The Basics

What happens when one of your organization's consumers has to navigate a change of benefit plans, a change of benefits, or a change of care settings?  All of these fall into the category of "transitional situations", which is the subject of this standard.

The standard is an open-ended requirement that the organization have a process for managing such situations.  That process should include guidance on how to communicate with both the prescribing provider and the consumer in such situations, although it is in the organization's discretion as to how that communication takes place.  At a minimum, however, the process must involve a method to identify consumers who are faced with transitional situations, protocols for communications, and guidance on how to handle consumer and prescriber inquiries about transitions.

Management Tips

When a standard specifically mentions the word "process", there is increased pressure to make sure you have a policy and procedure to address the requirements of the standard.  Merely handling transitions correctly will not suffice; you must have a clear policy and procedure that establishes accountabilities and protocols for identifying consumers and communicating with them throughout the transition process.

URAC Accreditation Tips

The single element in the standard is weighted 3.

The documentation for desktop review should be a policy and procedure, described above, sample notification letters, and perhaps even a screenshot of electronic announcement of a changing your formulary.

The on-site review will involve an interview of customer service and clinical staff members, as well as one or more compliance officers.  In addition, the reviewer will examine transitional request records and the organization's responses to those requests.

The Basics

This standard reflects URAC's all-pervasive interest in consumer safety.  It requires that the organizations drug utilization management program implement systems to address consumer safety issues. 

• The first of the required components of the consumer safety system is a method to identify drug-drug consumer safety issues through some form of communication to the requesting pharmacy and the prescriber. 
• The second required component of the consumer safety program involves the capacity to identify other situations that may compromise the safety of the consumer and escalate those safety issues as appropriate.
• The program must have the capacity to identify and manage risk.
• It must have a process to disclose clinically significant erros to affected consumers and caregivers.
• The DrUM program must report findings, including errors, to the quality management committee.

Management Tips

The approach you must take in developing the policy and procedures for this standard is much like that required by Pharm Core 39.  Even though the standard speaks of "a mechanism,” the reality is that it requires a system of mechanisms dealing with the full array of urgent situations that are likely to confront the applicant.  Your P&Ps should address the full array of likely issues.  Brainstorm with your colleagues about all the possible emergencies that could arise for consumers, and how your staff members might come into possession of that information.

However, the tricky part of passing this standard is not so much knowing what to submit with the application, but making sure your staff members know what the basic standards of care for each of these urgent situations is.

The upshot of this is that your staff training should include appropriate responses to urgent situations.  The URAC reviewers will pose a series of hypotheticals to your staff members, and will listen carefully to their answers to detect the quality of your training.

URAC Accreditation Tips

All five elements of this standard are mandatory.

At the desktop review level, documentation submitted should include both your confidence of policy and procedure on consumer safety and any documentation of the alert system at point-of-service.  This likely will be found in a pharmacy provider manual or other documentation describing the relationship with pharmacies.

Much of the on-site review process for this standard involves interviews with both management and staff-level personnel.  In fact, it is likely that, in connection both with the standard and Pharm Core 39, the reviewer will ask virtually everybody a variety of questions around consumer safety issues, from drug recalls to suicide prevention.  In addition, your organization likely will be called upon to demonstrate the clinical information management software regarding consumer safety issues.  Finally, the reviewer will examine case files for evidence that the organization's consumer safety mechanisms are functioning properly.

The Basics

This standard sets forth 14 minimal requirements for the organization's information analysis mechanisms.  Those mechanisms must be able to address:

• therapeutic appropriateness;
• overutilization and underutilization;
• generic drugs;
• the authorized exchange of therapeutic alternatives;
• duplication of prescription;
• drug-disease contraindications;
• interactions between drugs or between a drug and analogy;
• dosage;
• treatment duration;
• misuse or abuse of drugs;
• precautions concerning the use of a drug based on the patient's age;
• precautions concerning the use of a drug based on the patient's gender;
• pregnancy-related concerns; and
• limitations rooted in regulatory or benefit constraints; and
• benefit design.

These requirements typically are written into the organization's computer software, either in the claims the system or other clinical tools designed to alert the staff appropriately. 

Management Tips

It will not be enough to have well-design software to pass the elements of the standard.  Rather, the organization also has to have a comprehensive policy and procedure that requires that the software have all of these elements accounted for.  The policy and procedure should not only address the design of the software, but also the mechanisms for the intake of the necessary information and the implementation of appropriate interventions when the software generates alerts.

URAC Accreditation Tips

All of the elements of this standard are mandatory.

The documentation required for this standard is the applicable policy and procedure as well as a screenshot of the software used to handle the information required by this standard.

During the on-site review, the reviewer will observe the clinical review staff using the software, an interview staff members regarding the use.  In addition, the reviewer will examine utilization management review requests to see documentation of the use of clinical criteria and handling of those review requests.

The Basics

This standard establishes strict guidelines for the clinical review criteria that the organization uses in its drug utilization management program.  Those clinical criteria must be:

• the product, at least in part, of the effort of appropriate prescribing providers;
• based on current clinical principles;
• the subject of an annual review by the organization and actively practicing doctors and pharmacists;
• approved by senior clinical leadership, either the Medical Director, another senior clinical staff person, or a clinical committee such as P & T committee.

Management Tips

The organization's policy and procedure addressing clinical review criteria must clearly identify who is to be involved in the criteria's development.  That identification should include the names of qualifications of the reviewers.  The policy and procedure also should include a clear description of the process used in the development of the criteria, how often the criteria will be evaluated, and specifically who or what body will conduct periodic evaluations.  It is important to note that his clinical oversight is required even if the clinical review criteria are purchased from an outside vendor.

The annual review of clinical criteria need not happen all at once.  In fact, it is a best practice to stagger the review of criteria throughout the year.  A master index of all the criteria and their respective review dates will be an important tool to make sure no criteria fall through the cracks.

URAC Accreditation Tips

Six of the seven elements in this standard are mandatory; the remaining element is weighted 4.

At the initial document submission level, the organization should provide the applicable policy and procedure, job descriptions of the prescribers and pharmacists involved in development of the criteria, and meeting minutes or other documentation of the approval of clinical criteria.

During the on-site review, the reviewer will conduct an interview of the senior clinical staff person during which his or her involvement in the oversight of the clinical review criteria will be one subject.  In addition, the reviewer will want to see documentation of the tracking system that the organization uses to make sure all criteria are approved on an annual basis.  If the clinical criteria are purchased, a contract of purchase may also be reviewed during the on-site review.  Finally, the reviewer will almost surely not only interview drug utilization management staff members, but also observe such staff members at their desks doing their jobs.  One of the things the reviewer will look for is access to and use of clinical review criteria by utilization management staff.

The Basics

This standard requires that the organization's decisions about coverage be based on an assessment of peer-reviewed the medical literature, plus any of these four options that apply to a particular coverage decision:

• published practice guidelines, or
• a comparison of efficacy and side effects and drug interactions among alternative drugs, or
• prospects for patient compliance, or
• a thorough evaluation of all the benefits, risks, and potential consumer outcomes.

While this kind of evaluation can be outsourced to an external entity, the organization seeking accreditation is nevertheless obligated to know how the edits were developed and who developed them.

The oversight of this process, whether internal or external, rests with the clinical leadership of the organization.  That can be the clinical director or directors, or any committee designated for that purpose.

Management Tips

In developing the policy and procedure supporting this standard, management should be explicit in requiring evidence-based, scientifically valid data be considered in decisions about drug inclusions on the formulary.  In addition, if the organization purchases external criteria and then makes amendments to those criteria, the policy and procedure should describe a mechanism for relying on scientific evidence for those amendments.  Documentation of this process will be very important.  

It will be important that committee minutes demonstrate that the committee considered all of the issues covered by this standard.  Mere consideration of scientific evidence therefore will not be sufficient; discussion should include prospects for patient compliance, drug interactions, and alternatives.

URAC Accreditation Tips

All of the elements of the standard are mandatory.

The documentation required for the initial submission includes the applicable policy and procedure, P & T committee minutes that show the oversight mechanism in action, and perhaps a web link to the formularies.

The on-site review will include an interview of staff members involved in the development and maintenance of clinical criteria for coverage decisions.  In addition, the reviewer will examine a sampling of records demonstrating that the organization considered scientific evidence for drugs not approved on the formulary.  In addition, the reviewer will examine randomly selected coverage decisions and even interview a member of the P & T committee.

[Note as of February 1, 2010: the new version has an odd scoring regimen, one that, as written, would suggest only the first element (an assessment of peer-reviewed the medical literature) is required, and the other four are optional.  We don't believe that to be the intent, and so are going with the above interpretation until we hear otherwise.]

The Basics

This standard sets forth the general requirement that the organization's P&Ps address DrUM criteria for such things as: 

• identifying drug uses outside of the standard of practice,
• evaluation of the consumer clinical information provided with the authorization request, 
• review timeliness, and 
• discosure of the clinical oversight process to clients and prescribers.

The criteria for evaluating the data submitted by the consumer, prescribing provider, and/or pharmacy along with the request for authorization must:

• address discrepancies between optimal and actual use;
• coordinate intervention when it is appropriate to pursue treatment alternatives; and
• evaluation of program effectiveness.

It is particularly important to understand what URAC means by "Drug Utilization Management", or "DrUM" as we'll call it throughout these pages.  It is your organization's evaluation of the "medical necessity, appropriateness, and efficiency of the use of health care services, procedures, products, and facilities under the provisions of the applicable health benefits plan; sometimes called 'drug review.'”  URAC distinguishes this from straight, non-clinical benefit determinations.  So, for example, a benefit exclusion for a particular drug, say, Rogaine, is not DrUM.  On the other hand, a process that looks at a covered drug and determines whether it is medically necessary and/or appropriate for the particular patient is the DrUM process.  

Management Tips

Make sure to draft clear P&Ps that outline: 

• the process of developing the criteria mentioned in this standard, 
• the process used by the DrUM staff members to apply the criteria,
• the timeframes for each component of the DrUM process, from start to finish, 
• safety protocols used in the DrUM program, including the tracking system for outbound communications for safety interventions, 
• a description of the DrUM case tracking mechanism(s), and
• approaches to evaluating the DrUM program for effectiveness.

Mere tracking is not the same as aggregating and evaluation, as is required for the evaluation of effectiveness of the DrUM program.  Therefore, make sure that your tracking mechanisms' data are aggregated and perhaps turned into reports that go to the quality management committee for evaluation.

URAC Accreditation Tips

Each of the eight elements of this standard is mandatory.

For the desktop review, submit the applicable P&Ps, organization charts, functional charts, outbound communications tracking reports, and any evidence of program evaluation such as reports of such evaluations to the quality management committee.

The onsite review will involve an examination of your current applicable DrUM P&Ps, a demonstration that your staff members can access those P&Ps, interviews (at their desks) of DrUM staff members, and a review of any reports of program effectiveness, probably from minutes of the quality management committee. The reviewer also will examine P&T Committee minutes.

The Basics

This straightforward standard simply requires that your organization's electronic claims processing mechanism complies with the standards of the National Council for Prescription Drug Program.  The standard transactions are the codes set standards under federal privacy law for organizations operating in the retail pharmacy world.

Management Tips

While your organization no doubt complies with the standards, it will be particularly important that you clearly document, through policies and procedures for claims processing, that this is an internal requirement of your organization.  In addition, you will need to make sure that your pharmacy provider manual and your pharmacy agreements are consistent with your policies and procedures on claims processing.

URAC Accreditation Tips

This is a mandatory standard.

For the desktop review, you will need to submit your policies and procedures, pharmacy provider manual, and agreement template.

The reviewer will interview your information technology leadership and regulatory compliance officer about your claims processing standards.  In addition, the reviewer will want to see documentation that you monitor compliance with these standards.

The Basics

This very important standard requires that your organization have a process by which it may protect consumers from a participating pharmacy that poses a health risk to consumers or promotes fraud and abuse.  The process must provide for an expedited investigation and access by the suspended pharmacy, after the suspension, to the dispute resolution mechanism described in the previous page.  This standard is particularly important because it is a consumer safety mechanism, always at the top of the accreditation priority list.

Management Tips

Typically, organizations address the situation by empowering a senior clinician within the organization with a great deal of flexibility to suspend a pharmacy that poses a health or fraud risk.  URAC expects that senior clinician to have broad discretion that he or she will exercise when convinced of the health or fraud danger.  That discretion is counterbalanced by the fact that pharmacy, after suspension, will still have access to dispute resolution process.  The key here is that the senior clinician be able to do what he or she needs to do to protect consumers without getting bogged down in time-consuming dispute resolution procedures.

URAC Accreditation Tips

Most of the elements of the standard are mandatory.

The key document for the standard, of course, is the policy and procedure and/or pharmacy provider manual that describes the dispute resolution process, including the suspension mechanism required by the standard.

During the on-site review, the reviewer will ask for a list of any pharmacies that have been suspended under this mechanism.  It is very likely that you have none to report, but if you do, the reviewer will want to see the files.  In addition, if the committee is involved at any point in these processes, the reviewer will want to examine committee meeting minutes.   Finally, it will be very important that, during the interview process, the senior clinician with the authority to suspend pharmacies understands his or her responsibility to act expeditiously.

The Basics

This standard requires your organization to establish a pharmacy dispute resolution process to address situations where your organization makes a decision, that the pharmacy contests, involving its

• status within the network; or
• competency or conduct; or
• distribution channel contractual issues.

The exact mechanism is largely up to your organization to establish, so long as it stays within any external requirements that may be imposed by contract or regulation.

Management Tips

We recommend that dispute resolution be clearly spelled out in the pharmacy provider manual.  An alternative location for that description could be in policies and procedures, but the reviewer is likely to favor a document, like the provider manual, that is shared with the pharmacies.  In addition, you'll want to make sure that there is nothing in your contract with pharmacies that is inconsistent with the dispute resolution mechanism description.  Make sure that whatever mechanism you come up with is fair on its face.  Giving a participating pharmacy industry record resolution mechanism that seems to have a predetermined outcome will not pass muster.

URAC Accreditation Tips

Each of the three elements of the standard carries the weight of 4.

Your initial documentary submission should include the pharmacy provider manual or other policy and procedure that describes the dispute resolution process, as well as any written agreements that refer to the process.  In addition, if you handle pharmacy disputes through a committee mechanism, documentation about the committee's involvement in the process should be submitted, as well.

During the on-site review, the reviewer will ask for a list of complaints or grievances made by participating pharmacies, as well as a list of pharmacy disputes.  From those lists, the reviewer will select a sample of pharmacy dispute files and examine them more closely to make sure that you are complying with your own policies and procedures.  In addition, your network management staff will need to know how the dispute resolution process works.

The Basics

One of the reasons we have emphasized in the previous few pages the importance of having required contract language embodied in the pharmacy provider manual and/or policies and procedures is because of the existence of this standard.  Because it is not expected that you will go out and recontract with all of the participating pharmacies in your network with which you have agreements that do not comply with these accreditation standards, you may make up for the non-compliance of these older contracts by having the required terms in these administrative documents.  The reason we recommend having the required language incorporated into your pharmacy provider manual is that this is a document that you share with your pharmacies, whereas you may not share all of your policies and procedures with pharmacies.

Management Tips

Naturally, this standard is not applicable in the event that all of your pharmacy agreements comply with the previous couple of standards.  However, because there is a possibility that, somewhere out there, you have a letter of agreement or an old contract that does not comply with the requirements of these standards, it is a best practice to make sure that your provider manual contains all of the required language for your pharmacy contracts.

URAC Accreditation Tips

Both elements of the standard are weighted 4.

Documentation for this standard is straightforward, in that you need only submit the pharmacy provider manual and/or policies and procedures that "fill in the gaps" of your provider agreements.  When you do so, we recommend that you submit, in the Notes section, a section-by-section cross-referencing showing how the Manual meets the requirements of Pharm-DC 7 and 8.

In addition to the review of contracts described previously, the on-site review will involve an interview with network management staff and leadership as well as an examination of any tracking mechanisms you have for pharmacy agreements.