Testimony by Lynne Gilbertson for the July 26, 2005 NCVHS Subcommittee on Standards and Security Hearing

NCPDP Status of NCVHS Recommendations
To HHS on Electronic Prescribing for the MMA
July 26, 2005

Observation 3 (Prescription Messages)
Recommendation:

HHS should

• recognize as a foundation standard the most current version of NCPDP SCRIPT for
  • new prescriptions, prescription renewals, cancellations, and changes between prescribers and dispensers.
  • The NCPDP SCRIPT Standard would include its present code sets and various mailbox and acknowledgement functions, as applicable.
• include the fill status notification function of the NCPDP SCRIPT Standard in the 2006 pilot tests to assess the business value and clinical utility of the fill status notification function, as well as evaluate privacy issues and possible mitigation strategies.
  • Status:
    • NCPDP Work Group 11 ePrescribing & Related Transactions RXFILL Task Group created implementation and operational guidance to pharmacy and prescriber system participants for the consistent utilization for the Fill Status Notification transactions.
      • Guidance includes operational challenges such as automatic triggering of fill status notifications, triggering on return to stock, inferring pick up, privacy, liability, coordination with medication history, a patient changing physicians, etc.
    • These were added to SCRIPT Standard Implementation Guide Version 8.1. (They are not balloted items, but occur in this version of the imp guide.) Estimated publication of SCRIPT Standard Implementation Guide Version 8.1 in October/November.

Observation 4 (Coordination of Prescription Message Standards)
Recommendation:

HHS should

• financially support the acceleration of coordination activities between HL7 and NCPDP for electronic medication ordering and prescribing. HHS should also support ongoing maintenance of the HL7 and NCPDP SCRIPT coordination.
• recognize the exchange of new prescriptions, renewals, cancellations, changes, and fill status notification within the same enterprise as outside the scope of MMA e-prescribing standard specifications.
• require that any prescriber that uses an HL7 message within an enterprise convert it themselves, or utilize a switch, to NCPDP SCRIPT if the message is being transmitted to a dispenser outside of the enterprise. HHS also should require that any retail pharmacy within an enterprise be able to receive prescription transmittals via NCPDP SCRIPT from outside the enterprise.
  • Status:
    • Ross Martin to provide detailed update.

Observation 5 (Formulary Messages)
Recommendation:

• HHS should actively participate in and support the rapid development of an NCPDP standard for formulary and benefit information file transfer, using the RxHub protocol as a basis.
• NCVHS will closely monitor the progress of NCPDP’s developing a standard for a formulary and benefit information file transfer protocol, and provide advice to the Secretary in time for adoption as a foundation standard and/or readiness for the 2006 pilot tests.
  • Status:
    • NCPDP Work Group 11 ePrescribing & Related Transactions Formulary and Benefit Task Group presented a standard for approval to NCPDP at the March 2005 work group meetings.
    • NCPDP Formulary and Benefit Standard Implementation Guide Version 1.Ø
      • Balloted in April 2005. There were some comments to clarify usage and verbiage – positive comments.
      • Re-circulation Ballot in July 2005. Final review of comments at NCPDP Work Group in August. After appeal timeframe (September), the NCPDP Board of Trustees will be asked to approve (October).
      • ANS-approval is in tandem with the NCPDP process.
      • Publication expected in November/December timeframe.
    • The standard includes the sharing of
      • Formulary status lists (codes to explain how to treat non-listed brand, generic, OTC; whether the drug is on formulary or preferred status; relative value limit, etc)
      • Formulary alternatives lists (alternatives for specific drugs – the source/ the alternative)
      • Benefit coverage lists (conditions under which the patient’s pharmacy benefit covers a medication)
      • Benefit copay lists (the extent to which the patient is responsible for the cost of a prescription. The specification supports multiple ways to state this cost, including flat dollar amounts, percentages, and tier levels.)
      • Cross-reference file of user-recognizable health plan product name to the identifiers used for the Formulary, Alternative, Coverage, and Copay.

Observation 6 (Eligibility and Benefits Messages)
Recommendation:

HHS should

• recognize the ASC X12N 270/271 Health Care Eligibility Inquiry and Response Standard Version 004010X092A1 as a foundation standard for conducting eligibility inquiries from prescribers to payers/PBMs.
• support NCPDP’s efforts to create a guidance document to map the pharmacy information on the Medicare Part D Pharmacy ID Card to the appropriate fields on the ASC X12N 270/271 in further support of its use in e-prescribing.
  • Status:
    • NCPDP Work Group 3 Standard Identifiers task group completed a mapping document which has been posted to the NCPDP website and notification sent out with the 07/15/2005 NCPDP newsletter.

Observation 7 (Prior Authorization Messages)
Recommendation:

HHS should

• support ASC X12 in their efforts to incorporate functionality for real-time prior authorization messages for drugs in the ASC X12N 278 Health Care Services Review Standard Version 004010X094A1 for use between the prescriber and payer/PBM.
• support standards development organizations and other industry participants in developing prior authorization work flow scenarios to contribute to the design of the 2006 pilot tests.
• evaluate the economic and quality of care impacts of automating prior authorization communications between dispensers and prescribers and between payers and prescribers in its 2006 pilot tests.
• ensure that the functionality of the ASC X12N 278, as adopted under HIPAA, keeps pace with requirements for e-prescribing and that new versions to the Standard be pilot tested.
  • Status:
    • NCPDP Work Group 11 ePrescribing & Related Transactions Prior Authorization Workflow-To-Transactions Task Group is led by Tony Schueth of Point of Care Partners and consists of X12N WG10 Health Care Services Review Co-Chairs and other interested stakeholders.
    • Tony will present in the next session.

Observation 8 (Medication History Messages from Payer/PBM to Prescriber)
Recommendation:

• The following recommended actions address only exchange of medication history from payers/PBMs to prescribers. NCVHS plans to address other medication history communications in its March 2005 recommendations.
  • HHS should actively participate in and support rapid development of an NCPDP standard for a medication history message for communication from a payer/PBM to a prescriber, using the RxHub protocol as a basis.
    • Status:
      • RxHub submitted a Data Element Request Form (DERF) at the November NCPDP work group meeting for the protocol (based on SCRIPT).
      • SCRIPT Standard Implementation Guide Version 8.Ø has been balloted and approved.
      • NCPDP Board of Trustees is approving the ballot now.
      • ANS-approval is underway.
      • Expected publication in September.

Observation 9 (Clinical Drug Terminology)
Recommendation:

HHS should

• include in the 2006 pilot tests the RxNorm terminology in the NCPDP SCRIPT Standard for new prescriptions, renewals, and changes.
  • RxNorm is being included in the 2006 pilot tests to determine how well the RxNorm clinical drug, strength, and dosage information can be translated from the prescriber’s system into an NDC at the dispenser’s system that represents the prescriber’s intent. This translation will require the participation of intermediary drug knowledge base vendors until the RxNorm is fully mapped.
    • Status:
      • In June, NCPDP members held a conference call with John Kilbourne, NLM.
      • John will be attending the NCPDP August Work Group meeting where discussions with take place of the different business needs and where RxNorm might be used.

Observation 10 (Structured and Codified SIG)
Recommendation:

HHS should

• support NCPDP, HL7, and others (especially including the prescriber community) in addressing SIG components in their standards. This should include preserving the ability to incorporate free text whenever necessary (e.g., for complex dosing instructions, and to address special cultural sensitivities, language, and literacy requirements)
  • Status:
    • NCPDP Work Group 10 Professional Pharmacy Services Industry SIG Task Group led by Laura Topor of Allina Hospitals and Clinics, and Keith Fisher of SXC Health Solutions, Inc.
    • Laura will present the report in the next session.
• include in the 2006 pilot tests the structured and codified SIGs as developed through standards development organization efforts.

Observation 13 (Pilot Test Objectives)
Recommendation :

HHS should

• support the efforts of standards development organizations to incorporate in the foundation standards as many as possible of the additional functions required for MMA, as identified in these recommendations.
• include foundation standards with as many as possible of the additional functions required for MMA in the 2006 pilot tests.
• immediately begin to work with the vendors to ensure readiness for the pilot tests on January 1, 2006.
• identify and widely publicize specific goals, objectives, timelines, and metrics to guide the design and assessment and increase industry awareness of the 2006 pilot tests. HHS should include metrics that address economic, quality of care, patient safety, and patient and prescriber satisfaction factors.
• After the pilot tests, HHS should develop and widely disseminate information concerning any economic and quality of care benefits of e-prescribing, provide comprehensive education on implementation strategies, describe how e-prescribing can be implemented consistent with the privacy protections under HIPAA, and address other elements that contribute to successful and widespread prescriber adoption and patient acceptance.
  • Status:
    • Waiting on information from CMS.

Long Term Care

NCPDP’s Work Group 14 Long Term Care has formed task groups to work on the needs of this sector, especially in light of the MMA. They are working on billing needs. They are examining electronic prescribing needs and will work with NCPDP Work Group 11 ePrescribing & Related Transactions, to development enhancements to the SCRIPT Standard. They have done a lot of work showing the process flows in long-term care. They will be working on conformance criteria with the HL7 group for LTC EHR minimum functions. They have pulled expertise from across the long-term care industry, organizations, standards bodies, etc in these various efforts. They have many challenges, but they have built a solid foundation.

Thank you.