By Tony Schueth, CEO & Managing Partner
BACKGROUND: At the NCPDP meeting in Portland on November 8, there was discussion about the use of NCPDP SCRIPT for electronic prior authorization (ePA).
NCPDP’s Lynne Gilbertson led discussion on a Designated Standards Maintenance Organizations (DSMO) change request that would add the SCRIPT transactions we’ve leveraged for ePA to HIPAA. Drew Morgan from CMS’ Office of eHealth Standards and Services (OESS) contributed as did I, the leader of the Prior Authorization Workflow-to-Transactions Task Group.
After the meeting, I received an eMail from someone who was confused by the discussion. He may not have been the only one. The work group meeting is attended by individuals who have been involved since the task group was formed in November 2004, those new to ePA and many in between, which means that there is a varying base of understanding. Further clouding the situation is the fact that it’s, well, complicated.
His questions might be shared by others, and my response might be helpful. Here is a summary of his eMail and the basic content of my response:
I caught part of the ePA discussions, and am still struggling to understand … the part about being named by HIPAA as a standard … the implications … how the ePA standard could be exempted from being named by HIPAA … the process by which standards become [HIPAA] are named … who the HHS lawyers are and what it means practically for them to be against fast-tracking the ePA standard. Can you help, please?
My Response: During that part of the meeting, we were discussing a Designated Standards Maintenance Organizations (DSMO) request to include the functions of SCRIPT for ePA as HIPAA-named transactions. Such a request needs to ultimately be approved by the DSMO, which is made up of representatives of 6 organizations, one of which is NCPDP. (The process can be researched here.) NCPDP submitted the change request on behalf of the industry but, as a named organization, needed to approve it. The current HIPAA-named “referral transaction” (ePA) standards are the ASC X12 278 (between the provider and payer) and NCPDP Telecommunication (between the pharmacy and payer).
In 2006, the ASC X12 278 and “companion” transaction standards were pilot tested in four Medicare Drug Improvement and Modernization Act (MMA)-funded pilots for medication PA. In the subsequent report to Congress, the piloters observed that the ASC X12 278 didn’t accommodate the information required to obtain payer approval of medications. You could eventually get there using the standard and its companion transactions, but doing so was cumbersome and inefficient, mostly because fields were used differently than originally intended, and duplicate information was transmitted. In a nutshell, the issues sprung from the fact that the ASC X12 278 wasn’t designed for medication PA.
In 2008, the Agency for Healthcare Research and Quality (AHRQ) under direction from OESS convened an expert panel to review the pilot findings. That expert panel recommended that a new standard be built, a difficult and frankly political decision because one already existed. Under a subsequent AHRQ contract with us (Point-of-Care Partners), a great deal of analysis and legwork was done regarding the feasibility of such an endeavor. This included research about HIPAA implications, a value model, getting a “head nod” from OESS and providing an update to the National Committee on Vital and Health Statistic (NCVHS), a public-private advisory council that plays many roles, one of which is advising HHS on standards. In 2009, NCPDP acted on these recommendations. Over the next four years, NCVHS and OESS were apprised of each ePA milestone.
Most important to OESS has been identifying a standard that would be used by the industry. SCRIPT transactions for ePA fit that bill, because the workflow was “ePrescribing centric,” meaning the prescriber understands that PA is required before writing a prescription, the prescriber or staff requests/justifies PA and an answer is obtained, conceptually before the patient leaves. Evidence that this model would be preferred was provided by CVS Caremark, who piloted it with Allscripts and Navinet. There was also an open task group where scores of different stakeholders contributed many hours of design and review, taking the initial piloted transactions and refining them for industry standard use.
In February 2013, with the Task Group seeing a “light at the end of the tunnel,” OESS was apprised and began moving forward with the regulatory process. The new ePA transactions in the SCRIPT Standard were published in July 2013.
OESS wished to explore a non-HIPAA path; basically, determining that since the new ePA transactions were based on SCRIPT – the ePrescribing standard – it wasn’t HIPAA because ePrescribing is not part of HIPAA. (When HIPAA passed in 2006, ePrescribing was exempted from operating rules for HIPAA transactions).
While OESS is still arguing that the SCRIPT ePA transactions are ePrescribing, the Office of General Counsel of the Department of Health and Human Services (the “HHS attorneys”) has said that since “referral” is named in HIPAA, their opinion is that the ePA transactions would be part of HIPAA. It would be nice if we stayed away from HIPAA but, for the record, this was expected all the way back to the decision to create SCRIPT transactions for ePA. Because of this, NCPDP submitted the DSMO change requesting that this use of ePA for SCRIPT be named by HIPAA.
Why does it matter if ePA is HIPAA or MMA? What are the implications of either path? What if one wins out over the other? What do each stakeholder – PBM, health plan, intermediary or EHR – need to do to be ready? What happens if they’re not?
These are all questions we’ve been working on with our clients. We’d be happy to help you sort through them, as well, should you need the assistance.