For as long as we've been involved with URAC, which dates back to the late 1990s, the delegation standards applied only to the functions covered by the main standards of the module that is the subject of the accreditation. In other words, if a substantative standard (not a back-office, administrative function), required an applicant to do something, and the applicant hired another organization to do it instead, it was considered delegation and therefore covered by what are now Core 6-9.

In recent months (the duration of this period is the subject of some dispute among observers and participants), this interpretation was broadened to include administrative functions that dealt with PHI, such as storage and shredding of PHI. In other words, if you hired a company like Iron Mountain to store your documents, you needed to comply with the delegation standards.

After discussion among URAC staff, committee members, accredited organizations, and consultants, URAC came up with the middle-ground on this issue, finding that Core 6, 7, and 9 do not apply in such circumstances. Instead, what is needed in the document submissions for Core 8 are:

• A Business Associate Agreement and Vendor Agreement that addresses the following issues:

* Breach

* Breach remediation

* Transferring the data

* Requirement of training for the BA's staff

* Proper handling of the PHI

• A policy on how IIHI (for workers comp) or PHI (For HIPAA covered entities and business associates) is handled within the organization and how IIHI or PHI is turned over to the vendor for shredding and destruction, whether onsite or offsite.

The Basics

This standard calls for your organization to disclose the following three things to current and prospective clients:

1. A description of the program evaluation methodology described in the previous two standards;
2. A description of the strengths and weaknesses of that methodology; and
3. Evidence of external validation of then program evaluation methodology.

Make sure you review the organization's P&P describing the disclosure process so that you are familiar with who is accountable for seeing that the disclosure takes place as required by your policy.

Management Tips

As in the previous disclosure standards, it is essential that your P&P make clear who is responsible for disclosure and the steps to be taken to provide the requested information. Note that the description of the methodology is a mandatory element.

URAC Accreditation Tips

While the requirement for disclosure of methodology is mandatory, the elements addressing evaluation strengths and limits, as well as external validation, are "leading indicators."

The desktop review submission should include the disclosure P&P, an example of the disclosure that includes an analysis of strengths and limitations of the evaluation methodology, and a contract with an external validation vendor.

The onsite reviewer will interview staff members. In addition, she will review examples of the reports required by this standard, as well as conduct an interview with the validation vendor regarding the documented report.

The Basics

This straightforward standard requires that your organization demonstrate that it has a process to measure the PM program's quality. URAC grants to organizations broad leeway in selecting how to measure program quality. Measurements to assess performance can be in areas such as medication overuse, underuse, and adverse drug events. The measurement process can involve either internal or external measures. Your best preparation will be to find out which approach your organization is taking and review reports from these quality measurement efforts.

Management Tips

URAC provides some suggested criteria for program quality assessment:

• Using drugs where there is no indication for such drugs to be used;
• Frequency of overdosing;
• Frequency of the selection of improper drugs;
• Indications that are untreated by appropriate medication;
• Frequency of inadequate dosage that indicated;
• Failures in getting the medication to the patient;
• Frequency of adverse reactions to drugs;
• Problems with drug interactions.

The program measurement approach should be described in the PM program description. In addition, the actual measurement processes and results should be well documented.

URAC Accreditation Tips

The single element of this standard is weighted 3.

The desktop review submission should include the PM program description and at least one report from the quality measurement process.

The onsite reviewer will interview staff members involved in program quality measurement, and review updated reports of those measurements.

The Basics

This single-element standard requires that your organization provide the program evaluation results to current and prospective clients upon request. It is not sufficient that you do this; in addition, you must have a policy that describes how to handle the client-request process. Make sure you are familiar with that process.

Management Tips

The most common mistake made around this type of standard is the failure to document the process for handling a request for evaluation reports. We recommend that you outline responsibilities for handling such requests that spell out in some detail:

• which staff members are responsible for handling such requests;
• time frames for handling requests;
• which reports are to be made available;
• how to make sure the most current assessment reports are provided.

URAC Accreditation Tips

This is a mandatory standard.

The detailed P&P outlined above should be provided for the desktop review. In addition, submit a template of information provided to current or prospective clients.

The onsite reviewer will interview staff members and examine reports to prospective and future clients.

The Basics

This standard requires that you provide patients with a list of their rights and responsibilities, and sets forth the following minimum list of those rights and responsibilities:

The right to

• knowledge about the PM program's philosophy and characteristics;
• have the PM program receive PHI only in accord with applicable laws and regulations;
• identify the PM program's employee name and job title (and talk to the supervisor on request);
• receive information about the PM program;
• opt-out at any time;

The responsibility to

• submit any needed forms;
• provide accurate and up-to-date information regarding both clinical and contact information; and
• tell the treating provider of the patient's participation in the PM program.

Management Tips

URAC's expectation is that the PM program communicate patient rights and responsibilities to the patient, not relying on the client to do so. This should happen before or at enrollment. If it occurs after enrollment, it needs to happen within a reasonably short time. So, we recommend that you not only develop the means of communicating the R&Rs, but also have a P&P that covers both the content and the means of delivery to the patient.

URAC Accreditation Tips

The obligation to notify the patient of his rights with regard to personal health information is mandatory; the other elements each weigh 4.

For the desktop review, provide the P&P covering the content and distribution of patient rights and responsibilities. In addition, submit both examples of rights and responsibilities documents and the mechanism for keeping track of when such information was conveyed to a particular patient.

Then onsite reviewer will interview staff members responsible for conveying rights and responsibilities to patients. In addition, she will review documentation evidencing that such information, in fact, has been sent to patients.

The Basics

The purpose of this standard is to assure that your PM program has a process to refer patients, where appropriate, to other benefits or providers. It does this by requiring that you have a P&P that requires your organization to provide information to patients about:

• outside resource programs offered by the purchaser of your PM services; and
• providers who are outside of the PM program.

So, reviewing your organization's policy on how this is handled is the best preparation for this standard.

Management Tips

It's entirely possible that your clients do not contract with your organization for such services. In such a case, you'll need to submit an attestation to that effect. If, however, your clients do contract for such a service, you'll need to have a clear P&P addressing this topic. The P&P should address all external resources to which you may refer patients, including disease management programs, care coordination programs, or the like. The P&P also should address how patients will find out about providers that may be needed out-of-network, in both emergent and non-emergent situations.

URAC Accreditation Tips

Both elements of this standard are mandatory.

For the desktop review, submit the P&P(s) that explain how to refer patients to other programs or out-of-network providers.

The onsite reviewer will interview members of your staff who interact with consumers about how they implement this policy.

The Basics

This standard stresses the importance of promoting patient decision-making. Specifically, it requires that your P&Ps address:

• how your patient communications will support patient decision-making;
• what decision support tools your program will provide to patients; and
• how your program will get patients involved in decisions.

Make sure you are acquainted with the P&P that specifies how your organization handles patient decision-making.

Management Tips

Be specific in your P&P around each of these issues: patient communications, support tools, and the patient-involvement process. The materials and decision support tools you provide to patients may include publicly available sources or materials you develop in-house. The tools can be sophisticated, web-based tools or simple print materials.

Patient decision-making is integrally involved with the patient management plan. Be sure that there is evidence that the patient has played a role in the development of that plan. The documentation should be in both then P&P and the case file.

URAC Accreditation Tips

All three elements of the standard carry a weight of 4.

For the desktop review, submit the applicable P&P as well as examples of decision support tools.

The onsite reviewer will look at your decision support tools and interview staff members to ensure implementation of your P&P.

The Basics

This standard lists six components of the patient management program:

• patient access to specialty drugs;
• mechanisms for obtaining the drugs on behalf of the patient;
• a drug utilization plan that is specific to both the drug and the patient;
• a mechanism to communicate the care plan to the patient;
• a means to notify the prescriber (e.g., treating physician) of the patient's care plan; and 
• a mechanism to coordinate care across multiple payers and/or providers.

Your best preparation for this standard is to be familiar with the patient management program description, which should contain all these components.

Management Tips

The documentation you'll need is either a program description or a set of P&Ps that address each of the 6 elements of this standard. Remember, a patient management program under this accreditation module is not offered to all pharmacy patients, but instead targets specific conditions and specific patients.

URAC Accreditation Tips

Each of this standard's 6 elements carries a weight of 4.

For the desktop review, submit either the patient management program description of a collection of P&Ps that describe the mechanisms for getting the appropriate drugs and information to patients, providers, payers, and other involved parties.

The onsite review will consist of a patient record review that looks at patient management plans, as well as a document review that includes eligibility verification data analysis.

The Basics

This standard requires that your organization implement P&Ps regarding communications between pharmacy providers and consumers. It has six required components of those communications P&Ps:

• How to make sure that the educational materials reflect the target population's learning needs
• How to include best practices in patient management in the materials;
• How the organization will document which educational materials are provided to each patient;
• How to describe to patient the benefits and limits of receiving patient management services;
• How to reach the patient management program; and
• How to describe any applicable opt-in or opt-out opportunities.

Management Tips

This standard addresses a full array of communication modalities, including written materials, personal contact via telephone or in-person, meetings, or other electronic communication. It will be important that affected staff members be trained on how to address issues of health literacy and cultural sensitivity. This interacts with the Pharm Core standard that requires that you review your educational materials at least annually.

Make sure any policy you draft to address the requirements of this standard focus on consumers -- who they are, what special communication needs they might have, and how you are going to address those needs.

URAC Accreditation Tips

Two elements of this standard are mandatory (requiring individualized documentation and describing the pros and cons of receiving PM services). The remainder of the elements have weights between 2 and 4.

For the desktop review, submit evidence of how you document which materials are sent to each consumer. Additionally, examples of communications materials that address elements of this standard, such as the opt-in procedures, should be submitted. Include your communications plan and/or P&P on communications.

During the mock onsite review, your reviewer will examine communications materials/scripts, interview your staff members, and examine your communications tracking mechanism.

The Basics

This standard outlines several requirements for your program's patient education activities.  They should have as a purpose teaching patients what they need to know to use the available clinical and educational resources to self manage the medication.  Specifically, your educational program should address the following issues:

• proper use of medications;
• timeliness of medication use;
• possible side effects;
• contraindications;
• precautions the patient should take related to safety;
• materials related to the promotion of medication reconciliation;
• disposal of medication;
• storage of medication; and
• information about use of over-the-counter medication.

It is important that your education program be designed in a way that is sensitive to the needs of the particular patient population.  This includes an understanding of the demographic composition of your target population.  Pay close attention to your organization's materials that describe how the program's educational program targets were population for education and counseling.

Management Tips

Because nearly all of the elements of this standard are mandatory, it will be particularly important that your policy and procedure or program description be explicit on each of the elements of the standard.  In addition, your policy and procedure or program description must explicitly address how your program will sure that education and counseling efforts target your particular population.  Vague references will not suffice; failure to address even one of these elements could result in a denial of a full accreditation.

URAC Accreditation Tips

Eight of the 10 elements of this standard are mandatory; the other two are worth four points each.

The only documents you need to submit at the desktop review level are the applicable policies and procedures and/or patient management program description.

The on-site review will involve both the review of documents (education materials or scripts targeting consumers, mechanisms to track targeted communications, and any other documentation that addresses how information is provided to consumers), as well as an interview of clinical staff members involved in consumer education and counseling.