1. Quality Measurement Task Force 2016 Physician Fee Schedule (PFS) July 21, 2015 Cheryl Damberg, Co-Chair Kathleen Blake, Co-Chair

2. Membership 2 First NameLast nameMember TypeOrganization CherylDambergCo-chairSenior Principal Researcher, Rand Corporation KathleenBlakeCo-chairMD, AMA LoriCoynerMemberDirector of Health Analytics, Oregon Health Authority FloydEisenbergMemberMD, MPH, iParsimony, LLC JoeKimuraMemberDeputy Chief Medical Office, Atrius Health GinnyMeadowsMemberVP, Regulatory Strategy, McKesson Corporation ElizabethMitchellMember President and CEO, NHRI JasonMitchellMember MD, Chief Medical and Clinical Transformation Officer for Presbyterian Healthcare Services SallyOkunMemberVP Advocacy, Policy and Patient Safety, Patients Like Me FrankOpelkaMemberMedical Director of Quality and Health Policy, American College of Surgeons DanRiskinMemberMD, MBA, FACS, and CEO and Founder of Vanguard Medical Technologies DavidLanskyMemberPresident and Chief Executive Officer, Pacific Business Group on Health

3. Radiology SMEs 3 First NameLast nameOrganization CharlesTruwitMD, Chief Innovation Officer and Chief of Radiology, Hennepin Health System MichaelMirroMD, Chief Academic/Research Officer, Parkview Mirro Center for Research and Innovation

4. Proposed QMTF Schedule QMTF CallJuly 21 st 10:00 AM – 11:30 AM ET 09:00 AM – 10:30 AM CT 07:00 AM – 08:30 AM PT QMTF CallJuly 24th 2:30 PM – 3:30 PM ET 1:30 PM – 2:30 PM CT 11:30 AM – 12:30 PM PT QMTF CallJuly 30 th 2:00 PM – 3:00 PM ET 1:00 PM – 2:00 PM CT 11:00 AM – 12:00 PM PT Final QMTF CallAugust 4 th 12:00 PM – 1:00 PM ET 11:00 AM – 12:00 PM CT 9:00 AM – 10:00 AM PT Presenting at HIT Policy Committee Meeting: August 11 th, 2015 4

5. 2016 PFS Areas for Review 5 Task Force to Focus on: 1. Appropriate Use Criteria (AUC) for Radiology CDS 2. Revision of Certified EHR Technology (CEHRT) to require clinical quality measures (eCQM) reporting using CMS’ QRDA IG (for providers who choose to submit eCQMs) 3. Meaningful Use (MU) measure for Accountable Care Organizations (ACO)

6. Appropriate Use Criteria (AUC) for Radiology CDS AUC are a set of individual criteria that present information in a manner that links a specific clinical condition or presentation, one or more services, and an assessment of the appropriateness of the service(s). – The program is required to promote the use of AUC for applicable imaging services furnished by an applicable setting by ordering professionals and furnishing professionals. However, there are different views about how to best roll out AUC into clinical practice. CMS believes a successful program would allow flexibility, and under section 1834(q) of the ACT, CMS foresee competing sets of AUC developed by different provider-led entities, and competing CDS mechanisms, from which providers may choose. 6 Background

7. Appropriate Use Criteria (AUC) for Radiology CDS (cont.) 7 1. Establishment of AUC by November 15, 2015 (section 1834(q)(2)) 2. Mechanisms for consultation with AUC by April 1, 2016 (section 1834 (q)(3)) 3. AUC consultation by ordering professionals and reporting on AUC consultation by furnishing professionals by January 1, 2017 (section 1834(q)(4)) 4. Annual identification or outlier ordering professionals for services furnished after January 1, 2017 (section 1834(q)(5)) Timelines There are four major components of the AUC program under section 1834(q) of the Act, each with its own implementation date:

8. Appropriate Use Criteria (AUC) for Radiology CDS (cont.) Second major component of the Medicare AUC program is the identification of qualified CDS mechanisms that could be used by ordering professionals for consultation with applicable AUC under section 1834(q)(3) of the Act:  CMS envisions a CDS mechanisms for consultation with AUC as an interactive tool that communicates AUC information to the user.  The ordering professionals would input information regarding the clinical presentation of the patient into the CDS tool, which may be a feature of or accessible through an existing system, and the tool would provide immediate feedback to the ordering professional on the appropriateness of one or more imaging services.  Section 1834(q)(3)(A) of the Act states that the Secretary must specify qualified CDS mechanisms in consultation with physicians, practitioners, health care technology experts, and other stakeholders. 8 Background

9. Appropriate Use Criteria (AUC) for Radiology CDS (cont.) However, all CDS mechanisms must meet the requirements under section 1834 (q)(3)(B) of the Act which specifies that a mechanism must: 1.Make available to the ordering professional applicable AUC and the supporting documentation for the applicable imaging services that is ordered 2.Where there is more than one applicable AUC specified for an applicable imaging service, indicate the criteria it uses for the service 3.Determine the extent to which an applicable imaging service that is ordered is consistent with the applicable AUC 4.Generate and provide to the ordering professional documentation to demonstrate that the qualified CDS was consulted by the ordering professional 5.Be updated on a timely basis to reflect revisions to the specification of the applicable AUC 6.Meeting applicable privacy and security standards 7.Perform such other functions as specified by the Secretary (which may include a requirement to provide aggregate feedback to the ordering professional) 9 Background Section 1834(q)(3)(C) of the Act specifies that the Secretary must publish an initial list of specified mechanisms no later than April 1, 2016, and that the Secretary must identify on an annual basis the list of specified qualified CDS mechanisms.

10. Appropriate Use Criteria (AUC) for Radiology CDS (cont.) CMS anticipates that in PFS rulemaking for CY 2017, they will provide clarifications, develop definitions and establish the process by which CMS specifies qualified CDS mechanisms. The requirements for qualified CDS mechanisms set forth in section 1834(q)(3)(B) of the Act will also be vetted through PFS rulemaking for CY 2017 so that mechanism developers have a clear understanding and notice regarding the requirements for their tools. – The CY 2017 proposed rule would be published at the end of June or in early July of 2016, be open for a period of public comment, and then the final rule would be published by November 1, 2016. CMS anticipates the initial list of specified applicable CDS mechanisms will be published sometime after the CY 2017 PFS final rule. 10 CMS is not including proposals to implement section 1834(q)(3) of the Act in this proposed rule. CMS first needs to establish the process for specifying applicable AUC. Specified applicable AUC would serve as the inputs to any qualified CDS mechanism, therefore, these must first be identified so that prospective tool developers are able to establish relationships with AUC developers.

11. Appropriate Use Criteria (AUC) for Radiology CDS (cont.) 11 PAMA Sec 218 directs the secretary to consider a variety of qualified clinical decision support mechanisms, including mechanisms within certified EHRs, which ordering professionals must use to consult AUC when ordering radiology images: 1. How are providers successfully using EHRs and other health IT tools to consult clinical decision support criteria today? 2. Could existing CDS criterion meet anticipated needs, and what are the key forthcoming standards and certification criteria which may support these processes in the future? 3. What are the key strategic considerations ONC must address to ensure certified EHRs support these activities?

12. Advance Reading for CEHRT and MU measure for ACOs 12 Members are welcome to view the following slides regarding the revision of CEHRT, and Meaningful Use measure for ACOs in preparation of the next QMTF call.

13. CY 2015 PFS Final Rule: Beginning in CY 2015, eligible providers (EPs) are not required to ensure that their CEHRT products are recertified to the most recent version of the electronic specifications for the CQMs. »EPs must still report the most recent version of specifications for the CQMs. FY 2016 IPPS Rule: ONC proposed a certification criterion for “CQMs-report”. »This proposal would require that health IT enable users to electronically create a data file for transmission of CQM data in accordance with the Quality Reporting Document Architecture (QRDA) Category 1 and Category III at minimum. »As part of the “CQMs – report” criterion, ONC also proposed to offer optional certification for EHRs according to the “form and manner” that CMS required for electronic submission to participate in the EHR Incentive Programs and PQRS. FY 2016 IPPS Rule: CMS stated they anticipate proposing to require EPs, eligible hospitals, and CAHs seeking to report CQMs electronically as part of meaningful use under the EHR Incentive Programs for 2016 to adhere to the additional standards and constraints on the QRDA standards for electronic reporting as described in the CMS QRDA IG. »CMS stated anticipating proposing to revise the definition of CEHRT to require certification to the optional portion of the 2015 Edition CQM reporting criterion in the CY 2016 Medicare Physician Fee Schedule. Revision of CEHRT to require eCQM reporting using CMS’ QRDA IG (for providers who choose to submit eCQMs) 13 Overview

14. Revision of CEHRT to require eCQM reporting using CMS’ QRDA IG (for providers who choose to submit eCQMs) cont. 1.Revise the CEHRT definition for 2015-2017 to require that EHR technology is certified to report CQMs, in accordance with the optional certification, in the format that CMS can electronically accept (for example, CMS’ “form and manner” requirements) if certifying to the 2015 Edition “CQMs – report” certification criterion at §170.315(c)(3).  Specifically, this would require technology to be certified to §170.315(c)(3)(i) (the QRDA Category I and III standards) and §170.315(c)(3)(ii) (the optional CMS “form and manner”).  CMS notes that the proposed CEHRT definition for 2015 through 2017 included in the Stage 3 proposed rule (80 FR 16732 through 16804) allows providers to use 2014 Edition or 2015 Edition certified technology. 2.CMS also proposes to revise the CEHRT definition for 2018 and subsequent years to require that EHR technology is certified to report CQMs, in accordance with the optional certification, in the format that CMS can electronically accept.  Specifically this would also require technology to be certified to §170.315(c)(3)(i) (the QRDA Category I and III standards) and §170.315(c)(3)(ii) (the optional CMS “form and manner”). 14 To allow providers to upgrade to the 2015 Edition CEHRT before 2018, CMS proposes the following:

15. Meaningful Use Measure for Accountable Care Organizations (ACOs) In the November 2011 final rule, CMS finalized one measure under the Care Coordination/Information Systems domain, the percent of PCPs within an ACO who successfully qualify for an EHR Incentive Program incentive (76 FR 67878). CMS expanded it to include eligible professionals that qualified for payments to adopt, implement, or upgrade EHR technology, in addition to those receiving a payment for meeting Meaningful Use Requirements, in order to include these participants in the measure. A notice of proposed rulemaking for “Stage 3” of the EHR Incentives program, released in March 2015 (80 FR 16731), and a related proposed 2015 Edition of ONC certification criteria (80 FR 16804), aim to support provider’s ability to exchange a common clinical dataset across the continuum of care. In addition, ONC released a document entitled “Connecting Health and Care for the Nation: A Shared Nationwide Interoperability Roadmap” which focuses on actions that will enable a majority of individuals and providers across the care continuum to send, receive, find and use a common set of electronic clinical information at the nationwide level by the end of 2017.Connecting Health and Care for the Nation: A Shared Nationwide Interoperability Roadmap 15 Background

16. Meaningful Use Measure for Accountable Care Organizations (ACOs) (cont.) CMS is seeking early comment for the 2017 performance year: How this measure might evolve in the future to ensure providers are being incentivized and rewarded for continuing to adopt and use more advanced health IT functionality and broadening the set of providers across the care continuum that have adopted these tools. 1. Should this measure be expanded in the future to include all eligible professionals, including specialists, consistent with an updated definition of eligible professionals in the Medicare Access and Chip Reauthorization act? 2. How could the current measure be updated to reward providers who have achieved higher levels of Meaningful Use? 3. Should we substitute or add another measure which would focus specifically on the use of health information technology, rather than meeting overall MU requirements, for instance, the transitions of care measure required for the EHR Incentives program? 4. What other measures of IT-enabled processes would be most relevant to participants within ACOs? How could we seek to minimize the administrative burden on providers in collecting these measures? 16