The Basics

This standard sets forth the requirements for the situation in which you receive a request for certification, but determine that there is not enough information provided to make such a decision.

Check with your organization's P&P on this topic, because URAC has given your organization a lot of flexibility on how to handle such cases.  At a minimum, however, those P&Ps must:

• Establish clear and appropriate time frames for such things as how long you have to ask for more information, how long the patient/provider has to respond, and when you will issue an administrative denial for lack of information
• Establish a policy for what to do when the patient and/or provider do not provide the necessary information within the specified time frame

It will be incumbent on you to record in the case file all your activities, whether by telephone, email, or letter.  The URAC reviewer will be checking to make sure you are complying with your company's P&P (particularly time frames), so recording the dates of your activities will be important.

Management Tips

Note that this standard specifically mentions P&Ps, so pay close attention to how you write yours.  URAC gives you flexibility on setting time frames, but you should note that the Department of Labor regulations may dictate those for you.  Check with legal counsel on this.  

Make sure your P&P is not so demanding as to make the submission of sufficient information onerous.  If the provider provides some clinical information and tells you that is all that is available, your staff should process it as a regular request for certification (prospective, concurrent, or retrospective).

URAC Accreditation Tips

Both of the elements of this standard are weighted 2.

The only documentation necessary for the desktop review are your P&Ps on lack of information and appeals.  The onsite review will focus on the examination of case files (to make sure you are complying with your own P&P) and interviewing DrUM staff members (to make sure they understand your P&P).

The Basics

This standard requires that, in making the certification decision, the organization may only use the information that was available to the provider or the organization at the time the services were rendered to the patient.  In other words, there can be no "Monday morning quarterbacking," in which you use information acquired more recently than the rendering of the service to determine whether it was medically necessary. It applies to all three types of reviews: prospective, concurrent, and retrospective. 

Management Tips

This is designed to protect providers from the unfair situation of being denied payment because the decisions they made in good faith given the information they had turned out to be incorrect, at least when viewed with the 20-20 vision of hindsight.  The same P&P you use for the previous standard is an excellent place for this language, as well.  Because it is a bit counterintuitive for some people, it is probably worth emphasizing this requirement in staff training.  

URAC Accreditation Tips

Each of the three elements of this standard has a weight of 3.

The P&P on this topic will be the only required documentation.  This is likely to come up in the onsite review only on review of case files and in interviews of peer reviewers and the DrUM staff.

The Basics

This standard establishes requirements for the organization's information-gathering activities in connection with drug utilization management.  

• First, it requires that the organization accept information in the context of an evidence-based process.  
• Second, it limits the information that is allowed to be collected to that which is relevant to the certification of the prescription.  
• Finally, it prohibits the organization from asking for more of the medical record than is necessary to review the request for certification.  

As is apparent, the purpose of this standard is to provide reasonable protection to the consumer and the prescriber from the risk of unreasonable requests for information.

Management Tips

Two things are required for this standard: a policy and procedure which incorporates the substantive limitations of the standard, and any forms of that you use for receiving information in connection with prior authorization requests.

URAC Accreditation Tips

The elements of this standard are weighted between 2 and 4.

Documentation at the desktop review level should be the policy and procedure and template prior authorization forms.

During the on-site review, the reviewer will examine case files, with a particular eye toward the use of prior authorization request forms, to determine compliance with the standard.

The Basics

This standard prohibits an organization from reversing a decision to certify unless the organization receives new, relevant information that it did not have when it first certified coverage.  For example, if the PBM later finds out that it should not have certified because it was a duplicate claim, but did not have the information that it was duplicate when it first approved it, it should have policies and procedures that provides guidance on how it will go about reversing the decision.

It may be that the organization never reverses decisions to certify regardless of new information.  Check your policy and procedure to see if this is the case for your organization.

Management Tips

First, it must be said that your organization does not have to have a provision under which it reverses certifications.  If you like, you can prohibit certification reversals altogether.  However, if it is your organization's policy to reverse certification decisions, you'll need a policy and procedure that explains under what circumstances you will do that. In that case, your policy and procedure must state that you will do so only with newly-acquired information.

It also makes sense to draft a template letter for such circumstances.  This will help assure that you implement your policy and procedure in a uniform and consistent way.

URAC Accreditation Tips

The standard has a weight of 4.

For desktop review, and you should submit both the applicable policy and procedure and any templates correspondence you have developed to implement the policy and procedure.

During the on-site review, the reviewer will ask staff members about your policy of reversing certification decisions.  He/she is also likely to look for examples of certification reversals among the denial files that she selects for review.

The Basics

This standard describes the minimum requirements for the written notification of the organization's non-certification decision.  The PBM must send that notification to both the consumer and the prescriber. 

• First, it must include the "principal reason" for the non-certification.  To qualify as a "principal reason", the reason must explain why the consumer is not meeting the clinical guideline.  A general statement that the drug is not medically necessary or that the consumer does not meet guidelines will not be sufficient.  There will need to be some reason that connects the patient's situation with the failure to meet guidelines.
• Second, the written notification needs to explain to the consumer and prescriber that they can obtain a more detailed clinical description of the reason, known as a "clinical rationale", if they submit a request to the PBM.  The letter also must explain how to submit such a request.  The clinical rationale is more specific than the "principal reason" in explaining the specific reasons why clinical review criteria were not met.
• Finally, the written notification must explain how the consumer and/or prescriber would go about initiating an appeal from the PBM's decision.

Management Tips

It will not be sufficient to have your template letter comply with the standard.  Rather, in addition to a compliance template written notification of non-certification, you will also need a policy and procedure that clearly describes the minimum requirements for that written notification.

In addition, it will be important to make sure that the physicians or pharmacists making the non-certification decisions are sufficiently trained in how to write a "principal reason" in a way that qualifies under this standard.  Many reviewers, when pressed for time, will simply say something like "does not meet criteria."  However, URAC has made it clear that this will not qualify as a "principal reason."

URAC Accreditation Tips

The five elements of this standard are each weighted 4.

The documentation required for the desktop review is the applicable policy and procedure and the template letter.

During the on-site review, the reviewer will examine case files of denials of requests for certification to determine whether the written notifications have been sent to both the patient and prescriber and whether those written notifications contain the necessary components as required by the standard.  In addition, the reviewer will be looking for examples of cases where the prescriber or patient asked for a written description of the clinical review criteria upon which a non-certification was based.

The Basics

To protect against the possibility of inappropriate denials by the automated review system, this standard requires that the automated review process be overseen by one of four persons or bodies:

• a licensed health care professional with professional experience in providing patient care who holds a post secondary degree in healthcare;
• a senior employee or consultant who is clinically qualified form clinical triage and provide health education services;
• the P&T committee; or
• an appropriate committee composed of at least two experts (physicians, pharmacists, or other providers).

Check your organization's policies and procedures on how that oversight is exercised.  Your organization has a great deal of flexibility within the standard as to how it conducts oversight.

Management Tips

This standard grants a lot of flexibility around how you design the oversight of the automated review system.  It could include a transfer of proposed denials to a senior clinician, periodic review of inappropriate denials by the oversight committee, or a decision by a senior clinician to override the automated review process for specific situations.

URAC Accreditation Tips

This is a mandatory standard.

For desktop review, documentation should include the appropriate automated review policy and procedure, as well as any documentation as to how your organization tracks denials and appeals from automated review decisions.

During the on-site review, the reviewer will interview clinical staff involved in the oversight of the automated review system.  He/she also will examine selected automated review appeal files and minutes from any committee charged with the oversight of the automated review process.

The Basics

This standard deals with the subject of "automated review,” which is defined as "a computerized process whereby a validated algorithm is used for drug management."

The standard imposes two requirements on the organization's automated review process. 

• First, the organization must define the algorithmic protocol.  This involves identifying the evidence-based guidelines and parameters contained in each algorithm.
• Second, your organization must validate the algorithm.  In this process, the organization ensures consistent responses to the same set of data inputs.

Management Tips

Naturally, a clear policy and procedure is the best start to addressing this standard.  However, your policy and procedure also should set forth a method of documenting the algorithm definition and validation processes.  This no doubt will involve" nation with the information management staff assigned to the maintenance of the automated review process.

URAC Accreditation Tips

Both elements of the standard are mandatory.

Initial documentation should include the appropriate policy and procedure as well as documentation of the process of validating the automated algorithms.  In addition, your pharmacy provider manual section that describes minimum requirements for submission of requests to the automated review system should be submitted.

For the on-site review, make sure you have ready to show the reviewer documentation of recent validation of the algorithms.  In addition, make sure that your information management staff members associated with the automated review process are up-to-date on algorithm definitions and validation.

The Basics

This straightforward mandatory standard simply requires that all non-certifications be rendered by either a pharmacist or physician.  Naturally, this does not prohibit other staff members from issuing a denial on purely administrative grounds.  However, it is an absolute prohibition on clinical denials by anyone other than a pharmacist or physician.

Management Tips

In addition to taking sure you have a clear policy and procedure that embodies this critically important standard, it is also important that every member of the drug utilization management staff understand it.  In addition, because compliance with the standard will be assessed primarily through case file review, it is vital that documentation of who makes the non-certification decision be absolutely clear.

URAC Accreditation Tips

This is a mandatory standard.

Documentation for this standard is simple: combination of job descriptions of the prior authorization staff members and a policy and procedure making it clear that only physicians and pharmacists may issue clinical denials should suffice.

During the on-site review, the reviewer will interview the personnel who issue non-certifications.  In addition, the reviewer will request a log of non-certifications, from which he/she will select 30 files.  Those files will be examined to assure compliance with the standard.

The Basics

This standard sets forth minimum requirements for the persons who conduct prospective review for the drug utilization management program.  Such a person can be one of two types of individuals:

• a licensed "health professional" with formal training in healthcare, experience in patient care, and a post-secondary degree in healthcare; or
• a pharmacy technician, trained to follow established criteria, who is licensed, if required by state law.

URAC requires that a pharmacy technician be "adequately trained to prepare and dispense pharmaceuticals and related products under direct supervision of a licensed pharmacist."  The training requirements can be met by showing either substantial training or extensive experience in a pharmacy.

It is particularly important that, if your organization uses pharmacy technicians for prospective review, they have access to a supervising pharmacist in the performance of their review duties.  In addition, pharmacy technicians must work entirely within the confines of algorithms that guide their decisions.  This means that, if the review is non-automated, the pharmacy technician cannot issue a denial of a clinical request for certification.

Your organization undoubtedly has a policy and procedure on this topic which may limit reviewer qualifications to one of these two options, so be sure you are familiar with your organization's policy.

Management Tips

While the requirements for prospective reviewers could be expressed only in the job descriptions, it is better practice to put such requirements into a relevant policy and procedure, too.  In addition, check with the organization's compliance department to make sure that the organization is taking into account all relevant regulatory requirements.  This is particularly important for organizations that operate in more than one state, as state regulations will vary on this point.

Make sure the job titles match up.  If your policy and procedure names one position as being qualified to perform prospective review, and you submit a job description for a position with a different title, you will end up confusing the reviewer.

URAC Accreditation Tips

All elements of the standard are mandatory.

For the initial submission of documents, the organization should submit job descriptions and/or a policy and procedure describing the minimum requirements set forth in this standard.  In addition, if state law or regulation governs the qualifications of the prospective reviewer, a sample of compliance documentation for such a regulation should be submitted.  Quality audits of prospective review staff and the organization's training plan for such their also will strengthen the submission.

During the on-site review, the reviewer will select the personnel files of the pharmacy technicians and other prospective reviewers.  The reviewer will select all of the personnel files if there were 30 or fewer; only 30 files will be selected if there are more than 30 personnel performing this function.  The reviewer will examine the personnel files to check issues such as credentialing, job descriptions, performance evaluations, training, and the verification of credentials.

In addition, the reviewer will interview prior authorization staff at their workstations.  It is particularly important that the reviewer be able to see quite clearly that any pharmacy technicians are using automated systems to conduct prospective review.

The Basics

This single-element standard contains the simple requirement that members of the drug utilization management staff identify themselves by first name, title, and the name of the organization upon request.  If you work for a subcontractor of the organization, it is the name of the organization that employs the subcontractor that you must identify on request.  The standard primarily deals with incoming calls from consumers, pharmacies, and prescribers.

Management Tips

Management's responsibility with regard to this standard is simply to make sure that this requirement is included in the policy and procedure and to make sure that the staff is trained to give this information upon request.

URAC Accreditation Tips

The single element of this standard is weighted 2.

The only documentation that you need to submit for the desktop review is the applicable policy and procedure.

For the on-site review, not only will the reviewer interview those members of the drug utilization management staff who receive inbound calls, but also will listen in on such calls to make sure that staff members comply with the standard.