The Basics

Pharm Core 21 requires mechanisms to assure clear communications about services to clients and consumers and protections against misleading communications.  These mechanisms must operate before a marketing piece goes out and, in addition, in a process of ongoing monitoring for accuracy.  In addition, this review must happen through an interdepartmental process.  Finally, if you make a material mistake in your communications, you need to implement a mechanism to correct that mistake in a timely manner.

It is important to note that even organizations that have no direct contact with consumers must comply with this standard, as it covers communications with clients, as well. 

It is also very important for everybody involved with the organization's communications to understand that this standard does not apply only to newly-developed marketing materials.  Note that subsection (d) applies to existing materials.  Therefore, not only your policy and procedure, but also your execution of that policy, must include a documented periodic review of existing marketing materials for accuracy. 

Management Tips

While the intent of this standard is to assure that the information that applicants give to consumers about their services are accurate, it is not the kind of standard about which the URAC reviewer can directly assess compliance.  In other words, it is highly unlikely that the reviewer will be able to look at a piece of marketing material and determine that it is a misrepresentation about the organization’s services. 

The only example of this kind of direct assessment of compliance with the standard that I can recall had to do with the use of the URAC logo to signify accreditation status.  One thing about which URAC is quite clear is which organizations have received accreditation and for what programs.  If you use the logo in a way that suggests the scope of your accreditation is broader than it truly is, in that case, URAC is likely both to detect it and frown upon it.  Otherwise, however, the assessment of compliance with the standard is largely a process-oriented assessment. 

Be particularly allert to the requirement that existing materials need to be reviewed periodically.  It is not enough if your process applies only to new consumer materials; you need documentation that all of the materials have been reviewed.

URAC Accreditation Tips

The elements of this standard dealing with safeguards against misrepresentation and correcting material misrepresentations are both mandatory.  The other elements are weighted either 2 or 3.

The reviewer will focus his/her attention on mechanisms and processes.  Our baseline recommendations for compliance with the standard are:

• A policy and procedure that clearly describes the full array of mechanisms for communicating with consumers and clients, including those components of the processes that address assuring the accuracy of those communications;
• Documentation (meeting minutes for marketing materials review audit sheets) clearly demonstrating that the materials review process was interdepartmental;
• Documentation that all current marketing materials, whether print or electronic, have been subject to this interdepartmental review process.

The on-site review, in addition to containing an interview with managers responsible for the accuracy of the organization's communications, is likely to involve the following process: the reviewer asks for a list of printed communications materials, selects several of them, and asks for documentation that all of the selected communications pieces have gone through the required interdepartmental review, whether the pieces are new or have been in use for several years.