basis of direct review if it led to us having a reasonable belief that there is even a potential nonconformity. Does that answer your question in terms of all your questions there or no?

Paul Tang, MD, MS – Vice President & Chief Health Transformation Officer – IBM Watson Health Yes it does. Thanks, very much.

Mike L. Lipinski, Esq. – Director, Division of Federal Policy & Regulatory Affairs – Office of the National Coordinator for Health Information Technology Okay.

Paul Tang, MD, MS – Vice President & Chief Health Transformation Officer – IBM Watson Health Thank you.

Elise Sweeney Anthony, Esq. – Director, Office of Policy – Office of the National Coordinator for Health Information Technology Yeah and I Mike hit on all the points, nothing to add from this front. Any additional questions?

Michelle Consolazio, MPA – Federal Advisory Committee Program Lead – Office of the National Coordinator for Health Information Technology Yes, there are a number of questions in the queue. Josh Mandel?

Joshua C. Mandel, MD, SB – Research Faculty – Harvard Medical School Thanks very much for the presentation. I just wanted to ask the question with sort of a standard hat on which is when these reviews are done, and in particular when surveillance results become available, is there information about how those surveillance results will be structured?

And I’m thinking particularly about standards conformance problems that may be discovered. Would there be an expectation that there would be detailed results that would explain what went wrong in something like a CDA document or an HL7 version 2 message or whether any actual content like invalid documents or invalid messages would be shared as part of that result reporting?

Mike L. Lipinski, Esq. – Director, Division of Federal Policy & Regulatory Affairs – Office of the National Coordinator for Health Information Technology So, I’m not as close to this as, you know, our operations, you know, if you guys are familiar with Alicia Morton who runs our certification program, but I can say that we’re obviously working on the format of the CHPL as it relates to this new information that will begin to be posted and we intend to, you know, get some stakeholder input about how that displays so I will say that first so that it makes sense and it’s not misinterpreted on the CHPL. So, that’s one thing I want to say about that.

As to what the actual issue about what would be wrong it would be, you know, obviously part of the…CAP, right, so they have to…like as I mentioned identify, you know, the issue, the severity of it, how they’re going to resolve it. CAPS are posted now on the CHPL and I believe actually a colleague just mentioned to me that this information is currently in the CAPS.


So, I don’t know how detailed, I would have to look like as to your issue you’re saying like if it’s a particular standard and maybe a particular use case of that standard you’re getting at, right, or a particular data element, is that what you’re asking like is it that granular?

Joshua C. Mandel, MD, SB – Research Faculty – Harvard Medical School Yeah, that’s right, if for some reason the data in a system aren’t conforming to the standard would there be detailed information about what exactly didn’t conform? This is important feedback for the standards developing process to see where implementers go wrong. I mean, it’s very hard to actually get insight into those kinds of problems.

Mike L. Lipinski, Esq. – Director, Division of Federal Policy & Regulatory Affairs – Office of the National Coordinator for Health Information Technology Well, I think, you know, that…I’m definitely going to take that into consideration and take it back to some of our folks. I think…just so your awareness-wise, currently, you know, all CAPS are developed between the developer and the certification body. So what actually ends up on the CHPL is a result of that. We, ONC, doesn’t have a say in that so to speak, right, well we require, you know, that they…part of their accreditation and so forth is to do that.

But, you know, in terms of what gets reported on the CHPL it comes from that process so it depends on, you know, what they’ve put into the corrective action plan between them, the developer and the certification body and then that’s what ends up getting reported.

But like I said, we’ll take that, you know, into consideration, your comment about the level of granularity. I think, you know, it obviously depends on the audience, right, like too much granularity on the CHPL may be confusing to some stakeholders, right, who are looking at it and it may possibly even lead to misinterpretation but maybe somebody such as yourself or others with a viewpoint of standards they would care more about that granularity.

So I think, you know, while we’ll take under consideration what you said I think there’s probably a bit of a balancing there as to what ends up on the CHPL and maybe it is a user interface. Maybe it’s something a level deeper if you want to click on a link or something to get to that we’d have to I think assess that internally.

Arien Malec – Vice President, Clinical Solutions Strategy- RelayHealth Corporation I’m going to take a…this is Arien, I’m going to take a chair’s prerogative and just comment that the field certification rule is really intended at addressing whether certification requirements are honored in practice and it’s a fairly blunt tool, if you will, because most of the outcomes, most of the heavy outcomes are things like decertification, withdrawing a product from the field and the like.

What Josh is pointing out is improving the actual practice of interoperability based on learnings from the field and that really requires a willing participant in the sense of an HIT developer who, you know, honestly wants feedback and wants to improve interoperability which is almost out of the running relative to some of the problem space that this rule is intended to address.

So I guess my editorial comment here is that, you know, I know what Josh is asking for, I believe it’s what’s required to drive real world improvements in interoperability and I think in this case it’s probably the wrong process applied to the right problem whereas the certification rule is really intended at gross mismatches between a practice in the field and practice in certification.


Elise Sweeney Anthony, Esq. – Director, Office of Policy – Office of the National Coordinator for Health Information Technology And this is Elise, just to echo Mike’s comment, you know, we’ll take it back and we’ll look at it a little bit. One thing I would just add and Mike highlighted this on his side of the presentation as well, but, you know, again, decertification…the blunt instrument of decertification is not as much as where we are focused on just for clarity purposes Arien, we really do want to focus more on the corrective action plan process which I think is a much more nimble process and it’s a process that is not just us acting upon a developer but really trying to understand what the problem is and how…or the nonconformity is and how to address it and I think that working with the developer will make that process even more sound.

So, we actually…we encourage developers to work with that on that process and the corrective action plan again focused on figuring out how to address the problem to make sure that the users are able to go back to using the technology as it should be used and decertification and suspension are tools that are available as well but we really do want to try to use the corrective action plan whenever possible.

Arien Malec – Vice President, Clinical Solutions Strategy- RelayHealth Corporation Thank you for that clarification and I apologize for confusion. I do believe though that relative to where Josh is wanting to go I think having feedback from the corrective action plans, as Josh notes, would be useful and also more voluntary coalition of the willing kinds of activities with health IT developers who honestly want to improve their interoperability and practice may require a slightly different process, some of the stuff for example that we’ve been doing in Argonaut Project and others, but I will end the chair’s prerogative and go back to Michelle for the next question in the queue.

Joshua C. Mandel, MD, SB – Research Faculty – Harvard Medical School Let me just actually jump into this. Thank you for that perspective on this and maybe the right framework for thinking about this is given that all these procedures exist and that the surveillance steps are going to be taken and reports will be produced, are there some natural byproducts of that process…

Arien Malec – Vice President, Clinical Solutions Strategy- RelayHealth Corporation Right.

Joshua C. Mandel, MD, SB – Research Faculty – Harvard Medical School That might be able to help better inform the standards development itself and I think that from what we’ve heard there are a few places where those kinds of artifacts could be generated.

Arien Malec – Vice President, Clinical Solutions Strategy- RelayHealth Corporation Yeah, thank you for that and I do think it’s a super helpful perspective for ONC as they operationalize this process going forward. So, Michelle?

Michelle Consolazio, MPA – Federal Advisory Committee Program Lead – Office of the National Coordinator for Health Information Technology Thanks, Arien. Gayle Harrell?

Gayle B. Harrell, MA – Florida State Representative – Florida State Legislature Thank you so very much and I want to thank you for this excellent presentation. I do have some questions, I have several questions. First of all deals with the impact on the provider who actually purchased that certified product and if that product is banned or I guess it doesn’t matter if it’s suspended, but if it is decertified and then the vendor banned, what impact does that have on the provider who is now required under the new payment models to have a certified product when they do


their reporting? And what impact does it have post facto on reports that they…reporting requirements and payments that have been already received?

Elise Sweeney Anthony, Esq. – Director, Office of Policy – Office of the National Coordinator for Health Information Technology So, I can start it and Mike, feel free to jump in. So, this rule focuses on the products and by corollary the developer not on the provider per se. We do however work with CMS on a regular basis in situations where this could come up and I think that the way to address this is not actually new because even under ACBs if a product was decertified there could be an impact on the provider. And what we’ve done in the past has been to work with CMS on how to address that.

So, in the case where…and it happens rarely but when a product was decertified in the past we worked with CMS to determine a hardship exception in that particular case and there’s actually a standing CMS

FAQ, or Frequently Asked Question, that addresses this in specific.

So, I think going forward if a product should come under direct review and they go through the corrective action process and that process does not work out for some reason or another and they end up at termination, which obviously, you know, there are many steps in between to try to get to resolution but let’s say it does end up at the termination stage we would work with CMS to determine how to best address that for the provider population that might be impacted by that.

So, I think that this would be a kind of ongoing conversation but there is a fair amount of work that’s already been done in this space through the frequently asked questions and providing a hardship exemption for that provider. Mike do you want to add anything to that?

Mike L. Lipinski, Esq. – Director, Division of Federal Policy & Regulatory Affairs – Office of the National Coordinator for Health Information Technology I mean, other than, you know, that is an area that we are committed to addressing and we’ve emphasized that actually in the final rule itself that, you know, when a final rule comes out it goes through…it’s just not a reflection of ONC, but it’s a reflection of the department. It goes through department review and consideration and so as Elise has mentioned we always work with our colleagues at CMS and others that are relying on certified health IT and we look at it, you know, from a holistic perspective and so as I said in the rule we emphasize that, you know, if a product were terminated we would take the steps to make sure proper notification was made as well as, you know, what providers and what programs were affected to work with them, them being the agencies running those programs, to identify and make available, you know, the appropriate remedies for participants under that program.

So, as Elise mentioned there is an FAQ on that and how under the EHR Incentive Program how providers should address situations where a product is terminated and that’s just one instance...

Gayle B. Harrell, MA – Florida State Representative – Florida State Legislature Thank you.

Mike L. Lipinski, Esq. – Director, Division of Federal Policy & Regulatory Affairs – Office of the National Coordinator for Health Information Technology But, I think, you know, wherever it came up we would definitely be working with our colleagues to address it for providers.


Gayle B. Harrell, MA – Florida State Representative – Florida State Legislature Yeah, I think that is absolutely critical. I do have one other question though. When you find that there are products that you do need to decertify or even when they’re identified and they go into a corrective action plan are you then looking back at that certifying body and seeing why perhaps these problems existed and are you looking at the certifying body to make sure that they are doing what they should be doing as well?

Mike L. Lipinski, Esq. – Director, Division of Federal Policy & Regulatory Affairs – Office of the National Coordinator for Health Information Technology So, there’s already processes in regulation for the certification bodies and now there is a similar process for ATLs that if there was anything…we have principles of proper conduct that they must follow and trainings that they have to take on, you know, certification and testing a product so there’s all that in place.

And then if something, you know, some type of malfeasance, we’ll call it, took place there are actually provisions in the rule for us to go in and, you know, revoke their status if need be and then if we feel that, you know, for whatever reason that basis was on we can look at the certification issued by the developer or excuse me by the ACB and if needed require recertification.

So, there are backstops in place. Obviously it’s been, gee, six, seven years since this program…

Gayle B. Harrell, MA – Florida State Representative – Florida State Legislature Right.

Mike L. Lipinski, Esq. – Director, Division of Federal Policy & Regulatory Affairs – Office of the National Coordinator for Health Information Technology Well, six years I guess and we haven’t had to do that I think and hopefully we’ll never have to do that but if it came to that we have a process in place to address that and also, you know, as noted as part of the regulation for our direct review, there is a specific provision as Elise talked about if we’re concerned about the validity of that certification in the first place, that, you know, like there are some test procedures that are tools, some that are observation, some that are attestation regarding criteria and, you know, it’s not…the ACBs have in place procedures to, you know, a certain extent about the validity of that but that doesn’t prevent somebody from, you know, committing some type of, like I said, malfeasance or, you know, fraud, for a lack of better word, in terms of what they tell, you know, the ACB about their product or attest, or show them in terms of observation.

So, you know, we’ve tried to make sure we can address those situations both from the certification body and from the developer itself. So, you know, I guess that’s the reassurance I would provide you in terms of we do have ways to address that if that came to light.

Gayle B. Harrell, MA – Florida State Representative – Florida State Legislature Thank you, very much. I think the emphasis on corrective action plans is very, very important and I’m very glad that you’re going down that route, especially for the provider who’s at the end of the road and who is the one who is really going to suffer if that corrective action plan does not work. So, you know, making sure you make the provider whole at the end of the day is key in the corrective action plan emphasis I really, really appreciate. Thank you.

Elise Sweeney Anthony, Esq. – Director, Office of Policy – Office of the National Coordinator for Health Information Technology Thank you and thanks for that feedback.


Mike L. Lipinski, Esq. – Director, Division of Federal Policy & Regulatory Affairs – Office of the National Coordinator for Health Information Technology Yeah, just…

Elise Sweeney Anthony, Esq. – Director, Office of Policy – Office of the National Coordinator for Health Information Technology Sorry, Mike, go ahead.

Mike L. Lipinski, Esq. – Director, Division of Federal Policy & Regulatory Affairs – Office of the National Coordinator for Health Information Technology Yeah, no I was just going to point out your position is a position we heard in the rule and is actually, you know, as we said, part of the certification ban like even if they were terminated the whole goal regarding lifting the ban is to make sure there’s appropriate remediation for those customers in that situation as well.

Gayle B. Harrell, MA – Florida State Representative – Florida State Legislature Thank you.

Michelle Consolazio, MPA – Federal Advisory Committee Program Lead – Office of the National Coordinator for Health Information Technology Leslie Kelly Hall?

Leslie Kelly Hall – Senior Vice President of Policy – Healthwise Yes, thank you. I have two questions. First is, how does the public participate as an individual patient in reporting what they believe is unsafe usage of the technology?

And then the second is because we will see a lot of variability on implementation of certified technology how will best practices for the use of that certified technology come out of this? Because it will be very difficult to determine is this the result of the certified technology itself or the way that has been implemented?

Elise Sweeney Anthony, Esq. – Director, Office of Policy – Office of the National Coordinator for Health Information Technology Yeah, so I can start. You broke up on my end on the first half of the question but I think your question was whether patients could provide feedback to ONC that a product is not doing what it’s supposed to do. Is that…

Leslie Kelly Hall – Senior Vice President of Policy – Healthwise Yeah, that’s the first question, yes.

Elise Sweeney Anthony, Esq. – Director, Office of Policy – Office of the National Coordinator for Health Information Technology Okay. Yes, so absolutely, so we actually currently have a web interface and we can send this out, Michelle can send this out later, but we actually have a way for anybody it could be a patient, it could be a provider, you know, it could be a developer, it could be whoever to actually report when they’re having a problem with technology and I don’t know if that’s in our slide deck, but we can definitely send it around and that’s one of the key ways that this can happen.

In addition, you know, if we heard something as well from a number of different individuals, right, and it just came to our attention we can look at it that way as well. So, there’s a number of different ways but I


think the easiest and most accessible way for a patient may possibly be through the web portal and the e-mail address that we will send out later. So, that’s one way. So we have that and we’ve had that for some time so it’s not new to this particular rule.

And then your…can you remind me what your second question was? I’m sorry.

Leslie Kelly Hall – Senior Vice President of Policy – Healthwise It’s really the difference between implementation quality…

Elise Sweeney Anthony, Esq. – Director, Office of Policy – Office of the National Coordinator for Health Information Technology Oh, right, yes.

Leslie Kelly Hall – Senior Vice President of Policy – Healthwise Where we’ll see variation, how do we collect and promote best practices that we identified and also distinguish between that certified technology is in place but the implementation is poor?

Elise Sweeney Anthony, Esq. – Director, Office of Policy – Office of the National Coordinator for Health Information Technology Right, so and in the rule we talk about this a little bit in terms of when we are looking at whether direct review should come in or going through the process one of the things that we would consider and look at is whether it’s the technology itself or how it may have been implemented. So, those I think would be factors for consideration and that’s part of the reason why we set up the regulatory framework as a case-by-case analysis because there are so many factors that can inform how the fix occurs and whether the fix is something that is a result of the certified health IT itself or how it functions within the product or whether it is actually just an implementation issue.

So, we would look at all those things as part of our analysis. I think we’re always open to the best way to take in best practices and try to disseminate that across the community. A lot of that work I think from that perspective happens on our quality and safety team that’s led by Andy Gettinger as well. So we don’t have the collaboratives in place yet but I think that would be part of that should that move forward.

Mike L. Lipinski, Esq. – Director, Division of Federal Policy & Regulatory Affairs – Office of the National Coordinator for Health Information Technology Yeah.

Leslie Kelly Hall – Senior Vice President of Policy – Healthwise Okay.

Mike L. Lipinski, Esq. – Director, Division of Federal Policy & Regulatory Affairs – Office of the National Coordinator for Health Information Technology I’m just going to piggyback on that because that’s where I was going and I think it’s maybe an opportunity for clarity and back to Paul’s point of clarification. So, this rule is, you know, geared on making sure that the product that was tested and certified continues to work as tested and certified when it’s implemented. If it’s an issue of implementation beyond the developers control, reasonable control, then it’s not within the purview of this rule in terms of taking action, finding a nonconformity and so forth, that could be identified as part of our review but once that happens and that’s like the examples we have in the rules, you know we’ve got example A versus example B when it’s an issue of a


provider implementation versus a developer issue, provider implementation we can identify that but then that ends our review.

The collaborative, yes, as Elise mentioned, there is where you have those type of issues that, you know, can be reported and used to collate best practices for how to implement and so forth. But just, you know, clarity, you know, the goal regarding, you know, the scope of this rule and focus I thought that was a good question to provide that I think to everyone.

Leslie Kelly Hall – Senior Vice President of Policy – Healthwise Thank you.

Michelle Consolazio, MPA – Federal Advisory Committee Program Lead – Office of the National Coordinator for Health Information Technology That was our last question in the queue unless there are any other questions? Okay, well, thank you Elise and Mike for that presentation. I think we will actually be able to wrap up a little bit early today. I just want to check and see if there are any other closing remarks before we open for public comment. We do have a few remarks that we’ll make when we open to public comment, but from the chairs or anyone else are there any comments before we do that? Okay. Lonnie, can you please open the line?

Public Comment

Lonnie Moore – Meetings Coordinator – Altarum Institute Most certainly. If you are listening via your computer speakers you may dial 1-877-705-6006 and press *1 to be placed in the comment queue. If you are on the telephone and would like to make a public comment, please press *1 at this time. Thank you.

Michelle Consolazio, MPA – Federal Advisory Committee Program Lead – Office of the National Coordinator for Health Information Technology Thanks, Lonnie, while we wait for public comment I’m going to turn it back over to Elise to make one announcement.

Elise Sweeney Anthony, Esq. – Director, Office of Policy – Office of the National Coordinator for Health Information Technology Hi, everyone, back again, so this is on actually a different topic. As many of you may recall from, I believe our October meeting, Jim Daniel, our Public Health Coordinator and Leader on Health IT components to help address the Zika…to assist in the Zika response here at HHS, he presented on some of the issues that we’ve been working on and how we’re thinking about assistance to CDC and others regarding Zika response.

One of the things that we are going to continue on as part…that was touched on…one of the issues that was touched was regarding pregnancy status and we talked a little bit about that during the October presentation. We’re starting up a Public Health Task Force and we’re going convene it to provide recommendations on public health issues and challenges related to health IT more specifically the Task Force is going to be asked to review the availability and the standardization of pregnancy status in EHRs as well as the subsequent transmission of that status with laboratory orders. This is critical to the Zika response and an important component of what we’ve heard from stakeholders as being necessary and helpful to the ongoing effort to address Zika.

The Task Force will make specific recommendations on the some key areas around the pregnancy status question. Those are recommendations obviously will be critical for the Zika response but also generally


to address other public health issues and that builds upon the concept of the all hazards approach that we discussed in October. So, more to come on that but if you are interested in participating and are a committee member, please send information to Michelle to let her know.

We’re going to start this up pretty quickly and we expect that it will hopefully have a short duration to really address this issue as quickly as possible and to get your feedback. If you are a member of the public, please apply through the FACA database which can be found through the healthit.gov website on the FACA pages. Thank you so much everyone. I really appreciate it.

Before we go to public comment just a reminder that the next meeting is scheduled for January 10th and that will be an in person meeting at the Omni Shoreham.

Michelle Consolazio, MPA – Federal Advisory Committee Program Lead – Office of the National Coordinator for Health Information Technology Thanks, Elise. So, it looks like we have no public comments. So, thank you all. I look forward to seeing you in January and I Wish you all a Wonderful Holiday Season and enjoy the rest of your day. Thank you.

W Thank you, Michelle, you too.

Paul Tang, MD, MS – Vice President & Chief Health Transformation Officer – IBM Watson Health Happy Holidays. Bye-bye, everybody.

M Happy Holidays.

Gayle B. Harrell, MA – Florida State Representative – Florida State Legislature Thank you, Michelle, Merry Christmas.

W Happy Holidays.

Mike L. Lipinski, Esq. – Director, Division of Federal Policy & Regulatory Affairs – Office of the National Coordinator for Health Information Technology Happy Holidays.

W Happy Holidays.

Michelle Consolazio, MPA – Federal Advisory Committee Program Lead – Office of the National Coordinator for Health Information Technology Thanks, everyone.

Public Comment received during the meeting

1. Kevin Johnson, MD. Vanderbilt - Has any consideration been given to aligning the MIPS Improvement activities with Medical Specialty Board Maintenance of Certification activities (Performance in Practice)?


Joint Committee

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Eric Rose X X X X X X X X

Floyd Eisenberg

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Gayle B. Harrell

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James Ferguson

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Jon White X X X X X X X

Jonathan Nebeker

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Josh C. Mandel

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Karen van Caulil

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Kathleen Blake

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Kay Eron X X X

Kevin B. Johnson

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Paul Tang X X X X X X X X X X

Peter Johnson

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