Shameless Care: Exploring the Labyrinth of Sexual Health Testing

Transcript

Speaker1: You're listening to a podcast right now. Driving, working out, walking the dog. If you're into podcasts, chances are you have something to say too. With RSS.com, starting your own podcast is free and easy. Upload an episode and we distribute it to Apple Podcasts, Spotify, Amazon Music, and more. Track your listeners, see where they're from, and start earning from ads just like this. If you've been thinking about starting a podcast, this is your sign. Start your new podcast for free today at RSS.com. I'm Russ. And I'm Ashley. And this is Hot Couple Chronicles. Well, kinda. I know we're on a season break right now. Miss us. You miss us. We miss you. But we decided to team up with our friends at Shameless Care Podcast. And we're going to share one of their latest episodes from right after Thanksgiving. I want to say we miss you guys. We're going to come back real soon. And I hope you guys have a very Merry Christmas. Merry Christmas and a Happy New Year. Love you guys. Love you guys. Bye. Bye. Welcome to the Shameless Care Podcast, where sex is normal, pleasure matters, and your search history finally feels like research. From science to the sheets, we break down the wild, hilarious, frustrating, and absolutely essential truths about sexual health. No shame, no judgment, no sugarcoating. And now here's your host, the guy who never set out to start a telemedicine company. He just got tired of doctors guessing and startups pretending to care. Here's Robert. Welcome to the Shameless Care Podcast, everyone. My name is Robert, and as always, I am joined by the beautiful Anna. Well, hello, everyone. Today's podcast is about lab certification, C-L-I-N. CLIA certification. What is that? What is CLIA? Why does it matter? Well, I'll tell you why it matters right now. Let's not let's not wait around on that, Anna. I think it's important we explain why it's important. Because it is the main certification that you can look to to see that your lab is a quality lab and actually doing great work. And in today's age of Internet, you know, you can get anything you want on the Internet. That matters more than you might think. Absolutely. It really does. I've never heard that before, but you guys can correct me. If you're in the medical world, do you call it C-L-I-A or CLIA? Let us know. I have never heard CLIA, but she assures me. Oh, my whole career. It's a CLIA lab. There you go. I don't know. I've worked with two different CLIA labs at Shameless Care, but they never referred to them as CLIA labs either, so you'll have to let us know. Anna, did you have a wonderful Thanksgiving? I did. It was a lot of driving, a lot of family, And it's always a lot of food. I'm still in a food hangover, I think. How about you? Yeah, absolutely. I went to Missouri and had a fantastic time. What is your favorite Thanksgiving food? Oh, that's an easy one. My aunt makes these bread rolls from scratch, and we fight over them. They are so good. Nice, nice. Well, Anna, it is Black Friday, so if anybody would like to get any STI testing done from a CLIA or CLIA, in your words. Uh-huh. Lab through our Physicians of Shameless Care. You can use coupon code PODCASTSALE. One word, PODCASTSALE. And you can take 20% off of the testing this week. Or the other thing that's on sale are gift certificates. So you can basically get yourself set up for next year. And that is quite a discount. I do want to warn everybody, though, we did a podcast on FSA and HSA. And while the Shameless Care website will always take those debit cards, gift certificates are never an allowable expense on either your FSA or your FSA. your HSA account. We learned that in doing the podcast. There you go. And it's great that people can save some money and get their health care. But STI testing definitely is. Anna, I want to go ahead and just remind everybody the format of the show. We're trying to do a better job at that. So right now we're doing an introduction. The next thing we're going to do is the Shameless Care Dirty Joke of the Week, even though we do two podcasts per week. And in fact, two dirty jokes a week. We're just going to having a hard time not saying Dirty Joke of the Week. And then we do a four-play segment, which is a little bit of news. And then we get to our main event, which is the, today we're talking about the lab certification process. And then aftercare. So Anna, with that in mind, what do you say we go ahead and get to the Dirty Joke of the Week? I can't wait. It's time to break the ice with the Shameless Care Dirty Joke of the Week. All right, this is a part of the show where I tell a dirty joke and Anna judges it. And if she gives it a thumbs up, then we hear a... But if she gives it a thumbs down, which she did last time, and I have not really recovered, my Thanksgiving was not, not perfect. Then we hear this sound and everyone's sad. Anna, are you ready? I hope so. A couple of men drove up to a rural drive-in restaurant in a new Royals Royce. When the waitress saw the expensive car, she ran out to take their order in expectation. of a big tip. Unfortunately, the men ordered only coffee. Though disappointed, the waitress brought their order and struck up a conversation about the rolls. The driver reached into his pocket for some change to pay for the coffee and at the same time pulled out some golf tees. What are those? asked the waitress. Gold tees, replied the driver. What are they for? she queried. We put our balls on them before we drive, said the second man. Damn, the waitress said. Those Royals Royce people think of everything. Thumbs up. All right. I kind of thumbed up the last line there. I couldn't say Rolls-Royce for some reason. Anyway, good job, everybody. I don't know why I said everybody. It was really me. Actually, it was this joke book. All right, Anna, are you ready for some foreplay? I am. Next up, foreplay. News about sex. All right, Anna, this article comes from ScienceFocus.com writer Hattie Wilmoth, and the title is... Japanese people still aren't having sex and nobody knows why. Tagline, around 1 in 10 Japanese people reach their 30s without ever having had sex. And Anna, you are going to freak out when you see these statistics. I am shocked already. Let's learn more. All right, now in 2002, so just over 20 years, Twenty years ago, just over one in three Japanese adults aged 20 to 24 reported being sexually inexperienced. By 2020, that had reached as high as 60 percent. So it doubled, basically. Wow. What's even more insane, Anna, is that a lot of these people are having sex with sex workers, which is fine. I don't mean that that's insane. It's just they're not having sex in any other way. Huh. That's fascinating. Right. Up to 60 percent of Japanese men said they had previously paid for sex. sex. Here's another statistic from this article. A 2020 online survey indicated that 20 to 30 percent of men aged between 20 and 39 years old said they didn't want to have sex. Now, that is just really hard to fathom. That is a different culture than I am accustomed to. It's a different world. We keep reading article after article about sex recession. We keep hearing about things like lower testosterone levels. It's hard to know what's going on, but something certainly is afoot, as they say. Yeah, and I would like to be curious about what the same stats are in the U.S. about how many people in that age group have also not had sex here. It'd be something worth looking up. It sure would. Anna, are you ready for the main event? I can't wait. And now, the main event, the part you came for. Guest interviews, taboo topics, and real talk you won't hear in your doctor's office. Anna, for the sake of this podcast, you and I will reach an agreement. We're going to call it CLIA, not CLIA. So you don't make me laugh, all right? I will do my best. Even though I suspect you're probably the one that's correct. Well, like I said, I think we just give acronyms and names to as many things in the world of medicine we probably shouldn't. Well, Anna, what is a CLIA-certified lab? Well, CLIA stands for Clinical Laboratory Improvement Amendments, and that's specifically of 1988, a federal program that was built to ensure labs are A CLIA, the certified lab, is a laboratory that tests human specimens for health purposes and meets federal quality standards to ensure accurate and reliable patient test results. Basically, if a lab is handling your blood, a swab, or other samples for diagnosis, it must have that CLIA certification. With very few exceptions like research labs. But, you know, in fact, CLIA covers roughly 323 So whenever you hear that CLIA lab certified, think federally approved lab that meets quality benchmarks. I feel like I'm a salesperson for the CLIA labs right now. There you go. The touch, the feel, the cotton. Correct. All right. So now let's go ahead and talk about how labs get that CLIA badge. It's not a one-and-done deal, right? That is correct. Labs start by applying for that CLIA certificate with CMS, specifying the complexity of tests they will perform, and paying for the required fees. Whoa, Anna. What is CMS? That's a good question. That's the Centers for Medicare and Medicaid Services. Once certified, a lab has to continually uphold CLIA standards. This means undergoing regular inspections, which are typically every two years and reporting and participating in proficiency testing programs to prove they can consistently get the correct results. In other words, CLIA certification is an ongoing commitment. It's kind of like you have to recertify your marriage every couple of years. But labs must document their procedures, training personnel, and promptly fix any issues found by inspectors. The certification isn't eternal. Labs have to renew their CLI certification and pay renewal fees every two years. They also need to stay on top of the regulatory updates. For example, if new quality control rules come out or new tests are added, the lab must update its policies and procedures to remain in compliance. Basically, running a CLIA lab is like maintaining a high performance. You're listening to a podcast right now Driving, working out, walking the dog If you're into podcasts, chances are you have something to say too With RSS.com, starting your own is free and easy Upload an episode and we distribute it to Apple Podcasts, Spotify, Amazon Music, and hundreds more Track your listeners, see where they're from, and start earning from ads like this Even with just 10 listeners a month If you've been thinking about starting a podcast You're listening to a podcast right now. Driving, working out, walking the dog. If you're into podcasts, chances are you have something to say too. With RSS.com, starting your own podcast is free and easy. Upload an episode and we distribute it to Apple Podcasts, Spotify, Amazon Music, and more. Track your listeners, see where they're from, and start earning from ads just like this. If you've been thinking about starting a podcast, this is your sign. your new podcast for free today at rss.com it's a car you get it licensed but then you have to keep tuning it up you have to keep upgrading it and keeping it up to speeds okay so now who oversees clia certification and enforcement who's watching over all of this and who actually makes sure that these labs are playing by the rules well the big brother committee or the oversight is shared by two big agencies the centers for Medicare and Medicaid services is the chief enforcer. That's the head honcho. That's that CMS that we were talking to earlier. And they are the ones that issue the lab certificates, collect fees, conduct inspections and enforce compliance. But CMS isn't working alone. FDA and CDC are also involved. The FDA classifieds tests by complexity, decides which tests are simple versus highly complex. And the CDC provides technical expertise developing lab practice guidelines and monitoring quality. In practice, CMS and its partners keep labs in line. CMS approves private accreditation organizations to inspect labs on its behalf and can even approve certain states to manage CLIA enforcement. Plus, state health agencies often carry out on-site inspections for CMS and are authorized to enforce CLIA standards at the state level. Some states are what we call CLIA-exempt for having equally strict programs. New York is a famous example. They run their own quality lab programming. But generally, federal and state regulators collaborate. The feds set the baseline rules, and states, can add extra regulations on top of that. Either way, a CLIA certified lab answers to multiple watchdogs to ensure quality. And I'm going to take a time out here, Anna, to talk about New York. So we do not own and operate a lab ourselves. We contract with labs. We've contracted with two now. Neither one of those could test samples from New York. And if you look at virtually any telemedicine, telehealth, whatever company across the landscape, you get you try to get STI tested anywhere you you can possibly find on the internet virtually speaking none of them can test in New York because New York has some very specific rules and their own certification process that only a couple of labs have have made it through essentially not that labs in New York are more accurate than others they just have kind of a I'll say it peculiar set of rules which makes them the oddball the one state out of 50 of which it's very hard to do lab testing in. That's fascinating I didn't know that. All right Anna segue sidebar whatever you want is over. The thing you need to understand is that there's layered oversight. Your lab in, say, Ohio or California is certified and monitored under federal CLIA by CMS and might also be subject to state-specific lab laws. With FDA and CDC in the mix for test standards and guidance, it's a whole team effort to make sure that everything is done properly. No cut corners in this process. Yeah, exactly. Quality. CLIA is all about making sure labs get accurate results. CLIA-certified labs have a battery of quality control measures. They run control samples with their tests, calibrate their equipment regularly, and meticulously document things like a reagent lot number, expiration dates, and things like that. For example, if a lab is doing COVID PCR or an STI test, they'll include positive and negative control samples in each batch to make sure the reagents and machines are performing properly. Labs also do something called proficiency testing. This means a few times a year, the lab gets sent mystery samples from an external program and must test them. The lab's results are then compared against a reference or a peer group, essentially like a pop quiz, If the lab scores poorly, it's a red flag that triggers investigation or corrective action. CLIA actually requires labs performing moderate or highly complex tests to pass these proficiency tests to regularly keep their certification. Another piece is personnel competency. CLIA labs must ensure their testing staff are properly trained and evaluated. Labs often have protocols like having a second technologist or supervisor double-check critical or abnormal results for accuracy before they go out. In many labs, if one technician finds a positive STI result, a second qualified person will verify it. This redundancy helps catch errors and is part of a good lab practice. So between machine checks, human checks, and external checks, CLIA labs create a net of quality assurance. It's not foolproof, but it generally and greatly reduces the chances of you getting a false result. Anna, this redundancy is something that's probably worth stopping to talk about. It is. So our testing panel at Shameless Care has 14 different sexually transmitted infections. Five of those are blood tests. HIV, syphilis, hep B, hep C, and HSV2. But we have patients fill out a a 10 circle dried blood spot card. So there's actually 10 different samples, even though the lab only needs to run five. Anna, can you guess why there has to be 10? Because if you get one that's positive, you got to double check it. Ding. There you go. Nobody wants to find out. You might have syphilis, but we ran out of sample. We don't know. We don't know for sure. We don't know for sure. Don't ever say that. Yeah, the goal is that when your lab report says you're positive or negative, for something, you can trust it. As CLIA puts it, all patient test results should be accurate, reliable, and timely. And they enforce an entire framework to make sure that happens. CLIA doesn't just regulate machines and tests. It also sets personnel requirements. You can't just have anyone off the street running a medical lab. There are specific roles that must be filled by qualified individuals. First and foremost, every CLIA lab This person is often an MD or a DO, licensed in the state, or in some cases a PhD scientist with appropriate board certification, who takes ultimate responsibility for the lab's operations. The lab director is like the captain of the ship, responsible for overall management, ensuring the lab meets all regulations, employs qualified staff, and maintains proper documentation. There are other key players. For high-complexity testing labs, CLIA regulations specify roles such as technical supervisors, clinical consultants, and testing personnel. The technical supervisor must have advanced training and provide scientific oversight of testing. The clinical consultant is often a physician who is available to advise on test interpretation. And of course, the testing personnel are the lab technologists who actually perform the assays. are run correctly and results are interpreted properly. Think of it this way. A lab is not just machines and chemicals. It's people. You need a head chef, which is our lab director in this case, with the right credentials and a kitchen staff, which for us is supervisors and techs with proper training, to follow the recipes correctly. CLIA requires that mix of expertise so that when you mail in your sample or give a blood sample, the folks handling it know what they're doing. All right, Anna. So now let's talk about direct-to-consumer STI testing, which states require a doctor on behalf of the patient to order the test and which can go direct-to-consumer because not every state allows direct-to-consumer STI testing. We're going to talk about that now. The federal CLIA law doesn't dictate who can order a test. That's actually left to state law. As of recent surveys, the majority of states, which is about 37 states, explicitly allow direct access testing in some form. And that means consumers can initiate lab tests on their own without a physician's order in those states. However, that leaves a chunk of states that do not allow this. So in those places, you still need a doctor's involvement to get an STI test or, quite frankly, almost any medical test. So which states are in the no-do-it-yourself lab test camp? Well, New York is the poster child. It outright prohibits labs from performing tests without a duly licensed medical provider requesting them. Aside from New York, other holdouts include New Jersey and Rhode Island, which by law forbid direct access testing. Basically, labs in those states cannot accept test orders from patients without a physician's prescription. I'm going to stop there for a second, Anna, because I looked at CVS, for example. You can go to CVS and you can buy a lab kit right off the shelf. If you go to their website and try to order that, it's a note on there that says they cannot ship that to Rhode Island and New Jersey for this very reason. If you as the patient go get one of these off the shelf or you order it to your home, that's direct access STI testing, which is not legal in those states. Wow, that's crazy. California is another example. California's law explicitly says a lab may only accept specimens ordered by an authorized provider. This one is a little bit. Now, let's take a time out here, Anna, to acknowledge something. There's 50 states and these rules change all the time. Of course. I mean, I'm in the telehealth industry. You're listening to a podcast right now. Driving, working out, walking the dog. If you're into podcasts, chances are you have something to say, too. With RSS.com, starting your own is free and easy. Upload an episode, and we distribute it to Apple Podcasts, Spotify, Amazon Music, and hundreds more. Track your listeners, see where they're from, and start earning from ads like this, even with just 10 listeners a month. If you've been thinking about starting a podcast, this is your sign. Start free at RSS.com. And so, for example, the rules around what creates a real doctor patient relationship in terms of prescribing medication changes multiple times per year when you look at all of the 50 states. For example, when COVID happened, a lot of the telehealth laws became much more, I would say, liberal because these states realize, my God, people can't literally go to the doctor right now. They need medical care. After, I'm using air quotes here, after COVID, after we all stopped caring about COVID, basically, a lot of those laws became more conservative again. But now they're kind of jumping around, right? Does that make sense? Yeah. So like all of our physicians at shamelesscare.com have to constantly be monitoring them in the states of which they're licensed. So when we give you information like this is a law in California, quite frankly, this is what we could find, but it may have changed in like the last month. We don't know. Yes. But with that in mind, I'm going to read a memo here from the California Department of public health and this was dated a few years ago. So like I said, this may have completely changed. But nonetheless, for the learning purposes of this podcast, I think it's fine because I don't think anybody in California is literally going to take this as like legal advice, right? Sure. We're just talking about these different rules surrounding STI testing in various states. So this is a memo from Karen Smith, and she's the director and state public health officer, at least at that time. And it says who is authorized to order clinical laboratory tests? It says under California Business and Professions Code Section 1288, quote, Any person conducting or operating a clinical laboratory may accept assignments for tests only from and make reports only to persons licensed under the provisions of law related to the healing arts. That's a very governmental way to put this, right? Yeah, I'm going to use that. The health care provider must be licensed in the state of California as a physician or surgeon or licensed as a health care provider. with the scope of practice that authorizes one to order clinical laboratory tests. If you get to the bottom, it says the laboratory must assure that the requisition or test authorization includes the name and address or other suitable identifiers of the authorized person requesting the test. A laboratory cannot accept a test requisition that does not identify the ordering physician or healthcare practitioner, and the laboratory must make a reasonable effort to assure that the person ordering the test is qualified to order the test. So all of that to say, if you go to testmybutt.com, which hopefully is not a real website, has a California resident, and you order the test yourself, and there is no medical intake form, you're not giving any medical information, there is nothing there that is providing you a real doctor-patient relationship, then unless this is out of date, which we're looking at, and hell, it may be, I just said that, then that's, you're doing something very much gray area, and I would have a little caution there if that makes sense. Yeah. And it's not just the coast. Georgia, for example, flatly state that a clinical laboratory, and this is a quote, shall examine human specimens only at the request of a licensed physician, dentist, or other person authorized by law to use the findings. Many states have similarly worded laws, effectively saying no doctor, no test. On the flip side, plenty of states are direct-to-consumer-friendly. Places like Texas, Ohio, or Washington, you can walk into a lab. You can request an STI test yourself. No doctor visit needed up front. Even among the states that allow direct-to-consumer testing, some put limitations on which tests are under what conditions. For instance, a state might allow direct-to-consumer ordering for routine wellness tests or common STIs, But not for more complex or sensitive tests without doctor involvement. Some states require a physician review for certain results or types of tests, so the rules are pretty nuanced. For consumers, this patchwork means you'll have to be aware of your state's rules. If you're in a state like New York or New Jersey and you can't directly order an STI test from a lab on your own, you'll need a telehealth doctor or clinic to get involved. In more permissive states, you'll have the green light to order at will. And even then, reputable services often have a doctor in the loop to answer questions or help with positives. It's a bit confusing, but companies usually make it simple in the front end. Input your state on their website, and they'll either allow the order or tell you that they can't service you due to the local laws. All right, Anna, let's go ahead and talk about standing orders. Now, in states that require a physician to be involved in this process, some do allow what's called a standing order. And that is kind of where a doctor is involved in this, but not necessarily really, actually. Okay. Let me explain. So you order a test from CheckMyButt.com and, you know, there's a doctor's name on it and an NPI number. And what does NPI stand for, Anna? It stands for National Provider Identifier. So that's the identity code of a physician or a nurse practitioner or somebody like somebody authorized, right? Correct. And that doctor is ultimately responsible. And that doctor did order the test. And I'm using air quotes, but it's a standing order, which means the lab has a contract with that doctor. And that doctor's name and NPI is going to be on every single even if they do 2000 a day, the doctor's name and NPI is going to be on all 2000 of those. That's a lot of tests to be responsible. Even though the doctor has no actual patient doctor relationship, meaning they don't know their identity, they don't know their medical history, they don't know anything like that. And that's totally legal. I'm not saying it's not. It's totally legal in many, many states. And you'll know if your lab company does this or not, because if you order the test and you get a lab requisition immediately, well, clearly a doctor hasn't had time to review that, have they? Correct. So that's what we would call standing orders. And that's perfectly fine. It's just different than like what we do at Shameless Care. And it's something that people should should know the difference about. Well, that's really interesting, Robert. I think we should probably talk a little bit about how the rules are enforced. All right, so we've got a bunch of laws on the books about needing a physician for lab tests in some states, but are these rules actually enforced? Do companies and labs follow them closely, or some just quietly ignore them and hope no one notices? Kind of like putting their fingers in their ears and going, la. But by and large, the legit companies do follow the rules. Most of the big direct-to-consumer lab tests providers partner with doctors, or have in-house physicians to review and authorize test orders in the states that require it. So if you order an STI test online in, say, New Jersey, the service will typically have a physician licensed in New Jersey electronically co-sign or approve that order. From the consumer perspective, it feels like direct access, but on the back end, they're involving a doctor to keep it legal. Enforcement tends to be pretty spotty, but real. as a prime example, have actively enforced their no-direct-to-consumer laws. In fact, New York's Attorney General has taken action before. In other states, we haven't seen much high-profile enforcement, possibly because companies preemptively comply. It's relatively rare to hear about an individual getting in trouble for ordering a test, but a lab operating outside of the rules is taking a big risk. A lab could face fines, lose its state license, or CLIA certification. In serious cases, even criminal penalties for violating medical testing laws can be part of the consequences. There's also practical enforcement mechanism, the lab themselves. Large national lab companies like LabCorp and Quest, etc. won't typically process a test without an authorized provider if the law requires one. Their systems are set up to comply state by state. So even if a rogue website tries to sell direct tests in a banned state, they'd struggle because lab processing and sample would check for a physician order on the requisition. Anna, I told you earlier we've contracted with two different laboratories. Neither one of them do any direct-to-consumer testing at all. Everything is done through physicians, and that's literally what we do at shamelesscare.com. I'll explain more about that later. But we have to have every physician on the team fill out paperwork. It's probably five or six pages long. sign it and there's over over two dozen doctors on the team so this is kind of an ongoing thing and as a new doctor comes on the team then they have to fill out the paperwork and the labs are extremely strict in all 50 states they just handle it the same way in all 50 states because they don't deal with direct-to-consumer stuff at all everything's done through physicians everything's got to be buttoned up or they're not proceeding forward at all and that's part of why i love the model of how shameless care works we're really just there to make sure patients are getting what they need we'll take it from a guy paying the bills. We're doing it in the most expensive way humanly possible. We cut no shortcuts much to my own harm, I suppose. All right, Anna, let's talk about key points for consumers and telehealth companies. Well, for consumers, whenever you use a home testing kit or online lab service, make sure that that lab is CLIA lab certified. That is your guarantee that your test is meeting federal quality standards. And that's a huge difference. That's like virtually everyone's happy, but no, really, it's close to half to people hate us. Yeah, that's bad. So I guess in theory, anybody could put CLIA certification on their website, but you can look up these certifications. And so we've had had people email us and say, I don't see shameless care in the CLIA, you know, certification, whatever. And it's because we contract with other labs. And right now we're using Nexus, N-E-X-U-S. And you're welcome to go look that up on the CLIA certified website. Another point that consumers should remember is that certain test results, especially for STIs, may trigger mandatory public health reporting. For example, if you test positive for chlamydia or gonorrhea, the lab is required by law to report it to state health departments or the CDC for surveillance. Right, and we're going to talk about that more in aftercare, but suffice it to say that there is a law in all 50 states, and we did a podcast on this. At this point, we've done a podcast on everything. A lot of people don't realize this, and it's a shame because there are some STI testing companies that do at-home testing, which I think is really like a misnomer. It's really self-collect. You're collecting the specimen and they're going to a lab. You're not really doing the testing at home. But they advertise their testing as being more discreet. It's not. I mean, if you stop and think about it, the people at the lab anyway know your name and your address and all of this stuff. If there's a physician involved, as I, my personal opinion, there ought to be, then that physician knows all of your information. It's no different than going to the doctor, really, other than you're doing it and you're drawing your own blood. Nobody's watching your blood come out of your arm, but that's the only difference, right? And then if you test positive for an STI, that, information, including your name, your race, your birthday, all of this information is going to go to the local county health department in the exact same way as it would have had you went to the doctor. Does that make sense, Anna? It does. So to me, it's not any more really discreet. And I don't know why lab tests self-themselves in that way. It doesn't make tremendous sense to me. I think sometimes it's how people feel that that really matters. And if doing the test at home makes them feel like it's more discreet, I guess that's what really matters. to everybody how it works at Shameless Care, because I said earlier that we do things kind of above and beyond. And even our latest lab partner was like, holy crap, you guys are going above and beyond. I think that was literally a direct, direct quote. They were like, this is the differentiator for you. And I was like, yeah, I know. But unfortunately, no one seems to care about me. But yes, if you order a lab test at shamelesscare.com, you immediately fill out a medical intake portal. So that's if you want to I don't know if a doctor is really involved or not that's part of it right if you click purchase on a test and it and it just ends it's like oh thank you your order will be shipped soon okay well then there's no medical information and obviously there's no doctor involved in that situation at all right but for us you click order and then we don't actually capture your payment we authorize your card and then you're presented with a medical intake form where you fill out all sorts of information about your medical history medications that you're on allergies are you on HIV antiviral medication. Have you ever tested positive for syphilis before? Like there's a lot of information that you really have to know to be able to test somebody properly. A physician then reviews that information and it may take 30 minutes. It may take 12 hours. It may take 24 hours. Our doctors have up to 24 hours to review that information, but nothing is odd of me. It's a real human being with real eyeballs, really looking at your information and deciding should we STI test this Now, the obvious question people have is, well, I want the damn thing. What difference does it make? Give it to me. Well, true. And in most cases, they are going to order it for you. But they just need to make sure that it's appropriate. For example, some people say they're already having symptoms. And that's not an appropriate at-home test. That's go straight to your doctor and get treatment today. Don't wait. Yeah, exactly. The at-home test is just as accurate. But by the time the kit even gets to your house, a couple of days are going to have gone by and in which case you could be exploding with symptoms and having some real health complications yeah it's much better to get prompt service if you are having symptoms absolutely and we're not going to make the sale just to just to make the sale if the patient is better off getting in-person care than by all means go to your local urgent care for heaven's sakes and get this taken care of immediately right correct but if the physician approves then the test is ordered and sent to the patient's house the patient collects the specimens themselves mails it back to the lab. The lab processes the specimens and sends the information to the... Guess, Anna? Guess who it goes to? It's to the doctor. That's right. So the doctor gets the test results. And, you know, most of the time the person has nothing. So there's really not much to do. If the patient tests positive, though, the doctor treats the patient if it's something appropriate for telemedicine. Okay, let's go ahead and talk about this. What isn't appropriate for telehealth, right? Well, obviously, if you have something like HIV, or something like that that's going to require management for the rest of your life, hopefully someday there's an outright cure. But for right now it's the rest of your life, then that's a pretty serious thing of which you need in-person care. Gonorrhea is another one where the CDC-preferred treatment is a intramuscular injection, which is really probably not appropriate for telehealth, I dare say. Our physicians will send the appropriate oral antibiotics if someone is like, I'm not going to the doctor, so you need to treat me, then they will do that. But in most cases, it's like, hey, you need to go to urgent care, take these test results, that sort of thing. But for most things, mycoplasma, you know, chlamydia, these sorts of easily cured infections, then the prescriptions are just sent automatically from the physician to the patient's pharmacy, something they filled out in the medical intake profile to begin with. There you go. We don't care what the state is. Everything that we do is through our physicians. And we're going to talk more about if direct-to-consumer is a good thing or a bad thing, the ups and downs, the left's right. in a few minutes, but for right now, that's kind of what we do at Shameless Care is we are a telehealth company, and everything that we do is through our physicians in all 50 states. No ifs, ands, or buts about it. We have no direct-to-consumer STI testing at all. That's pretty cool. Anna, are you ready for some aftercare? I am. It's time to wrap things up with aftercare, because thoughtful conversations deserve thoughtful endings. Well, Anna, it is a brave new world. It's pretty clear that direct-to-consumer STI testing is becoming legal in more and more states. It's already legal in, what did it say, 37 states? Yeah. I mean, it may be even more than that by now. Eventually, I dare say it's probably going to be all 50 states. Except for maybe New York. I don't know what's going on in New York. I really don't, but it's a difficult nut to crack, and I'm not really in the lab business directly, but it is an interesting topic all in of itself. But here's the ups and downs of direct-to-consumer STI testing. First and foremost, the thing that comes to mind is the mandatory reporting for STIs. Now, I think if you're someone who hasn't thought a lot about this, your immediate instinct might be, you know, it's my privacy, it's nobody's business but mine if I have an STI. But here's the counterpoint to that, everyone. These laws have been in place for about 100 years, and they're the reason why we have rock-solid statistics on sexually transmitted infections in a way that we don't other infections. We know almost exactly how many HIV cases there are. We know almost exactly how many syphilis cases there are, et cetera. We know if it's going up, if it's going down, what the demographics are. For example, I could tell you what demographic of female is most likely to have HIV in the United States. And I know that because of mandatory reporting laws. Yep. And so as more direct-to-consumer testing becomes available, how are we going to handle that? Because you can say, well, that's easy. The labs themselves will keep reporting. Well, I don't know who's enforcing that. I really don't. And then also, we're coming into this situation now where there's more and more instantaneous tests at home. For example, the FDA approved Oroquik, an at-home HIV detection device, which lets you know with fairly good accuracy if you have HIV or not within 15 minutes in the comfort of your own home. It's not going to a lab. You literally find out the results while you're sitting on the toilet or wherever you were when you did this. I don't know why I said toilet. But it's a thing that goes in your mouth. It's not a pregnancy test. But yeah, it is one of those things where that doesn't ever have to hit federal reporting agencies. If you do that at home, if you know that you're positive and hopefully you go to a doctor at that point and then things can be reported at that from there. But yeah, there's no necessary reporting. There's also telemedicine companies now that will treat you even without a test result. And I don't know exactly how it works, but I could name one. I won't name them on the podcast. And I'm not suggesting anything wrong with this. They advertise it proudly and loudly and proudly. So, you know, good for them. But I'm just sitting here going like, this doesn't make sense. This doesn't make sense to me when I hear about it. They're like, yeah, we'll treat you for gonorrhea. No test required. Well, how do you know you have gonorrhea then? Yeah. How do you know it's not chlamydia or any number of trichomonas or any, any number of other things? I'm not really sure about that. That's one of those things where it's kind of scary, where it could make more resistance in drugs out there. So we have a situation where you can get tested in the comfort of your own home, and you're essentially treating yourself, and the mandatory reporting is going to get muddier and muddier and less and less of a point, I dare say. Yeah. Well, I want to thank all of you for listening, and once again, the coupon code for the next seven days is PODCAST And that's 20% off STI testing, which includes the physician, of course, as I've talked about at least once in this podcast, right, Anna? Just a couple of times. And 20% off for the gift certificates. And because I'm an honest person, I'll remind you again, you're not supposed to use your FSA card or your HSA card for gift certificates, but the gift certificates have no expiration date. So if you want to save 20% now and kind of be insulated against rising prices in the future, well, there you go. Have anything else to add, Anna? No, I only think I messed up and said CLIA one time instead of CLIA, so that's pretty good. I'm going to ask my lab partner on Monday, and then you and I'll argue about it some more. Sounds good. Thanks for listening. If you enjoyed this episode, feel free to subscribe, leave a review, or share it with someone who might find it helpful. See you next time.