URAC’s Specialty and Mail Service Pharmacy Accreditation Programs, v. 4.0 — Where are we after the first year?

On October 1, 2020, URAC unveiled its long-awaited v. 4.0 of the Specialty Pharmacy and Mail Service Pharmacy accreditation programs.

The occasion did not disappoint. There were webinars. There were frantic phone calls with consultants. There were meetings. And more webinars.

Clearly, something had happened. But what?

We’ve now had a bit over a year to digest the new standards. And, more importantly, we’ve had a chance to see how the new standards would be interpreted. The first wave of pharmacies to be accredited under the new standards is just now finishing up (with a bit of a delay for some because of the pandemic).

Of course, the most obvious change is the standards themselves. Some standards from the previous era went away (e.g., the dreaded call center “blockage rate” requirement). Some standards are brand new (e.g., a cluster of standards focusing on ethics). And nearly all the rest have been revised. I won’t detail them here — URAC’s cross-walk offers one view, and a February 2020 webinar I did with my colleagues offers another. Suffice to say that, at the level of the standards, the scope and depth of the changes are pretty much we’ve come to know about what happens when there’s a major version change (e.g., from 3.x to 4.0), as opposed to the minor tweaks (e.g., 3.1 to 3.2).

Another development, though, seems to me to be underreported and more significant, that is, the elevated importance of the language of the interpretive information found in the URAC Accreditation Guide accompanying each set of standards. Historically, while important, that language was not always to be taken literally, by either URAC reviewers or applicants for accreditation.

This is no longer the case. The first round of Requests for Information (“RFIs”) from v. 4.0 have revealed that it is now essential for URAC applicants to take literally the interpretive language accompanying each standard in the guide. For example, if the interpretive language says you have to list the standards applicable to the functions you are delegating to your contractor, you’d better do that instead of simply referring to them as “the applicable accreditation standards”. This is more significant than you might imagine.

The first wave of v. 4.0 URAC Validation Reviews have also revealed a trimmed-down approach to the final stage of the accreditation process. Major portions of the standards have been removed from the Validation Review, shortening and simplifying the last stage. In other words, for a large portion of the standards, once you’ve gotten past the Desktop Review phase, you’re done.

Obviously, I’ll be writing a lot more as I learn more, so stay tuned!

Tom Goddard