THE DEA And ACCESS TO TRT TELEMEDICINE

[Nelson Vergel]

Edit: after reading more carefully, the "30 day supply" option is the LIMIT. After a single 30 day supply, you will then have to see the provider in person or do the whole local provider/telemedicine thing above. The telemedicine provider can't just keep prescribing 30 day supplies.

@xqfq You are always so good at doing a better job at putting things in simple terms. You did the same with the FDA NASEM fiasco (which has not happened yet). I edited my original post using your words. Thank you.

 

[Nelson Vergel]

We are not the only ones concerned:

Oppose the DEA Rule Change | Death With Dignity

Tell the DEA you oppose their proposed rule change that would make it harder for terminally ill patients to receive end of life care.

deathwithdignity.org

 

[Nelson Vergel]

From a friend of mine:


Attention DEA:



I am a military veteran and patient who has been diagnosed with hypogonadism, depression, and PTSD by multiple doctors over 20 years. I have been under the care of a telemedicine provider who has been prescribing me testosterone replacement therapy for more than 10 years. I also receive care from a different specialist at the same telemedicine clinic and am prescribed other medications which sometimes include a Schedule V medication for anxiety. I travel often to different States for work and currently have a residence in two different States. Not only has telemedicine provided me with a convenient way to receive care that includes testosterone replacement therapy, but my telemedicine provider has offered me outstanding care and results. I was not able to find adequate care from any local provider, and without telemedicine, it would be difficult to find a specialist who can provide the care I need. My current telemedicine care team has literally saved my life, and they go with me wherever I go.



DEA's proposed rule update for the Ryan Haight Act will eliminate my ability to continue receiving care from my current provider and will harm many other patients like me who are receiving care through telemedicine. My current care includes a follow-up done by virtual or phone consultation, and blood work performed every 6 months. When I am in a location that does not allow for two-way video, I opt for a phone call with my provider. The phone call is sufficient to address my lab results, lifestyle management, and symptoms. I receive a 3-4 month supply of testosterone along with ancillary medications, shipped to my home from a pharmacy or sometimes filled at a retail pharmacy if they carry the dosage form I am prescribed, which often the local pharmacy doesn’t have the exact medication I need.



DEA's proposed RHA rules will require me to find a local physician to conduct a physical examination and referral to my telemedicine specialist. The requirement for a physical examination doesn't make sense clinically as my therapy is monitored through comprehensive lab work and consultations that are conveniently conducted by phone. Additionally, it will be difficult, or impossible, to find a local physician who is willing to provide a referral for a medical service they know nothing about. In fact, any primary care provider I have seen admits to knowing nothing about my testosterone replacement therapy and sometimes tries to steer me toward other treatments that have caused me significant side effects in the past (ie SSRIs, Benzodiazepines, etc). DEA expects the examining physician to be present during my telemedicine encounter, which is tremendously inconvenient and again challenging as few to no physicians would want to participate in this. When I do see a conventional provider for an exam or something else, rarely do they see more for longer than 3-5min and it's usually a nurse who conducts most of the examinations. I don't see how a local provider with an over-flowing waiting room and few resources, not to mention the low payment received for an examination, would have any interest in attending a telemedicine encounter with a patient who just needed an examination.



DEA should not require an in-person examination for a life-long hormone replacement therapy that is adequately managed through a telemedicine specialist. If DEA does want to require an in-person exam to qualify for telemedicine care, as they did pre-COVID, then a simple transfer of records and ID verification is all that should be required. The prosed rules will make it near impossible to qualify for telemedicine care.



DEA's proposed RHA rule update will only allow patients like me a 30-day supply of a medication that I am taking for the rest of my life. This means I will have to time my refill request every 3-4 weeks and hope that I receive it in time for my next administration, for the rest of my life if I want to receive telemedicine care. I administer my testosterone twice per week and missing a single dose results in suffering and side effects including depression, loss of sex drive, muscle pain, and fatigue. Limiting my testosterone to a 30-day supply also limits my options to a few, expensive and hard-to-find single-dose vials instead of the convenient and cost-effective 5mL or 10mL sizes that last me about three months. The 30-day rule will cause me to suffer and increase my treatment cost. DEA should allow for a 90-day minimum, and recognize the pharmacy controls currently in place that mitigate diversion.



DEA's proposed RHA rules will require me to use two-way video, which is unnecessary for my life-long, managed TRT care. I receive good care by talking to my provider by phone and through HIPAA-secured chat. In fact, my telemedicine provider is more engaging and accessible than any "in-person" conventional or VA provider. This creates a burden as I am often in locations that do not have two-way video technologies, or sometimes don't have an adequate internet connection. DEA should not require two-way video and allow the medical doctor to determine what methods they want to establish patient care and engage the patient, as long as its a HIPAA-compliant platform.



Lastly, I read in the proposed rules that the DEA believes that most patients receive telemedicine care from inside a hospital or medical facility. Most patients I know receive telemedicine care from wherever they are located, and in their own home. Testosterone and mental health care is best received in a private, comfortable, and convenient setting. The care I have received by my telemedicine team in the comfort of my home is far better than any treatment experience I’ve had with a physcian in a hospital or facilty.

 

[Arcane]

You mean the clinics where all you need is a credit card a pulse and an email address and you had unlimited access to some combination of things like Nandrolone, Oxandrolone, Stanozolol, Oxymetholone, HCG, GH, Peptides, from anywhere in the country without ever seeing a Dr. under the guise of "Hormone Replacement" are going to ruin legitimate TRT for everyone?

thats how it should be

 

[AdamF]

Everyone please post a comment, whether you use telemedicine or not. Us guys using offices like Defy need all the help we can get.

 

[SteveCleves]

thats how it should be

And while I agree with you and think that steroids should be declassified, and should be non classified prescription medications, they are not and we have to live with the rule structure we have today and that gives the DEA the power to control these medications and it was only a matter of time before they did.

I mean, the person who got the longest sentence in history for dealing steroids, Ryan Root, opened a TRT telemedicine clinic where he was “legally” selling the things he just got out of jail for selling. That’s basically sticking your tongue out at the DEA and saying “na na na you can’t catch me”.

I reread the proposed rules again and as has been stated here, this 100% ends telemedicine TRT/HRT as we know it.

Anyone and everyone who has any interest in this not happening and wants to keep some sort of telemedicine TRT needs to submit comments.

 

[SteveCleves]

Here’s the DEA summary of these rules to clearly illustrate what they think these rules accomplish.

https://www.dea.gov/sites/default/files/2023-02/Telemedicine%20Rules%20Summary.pdf

@Nelson Vergel idk if this is helpful to add to your extremely helpful summary.

 

[Arcane]

Everyone please post a comment, whether you use telemedicine or not. Us guys using offices like Defy need all the help we can get.

Genuine question:

How many times have the people/recipients won a battle with the DEA?

I feel like every time they try to impose a new regulation/rule they always win despite overwhelming pushback

 

[SteveCleves]

Genuine question:

How many times have the people/recipients won a battle with the DEA?

I feel like every time they try to impose a new regulation/rule they always win despite overwhelming pushback

They are mandated by congress to take public comments into consideration. They will take to some extent serious comments into consideration, they have to show at least a good faith effort that they considered commentary. But, the real impact to be honest is going to come from industry groups and special interest and lobbyists who will try to get some concessions to soften or change some of the proposed language. @Nelson Vergel I’m sure knows more about this but I’m guessing someone like Rick collins is working behind the scenes on this.

That being said, barring congressional intervention, something is going to happen and I think the best thing we can hope for is some sort of carve out for Testosterone. I expect everything beyond that to de facto be off limits from a telemedicine perspective.

Hopefully the transgender advocacy community is also working on this as they have a stake in this as well. I don’t know if I said it on here but I made the observation somewhere on the irony that it would likely be the trans community that would end up saving TRT in some way.

 

[BigTex]

welp. We had a good run, boys.
Soon they'll an TRT for men outright

Out of the 43 years I have use anabolic steroids I have been able to get a legal prescription for 11 of those years. 32 years of that, our concerned federal government forced people like me to go underground. Thanks to Mexico, Russia, Turkey, India and China I had no problem getting anything I wanted. With all the men using TRT now days, the UG will be a booming place. These online blood testing centers will be very popular. Forums like this will still exist and knowledge will be passed on.

The DEA has been nothing but a disaster since they were created in 1973. Since then over $1 trillion has been wasted, $41billion spent alone in 2022. Since 1971 when Nixon started the WAR ON DRUGS there are more drugs, more money, huge illegal fortunes being made, the violence has escalated and the bodies are piling up. More Americans die each year from illegal drugs than were killed in the entire Vietnam War. The cartels are directly responsible for these deaths. But by all means let's go out and bust those TRT using old men. Around 23 countries have no laws against the use of anabolic steroids.

 

[Arcane]

Out of the 43 years I have use anabolic steroids I have been able to get a legal prescription for 11 of those years. 32 years of that, our concerned federal government forced people like me to go underground. Thanks to Mexico, Russia, Turkey, India and China I had no problem getting anything I wanted. With all the men using TRT now days, the UG will be a booming place. These online blood testing centers will be very popular. Forums like this will still exist and knowledge will be passed on.

The DEA has been nothing but a disaster since they were created in 1973. Since then over $1 trillion has been wasted, $41billion spent alone in 2022. Since 1971 when Nixon started the WAR ON DRUGS there are more drugs, more money, huge illegal fortunes being made, the violence has escalated and the bodies are piling up. More Americans die each year from illegal drugs than were killed in the entire Vietnam War. The cartels are directly responsible for these deaths. But by all means let's go out and bust those TRT using old men. Around 23 countries have no laws against the use of anabolic steroids.

Might be harder to do that when we are forced onto a CBDC

 

[SteveCleves]

Just looked at the comments on some of the other major TRT communities, like t-nation and Reddit and it’s wild how many people seem to think these rules are not going to change anything.

 

[BigTex]

The UG is ALWAYS one step ahead of governments @Arcane.
.

 

[Blackhawk]

Might be harder to do that when we are forced onto a CBDC

What is a CBDC?

 

[BigTex]

What is a CBDC?

Central Bank Digital Currency (CBDC)

The Federal Reserve Board of Governors in Washington DC.

www.federalreserve.gov

The fear is with this is that the fed will be able to control exactly what we spend money on. Has something similar happend before. Well in 2001 my wife lost her entire life savings to the Argentine banking system when they froze all accounts and devalued the peso, then dolled out what they thought people needed to live on. There is a massive UG banking system going on to this day that uses the American dollar.

 

[Blackhawk]

Central Bank Digital Currency (CBDC)

The Federal Reserve Board of Governors in Washington DC.

www.federalreserve.gov

The fear is with this is that the fed will be able to control exactly what we spend money on. Has something similar happend before. Well in 2001 my wife lost her entire life savings to the Argentine banking system when they froze all accounts and devalued the peso, then dolled out what they thought people needed to live on. There is a massive UG banking system going on to this day that uses the American dollar.

Oh for cripes sake!

I so love Dr Saya, been with him for 6 years and depend on his expertise. Mine has not been a simple case.

But time to look into a local promising lead. 2 hours away, but if having a local provider side steps the BS, so be it. I don't think the DEA can prevent us from doing the "consultation" without prescription appointments with Defy.

 

[Nelson Vergel]

Here’s the DEA summary of these rules to clearly illustrate what they think these rules accomplish.

https://www.dea.gov/sites/default/files/2023-02/Telemedicine%20Rules%20Summary.pdf

@Nelson Vergel idk if this is helpful to add to your extremely helpful summary.

Thanks @SteveCleves . You are knowleadable guy!
I am happy that after 13 years, we now have a bunch of super smart men on this site. I learn from you guys daily. It makes all my work keeping this site up and maintained well worth it! Thanks for helping me with this effort.

 

[Arcane]

Not to get political, but I think the US is well on its way to the same route

Central Bank Digital Currency (CBDC)

The Federal Reserve Board of Governors in Washington DC.

www.federalreserve.gov

The fear is with this is that the fed will be able to control exactly what we spend money on. Has something similar happend before. Well in 2001 my wife lost her entire life savings to the Argentine banking system when they froze all accounts and devalued the peso, then dolled out what they thought people needed to live on. There is a massive UG banking system going on to this day that uses the American dollar.

 

[SteveCleves]

Thanks @SteveCleves . You are knowleadable guy!
I am happy that after 13 years, we now have a bunch of super smart men on this site. I learn from you guys daily. It makes all my work keeping this site up and maintained well worth it! Thanks for helping me with this effort.

Thanks @Nelson Vergel , I just have a fair amount of experience dealing with these types of federal rules and how they get adopted at this sort of sub agency level. Process, feedback, etc. working with industry groups, lobbyists, public commentary etc.

And I 100% agree about this site. It is BY FAR the best site for this information on the web. The rest of them are literal clown shows compared to this one. This forum is like taking a graduate level class in men’s hormones.


Do you know Rick Collins? Would love to hear his take on how he thinks this affects the industry, I would consider his take to be the definitive one, there’s really no one out there that understands the legalities of anabolics as well as he does.

 

[Psychedelic Anabolism]

Genuine question:

How many times have the people/recipients won a battle with the DEA?

I feel like every time they try to impose a new regulation/rule they always win despite overwhelming pushback

Believe it or not, commenting works if enough people speak up. In 2016, the DEA was dead set on scheduling an over-the-counter herbal product called Kratom. Kratom has been used for years by consumers for things like opioid withdrawal symptom management, as an alternative therapy for pain management, and for anxiety+pain+depression. These are mostly people who do not want to take SSRIs, opioids or benzodiazepines for their condition. While both the DEA (aligned with FDA) was planning to make it a Schedule I substance, essentially making all forms immediately illegal, they did open a commenting period. Over 22,000 comments were received and the DEA backed down and withdrew its plan. Kratom is still available OTC.

Now, for the conspiracy part. The FDA Director at the time stepped down shortly after this and was part of a pharmaceutical company's advisory board that was attempting to bring a synthetic analog of the primary component in kratom (mitragyna speciosa) to the market as a new, better option for pain management. Is anyone surprised?

Commenting works, at least with the DEA. Dont be afraid to let them hear you. We all know that these restrictions do nothing to mitigate any diversion or abuse, as its easier to order illicit drugs online from 1000s of websites than it is to obtain abusable levels of controlled substances through telemedicine.

There are two sides to the DEA- criminal and diversion. The diversion side is responsible for these rule proposals and honestly, that entire side of the agency lives off gaslighting taxpayers into thinking they are actually doing anything positive for society. Instead, they create a matrix of unsustainable regulations to drive fine revenue from clinics and pharmacies. If people want to defund any LE in the US, we could literally defund 2/3rds of the DEA and there will be no negative consequence in our society

DEA delays decision on kratom ban after public backlash

Bowing to public pressure, the U.S. Drug Enforcement Administration (DEA) said on Thursday it had delayed a decision on whether to classify the botanical substance kratom, which is available online in the United States as a dietary supplement, as a dangerous drug with no medicinal use.

www.reuters.com