Is TRT Covered By Insurance?

Foreign. Talk about testosterone replacement therapy for men. And some things that led up to where we're at now with the fda, big pharma and doctor and patients decisions. So testosterone replacement therapy was approved in the 40s for men with low testosterone due to disorders of the testicles, brain injury, extra female chromosome or chemotherapy. First approved in 1943 for pellets, then in the 50s for injectables, and then in 2000 for a topical gel. And. And testosterone prescriptions really went on the rise between 2000 and 2013 when doctors were being really detailed by drug reps that this testosterone replacement for low T could be beneficial for men. Both quality of life, wellbeing, weight, sexuality, energy. And there's studies showing that, that it led to potentially better longevity. Prescriptions increased by 3 to 600% over, over a 10 year period, 10 or 13 year period. And then the FDA got involved and pretty much put a nail in the coffin in testosterone replacement and the relationship between a doctor, their patient for testosterone replacement therapy. So let's go over some basics. Testosterone replacement therapy is indicated in men based on either the FDA indication or insurance companies indications. Let's talk about the FDA indication. The FDA indication for testosterone replacement therapy is for men with low testosterone. That's defined by a level generally less than 280 nanograms per deciliter. That's a blood test that's actually severely low, but it's indicated for those men that have either disordered the testicles or brain, extra female chromosomes, in some case chemotherapy. But not for the indication of low testosterone due to aging. Aging is not considered a disease by the FDA and it's not considered disease by insurance companies. Blue Cross in Michigan, I'm based primarily in Michigan and their policy is testosterone is indicated when the level is below 280, drawn two mornings below 10 before 10:30 in the morning. For men under 50 and men over 50 below 200, that's actually severely low. And they must have symptoms such as poor development of the genitalia like underdeveloped penis or testicles, gynecomastia, which is breast enlargement, night flashes and hot sweats, which men rarely get, and loss of bone mass and shortened height. They lose height and secondary female characteristics such as loss of body hair. So this is really, they're saying basically we'll pay for it if they have, you know, severe low testosterone due to a medical condition that we recognize, but not for low testosterone associated with aging. Now that doesn't mean that you and your doctor cannot use testosterone replacement therapy for Age related testosterone decline. It just means that the insurance companies generally will not cover it. Okay, so. But doesn't mean it can't be done. The FDA regulates manufacturing and marketing manufactured products and testosterone has been manufactured for about 80 years. So let's look at what happened. 2000 AndroGel came out and the Androgel started promoting low, low T. They had low T commercials for men, low testosterone. And prescriptions went up because doctors became aware of low testosterone in aging men and they started writing prescription for men with low testosterone. They were having symptoms of low testosterone, which could be decreased energy and gaining fat, decreased stamina, decreased sexuality, decreased energy and decreased mood. And the drugs appeared safe. That we had numerous studies shown as cardiac protective and protective in most ways, helps reduce the chance of diabetes. But prescriptions went up and that brought the attention both insurance companies and the government to say, well, hey man, here we're paying for this stuff. Is this really an issue? So in 2013, the FDA came out and said, well, testosterone may cause heart attacks and strokes. Interesting. May cause heart attacks and strokes. They based that on an article in the New England Journal of Medicine, I'm sorry, the Journal of American Medical association, that was since retracted, that showed that testosterone caused more heart attacks and strokes in men. When in fact it was erroneously published. It was redacted. And there's been over 100 peer reviewed clinical trials showing just the opposite. The American Clinical Society of Endocrinologists came out with a position paper against that, stating that not only should doctors prescribe this for age related testosterone depletion, but also no evidence showing that it causes cardiac harm. The VA did a study and published in 2016 that showed that men who had low testosterone, these were men in their 60s, 83,000 men followed for about six years, up to 14 years that had low testosterone if they were treated. They were half as likely to be dead in the next several years if they were treated than those who were not treated. In fact, it's estimated that if you have low testosterone and you replace testosterone, you get about 10% longer lifespan and health span. But lifespan is not a medical indication. Again, the FDA does not recognize aging as a disease. And drug companies, I'm sorry, and insurance companies are not designed to make you live longer. They're supposed to pay for diseases when they occur. And again, aging is not considered a disease. So what's going on here? Well, we have to look at the history of testosterone replacement. So again, in the 40s is approved as a pellet, 50s is approved as an injectable right about the 60s, there are certain laws put in place that drugs had to not only be effective, but also be safe. And to pass the mustard, certainly safe. And for years we found that men that had low testosterone were better off being treated than not being treated. But doctors were pretty much not really tuned into this. They figured, well, I mean, aging is this normal process. Testosterone gets low as we age and therefore we shouldn't treat it well again. In 2000, the drug AndroGel came out. This is a topical form of testosterone. Not a fan of topicals, but it's one of the forms that's approved and something that you smear in your body. It brings the testosterone level up effectively and it was easy for doctors to prescribe it. Doctors typically like to prescribe non generic drugs. That's their nature because they get detailed by drug reps that bring donuts in their office and show them the new data. They go to seminars based on new drugs versus a drug that's been around 50 years. Doctors kind of forget about it. And it's not any standard of care to treat men with low testosterone due to aging because the FDA never proved it for that. So we have to think about a contemporaneous approach. Now there's been a, there's been studies looking at what's the incidence of low testosterone in men. We don't have any really good studies that just clearly state randomizing. Looking at men with, with, with no symptoms at all or with symptoms. What percentage have low testosterone? Have a large study with about 10,000 people. Then the Chicago area, about 10,000 men, 18 to 85, 36% of the men had low testosterone. Now they were maybe biased in their selection because they got a testosterone blood test done. But these weren't necessarily men that were looking to have their testosterone check. So somewhere around 30% might be the correct number. And of that, the ones that had low testosterone, the average level was very, very low, 194. Only 17% were treated with testosterone replacement therapy. Of those with known low testosterone, known low testosterone leads to more obesity. Decreased muscle mass, decreased bone mar mass, decreased libido, more urogen genital symptoms, more cardiovascular disease, more cardiovascular deaths, about double and more premature death or less longevity. Yet it's something we don't routinely check for and treat. Looking at the data in 2000-2013, that's the best numbers we have because that was leading up to the time that the FDA kind of intervened to try to get doctors not to prescribe testosterone. So often the number of men that had testosterone Replacement as a prescription was a half a percent. About 1 out of 200 men went to about 3% in 2013. And then when the FDA came out and said, hey, we think this causes heart disease, it actually got back down to 1%. It's been stable since that time. And this whole thing about testosterone called cardiovascular disease was actually a myth. It was not correct. When the papers was published, the FDA immediately jumped on and used as a reason to do what's called a black box on the, on the labeling doesn't prevent your doctor prescribing it. But they're aware that the FDA says this might cause heart disease. And when that study was retracted, the FDA didn't change their stance on it. They generally do not reverse regulation. That's just a nature of the executive branch of government. When they make regulation, unless there's a presidential order or judicial order, they stay, you know, for a long time, regardless of the outcome to people. So testosterone replacement therapy, the additional issue is for insurance. A lot of times they get question for men, why won't my insurance cover this? Well, they will under certain circumstances. So first off, I'll use Blue Cross in Michigan because that's a big one. In our, in our practice, there has to be two levels done before 10:30 in the morning. It's got to be extremely low. Less than 280 for men that are less than 50, less than 191, less than 200 men that are over 50, which is extremely low. If it's that low, you already have high diabetes and are usually obese at that time. And then this guy got to. They've got to have symptoms such as breast tenderness and gynecomastia, loss of height, loss of hair, underdeveloped genitalia, and hot flash and night sweats, which generally those. There's men that have that they have a clear endocrine problem. They should be worked up from that. They might have a tumor in their brain. They might have an extra chromosome, extra female chromosome. They might have a testicular injury. So that's a small group of men that definitely need to be worked up and treated. But there's a whole large group of men that don't have those symptoms and don't have such severely low testosterone. And today, 99% of them aren't being treated, maybe higher percentage than that. So this is a big say, disservice to men in our country for, for a drug that's pretty cheap, that you could pay for on your own, that your doctor can prescribe, that reduces cardiac Mortality substantially may extend your life. About 10% in men with low testosterone. So I think this is something we really need to realize that as physicians we're under diagnosing testosterone, low testosterone, because there's the assumption that the insurance company doesn't pay. In other words, if it's not free, men can't have it, can get stuff that's not covered by insurance. Your doctor is totally allowed to prescribe it in the right setting. It is a controlled substance. So it's gotta be under a doctor's guidance or provider's guidance. So can't just be taken without a prescription. The in the guidelines for what, what level of testosterone determines which men will benefit are quite vague. So we look at studies comparing different specialists. Doctors have the most expertise in hormone replacement would be endocrinologists. This is a residency that doctors undertake to specialize in hormone replacement therapy. And they generally go by symptom rather than men by an absolute level. In fact, a large study showed that the most likely men that had testosterone levels that were considered normal, that got replacement were by endocrinologists because they had symptoms of low testosterone, even though their testosterone levels were in this so called normal range. Because we know that normal range is not really helpful. It just means that that's where 99% of men fall. Additionally, the North Mayo Clinic Proceedings published international consensus guidelines for treatment of low testosterone in men with symptoms of low testosterone. And one of their position statements was there's no blood test that accurately predicts which will benefit from testosterone replacement therapy. So if you have symptoms of low t, we've talked about this before, the symptoms. One of the only ways you can tell if testosterone replacement is going to work is to try a testosterone replacement, assess your symptoms. And a good example would be high blood pressure. So somebody has borderline high blood pressure and they're starting to get some hardening of the arteries and some things that might be associated with high blood pressure, we diagnose it with a blood pressure cuff and we give a medication. And what do we measure? Do we measure the medication in the blood? No, we measure the blood pressure. Okay, so measuring the testosterone level to determine efficacy is probably a fool's game. There's not any level that predicts who will respond. And we don't really know what the ideal level of testosterone for men is. Now we could have taken everybody's testosterone level when they're 20, when they're the healthiest, when it peaks, is about 20 years old and say that's probably where it should be. Well, that would even be a false sense of security. Because when you take exogenous testosterone, in other words, testosterone from the outside, a shot or cream or pellet, your body makes something called sex hormone binding globulin, which is like a little sponge that binds up this testosterone that sees as outsider. So maybe that you're. Your pharmacologic blood level needs to be a little higher than the physiologic blood level, which we see commonly for both men and women. Additionally, when insurance does play for testosterone, they don't pay for enough testosterone replacement to get you to a therapeutic level. They pay for enough testosterone replacement to get you to a level where you're no longer severely hypogonadol or severely low testosterone. For example, Blue cross in Michigan will pay for 50 milligrams of injectable testosterone every two weeks. Now, the standard dosing in North America that we see is 200 milligrams every week or 100 milligrams twice a week. So 200 milligrams a week, say on average. And the Blue Cross says, well, we'll pay for 25 milligrams a week. But you give it 50 milligrams every other week, which is just too low of a dose. But it will get your level from 190 to say, 260 or 70 or 80. So that's, that's kind of their stance on it. It just gets you barely there. And we know that's not going to make a man feel better. So I think I accept the fact that everything that is related to your health is not going to be free. You know, you may have to pay for, you know, a gym membership. You might have to pay for, you know, a sauna. If you're trying to do some longevity stuff with sauna, you might to pay for healthy foods. You might have to pay for, you know, meditation classes or yoga, and you might pay for some of your medications. We see this with some of the weight loss drugs, which are very effective. Insurance companies don't see obesity as a medical disease. They might pay for them. And low testosterone due to aging is not considered medically necessary. But the benefits are fairly clear, at least in my opinion. I've written a book on this, and the book is called if your testosterone is low, you're going to get fat. This and 17 other things the FDA does not want you to know about testosterone. I published that, I believe, in 2017. This is basically a review of the medical literature supporting treating testosterone that is low, at least low symptomatically with Testosterone replacement therapy, even if it's low due to aging. Now again, there's causes of low testosterone that require a more thorough medical investigation. Extra female chromosome damage to the brain, damaged testicles and chemotherapy. But I'm talking about the fact that testosterone declines as we age some men faster than others. And if you are the man that has lower testosterone, you don't treat it. Your likelihood of long survival does diminish, your likelihood of heart attacks and cardiovascular disease, strokes and heart attacks goes up. So in summary, low testosterone can be treated. The FDA does not authorize the use of testosterone or low testosterone to age. But the FDA regulates manufacturing of drugs. It does not regulate the practice of medicine in any way, shape or form. This is called off label prescribing. It's quite common. So something where something's a drug's FDA approved for one thing, it could be used for another thing. And doctors are expected to use evidence based medicine, which in one case might be the society of clinical endocrinologists. They have some statements on this and they don't agree with the FDA stance that it should not be used for aging related testosterone deficiency. So we can say that's probably a good rule of thumb. There's certain numerous medical societies that have come out against the FDA's position on testosterone indications and the fact that might cause heart heart disease, which it doesn't. But the FDA does not dictate what you should do with your life. It doesn't dictate if you should take control of your health. And it doesn't get between you and your doctor, your provider. It does get between you and the manufacturer and the manufacturing, your doctor or your provider in that between you and your medical provider. So thank you very much.