The Basics

This standard requires that your organization design its pharmaceutical dispensing system so as to support e-prescribing.  Your system must comply with the National Council for Prescription Drub Program requirements for standardized transactions.  The NCPDP provides pharmacies with unique identifiers.  In addition, the NCPDP provider identifier requires providers and druggists to use a national identifier to identify providers in connection with Medicare Part D.  In addition, your dispensing system must integrate with your drug management system.

Management Tips

While your organization almost assuredly uses the NCPDP approach to standard identifiers, management should make sure that this is well documented in the form of policies and procedures or program descriptions that describe in some detail how your organization manages electronic information exchange.

URAC Accreditation Tips

This standard is mandatory.   For the desktop review, you should submit the P&Ps or program description that describe the e-prescribing function in your organization. The onsite review is likely to involve both a demonstration of the e-prescribing system and an interview with pharmacists to confirm the system's implementation.

URAC Accreditation Tips

Each of the four elements of this standard is weighted 2.

The documentation for the mission statement can be a screenshot of the mission statement from your website or a page from a printed document, internal or external.

The requirement of "organizational framework for the program" is a bit less evident, in our experience.  This language has confused clients from time to time.  We recommend a program description -- of the type often prepared for prospective clients -- that describes how your organization provides its services to clients and consumers.  It might be a marketing piece, or a template proposal, or a regulatory document -- anything that describes how you deliver services.

The element addressing the consumers your organization serve is designed to guide the reviewer as she looks at other standards, such as access and availability of services.  The reasoning here is that you cannot deliver services effectively if you don't know to whom you are delivering them.  Therefore, the description of your "population served" is likely to be in terms of demographics -- income level, literacy, English fluency, age, etc.  But if you are a national or state-wide organization?  in that case, submit documentation demonstrating that, and then reference the general demographic characteristics of the nation or the state that you serve.

The documentation for the element for "organizational oversight and reporting" is a description (narrative, organization charts, or both) of your reporting mechanisms for both staff and committees (most notably, the quality management committee).  

Most of the onsite review verification of this standard is melded with the verification of compliance with other standards, so once you get past the desktop review for Pharm Core 2, you are largely in the clear.

URAC Accreditation Tips

PHARM Core 1 requires that your organization clearly defines its structure, roles, and responsibilities.  This 2-weighted standard is rather straightforward and seldom the subject of a comment by URAC reviewers. Its purpose is to give the reviewer an understanding of the structure, ownership, and reporting mechanisms of the organization. The applicant should submit organizational charts at both the macro level (with senior organizational leadership described) and at the department level for the departments who are the subject of the accreditation under consideration. Additionally, organizational charts should show key committees, especially the Quality Management Committee and any other accreditation-relevant committees (e.g., credentialing committees for Health Plans and Health Networks). Any official company documents that describe the organization, particular the services that are the subject of the accreditation, will help, too.

If you submit these charts and program descriptions, you probably won't get any comments from the URAC reviewer. However, you may be asked for more information beyond this if there is something about the ownership structure that is unclear. For example, if you have a holding company or corporate affiliate, the name of which is all over your company documents but not reflected in the organizational charts, the reviewer may ask for some more detail.

The onsite review will simply be focused on making sure that what you said in the application is, in fact, the truth in practice. The interpretive guide says the following about the onsite review:

Recent (within past 6 months) reports demonstrating organizational oversight: reports will be analyzed along with any meeting minutes where they were presented and discussed.

This review of reports and committee minutes, however, will be going on anyway in connection with other standards, so very little happens specifically and exclusively in connection with this standard.

The Basics

This standard requires URAC accredited companies to have job descriptions for all staff members.  Those job descriptions must describe required background (education and experience), required competencies, licenses, and/or certificates, and describe the jobs' scope of role and responsibilities.

Management Tips

This standard typically is missed onsite by organizations that have not set minimum requirements for non-clinical staff members.  Therefore, we recommend a complete internal audit, particularly by the HR departments of first-time applicants, of all the job descriptions to assure that they all (clinicaland non-clinical) have minimum requirements.  

One other tip -- eliminate the words "or equivalent experience."  They are, in URAC's view (and mine), meaningless.  Describe what that equivalent experience might be, and you'll be fine. 

URAC Accreditation Tips

Each of the elements of this standard carries a weight of only 2, indicating how distant job descriptions are from consumer protection, at least in URAC's mind.  

The documentary requirements for this standard are straightforward -- submit up to 9 job descriptions of the staff members who do the bulk of the work in the areas that are the subject of the accreditation module(s).  The onsite review is, as you might expect, a random selection of actual job descriptions, chosen from the staff directory. 

The Basics

Pharm Core 22 requires that your organization implement a mechanism to inform both consumers and your clients of consumer rights and responsibilities.  Specifically, that mechanism needs to address at least advising them on how to obtain services and how to submit a complaint or appeal.

First, let's distinguish consumers and clients.  URAC defines "consumers" as follows: "An individual person who is the direct or indirect recipient of the services of the organization.  Depending on the context, consumers may be identified by different names, such as “member,” enrollee,” “beneficiary,” “patient,” “injured worker,” “claimant,” etc."  URAC defines "client" as "A business or individual that purchases services from the organization."  

It is entirely possible that the PBM not only does not handle communications with consumers at all, but also provides no consumer information to the client.  It's quite clear that in such cases, the standard does not apply.  In such cases, the organization mostly for consumer inquiries back to the client.

Management Tips

What managers need to understand about this standard is that your policies and procedures must describe the mechanism for providing information to consumers and clients about your organization's services and the complaint and appeal process.  It will not be sufficient to demonstrate to your act would provide consumers and clients this information.  You will need to have a policy and procedure that describes how you should do it.  In addition, you should have template letters of "bills of rights" to provide consumers.

URAC Accreditation Tips

Both elements of this standard have a weight of 4.

For the desktop review, your documentation should include not only your policy and procedure, but also documentation showing how you implement that policy and procedure, such as a Consumer's Bill of Rights, a portion of your member handbook, or a template of a consumer letter that describes consumer rights.

During the on-site review, compliance with this standard will be assessed primarily through interviews with both management and staff members charged with providing consumers with this information.  It will therefore be very important that preparation for the on-site review includes letting customer service representatives know that there are likely to be asked about the requirements of the standard when the reviewer tours the customer service department.

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.  

The Basics

This standard says, essentially, that if the organization has a system by which people are provided financial incentives that are based directly on consumer utilization of healthcare services, there must be mechanisms in place to make sure that these incentives don't end up compromising consumer care.  This policy includes capitation of providers.  Not all URAC reviewers over the years have interpreted this standard this way, so it is helpful to get official clarification on this sometimes controversial issue.

Management Tips

You'll need to assess all your compensation systems at all levels -- staff, management, contractors, and vendors -- to make sure you're thinking broadly enough about this standard.  If you do identify bonuses or incentives that trigger this standard, you'll need to make sure you have one or more methods of making sure that consumers are not underutilizing health services as a result.  Reviewers can be pretty rigorous in examining these methods for assuring your consumers are receiving adequate care, so don't cut corners here.  

URAC Accreditation Tips

This is a mandatory standard.

If you do not have financial incentives, provide either a P&P prohibiting them or a senior executive attestation that you do not and that, if you ever do, you'll first develop mechanisms for assuring that consumer care is not compromised.

If you do have financial incentives related to consumer utilization of health services, make sure you describe them reasonably completely, and then make absolutely sure you document your consumer utilization oversight mechanism.  Once this standard is triggered, the reviewer will be looking closely at how you assure there is no resultant underutilization, so you may as well document it thoroughly up-front.

During the onsite review, the key will be in the interviews.  The people in charge of the utilization oversight mechanism will need to provide reassurance to the reviewer that the methodology is sound, related to the incentives, and likely to detect any problems with consumer utilization.

This is a mandatory standard, so make sure you get it right!

The Basics

To have an effective compliance program under this standard, you need:

• to know what laws and regulations apply to you organization and 
• to have robust mechanisms to assure that these laws and regulations are consistently obeyed by your employees and agents.

So, everybody involved in the organization's compliance program should keep both of these components in mind -- tracking and adherence to legal standards.

Management Tips

I was conducting reviews for URAC at the time this standard was adopted, and, at the request of my fellow reviewers, developed some guidelines to help flesh out the meaning behind this rather bare-bones standard. I leaned on the recently released revisions to the Federal Sentencing Guidelines, and came up with what you'll see in the Program Guide:

"Elements of a corporate compliance program include: 

• standards and procedures to detect non-compliant conduct by employees and agents;
• promotion of an organizational culture to encourage ethical conduct and a commitment to compliance with the law;
• reasonable oversight by the governing body of the compliance program;
• clear designation of individuals accountable for the organization’s compliance;
• systems for assuring that both hiring and compensation practices encourage the creation and maintenance of a compliant work force;
• the existence of appropriate reporting and disciplinary mechanisms for instances of misconduct;
• ongoing training of employees and managers on the organization’s standards;
• monitoring and auditing to detect misconduct;
• periodic evaluation of the organization’s compliance program;
• post hoc analyses of instances of misconduct to determine whether a systemic change is suggested by the problem; and
• periodic assessment of risk and establishment of compliance priorities

Pharm Core 19 applies to both state and federal regulations that are applicable to the program standards."

URAC Accreditation Tips

Both elements of the standard are mandatory.

In the application, all you need do is submit a coherent and comprehensive compliance plan as well as some evidence that you have a decent mechanism for tracking laws and regulations that apply to your organization.

The challenge is in the onsite interview. Typically, in a URAC review, the interview of the compliance officer is brief, usually less than one hour. How can you assure that this interview goes well? Well, if your compliance staff can answer these questions and produce the requested documentation, you'll probably do pretty well:

• How do you track the existing laws and regulations that apply to your company? By what process do you incorporate the requirements of such laws and regulations into the policies and procedures of the company? Please show records demonstrating this tracking mechanism. In addition, please show documentation demonstrating the incorporation of laws and regulations into corporate P&Ps.
• How do you track changes in or new laws and regulations (both state and federal) that apply to your company? By what process do you incorporate the requirements of such laws and regulations into the policies and procedures of the company? Please show records demonstrating this tracking mechanism. In addition, please show documentation demonstrating the incorporation of laws and regulations into corporate P&Ps.
• Please describe your company’s program, including any standards and procedures, to detect non-compliant conduct by employees and agents. Please produce documents that confirm that you implement such standards and procedures.
• What does your company do to promote an organizational culture to encourage ethical conduct and a commitment to compliance with the law? Please describe the role of your governing body in the oversight of the compliance program. Can you produce minutes of meetings of that governing body that would substantiate that it is involved in compliance oversight?
• Who is accountable for the organization’s compliance? Please describe, and produce supporting documentation, of your company’s systems for assuring that both hiring and compensation practices encourage the creation and maintenance of a compliant work force.
• How do you let employees and agents know of the existence of appropriate reporting and disciplinary mechanisms for instances of misconduct? Please produce documentary evidence of such notice to employees and agents, as well as any tracking mechanisms for such reporting. How do you track your company’s program of ongoing training of employees and managers on the organization’s standards? Please produce documentation showing those tracking processes.
• How does your organization monitor and audit to detect misconduct? Who conducts such monitoring and auditing activities? Please produce reports to support this. To whom do these people report the results of their monitoring and auditing activities? Does your organization engage in periodic evaluation of the organization’s compliance program? Who conducts such an assessment? Please produce documentation demonstrating that periodic evaluation.
• Does your organization conduct post hoc analyses of instances of misconduct to determine whether a systemic change is suggested by the problem? Please show records of such analyses. Please describe, and provide supporting documentation, of your organization’s periodic assessment of risk and establishment of compliance priorities.

One last thing -- if a URAC reviewer finds that you haven't complied with a standard that has regulatory ramifications (e.g., clinical licensure), you'll also lose points on this standard and probably find yourself in conditional accreditation -- if not worse.

The Basics

This standard sets forth the requirements for your delegation oversight mechanisms for your contractors that are not URAC-accredited.  For each such non-accredited contractor, you must:

• conduct a periodic review (at least yearly) of your contractor's policies and procedures, as well as any documentation about quality improvement activities regarding the delegated functions;
• verify (at least annually) that your contractor is complying with the requirements of your delegation agreement and applicable P&Ps; and
• make sure that any financial incentives employed by your contractor do not compromise quality of care.

The trickiest of these elements is the last one.  You need to have a documented procedure to, first, know whether your contractor has financial incentives for its employees or agents.  If, as a result of your inquiry, you learn that the contractor does employ such incentives, you then need to document that you have conducted sufficient oversight to be comfortable that the incentives in no way compromise the well-being of patients.

Management Tips

The management key for this standard is documentation of oversight.  Most URAC-accredited companies keep all the documentation regarding a delicate in a dedicated binder.  Behind each tab (clearly marked, of course) are such documents as pre-delegation audits, the delegation agreement, reports submitted by the contractor regarding its performance under the delegation agreement, documented evidence of your organization's periodic review of the contractor's P&Ps, documentation of your compliance oversight process, and finally, documentation of a review of any impact financial incentives may have on patient care.

URAC Accreditation Tips

The element of the standard that addresses financial incentives is a mandatory element.  The other two elements are each weighted 3.

The documentation required to be submitted with the initial application is simply the applicable delegation oversight  P&P.  just make sure that it contains all the required elements of this standard.  In addition, it would be prudent to submit any templates for audit mechanisms you may use in the implementation of that policy.

As was the case with the previous three standards, delegation binders will be the focus of the reviewer's attention during the on-site review.  The reviewer will have an expectation that those binders are complete, well-organized, and clearly marked.

The Basics

This standard applies to all delegation arrangements, even to those with organizations that are accredited by URAC.  It lists eight specific requirements for the contract between your organization and all delegates.  Some of the requirements are perfunctory (e.g., that the contract describes which duties are being delegated and which duties are being retained by your organization), but there are several elements that you should not assume are already in all of your delegation agreements, particularly if you are a first-time applicant.  Two of those elements are mandatory and almost certainly are not in the delegation agreements of a first-time applicant.

Here are the particularly critical elements of the delegation agreement:

• a requirement that the contractor performed a delegated functions in compliance with your organization's policies and procedures and URAC standards;
• an affirmative requirement on your contractor that it notify your organization of any material change in its performance of the delegated functions;
• authorization for your organization to conduct surveys of the contractor;
• an affirmative requirement on the contractor to submit periodic reports to your organization regarding its performance of delegate function;
• a description of the circumstances under which the contractor may further delegate the functions your organization has delegated to it; and
• a requirement that, if the contractor does further delegate the delegated functions to a subcontractor, the agreement between the contractor and subcontractor specify that the subcontractor will perform the delegated functions under the terms of the delegation agreement between your organization and the contractor and URAC standards.

Of critical importance is that the language in your contract specifically mention URAC in both of the contexts described above.  Merely referring to "accreditation standards" will not suffice (although at one time such language would have been enough).

Management Tips

A sticking point for many applicants, delegation contracts require more attention than most aspects of a URAC accreditation application. 

A few things to remember:

If your delegate is URAC-accredited, this is the only standard that applies to that delegation relationship.

Subsection (b) is explicit about the agreement requiring that the delegate comply with URAC standards. A clause requiring the delegate to comply with your organization's standards (which, of course, comply with URAC standards) is not enough. Similarly, a clause requiring that the delegate comply with another accreditor's standards (e.g., NCQA) is not enough. 

Subsection (c) is another tricky one. Put simply, your contract must have a clause which confers an affirmative obligation on your delegate to let you know when circumstances have changed such that it can no longer perform the functions it's supposed to perform under the agreement. This is separate from the reporting obligation under subsection (e). Be explicit about this requirement on your delegate.

Subsections (g) and (h) are distinct requirements. Restated, (g) requires that your agreement describes what the delegate must do in order to subdelegate (e.g., get your permission in writing). If your agreement prohibits subdelegation, that will suffice. Subsection (h) is applicable only if subdelegation is permitted, and requires that your delegation agreement require that any subdelegation arrangement be subject not only to your organizational requirements but also to URAC's (or "applicable accreditation requirements").

URAC Accreditation Tips

The two elements that specifically reference URAC are both mandatory. The rest range in value between 2 and 4.

While URAC only requires that you submit your template delegation agreement, we also recommend that you submit a policy and procedure that requires that all delegation agreements comply with the standard.

During the on-site review, again, the reviewer's attention will be on the delegation binders.