Content Listing Overview of Rules - Friday, March 8 – Slides 2-19 Comments through Friday, March 29 – Slides 20-25 Next Steps: Slide 26 7/31/2019 Clinical Ancillary Services & Systems / Care Delivery Technology Services 2017 © All Rights Reserved.

HL7 CQI WG – Friday, March 8, 2019 Call 7/31/2019 Clinical Ancillary Services & Systems / Care Delivery Technology Services 2017 © All Rights Reserved.

CMS Proposed Rule Medicare and Medicaid Programs; Patient Protection and Affordable Care Act; Interoperability and Patient Access for Medicare Advantage Organization and Medicaid Managed Care Plans, State Medicaid Agencies, CHIP Agencies and CHIP Managed Care Entities, Issuers of Qualified Health Plans in the Federally- Facilitated Exchanges and Health Care Providers Name of Rule MA Plans and Medicaid/CHIP Managed Care Plans Providers (hospitals) States (transmit Medicaid MMA info to CMS daily for dual eligible) Applies to Timing Many provisions proposed with a 1/1/2020 deadline 7/31/2019 Clinical Ancillary Services & Systems / Care Delivery Technology Services 2017 © All Rights Reserved.

CMS Proposed Rule Implement an API to allow members to use third-party apps to access claims, provider directory, formulary data and plan coverage/cost data Send/Accept to/from next payer USCDI clinical data set available to the health plan (5 years back) via different methods, including API, Direct, HIE Health plan required to join a trusted exchange network (existing at time of rule deadline, even if ONC TEFCA rule not completed) Core Requirements Health Plans Information blocking: Public reporting of providers that responded “no” to three preventing info blocking attestation statements Publicly report provider who have not added a digital address to their record in the NPPES system Hospitals required to provide electronic notification to known primary care provider of a patient when admitted, discharged or transferred Core Requirements for Providers States: Transmit Medicaid MMA info to CMS daily Comments on how incorporating Promoting Interop. in Innovative Models RFI: Patient Matching (leveraging CMS authority to improve patient ID) RFI: How CMS can promote interoperable systems in LTC, post-acute care Other Requirements / Provisions 7/31/2019 Clinical Ancillary Services & Systems / Care Delivery Technology Services 2017 © All Rights Reserved.

References on Quality, HL7 Standards, FHIR Several references to quality payment and quality improvement programs in the NPRM, mostly to explain how the new requirements on health plans and providers would be consistent with these programs No specific references to quality reporting, eCQMs, quality reporting standards Several references to HL7 FHIR, but in the context of APIs and consumer access to health information from health plans (claims, provider directories, formularies, etc), and hospitals (ADT notifications). Don’t see specific areas for this Work Group to comment on Versioning Compliance Provider space – ADT transaction – stop short from providing that to payers 7/31/2019 Clinical Ancillary Services & Systems / Care Delivery Technology Services 2017 © All Rights Reserved.

ONC Proposed Rule 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program Name of Rule Health IT Vendors required to: Develop technology for new/modified ONC 2015 Edition CEHRT Criteria and Standards Support interoperability, expand patient access, and avoid engaging in information blocking Meet 7 new Conditions of Certification and ongoing Maintenance of Certification requirements Providers, who must use CEHRT for CMS programs, required to: Implement new/modified ONC 2015 Edition CEHRT Criteria and Standards Applies to Timing Generally changes to be implemented within 24 months of final rule 7/31/2019 Clinical Ancillary Services & Systems / Care Delivery Technology Services 2017 © All Rights Reserved.

ONC: 2015 Edition Certification Criteria - Updates Removes 2014 edition certification criteria as they are no longer applicable Removes 2015 edition certification criteria that were deemed unnecessary Modifies 2015 edition certification criteria, such as: Adopts ePrescribing standard NCPDP SCRIPT 2017071, as expected (effective 1/1/2020) Adopts the US Core Data for Interoperability (USCDI) standard to replace common clinical data set (CCDS) Modifies criteria for EHI export that would require IT developers to provide the capability to electronically export all of patients EHI data Modifies Data Segmentation for Privacy (DS4P) and Consent Management from document level to data element level API changes (next Slide) 3/20/2017 Clinical Ancillary Services & System / Care Delivery Technology Services 2017 © All Rights Reserved.

ONC: 2015 Edition Certification Criteria - Updates 3/20/2017 Clinical Ancillary Services & System / Care Delivery Technology Services 2017 © All Rights Reserved.

ONC: Information Blocking Provisions Defines key terms, including Electronic Health Information (EHI) EHI, in addition to patient personal and clinical data, includes data related to eligibility, benefits, billing information, and payment information Provides examples of practices likely to interfere with access, exchange, or use of EHI Restrictions on access, exchange, or use of EHI Disabling interoperability capabilities of Health IT Impeding interoperability innovations and advancement Rent-seeking and other opportunistic pricing practices Non-standard implementation practices Codifies compliance with information blocking provisions as a Condition of Certification Introduces 7 exceptions to the general prohibition on information blocking (next slides) Requests for information Disincentives for health care providers Including pricing transparency as EHI in future TEFCA certification criteria 3/20/2017 Clinical Ancillary Services & System / Care Delivery Technology Services 2017 © All Rights Reserved.

ONC: Information Blocking – Seven Exceptions §171.201 Exception 1: Preventing Harm §171.202 Exception 2: Promoting the Privacy of EHI §171.203 Exception 3: Promoting the Security of EHI §171.204 Exception 4: Recovering Costs Reasonably Incurred §171.205 Exception 5: Responding to Requests that are Infeasible §171.206 Exception 6: Licensing of Interoperability Elements on Reasonable and Non-discriminatory Terms §171.207 Exception 7: Maintaining and Improving Health IT Performance 3/20/2017 Clinical Ancillary Services & System / Care Delivery Technology Services 2017 © All Rights Reserved.

ONC: New Conditions of Certification for Vendors Establishes seven conditions of certification with accompanying maintenance of certification requirements that express initial and ongoing requirements for health IT developers and their certified Health IT Modules: (1) Information Blocking (2) Assurances (3) Communications (4) Application Programming Interfaces (APIs) (5) Real World Testing (6) Attestations (7) Future Electronic Health Record (EHR) reporting criteria submission 3/20/2017 Clinical Ancillary Services & System / Care Delivery Technology Services 2017 © All Rights Reserved.

Next Steps (March 8, 2019) Define comment statements on identified areas to comment Present/discuss with Work Group Incorporate into comment template from HL7 Policy Advisory Committee Achieve WG approval (March 29) Submit to HL7 PAC (April 3) 7/31/2019 Clinical Ancillary Services & Systems / Care Delivery Technology Services 2017 © All Rights Reserved.

HL7 CQI WG – Friday, March 29, 2019 Call 7/31/2019 Clinical Ancillary Services & Systems / Care Delivery Technology Services 2017 © All Rights Reserved.

Draft Comments for Discussion (March 29, 2019) 1. 2015 Edition Certification Criteria updates/modifications Issues: Any need to consider adding new CQI elements to the certification criteria, such as QI Core, CQL, CQL-based HQMF, other? Comment: Recommend including CQL in the “Emerging Standards” section of the rule Data Segmentation: From a CDS and Clinical Measurement, data segmentation at data element level (both current and historical data coming into a system) could create issues, biases, and other problems related to the completeness and reliability of the information being reported, including issues with numerator/denominator, CDS ‘false’ alerts. Recommend ONC clarify how to address segmentation of data when addressing CDS and Quality Measurement reporting. 7/31/2019 Clinical Ancillary Services & Systems / Care Delivery Technology Services 2017 © All Rights Reserved.

Draft Comments for Discussion (March 29, 2019) 2. USCDI: Issues: 1) Is the USCDI sufficient, or should there be additional data classes considered for inclusion, particularly those related to quality measurement 2) the new API Resource Collection in Health (see next slide). Is this sufficient and appropriate to be used/referenced? Should there be any ‘resource’ added to the ARCH to address quality measurement/reporting? Comment: Provenance: would be helpful in CQ to have provenance of the elements themselves; need clarification about the level of provenance being required to be use (bundle of data being exchanged vs data element level) There seem to be provenance about a message, and provenance about the resource; provenance resource addresses the message/bundle, but does not address the provenance of the individual resources in the bundle. There is also concern about consistent definition of “provenance” (Note: We will check with HL7 Security WG which focuses on Provenance; there is a PSS on this) Coverage and Identifier of the subject of the information; Coverage Resource carries that information; should be made part of the USCDI and the ARCH; there is also the need to use Payer Identifier to identify the payer that will receive the data 7/31/2019 Clinical Ancillary Services & Systems / Care Delivery Technology Services 2017 © All Rights Reserved.

Draft Comments for Discussion (March 29, 2019) 3. API – Versioning of FHIR: Issue: Four options proposed for FHIR standards: 1) Just FHIR Release 2 (as proposed); 2) FHIR Release 2 and Release 3 (either for certification option); 3) FHIR Release 2 and Release 4; or 4) Just FHIR Release 4 Comment: Recommend Option 4 – adopting Just FHIR Release 4 Timeline: implementation of the regulations projected for fall 2021 (24 months after final rule is published - projected Fall, 2019); by the time implementation is due two years from now, Release 2 will be several years old, and normative Release 4 will be almost 3 years into implementation. Importance of synching the CMS regulations (which references FHIR) and the ONC regulation. Currently, CMS rule’s implementation date is 1/1/2020, at least 18 months (or more) before the effective date of the ONC regulations. This creates an issue regarding which FHIR version to be use under the CMS rules, by 1/1/2020. Note: It is expected that many organizations in the industry will be calling for CMS to delay the implementation deadline at least to 1/1/2021, if not 1/1/2022. 7/31/2019 Clinical Ancillary Services & Systems / Care Delivery Technology Services 2017 © All Rights Reserved.

Draft Comments for Discussion (March 29, 2019) 4. CQM Reporting Standard: Issue: Proposed rule eliminates HL7 QRDA Release 1 and require ONLY the Health IT Modules to support the CMS QRDA Implementation Guide Comments: QRDA is an HL7 CDA-based standard. QRDA is an IG of the CDA which re-uses some C-CDA templates where applicable and CMS IG is and implementation guide using QRDA. Recommend continuing to name QRDA, Since other organizations use the HL7 IG (QRDA) it needs to continue and implementers reporting need to assure the same style for submission across programs. HL7 recommends that the QRDA persist to assure alignment with other standards and C-CDA, and to ensure a base standard alignment across implementers (e.g., CMS, The Joint Commission). We further suggest that CMS only publish specific constraints on the HL7 QRDA standards as the CMS IG, rather than a complete re-write of the standard. Especially with the desire to move to FHIR, changing standards is problematic. However, to reduce vendor burden, ONC certification testing should be based only on the CMS IG rather than the HL7 version. 7/31/2019 Clinical Ancillary Services & Systems / Care Delivery Technology Services 2017 © All Rights Reserved.

Draft Comments for Discussion (March 29, 2019) NOTE: we will wait for any final additional comments, and review/take action at the Friday, April 5 call, in time to submit to the HL7 Policy Advisory Committee 5. Any other topics to comment on? Issue: Comment: 6. Any other topics to comment on? 7. Any other topics to comment on? 7/31/2019 Clinical Ancillary Services & Systems / Care Delivery Technology Services 2017 © All Rights Reserved.

Next Steps (March 29, 2019) Submit revised draft comments to WG for additional review/final input (April 1, 2019) Present final set of comments for review/approval at the Friday, April 5 call Submit to HL7 PAC by COB Friday, April 5 7/31/2019 Clinical Ancillary Services & Systems / Care Delivery Technology Services 2017 © All Rights Reserved.