Welcome. I have to read all these things. All these sessions can be evaluated through the mobile app or on the online program. Please don't forget to evaluate this session, the course, and the faculty when it's done. All of us are required to verbally disclose financial relationships, which everybody will do on their slides. All rights are reserved. The visual and audio content presented here in this meeting is exclusive property of CHEST. Please make room for attendees to have a seat. I think we're good on that. CME claiming will be open Wednesday, October 11th. So, this is the maximizing oxygen efficiency in an ambulatory setting. My name is Rich Branson. I'm a respiratory therapist, and I am a professor at the University of Cincinnati in the Division of Trauma and Critical Care and the editor-in-chief of Respiratory Care in the Journal. I've been involved with oxygen concentrators a lot because of my experience in the military, but as well as with home oxygen delivery. And my first part here is going to be talking about concentrators and helping people understand them. So, it's a quick picture of an oxygen concentrator and the title of my talk, Getting the Most from the Script. Where I'm going to describe options for home oxygen therapy, list some of the common issues faced by patients, and understand the concerns related to over-the-counter oxygen concentrators. So, this is one of my favorite quotes about oxygen. It's actually really cut down. It's over a pair of two paragraphs, but Severin Calson Astrup, who knew a little bit about acid-base and oxygen, said, oxygen is toxic. It rusts a person in a century or less. When oxygen came, the danger and blessing of fire. If introduced today, the gas might have difficulty getting approved by the Food and Drug Administration. I've been tempted to add to that. It might have trouble being approved for payment by CMS as well. So, I don't want to spend a lot of time on this, but you know, if you're here, you're interested in oxygen therapy, and this is the data of all the studies that have looked at the ability of oxygen to change and have a mortality benefit. And it's clearly a dose response. The more oxygen you get, the better off you do in the long run. I'm looking a little bit further. Subjects enrolled in long-term oxygen therapy over the last 19 years in MRMC, the NOT trial. Again, there seems to be this overwhelming improvement in outcome with oxygen. So, we need to get oxygen to patients for long-term care, but we need to get it to them in a fashion that reverses their hypoxemia, and that's where sometimes we fail. You've probably all, you know, forgot about liquid oxygen, but liquid oxygen had a very good history. It can provide high FiO2 at high flows. It's very quiet operating. The disadvantages, you need to refill it, require special trucks. There's a risk of thermal injury because it's so cold. It's constantly off-gassing, so even when you're not using it, it's disappearing. It's significantly higher cost, mostly in the delivery and maintenance associated with refill and delivery. Concentrators are lower cost, they're safe, and they're fairly simple to use. They do require electricity, and in some cases can use quite a bit of electricity from the home. It does take a few minutes for them to warm up and reach the maximum O2 delivery. FiO2, depending on where it is and which one it is, is between 88 and 94 percent. It does require some maintenance filters. I think the big change we will see here in the very near future is the ability for the patient to change the sieve bed. Just like you have on your iPhone, that little icon that is the battery, and you see the battery is getting shrinking, shrinking, you'll have a you'll have a concentrator that has a picture of the sieve bed, and it will be telling you that only so much of it is efficient, and at some point you'll call, they'll send you one in a vacuum-wrapped package. You'll tear that one open, you'll pop open the concentrator and put the new one in. I really think that's very doable, and we should see it here in the near future. Compressed gas cylinders, of course, are very easy to use, but again, you need to deliver them and pick them up. I talked with Mike and John Studdard in the audience. My mother-in-law went on home oxygen therapy, and it became so difficult to get her a portable concentrator, and she only needs one liter a minute, so she's just defaulted to using the cylinders because it's just not worth the hassle. So, oxygen concentrators are all fairly similar in the way they work, and I'm not going to give you a lesson on how that operates here, but the size, the weight, and the noise, how much oxygen they can produce, what delivery methods, is it continuous, is it pulse dose, is it based on minute volume, how complex is it in terms of material and production. I spent a lot of years working with a couple of engineers looking at all the new zeolites, trying to find one that is more efficient than the ones we use today, and there are some marginal effects that can be had, but not huge effects. Connectivity and regulatory requirements, and this just kind of shows you, all concentrators have a motor, and they compress air into the sieve beds, and the sieve beds remove oxygen, or remove nitrogen, or absorb nitrogen, deliver oxygen and argon to the patient, and the rest gets exhausted to the room. One of my favorite projects on oxygen concentrators was done here in Hawaii on a naval submarine, because you realize that the oxygen gets concentrated essentially five to one, but there are other compounds in the air on a submarine that also might get compounded. So we did a long study to make sure that that didn't happen. So pulse dose oxygen therapy everybody is probably familiar with. You take it, patient takes a breath, it senses the effort, and that initial burst ideally is the gas that ends up in the alveoli and produces improvement in gas exchange. This reduces the wasting of oxygen, especially if you're using a cylinder. It prolongs the battery life of a concentrator when it's portable. You have to have the cannula in the nares. If it isn't picking up patient breathing, it will default to continuous flow, and because, like all oxygen systems, if you're ambulating versus when you're sitting, when you start to ambulate, the concentrator can't really do anything if you start to desaturate. It has a fixed output. This is a good description, and I'll show you some more pictures that are more for comparison. So the idea is you patient takes in a breath, and here's this pulse dose of 44 milliliters of oxygen during the very beginning of inspiratory flow, and then, of course, the last third of the breath you take in is all in the anatomic dead space, and that is ability to increase the FiO2 without giving continuous flow that gets wasted during the expiratory phase, and I left this in there just to ask you, but this is what's important. How much oxygen the device can give is based on the maximum output. I don't care if it says one, two, three, four, five, six, or one, two, three, or whatever the numbers are. If it can only produce one liter a minute of oxygen, then if you divide that by the breath per minute, that's how much you're going to get for pulse dose, but even that's more complicated. So you probably know which ones are these are. I blanked them out because we're not supposed to show names, so I'll just give you a little. These are four concentrators. Here are the flows that are available in pulse dose, one to three, one to three in continuous flow, one to six in pulse dose, one to six in pulse dose, one to five in pulse dose. The size is how long they last on battery and how much oxygen they create. So even within this group, if these two devices, just the one to six pulse dose, this one can create three liters a minute. This one can create just over a liter a minute. The six is not the same with both devices, and it's not equivalent to six liters a minute. And if you're all sitting there going, the speaker must not be very smart. No, everybody knows that. No, they don't, especially the patients. So at these devices, again, not naming them, this is the pulse dose that's available at each of the settings. You know, at one, three, and five. This one, of course, doesn't do a five. You get 80 milliliters of breath. This one, you get 60 milliliters of breath, and this one, 60 milliliters of breath. And it changes, obviously, with the respiratory rate. So if I were to look at that and say, okay, there's three kinds of concentrators, and here's the size, here's the maximum oxygen generation, very similar to that table. This is from a paper I wrote in respiratory care a few years back, and I'll just show you. So what what does the concentrator do to try to maximize oxygen and deliver it to the patient? So this is a continuous flow of oxygen in green, and this always being delivered, and this is where we see that waste of oxygen during the expiratory phase. This is the pulse dose, just like I showed you in that first drawing. Now here, some concentrators will maintain a constant pulse volume, but it'll give a same pulse. So if you, it's supposed to be 50 milliliters, it gives 50 milliliters. But if the patient breathes too quickly, the FiO2 falls. So instead of getting 94 percent at 50 milliliters, at a certain respiratory rate, you're only getting 85 or 80 percent at that same dose. Okay, or some of the devices will say, you know, I'm not going to ever give less oxygen than I said, so as the patient breathes more quickly, the volume of the pulse falls, but the concentration stays the same. Other groups have said, you know what, let's keep it the same pulse and the volume, but we'll just skip breaths. So we'll only give the patient oxygen every other or every third breath. So they're all very different. This is just to show you that last figure was from a paper that I did. This is from BMC Pulmonary Medicine, and again, I'm just trying to show you the blue are the pulses with the oxygen with the different devices on these different settings, and it's a, it can be a huge difference. The pulse volume is limited by the breathing frequency and the maximum oxygen generation. So this is a paper that was published in Respiratory Care by Rob Chaper and is a respiratory therapist from the Cleveland Clinic, and again, I'm just trying to show you, this is a bench study, so this is the cannula in this artificial nose that's been printed on the inside to have the same dead space as the human interface, and here's the change in respiratory rate and the changes in the individual devices. So here's the pulse dose, and these are identified here, but this pulse dose provides a flow of about 5 liters a minute, more than that, more than 10, 15, so they're all very different. So when you start thinking about home oxygen therapy, we have to give the patient the home oxygen therapy that relieves their hypoxemia and makes them ambulatory, and I, this isn't my idea, but I had a good friend who passed away recently, but he'd lost his leg below the knee and he had a prosthetic, and we were laughing that oxygen delivery at home is like a prosthetic for a patient who has pulmonary disease. Now, it's not an artificial lung, but it improves their oxygenation. If you took the patient who had a leg prosthetic and put a 50-foot tether on it so that that's all the farther they could ambulate, that would be a problem. Okay, you'd have to get halfway to the mailbox, take your prosthetic off and hop, open up the mail and come back. The idea of home oxygen therapy isn't just so patients can go home, it's so they can go back to the best quality of life they can possibly have. And this is a picture from the Blue Journal with Susan Jacobs, who's a nurse out of Stanford, who's done a lot of interesting work on how patients deal with their home oxygen therapy. So here's all the different kinds, the portable cylinders, the portable concentrators. This is the one where you can fill a cylinder from your home. This one has gotten less popular with time, and of course liquid has disappeared for the most part. But oxygen is not a simple undertaking. Again, this is from ATS and Susan Jacobs. The average number of problems identified by a respondent of a survey about home oxygen therapy was three and a half. Well, what are the most common problems? It's not working. I have trouble with oxygen when I travel. I have getting, my deliveries are a problem. I can't get the portables that I need that I can manage. Lack of high flow portable systems. Not enough tanks. Company doesn't respond to calls. All these things are problems that we continue to see. I'll tell you, all portable concentrators have the same similar operation I showed you. There's no best one. If you're going to the exhibit hall somewhere, there's no, somebody's is not better than everybody else's. They all have a certain size and weight and can produce a certain amount of oxygen. It's really, you know, we use oxygen concentrators in the military that barely fit into this room. That'll produce enough for a whole hospital. So it's just a matter of how much power do you have and how much space do you have and what's practical. It's important for the health care team to match the device to the patient's needs and demands. There's nothing worse in my opinion than sending somebody home with a treatment that we know improves outcome, but we don't give them, it's like giving the wrong dose of a drug. Oxygen's a drug. We all forget that because it doesn't have to go into the vein or into the IM. And I have to tell you, direct-to-consumer sales, where the patient can go and buy it directly from the manufacturer, has been incredibly successful for the manufacturers. I don't know that it's been incredibly successful for the patients, but I lectured at the Organ Thoracic Society early in this year and, of course, not as bad as here, but three hours off, I was up at four o'clock in the morning and there was an oxygen concentrator commercial on that lasted for a half hour and people were playing tennis with their oxygen concentrator on their back. And that's pretty cool. And you can just, you know, callers are waiting. Just call and buy one right now. And I can tell you, people with means, or even people with reasonable means, can afford a couple thousand dollar concentrator rather than deal with all the stuff that goes on with payers and CMS and deliveries and companies. And again, I have concerns about it because I'm not sure patients always get what they are supposed to get. So this is a very recent paper. Hopefully you saw it, and I didn't even put the citation on there. That's not very helpful. This is from Rich Casaberry's group. This is not from his. I got this, I sent this to John Studdard the other day. I just got this on one of those social media feeds. Hey, for three hundred and fifteen dollars, we'll give you our best oxygen concentrator. It goes, it's only three pounds and it'll give six liters a minute. Okay, so Rich Casaberry and his group, they published this in respiratory care early this year. This is their lung model for testing the device. And here are some over-the-counter concentrators. So here is essentially room air. So everything below the dotted line means the devices aren't giving any oxygen at all. And you can buy them on Amazon right now. If you click on Amazon and write oxygen type, oxygen concentrator, you can buy one for between three and seven hundred dollars. It probably won't work at all. So like usual, the OTC stuff has been good for some groups, but has been bad, I think, for patients in cases. I did want to show you that I think there's a lot we can do with the cloud and monitoring of patients on home oxygen, especially oxygen therapy. And this is from actually kind of a forward-thinking paper that was in 2007, so very old now, that we could have the concentrator provide information to the payer, to the DME, to the hospital, to the physician's office. How often did they use it? What was the dose setting? How often were they ambulatory? These things are all possible now and we really be helpful, I think, for this conundrum of are we giving patients what they need? And are they using it? Because, again, nothing's worse than paying for something, for treatment, if it doesn't work. So I think long-term oxygen therapy is, again, based on the MRC and the LOTT studies, which demonstrate the quality of life and survival benefit. The current Medicaid care competitive bidding kind of treats oxygen therapy not more like a business than a medical treatment. Again, home oxygen therapy is not the goal. You know, we were talking earlier about family stuff. I'm a grandparent. I have grandkids. The 11-year-old's here with me. If I need to be on oxygen, I don't want to sit at home. I want to go watch him play soccer. I want to watch him go do whatever he's doing. Home oxygen therapy is not the goal. We're talking about trying to figure out a better term. And again, that same idea about the prosthetic. And I really, you know, again, people say, well, that's because you're a respiratory therapist. There needs to be some kind of payment system by which a respiratory therapist or a nurse with training goes in and sees the patient, makes sure they're using the oxygen, and there's some kind of reimbursement for it, either under Medicare Part B, billing through the physician's office, or I realized for physicians, that's not always a positive, but something. Because while they're there, they can also ask about, how are you using your metered dose inhaler? What about your drugs that you're taking? Do you have any other issues? I think it really is important. I share this just because I think it's important, and then I'll end up here. But this is from CMS data about how many patients were getting liquid oxygen in the United States. So in 2004, you're up here around over 60,000 people, and in the last couple years, it's virtually nothing. The only people who get liquid oxygen are willing to pay for it on their own and have some ability to connect with people to make that happen, because it's so expensive compared to the other techniques. So I'm gonna end by saying, physicians need to be more involved in the development and standards and specifications of home oxygen equipment. I know ACCP is working on that, which I think is great. I don't know if this is right. Maybe we can talk about this later. I've always felt like rather than setting the setting saying 1, 2, 3, 4, 5, 6, it should say the dose. So at 1, it's 10 milliliters. At 2, it's 30 milliliters. Whatever it is, that at least would give everybody who's looking at these devices the ability to compare them. Oxygen purity standards are required for concentrators and appropriate alarms, which we don't see with these over-the-counter devices. There needs to be a standard of care or some way the physician writes an order. Hopefully we'll hear about this where, you know, the patient or the caregiver knows, well, mom gets oxygen at this point when she's sleeping, or she gets this point when she's sitting in the chair watching TV, but if she gets up and ambulates in the hall, she gets a higher dose. I think liquid oxygen, and this is out of my area, but it seems to be like we're seeing a lot more patients with pulmonary fibrosis and interstitial lung diseases, and those patients can't tolerate 2 liters or 3 liters a minute. They're going to need liquid if they're going to be able to go out in the community. And again, oxygen equipment reimbursement should reflect not just the product cost and the service, but the people to go in to ensure the effect of oxygen therapy. So I'm going to end there, I think, on time, and I think we're going to take questions at the very end, unless you can't stay. Anybody have a question or comment right off the top? Okay. Our next talk is going to be home oxygen regulatory updates. You guys are flipping. Okay, sorry. That's okay. Okay, our next talk is maximizing oxygen in the outpatient setting with Dr. Mike Nelson. Well, thank you, Rich. And Rich, I put this slide in just to prove that you're not right. See the oxygen purity is 90% and it's 5,500 meters. Does anybody know how much 5,500 meters is in like the English system? Me either, so I looked it up. 18,045 feet. That's where I carry my concentrator when I want to use it, too. Okay, I am Mike Nelson, and my disclosures are all of these, and most importantly, I am Oz, the great and powerful. And I do have a laser pointer, so don't cross me, stuttered. We're going to understand the guidelines from the updated CMS NCD and the LCD that came after it. Identify appropriate components of an oxygen prescription to understand the appropriate documentation for the oxygen prescription. Otherwise, the patient doesn't get their oxygen. So, qualifying assessments. What do you have to do to make your patient get oxygen? You either have to do an ABG or you have to do an SpO2, and they're both legal, but the ABG supersedes the SpO2 if there's not congruent numbers in terms of the values, okay? It needs to be ordered and evaluated by a treating physician or qualified health care provider. So, not, you know, Bob at the gas station can't ask for the oxygen. You have to write an order for it, and your office personnel can write that order if you sign it. Your respiratory therapist services can be done in your office if you sign them, and IDTF, so Independent Diagnostic Testing Facilities, do not allow you to qualify the oxygen, and the concern there is they write it, you sign it, okay, and then all of a sudden these people start getting oxygen. There was a number of years ago where CMS looked at how much fraud there was in oxygen utilization, and it's well over the billion-dollar mark, so they're fairly strict about who gets to do it and who doesn't. Qualifying ABG or SpO2 studies must be done at the time of need. So, the time of need is in the home setting, if your patient comes in and their SAT's 86% and you put them on oxygen and it improves, that would be a qualifying thing. If they're leaving the hospital, it needs to be within a couple of days of discharge, and then in the outpatient setting when they're ill, it's going to be at the time where you think they need it for as long as they need it, and we'll go into what the qualifications are afterwards. In other words, three months down the road, you're going to have to reassess that for that particular type of patient. In exercise testing, you have to do a three-part test, so you have to prove they go down when they walk, you have to prove that they go up when you give them oxygen, okay, and that it stays up. You don't get to use a they're fine while they're walking and then they stop and it goes down, and that actually is not uncommon in my experience with some of my COPD patients. Medicare will not allow you to qualify for that, so they have to go down while they're walking. All of those tests have to be performed at the same session. You can't do them over two or three days, and oximetry obtained while exercising gets you oxygen for exercising, so your specific prescription has to be an exercise prescription, not just give them three liters all the time. Overnight studies must be done in the facility or at home. Two hours of testing is required, so you should always look at the study and see there oftentimes are breaks where the person took it off their finger. If you don't have two valid hours, they will not accept that. Results from home sleep tests do not qualify, so if you do a home sleep test and they're desaturating during the home sleep test, you cannot use that for Medicare to qualify for oxygen, and results from an in-laboratory polysomnography do not qualify either. Oxygen with positive pressure therapy, so you have someone on CPAP, you have them on BiPAP, you have them on a fancy machine. You must adequately treat the OSA first and prove that you have done so. So you put them on their CPAP, you do a titration study on them, you note that the RDI, which we all think of as the AHI, but Medicare still hasn't fixed the RDI AHI problem, has to be less than 10 events per hour, and then you can start the oxygen as long as they desaturate while they are on the enough CPAP or BiPAP or whatever to get them lower than 10 events per hour. Oximetry or the oxygen desaturation has to be documented less than 89% on optimal therapy. And again, home sleep testing does not qualify you to do that. So three groups of oxygen patients. Group one is, and this is the old group that we've used for years, arterial PO2 at or below 55 millimeters of mercury or an oxygen saturation below 89% or 88 or less, okay? An arterial PO2 at or below 55 or an arterial oxygen saturation below 88% taken during sleep for a beneficiary who demonstrates a normal oxygen saturation while at rest, okay? Rest meaning sitting up awake, not rest meaning taking a nap. I think that's fairly straightforward. A decrease in the oxygen saturation or the PO2 of more than 10 millimeters of mercury or a decrease in saturation 5% from baseline taken during sleep associated with symptoms of hypoxemia such as impairment of cognitive processes, et cetera. You do not have to have each of those. You may have any of those. And lastly for group one, an arterial PO2 less than 55 or oxygen saturation is less than 88 taken during exercise with it being normal when they're not exercising. So that's group one patients, all right? I'll explain why the groups make a difference in a second. Group two, you have to have a PO2 56 to 59. This is also not different from the old one. And any of the following. They have dependent edema suggesting heart failure. They have pulmonary hypertension, core pulmonale as manifested by elevated pressures on echocardiography or EKG changes or they're erythrocytotic with a hematocrit greater than 56%, okay? So that's type two. Type three is the hard one. Qualify if they have the absence of hypoxemia defined in group one or group two but a medical condition with distinct physiologic cognitive and or functional symptoms documented in high quality peer reviewed literature to be improved by oxygen therapy. This is one of the reasons that the NCD changed. The NCD used to contain cluster headaches. This is the answer to cluster headaches because there is some data that treating cluster headaches with oxygen makes a difference. Other diagnoses I would be hard pressed to tell you would fit this criteria. I don't know what other diagnosis might make group three criteria. I'm sure there are some. Okay, nationally non-covered indications. So Medicare will not pay for angina in the absence of hypoxemia, okay? Dyspnea or core pulmonale in the absence of hypoxemia, okay? Severe peripheral vascular disease in the absence of hypoxemia. The thought is, well, maybe this will help if we give them some more oxygen. No data to support that, Medicare will not pay for it. And then the one which I hate the most but I sometimes get away with by telling half truths, terminal illness that do not affect the ability to breathe. I think terminal illness affects the ability to breathe personally, but that's just my personal opinion, so. All right, oxygen accessories. This is what you get when you order oxygen, okay? And I highlighted humidifiers because I take care of a lot of COPD patients and it amazes me how many of them do not get a humidifier. This is a covered benefit, okay? That means that if you order it, the DME company must give this to the patient. If you don't order it, then the DME is not going to give it to the patient because that's an extra cost to them. And this is a fixed payment to the DME company. So please order humidifiers, especially if you live in low humidity places. Oxygen furnished to an airline is also not covered. So you may have a portable concentrator that you can take on your airline flight, but that's already going to be covered as one of your benefits. If you order it from the airline, oxygen will not be paid for by Medicare, it will be paid for by you as an extra fee from the airline, okay? And I have a fair number of patients that want to travel and don't have portable concentrators. Always tell them, give you two months in advance to get the paperwork because the airlines do not do a very good job at sending you the paperwork. And each airline has a different sheet, okay? There's not a uniform sheet to use. So you want to make sure they contact their airline. We actually have the Delta American and Southwest in my office, and we just make copies of it. But a lot of people don't have that. I would suggest if you take care of a lot of COPD patients, it's worth getting. Okay, initial claims for oxygen requires information in the medical record. This is really, really important, okay? Evidence of the qualifying test result at the time of need and of an evaluation of the qualifying test results by the practitioner. If you do not have that in there, then the therapy can be denied. It will be first be denied by Medicare to the DMA, who will then take the patient's oxygen away, okay? If they're not getting paid for it, they're not going to leave it in the person's home. In order to provide initial coverage, there must be evidence of A through C criteria, at least one of them. Symptomatic normoxemic patient with a medical condition that improves with oxygen, patient that meets the criteria for one or two, or beneficiaries with concurrent obstructive sleep apnea qualifying for oxygen therapy using the things we talked about earlier. Okay, in order to keep the coverage, there has to be evidence in the medical record documenting for group one patients nothing, because the assumption is that they're sick enough and that you're going to treat them appropriately, and if they don't need the oxygen anymore, you'll take it away. And if they don't need it anymore, the patient will complain and you'll take it away. But you don't need to do it for group one. For group two, you have to reevaluate in 61 to 90 days after the initiation of therapy, and you have to write a new SWO, standard written order. And if you don't write that and it's not in there, again, the oxygen can be removed. And for group three patients, again, 61 to 90 days reevaluation and a new SWO by the treating practitioner. So what's in an SWO? Well, an SWO must have the beneficiary's name or their Medicare provider number, no, probably not provider, Medicare beneficiary identifier. You have to have a date that you order it. You have to put in that quantity that you're dispensing, if applicable. So be very clear about, I would like to have two liters at night time and three liters with exercise and no oxygen at rest. And I would put that on a standard form if you have one, and then I would write it in my note in addition to doing that. So there's no confusion by your friends in the DME company or in Medicare. You have to have your NPI number or whomever's treating them, and you have to sign the thing. And unfortunately, well, I'll get to that later. Medicare's so much fun. A standard written order must contain all of the elements, okay, description of what you're giving. Are you giving it a wheelchair? Are you giving them a hospital bed, et cetera? And the HCPCS code. Now these are things that you may not put in there, but that your home care, your DME provider might put in there. It's always good to know the oxygen ones and the other ones, especially if you're using multiple DME providers because a lot of the DME providers in large cities tend to not know what they're ordering necessarily. And if you put in the correct HCPCS code, then they are not, they don't do the wrong thing, and again, it's not necessarily because they're trying to, it's because they're putting in the wrong code. So I would suggest for oxygen, for humidifiers, for nasal cannula, you learn those HCPCS codes. You have to put in all of the other options that we talked about, and in the supplies you must include all concurrently ordered supplies that are separately billed. So if you're ordering an oxygen concentrator to be portable and you want to have one in home, you have to let them know about that as well. Okay, for additional information, you can go to the NCD, which is 240.2. Now an NCD, for those of you that aren't nerds, is National Coverage Determination. NIR writes that National Coverage Determination, and then it is sent out for public review. People like you and I can review that and write comments on that, and I would encourage you to do that when an NCD comes out. By law, they must respond to those. They won't respond to you directly, but they will respond to what's written when they come out with the final NCD. The NCD is then may or may not be turned into an LCD by what's known as a DME MAC. That's a Durable Medical Equipment Medicare Area Contractor. There's two of those for oxygen, okay? Their LCD, their local coverage determination is the same, so it makes it easier for us. They can change some of the stuff in the NCD as long as it's not going to negatively affect patient care or change the NCD purpose, okay, meaning the following. So they might add that you can use liquid oxygen if you want to do that. So the NCD will say delivery of oxygen, the LCD may say delivery of oxygen, which may come in the form of liquid, compressed gas, portable concentrator, et cetera. They cannot change the nature of the NCD. It has to stay the same, okay? Those LCDs are then used by the DME providers to determine does this person qualify or not qualify. And most of you remember that in the old days we had something called a Certificate of Medical Necessity, a CMN, and we would sign that and we'd put in two liters and we'd put in a blood gas or a saturation result and we'd send that over and that would work fine. That has gone away now and Medicare has decided that the really smart thing to do is to review physician's office notes because that takes so little time and is so inexpensive. And so that's what's going to happen in the upcoming future, okay? We are trying our best to get them to change their mind and have a template that they can use. We will tell you in the future whether that's going to happen or not, but at this point in time, don't hold your breath. Lastly, but not leastly, remember if you're at the beach you'll be happiest if you have lard in the morning, so eat your lard. Any questions I can answer? Yeah, so for those of you that aren't familiar with the, and I'm sure you're all familiar, so I'm just going to, the INOX trial was the nighttime oxygen trial which showed that there was really no benefit to the use of supplemental oxygen during nighttime in a trial that, if you read the New England Journal, had an awful lot of people saying, it's the dumbest thing I've ever heard. But the reality is, Medicare didn't read it or didn't decide to do anything about it and it's the same with the LOTT trial, and the LOTT trial was the long-term oxygen therapy trial, again, utilizing oxygen with exercise to determine whether it was beneficial in terms of exacerbations, in terms of hospitalizations, in terms of needing oxygen, and they found that it was a negative result. So I don't think Medicare's read that one either. I cannot tell you that won't change, in fact when I lecture about this to primary care providers, I say that same thing. We may go down the road. The problem is, you saw the MRC, the Medical Research Council, and the long-term oxygen therapy trial, the NOT trial, that were done in the early 80s. They both showed a benefit and were fairly well-powered. It would be very difficult to do a placebo-controlled trial where you give someone room air or oxygen and say, by the way, we have a couple of trials that would suggest you're going to die faster, and so it's going to be difficult for anybody to try to find a way to do that and still make an IRB like it, okay? So the answer to your question is, I'm not familiar with any changes in Medicare guidelines as yet, but I won't tell you that that won't maybe happen down the road. It's a supplement, because we're in a competition right now, it's right in the viewing house. Oh, okay. We're going to change. Are you? Okay. Well, I hope you do okay. I hope your COPD patients do okay. Yes, Anne? Could you just say a word about where advocacy stands, you know, with this organization? Absolutely. Tomorrow morning at 7.15. No, I'm just kidding. I mean, not just with Medicare, though. Right. So, Dr. Gay in the office, Dr. Studdard in the office, Rich, me, Katie, all are doing advocacy as best we can. We're trying to get Medicare to utilize a template rather than utilizing physician office notes. We had a call with them, was it August, something like that, and we're trying to get our template okayed by Medicare, and then we found out that Medicare has hired a company that's going to use a computer algorithm to take all of your EMR notes and go through them and make sure they have all the appropriate data elements to allow you to qualify the patient for oxygen. In my mind, that's the dumbest waste of money ever, but I'm not king and don't vote for me. Yes, John? Just to speak to Anne's question a little bit more specifically, basically in legislation there are two issues. One is the template that Mike just referenced, and Katie might be talking about this in the next conversation, and the other is legislation that's trying to find signature, primarily sponsored by ATS, ALA, and Pulmonary Fibrosis Foundation that just is supporting oxygen legislation that looks at removing oxygen permanently from competitive bidding, supporting the template, respiratory therapy care in the home, patient bill of rights, and liquid oxygen reimbursement. So the template conversation, if you want to take that, was done jointly with ATS and CQRC, which represents all of the three biggest DME companies, three biggest manufacturers, and we did that jointly with them. We created the clinical data element and the clinical elements of the template together in conjunction with them where we would be speaking with one voice. From a patient perspective, we feel good about where that stands. Unfortunately, CMS didn't really agree with us that they felt great about where that stands, but that's still a work in progress. I agree with Mike. I'm not terribly optimistic that anything's going to happen. Whoa, whoa, whoa. I didn't say I wasn't terribly optimistic. I'm terribly optimistic, but I think it's going to take some time, and unfortunately, you know, we had the NCD being considered by Medicare that was put through by Peter and his group a number of years ago. How long has it been? Two years, Peter? Two years ago. And we're on COPD, and we still have not, we've not heard that the NCD is even being allowed to be commented on yet, so it's a slow process. There's an awful lot of other doctors out there wanting to get their stuff done, too, and unfortunately, we're lined up, so. They can get an incomplete for as many days as they want, and if I got that many incompletes, I would never have graduated college. Peter, that's a political comment. Just stop right now. Okay. I would like to introduce Dr. Katie Sarmiento, who is going to do the next talk. Thank you. So, Mike should have had my title as well. I was taking a few notes during Mike's talk, but first of all, so my title was supposed to be Home Oxygen Regulatory Updates, but it sort of morphed a little bit following Mike's talk to not be the regulatory updates, but more about why you should come to VA and practice, because it's so much easier there. I think I was saying the same thing at the Telesleep Symposium earlier this morning, but anyway, I'm Katie Sarmiento. I'm from the San Francisco VA and UCSF. I don't have anything to disclose related to today's talk, and I really just want to describe maybe some additional nuances that are in play in our largest integrated healthcare system in the country, which is VA, and how VA does it with prescribing home oxygen, and to understand some of the other considerations like smoking hazards and prescribing home oxygen in smokers, which I found fascinating, actually, in doing the background review for this. So before we dive in, I just wanted to get a show of hands of how many of you are actually practicing in VA. I'm sure this is totally a job fair recruitment effort. Take a look, Elton. Elton's hiring here at the Honolulu VA, so I'm going to put the plug in. Come and talk to him. All right, so that's good to know. I'm just going to go through these bullets, because I figured some of this would be covered ahead of my talk, but to summarize, long-term oxygen therapy is a well-established treatment option for hypoxemic patients. This is a reality. Scientific evidence for its benefit dates back to earlier trials. This is real evidence. The potential benefits of long-term oxygen therapy in non-COPD patients is not well-researched. There's still work to do there, so there's a lack of evidence. This is a little older. In 2009, Medicare spent about $2.15 billion on home oxygen. This is a reality, and there's a huge percentage of oxygen prescriptions that don't follow established guidelines, and that's a reality. So my question is, what's wrong with us as prescribers? And this just goes to show this is a sample of 50 patients with COPD who received oxygen. Thirty-eight percent of those prescriptions were for patients who didn't meet blood gas criteria. Forty-one percent of another sampling of 237 patients didn't meet criteria for home oxygen. Fewer than half of the patients prescribed short-term oxygen after hospital discharge are reassessed after 90 days. And then at a single VA, to remain unnamed somewhere not on the coast or where any of you belong, 60 percent of prescriptions did not meet criteria for home oxygen use. So it's a problem at the prescriber level in being able to get the information needed in the medical record and on the prescriptions. I agree with Mike. I am going to just put a plug in for the template, which is a brilliant idea. And kudos to all the work that's gone in on creating this template. We are big utilizers of templates in the Veterans Health Administration. Although there is no current national template in use in VHA, it's very easy to share these files and have them installed, which I think does improve adherence and compliance with putting the correct information in EHRs and providing the needed information for compliance and oversight. So these templates will increase the likelihood of a claim being covered. It improves the ability, when there's standardized note titling, to locate the required documentation. This is autocorrect. It was EHR. Provides consistent data to conduct evaluations, such as quality assurance and quality improvement. And I think there's a lot of work to be done on that front in HomeOxygen. And then, as Mike mentioned, there was, and John, a template developed for this. John recommends not calling him personally to get a copy of this template. But do call, contact, email, CMS, whatever you want to do. Let them know you want this tool for your practice rather than an AI tool to find the information in your medical records. Those are more cost effective than these NLP or other solutions that find information but don't actually intervene at the provider level while we're making the mistakes in documentation. So I'm going to talk a little bit about HomeOxygen programs at VA. We do have a national directive, which is official guidance sent down through the program offices about how to manage HomeOxygen programs. There is a primary physician responsible, which is the chairperson of the committee. There's a prosthetics representative, and they serve in an administrative and procurement function. HomeOxygen is contracted out in VA, so there's a very standardized contracting process available for this. There should also be a HomeOxygen clinical coordinator, which is usually but not always a respiratory therapist. And depending on the facility, there are other professions that are represented, such as nursing, primary care, people from the quality office, safety, ethics, business compliance, and potentially even someone from the HomeOxygen vendor. I'm putting a single excerpt here related to VA's policy, but it is VA's policy that HomeOxygen services have to be provided to all eligible veterans that have a valid annual prescription and meet the medical indications for HomeOxygen and don't have risks that would produce serious harm with the prescription of HomeO2. This is really easy and straightforward. I wanted to make one comment on this fourth indication that's not covered, which is terminal illnesses that don't affect the lungs. And my comment here relates specifically to the policy. And you'll find in this directive, further down in the directive, that VA does require one determined to be a life-sustaining treatment, that oxygen is provided to patients. This is the one category of life-sustaining treatments where VA mandates that we provide these treatments to our patients. So that's, I'm going to just provide you with a few different examples of how we're a little bit different. For those who are in VA, this is available on the internal SharePoint, but it provides pretty similar information to the coverage that Mike reviewed in the NCD. And I'll go over a couple of deviations, too. There is, again, as I mentioned, no national template, although the CAC install files are very easy to email from one person to another to share standardized templates. Most of the notes, although we don't use a national note title and a national template, do contain fairly standard information related to the assessments for resting, exertional, and overnight oximetry documentation. Overnight oximetry is a tricky bag, and here's where we deviate also. VA is not interested in unnecessary low-value steps in patient care. We do use home oxygen values from overnight sleep testing and polysomnography. I am curious to see if anyone in this room feels you get different results from an oximeter from a PSG or HSAT compared to oximetry ordered alone, clinically what the basis might be. Mike says there is no basis. Did people hear different sampling times on the dedicated overnight oximeters, assuming you use different dedicated wrist oximeters for that? Anyone else? Peter, Charlie? Yeah, that's that's true and wading into the PAP area. Rich, any comments about oximeter differences in the three? There's been so much recently about skin pigment and oximeters, and some oximeters always overestimate, and some oximeters always underestimate. So you could actually pick an oximeter that tends to underestimate and probably qualify more patients for oxygen, and in dark skin patients you tend to overestimate the SpO2, so there's probably a lot of black patients running around who really qualify for oxygen, but we don't know that they do because the oximeter over overestimates their true saturation. The skinny I got from that was not that the oximeters are different, it's that if you're doing too many things in the PSG that the environment may be corrupt enough that you may be overly able to give them oxygen, but they won't need it. So it's really a restricting criteria. It's just a way that less people are going to be able to have access to this, and that's what happens. It's not the oxygen. Appreciate all the opinions. So definitely in that camp of thought, and so I think in our practical application on the VA side, and there are a few people who are practicing now, most of the time we don't do home oximetry, followed then later by a sleep study if it had been separately ordered. We just do a single test. We save appointments. We save equipment time. We improve access by being able to just consolidate the evaluation. But we do see some concerns surface for those of us who are practicing also on the sleep side. Overnight oximetry has been used in some practices to be it's used to qualify patients for home oxygen while they're waiting for a sleep study. So we will see oximetry done. People are hypoxic. They get prescribed home oxygen, and then if they don't show for a sleep study six years later, they're still on home oxygen coming back now finally for a sleep study. So that's one of the concerns we have about that approach. We also have patients who undergo overnight oximetry who will have home oxygen prescribed, but there's no intention of ever sending them for a sleep study. It's not being considered. It's just looking at is this person hypoxic at night because they might have high hemoglobin or hematocrit that's of concern to a primary care provider. And then we have the population who's already on CPAP with known obstructive sleep apnea, and we see this too where these patients come back after being put on APAP or fixed CPAP pressure with an O2 bleed, and then they come back and their serum bicarbonate level is 36. Their BMI is 45, and they're still on supplemental oxygen, and no one's really considered the diagnosis of obesity hypoventilation where they're hypoxic not because CPAP's inefficient, but because they need to be ventilated. And so these are some of the nuances that I think do need to be further fleshed out on the clinical side with education about the role of overnight oxy and the role of sleep tests. Every quarter, five patient charts are required to be audited in VA. So there's a checklist. I'm not expecting you to read this, but I did put the three-page checklist in here. So some member of the home oxygen team is responsible for going through five records and documenting this in the medical record for these patients to provide demonstration of compliance with the directive. And so I think this is also a good assurance that the vendors are doing what we're paying them to do and that the prescription for overnight or the prescription for supplemental oxygen is actually the therapy is actually being utilized. We have a number of patients in recent cleanups since this directive came out in 2020 and a modification in 2023 that had their home oxygen terminated because they weren't actually using it, but no one had been following up on those patients at home. So I think these are all good system-based changes to put into place. The highlights didn't move with the text, but I wanted to point out one other area in here. So what I was trying to highlight was active smoking is considered a relative contraindication for home oxygen. However, it's an absolute contraindication for home oxygen for desaturation with exercise, and a thorough consideration must be made of the risks and benefits of home oxygen therapy prior to and during treatment. Here VA clarifies that smoking includes marijuana, tobacco, e-cigarettes, or similar items as well. Which brings me to a few slides related to smoking and oxygen. So Medicare doesn't speak specifically to the risks associated with oxygen use in smokers. VA's position has historically been that smoking is a relative contraindication. Central office, VA's main headquarters, has not overtly changed this policy and still considers it a relative contraindication. But if you read the fine print like on page three of the directive, it does say a physician who knowingly continues to prescribe that therapy for a patient who continues to smoke is accountable. So it's a little bit of a stick to the prescribing physicians in the directive where it puts us in a quandary about what do we do with these patients? And this has come up quite a bit. So much so that, and Charlotte may speak to this at his own local facility, but what do we do with patients who are seeking oxygen treatment that may qualify, but who are active smokers? What are the potential harms? And smoking and oxygen, as we know, don't mix. In 2010, I think the ethics, VHA Office of Ethics, issued an entire report, and I'll give you the title of that in just a few slides, but they did a review of the ethics behind prescribing, which I found really interesting to read and would encourage those of you who are interested in this topic to also look into to see what's published in the literature. But there is a real risk of harm, whether they're fatal or non-fatal burn injuries related to smoking and oxygen. Those veterans at a single facility who were smoking, who had prescriptions for long-term oxygen therapy and were using oxygen, had a 32-fold greater odds of having a non-fatal fire. Burn injuries are twice more likely among long-term oxygen users, but more than 1,400 patients have to receive that oxygen to result in one injury. But if that injury is death, that's still not acceptable. In four states, 38 fire-related deaths and 17 non-fatal injuries over eight years were documented in those on oxygen who smoked. This is some old data, but it's going to persist that smoking materials were found or readily identifiable for those patients who were seen in an ER following burn injuries from oxygen. This is the report that was issued in March of 2010. It's a lovely report. It discusses the ethical considerations that arise for home oxygen patients who continue to smoke, knowingly continue to smoke. And I've boiled it down to one table to put into this slide. The take-home for me was really to learn how to listen to and appreciate the different perspectives involved in decision making. We as providers tend to approach this in a very paternalistic fashion with our perspectives about these patients do or do not meet the medical indications for prescribing. We don't know if someone's actually going to get benefit. We do want to relieve patient suffering and we do have a duty to protect the public. So we don't want people to start fires if they're smoking on oxygen. And then we have this instilled in us this fear of liability. From the patient perspective, all they can think about is oxygen is the equivalent to life. It allows them to do more and to feel better, but there's also stigma associated with tobacco use. They do seek an improved quality of life and they want to preserve and maintain their function. There are also unrecognized perspectives to be considered in these discussions, including implicit biases, the stigma associated with smoking, the stereotype that smokers are selfish, and that the problem leading to home oxygen therapy is preventable, and probably others that we aren't even aware of. So keeping these perspectives in mind, it's important when we have discussions and we think about prescribing home oxygen, but particularly in connecting and communicating with patients, to explain what the risks and benefits might be to this therapy. It is a medical gas. To consider the totality of all the ethically relevant factors and ensure that they understand their decision making and the rationale behind it. And then acknowledge that there's just going to be a degree of uncertainty in prescribing and their clinical course. And to the best of our ability, engage in harm reduction. And that's what these different checklists are intended to support. Just another nuance here, we still can prescribe for cluster headaches and neurologists can directly prescribe for home oxygen. So that didn't go away for us. And just to summarize, so I'm a big fan of this effort to create a template. I highly encourage you, if you have the ability to create a template that contains that necessary information, feel free to contact CMS, but do create one on your own or bug Mike until a download is available through the CHEST website. Discontinue therapy if it's not still indicated in your patients. Inform them about the harms and benefits as part of a shared decision-making process. Again, consider the totality of all ethically relevant factors and most importantly, engage in harm reduction. And with that, thank you. And Mike will field any further questions you might have. Thank you.

home oxygen therapy

guidelines

prescribing

qualifying patients

standardized template

VA programs

challenges

smokers

risks

ethical considerations