THE DEA And ACCESS TO TRT TELEMEDICINE

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It only took 22000 comments and a few congresspeople to stop the DEA from scheduling kratom, and that was with 60 days to comment. We are up to -15k comments and at least 6 congresspeople and two senators with one week left to comment and a far stronger case than with kratom. If the DEA ignores this it will discredit them with the public, and they cannot afford anymore distrust
Hopefully. One problem is that opioids are the big issue here. And unfortunately testosterone as a scheduled drug falls into the same basket for regulation purposes. Maybe applying different rules for different schedules drugs or removing some from this altogether
 
Defy Medical TRT clinic doctor
Canada is already super regulated and controlled. There are many cash based therapies (and lab tests) we access in the US that Canadians don’t have access to. I don’t think this will make access in Canada any more difficult than it is.
Thanks Nelson. We have now a couple of private companies that operate in canada. Easier access to treatment. I think we still decades behind though.
 
Chris Bell got them to give up on kratom with one text to Rogan. Since Rogan’s big on TRT and has gotten many people on it, I imagine half the people he knows have been texting him and he’ll shut all this down within a week. He’ll probably get Chris Bell and Derek and some others on all at once. They’d probably be willing to helicopter in if that’s what it took.
 
Hopefully. One problem is that opioids are the big issue here. And unfortunately testosterone as a scheduled drug falls into the same basket for regulation purposes. Maybe applying different rules for different schedules drugs or removing some from this altogether
We are now up to 14,000 comments in just a few days. The Kratom ban proposal had 23,000 comments with two months of time to comment. The telemedicine ban proposal has a total of less than one month to comment, so we are already ahead.

I think we can beat this if we keep spreading the word.
We only have 6 days until the deadline, mind you
 
I think they
Hey Nelson, I hope you are well.

Quick question, do you think this will have repercussions in Canada? Every time something happens in the US shortly after there is the cheap Canadian version. Have you heard anything? Gracias
The recent Androgen Society conference discussed Canada's new requirement for men on TRT to receive two digital rectal exams (DRE) per year, along with the other requirements, to qualify for TRT coverage. No provider agrees its necessary but they do agree it tempers the rising prescriptions of T which increases social healthcare costs for the CA system. Hopefully there are cash pay and telemedicine options for men in CA too. As one Doctor stated, "would you prefer two fingers or one?"
 
The recent Androgen Society conference discussed Canada's new requirement for men on TRT to receive two digital rectal exams (DRE) per year, along with the other requirements, to qualify for TRT coverage. No provider agrees its necessary but they do agree it tempers the rising prescriptions of T which increases social healthcare costs for the CA system. Hopefully there are cash pay and telemedicine options for men in CA too. As one Doctor stated, "would you prefer two fingers or one?"

Before starting TTh the DRE is only done at baseline and 12 months then it's once yearly!

Most in the know monitor symptom evaluation, blood work (TT, FT, SHBG, estradiol, PSA), and CBC which includes important blood markers such as (RBCs, hemoglobin, and hematocrit) every 6 months.

Baseline, 3, 6, and 12-month mark for the first year, and then the standard protocol for most would be twice-yearly.



21:30-21:41

*continued monitoring on treatment typically recommend a 3-month visit, a 6-month visit and then it can be yearly after that once the patient is on a stable regimen of testosterone replacement therapy






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I gave context to the situation and had chat GPT write an incredibly thought-provoking and long statement which I used. It worded everythign beautifully and thought of points Ihad never considered.
 
Defy Medical has a lengthy page up, which begins with this:

Executive Summary of Proposed Changes​

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.​

These rules would require in-person evaluations, stricter record-keeping, increased coordination between physicians, and more frequent smaller refills. This could create unnecessary burdens for both patients and doctors, leading to limited access to treatment and increased risk of harm to patients.

Doctors would face challenges like increased administrative tasks, technology requirements, limited prescription options, and reduced flexibility. Patients would be affected by the need for travel time for more in-person visits, frequent refill requests, restricted medication options, and higher costs.

The rules have not yet taken effect, and there’s still time to petition the DEA to reconsider. Public comments can influence the outcome, so sharing your thoughts on the matter is crucial. Proposed solutions include allowing a 90-day supply of medication without extra requirements, easing restrictions on examining physicians, and offering more flexibility in communication between doctors and patients.


You can submit a public comment to the DEA now through March 31.​

  • The proposed rules have not officially taken effect, and there’s still time to petition the DEA to reconsider.
  • The DEA has, in the past, reversed proposed rules after receiving feedback from doctors and patients.
  • Publicly posted comments play a major role in shaping how rules are adopted. Because the DEA considers all comments before the rule is adopted, now is your opportunity to influence change.

Sample Public Comment​

“I am a patient currently benefiting from telemedicine care for my hypogonadism. This treatment has made a dramatic effect in improving my quality of life and vitality. The proposed updated DEA rules on the Ryan Haight Act will create a new burden for me of travel time to see my doctor and to manage my more limited and frequent medication refills. This time requirement will decrease the time I am required to perform my job and family duties. I am happy with my current care and see no benefit in imposing these new rules on taxpayers like me.”

[And much more...]
 
Defy Medical has a lengthy page up, which begins with this:

Executive Summary of Proposed Changes​

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.​

These rules would require in-person evaluations, stricter record-keeping, increased coordination between physicians, and more frequent smaller refills. This could create unnecessary burdens for both patients and doctors, leading to limited access to treatment and increased risk of harm to patients.

Doctors would face challenges like increased administrative tasks, technology requirements, limited prescription options, and reduced flexibility. Patients would be affected by the need for travel time for more in-person visits, frequent refill requests, restricted medication options, and higher costs.

The rules have not yet taken effect, and there’s still time to petition the DEA to reconsider. Public comments can influence the outcome, so sharing your thoughts on the matter is crucial. Proposed solutions include allowing a 90-day supply of medication without extra requirements, easing restrictions on examining physicians, and offering more flexibility in communication between doctors and patients.


You can submit a public comment to the DEA now through March 31.​

  • The proposed rules have not officially taken effect, and there’s still time to petition the DEA to reconsider.
  • The DEA has, in the past, reversed proposed rules after receiving feedback from doctors and patients.
  • Publicly posted comments play a major role in shaping how rules are adopted. Because the DEA considers all comments before the rule is adopted, now is your opportunity to influence change.

Sample Public Comment​

“I am a patient currently benefiting from telemedicine care for my hypogonadism. This treatment has made a dramatic effect in improving my quality of life and vitality. The proposed updated DEA rules on the Ryan Haight Act will create a new burden for me of travel time to see my doctor and to manage my more limited and frequent medication refills. This time requirement will decrease the time I am required to perform my job and family duties. I am happy with my current care and see no benefit in imposing these new rules on taxpayers like me.”

[And much more...]
16894 comments as of this morning 3/27/2023
Any idea on when we should expect to know if this is passing or not?
 
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I just submitted my comment. While I am hopeful this will be stopped, the idea that they are even considering it is one more clear indication that we are going to need to build a new health-care model outside of the current system, since the current system is largely a gatekeeper to keep people in bad health.
 
Hopefully. One problem is that opioids are the big issue here. And unfortunately testosterone as a scheduled drug falls into the same basket for regulation purposes. Maybe applying different rules for different schedules drugs or removing some from this altogether
Opioids fall under Schedule II which is already carved out, these proposed rules only target Schedule III to V which includes non-narcotic medications like testosterone and other medications used in mental health and wellness. And there is already regulatory framework in place at the State and Federal level that mitigates diversion, which is the DEA's primary goal here. If you understood what is already in place including Prescription Monitoring Programs it becomes even clearer how unecessary these rules really are. This is the DEA being lazy and obtuse, as these rules were thrown together instead of doing what they were asked to do- that is to create a Special Registration rule for telemedicine prescribers to allow exceptions to the rule. The latter is what many law firms are calling out in their feedback to the DEA because they failed to create it and submitted these rules instead.
 
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