Update for the Workgroup for Electronic Data Interchange (WEDI) July 31, 2018
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1 Update for the Workgroup for Electronic Data Interchange (WEDI) July 31, 2018 Madhu Annadata, Director, Christine Gerhardt, Deputy Director, Division of National Standards
2 Administrative Simplification Responsibilities The Division of National Standards (DNS), within the Department of Health and Human Services, is responsible for establishing and updating regulations that adopt standards for the electronic exchange of health care transactions, in accordance with the HIPAA Administrative Simplification statutory provisions. In addition to issuing regulations regarding HIPAA Administrative Simplification, DNS is responsible for: Establishing outreach to and education of HIPAA-covered entities and other stakeholders Increasing industry participation in Administrative Simplification 2
3 Division of National Standards Updates on what we have been doing: Coordinating with our stakeholders at conferences and on workgroups Working with NCVHS on the predictability roadmap to develop recommendations for modernizing the update and adoption process for standards and operating rules Continuing the transaction and operating rule audit pilot o Pilot is about 2/3 completed o DNS will post de-identified results o Corrective action plans are being implemented o One entity so far had no findings Developed Subregulatory Guidance Communications Plan Developing a number of regulations 3
4 Update on the NCVHS Predictability Roadmap for Standards and Operating (1) Rules March 2018: NCVHS met with HHS to develop flow for regulatory process. May 2018: NCVHS conducted a Chief Information Officer (CIO) Forum with 21 senior executives representing a variety of health care organizations (covered entities and other types of organizations). Note: materials from each of these activities are available on the NCVHS website under the Products tab. 4
5 Update on the NCVHS Predictability Roadmap for Standards and Operating Rules (2) Current status and next steps: Sending draft recommendations to standards organizations to share with their membership at Fall 2018 conferences Holding industry-wide hearing in late 2018 to gather input from standards organizations and other interested stakeholders Sending a letter to the Secretary in early 2019 All meeting summaries can be found on the new NCVHS website: 5
6 DNS HIPAA Optimization Complaints Compliance Reviews 6
7 DNS Optimization Program Old Video: Enforcing HIPAA Administrative Simplification Requirements To help the health care community use electronic standards for administrative transactions, HHS released a video in August This animated short: Explains why national standards for electronic transactions, code sets, and unique identifiers helps reduce paperwork and streamline business processes across the health care industry. Describes the HIPAA-covered entities that must comply with HIPAA Administrative Simplification requirements. 7
8 DNS Optimization Program New Video: Reaching Compliance with ASETT the Administrative Simplification Enforcement and Testing Tool. To help the health care community use electronic standards for administrative transactions, HHS announces a new video, Reaching Compliance with ASETT. This animated short: Explains the benefits of complying with Administrative Simplification standards, including substantial cost savings. Describes how ASETT allows you to test transactions, both your own and your business trading partners transactions. Tells you how to use ASETT to file a complaint if you have noncompliant business trading partners. 8
9 DNS HIPAA Optimization Complaints Compliance Reviews Strategy Reactive Proactive Selection Complaint Driven Random Selection System ASETT Salesforce Audit Tracker Testing Tool Edifecs X-Engine Edifecs X-Engine Compliance Corrective Action Plans Corrective Action Plans Civil Money Penalties Civil Money Penalties Appeals Yes Yes 9
10 DNS Enforcement Program Enforcement Complaint Tool: ASETT is a web-based application which enables individuals or organizations to file a HIPAA and/or ACA complaint against a HIPAA covered entity for potential non-compliance with the non-privacy/security provisions of HIPAA Not for privacy or security complaints Allows submission of demographic information about the involved parties, details of the alleged violation, and any supporting documentation from both parties 10
11 DNS HIPAA Optimization Program : Process Complainants have the option to remain anonymous to the filed against entity The X-Engine Transaction Testing Tool supports X12 and NCPDP, versions 5010 and D.0, and transaction testing for compliance, syntax and business rules. The complaint website is We are in the process of revising the type and amount of complaint information that will be posted on the enforcement page of our website We welcome industry feedback on posting enforcement statistics 11
12 HIPAA Enforcement Revised Complaint Form Hardcopy Printable from CMS.gov under the Regulations & Guidance in the Enforcement section Revised version Updated to mirror ASETT system fields and address comments received from industry stakeholders Status In compliance with the Paperwork Reduction Act (PRA) entering second stage of public comment period (45 days) The revised form is being cleared and will be available in the near future 12
13 Compliance Review Program Compliance Review Pilot: 5 Clearinghouses and 1 health plan participating Providers not included in the pilot Participants randomly selected from volunteers Testing includes all of the standard transactions that an entity conducts Entities attest to compliance with the operating rules Pilot is two-thirds complete Full Compliance Review Program: Informational webinars, Q&A sessions, and broadcast material in development Initially planning 10 or more audits per year 13
14 What is Administrative Simplification Subregulatory Guidance? Subregulatory Guidance is information used to: explain the Department s interpretation of a statute or regulation, address complex policy implementation topics, provide technical information regarding the Department s processes and procedures. 14
15 Benefits of Subregulatory Guidance Subregulatory Guidance: Keeps industry up-to-date with Administrative Simplification as it applies to the latest advances in technology and business practices Allows the Department to be more responsive to recommendations from advisory bodies, questions from the public, changing industry needs, and environmental and technological developments Allows the agency to issue guidance documents quickly and allows for greater flexibility 15
16 Introduction of New Administrative Simplification Communication Tools DNS has established a protocol for developing and issuing guidance documents to bring more timely information and greater clarity to our stakeholders. DNS has developed 3 types of communications: Administrative Simplification Guidance Letters (Go-to Guidance) Administrative Simplification Information Bulletins (Go-to Info) FAQs (Go-to Answers) All three types are intended to improve DNS communications and are aligned with OMB Final Bulletin for Agency Good Guidance Practices. Our messaging through social media and other means will continue. 16
17 DNS Regulatory Publication Update 17
18 Administrative Simplification; Health Care Claims Attachments s This proposed rule would adopt standards for health care attachments transactions and electronic signatures to be used in conjunction with health care attachments transactions. It would also adopt operating rules that require acknowledgments to be used for the eligibility for a health plan, health care claim status, and health care electronic funds transfers (EFT) and remittance advice transactions. In addition, it would adopt acknowledgments transactions standards for the health care claim status, enrollment and disenrollment in a health plan, health plan premium payments, coordination of benefits, referral certification and authorization, and health care attachments transactions. Finally, this proposed rule would modify the standard for the referral certification and authorization transaction from ASC X12 version 5010 to ASC X12 version
19 Administrative Simplification: Update of Retail Pharmacy Standards This interim final rule with comment would modify the Retail Pharmacy Administrative Simplification standards to utilize version D.0.V Among other updates, this will allow for proper recordkeeping when less than the full amount of a prescription for controlled substances is distributed by the pharmacy. This enhancement is critical for retail pharmacy in light of the Opioid Crisis. 19
20 Adoption of a Standard for a Unique Health Plan Identifier Repeal This proposed rule would rescind the standard unique identifier for health plans (HPID) and the implementation specifications and requirements for its use, which were adopted in the Federal Register published on September 5, 2012 (77 FR 55664). This proposed rule would also rescind the other entity identifier (OIED) and implementation specifications for its use. 20
21 OPEN DISCUSSION 21
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