Nelson Vergel
Founder, ExcelMale.com
COMMENTS DUE DATE: MARCH 31.
THE DEA WANTS TO LIMIT YOUR ACCESS TO TELEMEDICINE
THE DEA WANTS TO LIMIT YOUR ACCESS TO TELEMEDICINE
EXECUTIVE SUMMARY:
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.
IN SIMPLE WORDS:
Just going to get a physical exam with a local doctor will no longer be sufficient for a telemedicine clinics to treat you.
You will need to:
1. Get an exam by a practitioner with a state DEA license. Not all of them have this.
2. Your telemedicine doctor will need to be present virtually *during* this exam via two-way video or voice chat.
3. The practitioner you visit for your physical will have to keep medical records of your exact treatment from your telemedicine provider. So, whenever your treatment is changed, etc., the practitioner will need updated records from your telemedicine provider.
So basically, you need to 1. find a local practitioner who is 100% down for the exact treatment the telemedicine practitioner is providing, 2. has enough time and energy on their hands to deal with the complexities of #2 and #3, and 3. spend extra money and time on all of this.
This is a nearly insurmountable barrier to care for most people.
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.
Here’s What You Need to Know:
· 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.
Example language (please add or edit to make your comment personal to your circumstances)
“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.”
Act Now: Post Your Comment by No Later than March 31: Here
Table of Contents
EXECUTIVE SUMMARY: 1
Summary of the Issue. 1
The New Rules Will Hurt Your Doctor’s Practice By: 2
The New Rules Will Hurt Patients By: 3
Here’s What You Need to Know: 3
Act Now: Send Your Comment to the DEA by March 31. 3
Proposed Solutions: 4
Rationale: 4
References: 8
Summary of the Issue
The current DEA waiver of the in-person exam requirement falls under exception #4 of the Ryan Haight Act, i.e., the Public Health Emergency (PHE). It will expire when the COVID-19 PHE ends May 11, 2023.The DEA’s proposal to update the Ryan Haight Act would drastically impair interstate telemedicine prescribing of non-narcotic Schedule III, IV, and V medications, creating unnecessary burdens on both patients and physicians resulting in limited access to treatment and increased risk of patient harm.
- The DEA’s newly proposed rules would require an in-person evaluation by the prescribing physician to prescribe controlled non-narcotic medications in Schedule III, IV, and V.
- If the telemedicine provider chooses to have the patient examined by another physician located in the same State as the patient, the DEA would also require examining physicians as well as prescribing physicians to have a DEA registration and that each physician maintain all records for the patient, even after a referral has been made.
- According to the new rules, recording the date of examination is no longer adequate record-keeping, as the DEA wants each physician to record the precise time of the visit.
- There would also be a requirement that the doctors coordinate the simultaneous use of two-way audio-communication during one of the patient’s visits.
- Most troubling is that without an in-person evaluation by the prescribing physician, only a 30-day supply of medication may be prescribed.
These over-reaching rules will create significant challenges for patients who are being managed on long-term therapies, negatively impacting millions of patients, both male and female, who require lifelong testosterone replacement. This would additionally impact critical patient populations who rely on telemedicine for long term, managed care therapies including children with pituitary dysfunction, those undergoing gender affirmation therapy (FTM), as well as veterans and patients with pituitary damage and insufficiency. In short, everyone receiving testosterone or other androgens via telemedicine, as well as the prescribing and examining physicians, will face additional burdens and barriers to care.
The New Rules Will Hurt Your Doctor’s Practice By:
1. Increasing administrative burden (record-keeping)2. Requiring two-way video and audio technology which the patient may not have access or inadequate broadband support
3. Decreasing the available pool of examining and prescribing doctors
4. Reducing scheduling flexibility
5. Limiting prescription options to small quantities <30 days’ supply
6. Requiring an in-person visit within 30 days of issuing the first prescription, if the physician wants to prescribe more than a 30-day supply
7. Requiring the provider to process refills every 3-4 weeks for every patient on long-term TRT, creating operational burden and costs. No 3-month refills will be allowed.
8. Blocking ability to follow appropriate testosterone monitoring guidelines established by the Endocrine Society and American Urological Association (2) which clearly state to wait a minimum of eight weeks to monitor treatment response after a patient starts testosterone replacement therapy (TRT).
The New Rules Will Hurt Patients By:
1. Requiring in-person visits within 30 days of a prescription. Many patients live far from TRT clinics.2. Requiring refill request of life-long medications every 3-4 weeks
3. Limiting dosage form options and pharmacy sources for medication
4. Adding an extra DEA license for physicians who perform baseline physical exams but who may not be involved in the prescription process
5. Increasing cost and time needed to sustain therapy
6. Risk of non-compliance and harm due to missed dosing due to the added requirements in the monitoring and refill process
Proposed Solutions:
1. DEA should allow a minimum 90-day supply of testosterone without any additional requirements.2. Physicians who performed physical exams (examining physicians) should not be required to have a DEA registration. A valid State license should be sufficient to complete the physical examination for the telemedicine physician.
3. Examining physicians should not be required to be present during the prescribing physician’s patient encounter.
4. Examining physicians should not be expected to maintain records for prescriptions they did not dispense.
5. The patient should always have the option to opt-in or opt-out of the video communication option due to comfortability/location and/or knowledge and capability of using video communication technology
6. The examining and prescribing physicians should not be required to do a live hand off.
Rationale:
For prescriptions of testosterone and other androgens, the mandated second visit within 30 days is overly burdensome and contradicts the underlying core rationale of telemedicine—that increased accessibility through technology will reduce barriers to effective care. Data produced within 30 days of beginning hormone therapy will be negligible at best, while greatly inconveniencing the patient with a visit that could have been a phone call, video conference, or lab work. Requiring a physician appointment within 30 days conflicts with clinical guidelines established by multiple medical associations including the American Urological Association (AUA), Endocrine Society (ES), and International Society of Sexual Medicine (ISSM). The follow-up requirements for testosterone replacement therapies range from 3 months or 6 months to once per year on maintenance therapy.For hormone replacement therapy, a 90 – 180-day follow-up visit would be more appropriate and give a clearer picture of the patient’s adaptation and the appropriateness of the drug and dose. This could easily and more conveniently be lab work within that timeframe, and a virtual visit. But not under the proposed rules, which would essentially take the “tele” out of telemedicine.
For women prescribed testosterone, this would be unduly burdensome as there are no commercial testosterone medications available to women. Women have relied on telemedicine care to receive androgen therapies for menopause, sexual dysfunction, reproductive health, and replacement therapy. The use of telemedicine offers access to specialized treatment that is otherwise inaccessible to their local communities. Additionally, the lack of commercialized testosterone pharmaceuticals for women requires the utilization of specialty or compounding pharmacies that specialize in testosterone dosage forms designed for use in women. Since the practice of testosterone therapies in women is specialized, it is common for both the prescribing physician and pharmacy to be in a different State than the patient resides. As this is a lifetime course of medication, at minimal dose, there is no reason to impose such a strict prescribing guideline. This is additionally true for men receiving TRT, either for early onset hypogonadism or andropause, as they are taking the medication for the rest of their lives. Again, for transition therapy, we are talking about a lifetime course of medication. Interruptions in treatment will only serve to have a negative impact on these patients, and in some cases will increase diversion and the use of illegal or non-regulated sources for hormones.
The general rule is that 5 x (half-life) is when steady state plasma levels are achieved. With longer-acting forms of testosterone, especially those widely preferred by men like testosterone esters, steady levels would not have been reached by the time the first in-person visit with the prescribing physician is required. In fact, for long-acting esters of testosterone requiring a weekly injection this is 35 days after the initial injection. Other forms of medication (*e.g., pellets or extremely long esters) might even be disallowed, despite patient preference. Even a 10 mL vial of testosterone will now become unavailable, and instead the patient will be forced to purchase multiple 1 mL vials to keep under the 30-day maximum. This significantly limits medication options available to patients.
If the patient is unable to complete an in-person visit with the telemedicine physician, the patient is required to obtain a referral from a local physician, who they must see in-person for an examination. Completing an in-person examination to provide a basic health assessment and identity verification is not necessarily burdensome, but the proposed DEA rules create significant challenges that cannot be practically implemented. DEA proposed requiring the examining physician to be present during the telemedicine encounter, in addition to providing a referral for telemedicine treatment. This places unnecessary barriers on the examining physician, prescribing physician, and patient that will significantly limit options or prevent the patient from receiving the care they need. This is especially true in the field of hormone replacement, where there exists a limited pool of specialists and experts. The examining physician cannot be expected to spend additional time conducting a live encounter with the telemedicine provider as this does not align with the reality of how a typical primary care practice operates. Under current healthcare constraints, the examining physician barely has time to complete a physical examination, usually seeing an average of 20-50 patients per day with little room to dedicate any more time for a non-billable service. Additional constraints resulting from insurance models and operational limitations within the examining physician’s practice create an atmosphere where the patient may encounter resistance, further limiting the pool of examining physicians. This will become especially apparent in regions that have fewer providers.
DEA has additionally suggested that when a physician other than the prescribing physician conducts the in-person examination, both would require a DEA license to prescribe controlled medications (if those are prescribed). This is an unnecessary expense for the examining physician who is not prescribing medication, nor are they specialized in the condition and resulting treatment offered by the telemedicine prescribing physician. According to the new rules, both the prescribing physician and the examining physician will be expected to keep dual sets of identical records. This unnecessarily increases the gross administrative burden for both physicians. The purpose of the physical examination is to establish baseline physical metrics for the prescribing physician to consider along with other data including extensive patient history, laboratory results, and symptomatology. The examining physician cannot be expected to maintain expertise in the prescribing physician's treatment specialty and requiring these unnecessary steps in the context of a physical examination creates barriers that are insurmountable in most primary care settings. The in-person examination requirement for hormone therapies is overall questionable as ‘at-home’ technologies increase the capability of physicians to collect the patient’s physical data, often more comprehensively and as needed.
We can expect the increased record keeping and licensing requirements to lead to a decreased standard of care as less doctors will be available and/or willing to examine patients and keep records for medications they did not prescribe. As the prescribing physician must examine the patient in-person for a second prescription, this severely limits the telemedicine practitioner to those within a reasonable traveling distance. Specialists, therefore, who are often widely spaced geographically due to the uniqueness of their field, will be unavailable to a greater extent than previously. Again, this is one of the pillars of telemedicine, and one of its greatest strengths, i.e., that everyone everywhere will have access to the highest standard of care, regardless of where they are physically located.
A limited supply of medication imposed through a 30-day limit puts undue strain on both administrative and medical staff. It places undue burden on the patient as well, who must allocate time for multiple visits and then multiple trips to the pharmacy to fill the subsequent prescription. This would cause an excessive burden on everyone from the person who schedules the appointment, to the examining physician, the prescribing physician, the pharmacist, and especially the patient. The additional expense, both in time and money, is doubled by everyone who participates in any aspect of telemedicine. Under these rules, a patient undergoing testosterone therapy will have to carefully time their refill requests every 3 weeks to receive the medication in time for their next administration. Treatment compliance now depends on the ability of the provider and pharmacy to coordinate the refill requests including the normal administrative prescribing requirements and expeditious dispensing and delivery of the medication to the patient. The patient would have to do this every 3-4 weeks, for the rest of their lives if they choose to be managed under telemedicine care.
Two-way video is also required for treatments outside of mental health. The DEA’s claim that patients often utilize telemedicine from a medical office is unfounded and irrational. Patients do not engage in telehealth from a medical facility. Most telehealth services are not done at medical facilities but rather in the patient’s home.
Two-way video is unnecessary and the patient ought to always be able to opt-in or out for any reason (comfort, location, familiarity with required technology, etc.). There are other specialties outside of hormone replacement, including but not limited to mental health disorders, each of whom rely more heavily on audio and have no per se visual requirement. Provider and patient should be able to decide for themselves under a uniform agreement as to what form the interaction will take.
In those circumstances where internet issues arise or video communication is not feasible, the decision to default to a phone call should be preferred to not completing the visit or not providing the required standard of care (or any care at all) – the standard of care should not be sacrificed for lack of technology.
Keeping the time of the visit is unduly burdensome as the date ought to suffice. In addition, doctors in different time zones would not have matching records, and this might cause investigatory confusion. Also, it is unclear whether the scheduled time of the visit is the time recorded, or the time actually seen. The time frame and record keeping under the 30-day prescription is too limited and short due to the fact that medical staff will now have their responsibilities and requirements literally doubled without cause.
The newly proposed rules are unnecessary to prevent diversion. The DEA has made clear that existing steroid control acts have virtually eliminated diversion. Industry estimates place actual diversion at less than five percent and likely closer to one percent of the illicit market.
Directly quoting the DEA’s RHA update, “The Controlled Substances Act (CSA) and DEA’s regulations only define the ‘practice of telemedicine’ for the purpose of establishing obligations under the CSA and DEA regulations. DEA is not attempting to define what constitutes appropriate telemedicine in other contexts”. Androgenic Anabolic Steroids (AAS) are Schedule III non-narcotic controlled substances under the CSA. They were not controlled under the original CSA (1970), either specifically or categorically, but were subsequently controlled under a subsequent act in 1990, which added them as a definitional category to the CSA.
Due to their unique status under the CSA, it is appropriate to treat them differently for the purposes of this proposed rulemaking; applying general rules not tailored to their medical use will result in unnecessary restraints being foisted on the telemedicine hormone replacement therapy market. These restraints will greatly reduce their accessibility, utility, efficacy, and otherwise result in administrative burdens that could impede the existing standard of patient care. Consequently, in 1988 the first bill attempting to regulate an anabolic steroid (specifically to add methandrostenolone to the CSA) was introduced to Congress. At the subsequent congressional hearing, the DEA testified in opposition to the bill.
“In this respect, the law is poorly suited to the steroid drugs. It is clear, based on the legislative history, that the Congress did not intend to encompass them within it.” [1]
This direct testimony from the DEA highlights the issues that conflict with their own proposed rules around telemedicine prescribing of testosterone-based hormone therapies.
Finally, Ryan Haight, for whom the Act is named, did not have a valid prescription nor doctor-patient relationship. The proposed amendments to his namesake act would not have prevented his tragedy and should be rejected by the medical and patient community in unison.
SUMMARY FROM ATTORNEYS AT BREADLEY LAW FIRM: DEA Issues Proposed Rule for Prescribing of Controlled Substances via Telemedicine
References:
[1] One Hundredth Congress, Second Session. Testimony regarding H.R. 3216. July 27, 1988. [JB2](2) Pelzman DL, Hwang K. Testosterone therapy: where do the latest guidelines agree and differ? Current Opinion in Endocrinology, Diabetes, and Obesity. 2020 Dec;27(6):397-403. DOI: 10.1097/med.0000000000000581. PMID: 33044244.
(3) Jethro C.C. Kwong, BMSc, Yonah Krakowsky, MD, Ethan Grober, MD, Testosterone Deficiency: A Review and Comparison of Current Guidelines, The Journal of Sexual Medicine, Volume 16, Issue 6, June 2019, Pages 812–820, Testosterone Deficiency: A Review and Comparison of Current Guidelines
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