Integral Healthcare Solutions blogs

Specialty Pharmacy Accreditation, Version 2.0 PM 22 - Program Evaluation Methodology Disclosure

Tom Goddard — Thu, 02 Feb 2012 11:09:17 +0000

The Basics

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

A description of the program evaluation methodology described in the previous two standards;
A description of the strengths and weaknesses of that methodology; and
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.

Specialty Pharmacy Accreditation, Version 2.0 PM 21 - Program Evaluation Outcomes Reporting

Tom Goddard — Thu, 02 Feb 2012 11:09:16 +0000

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.

Specialty Pharmacy Accreditation, Version 2.0 PM 20 - Program Evaluation Process

Tom Goddard — Thu, 02 Feb 2012 11:09:16 +0000

The Basics

This standard expands on the program evaluation concept enunciated in the previous standard by setting forth specific performance measures. Specifically, those measures include:

assessment of projected clinical outcomes of a PM program using measures of previous, current, and projected outcomes, as well as lab values and health screening data.
assessment of financial benefits of a PM program using measures of previous, current, and future outcomes.
assessment of the other impacts of PM programs, including quality of life, productivity, recruitment and retention of employees, among others.

Management Tips

URAC rewards a broad-based assessment program by granting points to each of the above-listed elements. So, as you design the program of assessment and its documentation, be as sweeping as possible in articulating the scope of your program assessment process. Other suggestions about program assessment include:

make sure the assessment is annual
document program assessment in your PM program description
make sure that each of the elements of your assessment process is documented in terms of both measurement process and results
report the results of program assessments to the QM committee at least annually

URAC Accreditation Tips

With the exception of the element requiring some sort of clinical program assessment, which is mandatory, all the elements of the standard have a weight of 1.

For the desktop review, submit both the assessment program description and sample results of your program evaluations. Also, submit at least one example of the QM committee receiving assessment reports.

During the onsite review, in addition to interviewing staff members involved in program assessment, the reviewer will examine QM committee minutes, assessment reports, and marketing materials.

Specialty Pharmacy Accreditation, Version 2.0 PM 19 - Quality Improvement

Tom Goddard — Thu, 02 Feb 2012 11:09:16 +0000

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.

Specialty Pharmacy Accreditation, Version 2.0 PM 18 - Information Regarding Other Resources and Providers

Tom Goddard — Thu, 02 Feb 2012 11:09:15 +0000

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.

Specialty Pharmacy Accreditation, Version 2.0 PM 17 - Participating Patient Rights and Responsibilities

Tom Goddard — Thu, 02 Feb 2012 11:09:15 +0000

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.

Specialty Pharmacy Accreditation, Version 2.0 PM 12 – Communication and Education Materials

Tom Goddard — Thu, 02 Feb 2012 11:09:14 +0000

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.

Specialty Pharmacy Accreditation, Version 2.0 PM 15 – Informed Decision-Making with Patients

Tom Goddard — Thu, 02 Feb 2012 11:09:14 +0000

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.

Specialty Pharmacy Accreditation, Version 2.0 PM 16 - Patient Management Integrated Approach

Tom Goddard — Thu, 02 Feb 2012 11:09:14 +0000

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.

Specialty Pharmacy Accreditation, Version 2.0 PM 13 - Customization of Education Materials

Tom Goddard — Thu, 02 Feb 2012 11:09:13 +0000

The Basics

This standard prods organizations to customize consumer educational materials to the needs of the patients. Specifically, the materials need to be accessible to all the members of the target population, in multiple formats, and for the entire period of then patients' participation. In addition, the PM program must document which materials are sent to each patient and that it reviews each bit of educational material (in all formats) no less frequently than annually.

Management Tips

The P&P you develop for this standard likely is the same as the P&P used for the previous standard. Make sure your process includes a thorough, annual review of the effectiveness of your educational materials and of your means of distributing those materials.

URAC Accreditation Tips

All five of the elements of this standard carry a weight of 4.

The desktop review submission should include the applicable P&P, a log that tracks your educational mailings, and a screen shot of any web-based materials that are part of your patient communications program.

During the onsite review, the reviewer will conduct a thorough examination of your educational materials in all formats.