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Title:	Telemedicine Listening Session 09/13/2023
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Body:	TRANSCRIPT OF PROCEEDINGS In the Matter of: ) ) TELEMEDICINE ) ) Listening Session ) Pages: 1 through 249 Place: Arlington, Virginia Date: September 13, 2023 HERITAGE REPORTING CORPORATION Official Reporters 1220 L Street, N.W., Suite 206 Washington, D.C. 20005-4018 (202) 628-4888 contracts@hrccourtreporters.com 1 UNITED STATES DRUG ENFORCEMENT ADMINISTRATION In the Matter of: ) ) TELEMEDICINE ) ) Listening Session ) 700 Army Navy Drive Arlington, Virginia Wednesday, September 13, 2023 The listening session was convened, pursuant to notice, at 9:00 a.m. PARTICIPANTS: ANNE MILGRAM Administrator, DEA MATTHEW STRAIT Deputy Administrator, DEA THOMAS PREVOZNIK Assistant Administrator, Diversion Control Program Virtual Presenters: LAURA JANTOS Healthcare Technology and Digital Healthcare Management Consultant FELICIA BAILEY Family Nurse Practitioner, Avaesen Healthcare BRUCE BASSI, M.D. Telepsych Health ALEX ARMITAGE, M.D. Baylor Scott & White Health Heritage Reporting Corporation (202) 628-4888 2 PARTICIPANTS: (Cont'd) Virtual Presenters: ROXANNE TYROCH, M.D. Intellimedicine PA CONNIE GUILLE, M.D. Medical University of South Carolina CAITLIN GILLOOLEY American Hospital Association MARC BERGER, M.D. JOHN HEAPHY New York State Department of Health, Office of Addiction Services Department of Health Mental Health PHILIP MOORE, M.D. Gaudenzia JESSE EHRENFELD, M.D. American Medical Association DELPHINE HUAN, M.D. California Mental Health Service Authority SARAH SPENCER, M.D. Ninilchik Tribal Council Alaska Tribal Health Consortium Commenters: DANIELLE VAETH Qbtech STEPHEN MARTIN, M.D. Boulder Care UJJWAL RAMTEKKAR, M.D. Quartet Health CHRISTA NATOLI CTEL JOHN WELLS Louisiana State University Health Sciences Center Heritage Reporting Corporation (202) 628-4888 3 PARTICIPANTS: (Cont'd) Commenters: JUAN HINCAPIE-CASTILLO, PharmD National Pain Advocacy Center JAMES ULAGER, M.D. Pursuecare HALLEY CRISSMAN, M.D. Planned Parenthood Federation of America JESSICA RIGSBY Ophella Health, Inc. MARCELO FERNANDEZ-VINA The Pew Charitable Trusts DAN GOLDEN East Coast Telepsychiatry KEVIN SIMON, M.D. Boston Children's Hospital Division of Addiction Medicine SHIRLEY REDDOCH, M.D. Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 4 1 P R O C E E D I N G S 2 (9:00 a.m.) 3 MR. STRAIT: Good morning. For those of you 4 who are returning, welcome back. For the new faces here with us today, welcome to DEA'S 2023 telemedicine 6 listening session. 7 I am extremely thankful and appreciative to 8 everyone who has taken time out of their busy 9 schedules to participate in person and virtually in this two-day event. 11 I am also appreciative for those who are 12 watching the live stream for this event from the DEA 13 Diversion Control's website, www.deadiversion -- all 14 one word -- .usdoj.gov. Let me now introduce the person who is 16 sitting next to Administrator Milgram and 17 Administrator Milgram herself. Administrator Milgram 18 was sworn into the DEA as Administrator on June 28 19 after being confirmed by the U.S. Senate by unanimous consent on June 24. As the DEA Administrator, she 21 leads the Agency of nearly 10,000 public servants who 22 work in any one of our 334 offices nationwide. 23 Next to her is Tom Prevoznik. Tom is a 24 career Diversion Investigator with 34 years of public service, I believe, and he serves in the role as Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 5 1 Assistant Administrator to the Diversion Control 2 Division. 3 Thank you, Tom and Anne, for being here 4 today. My name is Matthew Strait. I am a Deputy 6 Assistant Administrator in Diversion, and I oversee an 7 office known as the Office of Diversion Control 8 Policy. This is the office responsible for the 9 regulatory drafting efforts of the DEA which impact those authorized to handle controlled substances for 11 legitimate medical and scientific purposes in the 12 United States. I will be serving as the moderator for 13 this listening session event. 14 This listening session I want to say is novel for the DEA in that we have not generally held 16 public meetings to inform our regulatory drafting 17 efforts. I hope that this effort underscores our 18 sincere desire to improve upon our information- 19 gathering capabilities to better inform this important work. At no time has this novel approach been more 21 logical and more appropriate. And why do I say that? 22 Because these regulations will impact the delivery of 23 healthcare for every American in the United States, 24 and, frankly, we need to make sure that we get it right. Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 6 1 We've structured this event so that we could 2 hear from stakeholders who could either be here in 3 person or participate virtually. We issued a Notice 4 of Meeting in the Federal Register on August 1 and then gave the public until August 21 to register for 6 the event. We received a total of 1,308 registration 7 requests for those who wanted to participate. Of that 8 list, 186 people requested authority to present their 9 comments either in person or virtually. Due to the structure of the event and our 11 decision to let each commenter provide up to 10 12 minutes of remarks, we curated a list of commenters 13 with diverse views on a number of issues of interest 14 to the DEA. Twenty-nine were offered the opportunity to participate in person, and 32 were offered the 16 opportunity to participate as virtual presenters. 17 Yesterday, we heard from half of our 61 18 presenters both in person and virtual, and today we 19 will hear from the remainder of our presenters. Thank you all for being here. 21 Because we are transcribing the event and 22 that transcription will be part of DEA's 23 administrative record, our presenters were advised 24 that they could not use visual aids. While we know that some of our presenters and, indeed, those who we Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 7 1 could not accommodate wish to provide written 2 materials during this event, we will continue to 3 encourage those folks to provide written materials 4 when all interested parties are invited to respond to a forthcoming proposed rule on the subject. 6 For the folks who registered to attend this 7 event in person as an observer, I'm happy to report 8 that we were able to accommodate all of you, and I'm 9 thankful that you all chose to join us here today. Okay. Let's now go over a quick run of 11 show. This morning, our first block, our morning 12 block, will consist of as many as 15 virtual 13 presenters. I will call Virtual Commenter 1 shortly, 14 and that individual's image will be displayed on the screen up here on the stage. Virtual commenters will 16 be asked to state their name and their affiliation, 17 and then they will be asked to spell their first and 18 last name. 19 Once we have heard from all virtual presenters, we will take a break, and this should take 21 us to sometime around lunchtime, around the noon hour. 22 We will take a recess and begin our afternoon session 23 at 12:40 p.m., where we will then hear from as many as 24 14 of our in-person presenters who are up in the first two rows. Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 8 1 For all presenters, at the nine-minute mark, 2 commenters will hear a chime, and that will be their 3 cue that one minute remains. When our countdown clock 4 gets to 10 minutes, commenters will then hear a gentle buzz, which will be an indication to wrap up your 6 remarks. Upon completion, we will pause in the event 7 that Administrator Milgram or Assistant Administrator 8 Prevoznik have any clarifying questions for our 9 presenter. Before we begin, I want to just lay out a 11 couple of our ground rules. For our in-person and 12 virtual presenters, I ask that you make comments that 13 are related to the nature of DEA's rulemaking and 14 refrain from providing remarks which are not germane. As moderator of this event, if I believe 16 that your comments stray substantially from the scope 17 of our rulemaking, I will interrupt your presentation 18 and remind you to keep your comments to the practice 19 of telemedicine relating to controlled substances. For our folks in the audience, you are 21 welcome to get up and use the facilities at any time, 22 but we do require our visitors to be escorted. So, if 23 you need to use the facilities at any time, please 24 exit the door in the rear of the auditorium. There will be DEA staff there to escort you around the Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 9 1 corner to the restrooms. 2 If you need to leave the building perhaps 3 for a quick bite in our noon hour, please know that 4 you will have to return through the visitors center that you came in through this morning. 6 And also for our folks in the audience, much 7 like the DEA is in listening session, so are you. 8 There are, unfortunately, no opportunities for 9 questions and answers, and we ask that everyone stay silent during the session. This will not only improve 11 the quality of our transcription but the quality of 12 our simulcast for those who are watching virtually. 13 Also, please keep your phone on silent. If 14 you need to take a call, feel free to exit again the rear of the auditorium and take that call in our 16 lobby. 17 Second to last point. In the unlikely event 18 that an audience member is disruptive, as moderator, I 19 will ask our security team to escort you out of the building. Of course, I do not anticipate this to be 21 the case here today. 22 Last point. Please recognize that 23 Administrator Milgram and Assistant Administrator 24 Prevoznik may need to step away from this event for potentially significant periods of time in order to Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 10 1 attend to their duties. Should that be the case, you 2 may see senior personnel from either the Diversion 3 Control Division and/or the Office of the 4 Administrator sitting here in their stead. Last, before we begin, I do want to 6 acknowledge that as you walk in the courtyard between 7 these two buildings today you may see our flags flying 8 at half staff. That is to acknowledge the passing of 9 Howard Safir on September 11. He was a distinguished member of the DEA family whose federal law enforcement 11 career began in 1965 with the agency that actually 12 preceded DEA. He served in several capacities at DEA 13 and then later with the U.S. Marshals Service. 14 Howard went on to serve in roles as the Commissioner of the New York Police Department and 16 Commissioner of the New York Fire Department. His 17 connection to DEA always remained strong during this 18 time, and in our great tradition, we will always 19 remain forever grateful for his service and the enduring mark that he left on the DEA and the law 21 enforcement community at large. 22 So, with that, let me go ahead and say I 23 will now request Virtual Presenter No. 1 to be 24 displayed. MS. JANTOS: Good morning. Thank you for Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 11 1 allowing me to testify. My name is Laura Jantos, 2 spelled L-A-U-R-A, J-A-N-T-O-S. I'm a Healthcare 3 Technology and Digital Healthcare Management 4 Consultant, having more than 25 years of experience in the field, a two-time traumatic brain injury survivor, 6 and a patient advocate. I'm also the parent of two 7 kids diagnosed with ADHD. I'll be speaking from a 8 personal perspective today. 9 My testimony is focused on Methylphenidate, which I understand to be a Schedule II drug. I've 11 been disabled due to TBI since 2012. After that 12 incident, I was able to concentrate for 45 minutes 13 twice a day. Making it to medical appointments and 14 following provider directions was a significant effort, as were most activities of daily life, and I'm 16 left with chronic headaches, cognitive fatigue, and a 17 host of other symptoms because your brain basically 18 controls everything. Essentially, the effort of 19 getting through my healthcare was all I could accomplish. 21 Methylphenidate oral was the medication for 22 pain management prescribed to me after a second TBI in 23 2018 and helped me establish a platform for cognitive 24 recovery, which has taken years to accomplish and has allowed me to be able to work again enabling Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 12 1 organizations to leverage technology to improve 2 healthcare outcomes and reduce disparities. 3 Telemedicine was a significant factor in my 4 recovery because it eliminated the need for complex and time-consuming travel, navigation, parking costs, 6 and other interactions that reduced my ability to 7 improve and focus on more important tasks, yet every 8 month refilling medications for myself and my children 9 presents a significant challenge and burden with hurdles imposed by strict regulation, occasional and 11 unpredictable pair determinations, lack of access to 12 providers, and medication shortages. 13 For one of my children, this is further 14 complicated by attending college out of state and being subjected to different laws requiring providers 16 in both locations and different processes and time 17 frames virtual and face-to-face for filling 18 prescriptions, which often results in medication gaps. 19 The impact of TBI and other cognitive disabilities is often misunderstood and downplayed. 21 Again, think about what your life would be if you 22 could only focus for 45 minutes twice a day. It isn't 23 just about being able to perform well on tests. It 24 can be staring at a grease fire in your kitchen and trying to remember if you put that out with water or Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 13 1 if that's exactly what you're not supposed to do. 2 It's a difference between being able to work or not. 3 There are also documented interdependencies 4 between ADHD, anxiety, gastrointestinal disorders, that can be so crippling it's difficult to work, leave 6 the house, or participate in daily activities. 7 Consistent access to Methylphenidate is 8 critical to managing part of this triangle, and the 9 anxiety caused by not knowing if this month's refill process is going to be simple or not can be crippling. 11 Often, the process of refill itself results in delays 12 in access and lags that then require recovery. 13 So the key points I'd like to make today 14 with respect to telemedicine and e-prescribing are that, first of all, our existing certified EHR 16 systems, which we have spent billions of dollars 17 implementing over the past decades, our data exchange 18 standards provide sufficient documentation to track 19 prescribing provider, dosage, frequency, dispensing pharmacy, and patient information. 21 Our business intelligence tools and 22 artificial intelligence are available to mine this 23 data and identify aberrant patterns without requiring 24 undue or additional burden on patients. Having face-to-face encounters with Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 14 1 providers is, from my perspective, unnecessary. Needs 2 are sufficiently met by telemedicine either through 3 video or audio, and it's important to recognize that 4 audio-only telemedicine visits are critical from an equity perspective. 6 Refill processes for Methylphenidate are 7 overly complicated and archaic. They include very 8 short windows to call for that refill before you run 9 out, the provider verification process, again, state variability, limited quantities, and payer denials and 11 prior authorizations. And for someone with limited 12 cognitive abilities, this is a substantial burden that 13 manifests and causes significant physical issues. 14 People frequently travel between states for a variety of reasons, and I would like to see federal 16 law enable more consistency wherever possible so that 17 patients are not caught off guard by varying 18 regulatory issues. 19 I'd urge that regulation support the needs of the majority of individuals who are being aided by 21 appropriate use of these medications and not subject 22 everyone to compensate for the activities of a small 23 number of bad actors. 24 Thank you very much for your consideration. MS. MILGRAM: Good morning. If I could ask Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 15 1 one follow-up just to clarify. You talked about the 2 electronic health records system and the technology 3 and digital systems around that that would be 4 available for data mining and other sort of information-gathering. 6 I think two questions. One is I read you as 7 suggesting that as an existing and potential safeguard 8 for misprescribing and abuse or diversion. 9 And then the second is, are you suggesting that some of that information should be shared with 11 DEA and, if so, what information? 12 MS. JANTOS: I think there is potential for 13 that information to be -- yeah. I think there is 14 certainly potential for that information. Again, it already exists. From a patient perspective, you know, 16 personally, from my experience, I know how much 17 information is in those systems, yet day to day I'm 18 asked to repeat that every time I go to a visit. We 19 know it's stored. We have that access to that information. It certainly is possible to have access, 21 for the DEA to have access for that to mine it. 22 MR. STRAIT: Yeah. And thank you, Ms. 23 Jantos, for those comments. I do want to say that I 24 think, as kind of a clarifying nature question to Anne's point specifically, you know, there are a lot Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 16 1 of perceptions that we actually have access to that 2 information. We presently don't. And I think that's 3 the point that Ms. Milgram was trying to make, is that 4 it sounds like you're saying -- and we certainly take the point that that information does exist. The 6 question is whether or not it's available to those of 7 us who are charged with tracking diversion and misuse. 8 Thank you very much for your comments. 9 Before we go on to our second virtual presenter, I did want to acknowledge that we have sign 11 interpreters that are here with us today, and those 12 are for the folks that are here in the audience. So, 13 if there are folks that are hearing-impaired and you 14 need to move closer to see our sign interpreters, feel free to move at any time if that ends up being 16 beneficial for you. And I thank you all for being 17 here today. 18 Okay. Let's move on to Virtual Presenter 19 No. 2. You are ready to go, Dr. Bailey. DR. BAILEY: Oh, I'm sorry. Hi. Good 21 morning. My name is Dr. Felicia Bailey. I am a 22 family nurse practitioner. I am representing Avaesen 23 Healthcare in Frederick, Maryland. 24 My presentation will be coming from the perspective of a family nurse practitioner who also Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 17 1 provides addiction and psychiatric services, and I 2 would like to share some of my experiences with the 3 population that I serve, which generally are a 4 population with severe substance use. They typically need to be housed in inpatient units and things of 6 that nature and developing life skills for the 7 community. 8 One of the recommendations, and I will have 9 to say that there are a large population of my clients who are very good follow-through clients who usually 11 follow the diversion or criterias for prescribing and 12 things of that nature, they attend their appointments, 13 they follow up with their primary care providers. 14 One of the concerns that I have with the other half of my population is some of the common 16 things that I've seen with potential diversion. And 17 as a provider, it has been a challenge to make sure 18 that these clients stay in compliance and also take 19 care of their health. Some of the things are selling prescription drugs. 21 Also, doctor shopping, which some providers 22 may have multiple controlled substances from multiple 23 providers, and some clients may have frequent drug 24 theft reports. In that population, I would certainly Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 18 1 recommend that the DEA have more access to clinical 2 documentation, and some of that clinical documentation 3 may be screenings from other providers, a way that it 4 does not put the burden on a family or addiction specialist to have to call a psychiatrist and verify 6 what medications a client is on. 7 That database could possibly include other 8 measures to evaluate their medical health, their 9 physical health, and just making sure that we as providers understand whether it's pain, whether it's 11 substance use concerns, that they're also being 12 addressed with their medical providers as well, and my 13 recommendation would be for a collaborative 14 relationship between the providers and primary care. Some of the examples that I would recommend 16 is making sure that, for example, some of those 17 medications that are commonly misused would be the 18 categories of benzos, stimulants, pain medication 19 versus the substance use medications. If that information was readily available, it would help 21 providers in prescribing. 22 Also, making sure, and I'm not sure this is 23 possible, but there has been a challenge identifying 24 those clients who are on methadone. I have just noted this over the COVID transition, that there's not a lot Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 19 1 of clients reporting that they're on methadone. Most 2 of them are just on Suboxone, which is good. It's a 3 good thing that they are seeking some type of help, 4 but the barrier that I've seen is that methadone doses are not there. 6 I have seen some clients who, when I 7 requested them to come to the office, then I realized 8 that they are on methadone, or they have been 9 prescribed Vivitrol or a medication to treat their substance, but they're not showing positive for those 11 substances. My concern is mainly, again, making sure 12 that data is available for all providers, making sure 13 that we address population health. 14 We do understand that there are certain individuals that they have resorted to abuse of 16 substances because of their healthcare behaviors. 17 Having a provider guide those behaviors to improve 18 those behaviors certainly helps with the population. 19 What we perform in the primary care environment that I work in is we actually do HIV 21 testing, Hepatitis C testing, and we refer to 22 treatment. Referring to treatment also helps with our 23 children, their children, just to make sure that we 24 maintain treatment with that environment. I would certainly say that laboratory tests Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 20 1 would actually help us even as a substance use 2 provider initiate or encourage that client to continue 3 to treatment. 4 One of the other things that I've realized is the frequency of this population, and I say again 6 this population may be those with chronic medical 7 conditions and multi substance use concerns. 8 If there were emergency room data, this 9 population circles the emergency room very frequently. A lot of times they may not reveal to their family 11 provider that they just had an overdose two days ago, 12 unfortunately, but at least having that information so 13 that we can probe the patient and see if we can manage 14 their care a little bit more efficiently. The other recommendation is to make sure 16 that there is some type of point-of-care information 17 inside of our databases so that we can use that 18 information to apply treatment and counseling and 19 recommendations for further services. So I ask for these things with all respect 21 just to address the population again that I serve, 22 which I think is very common but missed, overlooked or 23 underserved population, and that way we 24 collaboratively care for our population and those with substance use disorders. Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 21 1 MS. MILGRAM: Thank you so much. Just a 2 couple of follow-up questions. To clarify, when you 3 were talking about the medications that you see being 4 abused, can you just go through that list again? I missed maybe the couple at the end. 6 DR. BAILEY: Sorry, I didn't hear you. 7 MS. MILGRAM: I'm so sorry. Can you hear me 8 now? 9 DR. BAILEY: Yes. MS. MILGRAM: Okay. Great. Just to 11 clarify, you went through a list of some of the 12 medications that you see being abused. I didn't catch 13 all of them. I was wondering if you could just list 14 those again, the ones that you see most frequently being abused. 16 DR. BAILEY: Usually, this population has a 17 combination of pain medication, anxiety medication, 18 stimulants. I have noticed in the COVID era that 19 there's a lot more individuals with that combination, and it could be any category of medication that's 21 controlled, but I've noticed there are a higher 22 amount. And not to the fact that I don't believe that 23 they need it. I believe that maybe a face-to-face 24 evaluation to just really hone in on what the body is saying to the provider would be very helpful. Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 22 1 MS. MILGRAM: Thank you. The other thing, 2 and I don't -- I'm just trying to make sure I'm 3 pulling together some of the threads that I was 4 hearing. It sounded to me like you were talking about having some sort of national database that providers 6 could access that would give you information on the 7 prescriptions that somebody's on, the provider visits, 8 the emergency room data. So the first question is, 9 did I get -- is that part right? Is that an accurate reflection of what I'm hearing? 11 DR. BAILEY: Yes, that is accurate. And I 12 will give an example. I live within 30 to 45 minutes 13 of three states, Pennsylvania, West Virginia, 14 Virginia, and Delaware, so I'm sorry, four states. If there is an opportunity for a client to drive within 16 an hour, I think it would be very beneficial for a 17 provider to have access to that data. 18 MS. MILGRAM: Is there anything else that 19 you would put in that data that a provider should have, list? 21 DR. BAILEY: Emergency room visits. Those 22 are key indicators that the client is going through a 23 crisis. And I'll make sure I clarify because I do 24 respect those clients who do what they're supposed to do and they have no intentions of misuse. You will Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 23 1 see cycles because the consistency is not there. 2 These clients may be under-insured. These clients may 3 be purchasing their medication from another patient. 4 And they have more frequency emergency room visits. MR. PREVOZNIK: With that system, would you 6 also want the pharmacists to have access to that as 7 well? 8 DR. BAILEY: Absolutely. That would be a 9 great idea. Great idea. MR. STRAIT: Okay. I think we are done with 11 follow-up clarifying questions and comments, so thank 12 you, Dr. Bailey. And we will move now on to Virtual 13 Presenter No. 3. 14 DR. BAILEY: Thank you. MR. STRAIT: Dr. Bassi? 16 DR. BASSI: Hi. I'm Bruce Bassi, B-R-U-C-E, 17 B-A-S-S-I. I'm with Telepsych Health. Good morning, 18 everyone, and thank you for inviting me to speak. I 19 want to first thank the DEA for holding these listening sessions. Thank you for trying to find the 21 right solution that is least burdensome but also 22 maximizes patient safety. 23 We heard a lot of great ideas yesterday, and 24 what struck me was the incredible diversity of practices and disease types that we all use controlled Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 24 1 substances to help treat. Treating substance use 2 versus chronic pain, versus hospice, versus ADHD are 3 all very different, and this emphasizes the great 4 challenge the DEA has in trying to apply a simple blanket policy across all disciplines in the entire 6 country. 7 All speakers were correct in their own right 8 because the decision to prescribe or not prescribe 9 should be one that's made between the clinician and patient. So the question becomes how to prevent bad 11 actors from taking advantage of a very lenient system 12 to prevent what happened during the COVID health 13 emergency when we essentially had a trial period for 14 how this would go. I think some of my recommendations would address that. 16 Let me introduce myself. I am Board- 17 certified in general psychiatry and addiction 18 psychiatry. I'm the sole owner of the private 19 practice Telepsych Health, which is mostly virtual and accepts commercial insurance and Medicare. We have an 21 office for in-person appointments in Jacksonville, 22 Florida, as well. Despite being a virtual practice, 23 we do not expect to profit at all by more lenient 24 regulations in this regard because we prescribe a very low percentage of controlled substances overall. Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 25 1 I have a DEA license in states where we have 2 partnerships with certain facilities, the most notable 3 of which is with our partnership with a prison re- 4 entry program, where we primarily evaluate substance use disorders and prescribe buprenorphine to some of 6 those individuals. In the year 2022, we had a total 7 of 32 patients prescribed buprenorphine. 8 The vast majority of our patients do see us 9 for general psychiatric reasons, and I run a virtual group therapy as well. During COVID, we wrote for 11 controlled substances for people with severe anxiety, 12 insomnia, and ADHD, and this comprised an additional 13 34 patients in 2022. In total, we sent in 15,000 14 different prescriptions that year, 406 of which were for controlled substances, for an overall rate of 2.6 16 percent of prescriptions sent. 17 Before I prescribe any controlled substance, 18 there are a number of factors that I consider 19 clinically before deciding if this is an appropriate choice. First, have they completed a written consent 21 form that outlines our clinic policies of 22 expectations. For example, they may be asked to 23 obtain or collect a urine drug screen randomly to be 24 done at their local lab within two days or at a facility that they're affiliated with. Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 26 1 Also, that the medications need to be locked 2 and out of reach of any other person to prevent 3 diversion and accidental diversion from any children 4 or teenagers in the home. Simultaneously, during the appointment, I'm 6 considering a number of other important factors, such 7 as, one, the patient's age and history of substance 8 abuse. If the person has a history of drug abuse, I'm 9 thinking about other co-occurring conditions, where they are in the recovery, do they have a sponsor, how 11 much support do they have, are they going to groups, 12 et cetera. 13 Secondly, I'm considering family history of 14 substance abuse. We know there's heritability of addictive disorders not only through genetics and 16 epigenetics but through its impact on childhood 17 trauma. 18 Third, I'm considering the duration of the 19 prescriptions. Is it a bridge to starting another medication, or is there no discernible end point to 21 the prescription? 22 Fourth, I'm considering escalating doses and 23 early refills, which I would find by checking the 24 PDMP, which I think is extremely important and I do before prescribing any controlled substance. Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 27 1 Fifth, what is the addictive potential of 2 the medication I'm prescribing. We know that not all 3 schedules are the same, and I consider what is the 4 time release rate of the formulation that I'm prescribing. 6 In 2022, of the 66 patients who were 7 initiated on controlled substances remotely with no 8 in-person visit, 93 percent of them were continued 9 without an issue. Of the 7 percent, we treat each breach of contract on a case-by-case basis to try to 11 figure out what was the underlying intent of the 12 relapse or if they intended to manipulate and deceive 13 us. If needed, I can expand more on how we might 14 approach those cases. In an informal Facebook poll of physicians 16 in preparation for this talk, 64 percent stated that 17 clinicians should be able to use their best judgment 18 in prescribing controlled substances virtually and 19 without any regulations; 32 percent stated patients should be required to see somebody in person first, 21 and only 2 percent agreed that there should be a 22 telehealth registry. 23 Therefore, the vast majority felt 24 prescribing controlled substances should be a decision made between the physician and patient. In my Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 28 1 opinion, I don't see a one-time in-person examination 2 reducing the risk of abuse, nor do I see it materially 3 altering the potential for diversion, nor would it add 4 to me substantial information to a psychiatric appointment that I could not gather virtually. None 6 of the five other clinical concerns I stated earlier 7 would be changed if some arbitrary person saw them 8 once previously. 9 Furthermore, it's important to point out online notaries have existed for a number of years 11 now. Thus, verifying an individual's identity 12 virtually has been legally acceptable. An in-person 13 requirement would also unfairly burden rural patients, 14 those without transportation, and those without childcare. 16 Like I mentioned earlier, the new rules 17 should take into consideration that there are 18 practices that have a high volume of controlled 19 substances and pose an overall greater risk to the public versus those who do not. I noticed during the 21 COVID emergency there were a number of companies that 22 popped up with their entire business model predicated 23 on solely prescribing controlled substances. Given 24 the addictive potential of controlled substances, this presents an unethical conflict of interest wherein Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 29 1 profit is inextricably linked to prescribing and, 2 thus, prescribers are partially incentivized to 3 starting and continuing these medications. 4 Therefore, I think the upcoming DEA policy should attempt to reduce the potential corporate 6 entities can profit off lenient prescribing rules but 7 without putting an excessive burden on those who are 8 thoughtful in their prescribing. One way to do this 9 is by having increased oversight on telehealth prescribers who choose to prescribe a large number of 11 controlled substances per month. There should be 12 transparency about what those cutoffs would be and 13 what additional oversight would be. 14 I would suggest a cutoff of more than 200 controlled substances per month, which can be tracked 16 through the PDMP, and I do support a national PDMP as 17 well. That was suggested earlier. 18 For all Schedules II to V, I would recommend 19 the following apply to all clinicians regardless of reaching the cutoff: (1) prohibit direct-to-consumer 21 and social media advertising for prescribing of 22 controlled substances, in particular for buprenorphine 23 or ADHD solely; (2) require that the clinic obtain a 24 copy of the patient's government-issued ID and that the telehealth visit must include a real-time Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 30 1 interactive video evaluation, not just a review of 2 questionnaires and symptom checklists that were 3 completed by the patient; (3) require that patients 4 complete a written consent form outlining risks, benefits, and alternative treatment options, 6 safekeeping of the medication, and clinic policies and 7 circumstances in which the prescriptions would be 8 discontinued; (4) allow clinician reporting to the 9 PDMP when a prescription was discontinued by the clinician due to an aberrant behavior or breach of 11 clinic policy. This would allow other clinicians to 12 see that the patient previously breached a contract 13 with that practice and take appropriate next steps to 14 perhaps reach out to that practice to get more information. 16 If the prescription was labeled to be made 17 via telehealth, I fear this would add unnecessary 18 scrutiny and fear by the pharmacists and add more 19 barriers to the patients receiving the medication. Also, for clinicians' safety, the prescription should 21 not publicize their home address if they're working 22 from home. The prescriber should only need a DEA 23 license in one state where they're physically present 24 and not have an office and DEA license in every state. Sixth, allow for one-time refills by covering staff in Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 31 1 the same practice. 2 Regarding the increased oversight beyond the 3 cutoff, I would suggest: (1) the practitioner be 4 registered for a high-volume DEA registry to cover administrative costs for additional supervision by the 6 DEA; (2) the practitioner should be required to 7 complete additional continued education for 8 recognizing and treating addiction and diversion; and 9 (3) be subject to increased audits of recordkeeping to ensure they're following the standard of care in their 11 prescribing practices. 12 In regard to the recordkeeping, I would 13 recommend all practitioners to document: (1) that 14 they verified the patient's identity with a government-issued ID and a correspondent to that video 16 image; (2) that they have obtained the written consent 17 form talked about earlier from the patient outlining 18 clinic policies and diversion mitigation steps; (3) 19 that they've checked the state PDMP prior to issuing the prescription; and (4) in addition to documenting 21 the standard medical history and current medications, 22 the practitioner should have evaluated for static and 23 dynamic patient risk factors for substance misuse and 24 abuse, including family history of addiction, any aberrant behaviors, such as a rapidly escalating dose, Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 32 1 lost prescriptions, early refills, and any actions 2 taken by that clinician to address these issues. 3 Thank you for your time. I was honored to 4 be invited today, and I welcome any opportunity to be part of the ongoing conversation and collaboration. 6 Thank you. 7 MS. MILGRAM: Thank you so much. 8 Could I ask you to expand a little bit on 9 the -- you mentioned you could talk a little bit more about the 7 percent that relapsed or had fraud. Could 11 you just tell us a little bit about -- 12 DR. BASSI: Yeah, absolutely. 13 MS. MILGRAM: -- you know, how did you 14 identify that -- DR. BASSI: Like some -- 16 MS. MILGRAM: -- what did you do? 17 DR. BASSI: Like somebody mentioned 18 yesterday, I try to not take a punitive approach. 19 Stopping the prescription and sending them to another practice makes that disease state become another 21 clinician's issue and they have no background 22 information off which to work with. 23 I would try to use the situation as a way to 24 rehabilitate the individual, promote honesty and reducing shame of withholding information in the Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 33 1 future. Some people make impulsive mistakes and they 2 need to learn from those. It doesn't help them in the 3 long term either to deceive us for certain scripts. 4 So, first, I would get confirmation testing of the UDS before jumping to any conclusions. I would 6 also start to reduce the quantity of prescriptions 7 that the pharmacy would be dispensing, increase the 8 frequency of appointments, and maybe perhaps implement 9 more peer support. There's a lot of virtual online peer support as well that we could require of that 11 patient. Request that they obtain a sponsor and 12 follow up with what they're working through with that 13 sponsor, and then also require that we perhaps obtain 14 additional collateral information from family members to help keep them accountable for what they say 16 they're doing in the clinic. 17 MS. MILGRAM: And how did you identify that 18 7 percent? 19 DR. BASSI: It was primarily through other clinicians who had reached out to us to let them know, 21 like therapists, and also positive urine drug screens 22 that led to a conversation about their relapse. 23 MS. MILGRAM: Sorry. Sorry, I'm going to 24 give it to Tom in one second. You talked about an audit checking the state Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 34 1 PDMP. One of the questions just to sort of ask you to 2 expand on that a little bit is, if we're talking about 3 a national -- you recommended a national registry for 4 telehealth or, you know, not having multiple registries. How would you go about identifying or 6 understanding whether or not there was a prescription 7 in another state? 8 DR. BASSI: So the PDMPs have expanded quite 9 substantially over the last year, two years even where you can add additional states, and that has been 11 extremely helpful. We know patients travel quite 12 frequently and they might live on a border, like 13 another presenter alluded to. 14 So many of them -- I'm registered with the PDMP in all the states that I have DEA licenses, and 16 in most of them now, you can add up to 30, 40 17 different states. I do think that while that's 18 progress in the right direction, it still leaves for 19 the possibility that you don't check off those additionally. It should just be by default that 21 you're seeing that across the country. 22 And also, I would add the previous presenter 23 mentioned a couple other additional points that could 24 be included in that PDMP, which is a great database we already have that we can just improve upon, is Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 35 1 identifying, okay, I'm seeing this patient who has 2 recently gotten a prescription over the last three 3 months from three different doctors. What does that 4 mean? Let's try to reach out to them. Like somebody mentioned, you often call an 6 office and you get a call center. Well, one way we 7 can resolve that is by marking down that this was 8 discontinued due to a breach of contract. That way, I 9 know, okay, this wasn't due to doctor shopping, but they actually had to travel for some reason or they 11 got stuck where they ran out of medication early or 12 they have an issue medically where they need a higher 13 dosage and that wasn't an aberrant behavior and so I 14 shouldn't look additionally into this versus something that was done with malicious intent where they were 16 trying to actually deceive and withhold information 17 from their previous prescribers. 18 MR. PREVOZNIK: Could you help clarify -- I 19 think you said and please correct me if I'm wrong -- that you did not want the prescriptions to indicate 21 that it was telemedicine. However -- is that correct? 22 DR. BASSI: I think I'm torn on that after 23 hearing from the previous pharmacists yesterday. I 24 really understand they are burdened with trying to identify if this is a legitimate relationship between Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 36 1 doctor and patient when on the spot they don't have 2 enough information to make that determination. And, 3 right now, there's so much stigma attached to whether 4 or not it was a telemedicine visit that those patients are placed under increased scrutiny in particular 6 states and particular pharmacies due to the excessive 7 overabundance of prescribing habits that we've seen 8 during the COVID emergency. 9 So it could include that it was telehealth if there was less fear among the pharmacists that it's 11 not up to them to establish whether or not it was a 12 correct relationship because they're not in the 13 doctor/patient appointments and it's not possible for 14 them to police that. It should be the prescriber's responsibility, and there shouldn't be additional 16 barriers where the patient needs to hop around to 10 17 different pharmacies and identify which pharmacy is 18 known for allowing them to give them their 19 prescription, which has happened in certain cities that we've experienced. 21 MR. PREVOZNIK: Okay. Thank you. But, to 22 further -- another point that you made was for us or, 23 yeah, for I guess DEA to identify the telehealth 24 companies to take the stance against the corporations. How would we do that if we don't know what the Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 37 1 prescription -- where it's generated from if it's 2 telemedicine, so how would we -- do you have 3 suggestions on how we would do that? 4 DR. BASSI: Right. The PDMP can include that it was made via a telehealth visit and then that 6 way they can monitor if that prescriber is approaching 7 or exceeding the cutoff that was already demarcated by 8 the DEA, and then they can apply for additional 9 registry. I think the burden should be on those individuals -- the increased regulation burden should 11 be on those individuals who are high-volume controlled 12 substance prescribers where they undergo those three 13 additional recommendations that I made, having a 14 registry solely for those individuals kind of like for buprenorphine previously, with varying levels for each 16 prescriber depending on their level of experience. I 17 think that that makes a lot of sense to me and that's 18 the only way that I can think of that would start to 19 separate those bad actors who are essentially becoming the "pill mills." I hate to use that colloquially, 21 but that's essentially what they've become known as. 22 MR. STRAIT: Okay. Thank you, Dr. Bassi. 23 I will now move on to Virtual Presenter No. 24 4. DR. ARMITAGE: Good morning. My name is Dr. Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 38 1 Alex Armitage. I'm a supportive nurse, supportive 2 palliative care nurse practitioner at Baylor Scott & 3 White Health in Texas. My name is spelled A-L-E-X-A- 4 N-D-R-A, last name Armitage, A-R-M-I-T-A-G-E. The assistant director of supportive 6 palliative care at Baylor Scott & White has asked that 7 I testify on behalf of our entire service line. 8 Palliative care at Baylor Scott & White consists of 13 9 interdisciplinary teams covering 18 facilities scattered across about a third of Texas. Most of our 11 patients come from the 11 million people living in the 12 service area, but we also draw patients from New 13 Mexico, Oklahoma, Arkansas, and Louisiana. 14 Our 13 supportive palliative care teams include 64 Board-certified hospice and palliative care 16 physicians and advanced practice providers. In fiscal 17 year 2023, we provided over 63,000 total patient 18 encounters, with over 6,000 outpatient encounters. 19 Early palliative services allow patients to be embraced holistically and cared for in the most 21 humane possible way at a time when they are most 22 vulnerable and most in need of care. Early delivery 23 of palliative care reduces unnecessary hospital 24 admissions and the use of unhelpful health services. In other words, palliative care patients are less Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 39 1 likely to receive non-beneficial treatments. 2 To demonstrate some of the challenges that 3 our patients face, let me share a clinical vignette. 4 Sally is a 36-year-old runner and mother of two children who I served since shortly after she was 6 diagnosed with stage 4 breast cancer three years ago. 7 Chemo and radiation therapy was initiated by her 8 oncologist, who also referred her to my clinic for 9 help managing her physical and temporal pain. As with most patients newly diagnosed with 11 metastatic cancer, she was not a hospice candidate as 12 her cancer was being actively treated and she had a 13 projected life expectancy of over six months. Her 14 pain was so great that traveling the two hours to my office was not imaginable to her. Due to COVID, I had 16 already been tasked with establishing telehealth video 17 services, full palliative care at Baylor Scott & 18 White, and so I was able to set up such a visit with 19 her. On our first video visit, Sally's pain was 21 so intense that she could not sit up in bed due to 22 metastatic lesions through her spine and pelvis. She 23 was literally reduced to tears because of her pain. I 24 was able to complete a comprehensive evaluation and we explored her goals of care. Sally and I agreed on Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 40 1 what an acceptable level of pain would be, and she 2 started on a combination of methadone and morphine. 3 Over the following months, we titrated her pain 4 medications not to complete absence of pain but to a level of pain control that would allow her to resume 6 at least some of her activities of daily living and 7 possibly get out of the house for a short period of 8 time. I am proud to say that we've been successful. 9 On her most recent video visit last week, she was out of bed and dressed. She had improved 11 enough to take a short trip to the hairdresser, which 12 made her proud as her hair was growing back after 13 chemotherapy. She was even able to get up and cook a 14 simple meal for her family. Yet she still struggles with traveling long 16 distances in the car. I'm not in her shoes, but I 17 cannot imagine her being comfortably able to travel to 18 my clinic, nor do I think it necessary. We know and, 19 more importantly, she understands that she will never be a hundred percent pain-free and that eventually her 21 cancer will return. But she, her oncologist and I are 22 thrilled at the moment that she no longer lives 23 immobile in a bed of pain. 24 In case it's not clear from my story, I have yet to meet Sally in person, but the treatments that Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 41 1 I've been able to provide to her via video have given 2 her her life back, and I thank the DEA for the 3 suspension of the in-person rule during COVID, which 4 allowed us to relieve her suffering. As many know, palliative care and hospice 6 services are frequently confused, and when that 7 happens, referrals come late, which diminish benefits 8 to patients, their families, and healthcare providers 9 alike. To help alleviate that problem, Texas law recognizes and my health system recognizes two types 11 of palliation. The first and more familiar to the 12 public is hospice for which enrollment requires the 13 patients to forego attempts to treat their primary 14 disease. There are over 570 hospice agencies in Texas serving less than 1 percent of us who will die in any 16 given year. 17 Hospice typically provides services for days 18 to weeks before death. My patient, Sally, was not 19 hospice appropriate as she was actively undergoing cancer treatment and had a prognosis of greater than 21 six months. 22 The second type of palliative care is what 23 Texas law and Baylor Scott & White refers to as 24 supportive palliative care. Our patient population is seriously ill, the sickest of the sick. Like Sally, Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 42 1 they often have extremely high symptom burden, 2 including some of the worst pain imaginable. 3 Although we would not be surprised if any of 4 our supportive palliative patients were to die in the coming year, annual mortality rates are in about the 6 50 percent range, clearly not hospice appropriate and, 7 like Sally, our patients wish to maintain disease 8 directed treatment. Thus, unlike the typically short 9 service time for hospice patients, in support of palliative care, we serve patients for months to 11 years, most commonly in a hospital or clinic setting. 12 Unfortunately, in Texas, supportive 13 palliative services are not as available as hospice. 14 For example, the most recent data available suggests that only 154 of the 262 hospitals in Texas offer 16 supportive palliative care services and most of those 17 are hospital-based only. Even in our system at Baylor 18 Scott & White with 13 supportive palliative care 19 teams, we are only able to staff six outpatient clinics. In addition, unlike hospice, we do not 21 receive a per diem fee and do not have the staffing 22 available to send professionals to the patient's home. 23 This means that if we are unable to provide telehealth 24 services, our patients must come to us. Hopefully, all can understand how Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 43 1 challenging such travel is given the symptom burden 2 and the distances involved, distances which can grow 3 to hundreds of miles in some cases. 4 I have set up two telehealth clinics in the last few years servicing hundreds of sic patients. I 6 could tell you many more clinical vignettes like that 7 of Sally, but we don't have the time. 8 In closing, my supportive palliative 9 colleagues and I recognize the need to protect the broad population from opioid abuse, but we believe 11 that such protection must not impair effective pain 12 treatment and other symptom management for the 13 seriously ill, the sickest of the sick patients with 14 life-limiting illness. Our patients cannot always travel to see a 16 medical provider in person because of the distances 17 involved and because of the severity of their 18 symptoms. For some patients, obliging them to do so 19 would effectively be denying them care. We advise against placing any regulatory hindrance in front of 21 the barriers already created by their life-limiting 22 illness and all the geographic distances required to 23 reach our limited clinics. 24 We believe that the Drug Enforcement Administration was correct in suspending the Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 44 1 requirement for the in-person visitation for opioid 2 therapy during COVID, and we recommend that at least 3 for patients of supportive palliative care 4 professionals that this humane suspension be maintained. We recommend that the DEA carve out 6 Schedule II prescribing rules for prescribers in 7 support of palliative care and allow such 8 prescriptions via telemedicine visits alone, thus 9 negating the severity of illness and travel distance barriers that I have shared with you today. 11 Thank you for the opportunity that you've 12 provided us to testify. My colleagues and I would be 13 happy to participate in any further dialogue. 14 MR. STRAIT: No? Okay. Thank you, Dr. Armitage. I think we have no questions, so we will 16 now move on to our Virtual Presenter No. 5. 17 DR. TYROCH: Good morning. Is my audio 18 okay? 19 MR. STRAIT: Yes, it is. DR. TYROCH: Thank you. My name is Roxanne 21 Tyroch. I live in El Paso, Texas, and I am an 22 Internist at Intellimedicine PA. As a primary care 23 physician in an office setting, I prescribe controlled 24 substances on a regular basis. The most common ones are for adult attention deficit disorder, which are Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 45 1 Schedule II amphetamines. 2 During the pandemic, it was reasonable to 3 drop the regular safeguards when there were no COVID 4 vaccines nor treatments. Now that the pandemic no longer poses these risks, there is little valid 6 justification to extend this laxity in safeguards 7 against diversion and health-related hazards. 8 Our clinic has urine drug screening for the 9 use of controlled substances. The patients must have their first visit in the office always and have annual 11 in-office physical examinations and wellness visits. 12 And, monthly, they have the option to do their drug 13 screen in the office and then have it at the same time 14 as an in-office encounter, or they can do a telemedicine visit and do the urine at their 16 convenience. 17 If there are any concerns during a 18 telemedicine visit as far as safety, say they have 19 chest pain or some symptom of concern, then the patient comes to the office and we can do a physical 21 exam or whatever is needed to do to remedy the 22 situation ensues. 23 In October 2022, the FDA announced a 24 shortage of amphetamine mixed salts, pointing to ongoing intermittent manufacturing delays at Teva Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 46 1 Pharmaceuticals, a major supplier of Adderall 2 amphetamines. 3 Due to the Adderall shortage, my patients 4 now have to call around to pharmacies in order to get verbal confirmation that there's adequate supply, and 6 then we hold their visit right away so they can get to 7 the pharmacy within hours of it being written, and 8 even this fails, and they'll have to find supply 9 elsewhere. By returning to proper safeguards of only 11 prescribing to patients that have had an in-office 12 evaluation, we are ensuring that the medication is 13 directed to people who are appropriate to receive the 14 medication. There are many other benefits to this procedure. The physician ensures cardiovascular 16 safety with the use of amphetamines with an 17 electrocardiogram and physical exam. Any concerns 18 found on drug screening can be addressed in a personal 19 setting. The American College of Cardiology published 21 guidelines on the topic in April 2015, and this was an 22 expert analysis with 28 references outlining the 23 challenges of prescribing these medications even in a 24 proper setting, such as an office. The package inserts for stimulant drugs warn Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 47 1 against use in patients with pre-existing heart 2 disease or cardiac structural abnormalities due to 3 risk of sudden death, stroke, or myocardial 4 infarction. Furthermore, the FDA issued a safety announcement in 2011 stating that stimulant products 6 in such areas should not be used in patients with 7 serious heart problems or for whom an increasing blood 8 pressure or heart rate would be problematic. 9 There have been reports that such errors have induced life-threatening Long QT Syndrome. It's 11 recommended that Methylphenidate amphetamine- 12 containing drugs be avoided in patients with 13 congenital Long QT Syndrome. Package inserts for 14 Modafinil and R-Modafinil warn against use with patients with a history of left ventricular 16 hypertrophy or those with mitral valve prolapse. 17 The final summary of this document 18 emphasized how proper assessment of clinical benefits 19 and risks should be made on an individualized basis when therapy is warranted. Monitoring of 21 cardiovascular parameters is in order and should be 22 limited to the lowest effective safe dose. 23 On an additional side note, my daughter is a 24 college student and I asked her, what have you noticed about people's use of amphetamines in school? And she Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 48 1 noticed that after the pandemic, when this change took 2 place, that just anecdotally it was noted more 3 diversion of stimulants in the college student setting 4 has been identified. And I understand the potential motive of 6 prescribers that seek to lower standards for 7 telemedicine only prescribing of controlled 8 substances. If no brick-and-mortar building is 9 required, overhead plummets and profit will rise. And I would submit to you that this is not a 11 good enough reason to allow for telemedicine only 12 prescribing of controlled substances in a setting of 13 drug shortages. All patients deserve the safeguards 14 and personal care that I've outlined. It's simply incomplete to not have those options available when 16 needed. Handheld cardiac devices and do-it-yourself 17 heart monitoring in my experience has not been 18 adequate to screen for arrhythmias. 19 I wish to thank the DEA for having this listening session and demonstrating that you want to 21 have as much information at hand with these important 22 decisions. Thank you very much. 23 MR. STRAIT: Okay. Thank you, Dr. Tyroch. 24 I don't see any questions, so we will proceed on to Virtual Presenter No. 6. Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 49 1 DR. GUILLE: Great. Thank you so much. My 2 name is Dr. Connie Guille. First name is C-O-N-N-I-E. 3 Last name is G-U-I-L-L-E. I'm from the Medical 4 University of South Carolina. Again, just wanted to say thank you very much for having us here today and 6 the opportunity to speak with you all. 7 As I mentioned, I'm from the Medical 8 University of South Carolina, where we're one of two 9 federally recognized and funded National Telehealth Centers of Excellence by the Health Resources and 11 Service Administration. Our center has over 300 12 telehealth programs throughout our state, on average 13 about 800 telehealth visits per day, primarily to 14 rural and underserved areas within our non-Medicaid rural state. 16 Since 2015, I specifically have been working 17 in the space of treating pregnant and postpartum women 18 with opioid use disorder using telehealth modalities 19 and particularly prescribing Suboxone via telehealth. My comments today are actually very specific 21 to the pregnant and postpartum populations and 22 recommendation to not require an in-person visit prior 23 to prescribing Suboxone for the treatment of pregnant 24 women with opioid use disorder and postpartum women. Just to highlight a few things that I think Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 50 1 are relevant, in the United States, our rates of 2 maternal mortality, which is death during pregnancy 3 and the postpartum year, is higher than any other 4 developed country, and the leading cause of maternal mortality in the United States is due to mental health 6 conditions, primarily due to suicide and drug 7 overdose, and the overdose deaths are primarily 8 related to opioids and they occur typically later in 9 that postpartum year. I think it's just important to note that 11 since 2010 to 2019 we've had about a 190 percent 12 increase in pregnancy-associated deaths just due to 13 drug overdose. The most recent data shows an 81 14 percent increase in those pregnancy-associated deaths due to drug overdose from 2017 to 2020. 16 The vast majority of these deaths that we 17 know from our state's maternal morbidity and mortality 18 review committees are actually preventable, and 19 they're preventable by providing better access to care and, particularly for opioid use disorder, life-saving 21 medications such as Suboxone. 22 There have been a number of studies, those 23 including JAMA Psychiatry, of over 200,000 Medicaid 24 recipients that have shown that telehealth expands access to treatment for opioid use disorder. It Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 51 1 results in improved retention and treatment and 2 reduced rates of overdose deaths. And, furthermore, 3 utilization of this during the pandemic was associated 4 with improved retention and treatment of opioid use disorder and decreased overdose deaths in comparison 6 to our pre-pandemic cohorts when we required an in- 7 person visit. 8 Our concern today is that any progress 9 that's been made towards improving access to evidence- based treatment for opioid use disorder and reducing 11 opioid overdose deaths will be reversed by requiring a 12 proposed in-person visit before we can prescribe 13 Suboxone for the treatment of opioid use disorder. 14 I just want to add that where we are in South Carolina we've had firsthand experience of the 16 detrimental impact of resuming the in-person visit 17 requirements. In April of 2022, South Carolina 18 announced a return to pre-pandemic state regulations 19 for prescribing controlled substances via telehealth. As a result, that has resulted in an increase in no- 21 show rates to the in-person visit and unsuccessful 22 treatment engagement despite actually an investment in 23 outreach and additional personnel to try to engage 24 people in the in-person visit. We were given 180 days to transition all of Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 52 1 our patients from the pandemic requirements to coming 2 in for an in-person visit. We were really 3 unsuccessful in doing that, and a number of patients 4 dropped out of care and were no longer retained in treatment, which retention and treatment is what 6 predicts a reduction in overdose deaths. 7 So I want to highlight that in our clinical 8 practice, when we see pregnant and postpartum women 9 with opioid use disorder, we can accomplish everything that we need to to safely manage that disease without 11 having an in-person visit. Using telemedicine, I can 12 make an appropriate diagnosis of what is happening 13 with that person. I can look for signs and symptoms 14 of intoxication and withdrawal. I can check my state prescription drug monitoring program. I would like to 16 be able to check other states' prescription drug 17 monitoring programs in order to determine if there's 18 any other prescribers on board or multiple medications 19 being prescribed to this patient. In that, I'm able to safely prescribe these medications. 21 The only thing that the in-person visit does 22 is it actually creates additional barriers to these 23 patients' accessing treatment and prevents a lot of 24 people from accessing these treatments. We've had the firsthand experience of requiring the in-person visit, Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 53 1 resulting in delayed care and an overdose death of a 2 pregnant woman, and, you know, to continue to have 3 that happen is not acceptable. 4 I agree with a lot of the presenters before in terms of the safeguards that can be put in place 6 with reducing drug diversion but just want to be very 7 clear that that in-person visit does not increase our 8 chances of reducing drug diversion. 9 With that, I will stop and just say again thank you very much for your time today and our 11 ability to present this information to you. 12 MR. PREVOZNIK: I have a question. You keep 13 saying inpatient, not having the inpatient visit. Are 14 you -- DR. GUILLE: In-person. 16 MR. PREVOZNIK: -- is your practice two-way 17 or is it audio only? I'd like to hear your 18 perspective of audio only as an initial visit or two- 19 way. Get your perspective on that. DR. GUILLE: Yeah. So sorry for not being 21 clear on that. When I say telemedicine and a visit 22 with a patient, it's using audio and visual 23 telehealth. The only thing I'm suggesting is that 24 they don't come in in person to meet with us before we prescribe medication, that we can achieve all of that Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 54 1 using audiovisual telehealth, synchronous encounters. 2 MR. PREVOZNIK: And, excuse me, you talked 3 really fast in the beginning. When you were talking 4 about the medical university, you indicated that it got some sort of certification? Could you explain 6 what that process -- what the certification is and 7 what was the process for you to get that 8 certification? 9 DR. GUILLE: Sure. So HRSA, Health Resources and Services Administration, is a -- HRSA is 11 a organization that has federally recognized and 12 funded MUSC, or Medical University of South Carolina, 13 as a National Telehealth Center of Excellence. And so 14 what we are tasked with within the Center of Excellence is advancing telehealth and demonstrating 16 the effectiveness of telehealth programs in terms of 17 providing greater accessible and effective care via 18 telehealth in our state. 19 MR. PREVOZNIK: Do you know what the process was for you to get that gold star of excellence? 21 DR. GUILLE: Yes. HRSA puts out a call for 22 proposals. There were many proposals throughout the 23 United States, and they only designated South Carolina 24 and Mississippi for that recognition as a Center of Excellence. Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 55 1 MR. PREVOZNIK: Okay. Thank you. 2 MR. STRAIT: Okay. Thank you, Dr. Guille, 3 for your time today. And we will now move on to 4 Virtual Presenter No. 7. MS. GILLOOLEY: Thank you. My name is 6 Caitlin, C-A-I-T-L-I-N, Gillooley, G-I-L-L-O-O-L-E-Y. 7 I'm the Director of Behavioral Health and Quality 8 Policy at the American Hospital Association. 9 And on behalf of our nearly 5,000 member hospitals, health systems, and other healthcare 11 organizations, as well as our clinician partners, the 12 AHA appreciates the opportunity to provide input on 13 the way forward for telemedicine prescribing of 14 controlled substances. And we recognize and appreciate the DEA's 16 efforts to support safe prescribing of controlled 17 substances via telehealth during the COVID-19 Public 18 Health Emergency. Indeed, during the COVID-19 PHE, 19 the DEA enacted certain flexibilities to ensure that patients could continue to receive life-saving 21 medications via telehealth while minimizing exposure 22 and preserving provider capacity. 23 However, we are deeply concerned about the 24 DEA's refusal to implement a special registration process for telemedicine prescribing of controlled Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 56 1 substances, and we disagree with the direction of the 2 two proposed rules issued this past March. The rules 3 would impose burdensome restrictions and 4 administrative requirements that we believe are overly burdensome on providers and patients which we are 6 concerned will adversely impact access to medically 7 necessary treatments. 8 So we have several recommendations in 9 response to the proposed rules. We expressed these in our written comments on the rules. We'll reiterate 11 them today. 12 Our primary recommendation to the DEA is to 13 develop and implement a special registration process 14 in lieu of the proposed regulatory guardrails contained in the aforementioned rules. 16 First, we urge the DEA to expeditiously set 17 forth a special registration process and establish a 18 pathway to waive in-person evaluations prior to the 19 prescribing of controlled substances for practitioners who register with the DEA. Indeed, the Ryan Haight 21 Act required that DEA establish this process nearly 14 22 years ago, and the Support for Patients and 23 Communities Act reinforced this requirement and 24 applied a clear timeline for the process's development by 2019. Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 57 1 In the March 2023 proposed rules, the DEA 2 noted that it had determined a special registration 3 process would be overly burdensome for providers. 4 However, as I will elaborate upon later in this testimony, the provisions proposed by the DEA would 6 certainly add significant burden for providers. 7 Further, we believe that a special 8 registration process would simply be complementary to 9 the existing DEA registration process rather than a new and distinct process that prescribers would have 11 to go through on top of their current licensure. 12 For example, practitioners, hospitals, 13 clinics, pharmacies, and others are currently required 14 to complete applications for registration and renewal of registrations for prescribing controlled 16 substances, namely, Forms 224 and 224A. 17 The process has already established 18 guardrails that build upon state medical licensure 19 processes and Medicare reporting, so rather than creating a novel and separate process or form, DEA can 21 add fields to those forms that providers already use. 22 This way, the special registration process would 23 include key elements that providers already report, 24 like their contact information, their employer, practice address, state medical licenses, liability Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 58 1 history, et cetera, and could add unique attestations 2 on patient identification verification via 3 telemedicine, drug monitoring, diversion control, and 4 emergency protocols. We would encourage the DEA to not require 6 reporting of home addresses if practitioners are 7 administering telehealth from their home address due 8 to privacy concerns. 9 We would welcome the opportunity to assist further in developing a proposed special registration 11 process and establishing appropriate guardrails. 12 Next, we appreciate that the DEA has 13 recognized the need for additional time to consider 14 creating a special registration process and has extended the COVID-19 pandemic-era rules through this 16 coming November for new patients and November 2024 for 17 existing patients. 18 However, considering the enormous volume of 19 comments received on the rules this spring as well as the wealth of information that is being shared during 21 these listening sessions and the additional comment 22 period announced yesterday, we believe that the Agency 23 will have to further extend public health emergency 24 waivers to ensure that people who need access to appropriately prescribed controlled substances can get Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 59 1 them, and that should be the case regardless of 2 whether they're a new or established patient. 3 So the DEA has already exercised its 4 authority to extend PHE waivers of the in-person visit requirement. We believe they should exercise this 6 same authority to create an additional provision that 7 would allow for extensions of the waiver for 8 prescribing buprenorphine for all patients, including 9 those who did not begin their OUD treatment during the PHE. Buprenorphine is a unique substance used for a 11 specific life-saving purpose, and the Agency has the 12 authority to extend PHE-era waivers to ensure 13 continued access to this treatment while we work to 14 develop a permanent framework. Alternatively, the DEA can use authority 16 granted under the public health emergency for the 17 opioid crisis, which was renewed most recently on 18 April 1 of this year to extend these waivers. Just as 19 DEA used its authority to allow for the initial evaluation to be conducted via telemedicine during the 21 PHE for COVID-19, the Agency has the discretion to use 22 the same authority under the opioid-specific PHE to 23 allow the practice of telemedicine when it is being 24 conducted during a public health emergency declared by the Secretary under § 247(d) of Title 42. Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 60 1 So we urge the DEA to act under this PHE as 2 intended to innovate and implement a variety of 3 actions to combat the opioid epidemic, such as a 4 special registration process for the telemedicine prescribing of controlled substances including but not 6 limited to buprenorphine for the treatment of OUD. 7 So this process would be an efficient and 8 effective way to allow practitioners in good standing 9 to appropriately prescribe controlled substances for legitimate clinical purposes. 11 Conversely, the provisions proposed by the 12 DEA in this March's rules would be overly burdensome 13 to providers and would erect unnecessary barriers 14 between patients and evidence-based therapeutics. So, in those rules, the DEA proposed that 16 prescriptions administered via telemedicine would not 17 be able to exceed a 30-day supply without an in-person 18 visit. We are concerned that these limits are 19 arbitrary, unnecessarily burdensome, and will reduce access to critical care. There is no scientific 21 evidence suggesting that 30 days is the appropriate 22 interval for patients undergoing treatment with 23 controlled substances to be evaluated by their 24 physicians. The 30-day limit would require patients to complete an in-person evaluation before obtaining Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 61 1 more medication. For many patients, it may be 2 impossible to get an appointment with a practitioner 3 in just 30 days, such as patients who live in 4 geographically remote areas, who have childcare limitations, or who have conditions that make 6 traveling to appointments physically painful. 7 While some patients may benefit from a 8 periodic in-person evaluation, the need for an in- 9 person evaluation should be left to clinical judgment rather than enforced through a general requirement 11 that ignores individual needs. 12 Telemedicine encounters are designed to use 13 the extremely limited availability of healthcare 14 professionals the most efficient way possible, and, thus, requiring superfluous interactions with little 16 benefit negates those gains. So we recommend removing 17 any supply limit and instead allowing clinicians to 18 determine the frequency of in-person exams. 19 The proposed rules issued in March would also impose significant administrative burden for 21 recordkeeping requirements of prescribing 22 practitioners, their referring providers, or other 23 providers physically present with the patient during a 24 telemedicine visit and their staff. We urge the DEA to reconsider what type of information is truly Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 62 1 necessary and whether it can be gleaned more easily 2 from other sources, like claims and medical records, 3 before imposing recordkeeping tasks on the already 4 overburdened workforce. In the rules, the DEA states that the 6 additional recordkeeping requirements are necessary to 7 mitigate the risk of diversion. However, the Agency 8 did not provide data demonstrating that the proposed 9 requirements are associated with decreased diversion, In fact, during the COVID-19 PHE, when practitioners 11 were allowed via waiver to prescribe controlled 12 substances, specifically buprenorphine, for the 13 treatment of OUD via telemedicine, the proportion of 14 opioid overdose deaths involving this substance did not increase, suggesting that the risk of diversion 16 did not increase absent additional guardrails. 17 So practitioners who prescribe controlled 18 substances already keep detailed medical records. 19 These additional recordkeeping requirements would not provide further protections. 21 Now, although many of our comments 22 specifically refer to the prescription of 23 buprenorphine for the treatment of OUD, we should not 24 lose sight of the longer list of use cases for other controlled substances. Because the rules focus Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 63 1 separately on buprenorphine and all other controlled 2 substances, we are concerned that DEA is unaware of 3 the myriad appropriate clinical use cases for these 4 medications. The proposed rules issued in March would 6 limit telehealth prescribing of controlled substances 7 without a prior in-person visit to Schedule III 8 through V non-narcotic medications and buprenorphine 9 only. The rule states that prescribing any Schedule II or narcotic substances via telemedicine would pose 11 too great a risk to public health and safety. The 12 Agency relies on a general assumption that because 13 controlled substances can be misused, an increase in 14 access would result in increased risk for diversion. The assumption not only overstates the risk of 16 diversion, as I previously mentioned, but it also 17 fails to consider the millions of Americans who may be 18 adversely impacted from an inability to access 19 medically necessary medication through virtual prescribing. 21 A few examples of the circumstances, and I'm 22 sure you've heard these today already, where 23 prescribing of Schedule II controlled substances and 24 narcotics may be clinically appropriate may include a homebound palliative care patient receiving opioids Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 64 1 for pain management; a person with cancer with 2 transportation limitations; a person with epilepsy 3 living in remote areas receiving anti-seizure 4 medication; a child receiving ADHD medication virtually due to a lack of pediatric psychiatrists in 6 the immediate service area. So we recommend that DEA 7 add circumstances under which Schedule II and narcotic 8 medications can be eligible for telemedicine 9 prescribing without an in-person exam. Circumstances which are worth waiving the 11 in-person requirement could include certain diagnoses 12 or disease burdens, like hospice and palliative care, 13 and/or the inability to travel to in-person 14 appointments. And, again, we are happy to assist with the 16 development of these provisions, and we thank the DEA 17 again for the opportunity to provide comment and would 18 welcome further dialogue on our recommendations. 19 That's all I've got. MR. STRAIT: Okay. Thank you, Ms. 21 Gillooley, for those comments. I do see that Tom does 22 not have any follow-up questions, so I will go ahead 23 and go to Virtual Presenter No. 8. 24 DR. BERGER: That me? I'm not sure. MR. STRAIT: Yes, Marc, you're up. Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 65 1 DR. BERGER: All right. Yeah, okay. I'm 2 having a hard time finding what was just there a 3 minute ago. Join us in Zoom now. Okay. I don't have 4 my televideo working. I'm having problems with that now, but -- oh, there we go. Can you hear me and see 6 me? 7 MR. STRAIT: Yes, sir. 8 DR. BERGER: Okay. Good. Fine. I am Dr. 9 Marc Berger. I am an old-fashioned, real general practitioner family medicine doctor, and I have a few 11 comments from my personal experience and also from 12 some of my beliefs. 13 One of the first ones is, when I was 14 practicing, I used to do controlled drug substance both in my practice individually and also as a 16 takeover physician for a narcotic clinic. At the 17 time, we were doing real visits once a month with 18 them, and I thought that was very good. 19 There are some interesting things I noted. One, telehealth, I feel very strongly opposed to it 21 for Controlled II narcotics, but I am perfectly in 22 support of telehealth, telemedicine for Controlled II 23 non-narcotics, particularly the ADHD drugs. I do 24 prescribe them on occasion. It has been a difficult burden. This is a chronic condition that is unlikely Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 66 1 to change, ADHD, Attention Deficit Hyperactivity 2 Disorder, on Ritalin, Adderall, et cetera. And I feel 3 that that would be very reasonable to do through 4 telemedicine. However, controlled drugs, particularly 6 Controlled IIIs and Controlled Iis -- I'm talking 7 about hydrocodone, which used to be a Controlled 8 III -- I find very difficult to perform telemedicine, 9 and I'll give you some examples. I do telemedicine for medical marijuana in 11 the State of Florida. This has been off and on. It 12 has been exceedingly difficult to perform telemedicine 13 because there is no physical examination possible, and 14 many of the conditions require a reassessment of the severity and the appropriateness of the continued use 16 of the drug. For things such as chronic pain, there 17 is no alternative to a physical examination to 18 determine if the pain is still severe enough to 19 continue with medical marijuana. For some of the other conditions, that might 21 not be unreasonable, but for some things, you do need 22 a physical exam. I have in the past suggested that 23 telemedicine for the purpose of any visit which 24 traditionally requires point-of-care testing or physical exam is substandard of care. I do not see Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 67 1 how you can diagnose sinusitis through telehealth. I 2 do not see how you can assess back spasm, chronic 3 pain, back pain, acute post-operative pain, or any 4 other issue by telemedicine. I believe that since ADHD is primarily a psychological condition and there 6 are screening tools and it is a talk that it is 7 reasonable to prescribe telemedicine for 8 non-narcotics. 9 Some of the missed opportunities I have noticed, there is an inability to do a random drug 11 screen or a true drug screen when you do not have an 12 in-person visit. My practice was to do an in-person 13 drug screen. We did occasionally find people who had 14 made mistakes, had cheated, had used marijuana, had other drugs. Some of them were counseled, some of 16 them were discontinued. Sometimes I required extra 17 testing. I've had people who have had random testing 18 that was false positive, and when they came to visit 19 me, I did a supervised high-quality liquid chromatography test and proved that was not the case. 21 So the point-of-care lab, especially urine 22 drug screens, cannot be done through telemedicine 23 adequately in my opinion. Physical exam cannot be 24 done. I routinely do examine my patients. I have found at least three people who I think I've saved Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 68 1 their lives from medical marijuana. Non-telehealth, 2 re-certification, established patients, finding 3 suspicious-looking moles, a new atrial fibrillation 4 arrhythmia, and one other diagnosis. I've also made suggestions for alternative 6 treatments that I have seen. I can't evaluate a 7 post-operative scar. I can't evaluate a CT scan, an 8 MRI report, a real film at telemedicine, and sometimes 9 that does change my prescribing, particularly for medical marijuana, but even for controlled drugs. 11 I have had patients on controlled drugs for 12 a temporary period post-operatively when the surgeon 13 did not do an adequate job. I've had patients on 14 chronic pain medication for many years. And, again, the opportunity to see them in person means that I can 16 perform real medicine and not just a simple re- 17 certification and a reissue. 18 The other thing that -- okay. The other 19 problem is you cannot actually touch the patient. You cannot do neurological testing. You cannot listen to 21 their heart and lungs. You can't do vital signs. You 22 can't see if their pulse oximetry is low. So, again, 23 I do not feel that it is within the standard of care 24 for a controlled drug, opiate, Controlled II, to have telemedicine. I used to do telemedicine for Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 69 1 Controlled III. It was unsatisfactory. 2 And in addition, at the VA, Controlled III 3 drugs were occasionally done by pharmacists, their 4 certification. I'm also concerned that paramedical professionals are really not qualified to treat 6 patients for chronic opioid use, and yet different 7 states are relaxing the standard such that in Florida 8 nurse practitioners can prescribe up to seven days for 9 acute conditions. They can prescribe for hospice patients. Physician assistants can prescribe. There 11 is no requirements for supervision by an M.D. They 12 are independent practitioners. So I do not believe 13 they have the training and experience to perform 14 telemedicine. The other issue I would say, oh, actually, I 16 used to also do non-medical -- non-drug therapy. I 17 would occasionally do joint injections, refer for 18 physical therapy, and do other treatments, such as 19 implementing muscle relaxers, anti-spasmodics, et cetera, topicals, which I don't feel comfortable doing 21 over telemedicine because I can't examine them. 22 One of the last things in terms of 23 diversion, I have done two things in my practice to 24 prevent diversion which I think should be publicized. One, for fentanyl patches, I have required patients on Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 70 1 fentanyl patches, once they take a patch off, to slap 2 it on a piece of paper and date the date they removed 3 it. When they come in for re-evaluation, they are to 4 present me the paper, which should have eight fentanyl patches on it that should be dated. Although this is 6 not perfect, it shows that they have not diverted the 7 patches to someone else or they're really sneaky and 8 took the patches back from who they diverted it to put 9 them back on the paper. So, if they don't have eight fentanyl patches back on the paper, I get very 11 suspicious that they may be diverting fentanyl 12 patches. 13 The other suggestion I have which has not 14 been approved is to allow pharmacists to do weekly partial drug fills. Not re-certification, not 16 renewal, but to allow voluntary, the pharmacist and 17 the physician, to allow the patient to only get a 18 one-week supply of medication at a time and be able to 19 come back every week to the pharmacist without seeing the physician to get the next week's supply. 21 The requirement is already available, but 22 the pharmacist cannot bill the $2 and so dispensing 23 fee, what makes it difficult. It would be 24 advantageous to the pharmacists. They would have a better idea of who's coming in because they would Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 71 1 expect the next three weeks of a four-week 2 prescription to be there. 3 It would cut down the number of drugs in the 4 house, on the street, for any given patient by three-quarters. They would only have one week's 6 supply of controlled drugs at any given time, which 7 makes it harder to divert, harder to steal, harder to 8 overdose. 9 In addition, they get extra supervision by the pharmacist, and for the pharmacy, they also have 11 the added benefit of having to walk through the 12 pharmacy and possibly buying other things from the 13 pharmacist. 14 So I think encouraging partial weekly drug fills, I write a prescription for 120 percocet. The 16 first week, the pharmacist gives 30. The patient 17 comes back next week, he gets another 30, the third 18 week another 30, the third week another 30. The 19 pharmacist will keep the records. I don't have to do it. My prescription is still for one month. So I 21 think partial drug fill weekly would significantly 22 help the overdose possibility and get a large number 23 of prescription drugs off the street and encourage 24 patients to come into the pharmacy more often. They still have to come into the pharmacy even with Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 72 1 telemedicine. But the opportunities that are missed, 2 including drug screens, physical examinations, 3 alternation of treatment, review of other 4 practitioners, particularly surgery, physical therapy states, and the opportunity to do point-of-care labs. 6 Again, I have had at least four patients die 7 from drug overdose. One was deliberate where he had 8 three different physicians prescribing three different 9 drugs. That was not found easily at autopsy. Another one had an incidental possible overdose that was 11 botched on autopsy. The other two were never 12 investigated properly. So I've had that. I've had 13 patients on various drugs. 14 So, in summary, I am opposed to telemedicine renew of medications that are Controlled II narcotics, 16 but I encourage the telemedicine review and 17 re-prescribing of Controlled II attention deficit 18 disorder drugs and other psychoactive non-narcotic 19 drugs. Thank you. MR. STRAIT: Thank you, Dr. Berger. I'm 21 looking over at Tom. I do not see that he has any 22 follow-up questions, so thank you. 23 And we will now move on to Virtual Presenter 24 No. 9. MR. HEAPHY: Hi. Good morning, everyone. Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 73 1 My name is John Heaphy. That's spelled J-O-H-N, 2 H-E-A-P-H-Y. I am the Deputy Director of the New York 3 State Bureau of Narcotic Enforcement. I have the 4 privilege of speaking to you today as the voice of New York State on behalf of the New York State Department 6 of Health, the Office of Addiction Services and 7 Support, and the Department of Mental Health. 8 I would like to thank the DEA for providing 9 stakeholders with the opportunity to contribute to the discussion regarding the telemedicine prescribing of 11 controlled substances. 12 The pandemic precipitated a rapid expansion 13 of telemedicine, which has benefitted many across the 14 country. These practices have contributed to health equity for many underserved populations, and we 16 believe there is a role for continuing telemedicine 17 prescribing of some controlled medications. 18 Evaluation should continue, and the Centers 19 for Medicare and Medicaid Services should issue guidance with particular attention to health equity as 21 there remains a risk that some more vulnerable 22 populations may be inadequately served. 23 With that said, the Drug Enforcement 24 Administration had posed several questions regarding the practice of telemedicine, and I will address those Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 74 1 now. The first asks, what framework would be 2 recommended if telemedicine prescribing of Schedule 3 III through V medications were permitted in the 4 absence of an in-person medical evaluation? It's important to begin by addressing 6 medications for opioid use disorder. The clinical 7 significance of both buprenorphine and methadone in 8 the treatment of opioid use disorder has been well 9 established. While there are currently limitations on the prescribing of methadone for this indication, 11 which New York State believes should be re-evaluated, 12 we have seen success in telemedicine-initiated 13 buprenorphine. 14 This practice should continue as it did during the pandemic to allow synchronous audio and 16 audiovisual interactions. Best practices are still 17 evolving, and we believe these should be shaped 18 predominantly by evidence-based medicine. 19 If telemedicine prescribing of Schedule III through V medications other than buprenorphine were 21 permitted in the absence of an in-person medical 22 evaluation, New York State recommends the following. 23 Practitioners must be registered to deliver, 24 distribute, dispense, or prescribe controlled medications in the state where the patient is located, Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 75 1 and they must maintain compliance with federal and 2 state laws when delivering, distributing, dispensing, 3 and prescribing the controlled medication. 4 The United States Department of Health & Human Services should be called upon to issue guidance 6 on which conditions can be managed appropriately by 7 telemedicine as the diagnoses and treatment of those 8 conditions will rely on history rather than physical 9 examination. The primary safeguard in the practice of 11 medicine is appropriate documentation, and the federal 12 government could standardize this component. The 13 telemedicine consultations should be synchronous or 14 audiovisual with the exception of continuing the option of initiating buprenorphine allowed through 16 synchronous audio-only consultation. 17 However, it is important to consider the 18 potential risks of permitting audio-only telemedicine 19 against the possibility of creating further health inequities or an increased risk of self-medicating due 21 to lack of access to buprenorphine, and this is 22 especially dangerous considering the increased 23 presence of counterfeit medications currently 24 available. Prescriptions should be issued in electronic Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 76 1 format to reduce the risk of fraudulent prescriptions. 2 The Prescription Drug Monitoring Program should be 3 consulted prior to prescribing to reduce the risk of 4 duplication or the issue of interactions. States should monitor the Prescription Drug Monitoring 6 Program for changes in prescribing patterns and 7 monitor data on morbidity and mortality related to 8 medications obtained pursuant to telemedicine 9 encounters. DEA posed a similar question as it pertains 11 to Schedule II medications as well. If telemedicine 12 prescribing of some Schedule II medications were 13 permitted in the absence of an in-person medical 14 evaluation, we have the following recommendations and considerations in addition to those previously stated. 16 Stimulant treatments for use with ADHD 17 should be considered. National data on youth mental 18 health show poor mental health outcomes and increased 19 school disconnectiveness. Restricting access to evidence-based 21 treatment for ADHD is likely to further increase poor 22 outcomes. Additionally, while the federal government 23 is making significant investments in school-based 24 mental health, there are not enough child psychiatrists, pediatricians, and other prescribers to Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 77 1 provide in-person services. 2 Allowing for stimulant prescribing for youth 3 with ADHD with a complete psychiatric evaluation by 4 audiovisual telehealth will have a tremendous impact in ensuring that youth receive timely and appropriate 6 treatment while expanding access to care. 7 Safeguards should include obtaining guardian 8 consent when prescribing to youth and possibly 9 limiting the types of practitioners who may prescribe by telehealth, for example, limiting it to 11 Board-certified child and adolescent psychiatrists or 12 pediatricians or other practitioners that have a 13 supervisory relationship with Board-certified child 14 and adolescent psychiatrists. And, lastly, DEA should include a component 16 covering stimulant prescribing and stimulant use 17 disorder in the required eight-hour course which was 18 instituted by the Medication Access and Training 19 Expansion Act of 2021. The final two questions posed pertain to 21 data collection by practitioners and pharmacies. 22 There is a great deal of data collected on Schedule II 23 through V medications, including prescription drug 24 monitoring program data, insurance company data, as well as private companies that collect health Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 78 1 information and make it available at a cost. 2 Practitioners and pharmacists should not be 3 asked for more data specific to these medications 4 except for the following: The National Council for Prescription Drug Programs, or NCPDP, script standard 6 includes a field to indicate that a prescription was 7 issued by telemedicine, and this field should be 8 utilized. 9 The DEA has historically issued location-specific DEA registrations to practitioners. 11 Continuing this practice will indicate the 12 practitioner's location where that telemedicine 13 prescription is issued. 14 Telemedicine practitioners could be required to submit the name of the telehealth practice or 16 company that they are representing. Additionally, we 17 do not see a role for requiring registration beyond 18 the current standard DEA registration. 19 The former X waiver DEA registration illustrates why this isn't necessary. History shows 21 that the requirement for a practitioner to have a 22 special registration to provide buprenorphine was a 23 deterrent to sound medical practice and to our 24 knowledge did not provide useful safeguards or data. However, if a telemedicine registration is Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 79 1 required, then we do recommend that 2 telemedicine-registered practitioners should submit 3 accurate data on the number of prescriptions in each 4 schedule and/or medication class prescribed. This, of course, should not include line-level patient-specific 6 data due to confidentiality concerns. 7 In closing, we recommend that further 8 regulatory changes be considered beyond today's 9 discussion. As mentioned previously, access to methadone for the treatment of opioid use disorder is 11 currently limited solely to opioid treatment programs, 12 and, as such, research on the ability to prescribe 13 methadone for opioid use disorder is limited. 14 New York State encourages new pathways be explored to increase research on this issue and allow 16 for improved access to utilize methadone for opioid 17 use disorder. 18 Thank you again for your time and the 19 opportunity to speak today. MR. PREVOZNIK: Could you elaborate on -- 21 you made the comment that the states would monitor. 22 So you talked about the EPCS format, the PDMPs, and 23 then you said states should monitor morbidity and 24 mortality. What would that monitoring be, and who would -- like, what is that report going to do? Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 80 1 MR. HEAPHY: We believe that if states were 2 to utilize prescription monitoring program data in 3 coordination with vital statistics, such as morbidity 4 and mortality, we would be able to analyze the impact that telemedicine prescribing of controlled substances 6 is having on fatal overdoses and overdoses in general. 7 MR. PREVOZNIK: But you did say that you 8 don't feel that there needs to be a special 9 registration. So how would you know that it was a telemedicine encounter plus -- 11 MR. HEAPHY: I indicated in my talk that the 12 PDMP field should be utilized which indicates the 13 origin of the prescription, which would be 14 telemedicine in this case. MR. PREVOZNIK: And how would that be marked 16 on the prescription? 17 MR. HEAPHY: There is a field that is 18 transmitted through electronic prescribing in the 19 NCPDP script standard which would indicate telemedicine prescription. That data would be 21 captured, could be captured by the prescription 22 monitoring programs if that field is required to be 23 submitted. 24 MR. PREVOZNIK: So this data that would be collected, this would be just monitored by the states. Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 81 1 There would be -- would there be any coordination with 2 DEA or law enforcement? 3 MR. HEAPHY: That would be up to DEA 4 purview. Our current recommendation is that it's collected at the state level. 6 MR. PREVOZNIK: Okay. Thank you. 7 MR. HEAPHY: Thank you.. 8 MR. STRAIT: Okay. Thank you, Mr. Heaphy, 9 for your comments. And we will now move on to Virtual Presenter 11 No. 10. 12 DR. MOORE: Hello. My name is Philip Moore. 13 I'm the Chief Medical Officer for Gaudenzia. My 14 background is internal medicine, addiction medicine, and medical toxicology. 16 Gaudenzia is the largest nonprofit provider 17 of treatment for people with substance use and 18 co-occurring disorders in the Northeast. Gaudenzia 19 has been treating people for the past 54 years in 50 locations, and we have a hundred programs in 21 Pennsylvania, Maryland, Delaware, and Washington, D.C. 22 Our largest footprint and our corporate 23 office is in Pennsylvania. Last year, we served over 24 15,000 people, and our stance, Gaudenzia strongly endorses the permanent integration of telehealth for Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 82 1 Schedule III to V drugs which was established during 2 COVID. 3 The way we were able to, you know, develop 4 these telehealth programs, our facilities created the infrastructure where our patients would come in for 6 counseling, they'd come in for urine drug screens, and 7 they would receive injectable medication, such as 8 extended-release buprenorphine, and they would receive 9 this from nurses when a physician or advanced practitioner was not onsite. We were able to create a 11 rotating schedule where a prescriber rotated around 12 between multiple sites. 13 And we offer telemedicine using encrypted 14 audiovideo platforms with multifactor authentication. And what our program allowed us to do was to bridge 16 MAT and mental health treatment until our patients 17 could transition from our residential facilities to 18 community providers or would allow us to really 19 maximize who we could see at our rural locations that may not have a licensed prescriber five days a week or 21 seven days a week. 22 We were able to pair the MAT with counseling 23 instead of just offering counseling alone at, you 24 know, a significant, you know, increased number of facilities. So we were able to reduce barriers to Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 83 1 care for people living in rural areas without 2 consistent convenient access to care. We were able to 3 increase the accessibility for people with 4 disabilities who have reduced access to consistent substance use care. We were able to maximize access 6 to physicians for vital medication-assisted treatment 7 induction and maintenance in both our residential and 8 outpatient settings. 9 More about the residential is that telehealth allowed us to expand access to start MAT 11 for individuals starting treatment. Our facilities 12 are 24-hour, and, you know, we might not have a 13 prescriber in the facility all 24 hours of the day. 14 So, if someone comes in in the evening, we have a small window of time before they start going into 16 withdrawal, and telehealth really helped us to improve 17 our retention in treatment so that people were 18 staying, you know, much longer than 24 hours. 19 So, you know, our endorsement is rooted in a belief that vital substance use disorder treatment, 21 including medication-assisted treatment, should be 22 available for all those who seek it and when they seek 23 it. 24 We've found that there's a small window of time to start these medications when someone requests Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 84 1 help. This is because modern drugs and their use have 2 been associated with the development of withdrawal 3 symptoms faster than what historically occurred. 4 Most recent data from the NIH and CDC reveals a concerning statistic. Just one-fifth of 6 nearly two-and-a-half million adults grappling with 7 opioid use disorder received medication-assisted 8 treatment in 2021. 9 Returning to the pre-COVID regulations, which mandated in-person evaluations, could 11 significantly compound access challenges, especially 12 in rural and underserved areas, which leads to 13 increased relapse and overdose rate. 14 During the pandemic, it really underscored the significant value of remote care, especially with 16 substance use disorder treatment. Gaudenzia's 17 outpatient sites in particular harness the flexibility 18 and accessibility to telehealth to increase MAT 19 services to the majority of the agency's outpatient sites and facilitate access to MAT for over 450 21 outpatient clients since May of 2020. 22 We were able to add 10 additional outpatient 23 sites in the last year and a half because of 24 telehealth. So telehealth has permitted the flexibility, improved access. It has not jeopardized Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 85 1 safety and accountability with counseling and nursing 2 staff playing an essential role in monitoring and 3 ensuring continued engagement and treatment. 4 We understand that these changes can only be made permanent with a meaningful framework, which is 6 what we strongly, you know, encourage, is that 7 telehealth is only offered by facilities that have the 8 appropriate infrastructure to monitor for diversion 9 and safe prescribing. Considering the patient's safety concerns 11 and the imperative of preventing controlled substance 12 misuse, Gaudenzia recommends enhancing patient 13 identification, verification, and monitoring protocols 14 alongside establishing tailored guidelines and standardized training specific to telemedicine 16 practices. 17 And we recommend continuing the access to 18 telehealth care that includes all forms of MAT 19 treatment when it's closely monitored, and we feel this will continue to improve necessary access to 21 these life-saving medications and care for persons 22 with both substance use and co-occurring disorders who 23 might not be able to access healthcare in the 24 traditional methods. Removing this much-needed flexible tool Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 86 1 could have significant negative effects on the opioid 2 and addiction epidemic which we're all working so hard 3 to stop. 4 In summary, telemedicine should be a vital option for facilities and prescribers that have 6 demonstrated a capability to safely manage with the 7 appropriate infrastructure to minimize the diversion 8 for Schedule III through V medications. 9 I really appreciate the opportunity to speak today. 11 MR. PREVOZNIK: Could you expand on your 12 thoughts on the patient ID, either what you do or what 13 you are suggesting on that? 14 DR. MOORE: So, using telehealth, if they're using multifactor authentication and if they're, you 16 know, using their appropriate, you know, their 17 corresponding name on that, that helps make sure that 18 you are speaking to that individual. 19 And then also, once they're on the line, have, you know, a way to confirm their identity, their 21 name and something like, you know, a code word or, you 22 know, last four digits of a number, something so that 23 you're allowed to or that you're able to more 24 accurately verify it is who you're supposed to be speaking with. Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 87 1 Similarly to when someone comes into an OTP 2 and you're, you know, verifying their identity by 3 looking at a picture that's been scanned into the 4 system and you have a copy of their driver's license and, you know, they give you a four-digit number or 6 some kind of word to also help identify who they are, 7 that's what we try to build into our telehealth 8 platform. 9 MR. PREVOZNIK: And, medically, what else do you see as this meaningful framework that a provider 11 would do in their evaluation? 12 DR. MOORE: As far as, like, what structure 13 we built that they're evaluating during the initial 14 and follow-up visits? MR. PREVOZNIK: Specifically, the initial 16 visit. Like, what medical steps is that provider 17 taking to ensure that they know they're assessing the 18 patient properly? 19 DR. MOORE: So all our patients, we have a workflow for intake, and the intake or admission 21 assessment is completed by multiple individuals. So 22 part of it will be in a facility. Part of it could be 23 remote by telehealth, but, you know, the same things 24 are completed as far as demographics, obtaining a copy of their insurance, their photo ID. You know, we Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 88 1 complete an insurance verification. We complete 2 things from a Depression Screener to Columbia's 3 Suicide Risk Assessment. There's a nursing 4 bio-psycho-social. There's also a counselor or clinician intake. 6 The prescriber would review all of these 7 documents and then individually confirm a history, you 8 know, of course, their identity and then with all this 9 information, which could also include a urine drug screen, which we require to be collected within seven 11 days of an admission in our outpatient program, and as 12 well as checking a Prescription Drug Monitoring 13 Program report, so, with all that data, our licensed 14 physicians or advanced practice practitioners would make a decision about the appropriateness for 16 outpatient treatment, or, in some circumstances, they 17 might recommend residential to start, then eventually 18 stepping down to outpatient. 19 Does that answer your question? MR. PREVOZNIK: Yes, thank you. 21 MR. STRAIT: Okay. All right. Well, thank 22 you very much, Dr. Moore. 23 I am being told by the production crew that 24 we have two more virtual presenters for our morning session. So we will now move on to Virtual Presenter Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 89 1 No. 11. 2 DR. EHRENFELD: Thank you very much. I'm 3 Jesse Ehrenfeld, Dr. Jesse Ehrenfeld, an 4 anesthesiologist and President of the AMA. It's Jesse, J-E-S-S-E, Ehrenfeld, E-H-R-E-N-F-E-L-D. The 6 American Medical Association really appreciates the 7 DEA hosting this public listening session to help 8 inform your regulations on prescribing controlled 9 substances via telemedicine. We want to commend the DEA for taking additional time to ensure that your 11 rules provide an appropriate balance between advancing 12 patients' access to care via telemedicine and ensuring 13 patient safety. 14 I want to first comment on Schedule III through V. The COVID public health emergency 16 demonstrated telemedicine prescribing of Schedule III 17 through V medications with and without an in-person 18 evaluation help patients with many medical conditions 19 begin and maintain necessary care. Whether it was audio-only, audiovisual, or in-person care, the 21 physicians provide-high quality, evidence-based care 22 that relies on thorough assessments and sound 23 decision-making. 24 So, for example, during the COVID public health emergency, audio-only and audiovisual Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 90 1 telehealth induction with buprenorphine for opioid use 2 disorder was extremely helpful for maintaining 3 continuity of care and preventing relapse for those 4 currently receiving treatment with medication for opioid use disorder. We strongly urge the DEA to 6 ensure that access to medications for opioid use 7 disorder is not interrupted through new requirements 8 that might impose a barrier to care. 9 There are many safeguards that currently exist through state law as well as the Controlled 11 Substances Act that provide a sufficient framework to 12 help ensure patient safety and prevent diversion. The 13 professional, the ethical, the legal obligations that 14 govern the practice of medicine and pharmacy can and should be trusted to provide ample safeguards for 16 ensuring patient safety. If a prescription is not 17 issued for a legitimate medical purpose, it should not 18 be dispensed. This applies regardless of the modality 19 used for patient evaluation leading to the issuance of the prescription. 21 Another key safeguard is that every state 22 requires controlled substances to be entered into the 23 state prescription drug monitoring programs when they 24 are dispensed. This information provides physicians and pharmacists with helpful clinical information, Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 91 1 including whether patients are obtaining prescriptions 2 from multiple prescribers and pharmacists. If the 3 dispensing pharmacist has questions regarding whether 4 a prescription for a scheduled medication is for a legitimate medical purpose or has other questions, it 6 is common for the pharmacist to talk with the patient, 7 contact the physician, or seek other information to 8 try and resolve the questions or determine that the 9 prescription should not be dispensed. These processes and relationships help 11 ensure patient safety as well as protect against 12 diversion. The framework for prescriptions issued 13 based on a telemedicine encounter must also allow 14 patients sufficient time to schedule an in-person visit when clinically appropriate. The AMA urges that 16 following an initial telehealth encounter the patient 17 be afforded at least six months to fill and renew 18 prescriptions before being required to have an 19 in-person visit. This can help ensure that the patient is stable on the course of medication therapy 21 so that the in-person visit can be a seamless 22 transition. 23 Having at least six months as a part of the 24 framework for prescribing Schedule III through V controlled substances via telemedicine addresses Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 92 1 multiple current barriers. These barriers include 2 health insurance network inadequacy; functional 3 limitations that can make access to in-person services 4 difficult; long travel times; racial disparities in access to buprenorphine versus methadone treatment; 6 long wait times for treatment; the need for a 7 caregiver to accompany the patient; stigma within the 8 medical community regarding drug users; and patients 9 experiencing unstable housing and lack of transportation or childcare. Telehealth visits for 11 opioid use disorder have helped many patients access 12 treatment, including buprenorphine. 13 Now let me mention Schedule II medications. 14 The AMA continues to support telemedicine prescribing of Schedule II controlled substances in the absence of 16 an in-person medical evaluation when clinically 17 appropriate. A telemedicine prescription can help 18 ensure that the patient receives timely therapy 19 without delay, including for patients with chronic medical conditions, cancer, in hospice, those living 21 in remote or underserved area, or other situations. 22 The AMA does not support sham practices that 23 have no assessment, evaluation, or other markers of 24 legitimate care, but the COVID public health emergency demonstrated that physicians can and do thoroughly Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 93 1 assess a patient via a telemedicine encounter. This 2 includes determining whether a prescription would be 3 clinically appropriate during an initial telehealth 4 visit or, for current patients, telemedicine can allow a physician to conduct pill counts, monitor toxicology 6 screens, and ensure medication adherence or identify 7 aberrant behaviors requiring a change in therapy. 8 For situations where an in-person evaluation 9 would result in a delay in care that could lead to patient harm, the AMA urges that telemedicine 11 prescribing of Schedule II medications be permitted. 12 When a telemedicine visit is scheduled or started, the 13 physician does not know how complex the patient's 14 illness or injury is or what medication or medications may be most appropriate to treat the illness or manage 16 its symptoms until the visit's been completed. 17 It's equally true that not all care could be 18 provided via telehealth, a lesson we have learned 19 well. If a physician determines during a telehealth visit that the patient needs to be seen in person, 21 that should be the next step. The AMA cautions DEA 22 about making new rules allowing only some controlled 23 substances to be prescribed based on telemedicine 24 visits. If at the end of a telemedicine visit the complexity of a patient's medical condition warrants a Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 94 1 prescription for a medication that is not on some 2 approved telemedicine list, the physician's options 3 will be to prescribe a non-optimal treatment or to 4 attempt to arrange an in-person appointment so they can prescribe the appropriate medication. This 6 includes Schedule II medications. 7 The AMA urges a targeted enforcement 8 strategy to deal with illegal online practices rather 9 than new rules that would adversely affect practices that provide high-quality evidence-based care to 11 patients with medical conditions benefitting from 12 Schedule II controlled substances. 13 Safeguards already exist in the Controlled 14 Substances Act and state licensure governing medical and pharmacy practice. The AMA recommends that where 16 it is suspected that the standard of care is not being 17 met and diagnostic integrity and accuracy may be 18 compromised, medical boards pursue focused oversight 19 to ensure appropriate patient care in prescribing of controlled substances. If there is illegal activity, 21 law enforcement intervention may be necessary as well. 22 The COVID public health emergency forced 23 physicians to adopt new ways to ensure evidence-based 24 high-quality continuity of care and increased access to care for patients with chronic conditions. We met Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 95 1 that challenge. Our patients benefitted. We 2 supported the Administration's efforts to extend the 3 PHE flexibilities, and we similarly urge DEA not to 4 reverse practices that are now helping patients. Let me just mention a few other data points. 6 The framework moving forward should avoid a new 7 burdensome recordkeeping requirement. We are 8 concerned about the DEA's proposal regarding records 9 being maintained for investigation purposes. Current DEA requirements for records related to prescribing 11 and dispensing of controlled substances should be 12 sufficient if the DEA needs to conduct an 13 investigation. The DEA already receives a tremendous 14 amount of data from manufacturers, distributors, pharmacies about controlled substances in the supply 16 chain. These entities are required to provide DEA 17 with suspicious order reports to help identify 18 potential problem areas. 19 State PDMPs contain personal health information regarding individual prescribers and 21 patients that's clinical in nature and should not be 22 shared or disclosed to law enforcement without 23 probable cause. DEA has the ability to seek judicial 24 approval for accessing a PDMP or conducting other surveillance activity. We do not believe the DEA Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 96 1 needs more data to strategically target illegal 2 activity, and we would be concerned if DEA proactively 3 sought state PDMP data as a part of data mining or 4 routine surveillance activities. Thank you very much for the opportunity to 6 provide these comments on behalf of the American 7 Medical Association. 8 MR. PREVOZNIK: You mentioned a targeted 9 enforcement strategy. What does that mean? DR. EHRENFELD: It means when you have a 11 signal that there's a problem that you look at those 12 practices that have an aberrant strategy going on and 13 you look at them with scrutiny. 14 MR. PREVOZNIK: Okay. DR. EHRENFELD: As opposed to taking a blunt 16 approach through a regulatory framework that 17 ultimately causes more harm than good. 18 MR. PREVOZNIK: And the -- where did I have 19 it here? I missed one of your -- after the six months you're -- the framework that you had, I had check 21 insurance, travel times, long wait times, and I didn't 22 get that -- what was the fourth one? It was -- stigma 23 was the one after that. 24 DR. EHRENFELD: So, when I was mentioning the framework, there are a lot of barriers to people Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 97 1 accessing in-person care. So health insurance network 2 inadequacy, functional limitations that can make 3 access to in-person services difficult, long travel 4 times, racial disparities in access to buprenorphine versus methadone, long wait times for treatment, the 6 need for a caregiver to accompany the patient, and 7 stigma within the medical community regarding drug 8 users and patients experiencing unstable housing, lack 9 of transportation, childcare are the barriers that we wanted to highlight. 11 MR. PREVOZNIK: Okay. Thank you. 12 MR. STRAIT: Great. Thank you, Dr. 13 Ehrenfeld. And I do want to just make a point of 14 clarification and it bears emphasis because I know that this, I think, is a fundamental assumption or 16 perhaps misunderstanding about our rule or the draft 17 rule that was published in March. And as Anne Milgram 18 mentioned on day one in her introductory remarks, the 19 Ryan Haight Act amended the CSA and required an in-person visit be established and then created an 21 exception to that requirement when the practice of 22 telemedicine was occurring. All right? And then the 23 statute then listed seven or eight different 24 circumstances that constituted the practice of telemedicine. Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 98 1 So one thing that we made clear in our rule 2 and the nature of our rulemaking forthcoming is that 3 when there is already an in-person relationship that 4 has been established, this rule does not in any way, shape, or form somehow impose a new requirement on the 6 types of controlled substances that could be 7 prescribed, the duration of the controlled substance 8 that is prescribed, and the instance in which a 9 patient must then come back and visit the practitioner. And it just bears emphasis because I 11 think we don't want to lose in our translation the 12 fact that this rule is not being applied broadly to 13 all telemedicine encounters across the entire spectrum 14 whether that in-person relationship has been established or not. So I just wanted to make that 16 clarification. 17 I appreciate Dr. Ehrenfeld's comments. And 18 we will now move on to Virtual Presenter No. 12, which 19 I believe is our last presenter for our morning session. Thank you. 21 DR. HUANG: Hello, everyone. My name is 22 Delphine Huang. That's D-E-L-P-H-I-N-E; last name is 23 H-U-A-N-G. Thank you so much for taking the time to 24 hear some of my thoughts and comments. I'm coming as a representative of CalMHSA, which is the California Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 99 1 Mental Health Service Authority. We're a joint power 2 of authority where we work with MediCal counties 3 across the State of California as collaborative 4 multi-county projects that improve behavioral and mental health for patients that are Californian and 6 for MediCal. We work together with them to pool 7 county resources, think about partnerships in 8 leveraging the technical expertise, and think about 9 the strategies. My particular role, I'm a medical director 11 of innovation and design. While a physician, I'm 12 actually responsible for thinking about the user 13 experience and how different services or technologies 14 are implemented. Today, I wanted to share just some 16 perspectives and mostly raise some questions around 17 for just us to think about where I'm curious when it 18 comes to prescribing I think, along with other 19 colleagues that I've heard here today, prescribing our resource-limited populations, which many of our 21 MediCal patients are facing, so we want to understand 22 better from the DEA what are some issues around 23 prescribing controlled substances in a telehealth 24 environment and the impact for vulnerable as well as resource-limited populations, especially in rural Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 100 1 areas, where there are really limited numbers of 2 doctors available. 3 In some of the MediCal counties that are 4 rural, we actually only have one to two child psychiatrists or two to six adult psychiatrists that 6 will be serving the entire county, and they use 7 telehealth as the only means to have the expansive 8 reach that they do. 9 We are also seeing a workforce crisis in mental health currently where we have declining 11 numbers of doctors and/or prescribers due to other 12 competitions, you know, for doctors working in private 13 or for Medicare, as well as an aging provider 14 population. This actually makes it very difficult to recruit and retain talent. We have several counties 16 that have difficulty even recruiting their one child 17 psychiatrist because they actually as a MediCal county 18 will be required to provide in-person services and 19 therefore must hire locally. So we're curious to hear from the DEA, you 21 know, what support if moving forward for these 22 requirements, what are the HIE and data-sharing access 23 that they're going to support, especially around flags 24 and notifications. Currently, CalMHSA has an EHR that we rolled out in July across 22 counties as a Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 101 1 semi-statewide EHR, and other counties are also coming 2 on board. 3 We have taken upon ourselves to create 4 fields where we can track whether or not doctors are reviewing CURES and they can report that, but we're 6 curious to hear because many of the things that they 7 are also requesting for in the EHR is ways in which 8 they can integrate with CURES and get notifications as 9 well as kind of local and population health in order to support their work, which they believe is in 11 accordance of tracking prescribed controlled 12 substances. We have also created ways within the EHR 13 to think about med reconciliation as well as 14 identification of the patient. I'm curious to hear from the DEA what 16 exceptions might be made, especially around some of 17 the things that folks are raising here, which is 18 around given the patient population, especially our 19 MediCal population, which may have difficulties both with transportation and getting themselves into an in- 21 patient appointment. 22 Really, where we see some of the issues are 23 when it comes to how patients are using their 24 controlled substance is really around that piece around data, how data is captured between the visits. Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 102 1 If you think about the visit being only a 15-minute 2 moment of time, what is happening between those visits 3 are actually more important when it comes to patient 4 safety, patient outcomes. A second area that we would love to 6 understand better from the DEA is understanding around 7 CF42 and both the need to respect privacy, patient 8 privacy, but also the need for data-sharing 9 transparency for making decision-making about prescribing controlled substances, especially around 11 Substance Use Disorder providers, SUD, and the mental 12 health and medical. 13 So, as I mentioned, with the EHR that we 14 have launched across our 22 counties and expanding more, there has been a lot of discussion around CF42 16 and how this has led to siloed prescribing. And so 17 thinking we want to understand better from the DEA how 18 they consider the CF42 that currently exists and what 19 it means when it comes to telehealth and data-sharing across different providers. We do think it's really 21 important when it comes to especially controlled 22 substances given the risk to maintain that 23 transparency in order for providers to be able to have 24 clarity on the diagnosis, the clinical decision-making, as well as the medication. Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 103 1 So, once again, thinking about what it means 2 when it comes to HIE and data-sharing when it comes to 3 these prescribed controlled substances and then 4 thinking about how you're tracking patient movement across different siloed systems that currently exist, 6 given that while we are moving towards having a 7 universal EHR, this is still very difficult when we 8 are not necessarily connected to the medical side and 9 then, therefore, if we are thinking about it from a telehealth perspective, these patients may be coming 11 and may have difficulty coming to their appointments, 12 and, therefore, follow-up is very tough to get that 13 information from the patient. 14 That's all my comments here today. More so providing kind of questions to the DEA to learn more 16 around the CFR 42, as well as thinking about how we 17 build accessibility for resource-limited populations 18 that also have very limited access to a small 19 workforce. Thank you. MR. STRAIT: Thank you, Dr. Huang. And I 21 believe that we may have a question, or do you have a 22 question, Tom? 23 Okay. It does not appear that we have a 24 question for you, so thank you for making time for us. And I think we are now going to conclude our Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 104 1 morning session. We will resume our afternoon session 2 at 12:40. I do know that Administrator Milgram will 3 be back for the 12:40 session. I thank everyone on 4 the virtual side for presenting, and those that are watching the livestream, thank you for attending, and, 6 of course, all of you that are here in the audience 7 today. We'll see you at 12:40. 8 (Whereupon, at 11:14 a.m., the listening 9 session in the above-entitled matter recessed, to reconvene at 12:40 p.m. this same day, Wednesday, 11 September 13, 2023.) 12 // 13 // 14 // // 16 // 17 // 18 // 19 // // 21 // 22 // 23 // 24 // // Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 105 1 A F T E R N O O N S E S S I O N 2 (12:40 p.m.) 3 MR. STRAIT: Okay. Welcome back from lunch 4 everyone. Thank you to our in-person commenters who were here early and so patient waiting as we walked 6 through our virtual comments from our morning block. 7 As I indicated, we will now be starting our 8 afternoon block of in-person presenters. I'm happy to 9 report we have Administrator Milgram back for our afternoon presentations as well as Assistant 11 Administrator Prevoznik. 12 So without further ado we will go ahead and 13 call to the stage commenter number one. I'll just 14 give a friendly reminder to all our commenters, if you would, state your name and your affiliation and then 16 spell your first and last name for our transcribers. 17 MS. VAETH: Welcome back everyone. My name 18 is Danielle Vaeth. That's spelled D-A-N-I-E-L-L-E. 19 Last name V-A-E-T-H. Thank you for the opportunity. I represent 21 QbTech, a privately held medical device company that 22 has dedicated the last 15 years to providing FDA 23 cleared evidence-based tools to improve assessment and 24 treatment monitoring for clinicians dealing with ADHD. I stand here today in alliance with DEA, Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 106 1 ATA, AMA, ABHW, ATA, an ADHD patient advocacy group 2 with more than 6,000 adult members and many others for 3 the importance of data-driven and equitable access to 4 telehealth services. We stand that telehealth is health, but 6 mental and behavioral care is health care. And to 7 reiterate Kyle Zebley's comments, that all -- should 8 be regulated on a level playing field regardless of 9 whether in-person or virtual. We appreciate the opportunity to promote 11 better safeguards for telehealth and in-person visits 12 particularly when it comes to prescribing medication. 13 I've been at QbTech for just under a decade 14 and personally have heard from hundreds of clinicians and want to reiterate that the thousands of people 16 including patient stories particularly that of later 17 in life adults like Dr. Teddy or mom Lori, who we've 18 heard from over the last few days, are not unique. 19 I must highlight that ADHD access is a public health issue, not just a private one, and was 21 reminded by expert in the field Dr. Tony Rothstein 22 this morning that none of the science and effort in 23 advancing the field is truly meaningful without 24 access. Based on our experience with over 12,000 Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 107 1 clinicians globally we believe that companies and 2 clinicians should consider adding a level of 3 protection for practices that is not yet widespread in 4 the U.S., leveraging data, better informs treatment and enhances patient outcomes which include those 6 receiving care for ADHD, a most treatable behavioral 7 health condition. 8 My aim is to share how prescriptions via 9 telehealth along the care continuum can be considered alongside FDA-cleared objective measurements in 11 sharing precise dose optimization and mitigating over 12 treatment. 13 Quality measurable data that can safeguard 14 virtual prescribing practices is currently available and utilized by thousands of clinicians nationally. 16 By way of introduction Qbtech, an FDA 17 cleared medical device has been available to U.S. 18 practitioners since 2012. It offers a simple and 19 computer-based test that measures hyperactivity, attention and impulse control. The test can be 21 conducted at home or in a clinic and is interpreted by 22 a trained, qualified health professional. 23 By comparing a highly visual report, 24 incorporating robust data against age and sex controls, clinicians can ensure that the right Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 108 1 patients receive the care that they need. 2 The same test is used to measure symptom 3 changes before and after treatment of any kind, often 4 as we know with Schedule 2's, to ensure effective symptom improvement. 6 Our experience has been that many patients, 7 parents and clinicians alike certainty, confidence an 8 clarity when it comes to both their diagnosis and 9 decisions around treatment. It is often a misunderstood condition both over and under-diagnosed. 11 It is a condition that is underserved in medical 12 training programs. For example 93 percent of 13 psychiatry residency programs do not include 14 formalized training in ADHD. Ill-prepared to accurately assess these 16 patients, clinicians search for objective data to aid 17 diagnostically as well as to quantitatively measure 18 response to treatment and to better titrate medication 19 dose. I not only represent Qbtech but the 21 clinicians we partner with including a clinical and 22 community advocate team, the ADHD Expert consortium. 23 This group created a call to action statement for 24 increased clarity, advanced education, tools and resources for which they have almost 900 signatures. Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 109 1 Their statement underscores the critical need for 2 data-driven care. The group includes the likes of 3 pediatrician James Wiley in Alabama who while educated 4 and resourced on the topic struggled to find an accurate assessment for his own daughter who was 6 initially incorrectly diagnosed with a learning 7 disability. 8 These clinicians add objective data to their 9 care pathway because ADHD is a chronic, prevalent condition. It is one of complexity where management 11 takes nuance. 12 A study by Vogt, Shameli showed that Qbtech 13 computerized objective data could not only identify 14 treatment response in 84 percent of patients, but could also separate those with a partial response from 16 those who are non-responders. 17 This is a pivotal moment in our history 18 where we can continue to provide equitable access, 19 evidence-based tools, and safeguards that have been extended in an already overburdened system. 21 We believe hybrid models of patient care are 22 necessary but need to keep in mind that ADHD has a 23 unique burden in this model as a chronic and complex 24 condition with high prevalence rate. Treated commonly with Schedule II medications, this is a condition Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 110 1 which can be missed. 2 Today we hope to shed light on the role FDA 3 cleared technologies and ensuring that quality ADHD 4 care can be delivered regardless of the delivery model. 6 Measurement based tools are providing 7 clinicians with objective data on symptom severity and 8 treatment response, better informing clinical 9 practice, providing accountability and facilitating safer prescribing practices without the need for an 11 in-person visit. 12 Prescriptions based on data points looking 13 at efficacy as well as time of day help to add 14 safeguards around controlled substance dispensing and to standardize a more step-wise process. 16 Our success extends globally. We have a 17 proven track record in countries that are already 18 prioritizing evidence-based objective data into their 19 pathways. Our testing system is now a standard of care within the National Health Service in England 21 where 70 percent of NHS clinics are routinely using 22 Qbtech testing which after three years of study and 23 70,000 patients we received a nice appraisal this past 24 March. We now serve over 4,000 clinicians in the Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 111 1 U.S. in varying size and geographic locations from 2 FQHCs and universities to health systems and private 3 networks. We know the need for mental health care 4 virtually has increased since the pandemic. ADHD evaluations and treatment especially among adults 6 surged 400 percent since 2020 while the supply of 7 qualified health care providers remains stagnant or 8 sadly decreased. 9 After five years of study, Qbtech launched an FDA cleared remote testing platform, ensuring that 11 quality of ADHD evaluations and medication monitoring 12 remained uncompromised for remote patients. So 13 clinicians like Heather Brannon, a doctor in rural 14 South Carolina, could continue to monitor medication efficacy without compromise just because her patients 16 were receiving care remotely. 17 To date we have tested more than 70,000 18 patients using our virtual Qb test. Our robust 19 quantitative data and highly visual reports are incorporated into clinical interview and patient 21 report symptoms. Qualified health care professionals 22 are trained by our masters level mental health 23 clinicians. 24 In 2023 we conducted over 6500 training episodes in the U.S. ensuring that clinicians are well Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 112 1 equipped to interpret and utilize our data 2 effectively. These clinicians all use testing as a 3 part of their assessment process. 4 Additionally, when it comes to initiating a treatment protocol, particularly for Schedule II 6 medications, many clinicians will conduct a repeat 7 testing on treatment to monitor results over time. 8 Depending on the type of treatment and time of day, 9 the clinician may be looking at efficacy, type, dose, class or consideration of wear-off. This data is then 11 utilized in context of interview and self-report to 12 guide next steps. 13 FDA cleared objective measurements ensure 14 precise dose optimization and can mitigate over- treatment. Objective data should be recorded at each 16 medication change as available, along with evidence of 17 patient benefit efficacy and to mitigate diversion. 18 Many clinicians monitor effectiveness long 19 term every six months to look at changes over time or across the day, both with subjective self-report and 21 objective testing data. 22 We have examples and study data that 23 similarly confirm the efficacy of Qbtech's objective 24 data in measuring treatment response. A study published in 2022 out of North Carolina where patients Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 113 1 completed a self-report and/or testing, were followed 2 up with their clinician at six months. When looking 3 at the patient self-report data alone, 36.6 percent of 4 adults reported improvement. Yet when analyzing their Qbtech results, 85.5 percent showed a measurable 6 change on their treatment, demonstrating that self- 7 report alone misevaluated over 50 percent of patients, 8 or 50 percent or patients were missed with self-report 9 alone when it came to treatment response measuring. Meaning that when employing FDA validated tools, were 11 leaving less subjectivity when it comes to measuring 12 if treatments are working. This could lead to 13 clinicians and patients agreeing on changes in dose or 14 medications that were unnecessary. Our data shows that Qbtech when used to 16 monitor treatment response can distinguish a treatment 17 effect within hours of pharmacological treatment if 18 prescribed a stimulant, meaning clinicians and 19 patients have additional data around treatment decision-making and can further be used for monitoring 21 long-term treatment effect. 22 Pediatrician Dr. Melinda Wellingham, a 23 member of our expert consortium who also serves as a 24 representative for the AAP on the Committee for Federal Government Affairs, who uses Qbtech to serve Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 114 1 an unserved community outside out of Atlanta she 2 describes as a care desert, shared this. In today's 3 evolving health care landscape, telemedicine presents 4 a unique opportunity to harness rich patient data, to advance precision care. By considering data as a 6 vital component in both assessment and treatment 7 response, we empower health care providers to tailor 8 interventions with greater accuracy, elevate the 9 standard of care, and ultimately improve patient outcomes. 11 In conclusion, telehealth is health care and 12 is providing more people with necessary care. We have 13 the ability to provide equitable and objective 14 approaches to care and ensure accurate screening, monitoring and clinical confidence, especially in 16 virtual visits as a safeguard. Together we can earn 17 clinicians with objective tools and enhance the 18 quality of care for those living with ADHD. 19 I thank you for your attention, and I thank you for your caring. I hope together we can achieve 21 what we've dedicated our lives to in making a 22 difference. 23 MS. MILGRAM: Thank you. If I could ask one 24 question. You talked a little bit about, I think you Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 115 1 talked about and I just want to make sure I'm tracking 2 and asking you to expand correctly. You talked a 3 little I think about the guidelines for prescribing 4 and I think I would love for you to expand a little bit on are there sufficient prescribing guidelines for 6 ADHD for children? And are there sufficient 7 prescribing guidelines for ADHD for adults? 8 MS. VAETH: I think I'll leave that up to 9 the clinical community to comment more. I know that AAP and SDBP, the Society for Developmental behavioral 11 Pediatrics, have clinical care guidelines around 12 treatment. The adult guidelines are being built right 13 now by ABSARD which is an organization I'm a member 14 of. But I think there is clarity. MR. PREVOZNIK: Could you expound on, you 16 said there was research platform testing of 70,000 17 patients. Could you -- 18 MS. VAETH: No. We've tested over 70,000 19 patients in our virtual platform. MR. PREVOZNIK: Are there results of that 21 testing? What has it shown? 22 MS. VAETH: Those are the number of people 23 who have had access to our testing via virtual. The 24 data, if you have specific questions about the data and treatment response, we've got 15 studies looking Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 116 1 at treatment response measurement varying in terms of 2 length and duration, time, from looking at efficacy, 3 time of day, for instance, wear-off, those types of 4 things. MR. PREVOZNIK: Okay, thank you. 6 MR. STRAIT: Commenter No. 2. Thank you. 7 DR. MARTIN: Good afternoon. Thank you very 8 much. 9 My name is Stephen Martin. S-T-E-P-H-E-N. Last name Martin, M-A-R-T-I-N. I'm with Boulder Care, 11 and I will also spell that because it is B-O-U-L-D-E-R 12 Care. 13 Thank you so much for this opportunity to 14 share comments on behalf of Boulder Care. We are a joint commission accredited 16 telehealth organization caring for people with opioid 17 and alcohol use disorders since 2017. I have served 18 as Boulder's Medical Director for research, education 19 and quality since early 2019. After attending medical school at Harvard 21 and residency training at Boston University I became a 22 family physician and addiction medicine specialist. 23 For nearly 20 years I have provided in-person primary 24 care in rural Massachusetts, where I'm also a professor of family medicine and community health at Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 117 1 UMass Chan Medical School. 2 I came to DEA headquarters today knowing of 3 your memorial and photographs for some of the people 4 who have been lost to opioids, especially Fentanyl. In my rural office above my desk I have my own photos 6 of health center patients we have lost to overdose as 7 well. I still care for their grieving families. 8 I begin my comments sharing this mutual 9 respect for those we have lost with you and recognizing we are here together to find the best way 11 forward to help everyone in need. 12 Almost 20 years ago in 2004 I was in my 13 residency training at South Boston Community Health 14 Center. An internist faculty member had just begun prescribing Buprenorphine which was recently approved 16 and his panel maximum was 30 patients. When that 17 number went to 29, people in the community knew about 18 it before we did. People were desperate for this 19 lifesaving medicine. Desperate. And we were essentially running a lottery for people to survive 21 addiction to Oxycontin. 22 Twenty years later we now have a lottery for 23 people to survive addiction to Fentanyl. A major 24 reason is that American primary care cannot take on the complexity of this type of care at the scale that Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 118 1 is needed. The numbers speak for themselves. People 2 can't even establish primary care let alone access 3 just in time expertise to care for this life 4 threatening condition. Even with the X waiver eliminated, 6 researchers and practitioners both acknowledge this is 7 unlikely to change the basic calculus of available 8 treatment. 9 If people can't access Buprenorphine through primary care, what are their choices? The outcomes 11 for Naltrexone continue to be disappointing to the 12 point that people have voted with their feet. It is 13 used less than one percent of the time compared with 14 the other two FDA approved medications. Access to Methadone in the U.S. is the most 16 tightly controlled in the developed world and has its 17 own well described and entrenched obstacles that are 18 doing harm. Unfortunately, they aren't likely to 19 change in the near term. If Methadone is not increasing in 21 availability and Naltrexone isn't useful, we are left 22 with Buprenorphine. 23 As a matter of policy, if this medication 24 isn't readily accessed in primary care, where can it come from? A relatively small number of the estimated Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 119 1 7.5 million Americans with opioid use disorder end up 2 at the emergency department where even when they are 3 seen for an overdose they are prescribed Buprenorphine 4 less than ten percent of the time. Twenty years after the scarcity of treatment 6 I saw in South Boston, the scarcity continues. 7 But we're here together because there is a 8 proven solution of telehealth. Let me tell you a bit 9 about Boulder care. Since the suspension of an in-person visit 11 in March of 2020, our clinical team has conducted over 12 50,000 visits on secure video and engaged in 600,000 13 secure telecommunication touch points with several 14 thousand patients. Almost 90 percent of our patients have Medicaid coverage -- the most underserved 16 population in substance use disorders and who have the 17 greatest needs. 18 Over 30 percent of our patients live in HRSA 19 designated rural areas and the vast majority lack transportation. 21 Despite the challenges of being in remote 22 areas, our rural patients have parity in outcomes 23 compared with those who are located in suburban and 24 urban locations as has also been found by other telehealth providers. Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 120 1 Sixty-four percent of our patients who 2 responded to a March survey said they have significant 3 barriers to in-person care, lacking access to 4 transportation, a nearby health care facility that can treat substance use, or a primary care provider, or a 6 combination of all three. 7 Hundreds of patients reported that they fear 8 losing their privacy and anonymity if forced to seek 9 services locally, particularly those residing in small towns. There is shame and humiliation associated with 11 in-person addiction treatment and there are related 12 risks of losing employment, child custody and social 13 standing. 14 Boulder care is relentless about using data to improve our work, publish research, and share 16 insights freely with others who may benefit. We are 17 held accountable for quality care by dozens of health 18 insurers who reimburse based on outcome metrics. 19 Between 2021 and 2023 through grant funding by the National Institute on Drug Abuse we conducted a 21 prospective cohort study with our research partner 22 Oregon Health and Science University, reporting our 23 findings this past June. 24 We found that telehealth only clinics, glocoms (phonetic) were the same or better than Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 121 1 treatment as usual. The study found Boulder Care's 2 six month retention to be approximately 90 percent -- 3 three times the national average for office-based 4 opioid treatment. Another analysis of our clinical outcomes 6 found that patients who stay in care with us for three 7 months have a 50 percent chance of staying with us for 8 more than two years. 9 Our data is consistent with a body of peer- reviewed research including recent reports from the 11 CDC and NIH that indicate telehealth only 12 Buprenorphine care is safe, effective, valuable to 13 society in the midst of a worsening national opioid 14 crisis. This research also finds that an in-person 16 evaluation is not representative or a proxy for 17 quality health care. 18 I can understand the inclination to 19 associate in-person with increased quality of care, but having been in health care for over a quarter 21 century there is a lot of terrible in-person care and 22 a lot of excellent care at a distance. 23 Having two warm bodies in the same room has 24 nothing to do with safer quality care. Everything one would want from a public policy perspective -- Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 122 1 improved equity, health, quality of life and help for 2 vulnerable populations -- is being done with 3 telehealth only care. 4 As practitioners with decades of clinical experience treating patients and prescribing 6 controlled substances in-person and through 7 telehealth, we'd appreciate sharing some 8 recommendations about policies that will impact our 9 ability to provide Buprenorphine treatment for adults. We echo prior comments about minimizing 11 burden place on patients and have ample evidence that 12 a mandatory in-person visit of any type presents a 13 significant barrier many patients will not overcome. 14 We concur with sentiments that regulating a clinical entity is preferable to adding requirements 16 for patients. 17 We caution against adding new forms of 18 patient surveillance not supported by medical evidence 19 or deemed necessary by the treating provider, having seen these protocols deter patients and providers for 21 decades. Examples include prescription dosing limits, 22 short term prescriptions and frequent drug tests. 23 We ask that the DEA consider the extensive 24 local, state and federal oversight already in place to regulate practice standards for practitioners. Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 123 1 Practitioners are already required to report 2 copious information to licensing boards, state 3 authorities, insurers and accreditation bodies in 4 order to practice. The DEA can make use of existing data sources for clear quality indicators and warning 6 signs to identify and root out the potentially few bad 7 actors. 8 A special registration, if enacted, should 9 not create unnecessary administrative burdens on telehealth providers with multi-state practices and 11 avoid exacerbating existing challenges to providers. 12 As stated by previous commenters, providers should not 13 be required to maintain physical addresses or 14 locations in multiple states. Lastly, telehealth prescriptions should not 16 be labeled or red-flagged. Pharmacies, particularly 17 certain large chains, have discriminated against and 18 refused to fill valid prescriptions from telehealth 19 clinicians as described during a SAMSA two-day meeting last year. Any requirement to label a prescriptions 21 as telehealth will further stigmatize and restrict 22 patient access to medication. 23 Pharmacist colleagues from around the 24 country are allies in supporting telehealth based care and do not see a need for such labeling. Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 124 1 Earlier this year we received hundreds of 2 comments from our patients about the hardships an in- 3 person visit would present for them or future 4 patients. With their permission, I appreciate bringing in their patient voice to this listening 6 session. 7 Patient one. To get the medication I need 8 to live a better life, my 75 year old mom was actually 9 driving me and another disabled individual almost every week to our Last Mat program. Not only would it 11 be traumatic to see a new doctor I'm not familiar with 12 as a war veteran with PTSD and dual diagnoses, it 13 would disrupt the continuity of treatment. 14 Patient two. The care I am getting at Boulder is available 24-7. I've utilized their on- 16 call doctor in the middle of the night and to reach my 17 peer support all week. My peer calls back within an 18 hour. My doctor answers my messages within seconds. 19 They have helped me live a safer, better life helping others and living up to my potential. We should be 21 trying to ease patients' fears and trepidation about 22 getting clean and sober, not making it more difficult. 23 Patient three. I've been with Boulder going 24 on two years. Suboxone care through telehealth has saved my life. My doctor's amazing. Although it is Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 125 1 through telemedicine we have a personal relationship 2 and I have an attachment to her, a real connection. 3 She has supported me more than just through addiction 4 and my eight month old baby has her mom back. Making quality treatment accessible ensures 6 that the right thing to do is also the easiest thing 7 to do. The alternative, purchasing Fentanyl on the 8 street for $3 by sending one text message should scare 9 and inform us. We can prevent diversion and overdose by giving people an immediate link to treatment as 11 soon as they are ready. Telehealth uniquely makes 12 this possible. 13 Lastly, very few health care interventions 14 actually scale, maintain quality and improve equity. Telehealth for opioid use disorder does each of these. 16 It Is truly a medical miracle and it is the only 17 demonstrated solution that can help this 18 administration meet its goal of dramatically expanding 19 quality care for opioid use disorder. We ask that you please ensure conscientious 21 telehealth providers can continue to readily offer and 22 expand this lifesaving care as they have for the past 23 three years. 24 Thank you for your time and consideration. MS. MILGRAM: If I could, just a couple of Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 126 1 questions. 2 DR. MARTIN: Please. Thank you. 3 MS. MILGRAM: Thank you so much. To clarify, 4 and I was taking notes -- DR. MARTIN: Oh, certainly. 6 MS. MILGRAM: -- but I might have missed 7 this. So you were talking about the expans -- the 8 removal of the X waiver -- 9 DR. MARTIN: Yes. MS. MILGRAM: -- and the expansion of the 11 number of providers -- 12 DR. MARTIN: Yes. 13 MS. MILGRAM: -- for Buprenorphine but I 14 believe you were saying that American primary care can't take on Buprenorphine. 16 DR. MARTIN: Yes. 17 MS. MILGRAM: I would love to have you 18 expand on that a little bit. 19 DR. MARTIN: Oh, I have a textbook I'm writing -- I'm very dedicated to primary care. I 21 think it is probably the best source of care for this 22 kind of work. 23 In Massachusetts right now if you're in 24 Boston you can't get primary care for six months, and that primary care is not likely to know what to do Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 127 1 with opioid use disorder. 2 In other settings over the country, those 3 data are worse. If you have MEDICAID, worse. If you 4 have no insurance, worse. Again, fewer than 5 percent of primary care providers have an X waiver showing 6 interest prior to the removal of the waiver. 7 The complexity -- this is not hypertension. 8 It really is very different. People are living with a 9 life threatening illness and we have a dedicated phone number for people on Suboxone so they can get right to 11 a knowledgeable nurse that hour, that day, that 12 minute. 13 Primary care, unfortunately, isn't built to 14 do that these days, and I wish it were. I hope to see it do it some day, but we don't have time. 16 I hope that helps. 17 MS. MILGRAM: Thank you. It's very helpful. 18 The guardrails, you talked -- 19 DR. MARTIN: Yes -- MS. MILGRAM: -- a little bit about -- 21 DR. MARTIN: Please -- 22 MS. MILGRAM: -- available data -- 23 DR. MARTIN: Yeah. 24 MS. MILGRAM: -- but it would be helpful to have you talk a little bit about what guardrails you Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 128 1 think should exist around telehealth providers. 2 DR. MARTIN: Oh, certainly. 3 I've been through the generation that came 4 to the prescription monitoring programs and the data that are available there are quite robust. People can 6 tell what Steve Martin is prescribing in any given 7 month to any given set of people in any given 8 location. That's a lot of information to work with. 9 I do think the tracking mechanisms that are available currently can let DEA evaluate not only 11 number of prescriptions but also types of 12 prescriptions and forms Buprenorphine that are 13 prescribed. 14 There are certainly cases where a monoproduct of Buprenorphine is in somebody's 16 interest. But I do understand the policy concern 17 about that becoming a majority of prescriptions for 18 any given provider. 19 MS. MILGRAM: So we had this conversation yesterday. DEA does not have access -- 21 DR. MARTIN: I apologize. 22 MS. MILGRAM: -- to the PDMP. So I think 23 the way to ask you to expand is, would you -- 24 DR. MARTIN: I would. Yes. I would think that a national PMP makes more sense, and I heard that Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 129 1 comment yesterday, I believe. The fragmented approach 2 right now is very difficult. If I have someone in 3 Vermont I have to press a separate box. If I have 4 someone -- and I don't know there what they're counting. Massachusetts looks like Gabapentin, but 6 others don't. 7 Again, I think because the relative downside 8 is relatively low but the upside is that DEA would 9 essentially have a passive collection of information that wouldn't require another degree of surveillance. 11 Thank you. 12 MR. PREVOZNIK: Could you expand on your 13 perspective of audio only and two-way? 14 DR. MARTIN: Yes, yes. Audio only, yes. Boulder, my company, does not do audio only. For good 16 reason, I think. We're in a new terrain, we're not 17 really sure how this will be evaluated. But I have 18 been advocating in Massachusetts on behalf of patients 19 for what we have in Massachusetts which is now law to compel the use of audio only payments. The reason is 21 very clear. Mass General came out with a study very 22 early on in the pandemic showing that the people who 23 are excluded from telehealth care are predictably 24 brown and older people, if video is required. There is no data to show that video is any Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 130 1 more helpful in any part of medicine other than 2 neurologic conditions such as Parkinsonism. 3 The barrier to entry with video is so 4 difficult and highly technical people can't get me on video and vice versa, no matter how hard we try. And 6 it seems to me -- I'm hesitant. It's almost a fetish, 7 this idea that video adds value. It doesn't. It 8 often detracts, unfortunately, and it detracts for 9 people who can least afford to lose care. I hope that helps. 11 MR. PREVOZNIK: It does. 12 How do you evaluate that patient, because 13 clearly this is a very difficult, OUD's a very 14 difficult thing to assess. So how do you assess that on the audio-only call? 16 DR. MARTIN: Certainly, certainly. 17 In my experience, patients present to me the 18 kind of patient that they think I'm looking for, and I 19 try to dispel that as quickly as possible because I want to know who they are as a person. 21 I don't think that's any different with 22 video. I don't think that's any different in person 23 and not with audio. 24 If someone called me and said that they had a Fentanyl disorder and they needed help, I would take Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 131 1 that at face value. 2 If someone wanted all the constraints and 3 difficulties of getting Buprenorphine and taking it, 4 there are far easier things that they could do in their lives. 6 But I think I've been finding that these 7 diagnoses are less difficult to make when someone 8 calls and said I overdosed and was in the ER 9 yesterday. Can I get some help? Hearing that over the phone would work just as well. 11 MR. PREVOZNIK: Thank you. Thank you very 12 much. 13 MR. STRAIT: Okay. Commenter No. 3. 14 DR. RAMTEKKAR: Good afternoon. My name is Ujjwal Ramtekkar, spelled as U-J-J-W-A-L, last name 16 R-A-M-T-E-K-K-A-R. I'm a double-Board Certified 17 Psychiatrist. Administrator Milgram and Assistant 18 Administrator Prevoznik, I really thank you for 19 holding these listening sessions, but as a psychiatrist, I would also say thank you for very 21 thoughtful commenting and very reflective clarifying 22 questions. It just shows your attention, your 23 interest, and your enthusiasm in doing the right 24 thing, so we appreciate that. I stand before you today as my role as the Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 132 1 Vice President and Executive Medical Director for 2 Quartet Health and Intertel Telepsychiatry. We are a 3 URAC accredited behavioral health company committed to 4 expanding access to high-quality mental health and substance use treatment for marginalized under-served 6 populations across rural, urban, and frontier 7 communities. 8 We have been operating for almost a decade 9 now, treating hundreds and thousands of patients across 31 states and Washington, D.C., across several 11 settings, whether it's health systems, federally 12 qualified health centers, community mental health 13 centers, and more recently, in their homes, as well. 14 For almost a decade we have delivered this very vital mental health service to people struggling 16 with all acuities, including serious mental illness 17 and substance use disorders as well. I'm also the 18 Adjunct Clinical Professor of Psychiatry at University 19 of Missouri - Columbia, and a consultant and faculty for several programs across the country that are 21 geared towards building capacity in providing mental 22 health access through primary care, as well, ranging 23 from statewide programs like Missouri Child Psychiatry 24 Access Projects, to learning collaboratives nationally like Project Echo for primary care and mental health. Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 133 1 It has been a great privilege, honestly, to 2 look at the evolution in the one-and-a-half decade or 3 so that I've been involved with telemedicine, 4 particularly telemental health, and as being a part of American Academy of Child and Adolescent Psychiatry 6 and American Psychiatric Association on their 7 telepsychiatry committee, on the quality committee, 8 developing some of the standards of care as to how to 9 deliver high-quality and safe telemental health and telepsychiatry for more than a decade. 11 We have enough data that it definitely 12 increases access, reduces no-shows, improves overall 13 outcomes and quality of care as well, when it's done 14 appropriately within the standards of care, which are, really, already established for more than a decade 16 there, as well. 17 I would like to share the Quartet Health's 18 recommendations today in front of you for the special 19 registration of prescribing controlled substances for the reasons of mental health treatment and substance 21 use disorders. 22 And let me also make a note that this has 23 been the collective voice and expertise, with three 24 other national large telebehavioral health companies: Array Behavioral Health, Iris Telepsychiatry, and Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 134 1 Talkiatry as well. In addition, we have been very 2 fortunate for getting input, expert guidance from a 3 lot of professional organizations like APA, ACAP that 4 represent thousands of clinicians across the country, as well. 6 So, I thank you again for this listening 7 session because it's not just about prescribing via 8 telemedicine; it's also about equity. About 50-to-70 9 percent of patients across the country do not have access to physical psychiatrists or a child 11 psychiatrist. 12 I remember the days where I dreaded getting 13 sick because if I would be out-of-commission for a 14 day, I had nowhere to place those young patients, for about nine months, when kids with autism who have to 16 drive with their parents four hours, in the heat, 17 while they're trying to save the gas money and 18 therefore cannot put the air conditioner on, they're 19 miserable when they cannot afford to find some accommodation or food for a 30-minute visit for a 21 psychiatrist. 22 That's miserable. And that is never a 23 reflection of what is the true state of the child or 24 that adult is, from a mental health perspective. It really makes more sense to see them, evaluate them, Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 135 1 and partner with them in what makes sense for 2 effective and safe treatment in their own equal 3 systems. 4 There are so many stories that we have heard around thousands of patients who would have not had 6 any care at all if not for telemedicine. In the last 7 two-and-a-half years, there are so many stories that 8 we heard that they had a diagnosis, they had a 9 treatment, that they had to discontinue. And the only reason they were seeing me or 11 my colleagues is because there was an option of 12 telemedicine, which they were connecting through their 13 local library's Wifi, with their permission, because 14 they could not even afford that. We have had several stories of patients in 16 frontier and underserved areas where their wait time 17 was three-to-six months and only because of 18 telemedicine it came down to two-to-three weeks. It 19 really is an issue of equity, access, and public health. 21 Unfortunately, last year we logged some of 22 the highest numbers of suicides -- about 50,000 -- and 23 someone told me it's about 3500 large plane crashes is 24 what it is. In one year. That's dark. Something is wrong, and we are really in a mental health crisis. Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 136 1 If we have blanket restrictions that also 2 affect mental health access, then that will be really 3 a problem for the society and for this country. So, 4 at the same time, we really understand and share the DEA's concern about potential diversion, and that's 6 why we are going to put some of these recommendations 7 for effective and safe prescribing of controlled 8 substances Schedule II-V via telemedicine. 9 And this will be for legitimate, appropriate prescriptions through telemedicine, without any 11 in-person care, when it's appropriate. Telehealth, in 12 our general framework, is not inferior than in-person 13 care. Telehealth is not necessarily just a modality; 14 it's a setting in which we deliver care. And sometimes that setting is not 16 appropriate, and that is totally up to the clinician 17 and patient's judgment about that setting being right 18 or not and referral to any in-person care needed -- 19 just as we do not force somebody who needs inpatient treatment to be treated in an outpatient setting. 21 There is no clinician who would say you need 22 in-person care or higher level of care but we still 23 are going to treat you with telemedicine. That just 24 does not happen. That is not the standard of care. So, as the general framework, we would Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 137 1 recommend that DEA implement a special registration 2 for telemedicine, for the short-term, until the agency 3 is satisfied with the longitudinal data of safety and 4 impact on potential diversion of these medications. And we hope it will go away in a few years 6 like the ex-members did. It will be a new 7 registration that would allow a provider to prescribe 8 controlled substances via telemedicine in absence of 9 in-person evaluation of referral, and this would be separate than the existing general statewide DEA 11 registration. 12 However, we recommend that the agency allows 13 the clinicians to have one, single national special 14 registration so that the clinicians are not required to have registration in each state as long as they 16 have one statewide regular DEA registration, or they 17 don't need to have any physical location to store and 18 dispense the medications either, because all of this 19 is happening through telemedicine. Well, in response to the agency's questions 21 for guardrails, we definitely do have some specific 22 recommendations for the safeguards. And again, these 23 are based on already-established clinical standards 24 that we do, no matter whether we are delivering care in telemedicine or in-person. Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 138 1 We would schedule the prescribing through 2 the special registration without in-person care in 3 telemedicine to Schedule II and non-narcotics III, IV, 4 and V. We may require providers to evaluate their patients at least once every 90 days, but should be, 6 again, left to the clinician's discretion around the 7 stability and the safety of the patient. It could be 8 more. 9 But generally for a controlled substance treatment, we could suggest a 90-day restriction, for 11 timing. We can require the providers the capability 12 to furnish a fully HIPAA-compliant audio-video 13 synchronous visits, as well. 14 Now, this would be really important, probably, in our mental health treatments for the 16 initial visits, but it certainly is a burden for a lot 17 of people who may not have access to technology or the 18 other means to make that happen, so follow-up cares, 19 again, could be with audio. But again, it should be at the discretion of 21 the clinician who wants to assess more or want to look 22 for some other signs that requires video, that 23 probably should be left to the discretion of clinician 24 for any follow-up visits. The initial visit, although, could be required for audio and video. Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 139 1 We should be prohibiting from requiring, 2 recommending, or referring to a specific pharmacy or 3 pharmacy chain unless it comes up from the patient, 4 because there may be only one pharmacy in their town and that's their option, so that's reasonable. 6 We would like to suggest excluding ketamine 7 from the list of medications that can be prescribed 8 under special registration because, again, per 9 standard of care, it requires about four hours of in-person observation with the physician on-site. 11 We should be authorizing prescribing 12 medications, but not necessarily storage or dispensing 13 of the medications as well, as a part of this 14 safeguard. And then, limiting the prescribing of Schedule II and non-narcotic medications like 16 stimulants for the treatment of mental health 17 conditions by a physician. 18 That includes primary care providers because 19 now it has become a competency, through their training and their professional organizations, to appropriately 21 train them in that; or with advanced-practice nurse 22 practitioners or physician assistants who have a 23 certified qualification in psychiatry as well. 24 We know that a lot of prescribing happens outside of these specialties, and that's purely a Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 140 1 reflection on access, demand, and supply, and that's 2 really a much-needed thing. But if you were to do it 3 safely, we would recommend that anybody who does not 4 have these certifications as an APRN or RPA, we recommend a one-time eight-hour training requirement 6 by an approved State Medical Board on prescribing 7 controlled substances, not necessarily about 8 particular condition. 9 We obviously cannot manage what we cannot measure, so in response to the DEA's request for 11 additional safeguards, we could propose placing a 12 limit on the number of prescriptions per provider per 13 month. 14 Again, this would be totally based on what would be the average full-time provider who sees 16 patients in an ambulatory setting with a mix of 17 emergency room consultations and, occasionally, 18 probably covering for their physician colleagues who 19 work in the same practice, as a bridge prescription. And, we could also suggest potential data 21 reporting, but with the caveat that the 22 resource-constrained not-for-profit organizations and 23 the providers practicing there be exempt from that, as 24 well. So, from the number perspective, it would Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 141 1 suggest possibly 500 controlled substance 2 prescriptions per provider per month, but its specific 3 circumstances if the provider exceeds that because it 4 is truly their specialty or it's really the specialty population they're treating, that we provide them with 6 an opportunity to write a statement of justification 7 for exceeding that one, rather than automatically 8 red-flagging it, because that might provide us some 9 insights into some legitimate reasons as to why that happened. 11 Second, we suggest the providers to maintain 12 data, and if required, provide the data in non-PHI 13 format, and that would include things like DEA 14 registration number of the healthcare entity, the name of the medication, the, possibly, NDC number of the 16 medication, the number of prescriptions written, and 17 the date of the prescription. 18 Now, I would also mention here that these 19 are the data elements that could be automated and appropriately stored in the electronic medical records 21 without any specific intervention from the provider, 22 because it's already a huge administrative burden for 23 the providers, who often -- myself included -- do not 24 get time to eat lunch. We are doing charting or often working in the evenings, just to complete the charts. Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 142 1 On top of that, if you are given this 2 administrative burden, it would be difficult, for 3 sure, and it might inadvertently reduce access because 4 then providers don't want to engage in that, at all. However, we definitely recognize the need 6 for measurement and data, as some of the previous 7 speakers have already said, and I would echo, that the 8 only prescription that is at-risk of diversion is the 9 prescription that is filled. And so, the real source of truth for that 11 kind of information is the pharmacy data. We also 12 have PDMPs, but we understand that either DEA does not 13 have access to that data, or there's a variability 14 between states about how that is managed and run and there's not really a national system. So this would 16 be a wonderful opportunity for DEA to lobby for 17 creating a national database similar to PDMP to 18 support and access any of those data, as well. 19 We have over two decades of evidence that high-quality mental health services can be safely 21 delivered through telemedicine in-accordance to the 22 standard of care. And so, imposing an in-person 23 requirement for patients seeking these mental health 24 treatments will certainly impede access to psychiatric care and worsen the crisis. Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 143 1 On behalf of Quartet Health and our 2 partners, I want to thank you for your consideration 3 for our recommendations for the special registration 4 and what we believe to be a good, collaborative path forward that will allow DEA to maintain some important 6 controls on diversion, but will also ensure that 7 practitioners can continue to furnish a very 8 high-quality and safe mental health to the patients 9 when they need it, how they need it, and where they need it. Thank you. 11 MS. MILGRAM: Can I ask a few follow-up 12 questions? Thank you so much. I just didn't hear 13 this clearly; you said DEA could lobby for the 14 creation of a national database like -- and then you had a bunch of initials. I apologize. I missed that. 16 DR. RAMTEKKAR: Oh, like the state PDMP 17 programs. Correct. 18 MS. MILGRAM: PDMP -- 19 DR. RAMTEKKAR: Correct. MS. MILGRAM: -- okay. When you talked 21 about a potential guardrail of requiring an evaluation 22 of a patient every 90 days, I assumed you were talking 23 virtually? 24 DR. RAMTEKKAR: Correct. Correct. MS. MILGRAM: Okay, thank you. Just wanted Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 144 1 to make sure. Thank you. And could you just expand a 2 little bit on ketamine and why you think that should 3 be excluded? And also, are there other things like 4 ketamine that you would have similar concerns over? DR. RAMTEKKAR: Correct. So, the rationale 6 for that statement is that it's still a newer 7 treatment, it is a very effective treatment, but we 8 still are looking for more and more safety data, and 9 currently there's a requirement of observation, in-person, with a physician on-site. 11 If the physician is on-site, then there's 12 probably no reason to prescribe it virtually, either, 13 because we are really observing them. And so there 14 could be other potential newer treatments that are still not fully tested in masses and has not really 16 become a standard of care that could include some of 17 the psychedelics, for example, as well. 18 I'm not saying that -- it may not change. 19 That's the good thing about science and evidence of space that it changes, and as it evolves, we evolve 21 our standards of care and safety protocols as well. 22 MR. STRAIT: Thank you so much. And I see 23 Commenter No. 4 coming to the stage, now. I'm going 24 to take a five-minute break at the conclusion of her remarks, just for us to stretch legs, and get out and Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 145 1 use the facilities, if anyone needs to do so. 2 So, I welcome Commenter No. 4 to the stage. 3 MS. NATOLI: My name is Christa Natoli. 4 C-H-R-I-S-T-A, N-A-T-O-L-I. I'm the Executive Director of CTel, the Center for Telehealth and 6 E-Health Law. We're a 501-C3 non-profit telehealth 7 research institute focused on policies and regulations 8 that impact the delivery of virtual care. We are 9 bipartisan and not beholden to any particular stakeholder. 11 I would like to express the deep gratitude 12 of CTel for the opportunity to provide comments today 13 concerning the crucial role played by the DEA in the 14 prescribing of controlled substances via telehealth. CTEL stands alongside the DEA in its commitment to 16 safeguarding our communities from drug abuse, 17 diversion, while supporting policies that promote 18 quality medical care and legitimate patient access. 19 As a research institute, we aim to present evidence supporting the long-term viability of the DEA 21 flexibilities implemented during the COVID-19 public 22 health emergency waivers. Dr. Yael Harris and her 23 team have collaborated with CTEL as impartial 24 third-party researchers. In these remarks, we will present data that Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 146 1 reinforces the ongoing use of telehealth for 2 prescribing life-saving treatments. It's my pleasure 3 to introduce my co-speaker, Dr. Yael Harris, the CEO 4 of Laurel Health Advisors. Dr. Harris has been an invaluable independent researcher for CTel, gathering 6 and analyzing data from across the United States to 7 evaluate the effects of telehealth. 8 MS. HARRIS: Thank you, Christa, thanks for 9 this opportunity. My name is Yael Harris. That's Y-A-E-L, H-A-R-R-I-S. I am the CEO of Laurel Health 11 Advisors, which is a health services research company 12 focused on using data to drive health equity and 13 access. 14 As a health services researcher, I have over 25 years of experience, half of that with the Federal 16 Government Department of Health and Human Services. 17 As a researcher, I love data, so I always look at what 18 the evidence shows me before I endeavor into doing any 19 new research. So, according to the Journal of Drug and 21 Alcohol Dependence, before the pandemic, in most 22 instances, diversion was associated with a real need 23 for treatment among those unable to access a provider 24 or obtain medication. This is a really important finding. Even Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 147 1 though there was illegal diversion taking place, the 2 root cause was access, not abuse or misuse. With the 3 implementation of the DEA's public health emergency 4 waiver, data reported by the American Psychiatric Association provides substantial evidence that the 6 expanded use of telehealth, despite unprecedented 7 growth in telehealth use, did not lead to an increase 8 in diversion. 9 According to data from NFLIS, the National Forensic Laboratory Information Systems, during the 11 pandemic, there was a decrease in buprenorphine 12 diversion. A March 2023 study in the Journal of 13 American Medical Association of Psychiatry confirmed 14 that the increase in telehealth provision of medications for opioid use disorder was associated 16 with a reduced risk for fatal overdoses. 17 Research studies and peer-reviewed journals, 18 including the Journal of Addiction Medicine, Journal 19 of Substance Use and Treatment, and the Journal of the American Academy of Child and Adolescent Psychiatry 21 have evidence that the ability to initiate and renew 22 prescriptions for controlled substances via telehealth 23 increased access to critical vulnerable populations, 24 which include children and young adults struggling to focus and succeed in schools, families of whom are on Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 148 1 either low-income, rural, and lacking proper fusion, 2 which would make it difficult and devastating to take 3 a day of leave from work to get their child care. 4 Pain management for individuals unable to leave their home and seek treatment, and access to 6 medications as a treatment are met for individuals 7 living with a substance use disorder. Also, access to 8 medically necessary Schedule IV anxiolytics for 9 individuals living with some serious mental illness. There's research presented by the Journal of 11 Substance Abuse Treatment points to the fact that, in 12 the absence of telehealth, we would have seen lower 13 levels of compliance for substance use disorder. 14 According to the National Council for Well-Being, many individuals experienced long wait times to get into 16 insurance-covered programs for behavioral health, even 17 those that live in areas where there is a 18 psychiatrist. 19 Access to in-person medical care is a privilege that many Americans with socioeconomic 21 disadvantages, or experiencing mental and physical 22 disabilities, do not have. According to the 23 Commonwealth Fund, as of March 2023, 160 million 24 Americans live in areas with behavioral health professional shortages, with over 8,000 more Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 149 1 professionals needed to ensure an adequate supply. 2 CTel's research has shown that, at the state 3 level, all states accept telehealth to establish the 4 patient-provider relationship, and according to recent data collected by the National Council for Mental 6 Well-Being, the national average wait time for 7 behavioral health services is 48 days. That's nearly 8 seven weeks. 9 Among those seeking treatment for substance use disorder, this wait is untenable. If you ask a 11 substance use specialist, they will tell you that when 12 a person that is living with a substance use disorder 13 is ready for treatment, even a 24-hour wait may be too 14 much. Without the benefit of being able to 16 promptly prescribe buprenorphine to this at-risk 17 population, many individuals who may have benefitted 18 from that therapy will go without. According to the 19 South Dakota Department of Social Services, limited access to MADD is associated with a reduction in 21 relapse and overdose, and greater access reduces the 22 risk of criminal activity and transmission of 23 infectious diseases. 24 Data from the American Academy of Pediatrics shows significant persistence shortages. Wait times Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 150 1 for pediatric Sub-specialists often exceed two weeks, 2 and according to the Children's Hospital Association, 3 families wait an average of almost 15 weeks to see a 4 developmental behavioral pediatrician. As a mother of children with ADHD, I know 6 firsthand the importance of timely diagnosis and 7 treatment. While my children were struggling in 8 school, many pediatric psychiatrists were not taking 9 new patients. As any parent knows, weeks can mean the difference between academic success and failure for 11 your child, affecting their self-esteem, their 12 confidence, and their mental health. 13 And I was fortunate. According to the 14 Centers for Disease Control and Prevention, less than half of children with ADHD even receive treatment. 16 Enabling patients to see providers virtually, as well 17 as receive prescription medications virtually, is a 18 critical component for improving our healthcare 19 system. Research published in the Journal of 21 Substance Abuse Prevention and Policy demonstrated the 22 impact of how increased enforcement to avoid harm 23 associated with controlling substances has actually 24 led to fear and unintended consequences. These include high rates of diversion of Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 151 1 opioid agonists; greater fear of disciplinary action 2 against opioid prescribers, resulting in forced 3 tapering and under-prescribing; and providers refusing 4 to take on patients who legitimately require opioids. The Controlled Substances Act proposed 6 establishing a special registration process, with the 7 key objective of increasing access to needed 8 medications safely. The rationale provided for this 9 registry was to prevent illegal prescribing and potential harms associated with diversion and 11 inappropriate use. 12 As I mentioned by my peers earlier today, 13 less access is actually associated with more misuse. 14 Let me turn it back to my colleague, Christa. MS. NATOLI: CTel is in support of any 16 policy change that will eliminate unnecessary 17 administrative burden on prescribers, while improving 18 access to quality healthcare interactions and 19 curtailing illegal diversion activities. These changes may include the use of 21 existing electronic data sources, including the 22 Prescription Drug Monitoring Programs in every state, 23 or creating a national program. 24 Use of pharmacy data to track and red-flag certain prescribing activity, and enhanced use of Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 152 1 electronic health records to evaluate and end improper 2 prescribing activity, as well as incentivizing 3 legitimate prescribers to flag inappropriate conduct. 4 We understand DEA is seeking input on potential guardrails and safeguards. Those that 6 already exist include medical exam requirements. It 7 is already necessary for the standard of care be met 8 for medical examination evaluation. High quality of 9 care does not require proximity. Physical examination does not always happen with in-person treatment, 11 either. 12 It's a standard of medical care independent 13 of the virtual issue. This is a process independent 14 of whether the exam is done via telehealth, in-person, or from collateral sources. 16 Number two: identity verification. The 17 in-person advantages of identity verification, vitals 18 verified in-person, drug screens, do not need to be 19 completed by a DEA-registered provider and can be done by another team member, such as a nurse, medical 21 assistant, therapist, or case manager, in-conjunction 22 with a licensed medical provider -- either in a 23 brick-and-mortar or in-home. 24 They can also be done via biometrics or in a facility at a point of entry where no DEA-registered Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 153 1 provider is in the building. And finally, number 2 three, prohibiting prescribing based solely on a 3 medical questionnaire. 4 While diversion was an issue even before the widespread use of telehealth, limiting access to 6 prescription medications via telehealth is not going 7 to solve the issue of diversion, but may, in fact, 8 exacerbate it by limiting legitimate prescribing 9 encounters while failing to root-out those diversion activities that have persisted for years. 11 Experience shows, any new burdens are likely 12 to lead to great public health and safety concerns 13 when patients aren't able to access needed medications 14 in a timely manner. As patients and prescribers alike have gotten accustomed to the regulatory flexibilities 16 implemented as part of the COVID-19 public health 17 emergency waivers, our data shows that diversion 18 activity has not necessarily increased. 19 Therefore, restricting these flexibilities is an unnecessary step that will impact patient care, 21 will not preventing problems DEA has identified. 22 To recap, CTel supports the continuation and 23 permanency of telehealth flexibilities made available 24 during the public health emergency wavier, the creation of the special registration, and guardrails Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 154 1 to protect against inappropriate prescribing, while 2 increasing access to life-saving care. 3 On behalf of CTel and the telehealth 4 community, we appreciate your attention to these important matters. Thank you. 6 MR. STRAIT: Thank you, both. Okay. I see 7 that it is now 1:38. We'll just take a five-minute 8 leg stretch or use of the facilities. Thank you. 9 (Brief recess.) MR. STRAIT: Thank you for that short break. 11 I am now pleased to call-up Commenter No. 5 to the 12 podium for his remarks. Thank you. 13 MR. WELLS: Thank you. I got it all written 14 down here. Hello. I'm John Wells, J-O-H-N, W-E-L-L-S, and I'll forego, you know, the typical 16 academics list of, you know, various accreditations 17 and things like that. I'll just say, I'm an 18 Associated Professor of Clinical Psychiatry at 19 LSU-HSC, so Louisiana State University Health Sciences Center, in New Orleans where, at least in part, I 21 specialize in providing integrated and mental 22 behavioral healthcare to remote and rural federally 23 qualified healthcare centers, which we'll call FQHCs, 24 as well as training residents to do so. Now, in Louisiana, we have, you know, quite Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 155 1 a few very rural and remote populations. I have no 2 financial conflict of interest to report. Really, I'm 3 primarily a clinician and a teacher. 4 The focus of my comments today really are to advocate, you know, irrespective of the other concerns 6 which have been spoken about already in terms of 7 specifics around buprenorphine prescribing, you know, 8 things like that -- stimulants for children. 9 The focus of my comments today is really to advocate for special rules in regard to FQHCs and 11 primary care clinics under that aegis -- so the 12 look-alikes as well. These clinics provide 13 longitudinal and, often, really intergenerational 14 patient care. And I've been really fortunate to be able to 16 immerse myself into some very well-functioning FQHCs 17 and see maybe, you know, a vision of what things could 18 be, or maybe it's only nostalgia for what things used 19 to be and things are really moving in a different direction. 21 Clinicians in these settings, they really 22 know their patients very well. They know their 23 patients' families and neighbors. They know their 24 livelihoods and, you know, these clinicians really share the unique economic and geographical challenges Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 156 1 of those patient populations in these FQs. 2 Our patients generally like to attend clinic 3 in-person. It's not always universally the case, but, 4 you know, at times in their lives, they experience limitations on their ability to do so, hence, you 6 know, telemedicine has been such a valuable, sort of, 7 additive tool in general. 8 For a variety of reasons, these remote and 9 rural communities have been profoundly affected by, you know, Schedule II-V controlled substance diversion 11 overprescribing and mis-prescribing, and in 12 particular, benzodiazepines and stimulants are 13 particular areas of concern, you know, for our teams, 14 which is why I'm a little bit hesitant, you know, to see things opened-up too much. 16 And so in that sense, perhaps this is a bit 17 of a cautionary note. One of the most difficult tasks 18 that we, you know, are faced with embedded in these 19 really rural and remote communities is what I call "de-prescribing" -- and certainly I'm not the one who 21 coined that notion -- but especially when our patients 22 have been able to access remote providers who are not 23 invested in their community, you know, we are kind of 24 left to mop-up the mess that's caused. And this is not unique to telemedicine; it Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 157 1 certainly existed before telemedicine. People would 2 drive to Texas and, you know, go get medications in 3 places where they knew they could access them. But 4 telemedicine prescribing of controlled substances certainly made it a lot easier. 6 You know, so, benzodiazepines, opiate 7 narcotics, right, stimulants and now cannabis, where 8 these patients are really getting the prescriptions 9 remote, geographically and culturally, from, you know, the place where really their primary care is housed 11 and where they live. 12 I know as a country we're facing a crisis in 13 primary care and we struggle to really incentivize 14 clinicians to work in these areas. That's one of the reasons why I bring the residents out with me, you 16 know, to try to get them interested. 17 On the other hand, many of the providers who 18 end up, you know, physically practicing in these 19 places came from these places and really have a vested interest in maintaining the strength of those and 21 health of those communities that they're from. 22 They know these populations better than 23 anyone else can, and really share in, you know, the 24 joys and losses and pains of these communities that they serve. So, there certainly is a problem Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 158 1 recruiting people, but when it works, it does work 2 well. 3 So, during the pandemic, telemedicine 4 exploded, as we all know, for a variety of reasons. Telemedicine had, before the pandemic -- and still 6 retains -- a critical role, really, as a tool, you 7 know, for the provision of primary care in these 8 communities. 9 But the community providers in these FQs certainly expressed to me that they are worried about, 11 kind of, a free-for-all of remote providers. It takes 12 away their business, you know, makes their clinic less 13 resilient, and then like I'd say, then we are often 14 left with, you know, mopping-up prescribing that has not been so clean when provided by providers who are 16 not embedded in these communities. 17 Our patients, you know -- just to paint a 18 little bit of a closer picture to home of where I 19 work, you know -- they're fishers, they're off-shore operators, boat operators, you know, they really don't 21 often have access to the same sorts of time scales 22 that we've talked about. 23 You know, like, a month is a very arbitrary 24 thing for somebody who works offshore for weeks at a time or has to travel, you know, many, many miles to Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 159 1 find work and may be there for several months or, you 2 know, who has to fish every hour of every day, you 3 know, during, say, the shrimping season. 4 And so, you know, for that reason, telehealth has really been, as I'd said, a critical 6 tool to help these primary care clinics maintain, you 7 know, their ability to really treat their patients in 8 the best possible way. You know, these clinics are 9 really trusted. And so, you know, I do think that providing 11 mechanisms for scheduled substances, you know, to be 12 prescribed by telemedicine should be expanded and, 13 essentially, made frictionless in a lot of ways. 14 I also do think that, you know, there are some problems with it being opened-up, sort of, 16 willy-nilly. And that's why I like, you know, I like 17 the idea, at least in my own mind, of utilizing, you 18 know, systems that are already in-place like the FQHC 19 system to help ensure that, you know, diversion, misprescribing, safe prescribing, are able to be, you 21 know, to be monitored. 22 So, you know, in this context, I guess I put 23 together some specific recommendations. I think that 24 many of the people who came before me, you know, have, sort of, more sophisticated ideas and better Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 160 1 understandings of what, you know, the national sort of 2 the push is for national providers and large-scale 3 providers. 4 We've talked a lot about the PMP. There are problems with the PMP, and I'm in complete agreement 6 with everyone else who's spoken about that as a 7 resource, really one that should be, you know, 8 expanded to be a national database. 9 You know, we often find problems with reporting from pharmacies and things like that, and 11 presumably -- and also, you know, different types of 12 medications which are not listed in certain states. 13 So those things have all been mentioned. 14 In the FQHC setting, you know, in particular, I mean, we like in-person visits, and we 16 really, you know, like to know our patients. And so, 17 you know, it wouldn't be remiss, from my perspective, 18 you know, to have some controls around whether or not 19 people should be seen in-person, at least at some point early in their course of, you know, being 21 prescribed a controlled substance, whether that's 22 before they are seen in-person or whether maybe it's 23 shortly after they're seen in-person. 24 But, you know, I guess what I would mostly push for is, I think that, as people have pointed out Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 161 1 before me, there are very few bad actors when we're 2 talking about primary care doctors and, you know, 3 community psychiatrists, and so really allowing a lot 4 of discretion in terms of what's the interval at which a patient needs to be seen in-person, you know, should 6 be allowed and should be just documented within the 7 clinical reasoning, which presumably physicians are 8 already, you know, doing. 9 And that would include also, you know, the in-clinic toxicology testing and screening, again, you 11 know, at the prescriber's discretion, because in this 12 FQHC context, right, we really are concerned about, 13 you know, sort of, a panel of patients who live nearby 14 us. And then, you know, finally, I guess, as 16 I've alluded to earlier, the restrictions on, you 17 know, the length of time, you know, 30-day supply, 18 that sort of thing, can be very onerous, especially, 19 you know, in addition, in my patient population, we have a lot of people worried about hurricanes and 21 things where at a moment's notice they might be 22 required to evacuate immediately. 23 And so, a 30-day, you know, supply of 24 controlled substances, the inability to reach your doctor or to have them be able to send, you know, a Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 162 1 stimulant across state lines sometimes can be very 2 problematic. 3 So I understand I'm not, you know, giving 4 really clear guidelines; I just wanted to point-out some issues that I thought maybe hadn't been brought 6 up. Thank you for the time. 7 MS. MILGRAM: Can I ask? Trying to 8 articulate this in your words, a little bit; you 9 talked about tox screens, how often patients should be seen, whether there should be a time limit, and I 11 would just ask you to expand a little bit on a, sort 12 of, I think, related question, which is: when we start 13 talking about deference to physicians and prescribers, 14 when we start talking about standards of care when it comes to prescribing some of the medicines you talked 16 about, should there be specific standards of care 17 related to telehealth prescribing? 18 I may not be articulating this well. If you 19 have someone coming into your office, you're doing a tox screen on a certain basis. If someone's virtual, 21 would you have that be the same timing, or different? 22 You know, would that change how you would see the 23 standard of care if it's a video relationship? 24 MR. WELLS: Thank you for asking that. I think that, you know, my perspective -- at least the Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 163 1 one, you know, that I'm illustrating today -- is 2 somewhat different because I'm not, sort of, 3 advocating for a national, you know, group that would 4 provide it really across state lines, but really, the health of community clinics. 6 And so, to answer your question, you know, 7 all of the primary care doctors that I work with -- 8 all of the psychiatrists and other people that we have 9 embedded in these clinics -- they know their patients. And so, really, telehealth, for us, whether it's 11 telephonic, whether it's with video, whether it's 12 in-person, it's the continuity of care across, 13 usually, multiple generations. 14 And so, you know, that's a little bit of an artificial question because it's no different to me if 16 I've seen a patient for the past 20 years and I have 17 to talk to them on the phone and they're going to be 18 gone, right? I mean, I feel comfortable. 19 But if they go to somebody who they just contact at 12 o'clock at night because they feel 21 anxious and that person is three-states-over, I think 22 that's a different situation. So I'm really 23 advocating for this community health clinic. 24 MR. PREVOZNIK: Actually, that's the last point that you just made is what I'd like to ask you Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 164 1 to expand on. How do you see dealing with that issue 2 of, you know, the patient three-states-away getting it 3 and now you have to mop it up, as you called it. 4 Like, I mean, I'm sure you've had these discussions, and so I'm just trying to pick your brain 6 on what those discussions were on. 7 MR. WELLS: Yeah, I mean, you know, it's a 8 larger problem than I can certainly -- I mean, I deal 9 with it at a granular level so, you know, that's why I really hesitate to advocate for just, sort of, an 11 opening-up of prescribing, you know, for -- and in my 12 world really, it's less, I'm not talking about, you 13 know, treatment for substance use disorders so much as 14 benzodiazepine and stimulant prescribing, okay, which are hugely problematic in these remote and rural 16 settings. 17 And so, you know, I spend a lot of time 18 really saying to people, "You don't need to be on," 19 you know, "six milligrams of Xanax a day that that other good doctor gave you," right? Of course, you're 21 seeing me, not that good doctor anymore, for whatever 22 reason -- whether they've been, you know -- I mean, 23 there's a whole myriad of reasons why they would not 24 longer be seeing them. So, I don't know if that quite answers your Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 165 1 question, but that's sort of the concern on-the-ground 2 in community clinics, I think. 3 MR. STRAIT: Okay. We'll now invite 4 Commenter No. 6. DR. HINCAPIE-CASTILLO: Okay. Good 6 afternoon. I am Dr. Juan Hincapie-Castillo, spelled 7 J-U-A-N, last name H-I-N-C-A-P-I-E - C-A-S-T-I-L-L-O. 8 I am an Assistant Professor of Epidemiology. I'm here 9 representing the National Pain Advocacy Center, or NPAC. As a researcher, I am at the intersection of 11 pharmacoepidemiology and injury prevention. 12 I leverage real-world data to evaluate and 13 promote evidence-based policymaking, and my primary 14 focus is on improving prescribing policies and the provision of equitable pain management. 16 Like I mentioned, I'm here today on behalf 17 of the National Pain Advocacy Center, or NPAC, where I 18 currently serve as President of the Board of 19 Directors. NPAC is a non-profit organization that takes no industry funding and advocates for the health 21 and human rights of people living with pain. 22 This means that I'm here today representing 23 the 50 million Americans who live with chronic pain, 24 the 17-to-20 million Americans with persistent pain so severe that it regularly prevents them from Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 166 1 participating in life activities and work, and 2 millions more with acute or episodic pain. 3 Chronic pain is the chief cause of long-term 4 disability in the United States, and pain frequently accompanies other disabling conditions. The explosion 6 of telemedicine and the shutdowns related to the 7 COVID-19 pandemic and the related PHE proved 8 transformative for countless patients with pain and 9 disability who were otherwise unable to access care. For these vulnerable patients, telemedicine 11 extended a needed breach to critical care, one that 12 the DEA must not now resign. Regarding the 13 prescribing of Schedule II substances for pain, NPAC 14 is chiefly concerned with the continuity of care for patients with long-term pain who currently take 16 opioids. Today, these patients face substantial 17 barriers to care that pose an imminent risk to their 18 health and lives. 19 As public health agencies from the CDC to the FDA have acknowledged, many such barriers stem 21 from government actions like those the DEA considers 22 today. Two studies by Laqyzetti (phonetic) colleagues 23 published in the Journals of Jaman Edward Copeland 24 (phonetic) in 2019 and Pain in 2021, for example, found that upwards of 40 percent of primary care Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 167 1 doctors will refuse to treat a new patient who uses 2 opioids to manage pain. 3 An NBC news piece recently highlighted the 4 plight of a patient who called 150 different providers, desperately trying to arrange care. 6 Disruptions in care are deadly. Many studies show 7 that opioid disruption places patients at increased 8 risk, including a three-to-five-fold increase risk of 9 overdose and suicide. Studied by Plants and Jaman Edward Copeland 11 in 2019, James in the Journal of General Internal 12 Medicine in 2019, Ed Levi (phonetic) in 2020, Ognoli 13 (phonetic) in JAMA 2021, Fenton in Jaman Edward Open 14 (phonetic) in 2022, and La Rachelle (phonetic) open both in 2022, all found a heightened risk for death, 16 overdose, or suicide with opioid disruptions. 17 Even destabilization of dosage carries risks 18 that continues for up to two years after dose is 19 destabilized, according to the study I mentioned by Fenton and colleagues in 2022. 21 Opioid disruptions are associated with other 22 risks as well, including the increased need for 23 emergency medical care and hospitalization, according 24 to Mark and colleagues in the Journal of Substance Abuse Treatment in 2019, and Magnum (phonetic) and Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 168 1 colleagues in the Jaman Edwards Copeland 2023. 2 This life-threatening and 3 health-destabilizing problems affects a substantial 4 number of people. As many as 8 million Americans use opioids to manage pain long-term -- more than 6 three-times the number with a diagnosed use disorder. 7 The DEA has seen the effects of patient 8 abandonment and opioid disruptions firsthand. When 9 the DEA suspended a doctor's license in California, for example, three people died, two of them by 11 suicide. Another, a wheelchair user with dystonia, 12 was able to prevent withdrawal by using a methadone 13 clinic, but the medication did not manage her medical 14 condition. She suffered persistent spasticity that continuously knocked her out of her wheelchair for 16 several months until she was able to arrange 17 alternative care that required her to travel to 18 another state in that condition. 19 The threat to life is not limited to overdose or suicide. Canermest (phonetic), for 21 example, a quadriplegic living in Colorado who 22 recently testified in the Colorado Legislature had a 23 heart attack and woke up on a ventilator after an 24 opioid disruption. At a moment when the street supply is Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 169 1 especially dangerous, when the CDC is warning 2 especially about deaths from counterfeit pills, and 3 when overdose deaths continue to escalate, surpassing 4 107,000 in 2021, making policy decisions to roll-back a proven avenue for care, and one that puts people in 6 harm's way, is reckless. 7 In order to protect continuity of care for 8 this population, our suggestion in-alignment with the 9 questions asked in the DEA framework is as follows: the DEA should allow telemedicine prescribing for 11 continuity of care in these patients by permitting an 12 established opioid dose from a previous in-person 13 prescriber to be continued using telemedicine. 14 This approach is analogous to guess-dosing permitted by SAMSA in an opioid treatment program, or 16 OTP, and is similarly protective of treatment 17 continuity. This is a preferred action, and would 18 leave in-place existing avenues for care for this 19 population. Alternatively, the DEA could allow 21 60-to-90-day initiation via telehealth by a new 22 provider, with appropriate documentation that accords 23 with relevant state medical board rules and 24 procedures. The DEA should also consider allowing a 60-day initiation via telehealth, even for new Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 170 1 prescriptions via telemedicine for pain in situations 2 when people cannot otherwise physically access care. 3 Often, a physical examination will precede a 4 Schedule II prescribing for a new opiate prescription, but care deserts in the United States are vast, and 6 in-person care is a poor proxy for a bona fide 7 healthcare relationship. 8 According to the Health Resources and 9 Services Administration, nearly 100 million Americans live in areas with a shortage of health professionals. 11 Rural areas where many clinics and hospitals have shut 12 down are especially burdened. 13 A 2022 systematic review on the barriers to 14 access to pain care for other adults in rural areas, conducted by Sontay (phonetic) and colleagues and 16 published in the American Journal of Palliative Care, 17 for example, identified transportation-related issues 18 as a major access barrier to pain and palliative care 19 -- precisely the type of barrier mitigated by telemedicine. 21 All impediments to care and continuity of 22 care are likely to be borne disproportionately by 23 people with disabilities, racialized populations, and 24 people living in rural areas or other healthcare deserts. Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 171 1 Disparities in pain experience biases in 2 pain assessment, and inequities in prescribing for 3 pain based on race, gender, gender identity, and 4 disability are all well-documented. In regard to prescribing for Schedules 6 III-V, the timeframes proposed by the DEA for 7 Schedules III-V medications are out-of-sync with the 8 realities of the U.S. healthcare system. According to 9 a large survey of wait times for doctor's appointments in the 15 largest metropolitan areas, conducted by AMN 11 Healthcare, for example, found that the average wait 12 times to arrange primary care was 26 days, with some 13 cities reporting 45 days. 14 For rural areas who are especially scarce, the wait times are longer. The DEA should extend 16 telemedicine to prescribing all controlled substances 17 in areas where patients lack realistic access to 18 in-person providers. 19 Doing so would likely require DEA to abandon existing geographic limitations, which reflect an 21 anachronistic pre-telemedicine world. These 22 considerations are extremely important, considering 23 the continued increase in drug-related overdoses in 24 the country. Patients living with opioid use disorder also need to have access to life-saving medications Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 172 1 that can be prescribed by telemedicine. 2 Now, regarding the Government's interest in 3 protecting against diversion and the evidence of 4 success of telemedicine prescribing amid COVID-19, importantly, the flexibilities that allowed for 6 telehealth prescribing during the PHE do not appear to 7 have resulted in documented harm. 8 A rise in prescription-related drug overdose 9 deaths is not evident in provisional data from the National Centers for Health Statistics. On the 11 contrary, studies that have examined the impact of 12 telehealth prescribing during the PHE found, not 13 surprisingly, that telemedicine prescribing reduced 14 overdose mortality. Notably, three major studies focused on 16 buprenorphine prescribing via telemedicine showed, 17 including a major study in which the lead author was 18 Christopher Jones, the former Director of the National 19 Center for Injury Prevention and Control at the CDC and current Director of the Center for Substance Abuse 21 Prevention at Samsung (phonetic), telehealth 22 prescribing reduced overdoses, providing a literal 23 lifeline to patients who experience lapses in, and 24 barriers to, care. Finally, with regards to the additional Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 173 1 question DEA asked in its framework about appropriate 2 guardrails, should the agency extend teleprescribing 3 of controlled medications. The best solution is for 4 prescription drug monitoring programs to be modified to include the mode by which the dispensed medication 6 was prescribed to identify telemedicine prescriptions. 7 Nevertheless, any such modifications should 8 be accompanied by an explicit avowal from the DEA that 9 telemedicine prescriptions are not inherently inferior, nor suspect, to avoid their being denied by 11 pharmacy chains -- something that we saw happening 12 during the pandemic by major chains in buprenorphine 13 dispensing. 14 A separate recordkeeping system for providers is not a good idea. It raises cost, burden, 16 and security concerns. A duplicative system increases 17 risk of error that may ultimately endanger patient 18 safety. Thank you for your time and for your 19 consideration. MR. STRAIT: Okay. And we're calling 21 Commenter No. 7. 22 DR. ULAGER: Absolutely. Hello, everyone, 23 my name is Dr. James Ulager, J-A-M-E-S, U-L-A-G-E-R. 24 I'm the medical director for a company called Pursuecare that provides addiction treatment Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 174 1 primarily, but not exclusively, by telehealth. While 2 I'm certainly here on Pursuecare's behalf, I'm also 3 first -- as a physician, I always think of myself as a 4 human first, a physician second, and then my affiliation third. 6 As such, my mission in life is not to sit 7 here and defend telehealth as an ideology. My very 8 mission in life is to make sure the patients that I 9 take care of every day don't end up on the fentanyl board that's out here because that made me really sad. 11 It's hard to go to the bathroom here because you have 12 to walk right by that. So that is my purpose, and 13 telehealth is the tool. 14 I would have never in a million years thought when I started a career in medicine that I 16 would be, number one, practicing addiction medicine 17 and, number two, doing it by telehealth. I went 18 through a bit of a conversion and I want to, in two 19 minutes or less, give you insight into that, and really what happens when we're treating a patient with 21 an addiction disorder with buprenorphine. That's 22 really important. 23 Buprenorphine is life saving medicine. The 24 meta analysis of half a million patients published in 2019 found people were eight times less likely to Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 175 1 overdose if they were in an NAT program. That could 2 be buprenorphine, Naltrexone, or methadone, but those 3 latter two have their own challenges. So eight times. 4 And compared to other chronic diseases and part of my agenda is to help people understand that 6 the opiate use disorder is a chronic disease of the 7 brain, as defined by the American Society of Addiction 8 Medicine, just like asthma is a chronic disease of the 9 lung or heart failure is a chronic disease of the heart. This is the same thing. 11 We do not have other pharmacologic 12 treatments in chronic care that reduce the risk of 13 death by eightfold. If we can get to a twofold 14 reduction in mortality, that is hitting it out of the park. The fact that we have a medicine that can 16 decrease overdose death by eightfold is astounding. 17 It's astounding, and it's so amazing that it starts to 18 become concerning to me not that we're rather than 19 asking what safeguards we put around it -- and the safeguards are important and I'll get to that in a 21 moment -- but how do we get this to everyone? 22 It's also life saving medicine because you 23 need to know when you sit across from a patient, 24 whether it's on telehealth or in a room -- and I've done both -- and you watch them coming in ready to Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 176 1 detox off fentanyl, and you watch the transformation 2 that they undergo physiologically, emotionally, 3 socially, in 72 hours, and I'm generalizing but you 4 can see it, in 72 hours, their hair is combed, their teeth are brushed, they're wearing clean clothes. In 6 four weeks from then they have a job. Three months 7 from then they have their kids back. That is why it's 8 life saving medicine. 9 I think most of us know this but this is so important to start the -- there's still this 11 perception that people who are using buprenorphine are 12 still getting high. Most people I've seen who get -- 13 by the time they come to me they haven't been high in 14 years, they're just trying to feel normal, and they can't go to work if they don't feel normal, and they 16 can't take care of their kids if they don't feel 17 normal. 18 The problem is buprenorphine is not 19 available. In December there was a publication that 13 percent of Americans with OUD get treatment, and 21 it's worse in rural areas. That makes it sound like 22 we're a developing country who doesn't have the 23 resources in place to take care of the chronic needs 24 of its patients, and the reason it sounds that way is because that's true. We don't have the resources in Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 177 1 place we need to give people access to this life 2 saving medicine. 3 Why is it worse in rural areas? A lot of my 4 patients don't have cars. They can't afford cars. They live at the end of the dirt road in eastern 6 Kentucky. If they did have a car, they couldn't drive 7 it because they lost their driver's license. I see 8 many patients with one pharmacy and maybe one doctor's 9 office in their town. And I love the FQHC, whoever it was, and my 11 heart is very much -- I was a rural family doctor for 12 over 10 years before I started doing this on 13 telehealth. Again, a big change in my life. But a 14 lot of them don't want to, or can't, go to those places because they may have burned bridges or they 16 may be too ashamed of what they're facing. 17 Other reasons for access. People have to go 18 to work. So when we're seeing somebody in the 19 buprenorphine program, we're seeing you a lot. At first we see you weekly, sometimes even more, and then 21 after three or six months we might go to monthly, but 22 we're never seeing you less than monthly. 23 My patients tell me, like, my boss wants to 24 know where I go every second Tuesday of the month. And, you know, having been an in office primary care Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 178 1 doctor in a small town for a long time, you could not 2 get into and out of my office in less than two hours, 3 I promise you. And I wish that were true, or 4 different rather. I wish it were different, but it wasn't. 6 And so it was a half day affair for people 7 who are trying to get their kids back, stay at work, 8 keep a job, and then it got worse because we want to 9 monitor patient safety, and when people aren't doing this, well, you see them more often. So then that 11 person whose boss wants to -- I said this is a real 12 conversation. Look, my friend, I've looked at your 13 drug screen. I'm concerned about what's going on. 14 I'm just going to give you a week's worth of medicine. Doc, I can't do a week. I'm going to get 16 fired. I'm going to get fired. And we could talk as 17 much as we want about protecting with an ADA or 18 protecting employment, but it still happens. So 19 people need to go to work. And then we just don't have providers in 21 rural areas. So most of the care I provide is in 22 rural areas, and our company provides are in rural 23 areas. There are no providers. Part of the reason I 24 left my rural community in Vermont, where I still live, by the way, that I still practice there, is, and Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 179 1 I would never say that Vermont has it all figured out 2 because we don't, but I knew there was a place in the 3 country that needed the resource more. 4 I'm not going to live in eastern Kentucky and West Virginia right now, but that's where the 6 epidemic of overdoses is worst and the need is 7 greatest. I love seeing my patients in eastern 8 Kentucky. People have been talking about personal 9 relationships. I have very personal relationships with my patients over telehealth. I see most of them 11 way more often than I ever saw any of my primary care 12 patients, and that's very important. 13 So telehealth is a very important part of 14 the solution, but it needs to be safe. I have a number of nurse practitioners I work with and we talk 16 a lot and they ask, say, Dr. Jim, how are we going to 17 keep our patients safe? And then I say we're going to 18 do -- all of the same things that we do in a face to 19 face clinic we're going to do on telehealth. If you're worried about somebody, you see them more, you 21 check the PDMP before every prescription, you check 22 their toxicology. 23 We have developed some unique ways of 24 improving toxicology and getting toxicology. I would say we haven't developed them. We're working with Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 180 1 people who have developed them. We're developing in 2 corporation would be a more adequate way of saying it. 3 We're doing all the same things, and, in 4 fact, some of those things are easier to perform by telehealth than they are when somebody's face to face 6 in my clinic. You could put on a good face when you 7 come to my clinic. When you're at home, I see what's 8 going on at home. I've found people in domestic 9 violence situations. I've realized that people are homeless. When they come to your clinic you don't 11 always find out that they're homeless. When you see 12 where they're calling you from you know they're 13 homeless. 14 And that's all what contributes to what we might call an aberrant thing. You know, not all 16 aberrancy is diversion, but it is always a cry for 17 help, and you can see that so clearly. And my 18 patients who are trying to keep their jobs, they log 19 in with me on their lunch break from their car, during a 10 minute coffee break. Doc, I'd be happy to see 21 you. We have providers who see people into the night 22 because we don't have to staff the clinic. We have 23 people who work second, third shift. I need to see 24 you at 9:00. No problem. We do that. So what about the numbers? And the numbers Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 181 1 are important. It's important that we not think about 2 -- I've heard people talk about telehealth as 3 something scary or whatnot. Let's look at the 4 outcome. And somebody else, I think it was Dr. Martin shared -- forgive me if it was somebody else -- it was 6 retention data. Retention is a great surrogate marker 7 for success. Not a perfect one, but a very good one. 8 Our 90 day retention is 85 percent, which is not quite 9 twice the national average for brick and mortar clinics. I think there's many reasons that that's 11 true. 12 And by the way, not all retention is good. 13 We certainly look for people who, you know what, maybe 14 this person isn't the right person for telehealth. I will also say I've stretched my notion of what is 16 appropriate for telehealth, not because I'm devoted to 17 telehealth, because I'm looking at the alternative. 18 So when people are advocating for in-person care, the 19 alternative is often not, well, do they have telehealth or in-person care, the alternative is 21 nothing. If we can't get the medicine on the end of 22 their dirt road where they don't have a car, their 23 dealer will. 24 So my simple request is just that -- two -- is that it's recognized that, as a telehealth Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 182 1 provider, we're real people. If there's a mess, we 2 need to help somebody clean up, we can be called. 3 There's a phone number on the prescription of who 4 prescribed your medicine. You can get a hold of us. We deeply care about our patients. 6 I watched, I trained in the opioid epidemic 7 in some of the crises of the mid-2000s. I nearly left 8 medicine because of how awful it was. Watched how my 9 fellow colleagues, myself, and my staff were treated in a small town that was getting eaten alive by the 11 opioid epidemic. I do not want that to happen because 12 of buprenorphine I'm prescribing, but buprenorphine 13 and telehealth together are part of the solution to 14 that. And we want to be held accountable in the same way any brick and mortar clinic would be. Thank you. 16 MS. MILGRAM: Thank you. If I could ask 17 just a couple follow up questions. 18 DR. ULAGER: Of course. 19 MS. MILGRAM: You talked about you are using unique ways to check the toxicology. Could you just 21 elaborate a little bit? 22 DR. ULAGER: Yeah. We use an oral swab. We 23 use saliva. I actually don't do it, it's our great 24 staff that does it, so they could speak to that, but there's a number, and they watch the patient put it Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 183 1 in, they read the number, they seal it, and you could 2 tell if they unseal it, and so it's an observed screen 3 that then gets overnighted and gone to the lab. 4 What's beautiful about it is that most urine screens are not observed and this is. This is 6 observed. It's online. Is there a way to cheat? 7 I've watched ways to cheat every drug test I've been 8 able to come up with, sadly, but it's pretty good. 9 It's not bullet-proof, but it's very good. MS. MILGRAM: Could you elaborate a little 11 bit, whether or it's your organization or what you've 12 seen, in terms of is your prescribing done by 13 physicians? Is it done by nurse practitioners? 14 Physician assistants? And there have been some commenters who've suggested potentially requiring 16 additional training for some prescribers that aren't 17 physicians or family docs. Just curious if you could 18 expand. 19 DR. ULAGER: We're primarily a nurse practitioner practice. So, we need to normalize the 21 prescription of this medicine. And it's totally 22 appropriate that my colleagues who are nurse 23 practitioners and physicians' assistants are providing 24 this care. If we didn't have that, access would be terrible. Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 184 1 And we could spend a half day seminar on 2 this: what appropriate collaboration supervision 3 looks like is -- and that's very near and near to my 4 heart -- a much longer answer, but I think that's where the money is. 6 MS. MILGRAM: Last question. You talked 7 about just buprenorphine generally, how do we get this 8 to everyone? You asked the question but you didn't 9 answer it, so can I in one or two minutes ask you to offer your -- 11 DR. ULAGER: Yeah. So I do think telehealth 12 is part of the solution. We remove as many barriers 13 as possible, is how we do it. The message I was 14 intending to send is I think the burden of proof is on the people -- people. I don't want to personalize us. 16 The burden of proof. Show me -- If we have something 17 that's eightfold effective in mortality, show me that 18 telehealth is dangerous. I'm being a little 19 provocative by saying please don't show me that telehealth needs to be saved. I'm flipping the burden 21 of proof a little bit. 22 And I don't entirely believe in that, by the 23 way. It's more of a rhetorical question, because I do 24 think we have a burden of doing no harm in everything we do. So I'm not being overly provocative. How do Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 185 1 we get it to people? We train more people. We 2 normalize it. We normalize. We normalize. 3 One concerning statistic I've heard a few 4 times today is a red flag that a certain clinician prescribes -- X number of percent of their 6 prescriptions are buprenorphine. I will save you the 7 time. It's almost all of my prescriptions because 8 that's what I do for a living. 9 We would never tell an oncologist that they're prescribing too much chemotherapy. Why is all 11 your medicine chemotherapy? Why is it all asthma, not 12 (sic) COPD medicine? That's not a thing. Of course 13 most of my prescriptions are going to be for 14 buprenorphine, because that's what we do. That's my specialty. We need to normalize it, like any other 16 chronic disease. 17 MR. PREVOZNIK: I would just like to get 18 your thoughts on -- we had a presenter yesterday who 19 was in Tennessee and he said he couldn't even think of the last time he had someone that came in just 21 suffering from OUD because of the methamphetamine, 22 because of benzos. Are you seeing that? 23 DR. ULAGER: Yes, we do. And that's a good 24 example of some of what I think is appropriate and inappropriate for telehealth. The benzodiazepine use Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 186 1 disorder is very difficult to manage by telehealth 2 because with withdrawal you have to check blood 3 pressure, you have to check pulse. 4 And, by the way, in two years, if there's a way -- or there are ways to do that by telehealth now, 6 but if they're more available and they're easy to do, 7 I would retract that statement. Right now the way we 8 do, so if somebody says, oh yeah, and I find that, 9 look, there's benzodiazepines in your tox screen, I would love to take care of you on our telehealth 11 platform, but that's not where we're going to be able 12 to help you. 13 Methamphetamine is different. I wish we had 14 better medicine for methamphetamine use disorder. We have some. They're not the best. And we need to be 16 with people while they're on their journey with meth 17 while we're keeping them safe on opiates. So those 18 people we do retain in our practice. We see them a 19 lot more often. We see them weekly instead of -- you know, they don't get to that month long thing. Thank 21 you. 22 MR. STRAIT: And we now have Commenter No. 8 23 to the stage. Thank you very much. 24 DR. CRISSMAN: DA Administrator Milgram and Deputy Assistant Administrator Prevoznik, thank you Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 187 1 for the opportunity to testify today. My name is Dr. 2 Halley Crissman, H-A-L-L-E-Y, C-R-I-S-S-M-A-N. I use 3 she/her pronouns. I serve as the associate medical 4 director and director of gender-affirming care at Planned Parenthood of Michigan, an affiliate of 6 Planned Parenthood Federation of America. 7 Planned Parenthood is the leading advocate 8 for high quality, affordable sexual and reproductive 9 healthcare for all people in the United States. As healthcare providers, Planned Parenthood's nearly 600 11 affiliate health centers prescribe patients medication 12 as medically necessary and appropriate, which includes 13 controlled substances, like testosterone, which will 14 be my focus today. I am a Board-certified 16 obstetrician-gynecologist, and I have a Master's 17 degree in public health. In my role at Planned 18 Parenthood I get to oversee gender-affirming hormone 19 care for more than 2,200 patients across 13 health centers and via telemedicine. My clinical work 21 focuses on reproductive and sexual healthcare for 22 gender diverse people. 23 I've published numerous peer-reviewed 24 journal articles related to gender diversity and gender affirming reproductive healthcare, and I've Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 188 1 trained more than 20 advanced practice providers in 2 gender-affirming hormone care. I also serve as 3 adjunct clinical assistant professor in obstetrics and 4 gynecology at the University of Michigan where I see patients both in-person and via telemedicine for 6 gender-affirming care. 7 Today I am proud to testify about the 8 critical need for testosterone to remain available 9 through a telemedicine prescription without an in-person evaluation requirement. Gender-affirming 11 care refers to a range of services provided to support 12 transgender, nonbinary, and gender diverse people. It 13 includes care related to physical, mental, social 14 health needs, and well-being, all affirming a patient's gender identity. 16 Medically necessary gender-affirming care 17 includes mental health counseling, non-medical social 18 transition, and, most relevant for the DEA's work, 19 gender-affirming hormone therapy. Gender-affirming hormone therapy, as well as other forms of 21 gender-affirming care, is the evidence-based standard 22 of care. 23 Appropriate recipients of this necessary 24 form of treatment are identified on a case by case basis with their healthcare provider. Gender-affirming Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 189 1 care is life saving care. It has implications that 2 are incredible for mental health and well-being. My 3 clinical experience has made it clear that 4 testosterone can be safely and effectively prescribed via telemedicine and that this path is essential for 6 patient access. 7 Since the DEA waived an in-person evaluation 8 requirement, providers have developed thorough 9 standards and protocols for attuned and high quality medical care via telemedicine. Every day via 11 telemedicine, patients and providers expect and build 12 full patient-provider relationships. Telemedicine has 13 proven essential for my patients to access 14 gender-affirming care, many of whom began treatment during the COVID pandemic because telemedicine care 16 made it possible for them to access care. 17 In Michigan where I practice, telemedicine 18 has played a crucial role in expanding access to 19 gender-affirming care, allowing the concentration of healthcare providers in the southern portion of the 21 state to expand their reach to the northern portion. 22 Requiring even a single in-person visit to access 23 testosterone could mean that many of my patients will 24 be prevented from accessing gender-affirming therapy, a potentially catastrophic result for their health and Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 190 1 lives. 2 In the months since the declaration of the 3 end of the public health emergency, which should be a 4 good thing, I have fielded countless calls and messages from patients worried they won't be able to 6 travel for an in-person visit, terrified they will 7 lose access to the care that has been a literal 8 lifeline. 9 Gender-affirming hormone care with testosterone is incredibly well-suited to telemedicine 11 care. Testosterone is a non-narcotic Schedule III 12 substance for which safety and diversionary concerns 13 are notably low. Testosterone is not an addictive 14 substance. In my years as a clinician, I have not seen a patient abuse or intentionally misuse 16 prescribed testosterone. 17 I understand the DEA's interest in ensuring 18 there is a diversionary framework in place, but an 19 in-person evaluation is neither the only, nor the best, solution. Moreover, the DEA's diversion goals 21 are advanced by providers reviewing recent PDMP, or 22 prescription drug monitoring program, data. 23 For testosterone, blood labs are typically 24 the only important information for safely initiating and monitoring testosterone therapy that cannot be Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 191 1 obtained directly during a telemedicine visit. 2 Thankfully, healthcare providers are well-accustomed 3 with protocols for having patients obtain labs locally 4 and are not reliant on labs obtained concurrently with an in-person visit. 6 Instead of an in-person visit requirement, 7 healthcare providers can instead order blood labs 8 which can be obtained at a healthcare facility or 9 commercial lab local to the patient and then transmitted to the ordering provider for review. 11 These avenues for obtaining lab results allow 12 healthcare providers prescribing testosterone to make 13 their own assessment of the patient, while being 14 equipped with information about the patient's physical state via review of pertinent lab results. 16 An in-person evaluation for testosterone 17 requirement is medically unnecessary and burdens 18 patients that would be disproportionately impacting 19 individuals affected by systemic and institutional forms of oppression. 21 Planned Parenthood centers, including those 22 I oversee, provide inclusionary care, but many members 23 of the LGBTQ+ communities, particularly trans and 24 nonbinary individuals, face discrimination and forms of violence when seeking healthcare, including Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 192 1 misgendering, invasive, unnecessary questioning, 2 unwanted touching, and abusive language. A recent 3 survey found that approximately half of transgender 4 and nonbinary respondents reported having at least one of these kinds of negative experiences with a doctor 6 or healthcare provider in the last year. 7 A particular vitriolic discourse now runs 8 rampant in some state governments and local 9 jurisdictions, compounding longstanding access issues. Gender-affirming care is healthcare. It has clear 11 support from all major American medical professional 12 associations, including the American Medical 13 Association and American Pediatric Association, but 14 numerous states have severely restricted access to gender-affirming care. 16 In 2022, state legislatures across the 17 country introduced more than 100 anti-trans bills. In 18 2023, there's been a dramatic expansion of anti-trans 19 legislation. Almost 500 anti-LGBTQ+ bills have been introduced in state legislatures this year. Roughly 21 130 of these target trans healthcare. These bills are 22 extremely harmful. People of all gender identities 23 deserve civil and human rights -- I shouldn't have to 24 say that -- including the right to high quality, affordable, and non-judgmental healthcare. These bans Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 193 1 actively impede access to care and stigmatize those 2 who seek it. 3 In this climate, telemedicine access for 4 testosterone is essential. An in-person evaluation, or a referral for one, is, for many people, simply 6 unattainable. A return to in-person evaluation 7 requirements would interrupt patient care and, for 8 some, present insurmountable barriers to accessing 9 prescriptions for testosterone that they need, particularly for patients who are young, live in rural 11 areas, are working to make ends meet, or live at the 12 intersection of multiple of these. 13 With respect to practitioner record keeping, 14 providers' record keeping obligations and practices are already robust. For provider privacy and personal 16 security, and because records could be misused by 17 hostile lawmakers to target individuals who have 18 obtained gender-affirming hormone therapy, providers 19 should be required to document only their city and state during a telemedicine appointment and maintain 21 any records at the registered location of their 22 dispensing registration. 23 Planned Parenthood's concern about the risk 24 of entities hostile to gender-affirming hormone therapy misusing prescribing records to criminalize Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 194 1 patients and/or providers, like me, who receive and 2 provide this medically necessary care, extends to all 3 data keeping requirements, as well as to the DEA's 4 consideration of a special registration. Planned Parenthood strongly urges the DEA to 6 exercise caution in deciding how to implement such a 7 registration. It is imperative that it be maximally 8 protective of patient and provider safety and privacy, 9 and does not burden access to care. In sum, because testosterone prescriptions 11 made via telemedicine are safe and effective, because 12 an in-person evaluation requirement would severely 13 interrupt care for patients who need access to 14 testosterone, and because there are alternatives the DEA could utilize to ensure a satisfactory 16 diversionary framework, Planned Parenthood strongly 17 advocates for the DEA to permit telemedicine 18 prescription of testosterone without burdening 19 patients with an in-person evaluation. Thank you for the opportunity to testify. 21 MS. MILGRAM: So a question, and I'm going 22 to ask you a general question that a number of folks 23 raised the same issue yesterday around provider 24 privacy and not wanting to have the specific address. You just mentioned, I think you mentioned, city and Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 195 1 state. What about zip code? If you could just sort 2 of expand a little bit about where you think that line 3 might be, that would be helpful. 4 DR. CRISSMAN: I don't know if I can comment on a specific line in the sand without seeing 6 something written, and I know we would be happy to 7 submit written comments, but what I would say is if 8 the DEA thinks that a national registry is necessary, 9 or that collecting more details of location are necessary, we urge adequate protections of this highly 11 sensitive medical information and urge cognizance, in 12 particular in relation to gender-affirming care, of 13 the hostility and real dangers that patients and 14 providers may face if this information is in hostile hands, including of regulators who are anti-trans. 16 Thanks. 17 MR. STRAIT: And we now have Commenter No. 9 18 coming to the podium. 19 MS. RIGSBY: Good afternoon. My name is Jessica Rigsby. That's J-E-S-S-I-C-A. Last name 21 Rigsby, R-I-G-S-B-Y. I am the head of legal 22 compliance at Ophelia Health. I'm a licensed attorney 23 as well as being certified in health care compliance. 24 I've been in the OUD treatment space for many years. Initially with a typical brick and mortar Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 196 1 clinic organization and now in telemedicine. I can 2 say from experience the additional privacy and ease of 3 access in telemedicine helps patients get in and stay 4 in care well beyond what is standard in-person treatment. 6 I'd like to start by thanking the DEA for 7 this opportunity to speak about the special 8 registration. I'm here today on behalf of Ophelia, 9 our clinicians and our patients. Ophelia provides medical treatment via 11 telemedicine for opioid use disorder and mental health 12 care under a team-based medication and counseling 13 model. Our mission is to make health high quality, 14 evidence based MOUD care safe, affordable and accessible to all. 16 I want to highlight that it's important to 17 understand that we believe telemedicine is a 18 complement to and not a total replacement for in- 19 person care. Telemedicine adds to the treatment ecosystem improving access, outcomes, satisfaction and 21 reducing costs. 22 During the last three years, Ophelia has 23 navigated through state and federal level regulations 24 an PHE flexibilities and at the same time proven that telemedicine MOUD care is safe and effective. Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 197 1 We've seen telemedicine decrease the 2 treatment gap which is one of the main drivers of the 3 epidemic of opioid overdose deaths. More than 80 4 percent of our patients had not received any type of OUD treatment before coming to us, demonstrating how 6 clearly telemedicine creates access. 7 We've also spent time publishing studies to 8 demonstrate and share what we've learned, including a 9 study that showed high treatment retention rates, irrespective of patient geography and race or 11 ethnicity. We've learned that 80 percent of patients 12 stay in care for at least six months if they can use 13 their in-network insurance benefits, but that some 14 insurance plans are skeptical of contracting with us due to the uncertain future of telemedicine controlled 16 substance prescribing. 17 I won't spend my time today reiterating all 18 the wonderful points others have made at these 19 sessions about how much telemedicine increases access, reaches populations otherwise unserved, et cetera, et 21 cetera. Ophelia submitted a lengthy comment in March 22 to the proposed rules which outlines all of that. 23 Instead I'm going to talk about some basic 24 best practices for telemedicine in general, follow up with best practices specific to telemedicine MOUD, Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 198 1 discuss a few misconceptions about at-home urine drug 2 screens, and also some truth about Buprenorphine. 3 All telemedicine prescribers regardless of 4 the conditions that they treat should be adhering to basic best practices and regulatory requirements. 6 This is a non-exhaustive list, but maintaining 7 clinical licensure and of course DEA registration in 8 good standing. Compliance with all state and federal 9 laws including state-level controlled substance registrations and any collaborative or supervision 11 requirements for nurse practitioners and physician 12 assistants. 13 We should all be abiding by clinically 14 appropriate policies and procedures specific to the care that we provide. And we should have established 16 processes for assessing patients for appropriateness 17 for telemedicine care and be prepared to refer 18 patients to in-person care either initially or at any 19 point during treatment when it becomes indicated clinically or becomes patient preference. 21 We should have protocols for detecting and 22 managing emergencies and protecting confidentiality. 23 Telemedicine providers should be willing to 24 participate with major insurance plans including public and private payers. And we should all be Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 199 1 addressing commonly occurring medical and psychiatric 2 comorbidities. 3 Clinicians prescribing Buprenorphine for OUD 4 via telemedicine should additionally be adhering to requirements like using synchronous audiovisual 6 clinical visits as a standard. Diversion prevention 7 and detection protocols to include the use of all the 8 tools available to us. Things like PDMP checks before 9 every single prescription, real time UDS screen protocols, film or pill counts when clinically 11 indicated, and advising patients on safe medication 12 storage. 13 Clinical leadership and supervision should 14 be done by qualified addiction medicine or psychiatry specialists and should conduct internal clinical 16 oversight like clinical case reviews and clinical 17 support for monitoring controlled substance 18 prescribing. 19 Clinical models should include minimum standards of care such as obtaining patient medical 21 and psychiatric history, collaborating with outside 22 providers like a patient's primary care physician or 23 other specialty care providers. Real time audiovisual 24 clinical evaluation starting with higher frequency and decreasing as patients stabilize with a minimum of at Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 200 1 least one clinical visit per month per patient. A 2 treatment agreement with the patient and a documented 3 clinical treatment plan as well as periodic UDS and 4 maintaining comprehensive medical records of treatment and medication accounting. 6 OUD telemedicine clinicians should build 7 referral and consultation relationships with treatment 8 programs in communities where their patients live. 9 These relationships should include primary care and specialty care services as well as other in-person OUD 11 care options including OTPs and residential addiction 12 care. Often OUD care is a patient's first meaningful 13 connection with health care and we should be using 14 this opportunity to connect them to other crucial preventative and comprehensive health care. 16 Before I move on, a few things about 17 diversion management. 18 We prevent diversion the same way in-person 19 care does, by establishing good relationships with patients, assessing their progress, and maintaining 21 open communication. All that in partnership with 22 regular documented PDMP review and urine drug screens. 23 The topic of urine drug screens has come up 24 a number of times in these sessions. Anyone who has been in health care for any time at all has heard a Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 201 1 wild story about a patient's attempt at faking a UDS. 2 Interestingly, though, a 2022 study found very low 3 rates of falsification of urine drug screens among 4 patients of OUD receiving treatment via telemedicine. Our own study at Ophelia which included 6 close to 3400 patients which were monitored for at 7 least 180 days was recently published in JAMA. It 8 showed that it is feasible to conduct regular urine 9 drug screening in a remote setting with very low rates of unexpected results such as being negative for 11 Buprenorphine or positive for other opioids. 12 At-home UDS kits are simple to use, screen 13 for multiple substances, include built-in tampering 14 prevention such as temperature readings and indicators of adulteration. These results are easy for 16 clinicians to obtain and view during a clinical 17 audiovisual visit with the patient. Every Ophelia 18 patient has at least one if not more sealed UDS kits 19 on hand at all times. We can also refer patients to local labs such as Quest if more sensitive or 21 comprehensive testing is indicated. We have detailed 22 UDS protocols and keep extensive records on the 23 collection and results of each UDS. 24 Now onto Buprenorphine. We understand the DEA's concern about Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 202 1 diversion in telehealth in general, but Buprenorphine 2 is different from other controlled substances. It has 3 a much different risk-to-benefit ratio. 4 Buprenorphine isn't a recreational drug. It blocks the opioid receptors in the brain, minimizing 6 cravings associated with OUD without producing a high 7 when used as prescribed. 8 Studies have repeatedly found that diverted 9 Buprenorphine is an attempt by individuals to initiate OUD treatment they don't have access to on their own. 11 Studies also indicate that 70-90 plus percent of 12 people who use illicit Suboxone report using it to 13 prevent cravings and withdrawal. 14 A recent study by health authorities found that despite increases in Buprenorphine prescribing 16 after the onset of COVID, there was not a correlating 17 association with the prevalence of Buprenorphine among 18 overdose victims. This study replicated findings from 19 an earlier study in New York City showing that Buprenorphine was incredibly uncommon in the toxology 21 reports for overdose victims, speaking to its risk 22 protective profile. 23 Our data speaks for itself. At Ophelia 24 we've treated over 10,000 patients during the past three years with only 10 overdose related deaths Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 203 1 reported to us. That is one-tenth of one percent and 2 it's well below the incredibly high rate of mortality 3 otherwise observed among individuals with OUD which is 4 typically 1 to 2 percent annually, possibly higher at this point with dangerous Fentanyl exposure. 6 Many individuals treated with Buprenorphine 7 are alive today because they were able to access this 8 treatment via telehealth. We firmly believe that 9 every patient in care is one less person seeking diverted opioids. We reduce diversion not just among 11 our patients with our internal monitoring protocols, 12 but by reducing the number of customers in the market 13 for diverted opioids. 14 SAMSA's own publications show that patients who discontinue OUD medication generally return to 16 illicit opioid use within just a few weeks or months. 17 Low barrier of access to quality Buprenorphine care 18 prevents diversion. 19 One final point. The opioid PHE is still in effect and has been for six years. We would ask the 21 DEA to repeat the flexibilities and extend it to all 22 controlled substances during the COVID PHE to 23 Buprenorphine under the opioid PHE for as long as it 24 lasts. In closing, we are directly addressing the Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 204 1 root cause of the opioid PHE one patient at a time. 2 We like to think we are your partners in the fight 3 against diversion and not the cause of it. 4 On behalf of our current patients and all those still looking for an answer to their OUD, thank 6 you for taking the time to listen to our 7 recommendations. We appreciate your care and your 8 attention. 9 MR. STRAIT: Thank you. I'm going to ask Commenter No. 10 to pause 11 before coming up. We're going to take just a five 12 minute leg stretch break. So we will come back at 13 2:55. Thank you. 14 (Brief recess.) MR. STRAIT: Let's get started. 16 I am happy to call Commenter No. 10 to the 17 podium. 18 MR. FERNANDEZ-VINA: Marcelo Fernandez-Vina, 19 M-A-R-C-E-L-O F-E-R-N-A-N-D-E-Z hyphen V-I-N-A. I'm with the Pew Charitable Trusts. 21 Good afternoon. I'm Marcelo H. Fernandez- 22 Vina appearing today on behalf of the Pew Charitable 23 Trust Substance Use, Prevention and Treatment 24 Initiative. Pew works with state and at the federal Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 205 1 level to address the nation's opioid overdose crisis 2 by developing solutions that improve access to timely, 3 comprehensive evidence-based and sustainable treatment 4 for opioid use disorder. The Pew Charitable Trust through its 6 Substance Use, Prevention and Treatment Initiatives 7 recommends that the pandemic flexibilities allowing 8 for Buprenorphine prescribing by all DEA registered 9 practitioners via telehealth without an in-person requirement be kept in place permanently. 11 Overdose deaths have reached unprecedented 12 levels in recent years with over 100,000 overdose 13 deaths occurring in 2022, the majority of which 14 involved opioids. In light of the public health crisis we 16 face, access to Buprenorphine should not be 17 restricted. Therefore, Pew urges the DEA to take 18 steps to maintain access to Buprenorphine in order to 19 curb the overdose epidemic. Allowing health care providers to prescribe Buprenorphine remotely during 21 the pandemic helped more patients start and stay in 22 treatment without increasing overdose deaths. 23 The pandemic telehealth flexibilities helped 24 veterans, people experiencing homelessness, individuals involved in the criminal justice system, Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 206 1 those living in rural areas, and racial and ethnic 2 minorities access Buprenorphine via telehealth with 3 audio-only visits helping many of these patients 4 access care. Allowing Buprenorphine to be prescribed via 6 telehealth decreases challenges associated with the 7 transportation and geography and helps patients with 8 work and child care responsibilities. Telehealth 9 improved access to care for rural and hard to reach populations, reduced wait times, and worked around 11 challenges with child care, work, transportation and 12 stigma. 13 Under DEA's pandemic flexibilities, 14 Buprenorphine was safely and effectively prescribed via telemedicine and reached more people including 16 people that traditionally face challenges accessing 17 Buprenorphine by centering patient access, comfort and 18 empowerment and reducing barriers to treatment. 19 DEA's pandemic flexibilities improved access to Buprenorphine by allowing patients to start 21 lifesaving medication via telehealth without having to 22 see a provider in person. 23 In multiple studies both patients and 24 prescribers report positive experiences with telehealth for Buprenorphine prescribing, including a Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 207 1 greater sense of ease, flexibility and autonomy for 2 patients. 3 Earlier this year researchers at Harvard 4 Medical School found that providing OUD care via telehealth may be comparable to in-person OUD care and 6 no evidence indicates that telehealth for OUD care is 7 unsafe or over-used. 8 A study published in JAMA Psychiatry found 9 that Medicare beneficiaries who received telehealth services related to OUD were more likely to stay on 11 medication and less likely to experience an overdose. 12 Similarly Veterans Health Administration 13 patients using telehealth for Buprenorphine treatment 14 were more likely to stay in treatment than patients being seen in person. 16 Based on this information additional 17 requirements for prescribing Buprenorphine via 18 telehealth including a special registration impose 19 arbitrary, non-evidence based barriers to lifesaving treatment. 21 During the pandemic all prescribers were 22 able to utilize telehealth with no special 23 registration requirement. Given the administration's 24 and this agency's commitment to prioritizing meaningful interventions that address substance use Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 208 1 disorders, DEA should carefully consider the effects 2 special registrations can have on restricting access 3 to Buprenorphine treatment. 4 Both DEA and the National Institute on Drug Abuse agree that increased Buprenorphine prescribing 6 decreases diversion. DEA has previously stated that 7 it's actually lack of access to Buprenorphine that 8 drives Buprenorphine diversion, and that increasing 9 access to medication may be an effective way to prevent diversion. 11 The National Institute on Drug Abuse has 12 also stated that as Buprenorphine access increases, 13 Buprenorphine diversion decreases. 14 An assessment of telehealth impact on adverse outcomes found no data indicating evidence of 16 increased diversion for patients receiving care via 17 telehealth. Rather, Studies found that virtual 18 Buprenorphine access led to few adverse events. 19 There are existing robust safeguards in place to prevent Buprenorphine misuse and diversion. 21 Prescribers of controlled substances are already 22 registered with the DEA and licensed through their 23 state boards, meaning they have to meet specific 24 standards of health care delivery to practice or they risk losing their license. Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 209 1 In addition, most states require prescribers 2 to use their prescription drug monitoring programs or 3 PDMPs to track prescriptions for controlled substances 4 in Schedules II through V. Most PDMPs update their data on a daily or weekly basis and participate in 6 interstate data sharing. 7 In our view, additional data collection by 8 DEA is unnecessary. Under DEA's pandemic flexibilities 9 Buprenorphine was safely and effectively prescribed via audio-only and audio video telemedicine without 11 additional data collection measures, and prescribers 12 in the future should not be subject to additional 13 arbitrary requirements which can reduce access to 14 lifesaving medication. I'd also like to note that CMS already 16 collects data on the use of telehealth by requiring 17 Medicare practitioners to use a modifier for 18 telehealth claims and Medicaid and other insurers 19 track telehealth claims. Buprenorphine is extremely safe and the 21 overdose risk on Buprenorphine is extremely low as the 22 drug has a ceiling effect, meaning its effects will 23 plateau and not increase even with repeat dosing. 24 It's notable that as Buprenorphine prescribing increased during COVID, overdose deaths Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 210 1 involving Buprenorphine did not increase. 2 The evidence is clear. Buprenorphine is 3 safe, effective and saves lives. Buprenorphine access 4 plays a vital role in reducing Buprenorphine diversion and there are major benefits to public health and 6 safety that the pandemic flexibilities provided to 7 patients with OUD. 8 The Pew Charitable Trust strongly recommends 9 that the pandemic flexibilities allowing for Buprenorphine prescribing by all DEA registered 11 practitioners via telehealth without an In-person 12 requirement be kept in place permanently. 13 Given the overwhelming evidence base in 14 support of our recommendations today, Pew urges the DEA to finalize a rule for telehealth prescribing of 16 Buprenorphine without an in-person requirement as soon 17 as possible. 18 To avoid reductions in access to treatment 19 during the rulemaking process, we urge DEA to extend the existing temporary rule or use the already 21 designated opioid public health emergency to keep the 22 pandemic flexibilities in place for Buprenorphine 23 prescribing via telehealth. 24 Thank you for the opportunity to offer comment on behalf of the Pew Charitable Trust and for Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 211 1 your attention to these matters today. 2 I'm happy to respond to any questions you 3 may have. 4 MR. STRAIT: No questions. Thank you. We re now calling Commenter No. 11. 6 MR. GOLDEN: He just told me not to worry 7 about the ten minute time limit, just do what I need 8 to do and go as long as I can. 9 (Laughter). MR. GOLDEN: Everybody here's been extremely 11 courteous for the last two days, but it is the driest 12 event I've ever attended in my life. I mean honestly, 13 the people that's been here yesterday and today are 14 changing the world. It's an emotional thing and I hope I can hold it together. All of my friends and 16 family are watching, but I'm passionate. 17 I've heard of doctors, lawyers, scientists, 18 professors from Yale, Harvard, Johns Hopkins 19 University, pharmaceutical representatives, representatives from the government. And I'll tell 21 you who I am. I am rural America. 22 My name is Dan Golden, G-O-L-D-E-N. For 23 further clarification I'm Commenter No. 11 which so E- 24 L-E-V-E-N. See, we're smiling and having fun. In all seriousness, I do represent rural Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 212 1 America. We have East Coast Telepsychiatry and our 2 provider is Amy Farr. She's a 29 year nurse 3 practitioner who is passionate about the care of her 4 patients. When the telehealth thing went in chaos at 6 the end of March we panicked. Everything that we own, 7 we put into doing a telehealth business to provide 8 care for people, and people don't understand in rural 9 America the numbers are different. Washington, D.C. and the DEA is not America. 11 America that I live in -- I live in Northumberland 12 County, Virginia. There are two stop lights in the 13 whole county. Twenty-three miles apart. And those 14 two stop lights are twice as many items that there are providers. There are not two providers in the county. 16 The closest hospital does not accept 17 psychiatric patients because they have no psychiatric 18 doctor that works at VCU, Tapahanock Hospital in 19 Virginia. So obviously the statistics are there. Rural America needs help. Rural America needs 21 telehealth, they don't need restrictions that punish 22 the patient. 23 Basic statistics that I'm going to try to 24 cover everything -- I want to talk like the micro- machine guy from the commercials back in the '80s. Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 213 1 By 2034 the American Medical Colleges report 2 there will be a shortage of 124,000 providers in the 3 United States. Another statistic that I don't know 4 that people are aware of, telehealth visits increased from 2019, from 840,000 to 52.7 million telehealth 6 visits in one year. From 2019 to 2020. According to 7 the United States Census Bureau, in the last four 8 weeks the survey was done in February, in the last 9 four weeks, 23 percent of all adult Americans had attended a telehealth appointment. 11 Many hospitals have no psychiatric 12 providers. There are providers available but the 13 average wait time, according to a study from Virginia 14 Tech School of Medicine and Medstate (phonetic) in the State of Virginia, only 18 percent of psychiatrists 16 were available to see new patients. The median wait 17 time was 67 days for in-person appointment, yet only 18 23 for Telepsychiatry. The crime factors, if the 19 patients don't get the medicine from providers, we prescribe a lot of Adderall conserved to Ivans 21 (phonetic 22 I can walk out probably on the corner of 23 this property and get that item from illegal drug 24 sellers, so we need to ensure that people are taken care of by proper care. Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 214 1 In 2008 the White House mandated that the 2 DEA create special exemptions. Fifteen years later 3 we're sitting here trying to do so. One thing that I 4 want to make very clear. I think the DEA liked having everyone here yesterday and today, getting this input, 6 and hopefully doing a lot of the work for them because 7 they can't think of all of the things that providers, 8 prescribers, doctors, pharmacists deal with on a day- 9 to-day basis. I think one thing that is very important is 11 that the DEA needs to build a team of providers, 12 pharmacists and any other key parties to meet 13 virtually, maybe every 90 days or six months, because 14 the decisions that you make in the next few months are going to be outdated in two years. Technology is 16 going faster than we can even fathom. 17 One thing that I do think is important 18 that's not been addressed, I do think a telehealth 19 visit should be done by a person, not an AI bot, because that is going to be a factor probably within 21 nine months, sooner, or may already be happening. So 22 those are things that need to be looked at. 23 The PMP Awareness Program, everybody has 24 mentioned it and I'm going to strive that that thing is crucial. We had a patient last fall, she scheduled Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 215 1 an appointment the first of November. She was 2 determined to have ADHD. She was prescribed Adderall. 3 She returned for a follow-up visit a month later. She 4 had obtained the exact same medication from four more providers, all within a 30 day period. 6 The PMP system needs to be federal. If it's 7 state level, they're all going to have their own 8 quirks and additions. It needs to be one shot. So 9 when I click in and the guy just moved from San Antonio, Texas to Lottsburg, Virginia, I can see what 11 he got over the last year, what medications he's been 12 on. 13 Talk about flagging providers and 14 pharmacists. The patients need flagged. If I put in a prescription or our provider, 16 Amy Farr, puts in a prescription for a patient and 17 they pick up that medication, the problem is with PMP 18 that's not been mentioned by anybody, it is hugely 19 flawed. And if the government picks up on the PMP today it will be an utter failure because pharmacists 21 put on the fill date of a medication. If I prescribe, 22 my buddy Pierre gets prescribed maybe Vyvanse, and we 23 send in the prescription electronically today and the 24 pharmacist has time to fill it this evening, he enters into PMP that it's filled and he hangs it on the rack Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 216 1 in the little plastic bag for people to come and pick 2 up. 3 Well, Pierre may not pick his medicine up 4 until next Monday or Tuesday. So then when he comes for his follow-up in 28 to 31 days, he's getting his 6 medication a week early. So now he's got extra 7 Adderall laying around where he can sell those seven 8 pills or he's not taking the medication properly. 9 Every patient that we see, and I do think this should be something added on to providers, every 11 patient, every visit there should be a PMP check 12 pulled and stuck in their file for review. For the 13 simple fact that it prevents people from drug 14 shopping. It prevents pharmacists from giving out the pills, even though somebody's gotten four different 16 prescriptions for Adderall 20mg in the last three 17 weeks. And something else the lady from Medicaid 18 yesterday mentioned there's fraud being done in the 19 EPCS. A federal PMP program would also eliminate that because Amy Farr can say I didn't prescribe these 21 three medicines. So she can report, hey, somebody's 22 hacked my account or done whatever. You know, there's 23 multiple safeguards that can take place there. 24 This is a common sense thing to me. That's why I'm glad I'm here and I don't have all those Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 217 1 degrees. I'm rural. I'm the country dude. I built 2 decks for 25 years. I have no medical background 3 until my wife decides we need to open a practice to 4 take care of people. She's been a nurse practitioner for 29 years, and is passionate. And the rules that 6 are currently in place could devastate every penny 7 we've ever spent. And I know these rules are 8 changing. That's why we're here. It's just a matter 9 of lining up the dots and getting things done. So we're thankful. 11 And this gentleman mentioned earlier, you 12 know, the grandfather thing. It's already in effect. 13 Don't worry about your current patients. The current 14 wording when you pull up on the DEA website is that exemption was placed from March until this November, 16 but for previous existing patients it's active until 17 2024. 18 That needs to change immediately, and any 19 pre-existing patients and cases the wording needs to say when somebody Googles it, they are grandfathered 21 forever. There's no reason that you have a patient 22 coming to us for the last 2.5 years and then November 23 2024, I have to say I'm sorry, I can no longer 24 prescribe your medication. I'm sorry about your anxiety. Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 218 1 What's going to happen to a person with 2 anxiety if they can't find a provider within two 3 months? And they can't get to an office? It provides 4 undue stress. So the people that we have, they don't need 6 to be limited to 2024. The patients we have now, we 7 have the right to keep those patients and they have a 8 right to choose and leave if they want to. 9 Drivers license, state ID or passport. In my opinion if a person is getting a controlled 11 substance they have to produce that to the provider 12 and they have to produce it every time they pick up a 13 prescription. It's not Motrin, it's not some simple 14 cold remedy, it is a controlled substance. Video visits versus telephone. A video 16 visit should be mandatory for at least the first 17 visit. Put eyes on the person so when the driver's 18 license comes in you at least know you're talking to 19 the same person. After that, go to a telephone. The same care can be given on a telephone. 21 We don't like to do it. We require video visits. On 22 rare occasions we do the telephone. Just for the fact 23 you can lay eyes on the people. They may tell you 24 they're perfectly fine, but they may have tears coming down their face. They may have physical problems. Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 219 1 They may have meth marks. You know, things that 2 people need to see. 3 So video's important. If it's done by 4 telephone only, that's okay, but the first visit I think we need to establish yeah, this is John Doe 6 because that's what his driver's license says. 7 Let me see if I have anything else. I know 8 my time is ticking. 9 The DEA is worried about the future. The future happened two years ago when the United States 11 was put into a pandemic, so it's too late. 12 You need to fix these rules now and you need 13 to ensure that you do things to continuously change 14 things as they need changed. Don't wait 20 years to address this topic again because it's not happening. 16 You will be left behind in the technological dust. 17 So with that I'd like to thank everybody for 18 my time and putting up with my passion. 19 MR. STRAIT: No questions. We are now welcoming Commenter No. 12 to the 21 stage. 22 DR. SIMON: Thank you to the Commenter No. 23 11, given the time that we're at. 24 My name is Dr. Kevin Simon. Kevin, K-E-V-I-N. Simon, S-I-M-O-N. I am here from the City Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 220 1 of Boston. I appreciate the Pew acknowledging study 2 from our group with regards to opioid use and 3 telehealth. 4 I'm here today representing dual roles. I serve as the first Chief Behavioral Health Officer for 6 the City of Boston. And professionally I am one of 7 these rare child and adolescent and adult 8 psychiatrists. I'm also board certified in addiction 9 medicine and operate or work through the Adolescent substance Abuse and Addiction Program, also known as 11 ASAAP at Boston Children's Hospital. 12 I get to care for families, youth. A mother 13 emailed me today with regards to her son who is 14. I 14 met him when he was 12. He had to go to the ED in part because he used to be in DYS, the Department of 16 Youth Services, the Juvenile Justice Service. Got 17 discharged on Friday and today is Wednesday or 18 Thursday. In school he was vomiting in part because 19 he's engaged in Percocet and other opioids. So telehealth is critical. It is a 21 lifesaving measure that we've demonstrated through our 22 group. Particularly when we were thinking about 23 adolescents, and this hasn't yet been mentioned. I'm 24 going off the cuff and not really with my remarks here. Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 221 1 In reference to -- for all the adult 2 patients that we're talking about, 90 percent began 3 their substance engagement before 18. So in terms of 4 who we really should be trying to target, it's those who are adolescents. The reality is, adolescence has 6 prolonged itself over time because socially you get to 7 be on your parents' insurance until 26. The average 8 age of marriage, back when my parents got married it 9 might have been 21. That's not the case anymore. So in terms of how do we ensure 11 appropriateness of care, we do it with our group. We 12 meet yes with the patient, but adolescents don't 13 really like to share information all that much, but 14 because they're under 21, or really under 18, we also meet with their parents or their guardian. The 16 reality is, you have access to collateral information 17 to ensure the patient that you may not be able to see 18 visually, somebody else is able to see that person. 19 So I want to talk about two fictitious but real patients. Anna, from rural America; and Jason 21 from urban America. 22 The reality is Anna, although she's not from 23 a city like D.C. or New York, she's not safeguarded by 24 having a condition like autism spectrum disorder which 50-60 percent of patients with autism have ADHD. Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 222 1 Patients that have ADHD, 20-30 percent of them have 2 autism. They're going to need medication. 3 If we're talking about Jason who lives in 4 let's say East Brunswick, it's really close to Jersey. It's really close to New York City. But complicated 6 factors, neighborhood disorder, make it such that he's 7 experiencing life in a health condition, substance 8 abuse engagement, pre-addiction. The fact of the 9 matter is unless we're providing telehealth services, we're going to miss a whole host of people and it's 11 actively happening now. 12 So of that 90 percent of adults that began 13 engagement with substances before 18, the truth of the 14 matter is less than 15 percent, the data here depends on the source, but less than 15 percent actually 16 received evidence informed treatment. Now there's 17 treatment, but then there's evidence informed 18 treatment. 19 The fact of the matter is telehealth allows clinicians to reach that population. 21 So I totally understand that the DEA is 22 required to do safeguards and practice and want to 23 ensure that there's no diversion. I practice 24 cautiously myself. But the truth is, as that gentleman said, you probably should convene a group. Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 223 1 And I get that we have a two-day convening here, but I 2 know that there's -- I know that there's working 3 groups that are in the DEA in the health fraud 4 division that are trying to find bad actors, because the reality is there are often bad actors. But just 6 trying to take away something that you've given to 7 many patients, the genie's out of the bottle. It's 8 hard to put the genie back in. 9 So in reference to proposed rules, the registration, I know it's been on the books. It has 11 yet to actually be enacted. You have a whole host of 12 people who are prescribing actively to try to get them 13 to actively do eight hour training will be difficult. 14 We've seen removal of the X waiver has not shifted the amount of people who actually should be prescribing 16 Buprenorphine. I prescribe it. But literally I have 17 colleagues in hospitals that say well, I'm not 18 comfortable. So I'm not really sure what adding an 19 additional layer of mandated requirements is going to do. It's probably just going to stem people from 21 actually engaging. 22 So the reality is that as the person I think 23 Commenter 10, some research from our group identified 24 that those that have substance abuse problems, mental health conditions, particularly that are adolescents, Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 224 1 actually do engage pretty well with regards to 2 telehealth services, and the key part about our study 3 was they were very willing to come in after being 4 established vis-a-vis telehealth. So I don't necessarily think you need a mandate. 6 The reality is, if you're with a provider 7 that you trust and it's been three months or six 8 months and you make the suggestion to come in, it's 9 very likely that they will actually come in. And if we're talking about those who are minors, if they 11 can't some in, some guardian can come in because 12 they're potentially not unhoused. 13 So when we're thinking about this idea of 14 the rural and the urban individual, the truth is you have tools that are at your disposal. Yes, the PDMP. 16 You don't have current engagement with it. I'm sure 17 that would be very difficult to do for the fact that 18 it's technically I think 49 states. I'm not sure if 19 Missouri has added it yet. So the truth is, this is a very complicated 21 issue. I greatly appreciate that you're attempting to 22 resolve some of the issues. I do think if we're going 23 to go back to the 2008 and try to do a special 24 registration there has to be some subset of criteria in terms of who can prescribe. Again, there's less Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 225 1 than 8,000 child psychiatrists. I'm one of them. You 2 should take a photo of me because there's not many of 3 us. But we're not the only ones who can prescribe 4 stimulants, not the only ones who can prescribe Buprenorphine. But again, even those that can, 6 aren't. 7 In terms of setting some kind of 8 standardization, just like every year for every state 9 that I'm licensed in, I have to get a renewal. So if you're going to have a special registration there 11 needs to be a renewal process. And physicians and 12 prescribers are already used to a renewal process 13 because we already have to do that for the respective 14 states that we're in. In terms of routine monitoring, I just don't 16 know what the jurisdiction is of the DEA in terms of 17 trying to set up some regular monitoring. The current 18 monitoring that I think is happening, there's somebody 19 who's a good whistleblower and says hey, something's going on here. Then you guys go in and search. But I 21 don't know that you have the capacity to set up some 22 kind of monitoring system. That would be ideal. 23 Again, this tech integration doesn't yet 24 exist, but if it could that also would be ideal. I know you've listened to many people and I Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 226 1 can see my time's winding down. The reality is the 2 special registration, that would be great. But the 3 problem that we're trying to figure out exceeds two 4 days of listening. And those of us at Boston Children's, Children's Hospital Association, all of 6 the advocacy groups that you heard from will gladly 7 partner in trying to figure it out. But literally, as 8 I'm standing here there's a patient of mine that I'll 9 see vis-a-vis telehealth tomorrow because I'm here and they're in Massachusetts. So it's going to be very 11 hard to curtail something that you've given to 12 millions of people over the last couple of years. 13 I'll stop there. Thank you for the 14 opportunity to be engaging here. MR. STRAIT: Okay. We are going to be 16 bringing up our 13th commenter. I will say that we 17 had up to 14 today and I don't believe that Dr. 18 Kolodny is here yet if at all. So I will say that 19 assuming that we have no one after Commenter 13 we will then go back to one in-virtual commenter who 21 could not join us in the morning and that will be our 22 last presentation for the day. 23 So, Commenter No. 13, welcome to the stage. 24 DR. REDDOCH: I have significant presbyopia, so I can't work off of a small device. I bring up a Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 227 1 laptop. 2 MR. STRAIT: Absolutely. 3 DR. REDDOCH: And I use, like, 16 point, 4 and, hopefully -- MR. STRAIT: Wonderful. 6 DR. REDDOCH: -- I can capture this. Thank 7 you. 8 Good afternoon. I'm Dr. Shirley Reddoch, 9 S-H-I-R-L-E-Y, Reddoch, R-E-D-D-O-C-H, a Board- certified pediatrician and pediatric hematologist/ 11 oncologist with 40 years experience in direct patient 12 care and as a pediatric residency and pediatric 13 hematology and oncology fellowship program faculty. 14 Currently, at the latter part of my professional life, I have a part-time faculty appointment in Pediatrics 16 at Johns Hopkins, a continuing appointment at Johns 17 Hopkins School of Medicine, where I serve as Clinical 18 Teaching Attending in the Children's Hospital. 19 Thank you for the opportunity to speak at this DEA listening session centered on the subject of 21 telemedicine prescribing of controlled substances and 22 the role or necessity of in-person medical evaluations 23 by the prescriber. 24 Today, I speak to you as an individual concerned physician and not representative of Johns Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 228 1 Hopkins or any other healthcare organization or 2 general medical or specialty associations, although, 3 like other presenters, I am a member of several 4 specialty organizations. To name some, the American Academy of Pediatrics, the American Society of 6 Pediatric Hematology Oncology, and the American 7 Medical Association. 8 Before specific comments on the current 9 question, I'd like to give you a little bit more of my background, experience, and observations over time in 11 medicine. 12 I started my residency training in 13 pediatrics in 1981, entering the Army on active duty 14 after completing medical school in the civilian sector. Subsequently, I served as a general 16 pediatrician in an Army community hospital and clinic 17 before doing my pediatric hematology oncology 18 fellowship training at then Walter Reed Army Medical 19 Center. Following fellowship, I served as Peds Heme 21 Onc and on pediatric residency faculty at two other 22 Army medical centers before transferring to this area, 23 Fort Meade, Maryland, in a healthcare admin role as 24 Deputy Commander for Clinical Services at Kimbrough. I then returned to Walter Reed, first leading the Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 229 1 Department of Health Plan Management, then returning 2 to full-time Peds Heme Onc practice and on pediatric 3 residency and fellowship program faculty, with 4 clinical faculty appointment at Uniformed Services University of Health Sciences. Those were my first 24 6 years of practice and were within the military 7 healthcare system, which I understood the beneficiary 8 population well as a member with a family in that 9 beneficiary community as well as a physician. Given the size of our program and resource 11 allocations, we all practiced in the inpatient and ou- 12 patient setting, so knew our patients in both those 13 environments. 14 In those years prior to formal telehealth programs, all care was considered in-person, though 16 telephonic communications were frequently made and 17 documented, with only occasional non-controlled 18 substance prescriptions associated with a telephonic 19 communication with a patient, again, already seen and followed by a physician or service team of physicians. 21 It's important to know medical students, 22 residents, fellows in training at that time, at this 23 time, understood and were engaged in the continuity of 24 care between inpatient and outpatient settings and direct communication between primary care and Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 230 1 specialty care. 2 Leaving practice in the military healthcare 3 system and affiliating with Johns Hopkins Pediatrics, 4 Pediatric Hematology, now 18 years ago -- I'm feeling older by the minute as I read this -- I recognized the 6 challenges of much larger socioeconomically diverse 7 patient referral populations not only geographically 8 spread but often with primary care or other specialty 9 care outside of the Hopkins medical system. As with any such system, there are those 11 patients who are well known to the service but many 12 others with only infrequent encounters within the 13 system and sometimes more in the emergency room or 14 inpatient setting than out. Various insurance coverages and/or no coverage further separated 16 accessible or covered sites and sources of care and 17 services. 18 Establishment of a sophisticated electronic 19 records system with expanding capabilities helped connect different electronic record sources via the 21 Health Information Exchange in the state, and PDMP 22 helped in monitoring certain controlled substance 23 prescriptions, but still the weaknesses interpreting 24 that information were often revealed when patients were seen for their in-person visits. Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 231 1 Although I cannot speak to all areas of 2 Hopkins medicine, as I recall now, outpatient 3 telehealth visits were just being implemented by my 4 service colleagues at or around the time the COVID-19 pandemic hit. My activity was in patient care at that 6 time, but our service case management discussions 7 ensured awareness of in-person and telehealth 8 encounters and often covered opioid use and pain 9 management of conditions like sickle cell disease with complications involving acute and chronic pain. 11 Formal video telehealth visits, video visits 12 with the ability to prescribe controlled medications 13 have greatly facilitated continuity of care of 14 established patients, but periodic in-person care, advisedly outpatient but also evident with episodic 16 inpatient care managed by the same service team, is 17 still the practice. 18 We should also remember that during this 19 time, these last few years, there were severe restrictions placed on outpatient in-person visits and 21 limitations set on who and how many members of the 22 care team and which members could even see patients on 23 the inpatient services directly and the level of PPE 24 required for a provider to wear to see patients in either setting, medical trainees, students, residents, Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 232 1 fellows, were getting a very different learning 2 experience from those prior to the pandemic years and 3 immersed in such removed evaluations and care of 4 patients with their rapidly developing facility and comfort with telehealth care. 6 It is my concern that this may heighten the 7 risk just in general for overuse of, overconfidence 8 in, or misapplication of telehealth, with emphasis or 9 preference for virtual care on the part of practitioners as well as patients. 11 Following my further conversations with 12 physicians across the country, to include hospital- 13 centered and community-based hospice and palliative 14 care programs, psychiatry, and a chronic opioid use pain management program, and listening to 16 presentations last day, my considered conclusion is 17 there still should be an inpatient evaluation that is 18 proximate in time and related to an initial telehealth 19 visit for prescribing controlled substances, and, ideally, that visit should be with that prescriber. I 21 said ideally. 22 Ongoing telehealth prescribing of controlled 23 substances by that prescriber should be within 24 appropriate disease and condition management that warrants such prescribing, with the telehealth Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 233 1 prescriber trained and appropriately certified in such 2 fields as substance use disorder or medical 3 specialties covering specific diseases, conditions 4 requiring frequent or chronic medications in the schedules of controlled substance or hospice and 6 palliative care medicine. 7 The telehealth prescriber must be licensed 8 for telehealth in the state where the patient resides 9 and if by chance is so geographically removed from the patient that the prescriber cannot see the patient in 11 person, there should be a primary referring 12 practitioner in room with the patient simultaneously 13 communicating on video platform, video visit platform, 14 with the consulting provider or specialist. Documentation of such a visit must be adequately 16 reflected in both the primary provider and consulting 17 provider's records system. 18 If the disease condition management with 19 prescribing of controlled substances is continued by the remote-only telehealth consultant specialist, 21 there should be a documented primary care or referring 22 provider relationship established to facilitate future 23 video, tandem video visits, in person as initially 24 established. If the primary care provider with the Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 234 1 ability to do periodic in-person evaluations assumes 2 responsibility for prescribing of controlled 3 substances following the specialty consulting provider 4 care plan, there should be follow-up recommendations with frequency and whether in-person or telehealth, 6 acceptable follow-up as stated and understood. 7 If the consultant specialist who is 8 accessible only via video visits assumes continuing 9 prescribing responsibility, it should be so documented. 11 Exceptions to this process can be codified 12 outlined in policy established state by state with 13 involvement of the state practitioners' licensing 14 boards, with consideration of the healthcare needs of the population, with attention to the underserved. 16 States should be cautious about permitting 17 any out-of-state practitioners organizations only 18 licensed for telehealth in the state to develop an 19 independent telehealth practice independent of any in- person direct healthcare service or working with such 21 a direct healthcare service residing within the state 22 as this may directly compete with and undermine the 23 work of such similar services that may exist within 24 the state that I heard alluded to in visits in presentations last day and with the in-state services Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 235 1 appropriately serving the state's populace. 2 Quality of care, adherence to care, outcome 3 measures should be tied to telehealth. Only exception 4 programs as well as those that offer in-person visit capability. This again requires additional insights 6 as may be ascertained from state medical societies, 7 licencing board, health departments, nonprofit 8 healthcare organization, independent practices, and 9 FQHCs within the state. Codification of policy at federal level for 11 exceptions to visits may also need to be reviewed 12 regarding programs that serve DoD and federal 13 institutions. 14 All controlled substances at high risk for diversion, abuse, or overprescribing should be 16 reported on a standard PDMP platform that can 17 communicate across state lines essentially nationally, 18 as many others have recommended. 19 And with such tremendous input and some concrete recommendations that have been presented by 21 in-the-trenches providers in these two days who have 22 identified specific risk mitigation measures to be 23 taken, including qualifications of providers 24 teleprescribing and particularly in psychiatric and behavioral health only, telehealth-only practice would Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 236 1 suggest that DEA specifically look at those 2 recommendations made. 3 But I would also recommend reassessing 4 adequacy of education on controlled substance use and prescribing for practitioners and pharmacists in 6 telehealth environments and a more robust standardized 7 education surrounding prescribing of controlled 8 substances in various settings, patient settings, 9 electronic prescribing, and telehealth platforms be formally incorporated in and across all graduate 11 medical education before upcoming physician 12 transitions from care oversight within residency 13 programs to widely varying and increasingly narrower 14 focus of independent clinical practice settings. This speaks to not just specializations in 16 care but sites of care, like ambulatory only, hospital 17 only, emergency medicine practices, where one can 18 easily narrow patient care focus to their environment 19 of care and can decrease attention to patients' overall healthcare which requires access to other 21 settings of care. 22 And believe it or not, my final concern to 23 raise is actually the primary one that brought this 24 listening session to my attention. It is that of legal lethal dose prescribing of single or combination Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 237 1 of medications prescription that can involve one or 2 more controlled substances or clearly off-label toxic 3 use of non-controlled medications. This type of 4 prescribing was legalized in several states via end- of-life option or medical-aid-in-dying legislation and 6 offers the most protection of those prescribers, no 7 protection of patients or transparency to family and 8 other non-medical-aid-in-dying-involved providers. 9 There's likewise no real monitoring of adherence to minimal documentation requirements, 11 thresholds for investigation, and no consistent way to 12 identify if and/or when the prescription is taken as 13 patients could have died of underlying qualifying 14 diagnoses before taking medication, delayed taking prescription, gotten better, changed their minds. 16 There are no particular skills or training 17 required of a prescriber to prescribe a killing dose 18 of any medication. One would say this is not chronic 19 care or continuing medication risk, but telehealth visits in lieu of in-person for this prescription 21 consultation promotes too-easily-obtained 22 prescriptions, no assurance of any care for the 23 patient by the prescriber who is not otherwise 24 involved in the patient's care if the patient chooses not to take or delays taking medication. Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 238 1 Such telehealth providers must be licenced 2 in the state of the patient's residence and should not 3 be able to violate visit prescribing rules of that 4 legislation if not enacted in the patient's state. There is ample opportunity to obscure 6 illegal prescribing as in illegal in certain states, 7 as in still the majority of states. 8 As I am not engaged in telehealth directly 9 with associated controlled substance prescribing, this particular DEA request for input in listening sessions 11 did not actually get my attention or many of the other 12 people I consulted who practice good medicine in their 13 fields with good documentation of telehealth and 14 prescribing. But my antenna went up when I heard that A Death With Dignity, that Death With Dignity sent out 16 alerts to their followers requesting and eliciting 17 approximately 10,000 comments by their count of your 18 38,000 comments to the DEA supporting telehealth-only 19 prescribing. I realized then that there's an underappreciated risk that lay in this ongoing 21 expansion of telehealth, so I bring that to your 22 attention. 23 And, subsequently, I was sent a copy of a 24 letter that I think may have already been sent to you from concerned organizations opposing assisted Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 239 1 suicide. So this is always on people's minds, and the 2 potential of this kind of use of telehealth actually 3 further undermines reliance and trust of those 4 providers involved in care of hospice and palliative care. 6 And one final comment speaking to what a 7 prior speaker, a recent prior speaker just raised is 8 that the specter of AI as threat to integrity of 9 telehealth. I think that is very real, and with so much imitation, you don't know sometimes will it get 11 so good that you won't even know if you've got a real 12 patient in front of you? Not just the provider but 13 the patient. So we need to move away from dependency 14 on this or any other singular encounter type as we may need to pivot as we've had to so many times in 16 medicine. 17 Thank you very much. 18 MR. STRAIT: Any questions? 19 (No response.) MR. STRAIT: Okay. Thank you so much. 21 Okay. And we will now, like I said earlier, 22 go to our Virtual Presenter No. 13. Thank you. 23 DR. SPENCER: Hello. My name is Dr. Sarah 24 Spencer, S-A-R-A-H, S-P-E-N-C-E-R, and I'm representing myself today. I'm an employee of the Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 240 1 Ninilchik Tribal Council and the head addiction 2 medicine consultant for the Alaska Native Tribal 3 Health Consortium. I'm here today to speak on 4 telemedicine regulations of buprenorphine for the treatment of opioid use disorder and to speak against 6 the requirement for an in-person visit. 7 I'm a Board-certified addiction medicine 8 physician, fellow of the American Society of Addiction 9 Medicine who has provided care for patients with opioid use disorder in rural Alaska for 13 years, and 11 I've been offering telemedicine for OUD for years 12 prior to COVID. 13 To remind you of the vastness of Alaska, we 14 are, of course, more than twice the size of Texas, and there are over 200 Alaska native villages spread over 16 660,000 square miles, most of them off the road 17 system. 18 I work in tribal health and I'm one of the 19 only addiction medicine specialists in the state that provides treatment of OUD via telemedicine for any 21 Alaska native person regardless of tribal affiliation. 22 I work on the rural southern Kenai Peninsula 23 and I'm the only addiction medicine specialist in our 24 25,000-square-mile borough. The next nearest addiction medicine specialist and the nearest Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 241 1 Methadone clinic are over 200 miles away in Anchorage. 2 In 2021, Alaska suffered the greatest 3 increase nationwide in our overdose death rates with 4 fentanyl-related deaths up 150 percent, and the overdose rates in Alaska native people are triple that 6 of white Alaskans. In fact, indigenous Americans 7 nationwide are among the populations with the highest 8 overdose death rates. 9 Buprenorphine has been shown to reduce mortality related to OUD by over 60 percent. However, 11 many remote areas in Alaska still have no local access 12 to this medication. Most of the 170 tribal village 13 clinics are off the road system, meaning patients can 14 only get in and out via boat or plane, and they are staffed only by community health aid practitioners, 16 with licensed providers, such as doctors, NPs, or PAs, 17 visiting just a few times a month or sometimes less 18 than once a month, and there are huge tribal regions, 19 such as the 115,000-square-mile Arctic slope and Norton Sound region, that have zero prescribers of 21 buprenorphine. 22 Historically, fear and stigma around 23 diversion or misuse of sublingual buprenorphine, as 24 well as the challenges in monitoring the use of this medication in remote areas, have caused many rural Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 242 1 tribal clinics to shy away from offering this 2 medication altogether. 3 Monthly long-acting injectable buprenorphine 4 has less stigma surrounding its use and it could potentially dramatically expand treatment 6 availability. But, unfortunately, due to DEA 7 restrictions, it cannot be shipped to a remote village 8 clinic staffed only by a community health aid 9 practitioner because it can only be shipped to clinics that have a resident DEA licensed provider. So, 11 unfortunately, this medication is also not accessible 12 to patients living in remote native villages. 13 Most of the tribal organizations who do 14 offer MOUD offer medication options that can be limited, and many only provide in-person care and they 16 require patients to travel from their remote home 17 villages to the hub clinic to attend in-person visits. 18 I am one of only two physicians in the State 19 of Alaska with the Indian Health Service Internet Eligible Controlled Substance Provider exemption to 21 allow for buprenorphine prescribing without an in- 22 person visit. 23 However, that exemption requires that the 24 patient be present at the remote village clinic site to receive services, and merely obtaining this Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 243 1 certification does not ensure the cooperation of the 2 distant tribal health organization. And I have 3 personally seen multiple incidences of patients 4 refused telemedicine access from their home tribal clinic to access buprenorphine therapy. 6 Within these large tribal health 7 organizations exist many individual tribal clinics, 8 all with different tribal councils, different 9 administrations, and some have policies against providing buprenorphine therapy, and they may refuse 11 to collaborate with an outside clinic offering the 12 service and refuse to host telemedicine specialty 13 consultation appointments originating at their clinic. 14 Patients may also be unable or unwilling to access care through their local clinic due to very legitimate 16 privacy concerns in these very small villages. 17 Since the Internet Eligible Controlled 18 Substance Provider exemption does not apply to 19 patients being seen in their homes, I cannot provide treatment to native beneficiaries living in these 21 underserved areas or to non-native patients living in 22 any remote native village if an in-person visit is 23 required. 24 The Alaska Native Medical Center in Anchorage is the specialty care referral hub of the Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 244 1 state for native beneficiaries, but it does not have 2 an addiction medicine department and has no system in 3 place to offer buprenorphine therapy via telemedicine 4 for remote patients. So uninsured native beneficiaries living in remote villages, lacking a 6 buprenorphine prescriber locally, essentially have no 7 access to this treatment. 8 When patients do need to travel for in- 9 person visits, the cost can be astronomical. The cost for a patient to get from a remote village in 11 northwestern Alaska to my specialty clinic for an in- 12 person visit could easily exceed $1500. 13 Even for non-natives who live on the Kenai 14 Peninsula, the majority live more than 20 miles from my clinic, and the nearest pharmacy is 35 miles from 16 my clinic. Ninety percent of our patients have 17 Medicaid, and most either don't own an operational 18 vehicle or they don't have a valid driver's license, 19 and even if they do have those things, many may not be able to afford the gas for the 70-plus-mile round 21 trip. 22 These patient costs were not adequately 23 accounted for in your cost impact analysis of this 24 regulation. Our clinic is the only one on the Kenai Peninsula of Alaska offering low threshold Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 245 1 buprenorphine treatment. We offer telemedicine to all 2 patients for their intake appointment, and this has 3 dramatically reduced our no-show rates. It also 4 allows us to offer a more flexible open access schedule so patients can get same-day telemedicine 6 appointments for urgent care. 7 To assist with medication monitoring, 8 patients who are not able to travel to the clinic may 9 choose to participate in drug testing through local clinic labs or through mail-order oral fluid tests 11 with virtually observed collection. We utilize random 12 medication counts conducted by video when needed. And 13 the patients also have the option of demonstrating 14 medication compliance through video directly observed therapy when appropriate for their care plan. 16 Most of our patients do a mix of 17 telemedicine and in-person care, and this flexibility 18 has greatly increased our ability to support our 19 patients' retention in treatment as well as improve patient satisfaction. 21 Most of our patients self-refer for monthly 22 injectable buprenorphine. However, it's not unusual 23 for patients to have to take sublingual buprenorphine 24 for more than a month prior to being able to travel to the office for their first injection. In fact, I've Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 246 1 had a patient that had to drive 250 miles one way to 2 get his first injection. 3 Also, there are many patients who struggle 4 and fall in and out of care in those first few weeks and months, and they may need multiple follow-up 6 telemedicine appointments over several months to 7 motivate and enable them to attend that first in- 8 person visit. 9 Buprenorphine interruption such as would occur if a patient had not attended their first in- 11 person visit by the end of 30 days is dangerous. 12 After buprenorphine discontinuation, 50 percent of 13 people return to use within a month, and one in 20 14 experience an overdose event the following year. The Ryan Haight Act was intended to reduce 16 the inappropriate prescribing of medications such as 17 prescription opioids that increase the risk of 18 overdose. Buprenorphine, however, is a very safe 19 medication since it does not induce respiratory depression and it dramatically reduces mortality risk 21 in patients with OUD. So it's not surprising that 22 overdoses involving buprenorphine did not increase 23 during the pandemic despite its increased availability 24 via telemedicine. In August '22, a JAMA Psychiatry study Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 247 1 looking at 175,000 Medicare beneficiaries who received 2 telemedicine for buprenorphine therapy, the use of 3 telemedicine to access buprenorphine was associated 4 with a reduced overdose risk and improvement in treatment retention. 6 Additionally, data that is gathered from in- 7 person visits such as urine drug testing has not been 8 shown to improve treatment outcomes or to reduce 9 diversion. In summary, requiring an in-person visit to 11 prescribe more than 30 days of buprenorphine for OUD 12 treatment will only result in further exacerbating the 13 already disproportionately reduced access to treatment 14 suffered by our most vulnerable and most affected populations, including Alaska natives and American 16 Indians, low-income patients, and those living in 17 rural areas. 18 The arbitrary decision to require an in- 19 person visit at 30 days has no basis in evidence to improve patient outcomes, while we have strong 21 evidence that uninterrupted access to medication for 22 OUD is critical to reduce mortality. 23 I strongly believe that the requirement for 24 in-person visits for buprenorphine prescribing will do more harm than good and recommend it to be removed Heritage Reporting Corporation (202) 628-4888 5 10 15 20 25 248 1 from the proposed telemedicine regulation. 2 Thank you for the opportunity to speak 3 today, and I welcome any questions. 4 MR. STRAIT: Okay. Thank you, Dr. Spencer. My understanding is there are no follow-up questions, 6 so I want to thank you for participating and for being 7 our last presenter. 8 And I will say that by purposes of 9 concluding remarks, again, thank you for everyone who took time out of your busy schedules to be here on 11 either one day or two days. 12 I want to give a special thanks to 13 Administrator Milgram and Assistant Administrator 14 Prevoznik for taking time out of their schedules to also listen. I think and I hope it demonstrates to 16 you and the public and those that are watching us 17 virtually that we really do care about trying to get 18 this right. 19 So, with that, I will say again thank you. Safe travels. And enjoy the rest of your week. 21 (Whereupon, at 3:55 p.m., the listening 22 session in the above-entitled matter adjourned.) 23 // 24 // // Heritage Reporting Corporation (202) 628-4888 249 REPORTER'S CERTIFICATE DOCKET NO.: -- CASE TITLE: DEA Telemedicine Listening Session HEARING DATE: September 13, 2023 LOCATION: Arlington, Virginia I hereby certify that the proceedings and evidence are contained fully and accurately on the tapes and notes reported by me at the hearing in the above case before the United States Drug Enforcement Administration. Date: September 14, 2023 Angela Brown Official Reporter Heritage Reporting Corporation Suite 206 1220 L Street, N.W. Washington, D.C. 20005-4018 Heritage Reporting Corporation (202) 628-4888