Urine Drug Testing Open Public Meeting - June 8, 2023 - JF Part A

Kari DuPreez:
Good afternoon, everyone. My name is Kari Dupree, and I am one of the Medical Policy Specialists here at Noridian Healthcare Solutions.

Before we begin the meeting, I would like to make the following announcements:

This meeting will be recorded. The recording and written transcript will be posted to our website following today's meeting. All lines are currently being muted and will remain muted throughout the meeting. Only those who registered to present will be allowed to comment on the proposed LCD today.

For the presenters, you are being allotted 10 minutes to make comments. Your line will be opened when it is your turn to speak. Make sure you are not on mute within your system, or we will not be able to hear your comments. You should be prepared to begin your presentation immediately when called upon and will hear the moderator's voice when one-minute remains. By signing in today, you are giving consent to the use of your recorded voice and your comments. Please be mindful of sharing any personal health information during the presentation.

In addition to comments that are made today, all comments should be also submitted in writing. All written comments received will be recorded in the Response to Comments article.

I will now turn this meeting over to Dr. Barry Whites. Dr. Whites, you may begin.

Dr. Barry Whites:
Thank you so much. Welcome everyone.

This proposed LCD is on Urine Drug Testing. And you can see in the slide that the two numbers, DL36668 for JE and DL36707 for JF.

This is a collaborative multi-jurisdictional workgroup, taken, due to and initiated by findings from the Office of the Inspector General, which found that the MACs had various [inaudible] policies that did not come close to matching, and our number one goal was to have consistency and transparency with the process. We had a previous policy. It was taken to an Open meeting on, in the Fall of 2022. It was retired due to significant amount of conflicts that arise from primarily having just two separate drug classes being allowed. It was felt that we should remove that part of it and in the new drug proposed draft does not have those categories mentioned, but we do have limitations based on frequency.

We also have the apparent drugs and the metabolite of those drugs will still fit into a one category group, but they're not being limited to 14.

The Risk assessment. It is not necessary that you use a specific risk assessment, but since you must use a risk assessment and it is contained in the medical record, the risk assessment is used to determine medical necessity and for the testing, the quantitative and definitive confirmation, again, definitive quantitative confirmation, drug testing their definitions in the policy, fairly well defined them in the CPT Code book. There are the definitive panels.

These panels are certainly limited and are numbered, and the CPT code book, so you are encouraged to do that. The definitive panels, really must be, backed up their orders based on the medical necessity in the patient history. Next slide, please.

Point of care testing, or presumptive testing covered when medically necessary in caring for the beneficiary and the intermediate test results for the intermediate management of beneficiary.

Again, this, these primarily are done when the beneficiary and the physician are in the same location i.e., the emergency room, patient, physician's office.

And so, what we've done, and these have all kinds of reasons, this kind of screening tests and that some have a very high cutoff point for detection. Some have very low cut-off, they cannot be used to identify drug dosages when they were taken. And there is some overlap, because the metabolites of one drug to another, and it may require definitive testing to further define whether a patient may be taking, for example, more than one opioid drug.

The number of allowed changes in a rolling week is seven rolling days, has been changed. And we're using the rolling days where we don't use a week. And that you could have somebody coming in on a Friday, and then on Monday and Tuesday. Repeat those same things, but this is a rolling week, and we'll be looking at that information and can now edit on that.

Blanket orders. Blanket orders, which are defined as the same orders on all patients in the practice is non-covered. Your orders should be based on the patient's history, the practice, history of what's in the community, and information obtained from families and other members anyway. And also just noticing the patient, has his demeanor changed, is he more withdrawn than he's been before, is he coherent as he's been before. Next slide.

The risk category and again, you do not have to have a specific risk category. We list one in the draft LCD, but it must be clearly defined in the medical record in determining the number of urinary drug testing billed over time and medical necessity.

Risk assessment, again, is another widely accepted tool for treating entities that are owned and being treated for opioid use disorders. And it must be, again, must be there a risk assessment. We use it to define the number of tests that can be allowed over a period. The provider must clearly define the risk assessment as part of the reasonable and necessary criteria, opioid risk to, again, is there in the LCD. And it is, again, not the only one that can be used, but it's one that certainly an example of one that is acceptable. Next slide.

We have Mr. Bush from the Senior Vice President of Market Access, Millennium Health, who is our first commenter. Certainly appreciate your attending and participating in this. If you would, Mr. Bush, before beginning your test, again, hope you'll give us your conflict of interest if there are any present before starting.

Also, I'll remind you that you will need to submit any presentation that you had and any comments before we to consider them that they would be submitted to us in writing. And those contact numbers will be forthcoming towards the end of the comment.

If you'll proceed, Mr. Bush.

Jeffrey Bush:
Excellent. Thank you, Dr. Whites. And starting with conflict of interests, I am employed by Millennium Health. And so, representing Millennium Health today. And name, of course, is Jeffrey Bush. Millennium Health, if you're not familiar with us, we are a drug testing laboratory. We are located in the San Diego area right here in California.

And I wanted to start by just thanking Noridian for this opportunity to speak today and provide input on the proposed LCD, and also thank Noridian for its leadership and thoughtful approach to LCD development for Urine Drug Testing. I think we've seen some things that were concerning, and I think cooler heads have prevailed. We certainly agree collaboration among medical policy decision makers and stakeholders in the industry and beyond is crucial for consistency, clarity, and, ultimately, successful policy implementation. So, again, really appreciate the opportunity to participate in the process. As the contractors aware, and probably most of us are aware, drug use and drug overdose deaths are currently the highest ever recorded, and we're seeing new dangerous compounds entering the illicit drug supply at a steady pace. One example that you may have heard of recently is Xylazine as an emerging threat.

Now, Fentanyl is one I hope we've all heard about over the last many months, couple of years. It's associated still, with two thirds of the overdose deaths in the country. And today, more and more, unfortunately, we're seeing it, in combination with other drugs, Xylazine happening to be one of those. And this is making drug use and abuse that much more difficult to predict and treat. And, thus, it's becoming more dangerous than ever.

Urine drug testing is the only objective tool that allows clinicians to obtain a clear picture of what a patient is using, so it can better inform the development and their execution based on an effective treatment plan for that individual patient.

Millennium's committed to partnering both with Noridian and the Medicare Program and many others to help to improve the care of, and ultimately save the lives of patients with substance use disorder.

We believe the latest draft LCD put forward by Noridian is a positive and proactive step toward ensuring that Medicare beneficiary access to Urine Drug Testing remains available.

We also wanted to highlight one clinical element of the proposed LCD and provide some related commentary. Specifically, we note that Noridian has excluded discussion of Ethanol within the context of the proposed LCD.

The contractor does state, however, and I quote, "Ethanol is a known drug of abuse but is routinely tested in blood, not urine."

I just want to point out a couple of considerations Millennium would ask Noridian to contemplate regarding Ethanol testing.

Testing for alcohol use via urine specimens is a necessary tool for clinicians that are monitoring patients in a number of settings and might be more accessible and useful than blood testing in certain circumstances, especially for those that are being treated and monitored in a clinical setting for an alcohol addiction or disorder.

Now, blood alcohol testing can be useful when levels of acute use are needed. For example, we're all familiar with the roadside motor vehicle sobriety tests and the blood testing makes a lot of sense there because you need to know was the driver actually under the influence. But this method does have limitations that do not align with clinical settings, particularly where abstinence is being monitored.

Detecting alcohol use by measuring Ethanol in blood has some additional important limitations that I want to just highlight briefly here.

Ethanol is rapidly metabolized, so detection can easily be avoided if you don't drink alcohol within about a 6-to-12-hour window before collection of a blood test. However, in urine, clinicians can monitor the alcohol metabolites, Ethyl Glucuronide, easy for me to say, also known as ETG, and Ethyl Sulfate, ETS, are used to detect the use of alcohol over several days, providing a more accurate indication of a patient's alcohol use over a longer time period. Additionally, many treatment settings do not have trained phlebotomists available to perform blood draws.

We believe that access to monitoring alcohol as a result of these considerations that monitoring alcohol via urine, when deemed medically necessary by the treating clinician, and, of course, documented in the in the medical record as you pointed out, Dr. Whites, it's important and should be considered in any future policymaking and hopefully not limited to availability via blood testing.

In closing, I'd again, like to thank Noridian and staff on behalf of Millennium Health for the opportunity to provide input on the draft LCD. This concludes my verbal comments, and we will follow with written comments to the contractor as outlined in the proposed LCD.

Thank you again.

Dr. Barry Whites:
Thank you, sir. I'll just mentioned one comment. As you said, in our draft LCD, we talk about it is not routinely tested in the blood. Also, the statement said it is not under discussion in this LCD. It is neither discussed as far as covered or not covered. It is not denied in this LCD nor is it necessarily approved in this LCD. But again, totally dependent upon the clinical situation, the documentation by the physician, but it is not something that would be included in this that says its excluded from coverage or for discussion but not excluded from coverage. I just want to make that point clear. We're not denying anybody the ability to check the Ethanol in any shape, form, or fashion. They may so do it, it's just not covered under this, and we're not making [inaudible] one way or the other.

I don't think we have any other commenters. We have any comments from the floor?

OK, again, I want to thank everybody, particularly Mr. Bush for your comments today, and also those who put this process up and own and allowing us to fulfill our obligations for open discussion of a LCD, a Local Coverage Determination which is absolutely necessary for transparency, where people can be heard and who have an interest, a voice in the process and we certainly want to continue that and think it's a very useful, useful timely part to do it at this point in the time, whenever the draft policy has been submitted before the final policy and gives us time to comment and consider other items that we may not have considered before and therefore as it did in the previous draft, caused us to rescind and step back and take another look.

I wanted to thank everybody who again has helped put this program on. I'd like to thank those who are listening.

Again, if you do have comments, those comments will need be addressed. We'll get the addresses in just one second to how they will come in, but I encourage you to do so.

The only bad thing that you might do is to remain silent on some part or item that may save a beneficiaries life or a family members life. If you can think of something that we might look at that is worthwhile that we have not considered, because none of us are perfect. So please, if you've got something to contribute, please do that. Silence is not being transparent. We do not want anyone to think that we're restricting anything that they might have to say. Thank you.

Next steps.

Kari DuPreez:
OK, OK, thank you, Dr. Whites. In closing, we would like to communicate the next steps in the policy development process. The comment period for the proposed LCD will remain open until June 12, 2023. All comments to be considered by our medical directors for the proposed LCD must be submitted in writing.

Written comments can be e-mailed to policydraft@noridian.com or mailed to the address on your screen. Comment information for our proposed LCDs are located on our website, at noridianmedicare.com.

Upon review of the comments, our medical directors will either finalize or retire the proposed LCD. Response to comments will be viewable in the Response to Comments article.

Please monitor our website or register for listserv notifications to be informed of actions taken on our proposed LCD.

Dr. Whites, do you have anything else you'd like to say before we end the meeting?

Dr. Barry Whites:
No, I do not. I just thank you again for your help and your expertise in putting this on and everyone who was involved.

Please, again, if you have a thought, please submit it to us, documentation that supports your thought, particularly peer reviewed information, is very useful, and will get lots more consideration. So, thanks, everybody. Have a good evening.

Kari DuPreez:
Alright, this does conclude our meeting. Thank you for attending the Noridian Open Public Meeting.