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TAHPNovember 17, 2020
2020
INTEROPERABILITY: INTERPRETING THE RULE AND DEFINING REQUIREMENTS
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Agenda
• Introductions• Brief Regulation Overview• Requirements & Interpretation• Recent CMS Implementation Guidance • Closing Remarks
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Change Healthcare Enhancing Member ExperienceSecurity
2,400Payer Connections
1 in 3US Patient Records
$1.5 TrillionAdjudicated
Healthcare Claims
15 BillionHealthcare Transactions
6,000Hospitals &
Health Systems
1 MillionPhysicians
125,000Dentists
700Laboratories
h
Intelligent Healthcare NetworkTM
Network coverage across all 50 states and 90% of all counties in the U.S.211M unique patients touched by our network
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Change Healthcare ConsultingThe Areas We Support
We work collaboratively with our clients to define new strategies and bring them to life, unlocking the opportunities created by change
Consulting Focus Areas
Healthcare Consumerism
Value-Based Healthcare
Population Health
Government Programs
Process & System
Modernization
Analytics & Insights
IT Risk and Security Services
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Regulation Overview
Section 1.0
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CMS Goal: Give patients true access to their healthcare data to make informed
healthcare decisions and better manage their care – supporting transition to value-based healthcare system
Rule Hierarchy
21st Century Cures Act
CMS Interoperability Act
• Signed into law December 2016, it is designed to help bring new innovation and advances to patients
ONC Cures Act Final RuleCMS Interoperability Act
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HHS Goal: provide
consumers with access to and control over
their healthcare data
Focus of Each Final Rule
ONC 21st Century Cures Act CMS Interoperability Act
Required information in the Rule:USCDI: • Plan of treatment• Care team members• Clinical notes (consultation, imaging
narrative, procedure note, discharge summary note, lab report narrative, progress note)
• Patient related info (patient goals, health concerns, immunizations, lab tests/results, medications, medication allergies, smoking status, patient demographics, problems, procedures, author info, unique device ID, vital signs)
Focus on Information Blocking
Required information in the Rule: • Medical and pharmacy claim
activity: Information from adjudicated claims, encounters, remits, enrolled cost sharing, appeals
• Provider directory information• Clinical data including lab results
(USCDI): If payer has the data in the USCDI format
• Payer to payer data exchange: Clinical and administrative data mandate 01/2022
Applies to Medicare Advantage, Medicaid Managed Care Plans, State Medicaid Agencies, CHIP Managed Care Entities, Issuers of Qualified Health Plans, Federally Facilitated Exchanges
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What Rule Effects You?
21st Century Cures Act
CMS Interoperability Act
• Medicare Advantage (MA) Organizations
• Medicaid Managed Care (MMC) Organizations
• State Medicaid Agencies (for FFS)• CHIP Agencies• CHIP Managed Care Entities• Qualified Health Plans (QHPs) on
federally facilitated Exchanges (if on state-facilitated exchange only, rules do not apply)
ONC Cures Act Final Rule
• Healthcare Providers• Developers of Certified Health IT • Health Information Network (HIN) /
Health Information Exchange (HIE)
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The Good News – These Capabilities Can Provide VALUE
Capability Value
Provide members access to their health informationImproved member engagementImproved medical adherenceIncreased customer loyalty
Provide members access to up-to-date provider directoryImproved provider steerageImproved adherence to clinical guidelinesReduced medical costs (for plan and member)
Automate administrative functionsReduced member phone callsImproved member satisfactionDecreased operational costs
Receive access to more timely clinical informationImproved coordination of careAccelerated proactive interventionsReduced unnecessary services
Access to ADT noticesImproved coordination of careAccelerated proactive interventionsReduced unnecessary services
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Think Beyond the RulePart of the industry’s digital transformation
Member Payments Member Alerts Personalized Health Content
Referral or Prescription
Request
Schedule Doctor’s Visit
Link to Telehealth
Access to Community
Services
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CMS Identified the Following Standards for Interoperability
HHS finalized technical, content, and vocabulary standards in the ONC 21st
Century Cures Act final rules.Relevant Reference Standards
Implementation GuidanceClaims/Payment, Encounter Data
CMS Blue Button 2.0 + CARIN Alliance Blue Button IG
Plan Coverage and FormulariesDa Vinci Payer Data Exchange US Drug Formulary IG
Provider DirectoryDa Vinci PDEX Plan Net IG
Clinical DataHL7 FHIR® US Core IG
Content & Vocabulary Standards
CPCDS (Recommended)Common Payer Consumer Data Set
USCDIUnited States Core Data for
Interoperability v1
Technical Standards
FHIR Release 4.0.1
Open ID Connect Core 1.0
Smart IG / OAuth 2.0
Reference Link: https://www.cms.giv/Regulations-and-Guidance/Guidance/Interoperability/index
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HL7 Da Vinci Project&L7 DA VINCI PROJECT
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Perspective on Standards• The rule builds on the success of Medicare Blue Button 2.0 – leveraging
APIs• Technical Standards were identified for the access, authentication and
technical envelope (FHIR)• The rule points to data standards that were identified for clinical
information by the ONC – USCDI • USCDI provides data classes and required detail elements but HL7/FHIR
provides the detailed specifications for this data• Data standards were not specifically identified for administrative
transactions. The rules pointed to “widely used, consensus-based standards identified by other means – such as HHS for other purposes or through a consensus standards development organization”
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What Payers Should Do
Understand• Understand the Rules, data
standards and what is required to be available and when
• FHIR 4.1• USCDI
• Understand where this data resides within your information architecture
• Assess your architecture to determine how to support these new requirements
• Data: Clinical, Administrative, Provider
• Integration requirements• Security requirements• Resource requirements
Plan• Develop your target
architecture• Information• Integration• Information Security
• Determine your approach to exposing this data to approved third parties via FHIR APIs
• Develop data flow diagrams• Develop policies and
procedures to support information security
• Develop your resource plan
Execute• Develop required APIs• Test, Test, Test• Publish information:
• On APIs• Privacy supporting new
requirements o Who governso Where to report
• Prepare for future requirements• Payer to Payer
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Implementation Considerations• Have you considered your approach to compliance – focused on the letter of the law or
what your members need? What about build versus buy?• Have you identified your sources of data for each requirement and are you concerned
about the quality or the timeliness of the data?• Transaction systems• ODS/EDW
• Have you identified your requirements and matched the specifications against what is available from your data sources?
• What type of clinical information do I currently have and what format is it in? And what does readily available mean?
• Have you considered your communication to your members regarding best practice privacy and information security requirements for 3rd party apps?
• Have you developed your approach to vetting 3rd party apps?• How are you going to support your members?
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Key Terms• Final rule defines ‘‘maintain’’ to mean the payer has access to the data,
control over the data, and authority to make the data available through the API.
• This includes information maintained on behalf of the payer by a contractor, including a vendor, for instance.
• It is up to each payer to evaluate how data are maintained in its systems for each enrollee
• In feedback from CMS – they use words like“ it really comes down to a payer assessing their system, their process, and in good faith working to get patients information timely”“But, ultimately, to be compliant, the payer would just have to justify their process and good faith effort to meet the requirements”
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Perspective on Implementation• The final rule provided responses to many questions that were posed
during the review of the proposed rule but…….many questions remain• We really need to pay attention to the implementation guides that the
rule points to• We also need to make sure we continue to look for updated guidance
from CMS as they have been responding to questions from the industry groups who have been building the implementation guides (DaVinci, CARIN etc.) as well as inquires from others including Change Healthcare
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Member Identification
• Required to ensure member access to their information across all required data sources
• “The Patient Access API is only for current enrollees”• Payer to payer exchange will allow enrollees to get information from their
former payer
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Source: CMS
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Claims/Encounters
• Initial payment decision • Delegated Entities – payers must ensure that data processed by a
contractor on the payer's behalf is avaible to the enrollee• “Until dental and vision claims are supported by the CARIN IG for Blue
Button, we understand that they will not be available via the Patient Access API”
• Encounter data must be available no later than one (1) business day after receiving the data from providers
• Encounters = capitated claim
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Provider Directory
• Provider Directory Data is to be publicly available • “Vision and dental providers are not excluded from the Provider Directory
API provisions in the final rule”
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Clinical Data
• If a plan maintains USCDI data as part of an enrollee’s record, , those data should be made available via the Patient Access API and payer-to-payer requirements
• Payers should focus on the USCDI data that can be identified at the data element level
• Clinical images are not included in the USCDI version 1. Scanned documents should be evaluated the same way as PDF documents
• A payer is not required to verify the current status of the USCDI data elements maintained
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In Summary
• Establish your approach• Make sure you have a plan focusing on the intent of the rule• Understand your data• Leverage available implementation guides and continue to pay attention
to updated guidance from CMS• Have a plan to communicate with and support your members
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