URAC’s New Specialty Pharmacy Accreditation Standards, v. 5.0: Part 8
(Patient Management)
In October 2022, URAC unveiled the new Specialty Pharmacy Program, v. 5.0. In this video, the last of a series of eight videos, we explore what’s new as it relates to the Patient Management (“PM”) module within that accreditation program.
In this educational video, IHS's CEO, Dr. Tom Goddard, sits down with the company's Chief Operating Officer and Senior Pharmacy Consultant, Dr. Jill Paslier, to discuss the changes in the URAC Specialty Pharmacy accreditation standards between version 4.0 and version 5.0.
Jill shares her insights and expertise on the updated standards, highlighting the key changes that impact specialty pharmacies seeking URAC accreditation. She also offers practical advice on how specialty pharmacies can ensure they meet the new requirements and maintain their accreditation status.
Whether you are a specialty pharmacy owner, operator, or clinician, this video is a must-watch. You'll gain valuable knowledge and a deeper understanding of the URAC Specialty Pharmacy accreditation standards and what it takes to achieve and maintain accreditation in today's healthcare landscape.
So, sit back, relax, and get ready to learn from the experts at IHS!
Topics covered include:
Patient Management Program (PMP)
Qualified Health Professionals
Review of Information by Non-Clinician
Annual Review and Approval of PMP
White Bagged Medications
Third Party Payer Programs
Sharing PMP Information with Patients, Payers, and other Stakeholders
Initial Assessment, Reassessment, Interventions
Patient Education / Counseling
Self Administration
Disclosing Clinical Evidence
Annual Review by Clinical Oversight Body (COB)
Clinical Intervention Outcomes
Outcome Methodology
Transcription
[00:00:21.780] - Thomas Goddard
Let's move on to patient management. And just for those following at home, patient management is what distinguishes mail service from specialty. This next section of our conversation is going to be just about the specialty pharmacy standards. Take it away. What have you found in the patient management section?
[00:00:39.210] - Jill Paslier
There's a few small changes to this section. I don't think anything too big of a change or that would be difficult for pharmacies. A lot of this is probably things you're already doing, but they just give a little bit more detail or guidance on to how to do it. The first thing that they've clarified in this section is how you define a qualified health professional. To make sure that your clinical services are being provided by a qualified health professional, they define that as a pharmacist, RN, and physician. Then they exclude certain staff roles that would be not considered a qualified health professional, such as technicians, interns, LPNs. However, they do make a note that there may be exceptions based on state laws and regulations based on what type of staff can do certain type of activities. But in general, your clinical services should be provided just by these qualified health professionals. Then similar to the last version, anytime a non-qualified health professional is collecting any information, you still need to have a process for the clinical staff to review that. That's actually similar to before. They did actually call out white bagging of medication. This is when pharmacies ship medications directly to the doctor's office for administration.
[00:02:05.160] - Jill Paslier
In the past, the previous version just didn't exactly mention it, but this one does mention it in the context of patients opting out. They do allow an exception for medications that you ship to the doctor's office. You can consider those patients as opted out of your specialty program and not providing all of the specialty pharmacy management program since those patients are being managed very closely by their doctor, as the doctor is literally the one administering the medication.
[00:02:32.110] - Thomas Goddard
That makes sense. I mean, if the doctor is seeing the patient on a regular basis, it removes that need for case management that is characteristic of a patient management program. So that makes sense. Yup.
[00:02:47.100] - Jill Paslier
And along with that, they also clarified you definitely want to make sure that you're documenting when the patient opts out of the program just so it's very clear who has opted in and then who has opted out. So a couple of other changes here. One other change that I thought was very interesting was regarding the assessments, and it specifically mentions that the initial assessment may be completed by a conversation with the patient or provider and/or by a review of the electronic medical record or provider notes or conversation with the provider or healthcare team. In the past, it didn't really specify this, and most pharmacies had been doing their initial assessment by talking to the patient directly. But a lot of this is really collecting that background and medical information from the patient. So the pharmacies are now allowed to actually use some of the doctor's notes and doctor communication to collect that information as well.
[00:03:41.510] - Thomas Goddard
I think what surprised me about this is that it does tend to place an extra amount of faith in the electronic medical record, trusting that that has all the valuable information. I found that a little surprising. Did that surprise you as well?
[00:03:58.950] - Jill Paslier
Not entirely. I think that a lot of times you can collect what you need to from the doctor notes. However, if you can't find certain information or if it's unclear, there's definitely... The pharmacists' best judgment would be to probably confirm that with the patient, or they may want to just confirm it anyways to make sure that what they have is correct.
[00:04:20.740] - Thomas Goddard
Got it. All right. What else?
[00:04:23.840] - Jill Paslier
Let's see. There's another section about clinical interventions. A lot of you have already been doing these interventions, and there's a little bit more detail of exactly what your rep wants you to be doing and documenting and reporting based on these. The verbiage has been updated to make sure that you are making and documenting clinical interventions, and that you're documenting the outcome for clinical interventions. They provide some examples of what that means as the outcome. This could be things like preventing hospitalization, preventing an adverse drug event, recommending that the patient discontinue an inappropriate therapy, or maybe you helped improve therapy adherence or effectiveness. These would be considered the outcome of the therapy. Specifically, URAC wants you to be documenting the outcome of your interventions. Then as a part of that, they want you to analyze and report program intervention, including that clinical intervention outcome data for review by the clinical oversight body quarterly. This one's a little interesting because most of the metrics that you're looking at within your program are going up to the Quality Committee quarterly. There's a few topics that go to the Clinical Oversight Body once a year in an annual review.
[00:05:37.620] - Jill Paslier
But this specific standard wants you to talk about this metric, clinical intervention outcome data by the Clinical Oversight Body quarterly. It's a little bit unique.
[00:05:47.460] - Thomas Goddard
That is unusual. Any census to put an advantage from an accreditation perspective or from an organizational perspective might be to report to the clinical oversight body as opposed to the QMC?
[00:06:02.930] - Jill Paslier
The reason I think that it's going to the clinical team is because it's a clinical metric. We're looking at intervention outcome data, and the clinical team is going to be the one who can make the best recommendations for how to improve your process or to make more meaningful interventions. That's why I think it's going to a clinical team rather than a quality team.
[00:06:23.210] - Thomas Goddard
Got it. All right. Anything else in patient management?
[00:06:27.030] - Jill Paslier
There is a new leading indicator regarding applicable data with other healthcare providers and stakeholders. It seems to me to be a little bit similar to some of the verbiage in the previous version, but just the verbiage is a little bit different and now it is a leading indicator. There's that one. And then there's also some new verbiage about the annual review by the clinical oversight body. So this is at the end of the PM standards. You'll have a specific annual review and there's different topics that they've listed out that they specifically want you to look at. So you're looking at a review of the value and effectiveness, including the goals and objective of your program. And then you're looking at some of those clinical metrics that you're probably looking at before, such as quality of life, clinical metrics, adherence metrics, which I guess that could be one of the clinical metrics that's not specifically required for this part of it. Then the intervention outcome data and financial metrics, those are the main ones that you're looking at. In the previous version, you were probably already reviewing these, but it didn't specify who's reviewing it. It could have been the quality committee, it could have been the clinical oversight body.
[00:07:38.860] - Jill Paslier
Now it's just clarifying these should go to the clinical oversight body, which again, I think makes sense because they're clinical and patient management related metrics.
[00:07:47.100] - Thomas Goddard
Right. If we pair this standard, PM 7-1, with PM 4-3, which you talked about a minute ago, it looks like URAC is shifting the major clinical tracking and trending to the clinical oversight body rather than leaving that unclear or left to the QMC.
[00:08:04.790] - Jill Paslier
There's some overlap as well because those clinical intervention outcome data, those are going to be reported quarterly and then also as a rollup as a part of this annual review as well. Those are the main new topics or small changes to the verbiage, but there's a few things that have been removed as well from the patient management section. I can go over those. A little bit of just minor verbiage that's been removed, I noticed, such as defining the services that you offer as a part of your patient management program and the educational materials, removing specifically that you're providing service in accordance with third-party peer programs. Again, you're probably doing this and you should be doing this. You just don't necessarily need to spell it out in your direct documentation. One other thing that they removed is for the pharmacy to share information regarding your program, including the potential health benefits and limitations and instructions of how to opt out. Typically, I've seen pharmacies put this information in their welcome packet. You may not need it in your welcome packet anymore if you don't think it's useful since it's no longer a requirement. Got it. Regarding the patient education section, there's just some small edits and tweaks to the verbiage in that section.
[00:09:26.860] - Jill Paslier
There's been a few details removed from the required education, just a couple of small tweaks like specifically calling out REMs, promoting self-administration, education on financial resources and support groups, which is actually covered in another standard anyways. But yes, so just little tweaks in that section. Then the concept was removed for disclosing clinical evidence that supports the interventions. This is one I've seen pharmacies often prepare for but never really have to use. It's not common that someone would ask for the clinical evidence to support their interventions. Pharmacies would usually have a fax or a letter template. They're prepared to share that information, but they never really got a request from the doctor or the payer or the patient. Honestly, I just don't think it was really used and that useful for a lot of people, so that could be the reason why it's been removed. Then one other that was removed is as a part of your patient management program and all the metrics that you're looking at, you no longer are required to define the methodology for each outcome and the strengths and weaknesses. So just considering the data that you're presenting to your clinical oversight body every year, that's no longer going to be required.
[00:10:50.770] - Jill Paslier
Those are all the main changes that I can think of.
[00:10:54.030] - Thomas Goddard
Excellent. Well, Jill, I appreciate you taking the time to dive into the details of these changes. It's a delight to be able to talking with you about this.