1 Operating Rules Status NCVHS Subcommittee on Standards December 3, 2010 Updated on enhancements to Operating Rules for Eligibility and Claim Status

2 What is NCPDP?  An ANSI-accredited standards development organization.  Provides a forum and marketplace for a diverse membership focused on health care and pharmacy business solutions.  A member driven organization that has been named in various government legislation and rulings, such as HIPAA and the Medicare Part D Regulation.  One of several Standards Development Organizations (SDOs) involved in Healthcare Information Technology and Standardization.  Focus on pharmacy services, and has the highest member representation from the pharmacy services sector of healthcare.

3 HIPAA Eligibility and Claim Status  NCPDP:  Telecommunication Standard Implementation Guide Version D.0  Batch Standard Implementation Guide Version 1.2  ASC X12:  ASC X12 270/271 Technical Report Type 3  ASC X12 276/277 Technical Report Type 3  Note: pharmacy industry utilizes the ASC X (remittance advice), 834 (enrollment) and the 270/271 (eligibility) is used as part of electronic prescribing.  Note: pharmacy industry does not use the claim status transaction.

4 Operating Rules Definition (1) DEFINITION OF OPERATING RULES.—Section 1171 of the Social Security Act (42 U.S.C. 1320d) is amended by adding at the end the following: ‘‘(9) OPERATING RULES.—The term ‘operating rules’ means the necessary business rules and guidelines for the electronic exchange of information that are not defined by a standard or its implementation specifications as adopted for purposes of this part.’’ Points from the regulation:  Recognized that business rules and guidelines may already be present in the implementation specifications.  Operating rules may cover exchange not already defined in the implementation specifications.  SDOs govern the data content of the transmissions and the business rules and reference documents required to support the data content.  Operating Rules cannot add, modify or remove requirements defined in the implementation specifications.

5 Operating Rules Recommendations  Publication of documents  Operating rules are impacted by implementation specifications.  Operating rules may also be updated between implementation specifications to satisfy appropriate business requirements that would not have an impact on the implementation specifications.  Operating Rule entities must collaborate where possible.  NCPDP, CORE and other named entities will continue to collaborate.  Operating Rule entities must use the existing process to bring regulatory requests forward – the industry understands this process.  Submission of new versions of operating rules to DSMO.  DSMO recommends new versions of operating rules to NCVHS.  NCVHS recommends new versions of operating rules to the Secretary of HHS.

6 Concerns that must be addressed The charge to operating rules entities was to address eligibility and claim status transactions.  Additional topics have not been vetted fully by the entire industry and therefore must not be imposed on the entire industry.  Connectivity  Response time  System availability  “Companion guides”  Difference identified  Acknowledgements  Additional topics to be addressed by HHS  Safe harbor  Certification

7 Connectivity There is a serious concern if regulations are issued constraining existing connections, for example, Internet as the only choice versus private network connections. If the regulation would include connectivity, it must  Allow existing connections (safe harbor). The regulation must not require a “rip and replace” of infrastructure already in place.  Clarify that Internet is not the only connectivity allowed. The regulation must clarify  Trading partners negotiate connectivity. Entities must be given the option of supporting both public or private connectivity.

8 NCPDP Connectivity  NCPDP created the NCPDP Connectivity Standard Implementation Guide for the CAQH CORE Connectivity Rule Version 1.0  In collaboration with CORE  Addressed real-time connectivity only when supporting CORE rule Actions:  NCPDP is creating a connectivity operating guide for NCPDP and X12 transactions used by the pharmacy and electronic prescribing industry.  Incorporate existing documents of X12 guidance for pharmacy industry.  Incorporate NCPDP defined Payload data elements for use.  Will collaborate with CORE where possible.  NCPDP membership will consider approval in 2011.

9 Response Time and System Availability Topics have not been vetted by the entire industry and therefore must not be imposed on the entire industry. If the regulation would include response time and system availability, it must  Clarify that the CORE rules do not address pharmacy and electronic prescribing requirements.

10 “Companion” Guides The term “Companion Guide” and its related issues are not shared in pharmacy and electronic prescribing industries. If the regulation would include the “companion guide” topic, it must clarify  The CORE or HHS rules do not address pharmacy and electronic prescribing environments.  NCPDP publishes a Payer Template Implementation Guide  This document has been used by the pharmacy industry since Telecom 5.1.  Provides rules on the creation of payer-specific information without changing the intended use of the Telecom guide.  Plans and payers use this template and guide to create their “payer sheets”.  Payer sheets are referenced in Medicare Part D claim processing requirements.

11 Acknowledgments DSMO recommendation: Approve. DSMO approves this request for ASC X12 transactions. However, the DSMO recommends further public comment be accepted about the 835 and 820 acknowledgments as there are business cases where acknowledgements may not be the most appropriate. We recommend that the acknowledgement files for the 835 and 820 transactions be based upon trading partner agreements. If a regulation were to name acknowledgements, it must  Support the DSMO recommendation.  Name acknowledgements as a HIPAA-named exchange.  Industry input on 835 and 820 acknowledgments.  Operating rules for the 999 acknowledgement would need to be developed if they aren’t already contained in the guide and/or developed by X12.

12 Certification It is unclear if certification will be stipulated in the regulation. If the regulation would include certification, it must  Allow existing connections (safe harbor). The regulation must not require a “rip and replace” of infrastructure already in place.  Clarify which entities are required to certify and what entities are to certify.  Provide specific requirements as to the certification process.  Allow entities the option of supporting both public or private connectivity. The CORE certification requirements were not intended for the pharmacy and electronic prescribing industries as these were outside of scope.

13 Pharmacy Eligibility ‘‘(i) ELIGIBILITY FOR A HEALTH PLAN AND HEALTH CLAIM STATUS.—The set of operating rules for eligibility for a health plan and health claim status transactions shall be adopted not later than July 1, 2011, in a manner ensuring that such operating rules are effective not later than January 1, 2013, and may allow for the use of a machine readable identification card.” How it works:  The NCPDP Telecommunication Standard Implementation Guide includes guidelines recommended by the industry.  The rules and guidance in the Implementation Guide adequately support the needs of eligibility verification use in commercial, Medicare, and Medicaid processing.  The pharmacy industry utilizes the real-time claim which provides the complete verification of eligibility/benefit checking as well as claims processing.  The network infrastructure is mature. See ID Card section at end of presentation.

14 Pharmacy Eligibility Recommendations Recommendation: The NCPDP Telecommunication Standard Implementation Guide Version D.0 Eligibility Verification rules be named as operating rules for pharmacy industry. NCPDP membership will consider approval of connectivity operating rules in 2011.

15 Eligibility and Electronic Prescribing Eligibility impact – electronic prescribing environment  ASC X12 270/271 are used to obtain and provide patient Eligibility, Formulary and Benefit information. Recommendation: Operating rules named for the X12 270/271 must not be adopted for electronic prescribing functions without additional NCPDP guidance.  Note: NCPDP has mapped the pharmacy-industry routing identifiers (BIN/PCN/Group) to the 4010A1 270/271 and the /271 for use in eligibility verification. This provides vendors the information to support a prescriber office using the standard pharmacy ID card to perform an eligibility check on a patient’s pharmacy benefits using the 270/271.

16 ID Card  NCPDP publishes a Health Care Identification Card Pharmacy and/or Combination ID Card Implementation Guide  WEDI has Health Identification Card Implementation Guide.  Both are based on standard ANSI INCITS 284 Identification Card - Health Care Identification Cards. Collaborative work.  NCPDP publishes a Pharmacy ID Card to X12 270/271 Health Care Eligibility Benefit Inquiry and Response – Excel document  Pharmacy routing identifiers (BIN/PCN/Group) and patient information from the pharmacy ID Card to the 4010A1 270/271 (and the 5010) 270/271 for use in electronic prescribing in obtaining Formulary and Benefit identifiers.

17 ID Card Concerns CORE 258: Phase II Normalizing Patient Last Name Rule if incorporated into regulation, should not include the ID Card. Its intent is the X12 270/271 transaction, but need to be clear.  It has not been vetted with industry whether this works with the NCPDP ID Card Implementation Guide.  It has not been vetted with industry whether this works with the electronic prescribing use of the 270/271. If the regulation would include ID Card topic, it must clarify  The CORE 258 rule is only for the X12 270/271 for eligibility verification (it’s intent).  The CORE 258 rule is out of scope for the ID Card and the electronic prescribing environments.

18 ID Card Actions Actions:  INCITS updated version will be published soon.  NCPDP and WEDI will update their guides to provide assistance on how to use the card for transactions.  NCPDP has collaborated with CORE in the development of a Phase III Health ID Card operating rule.  NCPDP is in the process of adding guidance for use of data elements found on the card in specific transactions.  NCPDP will discuss whether to submit the NCPDP ID Card Implementation Guide into the regulatory process.  NCPDP membership will consider approval in 2011.

and Pharmacy Industry The existing NCPDP “835 documents” (approved by X12) show how to take the NCPDP Telecommunication D.0 claim transaction data and consistently report the remittance advice data on the 835. Action: NCPDP operating rules document will incorporate:  The metadata fields at the envelope layer.  Allowance of any appropriate Acknowledgement as determined by the pharmacy industry, but will not require.  Existing NCPDP 835 documents (for the NCPDP claim to X12 remit).  Internet must not be the only option for 835 transport.  NCPDP membership will consider approval in 2011.

20 Thank You Lynne Gilbertson VP, Standards Development NCPDP Annette Gabel NCPDP Board of Trustees