Today, URAC held a conference call to explain to persons and organizations interested in the new PBM accreditation program and the beta testing process currently underway. Here is a summary of my notes (some of which were from the call, some of which are from the materials URAC provided call participants).

Implementation Timeframe Overview: Standards Development Process

• Committee develops draft standards Q3 2006 - Q2 2007
• Public input into Commercial Standards Q4 2006
• Forums (e.g. AMCP, NPC)
• Comment period
• Organization beta testing Q1-Q2 2007
• Final revisions to standards Q2 2007
• Approval by URAC’s Board Q3 2007
• Launch Q3 2007

Beta testing objectives:

• “Is the intent of standard clear to the applicant?
• “Can an organization demonstrate mechanisms to meet the standard?”
• “What are the various (multiple) methods companies can demonstrate compliance with the standard?”
• “Is the standard consistent with industry practice

Review team:

• Christine Leyden
• Annette Watson
• Janice Anderson

NEXT STEPS

• Confirm Onsite Operational Location for Beta Testing via the Application Form by March 5, 2007
• Confirm Beta Onsite Date with Janice Anderson, R.Ph. by March 5, 2007
• Execute URAC Business Associate Agreement prior to commencement of beta onsite activities
• Complete Beta Document List with the Organization’s Comments and Examples of Potential Compliance Methods by the date of the Beta Onsite for all standards
• Evidence of Compliance with Mandatory Standards available at the Beta Onsite

BETA PREPARATION

• Onsite Agenda Review is estimated 1.5 days onsite by a team
• Overview Presentation of the PBM’s Scope of Services with Organization Charts for areas within the scope of the PBM Accreditation
• Document List with Organization’s Feedback pertaining to the proposed standard
• Relevant Documentation Available for Mandatory Standard
• Interview Key Personnel (phone or in-person)

KEY PERSONNEL

• Appropriate Senior Staff and 1 to 2 Operations Staff for each module
• Corporate Quality Oversight
• Information Management System
• Regulatory/Legal Compliance
• Staff Training and Credentialing
• Claims Processing
• Marketing
• Member Communications

What’s Not Addressed in the Standards?

• E-Prescribing (address in next revision)
• Specialty Pharmacy
• Mail Service (See the NABP VIPPS Accreditation)

Other issues

• URAC Revises its Accreditation Programs every 2 years.
• Onsite Review for Beta will be 1.5 days, ending around noon on the second day.

Questions addressed

1. Q: What's the relationship between the document list and the agenda? A: The document list has a column that cross-references to the appropriate standards. In addition, the agenda specifically addresses the standards under review during each time frame in the Beta Onsite agenda.
2. Q: Regarding the beta onsite review, you're placing emphasis on "mandatory standards." Are those the standards rated "5"? A: Yes, we'll be looking for complete documentation on all standards weighted 5, but also will be looking at documentation for the other standards.
3. Q: Can you provide clarity around which standards apply to PBMs and which apply to plans? A: There may be some blurred lines, but we hope to find out during the beta testing process which standards don't apply to PBMs.
4. Q: To whom does "delegation" apply? A: Any organization to which the PBM off-loads any function that is the subject of any of the PBM standards.
5. Q: What happened to Module 7 as it relates to benefits? A: The standards that were eliminated between the "public comment" version and the "beta" version were deemed by the Standards Committee to be inapplicable to PBMs generally. The remainder were folded into the other module.
6. Q: Are there additional fees when you apply for accreditation. A: Generally, no. The only way you would be charged an additional fee would be if URAC needs to visit more sites than originally contemplated.

Draft, public comment, redraft, beta reviews, redraft, and approve.

That's the basic sequence for developing a new set of accreditation standards at URAC. While sometimes it seems as though this is a long, slow process (and sometimes it is), there are passages that seem like the Indy 500. In the history of the development of the URAC Pharmacy Benefit Management ("PBM") accreditation standards, now is one such time.

The public comments are in, and the second draft is being worked on. Yet, within a matter of weeks, URAC accreditation reviewers will be showing up on the doorsteps of the companies participating in the "beta" process to conduct their onsite reviews.

So, if you're a PBM that is participating as a beta applicant, some time in the next few days you'll get a copy of the revised standards and need to start gathering documents like crazy to be ready for the knock on your front door that could be as early as mid-March.

Now, of course, the beta process at URAC is different from the normal application process. The normal approach is to submit an application, receive an evaluation of that application from the reviewer(s), respond to that evaluation (called the "Desktop Review Summary") with additional documentation, then submit your organization to an onsite review. In the beta process, you gather your documents together, engage in a more dialogic back-and-forth with the reviews (and sometimes observers) during the onsite review, and then pull your formal application together after the reviewers have left.

Despite this difference faced by beta applicants, there is a big demand for fast action at this phase of the game. Staff training, gap analysis, document assessment and review, revision of P&Ps, mock onsite reviews, and much more, all within the next 30 business days. One of our clients is in this select crew, and we launch our effort tomorrow.

Ladies and gentlemen, start your engines.