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Webinar on the 21st Century Cures Act Final Rule

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Nalashaa Healthcare Solutions
Nalashaa Healthcare Solutions

The Cures Act Final Rule Introduces Many Revisions and Additions to the ONC Health IT Certification Program. Our Healthcare Expert covers the vitals

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21st Century Act Cures Rule iOS ANDROID WINDOWS CRM MICROSOFT SOCIAL CRM DESIGN EXPERIENCE CLOUDJAVA RWD www.nalashaahealth.com
www.nalashaahealth.com Agenda 2  CMS regulations: How you got here  21st Century Cures Act: Overview  Changes: ONC certification context  Ecosystem impact  Repercussions  Focus: Beyond the rule  Suggested approach
www.nalashaahealth.com US Healthcare – Then & Now! 3 Where you are now Where you have to be Interoperability HL7, CCDA, FHIR, NCPDP, DICOM ONC Programs MU3, MACRA, QPP, VBC Engagement Patient Portal, Apps - Wellness, PHM Data Related PHM, Care Mgmt., Coordinated care, Dashboards Automation Workflow alerts/notifications, Behavior tracking Data Driven Capacity forecasting, 360° patient view Compliance New/Revised criteria, USCDI, Open APIs, Info. Blocking Engagement Preemptive care, contextual Omni channel comm., Wearables, Nothing wrong with change, if in the right direction……
www.nalashaahealth.com 21st Century Cures Act: An Overview USCDIInfo. Blocking CEHRT HIT Vendors Care Providers Patients Health Plans HIEs/HINs Starts May 2022 May 2023Nov 2020 4
www.nalashaahealth.com eRx CEHRT – Revised Measures 5  Change/Cancel/Renewal - Request/Response  RxReason mandatory with all transactions  NewRx, NewRxRequest/Denied  RxFill, IndicatorChange  RxTransfer - Request/Response/Confirm  REMS(Initiation) – Request/Response  RxHistory - Request/Response  GetMessage, Relay Status, Error, Verify, Resupply  DrugAdministration, Recertification, ePA Transactions Impacted • SIG still optional • Oral liquid meds Rx only in metric standards • RTPB is still under discussion • Vitals info. required for patients under 18 • RxChange  Validate prescriber credentials  Request review of Drug  Request Prior Auth. New Features Move to NCPDP 2017071 from 1xxxx0.6 Mandatory Optional
www.nalashaahealth.com CEHRT – Revised Measures 6  Aligns with FHIR V4  ToC, VDT, CDA creation performance  e-case reporting, CApp. Access – all criteria USCDI No more CCDS Granular, Secured  Ambulatory, EPs/ECs  2019 CMS QRDA III IG  IP/Hospital Quality Reporting -  2019 CMS QRDA I IG  Changes include – Templates, Value-sets, entries  Cypress update to V5.4 CQMs No more HL7 IGs 24 Months  (d)(2).1.c is not applicable for the P&S testing  (d)(7) – End user device encryption is not mandatory  E 2147-1 --> E 1247-18  Not all audit functionality is verified for every measure Auditable Events  Follow UDI Release R1  Lot / Batch / Serial Number  Manufacturing / Expiration Dates  Distinct Identification Code Implantable DevicesNew IGs Standardized New IGs
www.nalashaahealth.com Data Export CEHRT – Revised Measure 7  Export Single patient EHI without intervention or support  Multiple patients when provider changes Health IT systems  Export files to be electronic & computable  To publish Data Export Format (Structure & Syntax) as hyperlink for reference  All Patient EHI stored in the system to be available for export  Initial step towards real-time access  Export of Image, Imaging Information & Image Element Export Now as Patient Population eHI export 36 Months
www.nalashaahealth.com CEHRT – Revised Measures 8  Use HL7 FHIR 4 and several other standards  Support single/multiple patient data results APIs Now eHI export Standardized Consent Management  Security model to permit access, use, or disclosure of sensitive PHI  Security tags at document, section & entry level for only CCDA  Re-use of security tags in metadata for FHIR resources  Avoid Information Blocking lawsuits with proper consent management while exchanging EHI  Consent2Share (C2S) IG / FHIR consent IGs prescribed for (g)(10) 24 Months
www.nalashaahealth.com CEHRT – New Measures 9  Password Encryption/Cryptographic Hashing  Adhere to FIPS PUB 140-2  New / revising certifications after Oct 2020 should attest Encrypt authentication credentials Multi-factor authentication  Via any – Phone, Badge, RSA token, figure prints, Retina scanner, heartbeat or biometric info  Adhere to standards like NIST publication 800 – 63B Digital Authentication Guidelines  New/revising certifications after Oct 2020 SHOULD attest Authentication Mandatory attestation under P&S certification f/w
www.nalashaahealth.com CEHRT - Removals 10 Jun 2020 Jan 2022 May 2022 May 2023  a(4,9,10,13): DDDA Interactions, CDS, Drug formulary & patient education  e(2): Secure messaging  b(6): Data export  a(6-8,11): Problem, medication, medication allergy lists & smoking status  b(4-5): CCDS send & receive  (e)(1)(II)(B) – VDT – audit history  g(8): API data category request Future Imminent Distant Immediate
www.nalashaahealth.com Interoperability - USCDI V1 11 CCDS USCDIevolving into Additional data classes & elements… Additions & their impact… ------------------  Comply to Minimum USCDI v1 Standards  SVAP (Standards Version Advancement Process)  ToC to use CDA to hold USCDI data  Procedures Data Class to use CDT to SNODENT  Patient contact information with US postal standards  Additional Vitals & growth charts for children  8 Clinical Note types for inpatient/ambulatory  Provenance class (author timestamp, org.)  Allergies and Intolerances in medication class  Medication allergies  Allergies & Intolerance
www.nalashaahealth.com • No registration process for Provider facing Apps • Condition of Certification – demo. registration process • Authorization standard is up to CEHRT discretion (OpenID, OAuth 2.0) • SMART Application Launch Framework • US Core server capability statement • Provenance & document reference – not mandatory • Single Patient APIs to use US Core IG  USCDI Data Elements  US Core IG FHIR Profiles • Multi Patient APIs to use Bulk Data Access in addition • SMART Backend Serv.: Auth Guide + Bulk data Access Interoperability - API 12 Data Response Search Operations Application Registration • Using TLS version 1.2 or higher • Secure connection for standalone & EHR launch • SMART on FHIR Core Capabilities Secure Connection • Grant / Deny access to patient data • Manage Refresh Token & validity • Support all SMART on FHIR Core Capabilities • Support all 19 Clinical entities • Offline Access • Patient Authorization Revocation • Verification of JWT + Json web signatures Authentication & Authorization • Exceptions & Error Handling • Publicly Accessible Hyperlinks API Documentation
www.nalashaahealth.com • Greater health data control • Wider choices • Easier clinical trial enrolments • Wiser health-plan purchases • 360o Patient picture • Patient tracking • Proactive sharing • Unique patient id Regulation – Impact on the ecosystem 13 Technology Focus Areas • Security • Audit & Logging capabilities • Identity Management • CRM capabilities • Workflow automations • APIs • Integration standards (USCDI) • Better and complete documentation • Shorter revenue cycles • Greater automation • Reduced bureaucracy • Simpler integrations • Greater innovation • Lower Xn costs • Universal security • Stringent audit capabilities HIT Vendors Providers HIEs Patients
www.nalashaahealth.com Repercussions: If we don’t update technology 14  Certification ban/termination  CMS wall of shame  Providers unable to attest from '21  Hampered ecosystem partnerships  Reduced marketability  Dipping customer satisfaction  Cumbersome compliance tracking/audit  Exposure to security risks  Higher cost of info. servicing Regulatory Relationships Operational BusinessTechnical Traceability Secured Access Interoperability Data Governance
www.nalashaahealth.com Focus areas: Beyond the cures rule 15 • Multiple access points • Archival plan • Reconcile Master data Security Data Governance Transparency Audit/Log tracing Unique Identification Patient Lifecycle tracking CRM capability Automation • “Follow" the patient • Proactive interventions • Contextualized engagement • One true version of ePHI • Less labor-intensive reconciliation • Avoid workflow ambiguity • Manage data access requests • Automated process setup • Protocols for 3rd party authorizations • Trail of actions • Demonstration mechanism • Raise violation flags • Timely action for info. blocking? • Automate compliance tracking • Responsiveness and efficiency • 3rd parties connect • Automate integrations • Defend information blocking allegations • 360o patient view • Trace 2nd or 3rd party requests • Apply population insights individually
www.nalashaahealth.com Suggested Approach 16 Regulation Checklist • Covering all possible aspects • Prioritize based dependencies Analyze • Impact areas and magnitude • Chalk out a preliminary approach Kick Off • Finalize execution plan for you • Start implementation Go to Market • Get certified • General Availability
www.nalashaahealth.com For more information, contact info@nalashaa.com Nalashaa Healthcare Solutions LLC. 510, Thornall Street, Ste 210, Edison, NJ 08837 +1-732-602-2560 Ext: 200 Thank You

More Related Content

Webinar on the 21st Century Cures Act Final Rule

  • 1. 21st Century Act Cures Rule iOS ANDROID WINDOWS CRM MICROSOFT SOCIAL CRM DESIGN EXPERIENCE CLOUDJAVA RWD www.nalashaahealth.com
  • 2. www.nalashaahealth.com Agenda 2  CMS regulations: How you got here  21st Century Cures Act: Overview  Changes: ONC certification context  Ecosystem impact  Repercussions  Focus: Beyond the rule  Suggested approach
  • 3. www.nalashaahealth.com US Healthcare – Then & Now! 3 Where you are now Where you have to be Interoperability HL7, CCDA, FHIR, NCPDP, DICOM ONC Programs MU3, MACRA, QPP, VBC Engagement Patient Portal, Apps - Wellness, PHM Data Related PHM, Care Mgmt., Coordinated care, Dashboards Automation Workflow alerts/notifications, Behavior tracking Data Driven Capacity forecasting, 360° patient view Compliance New/Revised criteria, USCDI, Open APIs, Info. Blocking Engagement Preemptive care, contextual Omni channel comm., Wearables, Nothing wrong with change, if in the right direction……
  • 4. www.nalashaahealth.com 21st Century Cures Act: An Overview USCDIInfo. Blocking CEHRT HIT Vendors Care Providers Patients Health Plans HIEs/HINs Starts May 2022 May 2023Nov 2020 4
  • 5. www.nalashaahealth.com eRx CEHRT – Revised Measures 5  Change/Cancel/Renewal - Request/Response  RxReason mandatory with all transactions  NewRx, NewRxRequest/Denied  RxFill, IndicatorChange  RxTransfer - Request/Response/Confirm  REMS(Initiation) – Request/Response  RxHistory - Request/Response  GetMessage, Relay Status, Error, Verify, Resupply  DrugAdministration, Recertification, ePA Transactions Impacted • SIG still optional • Oral liquid meds Rx only in metric standards • RTPB is still under discussion • Vitals info. required for patients under 18 • RxChange  Validate prescriber credentials  Request review of Drug  Request Prior Auth. New Features Move to NCPDP 2017071 from 1xxxx0.6 Mandatory Optional
  • 6. www.nalashaahealth.com CEHRT – Revised Measures 6  Aligns with FHIR V4  ToC, VDT, CDA creation performance  e-case reporting, CApp. Access – all criteria USCDI No more CCDS Granular, Secured  Ambulatory, EPs/ECs  2019 CMS QRDA III IG  IP/Hospital Quality Reporting -  2019 CMS QRDA I IG  Changes include – Templates, Value-sets, entries  Cypress update to V5.4 CQMs No more HL7 IGs 24 Months  (d)(2).1.c is not applicable for the P&S testing  (d)(7) – End user device encryption is not mandatory  E 2147-1 --> E 1247-18  Not all audit functionality is verified for every measure Auditable Events  Follow UDI Release R1  Lot / Batch / Serial Number  Manufacturing / Expiration Dates  Distinct Identification Code Implantable DevicesNew IGs Standardized New IGs
  • 7. www.nalashaahealth.com Data Export CEHRT – Revised Measure 7  Export Single patient EHI without intervention or support  Multiple patients when provider changes Health IT systems  Export files to be electronic & computable  To publish Data Export Format (Structure & Syntax) as hyperlink for reference  All Patient EHI stored in the system to be available for export  Initial step towards real-time access  Export of Image, Imaging Information & Image Element Export Now as Patient Population eHI export 36 Months
  • 8. www.nalashaahealth.com CEHRT – Revised Measures 8  Use HL7 FHIR 4 and several other standards  Support single/multiple patient data results APIs Now eHI export Standardized Consent Management  Security model to permit access, use, or disclosure of sensitive PHI  Security tags at document, section & entry level for only CCDA  Re-use of security tags in metadata for FHIR resources  Avoid Information Blocking lawsuits with proper consent management while exchanging EHI  Consent2Share (C2S) IG / FHIR consent IGs prescribed for (g)(10) 24 Months
  • 9. www.nalashaahealth.com CEHRT – New Measures 9  Password Encryption/Cryptographic Hashing  Adhere to FIPS PUB 140-2  New / revising certifications after Oct 2020 should attest Encrypt authentication credentials Multi-factor authentication  Via any – Phone, Badge, RSA token, figure prints, Retina scanner, heartbeat or biometric info  Adhere to standards like NIST publication 800 – 63B Digital Authentication Guidelines  New/revising certifications after Oct 2020 SHOULD attest Authentication Mandatory attestation under P&S certification f/w
  • 10. www.nalashaahealth.com CEHRT - Removals 10 Jun 2020 Jan 2022 May 2022 May 2023  a(4,9,10,13): DDDA Interactions, CDS, Drug formulary & patient education  e(2): Secure messaging  b(6): Data export  a(6-8,11): Problem, medication, medication allergy lists & smoking status  b(4-5): CCDS send & receive  (e)(1)(II)(B) – VDT – audit history  g(8): API data category request Future Imminent Distant Immediate
  • 11. www.nalashaahealth.com Interoperability - USCDI V1 11 CCDS USCDIevolving into Additional data classes & elements… Additions & their impact… ------------------  Comply to Minimum USCDI v1 Standards  SVAP (Standards Version Advancement Process)  ToC to use CDA to hold USCDI data  Procedures Data Class to use CDT to SNODENT  Patient contact information with US postal standards  Additional Vitals & growth charts for children  8 Clinical Note types for inpatient/ambulatory  Provenance class (author timestamp, org.)  Allergies and Intolerances in medication class  Medication allergies  Allergies & Intolerance
  • 12. www.nalashaahealth.com • No registration process for Provider facing Apps • Condition of Certification – demo. registration process • Authorization standard is up to CEHRT discretion (OpenID, OAuth 2.0) • SMART Application Launch Framework • US Core server capability statement • Provenance & document reference – not mandatory • Single Patient APIs to use US Core IG  USCDI Data Elements  US Core IG FHIR Profiles • Multi Patient APIs to use Bulk Data Access in addition • SMART Backend Serv.: Auth Guide + Bulk data Access Interoperability - API 12 Data Response Search Operations Application Registration • Using TLS version 1.2 or higher • Secure connection for standalone & EHR launch • SMART on FHIR Core Capabilities Secure Connection • Grant / Deny access to patient data • Manage Refresh Token & validity • Support all SMART on FHIR Core Capabilities • Support all 19 Clinical entities • Offline Access • Patient Authorization Revocation • Verification of JWT + Json web signatures Authentication & Authorization • Exceptions & Error Handling • Publicly Accessible Hyperlinks API Documentation
  • 13. www.nalashaahealth.com • Greater health data control • Wider choices • Easier clinical trial enrolments • Wiser health-plan purchases • 360o Patient picture • Patient tracking • Proactive sharing • Unique patient id Regulation – Impact on the ecosystem 13 Technology Focus Areas • Security • Audit & Logging capabilities • Identity Management • CRM capabilities • Workflow automations • APIs • Integration standards (USCDI) • Better and complete documentation • Shorter revenue cycles • Greater automation • Reduced bureaucracy • Simpler integrations • Greater innovation • Lower Xn costs • Universal security • Stringent audit capabilities HIT Vendors Providers HIEs Patients
  • 14. www.nalashaahealth.com Repercussions: If we don’t update technology 14  Certification ban/termination  CMS wall of shame  Providers unable to attest from '21  Hampered ecosystem partnerships  Reduced marketability  Dipping customer satisfaction  Cumbersome compliance tracking/audit  Exposure to security risks  Higher cost of info. servicing Regulatory Relationships Operational BusinessTechnical Traceability Secured Access Interoperability Data Governance
  • 15. www.nalashaahealth.com Focus areas: Beyond the cures rule 15 • Multiple access points • Archival plan • Reconcile Master data Security Data Governance Transparency Audit/Log tracing Unique Identification Patient Lifecycle tracking CRM capability Automation • “Follow" the patient • Proactive interventions • Contextualized engagement • One true version of ePHI • Less labor-intensive reconciliation • Avoid workflow ambiguity • Manage data access requests • Automated process setup • Protocols for 3rd party authorizations • Trail of actions • Demonstration mechanism • Raise violation flags • Timely action for info. blocking? • Automate compliance tracking • Responsiveness and efficiency • 3rd parties connect • Automate integrations • Defend information blocking allegations • 360o patient view • Trace 2nd or 3rd party requests • Apply population insights individually
  • 16. www.nalashaahealth.com Suggested Approach 16 Regulation Checklist • Covering all possible aspects • Prioritize based dependencies Analyze • Impact areas and magnitude • Chalk out a preliminary approach Kick Off • Finalize execution plan for you • Start implementation Go to Market • Get certified • General Availability
  • 17. www.nalashaahealth.com For more information, contact info@nalashaa.com Nalashaa Healthcare Solutions LLC. 510, Thornall Street, Ste 210, Edison, NJ 08837 +1-732-602-2560 Ext: 200 Thank You