interoperability: interpreting the rule and defining … · 2020. 11. 17. · © 2020 change...

© 2020 Change Healthcare LLC and/or one of its subsidiaries. All Rights Reserved. © 2020 Change Healthcare LLC and/or one of its subsidiaries. All Rights Reserved.

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


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


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


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


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


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)


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


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


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

https://www.healthit.gov/sites/default/files/facas/2019-04-10_CMS_Presentation_508.pdf


HL7 Da Vinci Project&L7 DA VINCI PROJECT


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”


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


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?


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”


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


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


Source: CMS


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


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”


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


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

interoperability: interpreting the rule and defining … · 2020. 11. 17. · © 2020 change...

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