URAC's Consumer Safety Concerns - They're Everywhere!

URAC's standards often revolve around keeping patients, members, and consumers safe. In this webinar, our experts will point out important standards related to consumer safety and describe effective ways to approach them.

Consumer safety topics include:

1. Senior clinical staff leadership (2:36)

2. Employment screening (5:03)

3. Consumer safety protocols (8:20)

4. HP and HUM only: Appeal process and appeal notification time frames (13:06)

5. HP and HUM only: Monitoring for financial incentives (17:09)

6. SP and MSP only: Proactive risk assessments (22:03)

7. HP only: Quality improvement projects (QIPs) (25:18)

8. Extra: Special tips on specificity with policy language (30:42)

Links mentioned within the webinar include:

1. Proactive risk assessment/FMEA resources: ISMP.org

This webinar was originally recorded in June 2020 and was updated in August 2023.

See more educational accreditation-related videos here.

Transcription

[00:00:07.020] - Thomas Goddard

Good afternoon. This is Tom Goddard. I'm the CEO of Integral Healthcare Solutions, and I'm delighted you can join us for this webinar today on consumer safety and the URAC standards. It's everywhere. I'm joined by IHS's Senior Clinical Officer, Sue DeMarino, and our President, Lesley Malus Reed, and... And we're going to go through a selected group of URAC standards that seem to have consumer safety in mind. We invite you to look throughout all of the standards that apply to your organization to make sure that you're capturing all of the things that you're at cares about. But these are the ones that we really wanted to highlight today when we talk about consumer safety. And so with that, I'll let my colleagues introduce themselves more fully than I did, and then we'll circle back around and start our review of these standards. Sue, why don't you tell us who you are and a little bit about your background?

[00:01:14.910] - Sue DeMarino

Hi, I'm Sue DeMarino. I've been with IHS for three years, and prior to that, I was at URAC for 17 years. I am a registered nurse. I have a master's in healthcare administration, and I am really happy to be here today. Les.

[00:01:31.810] - Lesley Malus Reed

Hi, I'm Lesley. I am the President of IHS, and I was at URAC from '97 until about 2005, where I met these characters, or 2003. In 2003, I started working at Integral Healthcare Solutions, helping our applicants get ready for accreditation. I have a background from the Canadian healthcare system, and we are very excited to touch upon this theme of standards today that seems to go through all of the modules. We are going to hope to reach out to a broad spectrum of applicants and modules there too. Tom?

[00:02:14.550] - Thomas Goddard

Thank you, Lesley. Very briefly on my background, before I founded this firm, I was Chief Operating Officer and General Counsel at Yarek, and naturally, a whole bunch of jobs before that. And my educational background is I have a law degree and a PhD in industrial organizational psychology. Core 32, the senior clinical staff responsibilities, what does this have to do with patient safety?

[00:02:52.090] - Sue DeMarino

Well, in that standard, the senior clinical staff person has to be responsible for all the clinical programs within the organization. So your job description has to clearly describe that that's one of their responsibilities. And then your policy would reflect how that's being done, like how are they demonstrating that they're responsible for all the clinical programs? Do they have final review over clinical policies and procedures? Are they the person that's signing off on the, for instance, in Health UM? Are they the person that's signing off on the clinical criteria? The other piece to that standard that's really important and that really relates to patient safety is having the appropriate clinicians making decisions about services that they're going to receive. So how can a plan demonstrate that they're in compliance with that? One way is for the senior clinical staff person to review clinical job descriptions, to be involved in the interview process, to do auditing on the clinical staff, or designating that responsibility to someone else and then reviewing the findings. Those are all examples on how the senior clinical staff person can have oversight of the process and ensuring that they have the right clinicians making those decisions.

[00:04:21.520] - Thomas Goddard

What do they mean by the appropriate clinicians or the right clinician? What is that?

[00:04:27.420] - Sue DeMarino

The appropriate clinician. So, for instance, if you had a behavioral health program, you'd want to make sure that the clinicians had training and experience in behavioral health. You wouldn't want a gerontologist to be the person making those decisions on behavioral health, right? So it has to make sense for the population that's being served. The specialty matching, that's very specific. That's another standard in and of itself.

[00:04:57.580] - Thomas Goddard

Yeah. So for another day, maybe next month's topic.

[00:05:01.690] - Sue DeMarino

Okay, there you go. Thank you.

[00:05:10.400] - Thomas Goddard

It's farm core 41. This is for background screenings, and it's really speaking to two different clusters of employees. I'll take them one at a time. For 41A, it requires... First of all, it applies only to employees who have access to consumer personal health care information, PHI or IIHI. Those employees who have such access must have a criminal background check done. So make sure you have a criminal background check for every employee who has access to consumer health care records. And then the second element within pharm core 41 applies only to those members of your staff that have access to medications. Now, we're going to put in a little caveat here about state regulations in a minute, but this is the URAC standard. So if a particular employee, even if it's not a part of their job to handle medications, if they have access to medications, then they need to go through drug testing and screening, and not just limited to illicit drugs. So do a full panel drug screen on those employees. Now, there are state regulations for this standard in particular that are more rigorous than that. In other words, might have a much broader implication in terms of who must go through either the critical background check or the drug screening.

[00:07:00.550] - Thomas Goddard

Make sure that you have checked your applicable state, board of pharmacy laws and regulations before developing your policy around this issue, because as I'm noting, we've seen instances where the state regulation is more rigorous than that. So again, employees have access to consumer health care records and personal information, then that requires a criminal background check. And then second, if they have access to medications, then that's drug screening.

[00:07:39.340] - Sue DeMarino

I'd like to add something to that.

[00:07:41.120] - Thomas Goddard

Oh, please do.

[00:07:42.270] - Sue DeMarino

We've noticed a recent trend when the URAC reviewers come that they actually want to see the results of the drug testing. It wasn't sufficient enough to be able to show that the drug testing was done. There are some state laws that prevent you from sharing that information. So you'll want to be aware of that and work without consent from the individual employee. So you may want to work that out ahead of time to make sure that you can demonstrate compliance with that to the URAC reviewer.

[00:08:25.200] - Thomas Goddard

The last of the core standards that we want to talk about in this context is the Core 38, the consumer safety mechanism. I'll throw this to Lesley.

[00:08:34.920] - Lesley Malus Reed

This standard requires a policy and it also requires a lot of training to make sure that staff know what to do. But let's break down what URAC is looking for. They're thinking about, first of all, a distressed caller. They think about more than that. But in their definition of a distressed caller, they're thinking about somebody who might call in who is in clinical distress, such as having a heart attack, somebody who's calling in who is going to harm others or harm themselves. And URAC expects your policy procedure to say something very specific. They want to make sure that the individual on the phone stays on the line at all times, never places the person on a hot, warm, cold transfer at all. They're always going to remain on the phone while they flag a second colleague. So if they're sitting at home as their remote user, they need instant message. And they will flag their second colleague to call 911. They will remain on the phone with this individual until 911 arrives. And this is a really good thing to go over with all of your staff who could potentially be interviewed during your on-site review to ensure that they can tell the same story.

[00:09:51.440] - Lesley Malus Reed

We recommend that you go over this maybe two weeks before you're on site. Certainly, we want everybody to know about it. We want everybody to hold things up in their desk, such as, well, not everybody, but we're hoping to give people tools because when they do get this emergency caller, they might panic. It's always a good idea to have a red card or a flag or even a stop sign with some of the basic information on it to give people notice of what they need to do, the steps they need to take to be able to address this 911 caller. What we don't want to see is during the the person to take open the policy procedure and start reading it. We're hoping they're going to be able to tell the story. They won't get dinged for having that policy procedure, but we're hoping everybody can tell the same story.

[00:10:42.980] - Thomas Goddard

The only thing I'd have to add to this standard is that there's a certain category of consumer safety threats that are within the scope of this standard that I would call the unknowable, the threat that you can't anticipate. What do you do with that? As long as there's a mechanism in place to elevate the issue to an appropriate level person to handle it, if your front line staff doesn't have the particular training appropriate to resolve that issue, just have an escalation mechanism, let's say, to the chief clinician in your organization or other senior executives, so that everybody has a clear idea of what do you do with a consumer safety issue that you've never seen before and never thought about, escalate it to somebody who might be able to handle it. Lesley.

[00:11:41.050] - Lesley Malus Reed

One more thing. I said all staff earlier, and the issue is that we expect that really it's going to be your front-line staff who have interactions with consumers to whom the scope of the standard is supposed to be limited to. But I'm going to tell you, in my experience, I was once at an on-site where a consumer call kept getting transferred to the boardroom, where us reviewers were. And unfortunately, because of that instance, they have now required that all staff, whether you're in credentialing or IT, they expect your medical director, your HR person to be able to answer this question, should they get into a circumstance where there is some caller on the other end in some distress? Please do ensure that your training will address all staff.

[00:12:36.110] - Thomas Goddard

That's a good point. In fact, I've heard that story enough times, including quite recently when I was doing a mock validation review for one of our clients, that they have been in a conference room. And as Lesley's example shows, and a consumer got through to them, a phone that you wouldn't expect a consumer to find. So now really, everybody's got to get trained on this one. Let's move on to HUM 33, non-certification appeals process. What does this standard have to do with patient safety?

[00:13:21.190] - Sue DeMarino

Sure. Health UM 33 and 38 go hand in hand, and it's all about the expedited appeal process. So if you have urgent requests for services where the patient could be... It could impact their health or impact their ability to maintain functioning, things like that, then you have to have an expedited appeal process. And if you are not contracted to do expedited appeals, then I would tell you you need an attestation that you're going to provide to URAC that says you do not do expedited appeals because you're not contracted. And you can strengthen the submission of your documentation for this standard if that's the case, by having an excerp from your contract that states that the health plan will retain the expedited appeal process or the appeal process in general. The other piece about expedited appeals that is very important is the turnaround time. It's 72 calendar hours. I will tell you that organizations struggle with this standard over long weekends, holiday weekends, where they get the request on Friday, and they're off Monday because it's Memorial Day or Labor Day, and they don't do the review till Tuesday. You've exhausted your 72 hours.

[00:14:58.140] - Sue DeMarino

Again, it's 72 calendar hours. This includes the verbal notification requirement. And what we typically see when I'm doing the audits, what is usually missing from the documentation for expedited appeals related to expedited appeals is the documentation of that verbal notification. After you provide that immediate notification to the member, to the provider, then you have three calendar days or three business days, I'm sorry, to provide the written notification. But it's really important for you to make sure that you're paying attention to the clock. And the other thing that's important to know is that there are a lot of state requirements that are tighter than the 72 hours. So you need to pay attention to the state's laws to make sure that there's not tighter time frames. I believe there's someone somewhere in New England, I don't remember the exact state anymore, where the turnaround time was four hours if the review was received by 2:00 PM on any day. And organizations were really struggling to meet this turnaround time. And they were setting a precedent where they were auto-approving those because of the turnaround time requirements. But then that sets them up for appeals for folks that were sent in timely in order to do the review, say, in the morning of the day and it's turned around within the 72 hours, and it's the same type of case, and they approve one and deny another.

[00:16:37.830] - Sue DeMarino

So you have to be careful about setting those precedents as well. Again, having an expedited appeal process, if it involves urgent care or the health of the patient or their functionality could be compromised without that decision, and then paying attention to the 72-hour turnaround time and making sure that you have that notification, that immediate notification well documented.

[00:17:07.180] - Thomas Goddard

The next one we wanted to talk about is Core 33, which is the Basic Financial Incentive Standard. To paraphrase it, Core 33 says if you have a system of financial incentives that is related to consumer utilization of healthcare services, then you need to have mechanisms in place to make sure that no harm comes to consumers. And we're all part of that as a result of that financial incentive mechanism. Now, for most of you watching this webinar, that's probably going to be not applicable at all. You may have financial incentives, let's say, related to your company's profitability or related to certain quality of performance measures that don't relate to consumer utilization of healthcare services. And if that's the case, then all you'll want to do is prepare a fresh attestation on company letterhead and sign by a senior official in your company that says, We don't have any financial incentives that relate to consumer utilization of healthcare services, and that standard goes away. Now, for the few of you who may have an applicable financial incentive, then you'll need to document and demonstrate through that documentation that you have a mechanism to ensure that looks at things like under-utilization or utilization patterns, perhaps over-utilization, to make sure that there's nothing going on with those financial incentives that is impacting consumer utilization of healthcare services in a negative way.

[00:19:10.310] - Thomas Goddard

You'll find this in some quality programs and elsewhere. In fact, this is a good point that we need to make sure of if it's not to you, it's not just an attestation that URAC will accept. It used to be that they did accept just an attestation. But now the interpretation is to submit both an attestation and a policy and procedure that says we're not doing this. And I can see why URAC would do that, because an attestation doesn't bind the organization over time, whereas a policy and procedure does bind the organization over time. You have to change the policy and procedure to allow for financial incentives. And so it makes sense to me why URAC would change its documentary requirements. What have I left out on this?

[00:20:10.110] - Lesley Malus Reed

Well, for those of you who have worked with us, just so you know, these are some of the things that we provide templates for. So we have templates that will help you come up with the right language to be able to make a clear statement that your organization doesn't provide incentives based on a consumer's utilization of care that could negatively affect their health. We have both an attestation and a policy procedure embedded in our platform called Goldfinch. I don't know if you want to take a minute to talk about that, Tom, but these are some of the tools that we have to offer you.

[00:20:43.530] - Thomas Goddard

Sure, thank you. I'd be happy to spend a second on this before we go on to the next standard. Lesley mentioned Goldfinch. We'll probably mention it one or two times later on. And just for those of you who haven't interacted with this, this is a proprietary piece of software, online software that helps us and our clients navigate the complexities of accreditation process, whether it's URAC, or ACHC, or VIPPS, or Joint Commission of Specialty Pharmacy standards. We provide all of our resources in there, like the templates that Lesley was talking about. We have our own interpretive language. We have the accreditation organization's interpretive language. Plus, it's a secure environment for our clients to send us documents, have us review them, score them, give comments, and manage the entire process from gap analysis through mock desktop review through mock validation review to use the URAC model. And we adapt it for the other accreditation organizations that we work with as well. So enough about Goldfinch. Let's dive. That was actually a word from our sponsor. Let's dive back into our standards. Let's move on to pharm-op 15, which is proactive risk assessment.

[00:22:15.240] - Sue DeMarino

Okay, so this standard is in the standard that deals specifically with the quality of the program, looking for ways to monitor things like errors and to prevent errors, and the proactive risk assessment. This is something that is done not as a result of an error, but to help prevent an error. And if you look at FEMA and their failure mode and effects analysis, you will find a document that is very long, very thorough, and will take you a great deal of time to fill in and address all the pieces that are required. Ihs has created a template that's basically three pages long that URAC has accepted and addresses all the things that URAC is looking for. So it's when you get a new drug, a new piece of equipment, you're looking at that drug, you're looking at that equipment to see how you can prevent an error from occurring. And then knowing what you know about your organization, how likely are the protocols that you have in place, how likely are they going to work to prevent that error? And it's looking at things like look-alike, sound-alike drugs, training on new equipment, things like that.

[00:23:43.910] - Sue DeMarino

Medications that are required to be stored in a special way, hazardous drugs. Those are typically the kinds of proactive risk assessments that are done. Now, I strongly recommend that you complete a proactive risk assessment with your application to your app. That then is something that they can then check off that it's done. If you haven't done it yet, I even strongly recommend that you create your template and at least submit that so that they know that you understand what the responsibilities are. Sometimes folks infuse the proactive risk assessment as your analysis that you've done when you have a big, bad error, and that's not the intent. This is done just as the word suggests proactively, helping to prevent some error from occurring. You know, FEMA has a lot of resources. You can go out to, and I'll put this link for you on ways to implement the failure mode and effects analysis. It's www.Ismp.Org. I'll put the link for you here so that you have it. You can go there. There's a lot of information that's available. As I mentioned, those of you that have contracted with us, we have a risk assessment template.

[00:25:09.270] - Sue DeMarino

It's found in Goldfinch under the Documents link, in this standard, in the pharm-op 15 standard.

[00:25:24.400] - Thomas Goddard

Core 24, and I'll toss this one to Sue. Sue, what is Core 24? Core have to do with consumer safety?

[00:25:33.360] - Sue DeMarino

Well, Core 24 has a requirement that anyone who's consumer facing must have a patient safety quality improvement project. And sometimes this scares organizations. They're like, Oh, my goodness, what am I going to do for patient safety? So I wanted to let you know that your interpretation of patient safety is pretty broad. And as long as you can make an argument on how it applies to your program and your population, typically, they accept that standard. Some examples, if you're talking about HealthOM, it might be your access to service. It might be an expedited appeal turnaround time. So you have to look at your opportunities for improvement. Look at all of your metrics, your dashboard to see if you've identified anything that you would like to improve, and you can go from there. There are some resources, and if you go into your program guides that you're at provides, they give you a whole list of resources on where you might be able to get safety quality improvement projects.

[00:26:45.050] - Lesley Malus Reed

And Sue, if I may ask you a question. Some of our folks are health plans, and they're already doing projects for Hedis, projects that they have to do in the health plan. Are those accepted by URAC as well?

[00:26:56.970] - Sue DeMarino

Yes, yes. The health plan standards require that all of their quips be clinical in nature. And if you're doing things like mammograms, diabetes, things like that, you can tie that to patient safety, and certainly one if not all of those clinical programs will relate.

[00:27:23.040] - Thomas Goddard

And what happens- So this is a distinct requirement from the clinical requirement. So it sounds like this is a subset clinical. Is that a fair characterization? We got clinical quips. And then this says one of those has to be patient safety in addition to being just clinical.

[00:27:40.390] - Sue DeMarino

Right. And they can identify which it is, and that's fine. Thank you.

[00:27:48.420] - Sue DeMarino

So for instance, what most organizations will talk about is how they identified the problem, and then what steps did they have to do to mitigate that issue? So did you have to do auditing to identify that you have a problem? Did you have to retrain staff? Did you have to revise policies and procedures? Did you have to put in new workflows? Things like that. Those are all examples. What outreach do you do to the consumer? Things like that. URAC doesn't tell you what those interventions should be. What you need to be able to provide to URAC is how it relates to the module, what the issue is, and then what you did about it.

[00:28:35.790] - Thomas Goddard

I've heard that described as passing the giggle test. I mean, if you have a performance quality performance issue, and if you propose an intervention that is quite obviously unrelated, so unrelated as to cause the people in the room to giggle about your intervention, you have not passed the giggle test. So as long as there's a logical connection between what your intervention is and what you're trying to accomplish in your quality improvement project, as Sue said, there's likely not to be any looking over your shoulder as to what you've chosen as an intervention. Now, with one caveat, if this quip is several years old and you've been using the intervention over and over and over and seeing no results from it, URAC might say, you might want to try a different intervention. This one is not cutting it. And it may not be even a problem with the intervention. It may actually be a problem with data leakage. There might be things outside of your control that are impacting the data in ways that are rendering your interventions useful. So if you do have old quips and they're just not working, for URAC sake, you might want to double-check and revisit the choice of interventions.

[00:29:57.250] - Thomas Goddard

Hopefully, that helps. And that's... Yeah, Sue.

[00:29:59.290] - Sue DeMarino

I was just going to add. And if you're not moving from your baseline to your goal, you need to be doing a barrier analysis to see, okay, is this anything that you can even impact? And at the end of the day, you may want to change your goal. You may say, We can't make an impact. There's so many variables out there that are impacting our ability to have any influence on this QIP that we need to close it. And URAC, okay with that. But then you remember you have to have these QIPs going at all times. So for instance, a health plan has to have three going at all times.

[00:30:38.480] - Thomas Goddard

Great. Thank you. This seems like a good opportunity to talk a bit about specificity, since that was one of the main points you were making about how you walk through, here's what we do in this situation. Here's what we do in that situation. That's just a general principle for policies and procedures in the world of URAC. Imagine this. You've got a new employee who's supposed to do this thing, and they get a policy and procedure, and all it says is the manager of such and such is responsible for doing this thing and doesn't explain how to do it. URAC has an expectation that your policy and procedure, particularly the procedure part, explains to the staff member how to do the thing they're supposed to do. So be specific and walk through as Sue described, step by step what needs to be done.

[00:31:33.980] - Sue DeMarino

I agree with you, Tom, but I think there's even greater emphasis in the pharmacy standards. Yeah. They want to have the very minute details. Who does it? Where is it documented? How is it done? How quickly is it done? That's right. If you can answer those questions in the pharmacy standards, you usually do well on your submission to URAC.

[00:31:56.610] - Thomas Goddard

That's right. That's why I'm just submitting some consulting firm's templates without getting down into the weeds with your staff and saying, This is how we do it at our pharmacy. If you rely simply on templates, then without doing that, then that's probably the single most common reason for denial of accreditation for a specialty pharmacy is that some consulting firm says, Oh, we got templates for that. Just use these. And we have been told over and over by veteran pharmacy reviewers that that's the most common problem that the specialty pharmacies face. So make sure that you're specific. I'm noticing we're about three minutes from the top of the hour, so there are a couple of things I want to tell you about. First of all, let's see if this works. At the bottom of your screen, you'll see an opportunity to schedule a call with Sue since bulk of these issues are issues that Sue has the deepest experience. And if you click that button, it'll take you to a piece of software that will allow you to schedule a call with Sue, and it'll take care of time zone differences. So please take advantage of that if you have any follow-up questions.

[00:33:15.500] - Thomas Goddard

Do write to us. You can go to info. You can send an email to info@integralHS. Com, and it'll come right to me. What did I leave out, Sue?

[00:33:28.440] - Sue DeMarino

I don't think anythingsounds good, Tom. I think we're good.

[00:33:32.680] - Thomas Goddard

Okay, so I'll put info@integralHS. Com in there. Again, that comes right to me. Thank you all so much, and I hope to see you next month on January 30th at 3:00 PM Eastern. Take care.

[00:33:45.160] - Sue DeMarino

Take care, everybody. Happy holidays.