THE DEA And ACCESS TO TRT TELEMEDICINE

[Arcane]

 

[SteveCleves]

This is nothing more than wishful/hopeful thinking. My prediction is that we get a carve out for Testosterone that allows it to continue to be prescribed as it is today. If you allow test you take away the transgender issue and you negate the mainstream TRT/HRT pushback. There are pretty sound straight faced arguments you can make for both of those situation.

I would be very surprised if the winstrol/anavar/deca/anadrol on demand model will be allowed to continue as is.

 

[Psychedelic Anabolism]

Attached is the latest comment being submitted by an industry representative for testosterone via a surrogate author. 40+ pages and will be signed by multiple stakeholders. We expect many other trade orgs like the ATA will be submitting lengthy comments. Lots of push brewing within the psychiatric space, veteran providers, HRT, trans, pharmacy, and conventional primary care telehealth markets.

 

[Psychedelic Anabolism]

This is nothing more than wishful/hopeful thinking. My prediction is that we get a carve out for Testosterone that allows it to continue to be prescribed as it is today. If you allow test you take away the transgender issue and you negate the mainstream TRT/HRT pushback. There are pretty sound straight faced arguments you can make for both of those situation.

I would be very surprised if the winstrol/anavar/deca/anadrol on demand model will be allowed to continue as is.

Believe it or not, the DEA does not separate anabolic/androgenic hormones. They are all Schedule III hormones to the DEA, they are not treated any differently from a regulatory standpoint. There are many physicians of different specialties prescribing things like nandrolone and oxandrolone for metabolic disease, joint pain, body composition, ED, etc. Even OBs are prescribing topical androgens like stanazolol for vaginal pain and FSD. The use of anabolics is progressing in even the most traditional settings (I get my nandrolone from a urologist at Baylor who believes its helpful to aging men with joint pain and of course it helps optimize body composition, which itself adds years to your life).

 

[Arcane]

. If you allow test you take away the transgender issue and you negate the mainstream TRT/HRT pushback. There are pretty sound straight faced arguments you can make for both of those situation.

I wouldnt be surprised if they were the exception for this rule

 

[Blackhawk]

I just received Defy's notification. I don't think it communicates the true nature of this issue. I find it softly worded and too encouraging of outcome from the proposed changes.

I doubt many will take the effort to respond as needed based on that email. I am disappointed and a bit surprised.

 

[SteveCleves]

Attached is the latest comment being submitted by an industry representative. 22 pages and will be signed by multiple stakeholders

Anthony Roberts??? The roidstore.com and steroid.com guy?? Lol. Industry representative? Lol. Jesus if he’s the guy we’re hitching our ride to we’re doomed. That being said it’s a pretty good response.

 

[Psychedelic Anabolism]

I just received Defy's notification. I don't think it communicates the true nature of this issue. I doubt many will take the effort to respond as needed.

I just received an email from Defy, if you click on the buttons its pretty clear with access directly to the docket. Im sure they will appreciate any feedback as most are sending multiple emails until the cut-off

 

[HealthMan]

@Nelson Vergel submitted my comments. Thanks again for letting us know

 

[Blackhawk]

I just received an email from Defy, if you click on the buttons its pretty clear with access directly to the docket. Im sure they will appreciate any feedback as most are sending multiple emails until the cut-off

Yes, I just think it unlikely to attract enough patients to take the effort. The opening blurb:

"The DEA has proposed new rules to update the Ryan Haight Act, which could negatively affect telemedicine prescribing of non-narcotic medications in Schedules III, IV, and V. Testosterone is considered a Schedule III medication.

These rules would require in-person evaluations (physical exams), stricter record-keeping, increased coordination between physicians, and more frequent smaller refills. If approved, the update would go into effect after the current DEA waiver of the in-person exam requirement expires on May 11, 2023.

This could create unnecessary burdens for both patients and doctors, leading to limited access to treatment and increased risk of harm to patients. "

Then at the end:

"Your Defy Medical team is continuing to monitor industry changes, and we are prepared to adapt to any regulatory updates. We will communicate clearly with patients as this situation evolves."

OK then sounds like no big deal, they have me covered.

People are lazy. All of this is stated in a mild mannered tone. I am surprised there is not a bit more urgency or intensity in how they presented this.

The suggested response comment is also mild and includes very little rebuttal substance.

 

[Psychedelic Anabolism]

Anthony Roberts??? The roidstore.com and steroid.com guy?? Lol. Jesus if he’s the guy we’re hitching our ride to we’re doomed. That being said it’s a pretty good response.

I don't know Anthony from either of those businesses, but I know Anthony the JD who is contracted across the industry as a medical-legal researcher who has contributed to successful commenting campaigns in the past. He is a contributing writer to this effort and is on Chris Bell's team as a researcher as they create the next documentary. We need to support all contributors to this effort. Even the most competitive of clinics are working together on this important issue.

 

[Psychedelic Anabolism]

Yes, I just think it unlikely to attract enough patients to take the effort. The opening blurb:

"The DEA has proposed new rules to update the Ryan Haight Act, which could negatively affect telemedicine prescribing of non-narcotic medications in Schedules III, IV, and V. Testosterone is considered a Schedule III medication.

These rules would require in-person evaluations (physical exams), stricter record-keeping, increased coordination between physicians, and more frequent smaller refills. If approved, the update would go into effect after the current DEA waiver of the in-person exam requirement expires on May 11, 2023.

This could create unnecessary burdens for both patients and doctors, leading to limited access to treatment and increased risk of harm to patients. "

Then at the end:

"Your Defy Medical team is continuing to monitor industry changes, and we are prepared to adapt to any regulatory updates. We will communicate clearly with patients as this situation evolves."

OK then sounds like no big deal, they have me covered.

People are lazy. All of this is stated in a mild mannered tone. I am surprised there is not a bit more urgency or intensity in how they presented this.

The suggested response comment is also mild and includes very little rebuttal substance.

it might be good to respond to them as I know they are fielding calls from patients already. There is more communication scheduled so any feedback from recipients might be appreciated. Our group is supporting multiple clinics as they build their campaigns, all of your feedback on this forum is helpful as I have been sharing this thread link.

 

[Graham]

So other Doctors with regular practices and pharmaceutical companies decided to suppress the competition…

 

[Psychedelic Anabolism]

So other Doctors with regular practices and pharmaceutical companies decided to suppress the competition…

I wish I could say this is a conspiracy like that, but its really a handful of siloed dea attorneys on the diversion side creating rules without any understanding of how clinics operate and how patients really use telehealth. It's government waste at its finest. The DEA dosnt even understand its own Scheduling and how the medications are used in clinical settings.

Even pharma supports telehealth as it brings more of their products to a larger patient base at scale. I can confirm there is at least some pharma money in this effort against the DEA rule update

 

[Arcane]

As far as im concerned its over.

 

[Phil Goodman]

I think people are misunderstanding the proposed changes, though yes I do think they are unnecessary and yet another example of how the goal isn’t really patient care and access to treatment…but rather pushing agendas for certain entities.


That being said, as I read it, they won’t require 30 day refills constantly. That is just to give people time to be seen in-person without missing a treatment. Once you have been seen in person you can continue to receive prescriptions as you have all along. And if you can’t be seen in-person then it will count as an in-person visit if the person doing the physical exam is licensed by the DEA and there is audio/video communication between all three parties during the exam. Once that is done then you are considered an “in-person” patient and can receive treatment the same as you have been receiving as a telehealth patient. And record-keeping will get more strict. At least that’s my understanding, but if someone can point out how I’m mis-interpreting it please do so. I’m also not clear on whether both doctors have to agree to the treatment or if one is just there for the purpose of doing the in-person exam. If those are the only issues it will present an added headache for sure but isn’t the end of the world. Or hell I may just drive to FL every two years for an in-person visit and keep going with my treatment(assuming they keep the 24 month maximum in place). But again that’s just my current understanding. And all that said, I certainly plan to submit a comment because it’s sad how eager they are to restrict access to treatment in this country. And it’s only going to get worse because we are heading for a major doctor shortage in the next 10-15 years. We should be doing everything we can to get ahead of that problem and making healthcare EASIER to access, and these assholes are driving us in the wrong direction!

 

[Trip McNeely]

The government can suck my cock.

 

[Phil Goodman]

After diving in it looks like my assessment is correct, and it looks like anyone lucky enough to have established the telehealth relationship during the Covid pandemic emergency is going to be grandfathered in anyway and exempt from the requirements being proposed to move from being a telehealth patient to an in-person patient.



If the practitioner otherwise completes their review of the PDMP system pursuant to paragraph (e)(2)(ii), or is otherwise able to comply with all relevant requirements in paragraph (e)(1), proposed paragraph (e)(3) would authorize practitioners to prescribe “no more than a 30-day supply across all such prescriptions” until the practitioner has conducted the required medical evaluation. Put another way, this provision would allow the doctor to provide up to a thirty-day supply in any combination of prescriptions and prohibits the doctor from going beyond that until the medical evaluation is conducted. This supply may include dosages that are titrated up or down depending on the patient's response to the medication and the practitioner's medical judgment, however, it may not exceed a supply sufficient to treat the patient for more than 30 days.

If the prescribing practitioner does not conduct a medical evaluation as described in proposed paragraphs (d)(1) or (d)(2) within a period of 30 calendar days, the practitioner would not be authorized to issue any subsequent prescriptions to that patient under proposed paragraph (f). This requirement would not apply to a practitioner who has a telemedicine relationship established during the COVID-19 public health emergency with the patient, as defined in § 1300.04(g), or to a practitioner employed by the Department of Veterans Affairs when prescribing to a patient of the Department of Veterans Affairs health system.

 

[Vin]

please pass this on to others to post your comments with the concerns that will impact on many of us.. if we can get some people with big followers to get this message out that would help as well., Joe Rogan might be interested in at least bringing up this topic and would get the word out as he doesn’t seem to agree with over reached control and this is definitely a controlling motion. Everyone Please comment

 

[Vin]

Where do we submit comments? Is there some kind of petition? What can actually be done about this?

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