The following are being submitted for consideration by the panelists, to include in presentations for the July 31, 2007 NCVHS meeting of the Standards & Security Sub-Committee. 

Issues for successful migration to next version of HIPAA Standards

  1. What is the business benefit to you in terms of moving to the next version of each transaction? e.g. greater utilization of some transactions? Fewer variances in companion documents?
    1. Extra information which will be available in the E1 – Eligibility Verification transaction will be beneficial.
    2. The COB (Coordination of Benefits) Claims will be able to be handled better in the next version
    3. It will be much better to be able to have a standard way to process the one-time fills for Part D drugs that are not on the new plans formularies.
    4. More LTC information will be on the claims, which will also facilitate claims processing, claims submission, and reporting after the fact

Are there transactions that although are currently implemented, have limited or no utilization?

The B3 – Rebill transaction is not used much at all.

E1 – Eligibility Verification is not used as a transaction being sent to the payers much, but it is used frequently to the TrOOP facilitator. 
N1  - Information reporting is not used by the pharmacies very much, but is used between the facilitator and the payer for Part D information

Are there transactions that you have implemented with a lot of work arounds in order to continue to meet advancing business needs?  

Currently we have been unable to meet the needs due to the limitations of the NCPDP 5.0 transaction set, and the HIPAA regulations against modifications to the standard.

  1. It has been suggested that there should be an overall industry implementation plan to assure a successful  implementation.  If you disagree, please explain why.  Please pick up the issues at e.
    1. Who should develop it?
    2. Should it be part of the regulation?
    3. Who should enforce progress?
    4. Are there incentives or penalties to assure meeting intermediate dates.
    5. What are the milestones for an implementation plan?  What are the issues involved with each?
      I disagree with the suggestion that there be an overall industry implementation plan, especially as it pertains to the implementation of NCPDP D0.  In the pharmacy industry, the sheer volume of the claims being transmitted, combined with the fact that pharmacies will not dispense the medication to the patient without having received a reply from the claims processor regarding proper copay and payment information is cause to allow the pharmacy software vendors, pharmacies, and pbm/claim processors to have time to conduct a slow and methodical implementation. 
      The initial test period should include voluntary participation by payers and pharmacies using a mix of “canned tests” so as to ensure that certain scenarios and claim types are tested, and also real claims.  Ideally, a period of several days worth of claims should be able to be reprocessed to compare the actual results with those of the test system, giving everyone an ability to compare results and justify or correct any differences.
      In the next phase of the testing period I envision a phased in approach with a few test sites (payers and pharmacies) using live data, real processing.    Those “Live Tests” should be conducted for at least three payment cycles to allow for the complete claim submission and claim payment cycles (835 and/or paper remittance advices) to be completed. 
      After a test period of actual implementation such as I’ve described, any problems or issues resulting from deficiencies or errors in the standard should be able to be corrected or changed as necessary before having the standard mandated by CMS.
      1. Software vendor readiness.
        Software Vendors have commitments to their software “users” to maintain compliance with the NCPDP standards.  They all must incorporate the standards into their software systems otherwise they would not be able to sell their software to the pharmacies.  That being said, the magnitude of the project to prepare the software systems to make use of the new standard, while still supporting the old version will differ from one vendor to the other.  QS/1 and Smith Premier Services have a long track record of always being ready to test a new version of the standard as soon as there are pharmacies/payers/processors willing to work with us.  What cannot be controlled is the cost and time involved at the pharmacy level to update their computer systems due to the unique factors at each pharmacy. 
      2. Phased implementation? (by transaction, industry segment, etc.)I do not believe a controlled or phased implementation should be mandated, and especially NOT by transaction, as that would surely be too confusing and most likely would cause more errors.  I prefer to allow testing first by those willing to participate and share results with those in the industry regarding any issues needing attention and changes in the standards, and then let the natural market forces work to roll out the changes.  Of course some future date should be mandated by which all entities must be using the new standard, but keep in mind that other factors are involved, not the least of which are financial expenditures to be borne by pharmacies, system vendors, and processors for software, programming, computer hardware/upgrades, etc.  These expenses can be significant, and have to be considered when setting compliance dates.
      3. Does phasing introduce additional support, cost, or other issues?
         It is impossible to declare that everyone in the entire industry must begin use of a new standard on a particular day.  We have dealt with phasing through natural business and industry processes for twenty years now.  Controlled phasing would unnecessarily increase the costs of support, and definitely create confusion throughout the industry.
      4. Internal Testing
        QS1 and Smith Premier have extensive abilities to conduct internal testing, including comparisons of data from existing live systems reprocessed under newer systems and claim standards to ensure like results.
      5. External Testing
        QS1 and Smith Premier have participated in external testing using test suites and live data, with pharmacies/payers/processors in an effort to ensure all facets of claims processing are tested using a new standard.
      6. Pilot test periods
        It is hard to predict the time period which is necessary to ensure complete testing of a new standard, as not every situation can be simulated in a test situation.  However, once alpha testing has been completed, beta testing can be implemented.   Pilots should be long enough (3 claim invoice/payment cycles at least) to ensure that all of the backend processes are also working properly and in concert with the new standard. 
      7. An industry testing coordinated plan.
        NCPDP members have always worked well in working toward a common goal of building consensus to create modifications to the standards to accommodate the needs and goals of the industry.  I see no reason why volunteer member organizations within the industry, representing all players and facets within the industry cannot again test a new standard, compare results and work together to ensure that any issues and problems within the standard are corrected or addressed prior to the standard being frozen.  It has happened in the past in this manner, and I feel quite confident that QS1 and Smith Premier would not be alone in our willingness to participate in a coordinated testing and results sharing forum to ensure that the standard is as accurate and solid as it can be so that we don’t have errors and problems that we would have to live with for many months and years to come.
      8. Can companies support a dual version of translators for the phase in period and/or beyond?
        Yes, companies can support multiple versions of a standard for a period of time, however, there does come a point in time, usually after 2 or more major software updates/upgrades where it becomes difficult if not impossible to support multiple standards.  What time period this represents is impossible to forecast, as it is definitely related to the changes that are going on in the software system and how they affect or are affected by the multiple standards being supported.
        What cannot be supported is the situation where a processor designates that it needs to have claims submitted to it under an old version of the standard for one portion of it’s claims processing, and the newer standard for another portion of it’s claims processing.
    6. How can we track the progress of vendors and other entities?
      While you can have some mechanism by which vendors and entities can report their progress, I firmly believe that the natural market place forces (competition between vendors, data needs of the processors, and other continuous software updates) have facilitated the natural migration to the newer versions of the standards.  Vendors and Processors may be ready to process claims using a new standard, but until the pharmacies upgrade their systems to be able to provide claims in that new standard, nothing will happen. 
    7. What measures are the most important to monitor in terms of readiness?
      The measures are different for each entity within the industry, with the bottom line being whether or not you are properly using the standard, and that your claims, responses, reports, payments, remittance advices, etc are processing correctly.  This will be different for each entity.
    8. How can application vendors demonstrate their software can process the standards?
      The only way to demonstrate that is to test.  I have always found that the vendors have always been eager to test their software.  Keep in mind, that when a prospective customer is reviewing a vendor’s system for purchase, one of the questions that is always asked, is if they are compliant with the newest version of the standard, or if the release of a newer version is imminent, they are asked about their readiness for that as well. 
    9.  What is the impact of vendors not being covered entities?
      Very seldom have we found that a payer would not want to test with the vendor.  Ordinarily they would prefer to test with a vendor, and so, there has not been any impact by not being a covered entity.
  2.  What are the Issues for Distinct Entities?  Not applicable
    1. Guidance from CMS
    2. Budget cycles
    3. Developing accurate cost estimates
  3. Education
    1. How should information about the changes in standards be provided?
      Pharmacies look to their vendors to educate them on how the standard and the associated new features are to be used in their systems. 
      Vendors of pharmacy systems and Processors generally have participated in the standards development process, or look to NCPDP for guidance on the use of the standards.  The NCPDP Implementation guides and FAQ lists are invaluable tools that NCPDP has built to be used by the industry using it’s standards.
    2. Was the CMS “Ask HIPAA” listserv valuable?  What are some alternatives?  We did not use the listserv, only NCPDP tools and guidance.
    3. When should the outreach begin? unsure
  4. Overlap with other potential HIPAA changes
    1. Claims attachments.  Claims attachments are not applicable to us.
    2. ICD-10.  QS1 will make the changes necessary to support ICD-10 when it becomes necessary, and will work to ensure the smooth transition to it for it’s pharmacies .
    3. Major annual Medicare program changes, payment cycles, etc.  QS1 looks forward to using D0 and the changes it represents in order to facilitate the claims billing of Medicare Part D claims.  Any changes to payment cycles might affect the pharmacies in their accounting procedures, but that would not affect QS1.
    4. Other health plan initiatives.  QS1 has for many years now supported the use of X 12 in the software that is used by the pharmacies for ordering with wholesalers.
  5. What were the “mistakes” during the initial HIPAA implementation that we must avoid?
    1. The first mistake was not allowing enough time to test the new standard. Also, not being able to make timely corrections to the standard after we began testing.  Also, we feel as though there was not wide enough representation throughout the industry to conduct enough testing to ensure that all types of claims were processed.
    2. We felt as though many processors did not have enough information available to the vendors to enable us to know how they were going to use the 5.1 standard, or even what their implementation time frames were.  We found that this resulted in a higher occurance of rejected claims, due to inaccurate or the lack of information.
  6. How long do application vendors need to finalize software after implementation guides are finalized.
    If a true testing period is permitted for a new version of a standard and its accompanying implementation guide, and revisions and corrections to address problems illuminated through testing are permitted to be made, then I feel that a 12 month time period would be needed, especially in light of the fact that some of the revisions between 5.1 and D0 are so great as to involve whole processes within the system ( example: Medicare Part D)
  7.  Is qualified staffing available to do all of this work?
    Yes
  8.  How can we best avoid extensions or contingency plan periods?
    Allow for proper testing, revisions and corrections to be made prior to true go-live dates.
  9. How does this project differ from the initial HIPAA implementation?
    The conversion from 5.1 NCPDP to D0 NCPDP will be even more difficult than the conversion from 3.2 to 5.1 was simply because so many years have past between versions, and so many business needs and processes have been incorporated into the D0 standard.  Testing will need to be longer and involve more different entities in the industry, but at the same time, we have not had any opportunity yet to test with the new standards.  We are not sure that the standards will truly work as we have envisioned them within our companies systems.
    Additionally, because the NCPDP Data Dictionary can change the way the version D0 standard is handled, we will have to keep up with each Data Dictionary that the payer implements.  If Payer A uses a July 2007 data dictionary, and Payer B uses a November 2007 data dictionary, the pharmacy software will have to keep up with the subtle differences in each dictionary.  Each new Data Dictionary that is distributed will have to be downloaded and maintained in the pharmacy system.
  10. Are there other specific policy issues that should also be in the proposed rule?
    (e.g, are there some non-medical codes that should be based on date of service?)