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| Title: | Telemedicine Listening Session 09/12/23 Revised |
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| Body: |
TRANSCRIPT OF PROCEEDINGS
In the Matter of: )
)
TELEMEDICINE )
)
Listening Session )
Pages: 1 through 294
Place: Arlington, Virginia
Date: September 12, 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 22202
Tuesday,
September 12, 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
Commenters:
ROBERT KRAYN
Talkiatry
GEORGIA GAVERAS
Talkiatry
SHABANA KHAN
American Psychiatric Association
DAVID HOFFMAN
Columbia University
KYLE ZEBLEY
American Telemedicine Association/ata Action
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PARTICIPANTS: (Cont'd.)
Commenters:
HELEN HUGHES
Johns Hopkins Medicine
BRIAN CLEAR
Bicycle Health Medical Group, P.A.
THOMAS MILAM
Iris Telehealth, Inc.
MELANIE MELVILLE
Legacy Community Health Services, Houston, Texas
LINDSAY LANAGAN
Legacy Community Health Services, Houston, Texas
DANIEL RECK
Matclinics
DORI MARTINI
Circle Medical
LORI USCHER-PINES
Rand
JAMES LEWIS
American Society of Consultant Pharmacists
CHRIS ADAMEC
Alliance for Connected Care
EDWARD KAFTARIAN, M.D.
JOSEPH ROTELLA, M.D.
American Academy of Hospice and Palliative
Medicine
Virtual Presenters:
ELIZABETH LINDERBAUM
National Association of Community Health Centers
MICHELLE COPE
National Association of Chain Drug Stores
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PARTICIPANTS: (Cont'd.)
Virtual Presenters:
STERLING RANSONE, M.D.
American Academy of Family Physicians
ANNA KESIC
Empower
ROBIN PLUMER, M.D.
JODI SULLIVAN
Investigations Medicare Drug Integrity Contractor
KEVIN DUANE, PharmD
KELLY CLARK, M.D.
American Society of Addiction Medicine
TEDDY WEATHERSBEE
Social Science and Public Health Researcher
TICHIANAA ARMAH, M.D.
Yale School of Medicine
Community Health Center, Inc
American Psychiatric Association
JOHN LUSINS, M.D.
Psychiatrist
JEFFREY CHESTER, M.D.
JEROME COHAN
Catalyst Health Solutions
TONY PRATT
Piedmont Access to Health Services
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1 P R O C E E D I N G S
2 (9:00 a.m.)
3 MR. STRAIT: Good morning and welcome to this
4 session. I am extremely thankful and appreciate to
everyone who has taken time from their busy schedules
6 to participate in person, and virtually in this two-
7 day event.
8 I am also appreciative for those who are
9 watching the live stream of this event from the DEA
Diversion Controls website. You'll hear me say it a
11 couple times, www.deadiverson.usdoj.gov.
12 I would now like to introduce Administrator
13 Anne Milgram. Administrator Milgram was sworn in as
14 DEA Administrator on June 28th, 2021, after being
confirmed by the U.S. Senate by unanimous consent on
16 June 24th. As the DEA Administrator, she leads an
17 agency of nearly 10,000 public servants who work in
18 DEA'S 334 offices across the globe.
19 It is with honor and respect that I now
welcome Administrator Milgram to provide opening
21 remarks.
22 (Applause.)
23 MS. MILGRAM: Thank you so much, and good
24 morning. I want to start by thanking all of you who
are here with us today both in person and online, and
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1 a special thank you to all of our presenters. It
2 means a lot to us to have all of you with us today as
3 we embark on these listening sessions.
4 I also want to say my deepest thanks to
Diversion Control, our head of Diversion Control, Tom
6 Prevoznik; our Deputy, Matt Strait, and the whole team
7 that has worked tirelessly on this day, today and
8 tomorrow, as well as the whole team at DEA who has
9 really given their all to make this day, and tomorrow,
a success.
11 We are very eager today to hear your
12 perspectives as we propose a path forward on
13 telemedicine. Before I turn things over to our
14 moderators, who will tell you about the ground rules
for the next two days, I want to speak generally about
16 telemedicine, and telehealth.
17 We recognize the importance of telemedicine
18 in providing Americans with access to needed
19 medications. DEA has been, and remains, committed to
expanding access to telemedicine in a way that puts
21 patients and their safety first. That means a final
22 set of rules that is simple to understand and apply
23 that reflects technological advancements, and that is
24 consistent with the lessons that we have all learned
during the COVID public health emergency, and that
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1 also recognizes and understands the ongoing opioid
2 epidemic.
3 Those in person with us today walked past
4 our faces of Fentanyl exhibition, and saw the nearly
5,000 faces of American lives lost to the opioid
6 epidemic, and in particular to Fentanyl. It has
7 wrought a devastating impact on our country.
8 Let me tell you a little of what these rules
9 do not cover to make that clear from the outset, and
maybe let me start with a little bit of background on
11 telemedicine, and what we mean when we say it.
12 The telemedicine regulations that we are
13 going to discuss today will be issued under the Ryan
14 Haight Act. That act was named for a California high
school student who died from a prescription drug
16 poisoning. Ryan had obtained those drugs after
17 receiving a prescription for a controlled substance
18 from a rogue online pharmacy.
19 Before obtaining that prescription Ryan had
never seen that prescriber in person. Those are the
21 concerns that the Ryan Haight Act confronts,
22 prescribing of controlled substances via telemedicine
23 when a practitioner has never seen a patient in
24 person.
That background should help to explain why a
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1 final set of regulations will not affect practitioner/
2 patient relationships if an in-person medical
3 evaluation has occurred at any point during that
4 relationship. Once there has been an in-person
evaluation of a patient, that practitioner/patient
6 relationship is not considered to be telemedicine
7 anymore under the Ryan Haight Act.
8 So as a patient if you have seen your doctor
9 in person before, whether it was a month ago, or a
year ago, the regulations we are discussing today will
11 not apply.
12 In addition, DEA regulations issued under
13 the Ryan Haight Act only apply when there are
14 prescriptions for controlled substances. This means
the final regulations will not apply to Telehealth
16 visits that result in no prescriptions at all, or that
17 result in prescriptions for noncontrolled medications
18 like antibiotics, insulin, birth control.
19 In sum, the final telemedicine regulations
will impact only a subset of practitioner/patient
21 relationships, those in which a practitioner is
22 prescribing controlled substances via telemedicine,
23 and has never seen that patient in person.
24 Finally, let's turn back to where we are in
the process, and where we're headed. This past March
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1 in concert with the Department of Health and Human
2 Services DEA issued two sets of proposed telemedicine
3 regulations. Those regulations would have allowed for
4 telemedicine prescribing of certain controlled
substances subject to safeguards, and would have
6 imposed an initial limit on telemedicine prescriptions
7 to a 30-day supply. To prescribe more, an additional
8 supply to a patient, the prescribing practitioner
9 generally would have been required to evaluate the
patient in person.
11 We received over 38,000 public comments in
12 response to those proposed regulations, and we read
13 every single one. We believe that is among the
14 highest number of comments we have gotten in DEA'S
history.
16 A significant majority of those comments
17 expressed concerns that the proposed regulations
18 placed limitations on the supply of controlled
19 substances that could be prescribed prior to an in-
person evaluation.
21 After evaluating these comments DEA wanted
22 to reopen this conversation about telemedicine
23 prescribing, and to allow for a public listening
24 session. We are now holding these listening sessions
to gather information from stakeholders in this space,
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1 including patients, practitioners, pharmacies, and
2 others.
3 We're going to hear from as many as 61
4 individuals over the next two days representing a wide
range of interests about a pathway forward. We will
6 also have another comment period this fall for written
7 comments before any telemedicine regulations are
8 finalized.
9 So to those who applied to present today,
but were not selected, thank you for your interest in
11 this issue, and we are looking forward to receiving,
12 reviewing, and responding to your thoughts as well.
13 Finally, to conclude, I want to thank the
14 presenters again, and to all the folks who are with us
today in person and online, for taking this
16 opportunity to provide us with additional valuable
17 input. We are looking forward to hearing from you as
18 we consider regulations in this important space.
19 As I say all the time here, eventually we
are all patients, and so this matters very much, and
21 doing this well matters very much to all of us at DEA.
22 Thank you.
23 (Applause.)
24 MR. STRAIT: Thank you for your remarks,
Administrator Milgram.
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1 Let me now introduce the person who is
2 sitting next to her on her right, Assistant
3 Administrator Tom Prevoznik. He's a career Diversion
4 Investigator, and oversees the work of the Diversion
Control Program. Thank you, Tom, for also being here
6 today.
7 My name is Matthew Strait. I'm a Deputy
8 Assistant Administrator, and I oversee the Office of
9 Diversion Control Policy. This is the office
responsible for the regulatory drafting efforts of the
11 Diversion Control Division.
12 I will be serving as the moderator for this
13 listening session event, and over the next two days we
14 will have, as Anne mentioned, as many as 61 presenters
both in person and virtual providing their unique
16 views and opinions on important regulations impacting
17 the practice of telemedicine with controlled
18 substances.
19 This event is being transcribed, and will be
part of the administrative record relating to DEA'S
21 rulemaking in this space. This listening session is
22 novel for the DEA in that we have not generally held
23 public meetings to inform our regulatory drafting
24 efforts.
I hope that this effort underscores our
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1 desire to improve upon our information gathering
2 capabilities to better inform this important work. At
3 no time has this novel approach been more logical, and
4 more appropriate. Why? Because these regulations
will impact the delivery of healthcare for every
6 American in the United States, and frankly, we do need
7 to make sure we get it right.
8 We've structured this event so that we could
9 hear from stakeholders who could either be here in
person, or participate virtually. We issued a Notice
11 of Meeting in the Federal Register on August 1st, and
12 then gave the public until August 21st to register for
13 the event. We received a total of 1,308 registration
14 requests for those who wanted to participate.
Overwhelming majority are people who wanted to be here
16 and listen virtually.
17 We received a total of that list 186 people
18 requested authority to present their comments either
19 in person, or virtually, and due to the structure of
the event, and our decision to let each commenter
21 provide up to ten minutes of remarks, we curated a
22 list of commenters with diverse views on a number of
23 issues that are of interest to the DEA. 29 were
24 offered the opportunity to participate in person, and
32 were offered the opportunity to present as virtual
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1 presenters.
2 Because we are transcribing the event, and
3 that transcription will be part of DEA'S
4 administrative record, our presenters were advised
that they should not use visual aids. While we know
6 that for some of our presenters, and indeed, those who
7 we could not accommodate who wished to provide written
8 materials during this event, we will continue to
9 encourage those folks to provide those written
materials when all interested parties are invited to
11 respond to our forthcoming proposed rule.
12 For the folks who registered to attend this
13 event in person as an observer, I'm happy to report
14 that all were given the opportunity to be here today.
Okay. So let's go over the run of show, and
16 then after that we'll lay out some basic ground rules.
17 This morning our block will consist of as
18 many as 15 in-person presenters all seated here in the
19 first two rows. Presenters will speak in the order in
which they arrived this morning.
21 I will call commenter number one to the
22 podium. I will ask that individual to state their
23 name and their affiliation. Our transcribers have
24 asked me to make sure that presenters spell their
first and last name. That way we have a better
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1 transcription of the event.
2 Each presenter will then have up to ten
3 minutes to provide remarks. At the nine-minute mark
4 commenters will hear a gentle chime letting them know
that one minute remains to their comments.
6 When our countdown clock gets to ten minutes
7 you may hear a gentle buzzer. Yes. Upon completion
8 we will pause in the event that Administrator Milgram,
9 or Assistant Administrator Prevoznik, have any
clarifying questions.
11 We will continue to call each of our in-
12 person presenters one after the other. This should
13 take us some time to just about before the noon hour.
14 We will take a recess, and begin our afternoon session
at 12:40, where we will hear from as many as 17
16 virtual presenters.
17 I will call virtual Commenter No. 1, and the
18 individual's image will be cast onto the screen up
19 here on the stage.
I will ask our virtual commenters to, again,
21 state their name and affiliation, and again, ask them
22 to spell their first and last name. Once we've heard
23 from all virtual presenters we will wrap up day one.
24 Okay. So now onto a couple little ground
rules and housekeeping matters. For our in-person and
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1 virtual presenters I ask that you make comments that
2 are related to the nature of DEA'S rulemaking, and
3 refrain from providing remarks which are not germane.
4 As moderator, if there are comments that stray
substantially from the scope of our rulemaking, I will
6 politely interrupt the presentation, and ask you to
7 keep your comments related to the practice of
8 telemedicine relating to controlled substances.
9 For our folks in the audience you are
welcome to get up and use the facilities at any time,
11 but we do require that visitors be escorted. So if
12 you need to use the facilities, please exit the door
13 in the rear of the auditorium. There will be DEA
14 staff at the door to escort you around the corner to
the facilities.
16 If you need to leave the building maybe for
17 a quick bite at our session --
in between sessions,
18 please know that you will have to return through the
19 visitors entrance that you came into this morning.
Also for our folks in the audience, much
21 like the DEA is in listening mode, we ask that you
22 stay so as well. There are, unfortunately, no
23 opportunities for questions and answers as part of
24 this event, and we ask that everyone stay silent
during the session. This will not only improve the
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1 quality of our transcription, but the quality of our
2 simulcast for those who are watching us virtually.
3 Also, please keep your phone on silent. If
4 you need to take a call, again, feel free to exit the
rear door of the auditorium, and take that call in our
6 lobby.
7 Second to last point, if an audience in the
8 unforeseeable situation where we have an audience
9 member who is disruptive, as moderator I will ask our
security team to escort you out of the building. We
11 don't anticipate that happening, but I just want to
12 say it for the sake of clarity.
13 Last point, and please recognize that
14 Administrator Milgram, and Assistant Administrator
Prevoznik, may need to step away from this event for
16 potentially significant periods of time in order to
17 attend to their normal duties. Should that be the
18 case, you may see senior personnel from either the
19 Diversion Control Division and/or the Office of the
Administrator sitting here in their stead.
21 Okay. That's the end of my remarks, and I
22 think it's time for us to get started, so I will now
23 invite Commenter 1 to step up to the podium. And
24 again, as a friendly reminder, please spell your first
and last name, and state your affiliation.
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1 MS. KRAYN: Hey, everyone. My name is
2 Robert Krayn, R-O-B-E-R-T, K-R-A-Y-N. I'm the
3 cofounder and CEO of Talkiatry.
4 Administrator Milgram, I'd love the
opportunity to shake your hand quickly before I get
6 started.
7 Talkiatry is a nationwide psychiatry group.
8 We directly employ over 300 Board-certified
9 psychiatrists across the country. We employ five
nurse practitioners, all of whom are Board-certified
11 in psychiatric mental health. We treat hundreds of
12 thousands of patients annually.
13 The average cost per visit for a Talkiatry
14 patient is on average less than $30. We operate at
the pinnacle of quality. Each psychiatrist is
16 directly overseen by a chief psychiatrist, who spends
17 90 percent of their time on administrative duties.
18 They oversee a cohort of no more than 50 doctors at a
19 time.
We have been accredited to issue continuing
21 medical education much like a large academic
22 institution or health system. We partner with every
23 major insurer in the country, including Medicare, to
24 off expand access to care on an in-network basis.
I would also like to introduce my cofounder,
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1 and Talkiatry's Chief Medical Officer, Dr. Georgia
2 Gaveras.
3 Let me be clear, we have no subscription
4 fees, we have no pharmacy affiliations, and we see our
patients on average once per month for 30 minutes.
6 MS. GAVERAS: Hi. I'm Georgia Gaveras,
7 G-E-O-R-G-I-A, G-A-V-E-R-A-S.
8 So I want to talk a little bit more about
9 what I do just so you can understand why I'm up here
with Robert. I'm a triple Board-certified
11 psychiatrist. I'm Board-certified in child and
12 adolescent, in addition to general psychiatry.
13 And I'm also an addiction medicine
14 specialist, so I'm Board-certified in addiction
medicine. So my clinical career before starting
16 Talkiatry with Robert was treating teenagers with
17 substance use disorders in addition to psychiatric
18 disorders.
19 I was the Director of Training and Education
in Child and Adolescent Psychiatry, and I ran the two
21 emergency rooms, mostly notably the one in Kings
22 County Hospital in Brooklyn, and if you know Kings
23 County Hospital in Brooklyn, it's a very, very busy
24 emergency room with a lot of substance use disorders,
and children.
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1 I've also had a long academic career as
2 well, which I'll spare you the details. Robert?
3 MS. KRAYN: Listen, I think that you're
4 going to be hearing from a lot of people today, and
they're going to be asking for a lot of things.
6 They're going to be asking for access; they're going
7 to be asking for no limitations, and they're going to
8 be asking for less restrictions, all of which, I
9 think, are valid requests.
But what I think you won't hear is you won't
11 hear a lot of specifics. You won't hear the hard
12 stuff, the guardrails, the specific framework for how
13 this can actually be put into operation. You won't
14 hear who can prescribe what medications, and for what.
What number of medications are they allowed to
16 prescribe.
17 These are the things that I think the DEA
18 asked us here to present, and provide data behind why
19 we're presenting these specific guardrails. And that's
exactly what Georgia and I are going to do here today.
21 We stand before you representing some of the
22 highest quality Telepsychiatry practices in the United
23 States: Talkiatry, CORE Telehealth, and Inova
24 Telepsychiatry, ERA Behavioral Care, and Iris
Telehealth, some of which are also speaking today.
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1 Together we directly employ over 1,600
2 clinicians, and we treat over one million patients
3 annually. We have worked with practitioners of all
4 types, and all care settings, to balance safety,
diversion controls, and expansion to access of care.
6 We've created a joint recommendation, and
7 we've spoken to a lot of other associations to get
8 their input, including the American Telemedicine
9 Association, the American Academy of Child and
Adolescent Psychiatry, the American Psychiatric
11 Association, and the American Hospital Association.
12 Before I get into specifics, let me provide
13 some background. In 2016 I was the subject of a
14 brutal home invasion. A friend suggested I go and
speak to someone. Their wife is a psychiatrist. In
16 the largest city in our country, with the most number
17 of psychiatrists, I couldn't find anybody.
18 You email 20 doctors, and whoever responds
19 is the doctor you go and see. It's a very high
likelihood that that's not the right doctor for you,
21 and an even higher likelihood that you're not the
22 right patient for that doctor.
23 For me it was a basement office with eight
24 doorbells on the side of the wall with tape underneath
each one. I assume it's linked to a bell in a
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1 doctor's office to let them know I'm here. In person
2 visits do not equal quality care.
3 The Flexibilities that Administrator Milgram
4 has afforded America over the last three years have
fundamentally changed access for millions of
6 Americans. You should be incredibly honored and proud
7 of the work that your team has done.
8 Make no doubt, we're on the precipice of
9 history. I say we. I'm including myself in that.
And I think that we have the opportunity to resolve a
11 special registration process under this Administration
12 that's been evading multiple Administrations for
13 decades.
14 MS. GAVERAS: So I want to talk a little bit
about quality because I think that's where --
when we
16 talk about in-person we look at what's the quality of
17 the medical care. At Talkiatry we're honored actually
18 to have been selected by the Department of Health and
19 Human Services to provide psychiatric care to migrant
children in desperate need while they're here in the
21 United States.
22 We also work with large organizations such
23 as HCA, one of the largest hospital associations, and
24 NYU Langone, who have selected us to be their partner
providing psychiatric care to patients they need to
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1 refer.
2 We've done studies of our patients. We're
3 running a little short, so I won't go into details,
4 but we've shown significant reductions in symptoms
purely by a means of Telepsychiatry.
6 Our studies are not yet published, but they
7 will be, where we have thousands of patients we've
8 reviewed. We've reviewed their symptoms. We've done
9 evidence-based research on the treatment via
telemedicine, and we've shown incredible reductions in
11 their anxiety and depression.
12 When it comes to ADHD, I think that's really
13 the hot topic when it comes to controlled substances.
14 We found that patients that came to us with the chief
complaint of ADHD only 40 percent after psychiatric
16 evaluation were actually diagnosed with ADHD.
17 I think what happens a lot of times is a
18 patient will come to us saying I have ADHD when
19 they're really saying I have attention problems, and
what it really takes, again going into quality, is of
21 somebody that knows what ADHD is, what psychiatric
22 illnesses are, to evaluate them, and really to
23 determine is this ADHD, and then treat them
24 appropriately.
About 25 percent of patients that we have
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1 seen who we have diagnosed with ADHD are actually
2 successfully treated with medications that don't fall
3 under the controlled substance umbrella, and we're
4 able to do that successfully.
For people on controlled substances we've
6 also shown significant reductions over time in the
7 prescriptions, and even discontinuation of treatment
8 for patients. These medications are an important part
9 of psychiatric care, and have evidence-based and FDA-
approved uses.
11 MS. KRAYN: Now, onto the proposal we're
12 here to share with you today with the limited time
13 that we have remaining.
14 We propose two paths for the DEA to allow
the prescription of controlled substances. One, the
16 existing registration, including the proposed notice
17 of proposed rulemaking that was issued on March 1st,
18 2023, to allow a path for referrals.
19 And second, the one we're actually here to
discuss, a new special registration which will allow
21 qualified practitioners to prescribe Schedule II-N
22 nonnarcotic III, IV, and V medications via
23 telemedicine without an in-person visit or a referral.
24 This predominantly impacts large provider groups that
see patients exclusively, or predominantly via
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1 telemedicine without an in-person evaluation.
2 We will propose exemptions from certain
3 requirements for A, providers at not-for-profit
4 organizations, for those at hospitals for profit and
not-for-profit, and for Buprenorphine prescriptions.
6 Some overarching points before we get into
7 the nuance. So long as a practitioner holds at least
8 one DEA registration in any state only one special
9 registration will be required to prescribe controlled
substances in all 50 states, D.C., and its
11 territories. Providers would not need a separate
12 registration for each state where they practice; only
13 a medical license in that state.
14 Providers would not be required to maintain
a physical location, or to physically store records in
16 each state where they practice. Providers can store
17 records electronically in common spreadsheet formats,
18 or certified electronic medical records.
19 And lastly, providers can prescribe
controlled substances under the authority of the DEA
21 registration, or the special registration, depending
22 on the setting in which the care they treat the
23 patient.
24 MS. GAVERAS: And some other specific
guardrails that come out of clinical experience in
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1 discussion with our very extensive clinical team. We
2 believe that requiring providers to evaluate the
3 patient at least once every 90 days to continue to
4 provide controlled substances is adequate. For
controlled prescriptions, prohibit telemedicine
6 practitioners from requiring, recommending, referring,
7 or suggesting a patient utilize a specific pharmacy
8 unless the patient requests a recommendation for a
9 pharmacy.
Another guardrail we propose is excluding
11 Ketamine from the list of medications that could be
12 prescribed under this special registration. Already
13 the intranasal formulation of this Ketamine requires
14 observation by a healthcare professional during its
administration. And we also believe that the at-home
16 prescribing of a substance that does have huge promise
17 for depression also has very significant diversion
18 risks, and we believe that it should be regulated
19 further.
We also recommend to limit Schedule II and
21 II-N nonnarcotic medications, and as far as we're
22 concerned, to the treatment of psychiatric diagnoses,
23 and require prescribers to satisfy one of the
24 following: either be a physician, and when it comes
to --
we're talking about psychiatric medications, a
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1 physician, a certified nurse practitioner with Board-
2 certification in psychiatric or mental health from the
3 American Nurses Credentialing Center, a P.A. with a
4 certification qualification in psychiatry from the
National Commission of Certification of Physician
6 Assistants, or complete state licensing medical board
7 medical education on specifically the diagnosis and
8 treatment of ADHD.
9 MS. KRAYN: And there was just a couple
more. We also propose an exemption for hospitals, and
11 things like that, but I feel like there's some
12 additional folks in this room who can speak to that.
13 We also believe that for entities that
14 aren't not-for-profits, or hospitals, or prescribing
Buprenorphine, we believe that a limit on the number
16 of prescriptions that can be prescribed in terms of
17 controlled substances may be appropriate. Our
18 proposed limit is 275 patients at a time, or 500
19 prescriptions in one month.
With our background we believe that our
21 doctors, the largest number of controlled substance
22 prescriptions that anyone of them has ever written in
23 a month is about 320, and the most patients that any
24 of our doctors have ever actively had on a controlled
substance is 220. And so we believe these limits are
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1 appropriate, and these are predominantly psychiatrists
2 who treat children, or treating military veterans, for
3 example, and it can be done in a high-quality way.
4 We also believe that there are some data
reporting requirements that are really needed to
6 ensure that the DEA has the information needed to go
7 after and stop diversion before it starts, and we
8 propose supplying to the DEA on a quarterly basis the
9 prescriber DEA registration number; healthcare entity
the prescription was affiliated with, for example,
11 Talkiatry; the name of the drugs prescribed; the
12 number of prescriptions for each drug, and the date of
13 prescriptions.
14 It's important to note that the data
reporting requirements in patient limitations in our
16 proposal would not apply for hospitals, for profit, or
17 not-for-profit, or for doctors who are seeing patients
18 in a not-for-profit setting, or prescribing
19 Buprenorphine. So any of those restrictions I just
mentioned on those two things would be excluded in
21 that framework.
22 That concludes our remarks today, but if
23 there's any questions, we would be happy to take them
24 from a clarification standpoint.
MS. MILGRAM: So thank you on that for your
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1 presentation. Sorry. Sorry. Thank you for your
2 presentation. I really appreciate it. And as Matt
3 said, we're only able to ask clarifying questions, so
4 just a couple of quick clarifying questions.
Who is conducting the studies? You
6 mentioned some studies of your work.
7 MS. GAVERAS: Yeah. We analyzed our data
8 from our patients. So we have a National Director of
9 Clinical Quality, who is a physician. She's a
psychiatrist. She is the one that ran the study, and
11 it's an IRB-approved study.
12 MS. MILGRAM: If you'd be comfortable
13 sharing any of that with us.
14 MS. GAVERAS: Sure.
MS. MILGRAM: And obviously I know it's not
16 done, but we always like to see --
17 MS. KRAYN: Of course. Yeah.
18 MS. GAVERAS: Sure.
19 MS. MILGRAM: --
that kind of information.
It's very helpful.
21 MS. GAVERAS: It's the Government, I'll tell
22 you.
23 MS. MILGRAM: Thank you. Can you tell us a
24 little bit about your payment model?
MS. KRAYN: Yeah. So we're entirely in
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1 network, so we do not have any subscription-based
2 models, fees. It's just like any other doctor. You
3 come to Talkiatry, and we have a contract with your I
4 insurance company, or with Medicare, or in this case
actually with HHS for migrant children, and we will go
6 ahead and bill them a contractually-obligated rate.
7 And so it's in accordance with your insurance plan, so
8 deductibles, coinsurance, just like a primary care
9 physician.
MS. MILGRAM: And could you just expand a
11 little bit on why you don't think that hospitals or
12 nonprofits should have to have data requirements?
13 MS. KRAYN: Yeah. I mean, I think that they
14 have limited resources, specifically on the not-for-
profit side. And I think that when you look at the
16 potential for diversion it really stems from people
17 who are gaining a profit from making the
18 prescriptions, and a lot of not-for-profits it's just
19 simply not the case.
It's also understandable that creating a
21 regulation that applies to everyone makes sense, but I
22 think that I'd be remiss if I stood here and said that
23 a not-for-profit has the same resources as Talkiatry.
24 The data reporting requirements are
cumbersome. They are not as easy as they might sound.
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1 Certain doctors who work at multiple not-for-profit
2 organizations treating many patients, those records
3 are scattered everywhere. They do not have the money,
4 the resources, or the technology know-how to a certain
extent to make this an easily reportable component.
6 I think Buprenorphine, for example, should
7 be treated separately just because of the Opioid
8 crisis if you will, and we just got rid of the ex-
9 waiver right, so adding those pieces of information
back might not be appropriate, but I think, we learn
11 something good that it could be valuable.
12 And so people like Talkiatry, who operate on
13 the for-profit space, is happy to take on that burden,
14 and report that information up front to the DEA so
that you guys have everything that you need to spot
16 diversion, or spot trends, and go in and take a look
17 at it. We've got absolutely nothing to hide, but we
18 also have more resources than other folks.
19 MS. MILGRAM: Thank you so much.
MS. GAVERAS: I have the information now if
21 you want, the data points.
22 MS. KRAYN: Yeah. The information that you
23 asked for.
24 MS. MILGRAM: Thank you.
MS. GAVERAS: So the study that we did our
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1 end was 1,800 patients over a median treatment length
2 of 96 days, and the median number of visits was five
3 visits. Over this period 26 percent of patients in
4 this study who came with either moderate or severe
anxiety no longer showed symptoms, and 51 percent had
6 a greater than 50 percent reduction in symptoms. 28
7 percent of the patients in this study who came with
8 moderate or severe depression no longer showed
9 symptoms, and 53 percent had a 50 percent or greater
improvement in their symptoms, and all this was 100
11 percent telemedicine.
12 Thank you, guys, very much.
13 (Applause.)
14 MR. STRAIT: Okay. I'd like to next invite
Commenter No. 2 to the stage.
16 MS. KHAN: Good morning. I'm Shabana Khan,
17 S-H-A-B-A-N-A, last name Khan, K-H-A-N. I'm a
18 physician that specializes in child, adolescent, and
19 adult psychiatry, and I'm speaking on behalf of the
American Psychiatric Association, and the American
21 Academy of Child and Adolescent Psychiatry.
22 I'm an assistant professor and Director of
23 Telehealth for the Department of Child and Adolescent
24 Psychiatry at NYU Langone Health of the NYU Grossman
School of Medicine. I chaired the Telepsychiatry
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1 Committee of the American Psychiatric Association, and
2 I cochair the Telepsychiatry Committee of the American
3 Academy of Child and Adolescent Psychiatry.
4 The American Psychiatric Association, APA,
and American Academy of Child and Adolescent
6 Psychiatry, ACAP, really appreciate DEA'S time in
7 conducting this listening session, and we welcome the
8 opportunity to collaborate with the DEA on our mutual
9 goals of ensuring access to care, preventing
diversion, and promoting public health.
11 APA is a national medical specialty society
12 that represents over 38,000 psychiatric physicians and
13 their patients, and ACAP represents 10,000 child and
14 adolescent psychiatric physicians, many of whom treat
adults and transitional age youth age 18 and above.
16 We understand that the DEA has renewed
17 interest in exploring the public safety of the
18 legitimate prescribing of controlled substances
19 through telemedicine, as well as a potential special
registration as an avenue to expand access to
21 clinically appropriate remote prescribing of
22 controlled substances.
23 Our recommendations focus on balancing
24 commonsense safeguards for DEA enforcement of
legitimate controlled substance prescribing without
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1 decreasing access to lifesaving treatments.
2 First, to provide some perspective on
3 psychiatric practice as it relates to telemedicine
4 prescribing. In a survey of psychiatrists that was
conducted by the APA in April and May 2023, 97 percent
6 of the over 1,600 respondents noted that they conduct
7 telemedicine visits.
8 Most clinicians maintain a physical practice
9 location where they're capable of seeing patients as-
needed, but many do not have any physical locations in
11 every state in which they carry a medical license, and
12 currently can see patients.
13 Respondents report medical necessity is the
14 primary factor determining their clinical decisions,
and they see the lack of clarity around telemedicine
16 regulations as the primary barrier to the ability to
17 serve their patients. Many particularly noted
18 restrictions around controlled substance prescribing
19 both at the federal and state level.
Respondents appreciate the opportunity to
21 use telemedicine to serve their patients with health-
22 related social needs, including mobility,
23 transportation, childcare, and other caregiving
24 barriers that prevent them from traveling to
psychiatric appointments, especially in the 55 percent
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1 of U.S. counties that have no psychiatrist, and 70
2 percent of U.S. counties that have no practicing child
3 psychiatrist.
4 As DEA has heard in APA and ACAP's comments
to their 2023 proposed rules, telemedicine has not
6 been shown to increase diversion, decreases no-show
7 rates, and increases access to care. Prescribing
8 practitioners are able to accommodate social
9 determinants of health and other barriers to in-person
care, such as employment hours, family care
11 situations, stigma, violence, reducing flexibility in
12 modalities of care, increases in equity, forcing
13 practitioners to cherry-pick patients that have the
14 ability to travel to in-person care.
Rather than a mandatory blanket requirement,
16 the need for an in-person examination of a patient
17 really should be left to the clinical discretion of a
18 practitioner who has the knowledge, skills, and
19 experience to make that decision.
I've been practicing telemedicine for over a
21 decade, and I'd like to describe what a typical
22 initial telemedicine visit that may result in
23 appropriate prescribing of a controlled medication
24 would look like. For example, a child, adolescent, or
adult diagnosed with ADHD who may be prescribed a
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1 stimulant.
2 Similar to in-person care, the identity of a
3 patient seen by telemedicine is verified. Appropriate
4 consents for treatment may be obtained as required by
state payer or organization rules.
6 The patient's location is confirmed as the
7 general rule is that a practitioner is licensed where
8 the patient is at the time of the visit; the
9 practitioner has obtained a DEA registration; the
practitioner is registered with the patient's state's
11 prescription drug monitoring program, the PDMP; the
12 practitioner insures malpractice coverage for the care
13 that's being provided; a thorough clinical assessment
14 is completed through telemedicine, just as it would be
in person; all the clinical data needed to properly
16 assess and diagnose a patient is obtained before a
17 treatment plan is developed.
18 If the clinical assessment indicates that
19 the patient may benefit from the prescription of a
controlled medicine, it's prescribed for a legitimate
21 medical purpose, and within the usual course of
22 practice, and scope of practice of the telemedicine
23 practitioner.
24 Prescribing is not based solely on an online
questionnaire, so it's a thorough clinical assessment
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1 just like we would do in person. Relevant assessments
2 are completed, and data such as vital sign
3 measurements as-needed can be obtained for a
4 telemedicine visit, just as they are in person.
We can conduct a complete mental status
6 examination via video. We can assess for potential
7 side effects of the medications we prescribe; home
8 monitoring devices can be used to obtain vital signs
9 like blood pressure, heart rate, weight. If needed,
we can also collaborate with primary care doctors,
11 school nurses, and other clinicians locally to ensure
12 that we have all the information that we need, and the
13 necessary data is obtained for an assessment.
14 Safety protocols are outlined prior to
initiating services. So for example, what steps will
16 be taken if a crisis or safety issue arises, or if
17 there's a technology failure during the telemedicine
18 visit.
19 Whether care is provided in person or
through telemedicine there are already the existing
21 processes and requirements I described that provide a
22 high level of oversight, and accountability of
23 prescribing practices.
24 Along with these existing requirements a
telemedicine special registration could allow
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1 practitioners to affirm their adherence to the
2 processes, along with additional key elements,
3 including having a plan in place if a patient may need
4 to be assessed in person at some point.
The special registration potentially would
6 allow care to be completely remote, but if a patient
7 needed to be assessed in person, what would be the
8 plan; whether the telemedicine practitioner could see
9 them in person, that may not always be feasible, or
they can collaborate with other clinicians locally who
11 are not necessarily DEA-registered. But they possess
12 the capability to capture and convey necessary
13 physiologic data as-needed to make appropriate
14 clinical decisions.
Required checks of the PDMP, the
16 prescription drug monitoring program. While this is
17 already required in most states, clinicians would need
18 to be able to access the PDMP in any state in which
19 their patient is located.
PDMP access data in time could be included
21 in the notes section of their prescription. Improved
22 interoperability of the PDMPs across states would be
23 helpful, so that practitioners can access PDMPs across
24 states should --
the data from PDMPs should be shared
across states, and that should be a policy commitment
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1 across federal agencies.
2 Required reporting by pharmacists, other
3 medical practitioners, or organizations. If
4 prescribers have a pattern of high-risk prescriptions
based upon the pharmacists or other providers check of
6 the PDMP defined as prescribing multiple scripts of
7 higher dosages than are recommended by clinical
8 guidelines, and/or duplicate prescriptions from
9 multiple providers for the same medication. Reports
would trigger an investigation, which may not result
11 in penalty or enforcement action.
12 One caveat there is that, let's say, you
13 have a specialist that specializes in a condition
14 diagnosis where controlled medicines are commonly
prescribed. They may have elevated rates that are
16 appropriate, but elevated rates of prescribing, so
17 that's just something to keep in mind there.
18 The special registration should not be
19 limited to a particular diagnosis or a condition. In
the longer term we believe that DEA should enhance
21 collaboration with healthcare agencies to integrate
22 data sources, and develop better algorithms, and
23 access to identify bad actors.
24 DEA should convene clinical subject matter
experts to the subspecialty level to develop
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1 appropriate enforcement frameworks by Subspecialty
2 patient population, and other clinical considerations.
3 Any DEA audits should also incorporate appropriate
4 clinical expertise to assess appropriate prescribing
practices.
6 DEA should also work with federal health
7 agencies and state PDMPs to create a national database
8 for PDMPs, and electronic prescribing of controlled
9 substances, EPCS, data for population-level monitoring
and enforcement.
11 A national special registration we believe
12 should not require a physical location in each state
13 as this would more closely mirror the current process
14 for state medical licenses.
Medical licensure should continue to be
16 required for DEA licensure in that state. The special
17 registration could require reporting of the
18 prescriber's employer to hold telemedicine employers
19 accountable as necessary.
Registration should also document the states
21 in which the clinician is licensed, registered, and
22 plans to practice telemedicine.
23 Registration can also collect key
24 considerations for the practitioners telemedicine
practice, including the patient population, or
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1 conditions that they typically serve. In applying for
2 a national special registration the prescriber would
3 be agreeing to additional accountability and oversight
4 by the DEA.
To respond directly to DEA'S existing
6 proposals in March 2023, the 30-day initiation period
7 would not be adequate given the current wait times,
8 given the shortages as I mentioned, 70 percent of
9 counties with no child psychiatrist; 55 percent with
no psychiatrist, would not be adequate for evidence-
11 based medicine.
12 Notating prescriptions as telemedicine
13 increases pharmacists' hesitancy to fill the
14 medications without good reason. We are already
finding this in our practice, so adding that
16 telemedicine indication on there could potentially
17 make it even more difficult for our patients to access
18 care.
19 Schedule II-N should be carved into all new
allowances as high quality assessment and care can be
21 done virtually in the same way as they are done for
22 other controlled medicines using clinical discretion.
23 I do worry that if the proposed rules are
24 finalized, and they are very restrictive, just as an
example, child psychiatrists may choose not to provide
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1 telemedicine into these communities that don't have
2 care. So now we're not only limiting access to ADHD
3 treatment, but we're limiting access to all
4 psychiatric care in the context of our current mental
health crisis.
6 On a practical note, practices and
7 clinicians are already scheduling several months out
8 for appointments. If the DEA waits to issue updated
9 rules much longer, there is a risk of disruption of an
abrupt severing of patient care.
11 Our recommendations reflect a shared
12 commitment across mental health services to providing
13 evidence-based, high quality, equitable care that uses
14 every tool in our toolbox to address the opioid and
the mental health crises in our country.
16 Thank you for your consideration of these
17 comments.
18 MS. MILGRAM: Just a couple of quick sort of
19 follow-up --
MS. KHAN: Sure.
21 MS. MILGRAM: --
expansion questions. You
22 talked about the clinical data that you collect as
23 part of --
when you gave the example of a telehealth
24 patient experience that you have.
Can you just say --
expand on what that
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1 clinical data looks like that you would be collecting
2 in your sort of average telemed?
3 MS. KHAN: Absolutely. So, if I am seeing a
4 child or adult who may have the diagnosis of ADHD and
a stimulant medicine is clinically indicated, we
6 measure vitals, such as blood pressure, heart rate,
7 height, weight periodically particularly for children
8 and adolescents. If the patient during the
9 telemedicine visit is home, then we can use home
monitoring devices and provide guidance to the patient
11 on how to accurately check. There is the option of
12 also working with school nurses to collect that data
13 or primary care doctor, pediatricians. So we just
14 have to get a little creative. But, if there were any
reason why we thought that we didn't have the
16 information that we needed before prescribing a
17 medicine, we would have a plan in advance of whether
18 we don't prescribe or have the patient go in to see
19 someone locally to get more information.
And then, if --
since most situations we
21 have electronic prescribing of controlled substances,
22 there's data that's automated that's already tracked
23 in terms of number of prescriptions, dosages,
24 pharmacies where they were filled, that
interoperability among PDMPs across states would be
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1 very, very helpful. I know New York. There are only
2 a certain number of states that I can check, but there
3 are many that I don't have access to. And then, with
4 electronic medical records as well, there's a lot of
data from a payor perspective, certain clinical items
6 that we track and that we document.
7 MS. MILGRAM: Great. Just one more
8 follow-up. You talked about following clinical
9 guidelines on prescribing. What do you use for ADHD
now?
11 MS. KHAN: The American Academy of Child and
12 Adolescent Psychiatry has practice guidelines for
13 assessment and treatment of ADHD, so that would be one
14 of the guidelines that we would use.
MS. MILGRAM: How about for adults? Do you
16 have the same?
17 MS. KHAN: American Psychiatric Association
18 as well.
19 MS. MILGRAM: Thank you.
Tom?
21 MR. PREVOZNIK: Yeah. Could you please
22 explain how you verify the identity? I know you
23 mentioned, like, you confirm the address and things,
24 but could you actually walk me through step by step
how you identify that that is the patient and then do
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1 you --
how do you assess that that is the patient the
2 next time you see him?
3 MS. KHAN: Sure.
4 MR. PREVOZNIK: I know we're talking
children, but I'm just trying to get --
6 MS. KHAN: Yeah.
7 MR. PREVOZNIK: --
a better understanding of
8 that.
9 MS. KHAN: So it would vary by practice.
Some practices may get a copy of the patient's state
11 ID or federal ID. Some patients --
some practices may
12 use biometric screening as well to verify patient
13 identity, so it would vary. We would --
in my
14 practice, we are collecting data, getting an ID
verification.
16 MR. PREVOZNIK: Okay. And how --
what do
17 you do about the address? How do you verify that?
18 MS. KHAN: So it would be on the ID or a
19 patient would self-report their address as well.
MR. PREVOZNIK: Okay. So --
but you're not
21 doing any other check to ensure that that's the --
22 that's all --
I'm just trying to clarify that. Okay.
23 Thank you.
24 MS. MILGRAM: Thank you.
MS. KHAN: Thank you.
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1 (Applause.)
2 MR. STRAIT: Okay. We will now proceed to
3 Commenter No. 3.
4 MR. HOFFMAN: Good morning. Let's step back
from ADHD for a moment and talk about pain. When
6 Congress passed the Food, Drug & Cosmetics Act in
7 1932, they could not have been contemplating
8 restriction on access to pain medication for
9 terminally ill patients, and neither should the DEA.
I appear before you today to urge the DEA --
11 MR. STRAIT: May I ask you to state your
12 name and affiliation? Sorry.
13 MR. HOFFMAN: Thank you. David Hoffman,
14 D-A-V-I-D, H-O-F-F-M-A-N, Columbia University and the
Completed Life Initiative.
16 MR. STRAIT: Thank you.
17 MR. HOFFMAN: I appear before you today to
18 urge the Drug Enforcement Administration to
19 acknowledge the dramatically different circumstances
society confronts when regulating access to narcotic
21 pain medication for terminally ill hospice patients
22 versus the same medications for people with treatable
23 chronic or acute pain conditions.
24 I'm here wearing several hats. I am an
assistant professor of bio-ethics at Columbia
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1 University, where I teach courses on law and
2 bio-ethics and organizational ethics and compliance,
3 among others. I also serve as a clinical ethics
4 consultant for a large urban hospice organization and,
importantly, for the purpose of today's discussion, as
6 hospital counsel and compliance officer for a group of
7 community hospitals in the rural northern-most part of
8 New York State, where you can literally see Canada.
9 But most importantly, I am proud to be the
Vice President and Secretary of the Board of the
11 Completed Life Initiative, an advocacy organization
12 dedicated to expanding access to the greatest range of
13 services for patients at the end of their lives. That
14 said, the opinions I express today are exclusively
mine.
16 It is with these positions in mind that I
17 urge the DEA to adopt a policy of bifurcation of its
18 regulatory initiatives. Treating access to pain
19 medication through telemedicine consultation for the
terminally ill is a wholly different and unrelated
21 circumstance than treating those who are non-terminal.
22 The causes of the opioid crisis we face are
23 many. We all know that. The Sackler family and
24 Purdue Pharma have significant responsibility, but so
do the very well-meaning American Pain Society and
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1 U.S. Veterans Administration, which in 1996 and 1999
2 respectively declared pain to be the fifth vital sign,
3 very well intentioned, but that suggested to many that
4 no one should experience untreated pain. The problems
of overprescribing and diversion can be traced back to
6 these and other triggers.
7 In end-of-life care, we often frame our
8 discussions about care management in terms of missing
9 the window of opportunity for a variety of
interventions, including medical aid in dying and
11 palliative care. Lack of access to a provider can
12 cause that window to be missed.
13 In the case of terminally ill patients who
14 lose the ability to travel, access to care can be
impacted by their physical limitations and geographic
16 location. The problem is particularly acute for
17 patients transitioning, as so many patients do, from
18 oncology care to palliative care.
19 Sadly, many oncologists I know do not
consider themselves even qualified to manage pain at
21 the end of life. For those patients in that
22 circumstance, it is important that prescribing
23 clinicians be afforded the respect and latitude to
24 decide whether it is safe and appropriate to prescribe
narcotic medication solely through the modality of
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1 telemedicine consultation. This is especially urgent
2 in rural areas because of the profound shortage of
3 physicians generally and of pain management
4 specialists in particular.
Medical education is, of course, not the
6 responsibility of the DEA. I understand that. But,
7 as part of its regulatory intervention, it must
8 consider that this physician shortage is borne of the
9 failure by medical education organizations and,
indeed, the federal government to acknowledge and
11 respond to the current physician shortage, which was
12 publicly acknowledged by the American Association of
13 Medical Colleges and the Accreditation Council on
14 Graduate Medical Education at least as early as 2005.
Rural hospitals need expansion of the number of
16 residency slots, at least enough to keep up with the
17 growth of the number of Americans in need of
18 high-quality end-of-life care, including palliative
19 care.
Now we know it's relatively easy to solve a
21 single-variable equation. And if all the DEA had to
22 be concerned about is elimination of opportunities for
23 drug diversion, then the proposed ban on telemedicine
24 for first prescribing of narcotics might make some
sense. But the interests of patients in need of
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1 relief from pain and suffering, particularly those
2 patients with terminal illnesses and, therefore,
3 limited ability to travel to doctor appointments, must
4 be considered a strong balancing consideration by the
DEA.
6 I therefore urge you to assess your
7 responsibilities more broadly than simply limiting
8 access to narcotics, grounding DEA policy instead in a
9 broader view of its obligation to protect patient
well-being, which is what the Food, Drug & Cosmetics
11 Act requires. While more difficult than just focusing
12 on diversion, it is nonetheless more responsible and
13 humane.
14 Both goals can be achieved by using enhanced
tracking of CPT codes for pain management of
16 terminally ill patients and by expanding use of CPT
17 code modifiers to create easier tracking of narcotic
18 use by hospital patient --
by hospice patients, excuse
19 me, and generation of exception reports from
e-prescribing systems to detect multiple clinicians
21 writing prescriptions for the same patient.
22 We have just incredible amounts of data
23 locked up in all of our electronic medical record
24 systems, more than enough information for DEA to be
able to monitor and easily readily detect the presence
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1 of overprescribing for patients experiencing
2 end-of-life pain, such as is experienced by patients
3 who have cancer conditions and are required to
4 transition from their oncologist to a pain management
specialist if they can find one.
6 There's no question drug diversion is a real
7 problem, particularly in rural areas, but the solution
8 should not come at the expense of patients who want to
9 squeeze out every possible day of comfort at the end
of their lives. Thank you.
11 (Applause.)
12 MS. MILGRAM: Can I --
I'm sorry --
can I
13 ask you just a follow-up?
14 MR. HOFFMAN: Absolutely.
MS. MILGRAM: In your recommendation, you
16 talked about enhanced tracking of CPT codes and expand
17 some of the CPT code modifications. Could you expand
18 on all those recommendations?
19 MR. HOFFMAN: Absolutely. The billing
methodology for healthcare services is elaborate,
21 would be a polite way of describing it, but it
22 provides many useful tools, and the CPT codes tied to
23 hospice care and pain management more generally are
24 useful for keeping track of which patients are at the
end of life.
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1 We have the opportunity to add modifiers so
2 that a clinician could clearly identify a patient who
3 transitioned from oncology care to palliative pain
4 management care so that you could, in effect, remove
them from the set of clinical encounters that you need
6 to be most concerned about from a diversion
7 perspective. You asked one of the earlier speakers
8 about the availability of data to identify who is
9 getting what modality of care, even within either
treatment for ADHD or pain or any number of other
11 conditions.
12 We can create CPT code modifiers that will
13 specifically identify, for example, patients who were
14 under the care of an oncologist and then transitioned
to the care provided by a palliative care or a pain
16 management specialist so that, again, you would be
17 able to identify those circumstances where a first
18 encounter with a clinician prescribing narcotics
19 wasn't, as you described earlier, Administrator
Milgram, the circumstance where someone out of nowhere
21 seeks a prescription from an online resource where
22 they have no contact, no prior involvement, no
23 introduction by a clinician, we will be able to
24 identify for your easy access the circumstance where a
patient was being treated by an oncologist often for
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1 months or years in person. That oncologist was no
2 longer comfortable managing that patient's care
3 because there was no longer any curative care possible
4 and that patient, at the most vulnerable and often
most burdened moment in their lives, is scrambling to
6 find someone to find pain medication.
7 And those people are incredibly hard to
8 find, especially in rural areas, so that we have pain
9 management specialists who of necessity are managing
hundreds and hundreds of patients because we are in
11 this odd moment in the baby boom --
and I can talk
12 about the baby boom because I'm part of it at the very
13 tail end --
we have doctors retiring from practice
14 just as people of their age are showing up in record
numbers looking for cancer care and end-of-life care,
16 and we have fewer and fewer people to take care of
17 them.
18 I don't expect you to solve the problem of
19 the physician shortage. I do ask that you acknowledge
that it is part of the challenge we face in the
21 clinical community and do what you can to write
22 regulations that are sensitive to that particular
23 circumstance.
24 MR. PREVOZNIK: Yeah, could you just expand
a little bit on the consultation?
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1 MR. HOFFMAN: Right. So, when a patient is
2 finishing up some other course of treatment for an
3 acute or chronic condition, including conditions that
4 wind up being terminal, we can arrange a handoff from
that clinician who's providing curative care, whether
6 that's a physician, nurse practitioner, PA, clinical
7 psychologist, any other professional, to a virtual
8 prescriber for pain management and other palliative
9 care services without the necessity of a patient at
the end of life who may be in their living room in a
11 hospital bed having to physically travel to that
12 alternate provider.
13 The consultation can, because of the quite
14 remarkable capabilities of electronic medical records,
involve the transfer of treatment records. The key is
16 that we need people who are willing and able to
17 prescribe pain medication that in a patient who has an
18 acute treatable or chronic condition might be
19 problematic from a diversion perspective. I think,
when we have these controls in place and when we are
21 utilizing the CPT code and modifier data sets to track
22 these consultations, we can provide substantial
23 assurance on the provider clinician side, doctors and
24 hospitals and nurse practitioners, that there is a
warm handoff, albeit a virtual warm handoff.
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1 MR. PREVOZNIK: Thank you.
2 (Applause.)
3 MR. STRAIT: Okay. I'm inviting now
4 Commenter No. 4. Thank you.
MR. ZEBLEY: Administrator, Assistant
6 Administrator, my name is Kyle Zebley, K-Y-L-E,
7 Z-E-B-L-E-Y. I serve as Senior Vice President of
8 Public Policy for the American Telemedicine
9 Association, also known as ATA, and Executive Director
of ATA Action, which is the ATA's affiliated trade
11 association focused on advocacy.
12 We advance policy to ensure all individuals
13 have permanent access to telehealth services across
14 the care continuum, and we represent a broad coalition
of healthcare providers in over 400 organizations. It
16 is a guiding principle of the ATA that telehealth is
17 health, and healthcare practice should be regulated on
18 a level playing field regardless of whether in person
19 or virtual and regardless of virtual platform.
We have submitted a very comprehensive
21 letter to the DEA in advance of this meeting just last
22 week and which is available to the public on the ATA's
23 website summarizing our recommendations in detail
24 regarding a special registration process for the
remote prescribing of controlled substances, and my
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1 testimony today will summarize those recommendations
2 we shared last week.
3 We appreciate DEA's responsibility to write
4 rules that provide effective controls against
diversion and protect public health and safety, but we
6 believe that a requirement that a patient see a
7 clinician in person is not an effective control
8 against diversion and instead simply limits access to
9 legitimate healthcare.
During the COVID-19 public health emergency,
11 DEA has used its emergency authority to waive the
12 prior in-person requirement. This has enabled
13 providers to safely prescribe controlled substances
14 remotely using telemedicine, increasing access to
clinically appropriate medications.
16 After the initial experience of the
17 pandemic, a report found that over 70 percent of
18 providers surveyed reported that telehealth made
19 patient continuity of care better or much better and
that overall level of care provided via telehealth was
21 better or equal to that of in-person care.
22 We cite additional research regarding the
23 effectiveness of telehealth services for different
24 conditions in our letter and, of course, are happy to
work with DEA to provide further available clinical
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1 research.
2 Mandating an in-person evaluation prior to
3 prescribing a controlled substance via telemedicine
4 only results in reduced access to care and does not
enhance DEA's ability to do its job of limiting drug
6 diversion or pursuing illegal actors.
7 Every state allows a clinician and a patient
8 to establish a valid patient-provider relationship via
9 telehealth, and that relationship is just as
legitimate as one established in person.
11 While in-person requirements may be intended
12 to reduce diversion and illegal activity, they will
13 likely, in fact, do the opposite. As access to
14 legitimate healthcare is restricted, illegal online
drug sellers will fill the void.
16 We urge DEA to reject the notion that an
17 in-person visit is necessary prior to a telemedicine
18 visit and instead pursue other mechanisms to prevent
19 inappropriate access to medication via the internet.
And now I'll just do some recommendations
21 that will lay out how the DEA can do that, and we will
22 turn to our recommendations regarding a special
23 registration process for telemedicine. And we really
24 do so appreciate, as everybody in this room and
everybody watching online does, DEA's consideration of
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1 public input on the best approach.
2 We believe that if implemented without undue
3 burden or restrictions on providers, a special
4 registration process can be an appropriate mechanism
for DEA to fulfill its mission of preventing diversion
6 while allowing legitimate telemedicine to occur.
7 ATA Action urges DEA to consider two
8 principles when regulating telemedicine prescribing of
9 controlled substances. One, clinical practice should
not be limited by non-clinical decision makers, and,
11 two, telehealth is not a type of care but a modality
12 of care. Rules should take into account the unique
13 nature of the use of technology as a modality without
14 arbitrarily restricting its use.
ATA Action's recommendations for DEA for a
16 special registration process include seven tenets,
17 which I'll spend the remainder of my time describing.
18 First, the special registration process
19 should work in conjunction with the existing
registration processes. We recommend special
21 registration should be an optional supplemental form
22 associated with the existing registration process and
23 should result in a modifier on a practitioner's DEA
24 number, such as a T at the end, to indicate that the
provider has a special telemedicine registration.
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1 Second, telemedicine providers should not be
2 required to maintain local addresses in every state
3 where they practice. The value of telemedicine by
4 nature is only fully captured through the ability to
practice across state lines. Providers are already
6 required to obtain state licenses and authority in the
7 states where they practice. Thus, many telehealth
8 providers hold multiple state licenses.
9 However, the most significant limiting
factor to a multistate practice and the most
11 counterintuitive is the requirement to have a physical
12 location in every state where you practice. Having a
13 physical location in each state defeats the purpose of
14 serving patients remotely. Medical boards do not
require physicians to have an in-state
16 brick-and-mortar address in order to obtain a medical
17 license, and the DEA should follow suit with the same
18 approach in the special registration process for
19 applicants with multistate telemedicine footprints.
Third, special registration should include
21 the elements DEA needs to monitor for illegitimate
22 practitioners and illegal prescribing practices. We
23 outline specific elements that DEA could require in a
24 special registration, including business information,
state authority to practice, and attestations that DEA
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1 could ask of providers.
2 Fourth, special registration should not be
3 limited to any specific specialty or treatment
4 condition. Schedule II prescribing could involve
additional oversight but should not have additional
6 restrictions.
7 Clinical judgment should be left to the
8 clinician. There are not distinctions for prescribing
9 of controlled substances for different conditions or
treatments for in-person providers, nor should there
11 be for telemedicine providers.
12 However, we do, of course, understand that
13 Schedule II medications are classified as more
14 dangerous than Schedule III through V and recognize
DEA's interest in particularly limiting diversion of
16 these medications. Therefore, we recommend the same
17 general special registration process for all Schedule
18 III through V medications but with some additional
19 information required on the same form of registrants
who indicate interest in prescribing Schedule II
21 medications.
22 Fifth, dispensers. Pharmacies and
23 pharmacists should be able to identify legitimate
24 prescribers who have a current special registration.
When a pharmacist receives a prescription from a
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1 provider who has an active DEA special registration
2 for telemedicine, they should have confidence that if
3 the prescription originating from a geographic
4 location that is not near the pharmacy or near the
patient, that it is not a red flag. A part of the
6 purpose of telehealth is to reach patients that are
7 not in the provider's geographic area. We recommend
8 that DEA make clear that the addition of the T
9 modifier to the registration number should explicitly
indicate to the pharmacist that geographic red flags
11 should not be considered.
12 Sixth, the location of the patient should
13 not require any registration. Patients should be able
14 to receive telemedicine services from their home or
any other location. Those locations where the patient
16 is during the visit should not be required to have any
17 controlled substances authority. The prescriber
18 prescribing the controlled substance and the dispenser
19 dispensing it should have the controlled substances
authority, not the location of the patient, when they
21 see the prescriber remotely.
22 And, finally, the special registration
23 process should not place any arbitrary limits on a
24 clinician's ability to practice within the scope of
their authority. Prescribers should not be limited to
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1 treating an arbitrary number of patients in our
2 perspective. They should not be limited to issuing
3 prescriptions for an arbitrary time period. DEA
4 should not arbitrarily limit which clinician types
have which authorities or privileges, and
6 prescriptions should not be limited to FDA-approved
7 indications as off-label use of medications is legal
8 and, of course, common.
9 Thank you for the opportunity to provide
comments today. We urge the DEA to consider realistic
11 timelines when implementing these new processes. We
12 note that if DEA proposes a new rule regarding special
13 registration that the current pandemic flexibility
14 should be extended beyond November 11 to ensure care
is not interrupted.
16 We emphasize that following a final rule DEA
17 should allow adequate time for the healthcare
18 community to accommodate new clinical and
19 administrative procedures and update systems. We look
forward to providing further feedback on our
21 recommendations and otherwise assisting in this
22 process.
23 On behalf of the entire telehealth community
24 and our patients that those in the telehealth
community are serving, we thank you so much.
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1 (Applause.)
2 MR. PREVOZNIK: Yeah, just to follow up on
3 you mentioned that the registration, keeping the same
4 registration process that we have, but we could add
additional questions to those that are interested in
6 Schedule II.
7 MR. ZEBLEY: That's right.
8 MR. PREVOZNIK: Could you be a little more
9 specific on what you're suggesting that we might be
asking?
11 MR. ZEBLEY: Well, I know, on existing DEA
12 license forms, there is a clarifying question as to
13 whether or not you will be prescribing Schedule II,
14 and those have received higher scrutiny from our
understanding from clinicians in the field. So
16 modeled perhaps on that process of providing
17 additional information as needed. It is in the
18 letter, and we can definitely follow up with you on
19 those specific questions.
MR. PREVOZNIK: Okay. Thank you.
21 MR. ZEBLEY: Thank you.
22 MR. STRAIT: Okay. Thank you very much. I
23 will now invite Commenter No. 5.
24 DR. HUGHES: Good morning. My name is Dr.
Helen Hughes, H-E-L-E-N, H-U-G-H-E-S. I am the
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1 Medical Director for the Office of Telemedicine at
2 Johns Hopkins Medicine. And I'm honored to be able to
3 comment today.
4 In addition to my role as Medical Director
of Telemedicine, I'm also Assistant Professor of
6 Pediatrics in the Johns Hopkins University School of
7 Medicine and a practicing pediatrician in east
8 Baltimore.
9 It's my pleasure to comment today on
telemedicine prescribing of controlled substances
11 without an in-person medical evaluation. I'll be
12 making the following three key points in my comments:
13 First, there are many clinical situations which
14 require telemedicine controlled substance prescribing
without an in-person visit. Second, arbitrary
16 one-time in-person evaluation requirements do not
17 prevent abuse and diversion. And, third, the current
18 proposed requirements will be operationally and
19 technically burdensome to implement, especially for
complex health systems like our own.
21 Johns Hopkins Medicine, headquartered in
22 Baltimore, has seen a digital evolution in care
23 delivery spurred by the pandemic. We had fewer than
24 800 total outpatient telehealth visits prior to the
pandemic. We've had an Office of Telemedicine since
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1 2016, and due to a number of barriers, it was very
2 slow getting things off the ground. But, since March
3 2020, our providers have completed more than 1.8
4 million telehealth visits to over 470,000 unique
patients. This care represents over half of our
6 outpatient care during the early months of the
7 pandemic and 13 percent of outpatient care over the
8 last 12 months at our institution.
9 And this care spans a wide variety of
specialities, from psychiatry, genetics, neurology,
11 surgery, and oncology, and this rate has been steady
12 over the past one-and-a-half years with about 30,000
13 visits per month, and we consider this to be our new
14 normal.
Although we've seen telemedicine used across
16 all specialties at our institution, we found it
17 particularly impactful to increase access to mental
18 healthcare. At Johns Hopkins Medicine, 65 percent of
19 our outpatient psychiatry visits were conducted via
telemedicine in 2022, and 40 percent of the
21 provider-patient relationships in psychiatry were
22 maintained exclusively via telemedicine over the past
23 three years with no in-person visits.
24 Leveraging telemedicine in our view is the
only realistic pathway to achieve the goals of
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1 President Biden's mental health strategy seeking to
2 connect more Americans to mental healthcare.
3 We feel strongly that the Drug Enforcement
4 Agency should not interfere with reasonable clinical
decision-making. Telemedicine controlled substance
6 prescribing happens in a variety of settings across
7 Johns Hopkins Medicine, often without a previous
8 in-person encounter.
9 And I want to provide three specific
examples from specialties across our institution. In
11 child psychiatry, Adderall prescribed during an
12 in-person second --
sorry, telemedicine prescribed in
13 a second opinion ADHD telemedicine visit with a
14 patient who lives in rural Maryland and cannot travel
in person to Johns Hopkins. In neurology,
16 anti-seizure medication prescribed in a telemedicine
17 visit by a neurologist who is unanticipatedly covering
18 while her clinical partner is out on maternity leave.
19 In palliative care, opioids prescribed to a terminally
ill patient receiving virtual palliative care
21 services.
22 In each of these cases, the ability for
23 these providers to prescribe controlled substances and
24 to use their medical judgment over telemedicine
without a prior in-person visit allows patients to
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1 receive clinically appropriate essential care via a
2 convenient and patient-centered modality.
3 And we strongly believe the in-person
4 medical requirement should be removed in its entirety.
While the proposed rule would prevent or limit
6 prescribing in the above scenarios, it does nothing to
7 prevent a provider who saw a patient one time in
8 person even 10 years ago from recklessly providing
9 controlled substances via either telemedicine or
in-person care. And we've seen no evidence to suggest
11 that telemedicine controlled substance prescribing
12 over the past three years has led to patient harm or
13 increased inappropriate prescribing.
14 We would support several alternatives or
amendments to the current proposal. Our strong
16 preference, as I stated, would be to remove any
17 in-person requirement and to instead develop a
18 streamlined telemedicine special registration that
19 would allow the DEA to perform centralized
recordkeeping, prescription checking, and data
21 monitoring it needs to police prescribing practices
22 and prevent drug diversion and abuse.
23 This special registration process, without
24 other prescribing limitations, would provide an avenue
for practitioners who are willing to make this extra
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1 effort to complete a second application in order to
2 provide the care they deem necessary for their
3 patients when their patients need it.
4 If telemedicine prescribing of Schedule II
medication is restricted as proposed, we recommend
6 that DEA consider adding Schedule II non-opioids or to
7 end the exception or to allow for treatment of mental
8 health conditions, such as ADHD and other medical
9 conditions. This would be particularly important, as
has been previously mentioned, for pediatric
11 populations, where there is an even more significant
12 mental health workforce shortage that can be addressed
13 through telemedicine.
14 The burdensome operational and recordkeeping
requirements as proposed are not beneficial and
16 difficult to the doctor-patient-pharmacy relationship
17 which already relies heavily on IT interoperability,
18 which can sometimes cause confusion.
19 Our electronic health record does not
currently attach information to prescriptions
21 regarding the modality of an originating encounter and
22 the location of the provider or the location of the
23 patient at the time of healthcare delivery.
24 At a minimum, for the safety of our
clinicians, we recommend the DEA remove the
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1 requirement of the practitioners to report their
2 physical address during the telemedicine encounter,
3 especially if the provider is located at home, which
4 is a common practice location for our providers.
If any new prescription or recordkeeping
6 requirements are implemented, healthcares and
7 pharmacies should be given at least six months to a
8 year after finalization to implement these operational
9 and technically difficult requirements as many of them
involve changes to our electronic health record and
11 interoperability with pharmacies.
12 It's also unclear whether the proposed rule
13 applies to a number of common prescribing scenarios.
14 For instance, does the proposed rule apply and/or
address refills obtained from telephone calls or
16 electronic portal messaging? Does it apply to or
17 address providers who may provide refills while on
18 call or covering for someone else in their practice
19 group? More time will allow us all to navigate these
important questions together.
21 In summary, we truly appreciate the DEA's
22 careful attention to this important matter.
23 Telemedicine is now a routine care delivery tool for
24 providers across the country and at our institution.
We support the use of tools to track,
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1 analyze, and intervene in cases of inappropriate
2 controlled substance prescribing both for telemedicine
3 and for in-person care. However, we find that the
4 proposed rule arbitrarily limits clinically
appropriate care during telemedicine visits without
6 addressing abuse and diversion.
7 Thank you so much for the opportunity to
8 provide comment today, and we welcome any future
9 collaboration and discussion.
MS. MILGRAM: Thank you so much.
11 (Applause.)
12 MS. MILGRAM: If I could just follow up and
13 ask you to expand on you talked about a streamlined
14 special registration with centralized registration,
tracking of prescribers, and additional data tracking.
16 Could you just go through each of those three and give
17 a little more detail?
18 DR. HUGHES: Sure. We certainly support
19 what Mr. Zebley and the ATA put forward earlier. We
do not want to make this much more burdensome for our
21 providers. We found at least with the cross-state
22 licensure process that processes that are expensive
23 and/or result in a lot of additional paperwork are
24 difficult for our providers to keep up. So we would
want whatever special registration process is
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1 available to really sync up with the processes that
2 providers are already doing for the DEA.
3 In terms of analyzing and data tracking, you
4 know, through the prescription monitoring program, you
know, in Maryland, we have CRISP, which is a state
6 health record. I think anything we can do to have
7 nationally available records of prescribing practices
8 and to analyze those will be more impactful to catch
9 those who are inappropriately prescribing than limits
on needing to have an in-person visit first. I think
11 that is --
was there one more?
12 MS. MILGRAM: You just talked a little bit
13 about not expanding what doctors do beyond the DEA
14 process. Can you talk a little bit about information
that doctors already provide to payers that might be
16 available here or used here?
17 DR. HUGHES: Well, I mean, claims data. So,
18 certainly, at a Medicare level, I imagine Medicare
19 would have a lot of information about prescriber
practices.
21 For claims data for commercial insurers, I
22 think it would be more complicated, but I think, for
23 most states, there is sharing. I'm not sure on the
24 technical, if that information comes from pharmacies
or from payers. But I think the data do exist, and
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1 the more there is interoperability through ONC and
2 other groups, you know, I truly believe it is possible
3 for us to understand at a national level some of these
4 prescribing practices. Thanks very much.
MR. STRAIT: Thank you.
6 (Applause.)
7 MR. STRAIT: Okay. I will now invite
8 Commenter No. 6 to the podium.
9 DR. CLEAR: Good morning. I'm Brian Clear,
B-R-I-A-N, C-L-E-A-R, and I'm a family physician,
11 addiction medicine specialist, and I'm Chief Medical
12 Officer at Bicycle Health and speaking on behalf of
13 the organization today.
14 I directed in-person OUD care programs for
about five years prior to beginning telemedicine work
16 with the onset of the COVID public health emergency.
17 Through the flexibilities permitted by the waivers, at
18 Bicycle, we've come to employ 80 addiction medicine
19 specialist providers and treat over 11,000 patients
with opioid use disorder across 37 states.
21 When I began this work in 2020, like most of
22 our providers, I initially assumed that telemedicine
23 would be limited compared to in-person care. In some
24 ways, it is. But like all effective treatment
settings, it also has advantages, and these have been
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1 so significant. They've enabled us to expand access
2 and improve outcomes in ways that have exceeded
3 expectations from in-person experience.
4 We see a 90-day retention rate of 70 percent
compared to in-person norms of about 50 percent.
6 We're able to see and begin treatment for over
7 two-thirds of new enrollees within 24 hours of their
8 initial outreach. Nineteen out of 20 patients who
9 begin care with us achieve their initial effective
treatment dose within seven days, and 80 percent of
11 our patient population completes a drug screen in any
12 given month.
13 These outcomes would indicate an
14 extraordinary program in any setting, and we've
achieved them broadly at scale through telemedicine.
16 So why are we initially skeptical of telemedicine in
17 OUD care? We recently used a qualitative research
18 design to survey our own provider team to find out,
19 and we find common themes of initial hesitance around
starting telemedicine work that come from the newness
21 of the setting as it establishes credibility,
22 regulatory uncertainty, and also from assumptions
23 about who patients with OUD are, which leads to doubt
24 about telemedicine's ability to serve them well.
This third hesitation comes from a common
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1 misconception. If you look at a typical population of
2 an in-person OUD care program, you might assume that
3 the average person with opioid use disorder is
4 unemployed, has few or no family obligations, has a
high likelihood of being unsheltered, and has limited
6 access to technology and perhaps little ability to use
7 it reliably.
8 It would be wrong to extrapolate that to the
9 larger OUD population. Traditional OUD care programs
serve 10 percent of the population who need their
11 services and tend to design their programs for the
12 most severely affected 10 percent. As a result, the
13 majority of those with opioid use disorder, even if
14 there is a nearby in-person program, often don't
access it either due to conflicting obligations or
16 perception that the program is not intended for them.
17 Our survey results support that despite
18 initial skepticism, after beginning telemedicine
19 practice, our team feels effective and rewarded in
their role. Providers observe that we can effectively
21 build relationships with patients in the telemedicine
22 setting. We can see into patients' homes, we can meet
23 their families, we can see them quickly on their lunch
24 break when they can't get off work.
Our team also notes the ability to reach
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1 rural patients and treatment naive patients, which has
2 been especially rewarding; 18.2 percent of our
3 patients are rural, 67 percent are employed, and over
4 20 percent of new patients have not engaged with any
medical opioid use disorder treatment program before.
6 We're reaching patients who have not previously been
7 reached. As a result, like our patients, our
8 providers also tend to stick with us and stick with
9 telemedicine. We consistently see a less than 1.5
percent quarterly provider turnover rate.
11 Another element of telemedicine OUD care
12 that invites curiosity and skepticism is how drug
13 testing is performed. We utilize a randomized at-home
14 drug testing program that prompts patients on average
once every 30 days to complete a urine drug test.
16 Test results are submitted through a series
17 of timed photographs of the at-home kit, and we also
18 utilize video-observed saliva drug screens when
19 necessary. We know that sample falsification rates at
in-person programs range from about 5 percent to 18
21 percent in the literature.
22 To get a sense of our own sample
23 falsification rates, we ran a study that required a
24 cohort of patients to submit a one-time sample by mail
to our research partner, and following that
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1 submission, we collected a buccal swab under direct
2 video observation for genetic matching to the
3 previously submitted urine sample.
4 Among submitted samples, only 2.3 percent
were found to contain exogenous or spiked
6 buprenorphine or other evidence of adulteration; 0.8
7 percent were determined to be human urine from a
8 source other than the patient. These observations
9 support a high rate of drug screen adherence among
participants who completed the study, and full
11 findings are pending publication later this month.
12 When we do determine that a patient is
13 struggling to use their medication as directed, we now
14 have a new tool that I'd like to mention briefly.
Previously, if non-adherence continued following our
16 best interventions, our only option would be to refer
17 to an in-person program for sublocade or for daily
18 observed treatment.
19 More recently, we can now use sublocade via
telemedicine in some areas which has been administered
21 directly by a qualified pharmacist. Sublocade is a
22 once-per-month injected extended-release buprenorphine
23 depo. For some patients, it can solve medication
24 adherence issues and it's essentially impossible to
divert. It's not a magic bullet. It's still very
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1 costly and access is limited, but it is a promising
2 new resource that we've used now for several patients
3 and look forward to continuing to scale as more
4 pharmacies begin to offer the service.
The next experience I'd like to offer this
6 group is what happened when an in-person mandate was
7 implemented in the State of Alabama in July of 2022.
8 In July, Alabama enacted a law requiring that for any
9 controlled prescription to be issued on the basis of a
telemedicine encounter, the prescriber must have seen
11 the patient in person at least once within the
12 preceding 12 months.
13 When this law was enacted, we'd been
14 operating in Alabama and were treating just over 500
patients via telemedicine. In response, first, we
16 successfully supported 20 percent of those patients
17 and transferring to in-person programs, but that left
18 about 400 who were either unresponsive to the effort
19 or were unable or declined to find an accessible
in-person provider.
21 To try to retain these 400, we sent a team
22 of two physicians and support staff to Birmingham to
23 offer a weekend pop-up clinic. All patients were
24 asked to travel to the pop-up clinic to see our
physicians in person and satisfy the mandate for one
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1 year.
2 One hundred and sixty-two patients were able
3 to complete the visit. Over 200 patients did not and
4 were lost to follow up. Of the 162, 160 recently
completed their second annual in-person visit this
6 past July, and 158 also completed an experience
7 survey. Of these, every one of them arrived by car,
8 none by public transit. Mean travel distance was 86
9 miles; 25 percent missed work to attend even on the
weekend, and 16 percent needed to find childcare to
11 attend.
12 Patients disagreed with the following two
13 statements on a 1 to 5 Likert scale with a median
14 score of 2. One, seeing my provider in person
improves my care or my ability to succeed in
16 treatment, and second, I have other resources for
17 opioid use disorder care in my community.
18 In Alabama, we saw the in-person mandate
19 selected for the most resourced and engaged patients.
We know that almost everyone who completed the
21 requirement once went on to do it again a year later.
22 But we'd be foolish to assume that the in-person visit
23 itself had anything to do with achieving that 98
24 percent one-year retention rate. In fact, it created
a filter which removed the most vulnerable 60 percent
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1 of patients from our treatment program, and we don't
2 know what happened to them. By any measure, it was a
3 disaster.
4 Telemedicine OUD care has been highly
successful at expanding access and improving quality
6 of OUD care. Also, we've seen that improvement is as
7 vulnerable as a person in early recovery from OUD,
8 particularly in the face of hasty regulation.
9 My ask is that in designing a permanent
regulatory framework, we consider that we need it to
11 work for the majority, not just for the more resourced
12 and motivated minority.
13 For patients, we should understand that any
14 new barrier to patient access will discourage that
access, and regulating requirements for a patient, no
16 matter how seemingly small, it should already be a
17 universal component of good OUD care or it becomes a
18 barrier to good OUD care. A bonafide physical exam,
19 whether in person or via telemedicine, does meet this
standard, and so does maintaining a valid form of
21 patient identification. An in-person requirement does
22 not.
23 For providers, those us currently braving
24 telemedicine OUD care are highly motivated and willing
to accept risk and expense for public health and for
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1 the field. The majority of providers won't be as
2 eager to sign up for new costs and risks unless
3 there's an offsetting benefit.
4 If special registration is the pathway
chosen to enable telemedicine OUD care, it won't be
6 successful if its net effect is a burden and an
7 expense. My group would prefer for telemedicine OUD
8 care to be enabled through regular rulemaking as
9 opposed to the addition of a new special registration
process.
11 However, special registration could
12 potentially be a net benefit to multistate
13 telemedicine OUD practice if it offers a single
14 national registration pathway rather than
state-by-state registration.
16 For effective OUD care, it would only need
17 to permit the prescribing of Schedule III through V
18 medications that are FDA-approved for the treatment of
19 OUD. And, presumably, it would not authorize any
onsite medication storage or dispensing.
21 It would also be reasonable as a condition
22 of receiving special registration to require attesting
23 to certain practice elements that are established as
24 universal in good-quality telemedicine OUD care, such
as PDMP reviews, a formal medication adherence support
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1 or diversion control policy, and a formal drug screen
2 monitoring policy based on published standards of care
3 endorsed by a reputable professional society.
4 It would also be reasonable to require
e-prescribing. I strongly discourage requiring any
6 arbitrary dose, duration, or formulation requirements
7 in any framework.
8 Finally, I urge DEA to design any new
9 process to improve your ability to oversee and audit
prescribing patterns and to intervene when
11 exploitative practice is identified but to avoid
12 attempting preemptively to control or limit clinical
13 practice through regulation.
14 It's been my pleasure to participate in this
forum. Thank you for organizing this event and for
16 this opportunity.
17 (Applause.)
18 MS. MILGRAM: Thank you so much. Just a
19 couple quick questions. You know, you talked a couple
times about protocols around drug testing.
21 DR. CLEAR: Sure.
22 MS. MILGRAM: What are those protocols that
23 you follow currently?
24 DR. CLEAR: Certainly. So every one of our
patients, when they first begin treatment with us,
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1 they're mailed a set of three at-home urine drug
2 screen kits. They're also mailed a saliva drug screen
3 kit and a home pregnancy test. Patients agree to
4 complete one of these drug screen kits anytime they're
randomly prompted to do so through text messaging or
6 through our app. The providers control the average
7 interval at which these prompts are sent. They're
8 sent no less often than every 30 days. Patients
9 typically complete the first test within the first
three days of treatment for opioid use disorder. They
11 usually complete a follow-up test on a weekly basis
12 until they get their first favorable test. Then it's
13 at provider discretion thereafter.
14 We can do a video-monitored saliva screen
where the test is completely within the frame of the
16 video throughout the duration of taking the sample and
17 also developing it. So that controls for potential
18 sample substitution or adulteration. It's not a good
19 baseline test because it's much less sensitive for
buprenorphine or other drugs of abuse, but it is a
21 good deterrent for sample substitution that helps
22 preserve the integrity of our urine drug screening
23 system.
24 MS. MILGRAM: Thank you. You talked a
little bit about research that's ongoing. We'd love
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1 to see that when it's available. You can connect with
2 our folks. Anything you can share we appreciate.
3 DR. CLEAR: Absolutely. We've got two
4 publications that just finished peer review. They're
pending publication. We'll send them your way.
6 MR. PREVOZNIK: Can you just expand just a
7 little bit on, at the very end, you talked about a new
8 process of auditing. What is your vision of what that
9 would look like?
DR. CLEAR: I understand from I believe
11 informal comments that I have heard from DEA in
12 certain forums that one problem with auditing
13 multistate telemedicine practice has been that records
14 are dispersed throughout different practice locations.
Some of them are even unstaffed. It may just be a
16 computer in a room with a receptionist.
17 I would imagine that a consolidated special
18 registration process that's based around the primary,
19 single, primary practice location would make it easier
for DEA to require that all records of their entire
21 national or however many states they're practicing in
22 practice to be kept at that one location so that DEA
23 can be sure that you're getting a full picture of that
24 provider's practice with one audit rather than
multiple state-by-state audits.
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1 MR. PREVOZNIK: Thank you.
2 DR. CLEAR: Thank you.
3 (Applause.)
4 MR. STRAIT: Thank you. I will now call up
Commenter No. 7.
6 MR. MILAM: Thank you. My name is Thomas
7 Milam, T-H-O-M-A-S, Milam, M-I-L-A-M. I am the Chief
8 Medical Officer at Iris Telehealth.
9 Good morning. As I said, I'm Tom Milam and
I'm honored to be --
to have been invited to speak to
11 this DEA listening session, and I thank the
12 Administrator and Assistant Administrator and the
13 staff and colleagues that are here today for the time
14 and attention given to this important matter.
By way of introduction, I have been a
16 Board-certified psychiatrist for over 25 years and for
17 12 of those years have been involved in developing and
18 delivering telebehavioral health solutions for
19 underserved communities and healthcare systems
throughout the U.S.
21 As I said, I'm currently Chief Medical
22 Officer for Iris Telehealth. I'm President of our
23 medical group there, and I serve as Associate
24 Professor of Psychiatry and Behavioral Medicine at
Virginia Tech Carilion School of Medicine in Roanoke,
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1 Virginia.
2 Iris Telehealth is a Joint Commission
3 accredited healthcare organization that focuses
4 exclusively on providing behavioral healthcare
virtually to underserved community mental health
6 centers and primary care clinics, hospitals, emergency
7 departments, and residential treatment centers. We
8 currently employ nearly 450 U.S.-based psychiatrists,
9 psychiatric nurse practitioners, and therapists in
hundreds of care sites across 40 states. Iris has
11 been delivering care since 2013, well before the
12 pandemic, and over the years, we've had many
13 constructive conversations with DEA on various topics
14 like we are addressing today.
I want to say up front that I believe it is
16 imperative that we enable the prescribing of Schedule
17 II medications virtually via telemedicine and without
18 in-person requirements as long as proper safeguards
19 are in place to ensure patient safety and prevent
diversion. In my upcoming remarks, I will discuss the
21 numerous safeguards already in place, as well as some
22 that could and should be added or strengthened.
23 Ultimately, if in-person requirements are
24 mandated for controlled medications, particularly
Schedule II medications, simply as a means of
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1 diversion control, which is an important effort, it
2 will lead to unnecessary delays in care and the
3 prolonging of significant human suffering for
4 legitimate patients seeking legitimate treatment from
legitimate DEA registered providers.
6 I think it's important that DEA understand
7 what safeguards are already in place to ensure patient
8 safety and prevent diversion when prescribing
9 controlled particularly Schedule II medicines, whether
such medications are prescribed by in-person or
11 telemedicine providers.
12 First, before prescribing any new controlled
13 substance for a patient and periodically thereafter,
14 healthcare providers review the prescription
monitoring program for the state in which the patient
16 resides as well as numerous surrounding states when
17 that data is available.
18 While prescription monitoring programs vary
19 from state to state, they are a good initial safeguard
against the overprescribing of controlled medications
21 by multiple different providers and in quantities and
22 combinations that may prove dangerous or lethal.
23 Brandeis University's prescription
24 monitoring Center of Excellence issued a brief in 2012
stating that evidence is accumulating that
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1 prescription monitoring programs are effective in
2 reducing diversion of controlled substances, improving
3 clinical decision-making, and assisting in other
4 efforts to curb the prescription drug abuse epidemic.
While DEA does not have carte blanche access
6 to prescribing data from each state's prescription
7 monitoring program, most programs do permit interstate
8 data exchange and thereby provide collaboration and
9 early stage processes for preventing and stopping
aberrant and illegal prescribing practices.
11 Rather than create new additional
12 recordkeeping and reporting requirements for
13 controlled medications that put additional burdens on
14 providers and clinics, who are already working hard to
manage heavy caseloads for the patients they see, I
16 encourage the DEA to continue working closely with
17 state legislators, the Federation of State Medical
18 Boards, the National Association of Boards of
19 Pharmacy, SAMHSA, and other reputable national
organizations to expand the security, privacy, and
21 reporting of existing controlled medication
22 prescribing data. We do not have to create a whole
23 new reporting system de novo.
24 The second safeguard for ensuring patient
safety and preventing diversion of controlled
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1 substances involves the effective use of controlled
2 medication contracts. Whether in brick-and-mortar or
3 virtual care settings, patients who are prescribed
4 controlled medications, especially controlled Schedule
II medications, are required to sign contracts that
6 indicate under which circumstances those controlled
7 medications will or will not be prescribed. Those
8 contracts include items such as drug screening
9 requirements, refill contingencies, pill counts, and
the use of prescription monitoring programs to track
11 patient prescriptions. Patients and providers are
12 expected to adhere to the tenets of those contracts as
13 long as those controlled medications are prescribed.
14 A third safeguard for ensuring patient
safety and preventing diversion involves e-prescribing
16 controlled medications. Healthcare providers are
17 expected to use DEA's certified electronic or
18 e-prescribing platforms that require two-factor
19 authentication, that only allow registered legitimate
pharmacies to be listed, and that have hard stops to
21 prevent exceeding quantity and refill limits. Most
22 e-prescribing software is already incorporated into
23 commonly used electronic medical records, rendering
24 easily forged paper prescriptions obsolete.
E-prescribing controlled substances directly
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1 links providers with legitimate pharmacies which allow
2 patients to choose convenient local or mail order
3 pharmacies. Because these pharmacies are the nexus
4 between patients, providers, and controlled
medications, prescribing and dispensing is best
6 limited to data from pharmacies that take on
7 maintaining and reporting controlled substance
8 prescription data.
9 As I've said before, creating a new provider
or clinic-based reporting structure would be
11 cumbersome and would unnecessarily duplicate existing
12 reporting structures and safeguards.
13 In regard to the circumstances in which
14 telemedicine prescribing of Schedule II medications
should be permitted in the absence of an in-person
16 medical evaluation, the COVID-19 pandemic exposed what
17 many of us in the mental health field already knew to
18 be true: There is an incredibly dire and worsening
19 shortage of psychiatrists and many other mental health
professionals in the U.S. and worldwide.
21 DEA and CMS took bold steps during the
22 pandemic to help patients get access to the providers
23 and medications they needed to treat their physical
24 health, mental health, and substance use disorders,
and I applaud DEA and CMS for the steps that they
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1 took. They were the most amazing that I had seen in
2 25 years of practicing medicine. But the mental
3 health and opiate crisis have continued to expand with
4 little to no end in sight despite incredible effort.
So what can we all do to make sure patients
6 continue to have access to the care and medications
7 they need, including Schedule II medications, to get
8 and stay well while ensuring patient safety and
9 preventing diversion? First, DEA and Congress could
select an add federal and state-funded nonprofit
11 healthcare organizations to the list of those exempted
12 from the Ryan Haight Act. Community mental health
13 centers, FQHCs, rural health clinics, and other
14 nonprofit front-line health and addiction treatment
centers should be afforded the same exemption from the
16 Ryan Haight Act that Indian Health Services and
17 veteran clinics received.
18 You might say there already is an exemption
19 for DEA registered hospitals and clinics, but that
exemption is not as clear as it sounds. Companies
21 like Iris Telehealth work with hundreds of nonprofit
22 clinics and hospitals in communities across the U.S.
23 that remain very confused and don't understand if they
24 are or are not a DEA registered organization. That
leads to confusion and patients not getting the
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1 medications they need.
2 Second, for providers who choose to practice
3 and treat patients 100 percent virtually without
4 regard to an in-person examination and requiring one,
the long-awaited special registration referenced in
6 the Ryan Haight Act is imperative. Providers granted
7 special registration with the DEA could be identified
8 by the letter T and incorporated into their DEA number
9 in a manner similar to that done for X-waivered
providers who sought to prescribe buprenorphine to
11 help curtail the opiate epidemic. Such T waiver
12 providers could undergo FBI background checks and
13 other federal and state clearances so they could
14 prescribe for patients they treat in any U.S. state
without being required to have physical locations in
16 the state where they treat patients. Special
17 registration should not be simply granted by filling
18 out a Form 224 or 224A and paying a fee but should
19 come with requirements including additional and
meaningful training on patient safety and diversion.
21 Finally, regarding ADHD and Schedule II
22 stimulant prescribing, as a psychiatrist with 25
23 years' experience practicing in community and academic
24 centers, hospitals, and emergency departments, I can
assure you that ADHD is a very serious developmental
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1 and learning condition. It is often diagnosed in
2 childhood, but it can emerge and become disabling
3 under the progressive demands of early and middle
4 adulthood. I'm glad to provide clarity on that from
my book chapter, "Attention Problems," published in
6 the 2014 edition of Essential Psychopathology
7 Casebook.
8 Ten percent of children and 5 percent of
9 adults struggle with ADHD, especially in rural,
underserved, and ethically and racially diverse
11 communities across the country. It is very hard for a
12 lot of these folks to get the physical and mental
13 health and addiction treatments they need and deserve,
14 and they never will get it unless we implement
progressive community-oriented telemedicine reform at
16 the state and federal level without the encumbrances
17 of pre-pandemic geographic reimbursement and
18 controlled medicine prescribing practices. There is
19 no need to further frighten millions of children and
families and adults who fear losing access to their
21 medications and their telemedicine prescribers in our
22 efforts to prevent diversion control.
23 We can inform and transform the healthcare
24 landscape and ensure patients get the physical, mental
health, and substance use disorder treatment they need
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1 virtually anywhere. Thank you.
2 (Applause.)
3 MS. MILGRAM: If you'll just pause there for
4 one second, I'd like to clarify. Thank you. Just to
clarify quickly, I may not have accurately heard this.
6 You recognized that DEA does not have access to a lot
7 of the PDMP data. Did I hear you say that you did not
8 think DEA should get access to the PDMP data? I
9 wasn't sure.
MR. MILAM: Yeah. No, that's a great
11 question. It's my understanding that they have access
12 to the data but can only use the data in a limited
13 scope for seeking criminal behavior or investigating
14 complaints, but not carte blanche access to all the
data in prescription monitoring programs.
16 I think they should have access to that data
17 and work with the organizations that I mentioned for a
18 collaborative effort that you all get the information
19 that you need to prevent diversion control, work --
that's helpful to us and to communities, but it
21 doesn't burden patients with going through a lot of
22 additional steps to get the medications they need to
23 be refused medications for legitimate prescriptions at
24 pharmacies when they present them just because they're
prescribed by telehealth. There should be access to
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1 data that is very transparent so that some of this
2 confusion around legitimacy is clarified.
3 MS. MILGRAM: Thank you.
4 MR. MILAM: All right. Thank you.
MR. PREVOZNIK: You're not off the hook yet.
6 You mentioned about our 224 and 224A form,
7 but then you went on to say that there could be
8 perhaps another --
I'm not really sure what you were
9 striving for, but other requirements that we could
ask. Could you expand on that?
11 MR. MILAM: Sure.
12 MR. PREVOZNIK: Like, what you're thinking?
13 MR. MILAM: FBI background checks, which are
14 a routine part of our own credentialing process for
all of our providers, and that could include state and
16 federal checks to make sure people are who they say
17 they are, that they are not --
have been accused of --
18 or found guilty of criminal activity.
19 Educational processes, I think that's
something we can all work together on, having
21 meaningful substantive required education courses, one
22 hour, three hours, eight hours, kind of like what was
23 done for buprenorphine prescribing in early days,
24 something like that that's not onerous but meaningful,
that people can have when they new or renew their DEA
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1 registration or special registration and that could be
2 updated regularly so that providers, clinics, and
3 others are getting regularly updated data about
4 diversion control efforts because we don't hear a lot
about that and about meaningful prescribing patterns,
6 best practices, things like that so that you all know
7 that the people that are providing legitimate
8 prescriptions are educated at a level that's
9 meaningful to you as well.
MR. PREVOZNIK: Thank you very much.
11 MR. MILAM: All right. Thank you.
12 (Applause.)
13 MR. STRAIT: And I'm now inviting Commenter
14 8.
MS. MELVILLE: Thank you. Good morning.
16 I'm Melanie Melville, M-E-L-A-N-I-E, M-E-L-V-I-L-L-E.
17 I'm a psychiatrist by training, and I'm the Medical
18 Director of the Department of Behavioral Health at
19 Legacy Community Health. I oversee a department that
has over 140 clinicians, including 40 psychiatrists.
21 We're very thankful for the opportunity to be in front
22 of the DEA and represent the hundreds of thousands of
23 underserved patients that we care for every year.
24 Legacy is the largest Federally Qualified
Health Center, or FQHC, in Texas. We're the tenth
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1 largest FQHC in the country, and we serve nearly
2 200,000 community members across southeast Texas. We
3 have 54 widely dispersed clinics across the state.
4 Thirty-four of those are school-based health clinics,
and we provide services for all patients independent
6 of their ability to pay. Most of Legacy's patients
7 are at a significant economic disadvantage.
8 Ninety-three percent of our patients are at or below
9 the income level of $200,000 of the federal poverty
guidelines, and 69 percent of our patients are living
11 in poverty. Thirty-three percent of our patients are
12 uninsured, and 49 of them are on Medicaid.
13 We quickly worked around the clock in 2020
14 to develop procedures that were safe and appropriate
to implement telemedicine into our practice even
16 though Legacy has been providing behavioral health
17 services in Texas since the mid-'90s. Though we're
18 definitely not rookies in the practice of psychiatry
19 and therapy, this was definitely new ground for us.
Once we were able to establish telemedicine
21 and we didn't need to put our psychiatrists in
22 brick-and-mortar clinics, we were able to triple the
23 size of our department. We were able to finish 19,000
24 more appointments from 2019 to 2022; 19,000 more
appointments were completed.
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1 Through the pandemic, we all saw an increase
2 in depression. We also saw an increase in anxiety.
3 We saw an increase in academic difficulties for youth
4 returning to in-person school and even still doing
virtual care --
virtual learning. Sorry. We all saw
6 the negative effects of social isolation, and we also
7 saw even an increase in OCD behaviors relating to the
8 concern about transmitting an unknown virus. But you
9 all know this already. We all know that psychiatry
care now more than ever is needed.
11 So we ask the DEA to remove any red tape and
12 make it as easy as possible to intervene and prevent
13 costly interventions, such as ER visits and
14 hospitalizations that happen when these illnesses are
not treated in a timely manner. We believe that the
16 most responsible, most excessive and --
accessible,
17 sorry --
and appropriate need of meeting these
18 increased demands is through telemedicine.
19 At Legacy, we also understand that the
administration, we have very real concerns about the
21 legitimacy of telemedicine for prescribing controlled
22 medications. For this reason, I also ask that we note
23 that psychiatry is different than other disciplines in
24 medicine. I'm not throwing shade to other
disciplines, just pointing out the obvious.
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1 Psychiatrists treat conditions that often
2 don't necessarily need a physical exam to be diagnosed
3 and treated. We treat psychotic disorders. We treat
4 mood disorders, insomnia, ADHD, anxiety disorders.
All of these are appropriately treated through a
6 virtual exam and telemedicine follow-ups. In fact,
7 sometimes we can even learn more about our patients
8 when we see them in the comfort of their home. I can
9 give you an example of one of our patients who had
actually been seen in person by us several times, and
11 the first time that we saw them via telemedicine we
12 realized that this person actually met criteria for
13 hoarding disorder. We would have never been able to
14 catch that and treat it appropriately with medication
and psychotherapy if we had not been able to see this
16 patient in the comfort of their home.
17 Because we knew that at some point the
18 waivers were going to go away, we actually implemented
19 a procedure internally at Legacy trying to see all of
our patients that were being seen via telemedicine in
21 person at least once a year since last August. I'll
22 give you an example of one of my patients that I
23 started seeing via telemedicine.
24 This is an autistic patient who also has
ADHD. Without the use of Vyvanse, which is a
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1 stimulant --
as you all may know, it's a controlled
2 medication --
he's unable to participate in school.
3 He becomes aggressive. His hyperactivity and
4 impulsivity prevents him from actually participating
meaningfully in school. His mother had to take the
6 entire day off. His grandmother also had to take the
7 entire day off to take care of my patient's sibling
8 because they had to drive four hours each way so that
9 they could come and see me so that I could say, check,
I've seen this patient in person, I can continue to
11 prescribe. That's two adults and a child missing of
12 their daily activities and incurring in the cost of
13 time, effort, and resources of a four-hour drive each
14 way to see me for 20 minutes so that I can check this
box. And we're not even started, right? This is not
16 even already a requirement. This is something that
17 internally we try to be prepared for.
18 We also ask that the Administration consider
19 the availability of providers and specific
characteristics of each state. For example, Texas
21 experiences a severe shortage of mental health
22 providers in 248 of the 254 counties. In 2023, Forbes
23 identified Texas as the worst state for mental health
24 in the U.S. and notes that it's the state that has the
highest percentage of uninsured adults with mental
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1 illness. Those are my patients. Those are the people
2 that I see.
3 We also ranked highest in the percentage of
4 adults with cognitive disability who could not see a
doctor due to cost and highest percentage of youth who
6 had a major depressive disorder in the past year and
7 did not receive treatment. Psychiatry is one of the
8 hardest disciplines for us to fill positions. We have
9 a clinic in Beaumont, which is a hundred miles away
from our central clinic in Houston. That position was
11 open for three years. Three years we did not have a
12 psychiatrist in that clinic. As of yet, we have not
13 found a child and adolescent psychiatrist to provide
14 services in that clinic.
Before telemedicine was an option, we were
16 forced to meet the needs of our patients by hiring a
17 psychiatrist in Houston and they would drive twice a
18 week to see the patients in Beaumont. Of course, this
19 clinician burned out after two years after driving,
you know, twice a week to Beaumont and she eventually
21 moved to a clinic in Houston. We couldn't fault her.
22 Note that Texas is extremely large.
23 Transportation is one of the main barriers that our
24 patients have for attending their visits. When we
started doing the requirement of an in-person visit
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1 every year, which again was an internal requirement to
2 make sure that we could meet whatever requirement was
3 set out in the future, we saw an increase of 30
4 percent in no-show procedure --
in no-show
appointments even though we told our patients, hey,
6 it's very likely that if I don't see you in person I'm
7 not going to be able to continue to prescribe, and yet
8 they couldn't make it to their appointment. They
9 didn't have a ride. They didn't have childcare.
All of our locations are along a bus line,
11 but even if the patient has access to a bus,
12 oftentimes they have to change up to three buses in
13 order to make it to our clinics. Our wait list is
14 8,000 people. So, if I have a patient who doesn't
show because they didn't have transportation, that
16 means that I wasn't able to see another person either,
17 right, and I wasn't able to get these patients in. We
18 get 19,000 referrals a year for behavioral health
19 services.
In short, please, we ask the DEA to allow
21 clinicians to use their best judgment in determining
22 when a patient needs to be seen in person and when
23 they can continue to be seen via telemedicine. As my
24 colleagues have stated before --
and thank you for the
shout-out for us FQHC peeps --
an in-person visit
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1 doesn't preclude someone from practicing
2 inappropriately. It also doesn't mean that we can see
3 the patient for the whole person that they are, which
4 sometimes telemedicine actually allows us an
opportunity to do that.
6 That's all I have.
7 (Applause.)
8 MR. STRAIT: Thank you so much.
9 MS. MELVILLE: Yeah.
MR. STRAIT: Hold on one second.
11 MR. PREVOZNIK: I have one follow-up.
12 MS. MELVILLE: Sure.
13 MR. PREVOZNIK: In the beginning, you said
14 that in 2020 you started your safe procedures on what
your guidelines would be, what your protocols were.
16 MS. MELVILLE: For telemedicine?
17 MR. PREVOZNIK: For telemedicine.
18 MS. MELVILLE: We started in 2020.
19 MR. PREVOZNIK: 2020.
MS. MELVILLE: Yes.
21 MR. PREVOZNIK: Could you expand on what it
22 is that --
what were those protocols?
23 MS. MELVILLE: Yes, of course. So, in --
I
24 don't know if you're familiar with Texas law, but
Medicaid actually did not cover telehealth in Texas up
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1 until our organization, our --
over here, helped us
2 prepare the white paper that helped change the law.
3 So we did not provide --
we provided
4 telemedicine only for that Beaumont clinic that I was
talking about, and that was the only telemedicine that
6 we did. And to give you an idea, we knew that we were
7 not going to get any reimbursement from those
8 appointments, but we still hired a psychiatrist to do
9 telemedicine to Beaumont because we needed --
we knew
that those patients needed care.
11 So we had to very, very quickly determine
12 procedures and find a telehealth platform because our
13 electronic health record --
again, we're an FQHC, so
14 our electronic health record is not the fanciest one
--
so that we could start providing care for our
16 patients.
17 So, in a matter of two weeks, we were able
18 to go fully telehealth with our patient --
with our
19 clinicians in the clinic, and two weeks later we were
able to send all those clinicians home. And one of
21 the reasons for that also is because, including
22 behavioral health clinicians in the clinic where I
23 practice, the traffic of people is 400 people a day,
24 you know, so can you imagine how scary that was in the
middle of the pandemic. So, by removing half of that
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1 patient population, we were actually able to protect
2 not only our patients but also our primary care
3 colleagues, who were seeing patients in person because
4 they didn't have the option of telemedicine.
MS. MILGRAM: Sorry, just to follow up, you
6 said you have 140 clinicians, 40 psychiatrists. Who
7 are the other clinicians in that group?
8 MS. MELVILLE: They're psychotherapists,
9 integrated behavioral health consultants, and
psychologists.
11 MS. MILGRAM: Great. Thank you.
12 MS. MELVILLE: Mm-hmm.
13 MR. STRAIT: Okay. Thank you.
14 (Applause.)
MR. STRAIT: And in perfect succession,
16 we've got Commenter No. 9 coming to the stage right
17 now.
18 MR. RECK: Hi. My name is Dan Reck, D-A-N,
19 R-E-C-K, from Matclinics.
So, as I said, my name is Dan Reck. I'm the
21 CEO of Matclinics. We're the largest based opioid
22 treatment group in Maryland. On behalf of our
23 employees and our patients, I'm pleased to share our
24 thoughts on this proposed rule.
Each year, Matclinics treats over 3,000
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1 people suffering from opioid use disorder, and the
2 primary treatment modality we employ is the
3 prescription of buprenorphine products, often through
4 the use of responsible telemedicine.
In addition to prescribing a critical
6 medication, we offer our patients broad behavioral
7 health services, including case management, substance
8 use counseling, mental health therapy, and psychiatry.
9 And while we appreciate the DEA's attempt to
balance access to care with responsible prescribing of
11 controlled substances, we are concerned that the
12 proposed rule does not go far enough to control
13 diversion and the misuse of buprenorphine. If rules
14 around prescribing are too permissive, it is likely
that we will see a repeat of many of the excesses that
16 ultimately led to the over-enforcement and
17 restrictions on high-quality care in other areas of
18 medicine.
19 Unlike most well-intentioned public policy,
where we are often surprised by unintended
21 consequences, the negative consequences of this
22 proposed rule are likely to be all too predictable.
23 Buprenorphine is a controlled substance that
24 the DEA itself has described as "capable of producing
significant euphoria" while adding that it is "gaining
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1 popularity as a heroin substitute and is a primary
2 drug of abuse."
3 A robust illicit market for buprenorphine
4 exists. Diversion is an existing problem that
implementation of the proposed rule will inevitably
6 compound. The results of diversion should not be
7 minimized. Patients actively using illicit substances
8 can fund their use by selling their prescribed
9 buprenorphine typically for $500 to $1,000 per month.
Most patients who are prescribed
11 buprenorphine, however, find it to be incredibly
12 effective at relieving symptoms of physical dependence
13 on opioids. These patients take their medication as
14 prescribed and progress through treatment in a
constructive and healthy way.
16 We know this because, by deploying an
17 objective scoring methodology that we developed in
18 conjunction with scientists at NIDA, we can categorize
19 patient adherence to treatment into one of five
trajectories. I brought some visuals that I'd be
21 happy to share afterwards, but you're going to, I
22 guess, have to just put up with me trying to describe
23 the graphs with words.
24 Almost 80 percent of patients are stable
from the start of treatment or quickly achieve
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1 stability. There are, however, a meaningful minority
2 of patients who struggle in treatment. If the purpose
3 of treatment is to reduce illicit drug use and
4 adherence to buprenorphine, these patients need closer
attention from providers, not less. Without
6 persistent, reliable definitive drug testing, how
7 would a tele-only provider ever be able to distinguish
8 amongst their patients?
9 We have firsthand experience when adequate
controls are missing in the prescribing of
11 buprenorphine. In two situations over the last five
12 years, we inadvertently ran two natural experiments.
13 Experiment No. 1. In February 2018,
14 Matclinics began to accept Maryland Medicaid and
watched our patient census increase dramatically as
16 people learned that they could access buprenorphine
17 without paying anything out of pocket.
18 Simultaneously, we added definitive urine
19 toxicology testing to each of our Mat patient visits.
While we were gratified to see our patient census
21 increase over the first few months, we were shocked to
22 see how many patients were adulterating their urine.
23 As you would have seen in another graph I
24 brought, during those first few months, growth in
patient urine samples with unnatural levels of
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1 buprenorphine and/or missing Norbuprenorphine, the
2 metabolite that is generated by normal liver
3 processing, grew to more than 5 percent.
4 We quickly set up to minimize the potential
for adulteration, and now we see fewer than 4 in 1,000
6 samples with signs of adulteration, a more than 12
7 times drop. Had we not intervened to control
8 adulteration, it seems likely that we too would have
9 gained a reputation as a place to access uncontrolled
buprenorphine prescriptions.
11 Experiment No. 2. In May of 2020, we heeded
12 the advice of state and federal health agencies and
13 started conducting all patient visits via telemedicine
14 only. For those four weeks, we could not collect
urine samples and reverted to asking our patients what
16 we would find if they provided us with a sample. The
17 vast majority of patients who had recently presented
18 with opioids in their system reported that if they'd
19 give us a urine sample we would find only
buprenorphine in their urine. However, after moving
21 to a COVID-safe and in-person system for collecting
22 urine samples, most of those same patients tested
23 positive for opioids and many were missing
24 buprenorphine in their urine.
It seems highly unlikely that these same
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1 patients were adherent to treatment protocols only
2 during the time when they were not required to provide
3 a urine sample.
4 We urge the DEA to reconsider its proposed
rule and strike a better, safer balance between
6 increasing access to medication to treat addiction and
7 ensuring that treatment is both safe and of high
8 quality.
9 Buprenorphine prescribed judiciously is an
effective medication in treating OUD and a central
11 part of an effective response to the opioid crisis.
12 However, without proper oversight of patients
13 prescribed controlled substances, including regular
14 in-person visits combined with definitive toxicology
testing, there is no reason to believe that some
16 telemedicine-only providers won't become buprenorphine
17 mills just as pain pill mills once flourished.
18 We are concerned that the consequences of
19 unregulated buprenorphine will contribute further to
the already deadly opioid epidemic.
21 Thanks for your time today. Happy to answer
22 questions.
23 (Applause.)
24 MS. MILGRAM: You talked about protocols you
put in place to control the adulteration and you're
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1 now down to four in a thousand. Can you just talk
2 about what those controls were?
3 MR. RECK: So what most patients --
so not
4 all patients who adulterate are there to divert. A
lot of patients adulterate because they're afraid of
6 the consequences, because they're afraid that they
7 might be maybe thrown out of treatment or not be
8 allowed to go on because they've somehow relapsed.
9 And so what we've worked really hard with
our staff on doing is to make sure that if we see
11 evidence of adulteration that that patient is told
12 that, like, we can only treat them if they give us an
13 actual sample. It's the only way we really know
14 what's going on with them. We're not going to take a
punitive stance against them. That has helped a lot
16 in terms of making patients more comfortable with
17 giving legitimate samples.
18 But we also, of course, if patients are
19 being prescribed a medication for which there's no
evidence that they're taking it, over time, we just
21 can't --
that's not a patient who should be prescribed
22 buprenorphine anymore, and those patients are usually,
23 if they're using other illicits, they are --
you know,
24 we're just not sufficient, right? We're the lowest
level of treatment. We're outpatient level. Those
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1 patients probably need a higher level of care, and we
2 work to get them to those higher levels of care.
3 MS. MILGRAM: In the recommendation of what
4 you would sort of suggest, you said regular in-person
meetings, regular toxicology. Could you just
6 elaborate if there's anything else you would put on
7 that list?
8 MR. RECK: I mean, just I think that the
9 toxicology bit is nuanced. So a lot of what people
call urine drug testing are just, you know, like what
11 are called presumptive or screening tests, and those
12 don't have the sophistication to sort of see whether
13 or not the people are actually taking their medication
14 or not.
People can put buprenorphine directly in
16 their urine. You can't see whether or not they're
17 actually processing it through their system. So I do
18 think that there just needs to be, and I can't speak
19 to all controlled substances, but just on the
buprenorphine side, we have a lot of experience with
21 this. There just needs to be some amount of in-person
22 collection so that we can see what the temperature is
23 of the urine to make sure that it's actual, like their
24 sample coming from them, and then go through a
definitive tox. We think that is --
it's the easiest
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1 way that we know of to distinguish amongst patients.
2 And while there's a lot of history of abuse
3 of toxicology, but what we find is it actually reduces
4 total cost because, as we talked about, most patients
actually don't need to come in very often, right?
6 Most patients are very stable, react very well to the
7 medication. And so, by doing intermittent definitive
8 tox tests, we then can allow them to space out their
9 appointments over a much greater length of time. It
allows us to focus our attention on those who actually
11 need more attention.
12 MS. MILGRAM: And we'd love to get the
13 visuals if that's okay.
14 MR. RECK: Sure. Yeah.
MS. MILGRAM: Thank you.
16 MR. STRAIT: Thank you.
17 MR. RECK: Okay. Thank you.
18 (Applause.)
19 MR. STRAIT: And we now have Commenter No.
10 coming to the stage.
21 MS. MARTINI: Hello, everyone. My name is
22 Dori Martini. That's D-O-R-I and Martini like the
23 drink, M-A-R-T-I-N-I. And my affiliation today is
24 with Circle Medical.
Like I said, my name is Dori Martini. I am
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1 an operations expert with 20 years of experience, and
2 I most recently had the honor to be the Vice President
3 of Operations and Regulatory Affairs for Circle
4 Medical.
Circle Medical is a comprehensive,
6 tech-enabled, adult-only primary care practice.
7 Established its first brick-and-mortar clinic in 2015
8 in San Francisco. And through a lot of hard work, a
9 lot of perseverance, and, more importantly, the
commitment to the practice of ethical and
11 evidence-based medicine, we have gone from serving
12 what used to be hundreds of San Franciscans, mostly
13 coming through our brick-and-mortar location, to now
14 serving upwards of 50,000 patients per month in 23
different states.
16 A big part that facilitated this growth was
17 the fact that we were tech-enabled and we were able to
18 scale very quickly as a result of the secure
19 mechanisms that we had in place with our own
in-home-grown electronic health record system that
21 really allowed us to expand as soon as the Ryan Haight
22 Waiver lifted.
23 Now I do want to mention that we did kick
24 off with COVID, obviously, the pandemic, and I would
say for the first nine months of the pandemic we were
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1 essentially a COVID clinic offering services
2 nationwide.
3 Early in my career, I had the privilege of
4 leading compliance and expanding access to care
initiatives while working for some of the
6 top-performing early qualified health centers and
7 medical managed care health plans in the State of
8 California. Once I transitioned to the private health
9 sector seven years ago, I left my public health work
with the heart-wrenching notion that I would no longer
11 have the opportunity to serve the underserved.
12 But much to my surprise, my most recent
13 firsthand experiences have led me to hypothesize that,
14 in fact, the majority of Americans, even those
technically above the federal poverty levels, are also
16 incredibly underserved.
17 One segment of the population that is
18 chronically in need of being served is the more than 9
19 million adults in America that are diagnosed with ADHD
and the millions more that fail to obtain diagnosis
21 due to the systemic access issues and the stigma
22 associated with this condition all because
23 evidence-based medicine dictates that the most
24 effective first-line treatment for most patients that
meet this diagnostic criteria is a stimulant
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1 medication, which, as we know, is a controlled
2 substance.
3 Because of the stigma and difficulty in
4 accessing treatment, many of these people obviously go
without, and the results are devastating. The
6 distractability, the impulsivity that come with ADHD
7 lead to the extensive burden on our health system as
8 undiagnosed or inconsistently treated ADHD individuals
9 result in co-morbidities such as obesity, diabetes,
heart disease, risky sexual behavior, suicide, and
11 substance abuse. They get into more car accidents,
12 and when they do, they're more likely to be fatal.
13 When you add it all up, ADHD leads to a reduction of
14 life expectancy between nine and 13 years.
Ladies and gentlemen, ADHD is real and it is
16 a problem, and potentially the lack of consistent
17 treatment can lead up to another really big public
18 health emergency, which, of course, we're all here
19 together today to try avoid.
I understand and I care so much about these
21 9 million Americans because I am one of them. When I
22 think back to how I ended up in healthcare, I find it
23 to be fairly ironic. As a first-generation
24 Mexican-American growing up in Santa Barbara County in
California, even as a middle-class family, Western
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1 medicine concepts were not regularly sought in our
2 household, but rather we relied on a variety of
3 culturally influenced home remedies and other
4 alternative treatments.
To be frank, it actually was not until the
6 pandemic, due to the increased isolation that I
7 personally experienced, along with the rest of the
8 world, that I for the first time ever came to a
9 realization of, like, maybe I need help. Maybe
there's something wrong with me because my entire life
11 and process had been disrupted in terms of how I did
12 my work, and that routine had basically shifted very
13 aggressively and was broken.
14 It is true that the dramatic shift in social
norms really accelerated public dialogue around the
16 widespread need for behavioral health. As studies
17 have shown, in the height of the pandemic, 40 percent
18 of adults reported symptoms of anxiety or depression,
19 compared to only 11 percent in a pre-COVID world.
Fortunately, I did not hesitate at that
21 point in seeking care. I was able to connect for the
22 first time with a medical provider over a two-way
23 video audio visit. The security I felt in being able
24 to access this type of intimate and really scary
treatment and care for someone that historically
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1 didn't think anything was ever wrong with them, being
2 able to do that within the safety of my own home
3 really made seeking out this help a no-brainer for me.
4 And I can't help but remember that maybe I
put it off for so long not only because of this
6 unknown diagnosis but also because of the regular
7 daily barriers of daily life you kind of tend to
8 deprioritize if it's not something that's basically
9 preventing you from doing what you believe are your
daily activities of daily living.
11 Being diagnosed with ADHD in my mid-30s made
12 me realize how underserved I had personally been
13 through my childhood and young adult life, and I
14 couldn't help but wonder, what if I would have been
diagnosed earlier? Would my academic experience have
16 been different and maybe a little easier and not so
17 hard? Building social relationships, familial
18 relationships, could they have been easier?
19 However, finally being treated for ADHD has
had a vast impact on my life, and I would be remiss
21 not to share that in a way, a big part of my life's
22 personal work and professional work collectively has
23 really unknowingly brought me here, cross country, to
24 be speaking in front of all of you today.
During my time as Vice President of Circle
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1 Medical, I also authored and submitted a detailed
2 24-page letter to the DEA in response to the proposed
3 rule for the remote prescribing of controlled
4 substances, which is also available to the public
through Circle Medical's website.
6 I'd like to spend the remaining part of my
7 time addressing the critical questions raised by the
8 DEA regarding telemedicine prescribing of controlled
9 substances, focusing specifically on Schedule II-N
medications, non-narcotic medications, patient safety,
11 and proactive diversion strategies.
12 The first question, should telemedicine
13 prescribing of Schedule II medications be permitted in
14 the absence of an in-person medical evaluation?
First, let's consider the necessity of
16 in-person evaluations. The expansion of telemedicine
17 during the pandemic has shown that safe and effective
18 care can be delivered remotely. In the last three
19 years, over 500 Board-certified Circle Medical
practitioners conducted hundreds of thousands of
21 real-time two-way video/audio telehealth appointments,
22 demonstrating that safe evidence-based care remains
23 consistent irrespective of the modality.
24 However, what has been key in being able to
safely and effectively deliver this care are the
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1 safeguards that we have put in place, which brings me
2 to our second question. What safeguards would you
3 recommend for telemedicine prescribing of Schedule II
4 medications? Safeguards for prescribers such as
checking the PDMP are imperative. This should be a
6 requirement for all prescribers of all controlled
7 substances at the federal level and, at a minimum, a
8 best practice to validate this prior to issuing any
9 controlled substance over telemedicine.
Establishing a controlled substance
11 agreement between the prescriber and the patient
12 allows for the correct expectations to be set up front
13 so then that way the patient understands that they are
14 going to be held accountable to being seen through a
telemedicine visit every single month and being able
16 to disclose if they have any other conditions and/or
17 if they end up taking another medication, having to
18 divulge that information immediately to their
19 prescriber.
We understand the importance of ensuring
21 that clinically the recommended dosage and usage
22 guidelines provided be followed and believe this is
23 where the DEA and practices like Circle Medical can
24 stand to work together to help solve for diversion at
the point of patient entry as opposed to at the point
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1 of treatment because, when you're dealing with a
2 patient that is in need of treatment and has a
3 diagnosis, a legitimate one, it is so disruptive to
4 the care to be able to have to kind of stop because
they cannot get their treatment medication.
6 For example, Circle Medical has implemented
7 advanced patient ID verification mechanisms that
8 require the patient's ID to be electronically scanned
9 prior to being able to book an appointment. In other
words, this technology can actually tell if a fake ID
11 is being uploaded into our system, among many other
12 things that could indicate the potential for someone
13 attempting to access our services fraudulently.
14 One could argue that this level of
verification is not being done today in most in-person
16 clinical environments alone as it is customary for
17 most patients to simply present their ID and it gets
18 usually photocopied by a front desk person for the
19 medical chart and for billing purposes.
As a result, our tech-enabled practice, we
21 have had significant documentation and data that we
22 have been actually able to share with the DEA in one
23 specific incident where there was a criminal attempt,
24 essentially, of this individual who was going around
to various practices, both in-person and through
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1 telemedicine, to try to obtain as many controlled
2 substance prescriptions as possible. And the fact
3 that we had the level of data and all of the
4 information and all of the attempts and all the fake
ID attempts from this patient really allowed the DEA
6 agent in this particular case to be able to make a
7 charge.
8 We believe that this is one example of many
9 where technology can really help safeguard patients
who are truly in need of medically necessary treatment
11 while also supporting the DEA's ability to help
12 implement the necessary guardrails that will lead to
13 safer prescribing and de-risk diversion.
14 There is definitely something that we need
to talk about and that is Question No. 3, which is,
16 what telemedicine prescription data should be
17 collected, maintained, and reported to the DEA?
18 Today, the Electronic Prescribing of
19 Controlled Substances, known as the EPCS, is an
existing mechanism that is already in place that can
21 enhance prescription legitimacy, and I strongly urge
22 the DEA to consider revisiting this program as a way
23 to streamline additional information that can be
24 collected about the prescriber at the point of
prescription in real time as this is a device that
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1 they have to interact with in order to be able to
2 electronically prescribe.
3 Associate Administrator Thomas, I know that
4 you have been asking throughout today's presentations
what are some of those very specific questions that
6 can be asked as part of the special registration
7 application. I would say something that the DEA could
8 look into is the actual process for an
9 application-type question that is asked by a
malpractice carrier. Malpractice carriers will ask
11 physicians very specific questions about their
12 practice, such as what percentage of your care is
13 delivered via telemedicine versus in-person? What
14 kind of patients and/or populations are you serving?
What are the main areas of care that you're actually
16 providing care for? And taking it a step further
17 because this would be specific to prescribing, asking
18 what are some of the most frequent medications
19 specifically by name.
Many of these telemedicine practices have
21 been able to adopt very specific clinical guidelines
22 where they will not deviate from them, so more than
23 likely, you would be able to have a very strong view
24 of how they're practicing.
The other thing that I would really mention
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1 is that I think the DEA should really consider
2 evolving its technological stack and develop some sort
3 of universal plug-in for electronic health records so
4 that prescribers have direct access to report whenever
they come into contact with potentially a questionable
6 individual over a telemedicine encounter.
7 Going back to that case that I had the
8 opportunity to work on with the DEA, that was one of
9 the questions that the agent had asked me, are you
proactively reporting any of these individuals that
11 are maybe trying to tamper with your system or upload
12 these IDs, and when she walked me through what that
13 process would actually consist of, we both kind of
14 agreed that it's fairly rigorous and it's a little
challenging and that there's probably a better way
16 there.
17 My final question that I would like to
18 quickly address is, what telemedicine prescription
19 data should pharmacies collect, maintain, and report
to the DEA? Folks, I cannot stress enough that if we
21 were to wave a magic wand and come up with the most
22 amazing, perfect process special registration today,
23 walk out of here, our work is done. It does not mean
24 that the patient is going to get that medication at
the pharmacy.
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1 Pharmacies need guidance on their
2 responsibilities in verifying prescription
3 information. The pharmacist has no way of knowing
4 without extensive communication with prescribers and a
lot of back-channeling whether all rules have been
6 "followed." To address this, one option is to
7 establish a more collaborative agreement between the
8 prescriber and the pharmacies. This is something that
9 is done today a lot within cancer centers where
they're working in tandem and in partnership when it
11 comes to really knowing the inner workings of the
12 patients that they're serving.
13 There's always a lot of mentions from
14 pharmacies when we speak to them because we have an
average of about 400 patients a day at Circle Medical
16 that report their inability to access their legitimate
17 treatment at the pharmacy level. The two top reasons
18 that they list that they're refused that prescription
19 is shortages and the second one is that it was
prescribed through telemedicine and, therefore, there
21 is a discomfort by the pharmacist to dispense that
22 medication.
23 And it's understandable that they're
24 uncomfortable because there is a lack of clarity
around these "red flags." The pharmacists should know
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1 to what degree they are going to be held responsible
2 for and at what point does their due diligence
3 basically exhaust so that they can be confident that
4 they're not going to lose their pharmacy licenses,
their pharmacist licenses, at the point of dispensing
6 a legitimate medication.
7 Moreover, it's crucial to factor in the
8 administrative and financial burden imposed on
9 clinical practices and practitioners. Given the
current physician burnout crisis, we must also provide
11 sufficient time to streamline these types of
12 operations and prevent dangerous disruptions in care.
13 So no matter what it is that we try to do here, it's
14 really, really important that we have the time to
implement these things as well so that we don't end up
16 in a crisis-like state.
17 I really thank you for your time, and I'm
18 incredibly optimistic of bringing us all together
19 here. I think this is a great move in the right
direction, and I'm excited to see where it goes.
21 Thank you.
22 (Applause.)
23 MS. MILGRAM: Thank you. Could I just ask
24 one clarification question?
MS. MARTINI: Mm-hmm.
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1 MS. MILGRAM: You just talked a little bit
2 about a lack of clarity for pharmacies around red
3 flags. Could you just specify what information you
4 think pharmacies would need to be able to fill
prescriptions?
6 MS. MARTINI: Yeah. So part of the
7 inconsistency stems from the fact that the pharmacy
8 says all of this data, it looks the same. We don't
9 know if the prescriber is legitimate. We don't know
if the patient is legitimate.
11 I've had the opportunity to speak to some of
12 the bigger pharmacies, and some of the feedback that I
13 got was, you know, it would be really great if we
14 could even just get more access to some of the patient
data and patient information. For example, when was
16 the last date of service? When were they seen? How
17 were they seen? What is some of the ongoing
18 treatment?
19 There are some states that have adopted the
need to actually enter, you know, ICD-10 codes in the
21 notes section. But it's a systemic problem. It's
22 very inconsistent. The systems that power these
23 electronic prescription services should really be
24 required to, you know, universally list some
pre-approved fields so that those changes can be made.
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1 Circle Medical has gone even as far as to
2 pilot what we call kind of a brief medical chart
3 version. It's a one-pager just kind of giving the
4 pharmacy a snapshot of everything that they, you know,
would hopefully need to see. Also with a direct
6 telephone number to a dedicated phone team that is
7 only taking the phone calls from the pharmacists
8 because, you know, if they have any follow-up
9 questions, they should absolutely be able to ask them.
And so being able to also provide them with
11 that type of support is also incredibly important.
12 But I will say that the feedback has been having a
13 faxed single medical chart is very, very cumbersome
14 for them to handle operationally on the receiving end.
Thank you.
16 MR. STRAIT: Thank you very much.
17 MS. MARTINI: Thanks.
18 (Applause.)
19 MR. STRAIT: Okay. I do want to say we have
three more presenters for our morning session. I'm
21 calling up Commenter 11 now. But just in the way of
22 expectation management, we have three left to go, and
23 then we will make our switch to our afternoon virtual
24 session. So, without further ado.
MS. USCHER-PINES: Good morning, everyone,
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1 and thanks for bearing with us. My name is Lori
2 Uscher-Pines, that's L-O-R-I, U-S-C-H-E-R, P-I-N-E-S,
3 and I'm a health services researcher at Rand, which is
4 a nonprofit research organization. I represent a team
of researchers and clinicians from Harvard and Rand
6 that have been conducting research on telehealth for
7 opioid use disorder for about a decade now, and today
8 my comments are going to focus on prescribing of
9 buprenorphine via telemedicine.
First off, we applaud the DEA for
11 reconsidering a special registration process that
12 would allow some clinicians to prescribe buprenorphine
13 without an in-person medical evaluation.
14 In our research, we have shown that
telemedicine was used for about 15 percent of all
16 buprenorphine inductions in the early pandemic, and
17 greater use of telemedicine for opioid use disorder
18 has not resulted in inferior outcomes.
19 Our research, as well as the research of
others, has shown that permitting telemedicine to
21 start patients on buprenorphine can improve access to
22 care without obvious negative impacts on patients.
23 We also recognize that the DEA is concerned
24 about a new framework that fundamentally expands
access to a controlled substance, and DEA wants to
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1 ensure the permanent flexibilities to prescribe
2 buprenorphine via telemedicine does not result in
3 greater diversion.
4 The DEA is looking to strike the right
balance between an overly restrictive system that
6 limits patient access and an overly lax system that
7 results in more diverted buprenorphine, so, you know,
8 looking for some guardrails to really strike that
9 important balance.
I'd like to start today with a few
11 overarching principles that can inform the design of a
12 special registration process, and then I'll talk about
13 some specific guardrails that the DEA can consider
14 incorporating into that process.
The first principle is to limit the special
16 registration process to higher-volume clinicians, such
17 as those who start more than five patients per year on
18 buprenorphine via telemedicine. This focus on the
19 higher-volume prescribers would limit administrative
costs and focus regulation on clinicians in a position
21 to have the greatest negative public health impact.
22 So clinicians who only treat a handful of patients via
23 telemedicine would not have to register under this
24 model or be subject to additional guardrails, but we
believe that their likely impact on public health
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1 would be small even if a minimal amount of diversion
2 were occurring.
3 According to our estimates using Medicare
4 claims data, in 2022, about 25 percent of
buprenorphine prescribers started at least one patient
6 on buprenorphine in that year via telemedicine.
7 Excuse me. So 25 percent started at least one
8 patient. However, only 1 percent started five or
9 more. So, if you limited a special registration
process to the 1 percent versus the 25, that would
11 greatly limit the administrative burden for DEA and
12 for registering clinicians.
13 The second principle is that when selecting
14 guardrails, the DEA should try to avoid burdening
patients who already face numerous barriers to care,
16 and we've heard a lot about that today. When choosing
17 between a guardrail that creates additional hurdles
18 for patients or for clinicians, choose to
19 inconvenience the clinician.
Third, the DEA should avoid guardrails that
21 interfere with clinical decisions and require that
22 clinicians play the role of police. This can have
23 negative impacts on care quality and on therapeutic
24 alliance.
Fourth, the DEA should not interpret small
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1 increases in diversion that may be associated with new
2 prescribing flexibilities as problematic, and this
3 point is a little bit new and key, I think. It's
4 important to emphasize that diversion is very common
with in-person care, and telemedicine did not create
6 this problem.
7 For example, a JAMA article, a recent on,
8 showed that buprenorphine users misused buprenorphine
9 about 30 percent of the time or 30 percent of users
misused it before the telemedicine flexibilities were
11 put into place in 2019, and another study found that
12 buprenorphine diversion has been increasing over time
13 with increased buprenorphine use. So it's probably
14 impossible to increase access and use of buprenorphine
through telemedicine or through any other means
16 without increasing diversion.
17 The DEAS should not be asking are new
18 prescribing flexibilities increasing diversion if it's
19 doing that through the mechanism of improved access.
Rather, the question that you should ask is whether
21 the rate of diversion is higher with telemedicine
22 prescribing versus in-person prescribing, and to our
23 knowledge, there is no evidence yet that this is the
24 case, that when high-quality clinicians deliver
telemedicine there's more of a risk of diversion.
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1 So this final principle not to interpret
2 small increases in diversion as a result of greater
3 access as a failure is important as the DEA evaluates
4 the impact of a special registration process and works
to improve it over time.
6 So now I'd like to pivot and present a set
7 of specific guardrails that can be incorporated into a
8 special registration process that align with some of
9 the principles that I just mentioned. We recommend
that the DEA consider implementing a few of these in
11 combination rather than all of them, and that is the
12 case because, at some level, too many barriers are
13 just going to prevent clinicians from offering
14 telemedicine as a treatment option, and too many
guardrails will yield diminishing returns with respect
16 to diversion risk.
17 Further, the DEA should gather feedback on
18 the acceptability of some of these different
19 guardrails from a range of stakeholders before making
any final decisions.
21 The guardrails that we recommend, as well as
22 some more concerning guardrails, are detailed in a
23 health affairs article that our team published on
24 September 1 in preparation for this discussion today.
We recommend that you take a look at the full list
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1 that's published there for additional context.
2 So, for the guardrails, first, DEA could
3 consider requiring electronic prescribing, that is,
4 prohibit the use of paper scripts.
DEA could require registered clinicians to
6 accept insurance. This could prevent the growth of
7 cash-only pill mills.
8 Third, DEA could require that all registered
9 clinicians submit a diversion mitigation plan that
really outlines organizational policies to prevent
11 diversion. For example, registrants could discuss
12 their policies around urine drug screening and how
13 results that may indicate diversion or misuse will be
14 used to inform treatment decisions.
Fourth, the DEA could require that
16 clinicians take steps to verify the identity of the
17 patients they're treating, especially in the case that
18 these clinicians are delivering audio-only visits
19 without that face-to-face component.
Fifth, DEA could require clinicians to use
21 prescription drug monitoring programs before
22 prescribing and at regular intervals.
23 Sixth, DEA could require that organizations
24 or clinics doing telemedicine inductions are certified
by an external entity, such as the Joint Commission or
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1 NCQA.
2 Seventh, DEA could require that
3 organizations doing telemedicine inductions involve an
4 addiction-trained clinician in some sort of
supervisory role or perhaps on the leadership team.
6 Eighth, DEA could require additional
7 training for clinicians on why diversion is a problem,
8 detection, and how to respond. A 2018 survey showed
9 that while approximately 80 percent of prescribers
report that they assess patients for diversion,
11 specific practices differ. So the goal of training,
12 additional training, would be to ensure that all
13 prescribers, not just 80 percent, do this and do this
14 routinely and that they accept the responsibility of
partnering with the DEA to prevent diversion.
16 Ninth and finally, the DEA could require
17 that clinicians only prescribe buprenorphine naloxone,
18 as opposed to buprenorphine mono-product, unless the
19 patient is pregnant or has a documented naloxone
allergy because of decreased risk of diversion
21 associated with combination treatment.
22 So it's important to emphasize that there
23 are guardrails that others have discussed in the
24 literature or have been applied to in-person care in
the past that we don't recommend because they're
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1 likely to reduce access to care by burdening patients
2 or could even undermine promising care models that
3 have emerged in the past few years.
4 For example, one guardrail we recommend
against is limiting the length of the prescription,
6 for example, only allowing up to two-week
7 prescriptions for the first two months of treatment.
8 Another we recommend against is requiring observed
9 dosing via telemedicine. Both of these are burdensome
for patients and may reduce the likelihood that they
11 remain in treatment.
12 So one final thought before closing. DEA
13 and public health stakeholders sometimes seem to be
14 speaking different languages. In the public comments,
thousands spoke about the critical role of
16 telemedicine in increasing access to controlled
17 substances like buprenorphine given the many
18 communities' lack of prescribers and there's stigma
19 associated with opioid use disorder.
In announcing the listening sessions, DEA
21 expressed concern about the very thing the public
22 health stakeholders are so excited about, and that is
23 a new policy environment that fundamentally expands
24 access to controlled substances.
Greater access either represents something
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1 to strive for or cause for alarm depending on where
2 you sit, and this doesn't need to be the case. In
3 summary, we believe that there is a potential
4 compromise. DEA can implement a special registration
pathway with a few select guardrails that apply to a
6 certain population of prescribers. This can
7 incorporate important checks against diversion and
8 increase access to this life-saving medication.
9 Thank you for your time.
(Applause.)
11 MR. STRAIT: Stay right there just in case
12 we have some questions for you. Any questions?
13 (No response.)
14 MR. STRAIT: Thank you so much.
Okay. We are getting close to the end of
16 our morning segment. I'll call up Commenter No. 12.
17 MR. LEWIS: Good morning. Thank you very
18 much for joining us. I especially appreciate the
19 Administrator and Deputy Administrator being here in
person. It shows your true commitment to getting this
21 problem --
getting this solution right for all of us,
22 and I really appreciate your consistent commitment to
23 that in your role as Administrator and then also with
24 our interactions with DEA.
My name's James Lewis. I'm here on behalf
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1 of the American Society of Consultant Pharmacists. We
2 represent thousands of pharmacists who specialize in
3 senior care and medically complex care, practicing in
4 a number of settings around the country, including
long-term care facilities, skilled nursing facilities,
6 assisted living, group homes, home and community-based
7 care, as well as individuals who are incarcerated. So
8 we've got the whole setting.
9 And so my comments today are focused on two
main points: one, ensuring appropriate, safe, and
11 accessible access to care; and two, a series of
12 questions that were enumerated in our formal comments
13 to the Agency on the role of pharmacists in
14 implementing whatever DEA regulation is put forward.
So I'll start with the first piece. Having
16 read the rules, they are great and they put forward
17 great ideas, but they are very, very focused on the
18 ambulatory setting. From sort of top to bottom, it is
19 envisioned that this individual may or may not be able
to even go to a physical office.
21 In our setting, while we do have patients in
22 front of practitioners the entire time, we do leverage
23 telemedicine to connect them with specialists,
24 especially addiction medicine specialists and
geriatric psychiatrists, both of which we have very,
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1 very few of in this country, and so the use of
2 telemedicine for us in our setting is especially
3 important to get our patients access to those
4 individuals who have the specialized care and training
for their needs.
6 So I just sort of encourage the Agency as
7 it's looking at those issues to think about those
8 patients who may be in front of a practitioner but may
9 not be in front of the right practitioner and that
telemedicine can solve those problems.
11 In the rulemaking, there is the proposal for
12 a non-
sort of -prescriber to make the referral that
13 would allow for this to occur. We do have sort of
14 questions and concerns about that as well. In
particular, the definition of practice of telemedicine
16 proposed in the rules could be artificially
17 restrictive to pharmacists given especially the fact
18 that in many states --
California, Idaho, Montana,
19 Washington, Massachusetts, North Carolina, Ohio,
Tennessee, and Utah --
pharmacists are authorized to
21 prescribe certain substances and in many states aren't
22 prescribed to initiate buprenorphine treatment.
23 Additionally, we are concerned as well,
24 getting back to the need, that this telemedicine
prescribing would be limited to specifically what's on
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1 the FDA label. As discussed, our pharmacists
2 specialize in the care of the medically complex.
3 Oftentimes, we are forced to use medicines off label
4 because it is the right choice for that patient, that
patient's needs, and that patient's setting.
6 So, again, as we look at this for sort of
7 patients in the non-ambulatory setting, you know, will
8 there be sort of greater flexibility to allow a
9 physician or prescriber to make the appropriate choice
for that patient based on their training and expertise
11 regardless of the FDA label.
12 And then finally, just, you know, on the
13 concept of some sort of new waiver, I worked on the
14 Hill before joining ASCP. I remember all of the
consternation around the X waiver and the thought for
16 years of trying to get rid of it. Congress finally
17 took action and did it. Are we just going to create
18 another waiver that's going to create another series
19 of artificial barriers between people who know they
have a problem with opioids and those people seeking
21 and getting the care they need to get clean and sober?
22 Finally --
so this is moving into the second
23 part --
you know, I do appreciate the Agency's efforts
24 for the incorporation of ACPS. You've gone a lot
further than some of the other federal government
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1 partners on that, so we really appreciate that.
2 But ACPS will not solve all of the concerns
3 that pharmacists have. We've already heard from other
4 speakers that pharmacists are already hesitant to
dispense medicines via telemedicine because there is a
6 severe risk that they could be held accountable for
7 that.
8 So our questions remain, you know, is a
9 pharmacy responsible for verifying that an in-person
visit was conducted, or if this is a referral, that
11 the appropriate in-person evaluation for the referral
12 was conducted? Is the pharmacist responsible for
13 verifying the national provider number and DEA
14 registration number of each, also understanding that a
lot of times our patients are coming in from a
16 hospital transfer or another transition of care? Does
17 that transition of care from another setting --
a
18 hospital, acute care, or home-health agency --
qualify
19 as that telemedicine referral? And, finally, will a
pharmacy be responsible for verifying the DEA
21 registration in two states if the prescriber is not in
22 the same state as the prescribee?
23 So, again, I thank you for your attention to
24 this. We have submitted our formal comments, which
goes into greater detail about all of these concerns,
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1 but in particular, I just want to stress the need of
2 two things.
3 One, we've got to make sure that we are
4 taking care of all of our patients, not just the 90
percent of our patients who operate in the ambulatory
6 setting. There are a lot of patients who have a lot
7 of need, and we are seeing increased demand from
8 buprenorphine treatment in our long-term care
9 facilities.
And second, I encourage the Agency to
11 continue to think about what is going to happen at the
12 state levels with either state scope of practice,
13 collaborative care, or expansion of care teams, that
14 the rules should not artificially prohibit a provider
with the training, expertise, and blessing of their
16 state to carry out something within their state's
17 scope of practice. Thank you.
18 (Applause.)
19 MR. STRAIT: Pause right there if you would
just to see if we have any questions for you.
21 MR. LEWIS: Any questions?
22 (No response.)
23 MR. LEWIS: Thank you.
24 MR. STRAIT: Thank you so much. All right.
And we have Commenter No. 13 here. Welcome.
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1 MR. ADAMEC: Chris Adamec with the Alliance
2 for Connected Care. The Alliance appreciates the
3 opportunity to testify to this listening session on
4 DEA's regulations on the prescribing of controlled
substances via telemedicine.
6 As a way of introduction, the Alliance is an
7 organization dedicated to improving access to care
8 through telehealth and remote patient monitoring. Our
9 members are leading healthcare and technology
organizations from across the spectrum, representing
11 health systems, health payers, technology innovators,
12 and others. The Alliance works with an advisory board
13 of approximately 50 patient and provider organizations
14 who wish to better utilize the opportunities created
by telehealth.
16 We appreciate the DEA's quick response
17 during the COVID-19 pandemic to allow prescribing via
18 telehealth. This was also a hugely meaningful
19 expansion for many Americans who had other barriers to
accessing care. These include individuals who are
21 frail, home-bound, or lack transportation, who live in
22 areas with provider shortages, and caregivers of all
23 kinds whose responsibilities serve as a barrier to
24 care.
We strongly support the development and
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1 implementation of a permanent policy for the
2 prescribing of controlled substances through
3 telehealth to ensure that these individuals do not
4 lose access as these are not challenges which will go
away.
6 As others have noted, mental health and
7 substance use disorder visits continue to represent a
8 growing share of all telehealth visits due to several
9 factors, including growing needs for mental health
services and well-documented workforce shortages
11 across the nation.
12 Americans rely on access to telehealth, with
13 mental health representing 62 percent of all mental
14 health treatments last year. I also want to note that
while mental health is the predominant condition,
16 there are many others that are relevant, including
17 access to end-of-life care for home-bound patients.
18 We believe future DEA actions to preserve
19 access to this care will be a crucial pillar in
supporting President Biden's mental health strategy,
21 which seeks to connect more Americans to mental health
22 care through the widespread use of telehealth.
23 In our testimony today, the Alliance will
24 discuss the importance of a special registration as
the primary guardrail to identify and mitigate risks
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1 of diversion in the prescribing of controlled
2 substances through telehealth and will discuss
3 implementation concerns with any proposed regulation.
4 We'd like to begin today by recognizing the
importance of DEA's work in preventing the diversion
6 of controlled substances and zeroing in on exactly
7 what needs to be accomplished in this rulemaking. As
8 you guys know, the DEA's mission includes both
9 protections against the diversion of controlled
substances and ensuring an adequate and uninterrupted
11 supply for legitimate medical, commercial, and
12 scientific needs.
13 We do recognize that there have been highly
14 public instances of inappropriate prescribing
demonstrated during the emergency, and these
16 demonstrate the need for a regulation. These examples
17 emphasize the need for a regulation that allows good
18 actors to differentiate themselves from those engaging
19 in questionable medical practices.
They should also give the DEA very clear
21 insights into what types of practices may require
22 additional oversight, as explained here. These are
23 our preferred solution rather than a blanket
24 restriction on telemedicine.
As noted in its mission, it's crucial that
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1 DEA balance their concerns around diversion with the
2 huge number of Americans who are relying on the
3 leaders at DEA for an uninterrupted supply to
4 medication for legitimate medical needs.
We believe that the regulation proposed this
6 spring failed to kind of strike that balance because
7 it did not create a pathway for practitioners to treat
8 patients through telemedicine without having had an
9 in-person interaction, effectively ending access to
care for many who have the highest needs.
11 We do think that the special registration
12 outlined by Congress laid a strong foundation for the
13 right balance between empowering the DEA to identify
14 and address diversion while not inappropriately
interfering with the practice of medicine and medical
16 decision-making, best left to practitioners and
17 patients.
18 For healthcare providers, this special
19 registration process should be an opportunity to
subject themselves to a higher level of scrutiny,
21 share additional data with DEA, and in exchange, have
22 greater flexibility to prescribe without an in-person
23 requirement, without prescribing time limits, and with
24 the ability to prescribe a wider range of substances.
Having met these criteria, they should not
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1 be subject to other burdensome guardrails. We
2 strongly believe that the registration itself is the
3 protection and does not need to be accompanied by
4 restrictions on the practice of medicine.
For DEA, the special registration should be
6 a tool that allows for the tracking and understanding
7 of who is prescribing controlled substances in what
8 manner so that the DEA can effectively act in its
9 capacity as a law enforcement agency, using this data
to identify and investigate potential bad actors, as
11 we all agree is needed.
12 As noted, we support data-driven
13 decision-making on documented abuses of controlled
14 substances where they exist. We believe that rather
than creating overbroad restrictions on the practice
16 of medicine, there can be a targeted solution.
17 Turning to more specific recommendations,
18 when considering a rigorous special registration
19 process that allows the prescribing of telehealth
without an in-person visit, DEA should consider the
21 ability to streamline implementation of that
22 registration process alongside the existing DEA
23 registration in order to eliminate regulatory burden
24 for both DEA and practitioners.
One example of this would be the use of a
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1 single special registration number in conjunction with
2 the appropriate regular DEA registration number to
3 prevent pharmacies and others from having to store
4 multiple special registration numbers for prescribers.
Building on this thought, the ability to
6 have the special registration clearly cited on
7 prescriptions issued from a telehealth visit, along
8 with the appropriate regular DEA number associated
9 with the state where the patient is being treated,
would help address pharmacy-related barriers to
11 medication access.
12 As has been noted today, there have been
13 widespread documentation of pharmacies hesitating to
14 fill controlled substance telemedicine prescriptions
as the public health emergency has come to an end.
16 And we believe that consistent documentation clearly
17 endorsed by DEA will resolve many of the concerns that
18 have led to additional barriers to patients receiving
19 access to their medications.
While documentation is important, we do want
21 to note that DEA should take care to maintain the
22 confidentiality of a telehealth prescriber's home
23 address, noting that many practitioners work from home
24 today, and release of this information would create a
safety risk for the healthcare provider and their
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1 family if released publicly in any way. Prescribers
2 should be allowed to use a prescribing address that
3 may be a physical practice location or a corporate
4 address if appropriate.
As also discussed today, DEA should work to
6 partner with the CDC, states, and others to obtain
7 telemedicine-related data that may be reported to a
8 PDMP. We think that would strengthen the work.
9 With a strong registration in place, we
believe it would be appropriate for DEA to continue
11 its flexibility when it comes to individual
12 registrations for each state where a provider
13 prescribes to patients. We think the special
14 registration framework in particular would be ideal
for addressing multistate telemedicine provider
16 registrations, and we request that the DEA offer
17 additional clarity and streamline how providers with a
18 multistate practice can meet registration requirements
19 efficiently.
Finally, I do want to flag that DEA must
21 allow an appropriate amount of time for the healthcare
22 industry to make system updates and accommodate for
23 the final rule and promote ongoing compliance. This
24 is not only healthcare providers but also the many
systems that support them, such as electronic health
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1 records, pharmacy dispensing systems, licensure
2 verification systems, et cetera.
3 Finally, we do want to flag that we urge DEA
4 not to finalize some requirements that were proposed
this spring. Specifically request that you do not
6 finalize any provision that requires an in-person
7 visit prior to the delivery of a telehealth visit.
8 The primary challenge with an in-person
9 referral mandate is the limitation it creates for
millions of Americans seeking treatment for a
11 condition for which there are significant barriers to
12 access. These can include stigma, provider shortages,
13 long distances to see providers, and many other
14 barriers.
There is no reliable guarantee that patients
16 who found access to care through telehealth over the
17 last few years will be able to obtain a meeting with
18 an in-person practitioner who is able to make an
19 examination referral.
Please do not omit Schedule II and
21 non-narcotic substances from the rulemaking. The
22 public health emergency demonstrated almost three
23 years of evidence for the prescribing of Schedule II
24 and non-narcotic controlled substances via
telemedicine.
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1 In the broader interest of continuing to
2 prevent substance use disorder, we make specific note
3 that proper treatment of a condition like ADHD with a
4 controlled substance can be crucial to lowering the
likelihood of a future substance use disorder.
6 Finally, please do not add other
7 restrictions, such as the 30-day limits on
8 prescribing, which interfere with the practice of
9 medicine and create barriers to high-quality care.
Building on that specific example, if we think about
11 this restriction in practice, it means that a
12 telehealth clinician will be pressured to prescribe a
13 medication to a patient without a clear knowledge of
14 whether that patient will be able to complete the full
treatment regimen. Many other restrictions would have
16 similar challenges for the practice of medicine.
17 Thank you so much for this opportunity to
18 comment. We continue to believe it's both reasonable
19 and possible for the DEA to protect Americans while
differentiating between higher-risk business practices
21 and the normal provision of medicine through
22 telehealth.
23 We urge DEA to continue working with
24 stakeholders, as you are now, and find a nuanced
approach to diversion that allows ongoing
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1 relationship-based care between patients and their
2 virtual providers. Thank you so much.
3 (Applause.)
4 MR. STRAIT: Thank you. Just hang here for
one second.
6 MR. ADAMEC: Yup.
7 MR. STRAIT: Any comments? Tom, any
8 comments for you?
9 (No response.)
MR. STRAIT: Okay. Thank you so much.
11 Appreciate it.
12 Okay. Well, we are at the conclusion of our
13 morning block of in-person commenters. I want to say
14 thank you to all 13 individuals and the organizations
they represent for coming all this way to be here. I
16 think we got a lot of great information.
17 As I alluded to at the onset, we are going
18 to break until 12:40. 12:40 is when our virtual
19 presenters are all going to be lined up, so we do kind
of want to start on time.
21 For those that are planning to stay for the
22 virtual event, you'll basically have between now and
23 then to potentially go to use the facilities or to go
24 outside and get something to eat. I will just remind
you that if you do have to go and leave the building,
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1 unfortunately, you will be asked to go right back to
2 that visitor entrance to go back through our
3 magnetometers, which is just kind of protocol, so I
4 apologize for that.
5 Again, thank you so much, everybody, and
6 we'll see you at 12:40.
7 (Whereupon, at 12:02 p.m., the listening
8 session in the above-entitled matter recessed, to
9 reconvene at 12:42 p.m. this same day, Tuesday,
10 September 12, 2023.)
11 //
12 //
13 //
14 //
15 //
16 //
17 //
18 //
19 //
20 //
21 //
22 //
23 //
24 //
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1 A F T E R N O O N S E S S I O N
2 (12:42 p.m.)
3 MR. STRAIT: I know we didn't have a
4 significant amount of time to go out and grab
something to eat. I hope everyone who was able to or
6 wanted to get something was able to do so.
7 We have our panel back here with Assistant
8 Administrator Prevoznik and Administrator Milgram.
9 Thank you all for joining us.
As I mentioned at the outset, we are now
11 going to begin a virtual block of comments. So as I
12 started saying earlier today, I believe we have up to
13 17 virtual presenters. I'm told we will have a total
14 of 14, or at least at this point we have 14 confirmed.
And I am going to basically be sitting here as
16 moderator, but most of the comments and the
17 conversation will be coming and being displayed on the
18 screen here. We'll do just like we did earlier at the
19 end of our virtual commenters' remarks, we will pause
and give Administrator Milgram and Assistant
21 Administrator Prevoznik the opportunity to ask any
22 clarifying questions.
23 So without further ado, let me now call up
24 Virtual Presenter No. 1.
MS. LINDERBAUM: Thank you.
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1 Hi, my name is Elizabeth Linderbaum, spelled
2 Elizabeth, E-L-I-Z-A-B-E-T-H. Last name Linderbaum,
3 L-I-N-D as in Dog, -E-R-B as in Boy, -A-U-M as in
4 Mary. I am with the National Association of Community
Health Centers, otherwise known as NACHC.
6 I just want to say thank you so much for
7 selecting us to discuss the importance of
8 teleprescribing and how it decreases barriers to
9 accessing crucial medications for the vulnerable
patients that health centers serve.
11 Just a bit about NACHC. NACHC is the
12 national membership organization for federally
13 qualified health centers, also known as FQHCs or
14 health centers.
Health centers are federally funded or
16 federally supported non-profit community, directed
17 provider clinics that serve as the health home for
18 31.5 million people including one in six Medicaid
19 beneficiaries and over three million elderly patients.
It's the collective mission and mandate of over 1400
21 health centers across the nation that provide access
22 to high quality, cost effective primary and preventive
23 medical care as well as essential behavioral health
24 and pharmacy services and other enabling or support
services that facilitate access to care to individuals
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1 and families located in medically underserved areas
2 regardless of their insurance status or ability to
3 pay.
4 We see teleprescribing as a health equity
issue. It really helps reach patients who otherwise
6 may have difficulty obtaining a prescription
7 in-patient due to social drivers of health.
8 Health centers serve some of the most
9 vulnerable people. Sixty-six percent of health center
patients are at or below the federal poverty level,
11 the FPL, and 90 percent live under 200 percent FPL.
12 Additionally 80 percent of health center
13 patients are uninsured or publicly insured.
14 Furthermore, health center patients have always had
complex care needs and these needs have grown
16 increasingly complex in the past few years.
17 From 2013 to 2017 the percentage of health
18 center patients diagnosed with substance abuse
19 disorder grew 73 percent, and patients diagnosed with
depression grew 39 percent.
21 We see access to medications to treat
22 conditions like these via telehealth as a lifeline for
23 these health center patients. Teleprescribing is also
24 a harm reduction strategy. For example, when
discussing substance use and the readiness to change,
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1 we see the best time to intervene is when the patient
2 is ready, not when they can get a ride to the clinic.
3 If the goal is to minimize risk associated with use
4 such as HIV, Hepatitis C, syphilis or overdose, then
allowing individuals to have access to a prescription
6 without additional barriers to engagement is very
7 important.
8 So both adults and children were able to
9 continue accessing medically necessary controlled
substances via telemedicine by waiving the requirement
11 that the patient have a prior in-person visit
12 regardless of their location during the PHE, and we
13 were very supportive of that.
14 I just want to echo some of the comments
that we put in our previous comment letters, that we
16 are not just concerned about the potential negative
17 impact that an in-person medical evaluation or
18 requirement may have on a patient's ability to receive
19 subsequent prescriptions and their ability to maintain
continued access to necessary controlled medications.
21 We see the in-person requirement potentially
22 affecting and impacting myriad types of patients that
23 health centers serve. For example, patients who face
24 transportation barriers, parents with young children
at home, older adults, patients who started on a
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1 controlled substance during the pandemic and then
2 subsequently became bed-ridden or homebound, unable to
3 come to the clinic for care. People with disabilities
4 and people experiencing homelessness. All of these
patients can face significant obstacles to meeting
6 that in-person requirement, and NACHC is concerned
7 about the negative health implications of that
8 proposal.
9 We also think that an in-person requirement
could affect some special populations that health
11 centers serve. For example, health centers that serve
12 the LGBTQ population. They often report that these
13 individuals come from outside of their service area to
14 seek services from the health center via telehealth
because in their community there's a lack of access to
16 affordable services that truly take into account the
17 unique clinical needs of the LGBTQ population. This
18 in-person requirement could create disruptions and
19 care for patients who choose a certain health center
based on the services available, which may not be
21 located in close proximity to them.
22 Having an in-person requirement could also
23 negatively impact the health care workforce which is
24 already struggling to recruit and retain staff.
NACHC released a recent survey that found
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1 that 68 percent of health centers lost between 5 and
2 25 percent of their workforce in early 2022 with a
3 majority citing financial opportunities at a large
4 health care organization as the main reason for
departure.
6 Health centers have reported extreme
7 difficulty in retaining behavioral health staff like
8 psychiatrists and licensed clinical psychologists, and
9 many health centers have tried to fill the gap by
utilizing telepsychiatry providers for psychiatric
11 needs. Even so, some health centers have reported a
12 limited supply of psychiatric prescribers, resulting
13 in longer wait times for patients to see prescribers.
14 We also think that having an in-person
requirement could disproportionately impact the
16 workforce for health centers and their patients
17 specifically in rural areas. Nearly 400 health
18 centers operate 5600 service delivery sites in rural
19 communities and health centers serve 1 in 5 Americans
living in these rural communities.
21 Many providers live in major cities and
22 they're unable to physically travel to these remote
23 cities and therefore, they see their patients via
24 telemedicine.
Rural providers also use telehealth to form
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1 partnerships with providers in urban and larger cities
2 to expand their network, to reach more patients.
3 By enforcing in-person requirements many
4 patients might not be able to continue seeing their
providers, especially in regions with less access to
6 care.
7 For instance, one state primary care
8 association told us that 40 percent of their health
9 centers from their main site located (technical
interference) areas, and we see that as very critical
11 that health centers are able to maintain their ability
12 to provide care to the most vulnerable patients and
13 use telehealth to meet the patients' needs in the
14 least burdensome way.
The in-person requirement could also
16 increase wait times for appointments. The average
17 wait time for a physician appointment across the
18 country is 26 days, with specialty medical
19 appointments with an even longer wait list for
in-person appointments. And these wait times can
21 result in more patients going without proper
22 assessment and treatment because of an in-person
23 requirement and that could likely add to the burden on
24 the hospital systems. Patients may seek treatment in
different forms such as emergency rooms and urgent
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1 care centers where their needs will most likely not be
2 met.
3 We really appreciate the DEA's time and
4 consideration of our comments. For health center
patients the ability to access vital controlled
6 substances via teleprescribing really enhances health
7 equity by breaking down barriers to care and better
8 meeting patients where they are. Teleprescribing
9 possibilities given during the pandemic really ensured
continued medication regimen and ensured that care
11 plans were not abruptly disrupted, and we hope that
12 this can continue.
13 Thank you so much for the opportunity to
14 speak, and I'm very happy to answer any questions.
MR. STRAIT: Okay, okay. Thank you so much
16 for your comments. I have paused, the Administrator
17 and Assistant Administrator Prevoznik are saying
18 there's no questions.
19 So what we will now do is cue up Virtual
Presenter No. 2.
21 MS. COPE: Thank you. My name is Michelle
22 Cope spelled M-I-C-H-E-L-L-E C-O-P-E. I'm with the
23 National Association of Chain Drug Stores or NACDS.
24 NACDS represents chain pharmacies that
operate as traditional drug stores, supermarkets, and
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1 mass merchants with pharmacies. Chain pharmacies
2 operate over 40,000 pharmacies throughout the nation
3 and fill over three billion prescriptions yearly.
4 Thank you for the opportunity to share NACDS member
perspectives related to telemedicine prescriptions.
6 It is imperative that DEA work to ensure
7 that any requirements the agency establishes for
8 telemedicine prescriptions do not inadvertently and
9 unnecessarily stifle patients' ability to benefit from
telemedicine by unduly burdening pharmacies attempting
11 to fill telemedicine prescriptions. Any new or
12 special requirements for controlled substance
13 prescriptions issued via a telemedicine encounter must
14 be workable for pharmacies to implement.
NACDS previously submitted comments to DEA
16 on the NPRM's addressing telemedicine prescribing.
17 From our prior comments we want to reiterate and
18 emphasize the following points relevant to the focus
19 of today's listening session.
Number one, there's a strong likelihood that
21 controlled substance prescriptions issued via a
22 telemedicine encounter will be electronically
23 prescribed. Thus DEA must provide adequate time for
24 system vendors, practitioners and pharmacies to update
their EPCS systems to accommodate any new information
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1 that DEA might require on a telemedicine prescription.
2 Such as a special prescriber notation or, as we've
3 heard referenced today, as special new DEA
4 telemedicine prescriber registration number.
Such an endeavor will require coordination
6 across the entire health care system and will likely
7 take years to complete.
8 Number two, DEA must make it clear that any
9 requirements for practitioners related to prescribing
via a telemedicine encounter do not increase
11 obligations under pharmacists' corresponding
12 responsibility. Pharmacies don't have access to
13 prescribers' electronic medical records or progress
14 notes to verify prescriber compliance with all of
DEA's standards for telemedicine prescriptions.
16 Anecdotal reports indicate it can sometimes be
17 difficult for pharmacies to contact telemedicine
18 prescribers at the number listed on the prescriptions
19 which sometimes leads to an automated message advising
pharmacies to fax in any questions.
21 Number three, DEA should allow telemedicine
22 prescriptions for all Schedule 3, 4 and 5 and should
23 not impose any limitation based on a status of a
24 narcotic versus a non-narcotic drug. This might lead
to confusion among health care providers which is
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1 unnecessary because controlled substance schedules are
2 already stratified by risk.
3 For today's listening session DEA asked for
4 feedback on number one, what pieces of data to include
or exclude if pharmacies are required to collect,
6 maintain, and/or report telemedicine prescription data
7 to DEA; and number two, what data pharmacies already
8 report to federal and state authorities, insurance
9 companies, and other third parties.
With respect to any potential requirements
11 for pharmacies to report telemedicine prescription
12 data to DEA, we have significant concerns with DEA
13 imposing such a requirement on pharmacies. Any
14 requirement for pharmacies to report telemedicine
prescriptions to DEA would be administratively
16 burdensome requiring pharmacies to shoulder the burden
17 of weeding through and supplying DEA with prescription
18 data that DEA will presumably use for practitioner
19 investigation and enforcement purposes.
Furthermore, requiring pharmacies to report
21 telemedicine prescription data to DEA would be akin to
22 a DEA establishing and maintaining a national data
23 repository for telemedicine prescriptions, much like a
24 nationwide PDMP. If this is DEA's intent, we ask DEA
to clarify the agency's statutory authority for such a
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1 requirement.
2 To support DEA's investigation and
3 enforcement activities, we think the agency should
4 follow the same processes it uses to investigate and
enforce with prescribers who issue controlled
6 substance prescriptions to patients on the basis of an
7 in-person encounter.
8 However, if DEA remains intent on relying
9 upon pharmacy data for its enforcement efforts and
requires additional information to identify
11 prescribers issuing telemedicine prescriptions for its
12 investigation and enforcement purposes, then NACDS
13 recommends that DEA develop a separate, special
14 registration for practitioners that is used only when
prescribing a controlled substance via a telemedicine
16 encounter.
17 Additionally, DEA should require that the
18 transmitted prescription information clearly
19 identifies any affiliated telehealth entity.
With respect to any potential requirements
21 for pharmacies to collect or maintain new prescription
22 data unique to telemedicine prescriptions, e.g. a
23 telemedicine notation or a telemedicine DEA
24 registration number, as previously stated,
accommodating new prescription data elements would
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1 involve substantial changes to data transmission
2 standards and to electronic prescribing and record
3 keeping systems across the entire health care system
4 that would likely take years to complete.
Currently states, insurance companies and
6 other third parties do not require pharmacies to
7 identify or distinguish telemedicine prescriptions for
8 record keeping purposes or to process pharmacy claims.
9 So pharmacies don't collect, maintain or report such
data. Electronic prescribing and record keeping
11 systems changes would be needed to support this.
12 With respect to telemedicine prescriptions
13 issued electronically, we've now mentioned several
14 times that systems updates are needed to facilitate
the distinction or notation of a prescription issued
16 via telemedicine encounter.
17 The topic gets very weedy and technical, so
18 for the sake of time and clarity, I'm going to refer
19 DEA to NACDS' past comments on the 2023 NPRMs for
telemedicine prescriptions that really kind of dig
21 into this.
22 I'd also encourage DEA to consult with the
23 National Council for Prescription Drugs Programs.
24 That was the standard-setting organization that
developed health data transmission standards that
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1 facilitate the data exchange for electronic
2 prescribing of controlled substances, prescription and
3 pharmacy related health care claims, and other
4 information exchange.
But in short, if DEA officers require new
6 information on prescriptions to delineate telemedicine
7 prescriptions, pharmacies as well as EHR and pharmacy
8 system vendors would need adequate time to implement
9 system changes to support the transmission of these
data points so that pharmacies could record and
11 maintain any new required prescription information in
12 their records.
13 Lastly, to further support DEA's ability to
14 identify telemedicine prescribers and assess
prescriber compliance with the originally proposed
16 rules, we encourage the inclusion of two additional
17 data elements on controlled substance prescriptions
18 that are issued via a telemedicine encounter.
19 Number one, the practitioner's state license
number and the state into which the telemedicine
21 practitioner is issuing a prescription. And number
22 two, if the prescriber issuing a telemedicine
23 prescription is part of a larger dedicated
24 telemedicine practice, the name of that company or
group.
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1 Thank you again for the opportunity to speak
2 today, and I'm happy to answer any questions you might
3 have.
4 MS. MILGRAM: Can I follow up with a couple
of questions?
6 MR. STRAIT: Absolutely, yes.
7 MS. MILGRAM: Thank you so much.
8 When you talk about being part of a larger
9 telemedicine practice, what would the delineation be
for that sort of size?
11 MS. COPE: We do not have at this point a
12 specific recommendation for how many practitioners
13 would be under that practice, but I think what we're
14 kind of getting at is the large telemedicine groups
that have hundreds of prescribers. I understand that
16 DEA will be inviting further comment on that, so
17 that's a point that I'm happy to bring up with our
18 membership and to provide further insight on.
19 MS. MILGRAM: Could you expand a little bit,
in terms of you talk a little bit about what data the
21 pharmacists and the pharmacies are already collecting.
22 Could you give an example in one sort of prescribing
23 situation, could you expand on what that data looks
24 like that you collect today?
MS. COPE: Sure. It's what's required to
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1 process a claim or to meet DEA's existing record
2 keeping requirements or state-level record keeping
3 requirements, right? So it's the name of the patient.
4 It's all of that information that's delineated in the
DEA rules and laws that specify what goes on the
6 prescription. So what is required, that's what
7 pharmacies are maintaining. That's limited.
8 With respect to the data points that we have
9 heard brought up or that we saw raised in the rule,
currently, originally DEA had proposed a notation of a
11 telemedicine prescription for prescriptions that were
12 issued via a telemedicine encounter. And that's not
13 something that is collected now. Without jumping into
14 the NCPDP scripts standard, that's not something that
there is a dedicated implemented field for
16 transmitting that information to. So that's not
17 currently reported.
18 And if there would be a new DEA registration
19 number that would, that potentially would be something
that would have to be accommodated to.
21 So I think I answered the question, but, you
22 know --
23 MR. PREVOZNIK: What data is there --
I know
24 the Administrator just asked this, but a little bit of
aside, what data is there that could currently be used
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1 to leverage, to identify this?
2 MS. COPE: I did cut that out but I'm happy
3 to jump into that.
4 So what exists now is --
and we're thinking
like in terms of the e-prescribing, right? Because
6 most of this is going to very likely be an electronic
7 prescription and not an in-person encounter.
8 What could be used now and immediately is
9 the prescriber place of service and the usage of last
office visit. But that being said, that's not
11 something that's commonly sent to pharmacies. The
12 standard exists and that can support the transmission
13 of that information, but EHR systems, prescribers' EHR
14 systems are going to have to be updated to transmit
that. You know, it's a whole sort of trickle-down
16 effect.
17 So the standard has something to support it,
18 but it's not commonly sent and I don't believe that
19 may prescriber systems are set up to send it just now.
MR. PREVOZNIK: Good.
21 MR. STRAIT: Okay, Michelle. Thank you so
22 much for your comments.
23 I will now go to Virtual Presenter No. 3.
24 DR. RANSONE: Good afternoon Administrator
Milgram and Deputy Assistant Administrator Prevoznik,
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1 DEA representatives and leaders. My name is Dr.
2 Sterling Ransone. Spelled S-T-E-R-L-I-N-G
3 R-A-N-S-O-N-E.
4 I'm a practicing family physician in a small
clinic located in rural Deltaville, Virginia on the
6 coast of the Chesapeake Bay. I'm the immediate past
7 president and am serving currently as the board chair
8 of the American Academy of Family Physicians, or AAFP.
9 I'm honored to be here today representing the 129,600
physician and student members of the AAFP.
11 Family physicians provide comprehensive
12 person-centered primary care to patients across the
13 life span forming longstanding relationships with our
14 patients and serve them across all practice settings.
We are often our patients' first call for chronic care
16 management, acute illness, emergency care, and
17 increasingly mental health concerns. Our training and
18 uniquely broad scope of practice enables us to be
19 responsive to the needs of our patients, their
families and our communities including offering
21 telehealth visits and providing treatment for opioid
22 use disorder or OUD.
23 During the COVID-19 pandemic family
24 physicians like me found that telehealth services help
us improve access to care for our patients by removing
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1 transportation and other barriers that prevented them
2 from getting in to see us in the office. The
3 longstanding relationships I have with my patients
4 have enabled me to determine whether a telehealth or
an in-person office visit was most appropriate for
6 their condition. Such as when a patient needs
7 hands-on care or a new or renewed prescription for a
8 controlled medication.
9 Unfortunately, we also have observed how
appointments conducted by telehealth companies without
11 these preexisting relationships led to fragmentation
12 of care and at times lower quality care.
13 That's why the AAFP recommends permanent
14 telehealth prescribing regulations that prioritize
established patient/physician relationships while also
16 facilitating equitable access to care for our
17 patients, millions of whom live in health professional
18 shortage areas and are facing months-long waits for
19 chronic disease management via an in-person
appointment.
21 To achieve this, we strongly recommend that
22 DEA not impose additional telehealth prescribing
23 restrictions for controlled substances on physicians
24 who have already established the patient relationship
through an in-person visit.
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1 As family physicians we want to support our
2 patients by providing them time and flexibility to
3 overcome issues caused by transportation costs, child
4 care, stigma, distance, and other barriers to
treatment.
6 Many of my patients are quite elderly and
7 find it difficult or physically painful to visit the
8 office. Telehealth has allowed them to receive the
9 care that they need with the physician they trust in
the privacy of their own home.
11 A majority of my current telehealth visits
12 are in the behavioral health sphere. It allows me to
13 visit the patient at home, at work, or in their school
14 dormitory. It allows me a peek at their social
situation as well, so I can give better care and
16 maintain the important bond between the patient and
17 their physician as they heal.
18 I call telehealth the house call of the 21st
19 century. It's vital for the DEA to partner with us in
supporting our patients' access to care, and
21 telehealth prescribing is key to maintaining that
22 access.
23 Second, DEA should allow prescribers to
24 manage a known patient's condition via telehealth for
six months before requiring an in-person exam.
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1 Family physicians believe six months of
2 telehealth only prescribing with Schedule 3 through 5
3 medications achieves the appropriate balance of
4 facilitating access to care and protecting patients'
safety. With long appointment waits in many
6 communities like mine, a shorter time limit will
7 create operational challenges for physician practices
8 and for patients alike, and ultimately exacerbate
9 health disparities.
Third, we recommend DEA permanently allow
11 telehealth-only prescribing of Buprenorphine for the
12 treatment of opioid use disorder.
13 Studies conducted during the public health
14 emergency found that telehealth prescribing of
Buprenorphine improved treatment access and retention
16 as well as improved patient satisfaction wile reducing
17 illicit opioid use. Given the robust evidence in
18 support of telehealth OUD treatment, limited access to
19 OUD treatment providers and low rates of Buprenorphine
divergence, we strongly encourage DEA not to finalize
21 any proposal that would require an in-person visit and
22 exam for prescribers of Buprenorphine for OUD
23 treatment.
24 As family physicians we stand with the Biden
administration in strongly supporting expanded access
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1 to OUD treatment through telehealth.
2 Finally, we urge DEA to focus on addressing
3 diversion and improving oversight of telehealth
4 companies instead of imposing complex burdensome
regulations on physicians. While we have advocated to
6 permanently expand coverage of payment for telehealth
7 services and strongly support our patients' ability to
8 access telehealth services from their usual source of
9 care, the AAFP has also repeatedly shared concerns
that services provided by direct to consumer
11 telehealth companies may drive care fragmentation and
12 pose significant patient safety risks.
13 Most helpful for family physicians would be
14 increased agency oversight on telehealth provided by
companies that are not a part of a patient's usual
16 source of care. Better, more targeted oversight will
17 be more effective than burdensome reporting mandates
18 and duplicative licensing requirements for telehealth
19 prescribing of controlled medications within an
established patient/physician relationship.
21 Physicians are already overburdened,
22 particularly in small and rural practices like mine
23 and we encourage DEA to work with other agencies to
24 harmonize licensing requirements for prescribers. We
urge DEA to focus its efforts on addressing diversion
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1 and stopping bad actors through law enforcement
2 activities, not health care regulations.
3 In closing, family physicians are uniquely
4 positioned to safely offer comprehensive care that
integrates telehealth as a tool to help us provide
6 better care without additional burdensome requirements
7 that prevent us from serving our patients as they
8 need, or risk negatively impacting their outcomes.
9 We look forward to partnering with DEA to
uphold safe prescribing practices and to ensure
11 patients' continuous equitable access to care after
12 the PHE era flexibilities end.
13 Thank you for the opportunity to provide
14 this testimony. I look forward to answering any of
your questions.
16 MR. PREVOZNIK: Doctor, thank you for your
17 testimony.
18 I have a question in regards to what your
19 experience has been with audio only or two-way?
DR. RANSONE: The biggest thing that I've
21 noticed is a lot of my older patients, especially
22 those over 75, when we do a video teleconference or a
23 video visit, almost all of them have either an
24 assistant, a caretaker or a family member to help them
work the technology.
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1 Audio only telehealth services for my
2 practice have been --
and the ability to be paid for
3 those services, has been a boon because most of my old
4 folks know how to use a telephone. Unfortunately,
they don't feel as comfortable in using a computer and
6 video available services.
7 So I have used quite a bit of audio only
8 telehealth services.
9 The other problem is where I am, many of my
patients don't have broadband access. In order to
11 access some of the more advanced telehealth services
12 in my electronic health record, they can't get in
13 because they don't have broadband access.
14 So availability of a telephone really has
allowed me to reach them.
16 For my practice, most of my patients I've
17 known for 20-30 years, and when I speak with them on
18 the phone I can get a lot, just telling how they are
19 over the phone. So I personally have been quite
pleased and it has benefitted my practice to have the
21 availability of the audio only services.
22 MS. MILGRAM: Can I just follow up on the
23 audio only.
24 DR. RANSONE: Sure.
MS. MILGRAM: My sense from how you're
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1 describing it is that you don't have an identity
2 verification component because you have longstanding
3 relationships with that patient, but I don't want to
4 make that assumption. Is there an ID --
DR. RANSONE: That's true for most of my
6 patients. Most of these folks, when I do audio only,
7 they're folks that I know. And usually I know their
8 voice or I know their family members and things like
9 that.
As far as proving identity when we speak,
11 most of mine is experience.
12 I would have to defer to the AAFP for any
13 other physicians' experience for those who don't have
14 these longstanding relationships.
MS. MILGRAM: One last question.
16 You talk a little bit about some concerns
17 with the telehealth companies that were doing
18 appointments with some of your patients. Can you just
19 elaborate on that a little bit? Give us some
examples, maybe.
21 DR. RANSONE: Yes, ma'am. I practice in a
22 rural area with my wife who's a pediatrician. And we
23 frequently will have patients come in to see us for
24 followup after a visit that was a telehealth visit
with one of these companies where we have not received
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1 the data, i.e. diagnosis or treatment plan or
2 treatments from those companies when the patient sees
3 us for followup.
4 Very frequently, for something that might be
a viral infectious disease, we'll see these folks
6 coming in on antibiotics or other substances which we
7 personally wouldn't have used because we know these
8 patients and we know the things that they get and
9 where they've been. Plus we know the bacteria that
are in our area, we know the sensitivities and
11 resistances of folks in our area, or of the diseases
12 in our area which folks who aren't in this area might
13 not know it.
14 So the biggest concern is probably the
fragmentation of care. Unfortunately, when patients
16 come in and I ask well, what did they do? Well they
17 put me on a white pill. Do you have it with you?
18 Usually they don't bring it. Then I'm scrambling
19 trying to figure out what medication they were placed
on so that I don't do harm by out-prescribing a
21 medication that might interact with the drug that
22 they've been given, and I don't have the data to know
23 what it is that the patient's been treated with.
24 So that fragmentation of care has been quite
concerning for us.
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1 MR. STRAIT: Great. Thank you, Dr. Ransone.
2 And I am just going to add as just a point
3 of clarification, I know Administrator Milgram
4 mentioned it at the outset and it just deserves an
assurance that we're providing clarity. Dr. Ransone
6 has specifically been talking about his experience as
7 a family medicine practitioner in his rural community
8 where he knows and has treated many of those patients
9 in person in the past. Our telemedicine regulations,
we're seeking to create a situation where that
11 in-person medical evaluation had not previously been
12 coordinated. So I just want to throw that out there.
13 In the instance of an existing patient that
14 a doctor is treating, once that in-person medical
evaluation or that in-person treatment has been
16 established, which could have been years back or
17 relatively recently, the requirements of what we were
18 proposing in our regulation would not exist because
19 that in-person relationship's already been
established.
21 Okay. With that, let me pull up Virtual
22 Presenter No. 4.
23 MS. KESIC: Good afternoon. My name is Anna
24 Kesic, that's A-N-N-A, K-E-S-I-C, and I am the CEO of
Empower, located in Florida. We are a non-profit
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1 behavioral health organization in-operation since
2 1994. We serve over 9,000 individuals a year in our
3 various programs, and I have been blessed to be in
4 this role with the organization over the last 15
years.
6 Empower's primary care client base consists
7 of Medicaid recipients and members of the uninsured or
8 the underinsured population. Our goal is to provide
9 access to quality treatment for those in-need of
behavioral health services.
11 It is well-documented that if patients have
12 telehealth access to behavioral healthcare, they are
13 more likely to initially engage in treatment and more
14 likely to remain in treatment. Since the inception of
telehealth treatment at Empower's psychiatric clinic,
16 patient appointments have more than quadrupled in
17 number.
18 Within the first year alone, a 60 percent
19 pre-telehealth no-show rate for in-person dropped to
12 percent via virtual telehealth. Empower has built
21 a very robust and safe telemedicine practice which is
22 predicated on clinically sound treatment and a fully
23 compliant face-to-face secured virtual platform.
24 With over 210,000 telehealth services
conducted since the PHE in 2020, Empower considers
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1 itself experts in telepsychiatry in the state of
2 Florida, and many of our state employees and
3 telehealth associations agree with that.
4 Telehealth treatment has exponentially
increased each year. Please let me provide you with
6 some of our statistics. We are currently serving 489
7 individuals that are underinsured or underinsured in
8 our clinic. For all of our funders from April 1
9 through August 31 of this year, the agency provided
8,177 psychiatric services, of which 7,539 were
11 medication management and 638 were psychiatric
12 evaluations.
13 During COVID, October 1, 2021 through May
14 31, 2023, 500 individuals were served at our clinic at
Empower. A total of 7,332 behavioral health services
16 were provided to all of our clients during this time.
17 Nationally, prior to the COVID-19 pandemic, less than
18 one percent of all behavioral health visits were
19 performed via telehealth.
However, in the second quarter of 2022, that
21 number rose to 32.8 percent, and in the same quarter,
22 63.8 percent of all telehealth visits were for
23 behavioral health. According to a new analysis by
24 Truliant Health, telehealth-delivered behavioral
health services jumped 45-fold since the inception of
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1 the pandemic, demonstrating a critical need for such
2 services.
3 The pandemic helped to lift the stigma for
4 receiving behavioral health services. It has also
contributed to an increase need to many of the
6 individuals who have lost loved ones, jobs, personal
7 related health issues, et cetera. We are only
8 beginning to see the aftermath of the toll the
9 pandemic has taken on individuals' mental health
well-being and put it in jeopardy.
11 Under the definition section in your rule,
12 it states that, "CMS recognized that for many mental
13 health services, visualization between the patient and
14 the clinician may be less critical to the provision of
service. Mental health services are different from
16 other services because they principally involve verbal
17 exchanges between the patient and the practitioner."
18 For these services, face-to-face visits are
19 not necessary to provide sound and quality treatment.
Empower's mission to serve the uninsured and
21 underinsured population of Florida --
there is a
22 national critical shortage of psychiatric providers,
23 and this data is mirror here in this day. There are
24 even fewer psychiatric practitioners willing to work
with our population, and even fewer Child
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1 Psychiatrists than the national average.
2 For these reasons, it is even more critical
3 to utilize telehealth to meet the need. Without
4 telehealth, this large segment of the population will
not and cannot be served. Regrettably, the
6 flexibilities outlined in the DEA proposed language
7 are construed too narrowly to appropriately address
8 the needs for the behavioral health population,
9 especially for lower-income clients without
transportation, children of families in the child
11 welfare system, individuals in rural areas, and
12 individuals residing in provider-impoverished areas.
13 Instead, the proposed language is highly
14 focused on narcotic medication and does not give the
same credence to behavior health patients who have a
16 longstanding, valid doctor-patient relationship via
17 telemedicine and are in need of non-narcotic
18 controlled substances for psychiatric treatment.
19 In fact, the majority of telehealth visits
pre-
and post-pandemic have been for the treatment of
21 behavioral health conditions. In the DEA intent of
22 proposed language, it states, "More than 75 percent of
23 all counties in the U.S. are classified as mental
24 health shortage areas, and 50 percent do not have
mental health practitioners."
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1 Behavioral health practitioners and
2 organizations are left to ask: how will the in-person
3 requirement help patients who need non-narcotic
4 controlled substances for their mental health? The
simple, and direct, and honest answer is: it doesn't.
6 Rather, it will create unintended discriminatory
7 hardships on mental health patients who are not
8 abusing medication, and impedes timely access to care
9 and continuity of their treatment.
Empower's referrals for these services
11 mainly come from school systems, family members,
12 corrections, diversion programs, the judicial system,
13 juvenile justice, and the child welfare system.
14 Rarely are they referred from primary care physicians,
and although having a primary care medical home is a
16 best practice, many of these clients do not have
17 access for a variety of reasons.
18 Furthermore, the language seems to focus
19 principally on the enforcement component of DEA and
not the practical solutions. The vast majority of
21 medical practitioners are not, and have not
22 contributed to the misuse and abuse of prescribing
23 controlled substances.
24 This is particularly true for behavioral
health practitioners. With such a focus, these
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1 individuals that truly need services and have access
2 to care issues are being penalized, as well as the
3 dedicated practitioners who provide these services.
4 Behavioral health providers propose that an
exception be made for the prescribing of Schedule II
6 non-narcotic medicines for the treatment of ADHD, and
7 Schedule IV substances for the treatment of anxiety.
8 In fact, because of our advocacy at Empower, the State
9 of Florida Board of Medicine recognized the importance
of this, and in March of 2017, enacted the following
11 language.
12 And I quote, "Controlled substances shall
13 not be prescribed with the use of telemedicine except
14 for the treatment of psychiatric disorders." The DEA
intent of proposed language states that the Ryan
16 Haight Act, or RHA, intended to address threat to
17 public health safety caused by physicians who
18 prescribe controlled medications via the internet
19 without establishing a valid doctor-patient
relationship through such fundamental steps as
21 performing an in-person medical evaluation of a
22 patient.
23 It is important to point out that when the
24 RHA was implemented initially, telehealth did not
exist as it is at all today. In fact, it was vastly
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1 different. This is especially true for behavioral
2 health providers.
3 The proposed language is overly focused on
4 the opioid use disorder and does not consider
mainstream psychiatry and the essential need for
6 non-narcotic Schedule II and Schedule IV medications.
7 The proposed language creates a greater risk that
8 non-specialty behavioral health practitioners without
9 specific current knowledge of psychiatry will
prescribe controlled substances during their in-person
11 examination, rather than defer and refer patients to
12 specifically trained psychiatric practitioners.
13 It is important to note that PCPs write 79
14 percent of all antidepressant prescriptions and 45
percent of antipsychotic medication, and may
16 inadvertently contribute to overprescribings of these
17 drugs nationally.
18 In summary, longstanding non-profit
19 organizations such as Empower have been the backbone
of behavioral health treatment from the uninsured and
21 the underinsured for years. We have figured out how
22 to do best and to meet the needs of those populations
23 to keep them safe, out of higher levels of care, and
24 ensure they have access to the services they need to
live their best quality of life.
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1 Empower has always done that and will
2 continue to prioritize quality while working to
3 eliminate unnecessary barriers to care. For these
4 reasons, Empower is here requesting that the DEA
carve-out an exception to the face-to-face requirement
6 for behavioral health services in which non-narcotic
7 controlled substances are prescribed.
8 We ask that there be a provision in the rule
9 that allows for telehealth behavioral health entities
to be vetted, particularly longstanding practices and
11 non-profit organizations, and be exempt from the
12 in-person requirement. I thank you very much for your
13 time, and I'm happy to answer any questions.
14 MR. STRAIT: Okay. Thank you, Anna. We
actually have just been told there are no follow-up
16 questions, so we will now move onto Virtual Presenter
17 No. 5.
18 DR. PLUMER: Hello. My name is Dr. Robin
19 Plumer, spelled R-O-B-I-N, P-L-U-M-E-R and I'm an
end-of-life physician in New Jersey. When I first
21 heard about the proposed restrictions regarding the
22 prescribing of controlled substances by telehealth, I
23 was extremely alarmed, and my first thought was,
24 "Wait, I think they forgot about the end-of-life
community."
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1 Individuals who are at the end of their
2 lives often rely on controlled substances to relieve
3 what can otherwise be debilitating pain and unbearable
4 shortness of breath. As a hospice physician, my
patients rely on me to be able to prescribe these
6 medications in a timely manner, and I rely on
7 telehealth to help care for them.
8 Deeply concerned for my patients' access to
9 the medications necessary to relieve their suffering,
I, along with representatives from Death With Dignity
11 and the Completed Life Initiative, went to D.C. in
12 April of this year to advocate for the judicious use
13 of telehealth to prescribe controlled substances for
14 end-of-life patients.
We visited the DEA headquarters in D.C. to
16 personally deliver boxes containing over 10,000
17 letters from concerned members of the end-of-life
18 community regarding this issue. These letters
19 represented 25 percent of the total letters sent to
the DEA asking for reconsideration of the proposed
21 rule.
22 Clearly, there are many highly concerned
23 end-of-life practitioners, patients, caretakers, and
24 loved ones who realize just how devastating the DEA's
proposed regulations and the loss of telemedicine
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1 would be to this vulnerable group of patients.
2 I am uniquely positioned to appreciate the
3 DEA's intention to implement safer prescribing
4 practices for controlled substances amidst the opioid
epidemic, as I was an emergency physician for 30 years
6 before shifting my practice to end-of-life care.
7 As an ED doctor, I saw firsthand the
8 devastating impact of opioid misuse, abuse and
9 dependence, and I applaud the DEA for trying to
develop strategies to address the opioid crisis and
11 acknowledge the value of an in-person clinical
12 assessment when prescribing controlled substances for
13 the population at-large.
14 However, having spent the last eight years
caring for individuals at the end of life, I rely on
16 opioids and other controlled medications to relieve my
17 patients' suffering. These patients are often weak,
18 homebound, bed-bound, and they lack transportation to
19 attend a clinic visit in order to obtain their needed
medications.
21 Hospice fills this role admirably by
22 providing patient-center care in the patient's home.
23 Prior to the COVID pandemic when I worked as a hospice
24 medical director, the standard of care was that a
hospice nurse would see a new patient in the community
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1 and then phone the hospice doctor to give a report
2 about hospice eligibility and the patient's needs.
3 Based on that, the doctor would order
4 initial comfort care meds, which generally included
liquid morphine and Ativan. Now, with the new
6 proposed rules, the DEA is, perhaps incorrectly,
7 sending the message to hospice patients and workers
8 that they want to go backward and destroy the system
9 that has served hospice patients for years.
Not only are terminally ill patients on
11 palliation, not to worry about in terms of drug abuse
12 or illegal activity, but they should never be forced
13 to suffer extended pain and lack of access to
14 necessary medications in their final days of life.
Let me tell you a story about John. John
16 was an elderly man suffering from severe pain in his
17 abdomen and bones from end-stage cancer. He was
18 bed-bound, weak from being unable to eat, and short of
19 breath from fluid in his chest and abdomen. He
required oxygen to breathe.
21 His wife, who was his primary carer, was
22 herself frail and elderly, and certainly would not be
23 able to get him to a clinic visit. The ability to use
24 telehealth so I that I could assess his condition and
prescribe the right medications to treat his symptoms
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1 has been an amazing advance to make both of their
2 lives easier.
3 Most people in such a situation would want
4 this kind of patient-centered care in the comfort of
their own homes for themselves or their loved ones.
6 Mandating in-person visits prior to prescribing
7 controlled medications in this unique population would
8 create a devastating burden to these patients, and it
9 would delay their ability to obtain these medications
in a timely fashion.
11 At worst, many individuals would go without
12 the medications necessary to mitigate their pain and
13 ease their breathlessness, and instead, their last
14 days would be devoid of comfort and dignity.
Some hospices care for hundreds of patients,
16 and this is, and has been the model of care across the
17 U.S. A change to the current procedure, requiring the
18 hospice doctor to visit every new patient in-person,
19 would be completely out of the question due to the
number of patients that would need to be visited.
21 There are simply too many dying people and
22 not enough doctors, especially in rural areas.
23 Currently in my own end-of-life practice, I am able to
24 care for patients who live anywhere in New Jersey.
Some are three hours away, and it would be impossible
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1 for me to spend six hours round-trip to see a new
2 patient in order to prescribe for them.
3 Some of these patients live in rural areas
4 where they would simply lose access to care if
telemedicine were not an option. The terminally ill
6 patients I care for don't just live in cities near
7 major medical centers. We all know the challenges our
8 healthcare system has in delivering quality care to
9 rural areas.
For the terminally ill, this problem is even
11 worse, for they lack easy access to specialized
12 physicians who can provide the care they need.
13 Telemedicine has become so accepted in general medical
14 practice since COVID that the thought of withdrawing
this option seems like a giant step backwards. It
16 certainly will not enhance compassionate care for
17 terminally ill patients.
18 Our goal as medical practitioners is to
19 reduce suffering, and provision of needed medication
is a huge part of this. This group of patients is at
21 very low risk for abusing controlled substances, and
22 will undeniably suffer if we limit their access to
23 pain-relieving medications.
24 Their legitimate need for opioid medications
at the end of life is not disputed by anyone in the
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1 medical community, and I hope that the DEA can protect
2 this specialized population and exclude end-of-life
3 providers from unnecessary and cumbersome
4 restrictions.
Please do not further complicate our
6 patients' final days by limiting their access to the
7 medications which are carefully prescribed to minimize
8 their suffering. The CDC realized the critical need
9 for hospice and palliative care patients to receive
adequate symptom relief by specifically stating in
11 their guidelines for prescribing opioids that their
12 recommendations to not apply to pain management
13 related to palliative care or end-of-life care.
14 I hope the DEA will make a similar
thoughtful exception to these well-intended proposals
16 regulating controlled substances by excluding those
17 individuals at the end of life. Thank you.
18 MR. STRAIT: Thank you, Dr. Plumer. Do we
19 have any comments? Tom? Anne? Okay. Thank you very
much. We will now move onto Virtual Presenter No. 6.
21 MS. SULLIVAN: Hi. My name is Jodi
22 Sullivan, J-O-D-I, S-U-L-L-I-V-A-N, and I represent
23 the Investigations Medicare Drug Integrity Contractor.
24 We investigate part D drug fraud cases. Part D is the
main drug coverage for Medicare and covers over 51
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1 million patients.
2 So, as part of our daily activities, we do
3 investigate both drug diversion and telehealth fraud
4 cases, so our input is relative to the DEA in terms of
minimizing diversion and improving patient safety as
6 part of an enhanced registration.
7 So, we do appreciate the time and
8 collaboration here, and we would be willing to
9 participate in any future discussions with the DEA
regarding this. So, the main points we want to bring
11 up are some of the things we see in our
12 investigations. One is, with embracing this, we
13 really need a Federal standard as to what a true
14 telehealth visit would require for controlled
substances.
16 As discussed by some of the other speakers,
17 there is a variety of different types. In our cases,
18 we sometimes see unlicensed personnel taking medical
19 histories --
call center employees, for example --
so
it is very important that the DEA establishes a
21 Federal standard for this as part of an enhanced
22 registration.
23 State laws vary greatly and we may have a
24 prescriber, a pharmacy, and a beneficiary all in three
different states that we are trying to evaluate as
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1 part of a diversion case and telehealth case. There's
2 two other components to a standard that should be
3 evaluated.
4 One is: how do you monitor and evaluate
these patients without the inpatient visit, and what
6 would be a minimum that would be required? And this
7 might vary depending on what type of patients and
8 therapeutic area you're addressing.
9 But in medical record review with bad actors
in this space, we do often see that the need for
11 controlled substances initially and ongoing is poorly
12 documented. So, we would need to have some sort of
13 standard to help us evaluate and determine what would
14 be inappropriate and should be referred to law
enforcement.
16 Urine drug screens are another important
17 tool that we often find are problematic in these
18 patients' medical records reviews and often lead to
19 patient harm from the inaction to accuse of misuse,
abuse, and addiction by providers.
21 So, when we evaluate these, how are we going
22 to monitor these in a remote environment? There's a
23 variety of discussion out there, including sending
24 packages to patients and having them return them. We
do see falsification, a lot of times --
samples that
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1 are not consistent with human urine --
and so you need
2 ways to prevent tampering for that.
3 So, the DEA should endorse some ways to
4 appropriately remote monitor patients with urine drug
screens that would not be subject to tampering by
6 patients with drug use issues.
7 Confirming a valid relationship. This is
8 really important for a couple of aspects. One is,
9 patients. We see very often in telehealth scams that
patients do online searching for their own medical
11 care that's very common these days, and they are often
12 bait-and-switched into a scam to get their medical
13 information and to prescribe and dispense medically
14 unnecessary prescriptions that may not at all address
the patient's medical need, and so there's a variety
16 of patient harms that can come from that, as well as
17 the financial harm to a payer like Medicare.
18 So, that is something that's very important.
19 A patient should be able to see if an organization or
a prescriber has this valid registration, something
21 like an internet page symbol or a national lookup
22 where you could verify and say my prescriber is
23 enrolled and I know they're valid, as well as a way
24 for a patient to submit a complaint.
If they have had someone misrepresent their
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1 status, then the DEA should be able to get that
2 complaint and investigate it. Pharmacists should be
3 able to verify these claims, especially when they're
4 remote. They don't know this prescriber, so they need
to be able to verify that, and I think a few pieces of
6 information added to the prescription would be key to
7 that.
8 One would be the fact that it is a
9 telehealth prescription. A lot of times we do see
that prescribers do this practice on top of another
11 practice --
a day job --
so it is important to be able
12 to discern the two different patterns sometimes and
13 what is legitimate and is not legitimate.
14 ICD-10 codes would be another thing that
would be helpful, particularly if the DEA did the
16 enhanced registration specific to only certain areas
17 like hospice or mental health. Being able to
18 determine that it was related to those and not outside
19 of scope for a virtual visit would be important for
pharmacies, pharmacists, as well as insurers.
21 Those information should be added to
22 electronic prescription drug claims so payers could
23 have access to that as well. Medical records.
24 Although those are onerous and time-consuming for
people to provide and to review, sometimes they're
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1 warranted for investigations, and we do find they're
2 difficult to get from drug diversion and telehealth
3 cases a lot of times, typically because the medical
4 records do not meet minimum standards for a medical
record or evaluation and management services for
6 Medicare, and they have not been charged Medicare;
7 they have been done through cash payments or other
8 payments.
9 So, when we evaluate these, you really do
have to consider whether medical records can be
11 obtained. So, medical records should be obtainable
12 with reasonable requests. If not, that should open a
13 pathway to the DEA for revocation of the registration.
14 Payment of services should be transparent.
We do find that financial interests by the telehealth
16 company or pharmacies can often lead to kickbacks and
17 also drug fraud, so it does need to be transparent who
18 paid for the medical services if they were not
19 submitted to the insurer.
In controlled substance investigations,
21 patients who are drug seekers often pay cash to get
22 around insurance utilizations and to seek out
23 physicians or prescribers who will enable their drug
24 diversion, their drug misuse.
Data sets. I would like to bring up state
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1 PDMP. These are very helpful data sets. They aid
2 patient safety and they assist dispensers and
3 practitioners, prescribers, in providing appropriate
4 patient care and preventing drug use and misuse.
With enhanced electronic prescribing of
6 controlled substance and now virtual prescribing of
7 controlled substance, I think we are at a point where
8 we need Federal PDMP. Every program is state-level,
9 and I honestly do not feel they're sufficient, either
from an insurer payer or from a practitioner
11 standpoint, to really support a Federal prescribing
12 system like we're talking about here with enhanced
13 registration.
14 We do appreciate your time and
consideration. On behalf of CMS and the investigations
16 medic, and I'll be happy to answer any questions at
17 this time.
18 MR. STRAIT: Thank you, Ms. Sullivan.
19 MS. MILGRAM: Thank you so much. Could I
just ask you to expand a little bit on the idea of a
21 Federal PDMP? What would you want to see in that?
22 Would you see it being identically structured to the
23 current State PDMPs?
24 MS. SULLIVAN: I think payment type is very
important, as I talked about. I think the
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1 transparency of that has definitely been shown with
2 controlled substance investigations. If it's not
3 through insurance, I think was it paid by the patient
4 or not, and I think that's a little bit different for
telehealth compared to regular State PDMPs, but I
6 think that would be something that would be very
7 helpful.
8 I also think having access by insurers and
9 payers. In certain states, somebody like myself, an
Investigations Medic, cannot access that system,
11 although I can access it as a pharmacist if I'm
12 dispensing it as a prescription to that patient. But
13 we may be equally trying to determine diversion in
14 those patients.
A payer may be looking at evaluation for a
16 lock-in program. They may be trying to look at case
17 management of a patient to prevent harm, and
18 reasonable access may be limited to certain fields,
19 but that reasonable access to that Federal system
would greatly assist payers like Medicare Part D
21 sponsors and the Investigations Medic in their work.
22 MR. PREVOZNIK: Tom, we've talked a lot this
23 morning and this afternoon about drug screening.
24 Could you give examples of good things that you've
seen with drug screening, how it's done, and also
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1 maybe some examples of where it's not been so good?
2 MS. SULLIVAN: Sure. So, on the good side,
3 I would say people who screen with some
4 unpredictability, you know, not just at a visit but
also random drug screens as well. You can do a, sort
6 of, broad-based test, you know, but you do want to go
7 definitive for if you have abnormal results or
8 atypical findings.
9 So, things where it's unexpected, you do not
see the drugs prescribed in the urine, anything
11 consistent with tampering of the urine or
12 falsification of urine samples, as I was talking
13 about. Those things should be acted on. And then
14 also, unexpected positive findings. So, if there's
illicit drugs, for example.
16 I don't know if it's been mentioned in
17 others' talks, but many of the overdoses we see are
18 with illicit drugs now. We've moved away, a bit, from
19 a prescription drug overdose problem to one that
contains illicit drugs.
21 So, many of the overdoses we investigate
22 with medical records, facility records, and toxicology
23 reports as well as autopsies, do note illicit drugs,
24 such as methamphetamine, for example, or cocaine. So
it's very important if a provider has seen that in a
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1 drug screening to act on it. It could save a
2 patient's life. I hate to be overly dramatic, but
3 that's absolute truth.
4 On negative sides, what we see very
frequently is failure to do any urine drug screens, or
6 sometimes excessive drug screens where they're billed
7 to Medicare, and there's also failure to act on any of
8 the results. So, we see that very often or where
9 people are turning a blind eye to multiple problems.
We had a review recently where someone just
11 kept noting, "Will re-order drug screen and then opine
12 on results," and there was no changes to the
13 prescription and that patient was somebody who did
14 overdose and did suffer harm because the misuse and
abuse was not acted upon by the prescriber.
16 So, the other thing is just ignoring those
17 signs of tampering. I mean, a urine drug screen done
18 by a lab will note if a sample is not consistent with
19 urine, if the temperature was off, if the creatinine
was off, if there was evidence of spiking, for
21 example, where there's no metabolites of that drug so
22 it looks like they weren't taking it --
they just
23 inserted some in the urine.
24 So, all of those factors are noted by
reliable labs, so that's something that if it's there,
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1 they should act on. And it is important to utilize a
2 true lab test for some of those reasons, at least on
3 occasion, even if screening is done, in doctors'
4 offices, for example --
random dipsticks and things
like that.
6 But you do need that full lab test to give
7 you some of those information, sometimes.
8 MR. STRAIT: Okay. All right. Well, thank
9 you, Ms. Sullivan. We are actually going to take a
10-minute break, so if folks need to get up and
11 stretch their legs or use the facilities, please feel
12 free. We will start and resume our virtual presenter,
13 starting with Virtual Presenter No. 7, at 1:57, okay?
14 (Brief recess.)
MR. STRAIT: Okay. We are now back. We'll
16 welcome Virtual Presenter No. 7 to the screen. And
17 Mr. Duane, at your convenience.
18 DR. DUANE: Thank you. My name is Kevin
19 Duane, K-E-V-I-N, D-U-A-N-E, and I'm a community
pharmacist in Jacksonville, Florida. I own and
21 operate two pharmacies in the Jacksonville area, along
22 with my wife, who's also a pharmacist.
23 During the COVID-19 pandemic, we saw
24 firsthand the flexibilities in prescribing of
controlled substances, and really, the explosion of
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1 telemedicine in general. But it was the flexibilities
2 that were taken-up so quickly that surprised us.
3 While we understood that the unprecedented
4 situation called for loosening regulations to ensure
that people could continue on with their medications,
6 we also believe that the pandemic is well-past us now
7 and we need to carefully strike a balance between our
8 previous rules and regulations and the kind of
9 Pandora's box that's been opened up now in the
interim.
11 So, I appreciate the opportunity to provide
12 insights and some recommendations on the evolving
13 landscape of telemedicine, especially as it concerns
14 prescribing of controlled substances.
And while I recognize that there is some
16 significance to establishing a secure set of
17 guidelines that uphold the integrity of the
18 practitioner-patient relationship and then the
19 pharmacy-patient relationship, we also need to be
adaptive to technological advances.
21 Regarding existing regulations, we have
22 found in our practice that the rise of audio-only
23 telemedicine has presented some challenges for us, and
24 by that I mean that it has become very difficult for
us to validate that the person that worked with or
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1 spoke with the practitioner to obtain the prescription
2 is actually the person whose name the prescription is
3 being presented for and that that is the same person
4 that is actually receiving the prescription.
So, we believe that while there may be some
6 cases where audio-only interactions are acceptable, we
7 believe that audio-only interactions should really be
8 the exception, rather than the rule, and that they
9 should not be approved in a blanket way.
And we also believe that it's imperative
11 that, at some point, the patient is seen physically by
12 a healthcare provider. I know that we've all heard
13 stories about how, you know, the pandemic and a
14 reduction in the access to physical exams has led to
progressions in cancers and other incidental findings
16 --
or non-findings, as it may be.
17 But in the case of controlled substances,
18 the physical exam and having seen someone at some
19 point physically will help to cut down on some of the
issues that I described earlier with audio-only
21 telemedicine.
22 As far as the Notice of Proposed Rulemaking,
23 I'll first limit my comments just to the general
24 telemedicine Notice of Proposed Rulemaking, and then
I'll address the buprenorphine comments separately.
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1 I firmly believe that a separate
2 registration process should be in-place so that
3 there's a separate DEA number that's used for
4 telemedicine encounters, and that's because, as I
think was probably mentioned earlier, there are some
6 practitioners that, kind of, moonlight and will do
7 their normal day job and then do telemedicine on the
8 side, or something like that.
9 But for pharmacies, it's very difficult to
understand where this prescription's coming from. Is
11 it coming from their live practice, or is it coming
12 from a telemedicine side-gig or something like that?
13 And so the scrutiny or the corresponding
14 responsibility that we undertake in order to discern
whether or not the prescription is issued for a
16 legitimate medical purpose in the usual course of
17 professional practice is different.
18 And so we need to, as pharmacists, be able
19 to understand which silo that this is coming from.
And we do believe that all practitioners --
in the
21 state of Florida, practitioners are required to check
22 the PDMP before issuing prescriptions, but for
23 practitioners that are doing telemedicine outside of
24 our state, you know, their state laws can be different
than ours, so just standardizing that would help us to
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1 understand, you know, where that prescription's coming
2 from.
3 We also think that there should be ancillary
4 data provided that is not required to be provided
right now, such as a diagnosis code. You know, for
6 example, a benzodiazepine that's being prescribed for
7 a reduction in, you know, a large amount of seizures
8 per day is much different than a benzodiazepine that's
9 being given to someone for anxiety or for sleep
first-line.
11 We also advocate against allowing the
12 prescription of narcotic-based drugs just solely based
13 on a referral, unless that referral to telemedicine is
14 from an in-person practitioner exam and those two
practitioners are part of the same health system. We
16 think that otherwise it creates a kind of perverse
17 incentive for a kickback scheme or other kind of
18 referral scheme that can distort the actual
19 relationship.
We also think that the grandfathering
21 provision that allows for care that was established
22 during the pandemic to continue without a physical
23 exam should be sunsetted. At some point, you know, we
24 believe that patients do need a physical exam because
although we're seeing them in the pharmacy, we don't
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1 know that that means that, you know, the physical exam
2 is catching things that need to be caught.
3 As far as buprenorphine goes, we think that,
4 again, there should be a separate registration for
telemedicine prescriptions for buprenorphine. I also
6 think that particular care should be given to the type
7 of MAT that is given. We have seen in our practice
8 that, you know, prescriptions for buprenorphine
9 contained with naloxone, and then prescriptions that
are for buprenorphine sublingual tablets without
11 naloxone.
12 Our law enforcement here have, you know,
13 made it very well-known that, you know, buprenorphine
14 without naloxone is as much more readily obtained on
the streets and is used or misused often.
16 So, telemedicine prescriptions, as far as
17 some of the new questions that were proposed, should
18 really be limited, possibly, to psychiatric
19 evaluations if there's going to be no in-person
evaluation at all, or perhaps terminally ill patients
21 or patients in hospice care.
22 I can't see another scenario where Schedule
23 II medications, outside of psychiatric evaluations or
24 terminally ill patients, should be prescribed,
especially not for conditions like chronic
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1 non-malignant pain. That's a huge problem that we've
2 seen here in the state of Florida.
3 I think that the DEA should require the
4 collection and reporting from practitioners of
demographic data, such as patient zip codes, patient
6 ages. I think, that way, they would be able to
7 quickly identify outliers and practitioners that may
8 be, you know, well-beyond what a typical telemedicine
9 practitioner is doing.
Also, recording things like the number of
11 referrals or the number of exams that are done and
12 then referred to by the same
13 practitioner-telepractitioner set, and other types of
14 patient-practitioner relationships would be helpful to
identify certain patterns that may be indicative of
16 diversion.
17 And then, I think documenting and reporting
18 the number of telemedicine visits that that
19 practitioner performs that does or does not result in
the prescribing of a controlled substance, and then I
21 think that, in the absence of the ability to compel
22 PDMP data nation-wide, that there should perhaps be
23 voluntarily disclosure of all practitioner
24 prescriptions that are sent so that the DEA can use
those to examine them and then look for any outliers.
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1 Supplying data to the pharmacies I think is
2 very important because we are charged with this
3 corresponding responsibility but we don't often have
4 or cannot easily obtain all of the data necessary to
do that.
6 I think that providing urine drug screen
7 results when they're performed would be very helpful
8 to pharmacies, just to understand if there is a
9 positive that shouldn't be there or if there is a
negative when a positive should be there, that helps
11 us, kind of, understand where the patient is at in
12 their therapy.
13 And then, to have a full and complete list
14 of diagnosis codes --
I have seen prescriptions that
lack diagnosis codes. It's impossible for me to know
16 whether it's for oncologic-related pain,
17 end-of-life-related pain, or chronic non-malignant
18 pain --
you know, acute pain versus non-acute pain.
19 So the obligation to provide those will simplify and
streamline the ability for us to perform our
21 corresponding responsibility when it comes to
22 controlled substance medications.
23 And then, of course, while Florida does
24 require it, it does not require the practitioner to
endorse to the pharmacy that they did check the PDMP,
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1 so we're kind of left in the dark as to whether or not
2 they are performing, you know, their part of their
3 obligation.
4 The last thing that I'll say is, you know,
we've seen a lot of fraudulent prescriptions come with
6 the advent of electronic prescribing. We had hoped
7 that electronic prescribing would lead to less
8 fraudulent prescriptions, but it's just that the crime
9 is getting more sophisticated.
So, understanding who we are looking at,
11 especially when it comes to mid-level practitioners
12 and practitioners like podiatrists and dentists will
13 help us understand where they are in their practice.
14 And again, that separate registration will also help
us to understand, you know, what they do as far as
16 telemedicine and the non-telemedicine portion.
17 So, I believe, in closing that the
18 suggestions do balance the need for innovation in
19 healthcare, but also the imperative of patient safety
and the prevention of drug diversion. Thank you for
21 your consideration, and I'm happy to answer any
22 questions that you all may have.
23 MS. MILGRAM: Thank you so much. Just a
24 follow-up: could you expand a little bit on what type
of fraud you're seeing with the electronic
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1 prescriptions?
2 DR. DUANE: Yeah, sure. So, yeah, it's
3 actually been very incredible, to me. We've seen very
4 sophisticated fraud where completely EPCS-certified
prescriptions are coming through. From what we
6 understand, bad actors are obtaining credentials of
7 DEA-registered providers and then reaching out to
8 electronic health record systems.
9 I believe probably the breakdown is that the
electronic health record systems are not rigorously
11 enough vetting the persons that are purporting to be
12 the practitioners, and so these bad actors are able to
13 obtain credentials in the name of --
most commonly I
14 see mid-level practitioners and dentists, and then
they use them to, you know, send prescriptions to
16 pharmacies.
17 The good thing, I think, is that you could
18 stop this very easily. Like for example, in
19 Jacksonville, we had one where there was a doctor that
was a dentist that was out of Chicago that was rapidly
21 sending prescriptions for promethazine with codeine to
22 different pharmacies in Jacksonville.
23 And so, you know, there were prescriptions
24 being sent for a patient, from what we ascertained,
you know, 20 or 30 patients within the first hour of
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1 the day that pharmacies in Jacksonville were open. So
2 it's like, you know, any time an EHR saw that kind of
3 data so rapid-fire, different kinds of controlled
4 substance prescriptions are the same for many
different people, you know, that should raise red
6 flags.
7 But it becomes more difficult for the
8 pharmacy to determine whether or not those are
9 legitimate prescriptions. You know, back in the olden
days, we could tell, oh this handwriting is much too
11 neat, or this prescription looks photocopied or
12 tampered with somehow, but, you know, the
13 prescriptions that we're seeing now are "legitimate"
14 --
quote-unquote --
prescriptions from EHR that pass
all of the normal EPCS regulations because they're
16 simply just issued --
the credentials are --
to bad
17 actors who have not been properly vetted that they are
18 the practitioners that they say that they are.
19 MS. MILGRAM: Thank you so much. Could you
say a little more; you talked for a minute about some
21 of the issues you've seen with chronic pain. You just
22 mentioned in-passing talking about telemedicine
23 prescribing. You were talking about psychiatric care,
24 patients in hospice care, or terminally ill, and then
you raised a concern around chronic pain patients.
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1 Can you just expand a little bit on what
2 you've seen related to telemed?
3 DR. DUANE: Sure. You know, as a
4 pharmacist, I think that it requires more due
diligence on our part when we see a prescription for
6 chronic non-malignant pain. Number one, the State of
7 Florida requires it in the statute, but also, you
8 know, someone spoke earlier about end-of-life care,
9 and I think that, you know, it's pretty obvious when a
patient, or patient who's being seen by hospice, and
11 the need for opioid therapy.
12 And that's not to say that all chronic
13 non-malignant pain patients do not have an obvious
14 need for opioid therapy either; it's just that,
especially during the pandemic when there was no
16 differentiation via a different DEA registration
17 number or something like that, it's impossible for me
18 to know, okay, is this a patient that was seen
19 in-office, you know, had hands laid on them, you know,
was face-to-face with a person to understand not just,
21 you know, what their problems are but their body
22 language, their mannerisms, the way that they're
23 presenting themselves.
24 Or, was this a patient that was seen via
telemedicine and, you know, to my other point, like,
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1 audio-only telemedicine, or are the standards for
2 audio-visual being enforced by the practitioner when
3 they're being seen by the practitioner.
4 So it just puts an extra burden on us to
understand, you know, whether the practitioner was in
6 the office that day or whether they were seeing
7 patients from home, or if this patient was being seen
8 by a practitioner that was in the home, was the
9 patient seen in the office and was still oriented by
the nursing staff or a mid-level practitioner but then
11 seen via telemedicine by the physician, as a
12 pharmacist, you don't know all of those things.
13 So because you don't know all of those
14 things, you know, you have to look in other places to
understand, you know, was this prescription issued for
16 a legitimate medical purpose in the usual course of
17 professional practice. And as we expand telemedicine
18 and people are referred to physicians or mid-levels
19 that are outside my state or outside of my city, it
becomes even harder to understand.
21 You know, I may only see one prescription
22 from that physician or mid-level per day, but is that
23 one of, you know, a thousand prescriptions that a
24 quote-unquote "pill-mill" telemedicine operation was
issuing that day? I don't know anything, you know, to
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1 know that, so I think that, to my point about the DEA
2 being able to collect data like that, you know, a
3 physician that uses his or her telemedicine
4 registration to see a few patients per day to augment
their existing practice or to see patients that are
6 homebound or otherwise they wouldn't be able to see --
7 maybe they're in a rural area or something like that
8 --
that's much different than a practitioner that's
9 issuing hundreds of prescriptions per day.
But as a pharmacist, I don't know a
11 prescription coming over, which bucket that one may go
12 into, so it just presents a, you know, increased
13 difficulty in that sense.
14 MS. MILGRAM: Thank you so much. One other
follow-up on --
you mentioned a couple of times --
16 individuals who have day jobs and then, sort of,
17 moonlight with telehealth or other organizations. Can
18 you just expand on that, a little bit, of what you're
19 seeing?
DR. DUANE: So, I mean, I think I'm
21 referring to, like, the Cerebral and the Done type
22 prescriptions for, you know, Schedule II stimulants,
23 and so I think that, you know, if with these proposed
24 rules that type of ability to issue prescriptions for
psychotropic medications like amphetamine-type
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1 stimulants or even benzodiazepines for the treatment
2 of anxiety or other psychiatric-type conditions, I
3 think it will become more in-vogue or prevalent for
4 physicians to lend their credentials, or mid-levels to
lend their credentials to some of these services.
6 And I worry about the continued erosion of,
7 you know, is there a robust and satisfactory
8 patient-practitioner relationship that exists before
9 these prescriptions are issued. If we saw anything
with, like, you know, the whole ADHD stimulant
11 issuance via telemedicine, I think the answer was, at
12 least at first, no.
13 So, as a pharmacist, how do I know that the
14 patients that are coming in that are being evaluated
by these practitioners --
you know, it's much
16 different if there's a practitioner who devotes their
17 practice solely to only, you know, anxiety or other
18 psychiatric conditions solely via telemedicine.
19 It's quite another if they're someone who is
looking to make a little bit of extra money so they
21 want to see a few extra patients via one of these
22 telemedicine referral services in addition to, you
23 know, the day job that they work as a primary care
24 physician with a health system, or something like
that.
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1 While that certainly is allowed, it just
2 makes it more difficult for us to understand, again,
3 is the practitioner-patient relationship robust enough
4 for us to be able to say that this is a prescription
that was issued in the usual course of professional
6 practice.
7 MR. PREVOZNIK: Just to follow up on the one
8 statement that I really would like you to expand on,
9 you said it's obvious when someone's being seen at the
end-of-life. Can you explain that?
11 DR. DUANE: Yeah, no, by that, I mean --
I'm
12 sorry --
it's obvious in some cases, but not in all
13 cases. Like, for example, the hospice that we have,
14 it presents directly on the electronic prescription
that the patient is being seen with, you know, XYZ
16 hospice, so it will say, like, County Hospice Program
17 so I know that that patient is being seen by a
18 practitioner in their capacity as a hospice
19 practitioner, you know, performing end-of-life care.
So, I mean, when I say "prescription" that
21 comes over, and it's from a doctor that I know is a
22 hospice doctor or it's from a nurse practitioner that
23 has on there that, you know, they're affiliated with
24 Haven Hospice, or something like that. Then I know
that the prescription's being issued for that purpose.
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1 Or, I mean, it could be as simple as an
2 ICD-10 code that is consistent with end-of-life care,
3 and so when I see something like that, I understand
4 that, you know, Florida regulations regarding chronic
non-malignant pain are much different than Florida
6 regulations that have to do with oncologic-type pain
7 or end-of-life or palliative care.
8 So, having those things available to us --
9 some practitioners choose to transmit those to us
freely; some do not --
so when we have those
11 transmitted to us, it's much easier for us to perform
12 our corresponding responsibility.
13 But when we do not, it can lead to delays in
14 care when I'm doing what I'm obligated to do by, you
know, State and Federal Law to ensure that the
16 prescription's being issued properly but I can't
17 because I don't have those, you know, ICD-10 codes or
18 other things readily available.
19 And, you know, like hospice, for example,
some of the prescriptions may come in at odd hours of
21 the day and so I'm not able to easily, you know, reach
22 into and connect with those practitioners to be able
23 to perform that corresponding responsibility right
24 away.
MS. MILGRAM: How often are you
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1 connecting-in with practitioners, would you say? Is
2 it frequent, rare?
3 DR. DUANE: I'm sorry, could you repeat the
4 question? I wasn't able to hear.
MS. MILGRAM: You mentioned a couple of
6 times the ability to, sort of, connect-in with
7 practitioners if you have questions. Is that
8 something that you do routinely? If you could just
9 elaborate a little bit on that?
DR. DUANE: Sure. So, I would say that I do
11 it routinely, but I would say that my experience is
12 not typical. I mean, Panama Pharmacy has been here in
13 the Jacksonville area for 100 years. We're very
14 well-known in the community, so I think that
practitioners know what we're capable of doing and the
16 great work that we provide for the community.
17 And that being said, you know, a lot of
18 practitioners have my cell phone number. They're able
19 to text me, or call me and reach out, and that's fine.
But like I said, that's not typical, and I think that
21 most employed pharmacists, especially at large chains,
22 do not enjoy the time ability to be able to have those
23 kinds of, and cultivate those kind of, relationships
24 with practitioners.
And I think the other side of the coin of
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1 that is --
and especially as telemedicine proliferates
2 --
you know, I see a telemedicine prescription; I have
3 no idea how to get a hold of a practitioner, you know,
4 in, you know, California, and you get an 800-number.
It's a call center. Someone screens it. And that's
6 not unique to telemedicine.
7 I mean, there's a large academic medical
8 center that's here in Jacksonville that has the same
9 thing; they have a call center that screens all calls.
You almost never get to talk to a practitioner. It's
11 always very time-delayed. So the more information
12 that we can get proactively along with the
13 prescription will allow us to perform, you know, a
14 more robust and satisfactory, you know, corresponding
responsibility compared to having to chase down
16 practitioners from apps, or in the case of healthcare
17 systems, you know, navigate through a call center or
18 something like that.
19 But, you know, I know that NCPDP standards
are trying to improve to where pharmacies are able to
21 message practitioners in the same way that
22 practitioners can send electronic prescriptions and
23 pharmacies can send electronic refill requests, but
24 that technology isn't mainstream yet and it really
hasn't hit the prime-time.
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1 So, until it does, while we can at my
2 pharmacy, I would say that that's not typical, and I
3 wouldn't expect that kind of relationship to duplicate
4 at most employed pharmacies and chain pharmacies that
see the majority of these types of prescriptions that
6 we're referring to.
7 MR. STRAIT: Okay. All right. Well, thank
8 you very much, Dr. Duane. Appreciate your comments
9 and your follow-ups there.
DR. DUANE: Absolutely.
11 MR. STRAIT: We will go ahead and move to
12 Virtual Presenter No. 8.
13 (Technical issue.)
14 MR. STRAIT: Okay, Teddy, we'll get you back
online. Let's move to the next presenter, Ms. Clark.
16 K. Clark.
17 DR. CLARK: Hi, I'm Dr. Kelly Clark.
18 K-E-L-L-Y C-L-A-R-K. I'm speaking on behalf of ASAM,
19 the American Society of Addiction Medicine.
Good afternoon. I'm a physician board
21 certified in addiction medicine and have practiced
22 medicine for over 30 years. I'm a recognized expert
23 on issues related to opioid use, addiction and
24 treatment as well as illegal prescription substances.
I currently serve in several leadership
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1 positions including as co-chair of the Telehealth
2 Working Group of the Actions Collaborative on
3 Countering the U.S. Opioid Crisis of the National
4 Academy of Medicine. I'm also a past president of
ASAM, or the American Society of Addiction Medicine.
6 ASAM is a national medical society
7 representing over 7,000 physicians and other
8 processionals who specialize in the prevention and
9 treatment of addiction. Today I speak on behalf of
ASAM.
11 ASAM has determined that the recent calls
12 for a special registration process to prescribe
13 Buprenorphine without an in-person evaluation while
14 well-intentioned are misguided.
In the March 2023 Notice of Proposed
16 Rulemaking for the induction of Buprenorphine, the DEA
17 and HHS got this part right. I'd like to thank the
18 DEA for hosting us with these public listening
19 sessions.
To truly address addiction and overdose in
21 this country it's critical that federal agencies take
22 the time to understand the disease of addiction when
23 developing policy, and especially policy governing the
24 prescribing of medications, whether in-person or via
telehealth. Such a policy will have immediate and
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1 direct impact on access to evidence-based addiction
2 care for tens of thousands of Americans.
3 Addiction involving opioid use is a
4 treatable chronic medical disease. People with
moderate to severe opioid use disorder or OUD, use
6 opioids despite harmful consequences because of
7 complex interactions on brain circuits, genetics, the
8 environment, and their individual life experiences.
9 Happily, there are evidence-based treatment
approaches for this disease which are generally
11 successful as those for other chronic medical
12 conditions. Like diabetes hypertension, OUD generally
13 requires treatment by a health care professional often
14 with medication and is best managed with a combination
of medication, psychosocial treatments and lifestyle
16 changes that are maintained over the long term.
17 However, this is not the way we have historically
18 approached addiction treatment in this country.
19 We now struggle to find our way out of an
ongoing and devastating overdose crisis because we're
21 still too often trying to solve a medical and public
22 health crisis with outdated treatment models and
23 haphazard policies, burdensome regulations and
24 requirements that give too few Americans access to
evidence-based care.
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1 Compounding this is the fact that addiction
2 treatment has historically been segregated from the
3 rest of medical and mental health treatment, and
4 therefore many clinicians don't even consider it
within their purview.
6 So while we do have scientifically based
7 treatments such as safe and effective medications to
8 treat addiction involving opioids, alcohol and
9 nicotine, they're still gross under-utilized.
Thus with a better understanding of both
11 addiction and our history of marginalizing appropriate
12 addiction treatment, we must now be willing to advance
13 older policies including codifying telemedicine
14 policies that will bring care to where it's needed and
save more lives.
16 Specifically, regarding the telemedicine
17 initiation of prescriptions of Schedules 3 to 5
18 medications which includes Buprenorphine, for
19 medications that are approved in the --
excuse me.
(Pause.)
21 MR. STRAIT: I see that Ms. Clark needed to
22 step away. Are you good now?
23 MS. CLARK: Sorry, I'm back.
24 I can't control my environment back here.
So regarding the telemedicine initiation of
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1 prescriptions of Schedule 3 to 5 medications including
2 Buprenorphine which are approved for the treatment of
3 substances disorder, ASAM urges the DEA and HHS to use
4 the authority found in 21 USC 802-54g to finalize a
rule that codifies a bonafide examination requirement,
6 not an in-person exam requirement. As well as certain
7 common sense guardrails that will inappropriately
8 impact patient access to care.
9 Those common sense guardrails are
prescription drug monitoring checks, proper
11 documentation around audiovisual and audio only
12 initiation, and required electronic prescribing.
13 As outlined in ASAM's comment letter
14 submitted earlier to the DEA this year, a bonafide
medical evaluation to prescribe Buprenorphine for OUD
16 via telehealth occurs when the prescriber obtains
17 information from collateral sources as well as the
18 patient through audio and/or visual examination which
19 is sufficient to make or confirm a diagnosis of OUD
and determine that the benefits of treatment outweigh
21 the risks. The latter is made on a patient by patient
22 basis, and that's important to keep in mind.
23 While there are recommended clinical
24 standards for performing a bonafide initial
examination to prescribe Buprenorphine for OUD, there
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1 are no reasonably defined and accepted approaches for
2 building a new special registration process for
3 medical practice to utilize this lifesaving
4 medication.
For example, some people recently called for
6 the special registration to initiate prescribing of
7 Buprenorphine, suggesting guardrails like requiring
8 telemedicine clinicians to accept Medicaid which often
9 has very inadequate payment rates, or restricting
lengths of dosing or maximum daily prescription doses.
11 But these proposals would cause profound barriers to
12 patient access by placing extraordinary barriers and
13 burdens on the providers who are at the front lines of
14 these crises and cause a mismatch with regulations and
the national practice guidelines as well as emerging
16 strategies in the age of Fentanyl and similar
17 synthetic opioids. Ironically placing these burdens
18 on providers may actually increase Buprenorphine
19 diversion by decreasing access to legitimate medical
treatment for OUD.
21 Establishing such a special registration
22 process would also disproportionately address
23 Buprenorphine diversion concerns by reducing access to
24 a treatment that provides benefits to both the public
health and public safety.
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1 The rate and disparities in overdose deaths
2 increase where there is a lack of access to treatment
3 with maintenance medications for OUD.
4 Research has repeatedly demonstrated that
the most common reason for Buprenorphine diversion is
6 likely self-treatment and lack of access to
7 prescribers.
8 Additionally, there's no evidence that
9 there's a threat to public health or safety due to
failure of the DEA's existing methods to track and
11 identify Buprenorphine diversion.
12 It's important to note a recent report by
13 the National Forensic Laboratory Information System, a
14 program of the DEA, which systematically collects the
drug identification results submitted to forensic
16 laboratories and drug places. It found that while
17 Buprenorphine reports had increased from the first
18 half of 2013 to the first half of 2019, they then
19 decreased through the first half of 2022 --
at the
very time that full telehealth flexibilities for
21 Buprenorphine initiation were in place.
22 So the published science is clear. The Ryan
23 Haight Waiver for Buprenorphine initiation has not
24 increased widespread Buprenorphine diversion but has
instead improved access to treatment.
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1 So in sum, recent calls for special
2 registration for telemedicine prescribing of
3 Buprenorphine are misguided. We don't need another
4 X-waiver. The DEA should be cautious about codifying
a final rule which requires authorizing the phrase
6 "legitimate need" when it comes to Buprenorphine which
7 is a statutory requirement for implementing a special
8 registration process, and cautious about a final rule
9 that disadvantages local or hybrid addiction medicine
practices that are more likely to be dissuaded by
11 additional administrative burdens.
12 The DEA should codify a modified examination
13 requirement, not an in-person examination requirement.
14 When and whether an in-person eval occurs
should remain a clinical decision between the
16 prescriber and the patient. Not rigidly dictated by
17 DEA regulations. This would inevitably result in some
18 clinically appropriate treatment being considered a
19 federal crime.
Prescribing of Buprenorphine for OUD,
21 whether telemedicine or in-person care, must remain at
22 the professional discretion of the clinician. The
23 common sense guardrails of prescription drug
24 monitoring checks, proper documentation around
audiovisual or audio only initiation, and required
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1 electronic prescribing can be included within the
2 DEA's final rule test, using the authority in 21 USC
3 802-54g. That statuary authority allows the DEA and
4 HHS to specify the circumstances under which
telemedicine prescribing has effective controls
6 against diversion, is otherwise consistent with public
7 health and safety, avoids the erecting of barriers to
8 providing critical treatment with a special
9 registration process for which there is no reasonably
defined or accepted approach.
11 So during the midst of this worst overdose
12 crisis in American history, those of us who work in
13 the field of addiction medicine have the
14 responsibility of bringing treatment to where patients
are, and to close this addiction treatment gap.
16 Front line clinicians need the DEA to take a
17 pragmatic approach and codify a telemedicine rule that
18 puts its thumb on the scales in favor of addiction
19 medicine and the public health so that we can reach
more Americans with addiction who are not currently
21 receiving care and save more lives.
22 Thank you.
23 MR. STRAIT: Thank you, Dr. Clark.
24 It does not appear that we have any
questions for you, so we will move on to Virtual
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1 Presenter No. 9.
2 MS. WEATHERSBEE: My name is Teddy
3 Weathersbee. That's T-E-D-D-Y W-E-A-T-H-E-R-S-B-E-E.
4 My pronouns are she/they, and I'm here today speaking
as a patient advocate, and not affiliated with a
6 specific organization.
7 I'm also a PhD social science and public
8 health researcher, but today I'm here to share my
9 personal experience as a person living with a
neurodevelopmental disability, Attention Deficit
11 Hyperactivity Disorder, and to talk about how my life
12 was saved after establishing a telemedicine only
13 doctor/patient relationship with a psychiatrist who
14 specializes in ADHD and eventually starting on a
Schedule II stimulant medication during the COVID-19
16 public health emergency. I appreciate this
17 opportunity to share my experience to help inform the
18 agency's regulations on prescribed and controlled
19 substances via telemedicine.
I'll start with some background and a
21 trigger warning. I'm going to briefly mention my
22 history of post traumatic stress disorder and suicidal
23 ideation.
24 I'm 61 years old and I've been in and out of
psychotherapy since age 25 after disclosing to family
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1 members that I had experience severe, long-term
2 childhood sexual abuse by my paternal grandfather.
3 Not surprisingly I'd experienced severe anxiety and
4 low level depression from a young age. I was severely
bullied for being a skinny introvert who when I did
6 speak sounded different from my peers. I was also
7 called a space cadet who walked into walls, oblivious
8 to time and space, always seeming to be thinking about
9 something else.
I was in the gifted program, but never
11 turned in homework and still managed to get all A's.
12 I was not, however, motivated like my over-achieving
13 younger sister, which my parents variously attributed
14 to laziness and my refusal to properly apply my high
intelligence to reach my full potential. Statements
16 that I continued to hear from family, teachers,
17 friends and partners into my 20s, 30s, 40s, and 50s.
18 As a teen and young adult in the '70s and
19 '80s, I often self-medicated in an attempt to get
relief from the constant noisy distraction in my head,
21 and the feeling that something was really broken in me
22 and in need of fixing. Along with the intense shame
23 and fear of others finding out, that became so
24 overwhelming at times that I longed to just not exist.
I also have a near phobic fear of death
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1 which was at least part of what kept me alive, along
2 with the constant thoughts of a new business, job,
3 relationship, state or country to live in as I
4 reinvented myself over and over again in a desperate
attempt to find someone or something that would click.
6 In my mid-20s I began to believe I could
7 possibly succeed in college, which started a winding
8 journey over the next two decades as I earned my
9 bachelor's degree and eventually landed in a very
competitive PhD program where at age 44, sober for
11 more than a decade, yet another therapist tried to
12 diagnose and treat my anxiety and depression with a
13 now growing list of failed medications with awful side
14 effects. Until one day the therapist gave me a
five-minute screening questionnaire, diagnosed me with
16 ADHD, and sent me home with a prescription for a
17 controlled stimulant, which I was terrified to take
18 and eventually discarded.
19 Weeks later a professor asked me to meet
with him after one of my qualifying exams and she
21 flung the paper at me across her desk and angrily
22 asked do you have a disability or something?
23 I was intensely ashamed and admitted maybe,
24 but then I went back to trying harder to just be
normal which I desperately wanted to be.
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1 I defended my dissertation four years later
2 and earned my PH.D. months after starting my first job
3 as a social science researcher, but my life continued
4 to be very difficult and my health was always
precarious.
6 Fast forward to November 2021, now 20 months
7 working from home in a new job I had started eight
8 months before the COVID-19 public health emergency. I
9 was alone at 59 years old, no family or friends
nearby. My mother had died somewhat unexpectedly ten
11 months earlier, and I reached a very dark place that
12 I'd never really experienced before.
13 I did have enough spark left to wonder if
14 maybe I really did have ADHD and maybe I could at
least find a place to meet other people who could
16 understand me because no one else ever seemed to. I
17 had long lost trust in therapists and psychiatrists so
18 I started looking for a meet-up group where maybe I
19 could find some peer support.
Then I stumbled across an educational
21 webinar by a psychiatrist who specialized in
22 diagnosing and treating ADHD. I was actually
23 surprised how familiar all the symptoms sounded and I
24 emailed him the next day, saying in part that I wasn't
even sure if he was for real or if he would answer my
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1 email, but I was desperate for help.
2 He sent back a very empathetic reply the
3 next day and agreed to set up an appointment and then
4 proceeded to evaluate me over multiple video-based
telemedicine visits before finally confirming the ADHD
6 diagnosis and discussing a treatment plan, but
7 emphasizing this wasn't about fixing me. This was
8 about helping me to be more my authentic self and
9 achieve my goals while living in the neurotypical
world.
11 I was still terrified to try medication, but
12 my doctor continued working with me, always discussing
13 the full range of therapies and support and
14 encouraging me until enough trust had been built and I
decided I wanted to at least try a small dose of
16 Adderall which I did.
17 It was like someone had finally turned the
18 loud radio down that had been playing in my head for
19 59 years, and severely distracting me from being able
to live a normal life.
21 My severe anxiety nearly immediately
22 disappeared, which was very surprising to me. And has
23 never returned, including severe panic attacks which I
24 was having over many years.
Over the next weeks and months my
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1 psychiatrist worked with me to find the best
2 medication dose and now 21 months later, my quality of
3 life has measurably and vastly improved, along with
4 dramatic improvement in my mood and neurocognitive
functioning.
6 I've achieved goals now that I've only
7 dreamed of before, like successfully managing my
8 household alone. Preparing all my own meals and
9 enjoying going out, visiting with friends, having
hobbies, while also working as a PH.D researcher.
11 Without these telemedicine visits I would
12 not have the access I need to the high quality
13 specialty care and medication that saved and continues
14 to save and enhance my life.
I've met hundreds of people now with similar
16 stories --
patients whose lives and families have been
17 saved and improved because of telemedicine only access
18 to high quality ADHD care and treatment that includes
19 Schedule II medications.
We are also all concerned about patient
21 safety and potential threats to public safety, but
22 believe there are mechanisms such as DEA special
23 registration for practitioners and other state boards
24 that are consistent with public health, safety and
effective controls against medication diversion.
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1 These include things like enhanced patient
2 identification and medical history review, video
3 consultations where possible, patient education and
4 follow-up appointments, secure electronic health
record systems that are integrated with state-run
6 prescription monitoring programs, evidence-based
7 clinical guidelines for prescribing Schedule II
8 medications via telemedicine, and also clinician
9 training with clear protocols for handling
emergencies, adverse reactions, or cases where
11 in-person evaluations become necessary.
12 So thank you again for your time. That's
13 all I have.
14 MR. STRAIT: Thank you, Dr. Weathersbee. And
I am looking over and I do not see any follow-up
16 questions, so thank you very much. We will now move on
17 to Virtual Presenter No. 10.
18 DR. ARMAH: Dr. Tichianaa Armah.
19 T-I-C-H-I-A-N-A-A.
I want to begin by just thanking you
21 Administrator Milgram and Assistant Administrator
22 Prevoznik for permanent vision for safe and effective
23 prescribing of controlled medication in telehealth,
24 and allowing me to speak today. I spent many
sleepless nights this spring preparing for the worst
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1 while praying for a message that came halting the
2 implementation of the initial proposal.
3 I'm a assistant clinical professor in the
4 Department of Psychiatry at Yale School of Medicine,
but the two roles most relevant today are my positions
6 as Chief Psychiatry Officer at the Community Health
7 Center Incorporated, and as President of a 600-member
8 district branch of the American Psychiatric
9 Association, the Connecticut Psychiatric Society which
holds as its core mission advocating for patients'
11 access to quality mental health care. That's why I'm
12 here today.
13 For our patients like my EJ, not her real
14 initials, who speaks only Spanish, suffers from
chronic pain, and tells me each time we have a
16 telephone visit, the fight for her to get the care
17 that she needs without limitations.
18 She requires audio-only synchronous visits.
19 Prior to COVID because of mobility,
transportation, support issues, she would miss more
21 visits than she would attend, and would often go
22 unassessed for long periods, falling out of care, and
23 would be without her medication which included a
24 controlled medication for debilitating anxiety and it
caused her and her family to suffer.
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1 Today her children are needed to help her
2 get on video, but they work so many hours they can't
3 commit the time to bring her for visits with me in
4 person or by video, any time between the hours of 7:40
a.m. and 7:00 p.m., which is when I see clients.
6 But she can pick up a phone.
7 Now despite being here today advocating for
8 it to become permanent today, I secretly hoped there
9 will be no permissions to provide telephone visits
because I assumed they would be sub-par care. Soon
11 after it was allowed and I provided the care and got
12 feedback about it individually and through our
13 formally conducted surveys, I realized that lives were
14 saved and I had to eat my words. Even with patients
on controlled medication.
16 But here is why these two connected points
17 are so important. EJ reflects the trend I see early
18 on that highlight that the current proposal would have
19 disproportionately negative effect on patients of
color, both Latino and mono-lingual Spanish speakers,
21 and black patients and most of the economically
22 disadvantaged patients.
23 At Community Health Center Incorporated, we
24 are a federally qualified health center and I've been
practicing psychiatry, providing bilingual care for
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1 now over a decade, and you may know that federally
2 qualified health centers are the nation's largest
3 safety net setting located in designated high need
4 communities, caring for 28 million patients annually.
And CHC is among one of the largest. And we treat
6 everyone, regardless of their ability to pay, taking
7 Medicaid, Medicare, all kinds of insurance, self-pay,
8 and over the course of a year we've served over
9 100,000 patients in over 600,000 visits, and our
behavioral health staff provided about 250 of those
11 visits, and our 34 psychiatrists and psychiatric APRNs
12 saw 5,000 patients in over 30,000 visits.
13 Now despite all but two of my staff
14 returning to the office and all patients being offered
in-person appointments, only six percent of those
16 visits were through telemedicine because patients are
17 feeling like they're better able to attend and being
18 in-person wasn't clinically necessary. Wherever we
19 feel that it really is, that's what we insist on.
But during the pandemic no-show rates really
21 dropped from the national averages in behavioral
22 health around 26. In our organization we were around
23 that national average, but it dropped to 18 percent by
24 phone, and 28 percent, a rise of 28 percent in person.
And since May when we got the call, we sort of really
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1 started to, we saw that proposal, we started to push
2 harder for in-person because we just thought at any
3 moment this may be snatched away.
4 What we saw is that in this time, since May,
14 percent no-show rate per phone --
26 percent
6 no-show rate for in-person; 26 percent no-show rate
7 for video. But the interesting part comes when you
8 break it down by race and language spoken.
9 We did an IRB approved study that we would
be happy to share when published, and we looked at
11 over 23,000 patients attending behavioral health
12 visits in a little under two years. Only 43 percent
13 had been seen in behavioral health prior to the
14 pandemic. So speaking to those patients who, those
first-time visits having to be in-person.
16 What we saw from the trends were non-white
17 patients --
Hispanic, Latino, Spanish-speaking
18 preference, Black, African American, Native American,
19 Asian and other races --
were more likely to attend
virtual-only visits. We also saw that with our older
21 patients. This was corroborated as well by a study
22 after I saw these trends, and started to look and see
23 if other people were seeing it, a study by Simon
24 (phonetic) and Sanchez that saw the same. They were
looking at the impacts of eliminating audio on the
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1 disenfranchised and really looking beyond
2 Buprenorphine telehealth accessibility. They found
3 the same.
4 So here's the thing. Telehealth is a
delivery modality and it's not the enemy to bad care.
6 I mean to good care.
7 I just want to highlight one of my concerns
8 as I was looking through the proposal and we were
9 starting to strategize how we're going to deal with
it. What I saw was a lot of potential for arbitrary,
11 routine paperwork. That concerned me. I think
12 anytime you do that, you lead to greater
13 stigmatization by taking care of folks with mental
14 illnesses. So stigmatization of mental health and
mental health care. You're decreasing the time
16 interacting with patients and assessing them, and
17 you're leading to a less efficient use of psychiatric
18 expertise, fewer psychiatry providers ending up being
19 willing to offer telemedicine at all, and the few who
are, then really offering fewer of those visits
21 because it becomes a hassle.
22 So a real danger is present --
the dangers
23 present prescribing powerful controlled medication
24 through telemedicine, by phone or video, are the same
dangers present when prescribing in-person.
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1 So I ask that you not sort of be distracted
2 by vilifying telemedicine or those who practice it as
3 an enemy to good care. I think the real enemy to safe
4 and effective mental health care are less time
available to see patients, less time to self-audit,
6 less communication, and time between systems. So
7 those electronic health records. Less support in
8 monitoring patient medication adherence and safety.
9 Also less time for supervision. And less accessible
hours from psychiatry providers.
11 I think some of this can be remedied by
12 working with other governmental agencies like EPSA
13 around mental health parity because of the cost
14 associated and the low payments for behavioral health
providers, I think it definitely adds to it.
16 So supporting internal auditing and
17 reporting I think is one of the solutions for
18 outpatient clinical administrators. So most
19 administrators who are clinical see patients, you've
heard my story, and so the time can be more limited.
21 So as much support as agencies can get in dedicating
22 time of those administrators with their expertise and
23 being able to look at the safety is crucial.
24 Increased support for incentives for the use
of the PDMP and the integration of EHRs. I will tell
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1 you that it's hands-down different since we integrated
2 and have the PDMP coming up into our EHR. It
3 skyrocketed for psychiatry providers, how many of them
4 were really just getting in there as much as possible.
Creating easy reporting systems as well, for
6 employees who are worried about organizations that may
7 be pushing unsafe practices, as well as supporting
8 quality care, allowing for the supervision and
9 adequate visit lengths. And really incentivizing high
quality, and those internal oversight time
11 expectations.
12 Finally, the economic support for outpatient
13 practices to join the EHR of neighboring hospitals,
14 and hospitals to work with outpatient facilities to
incorporate them.
16 So my central message is that hurdles to
17 care delay and prevent it. Clinical decision making
18 should reign over arbitrary deadlines. Patients
19 should be able to be seen the first time by
telehealth. Audio only must remain a viable option
21 without hurdles, otherwise you perpetuate racial and
22 ethnic disparities in mental health care. And any
23 registration should not be burdensome to health care
24 providers and should as much as possible look at the
systems that are already in place and try to
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1 incorporate. And finally, additional documentation
2 should be at a minimum. All additional paperwork is
3 an obstacle to provider/patient interaction time.
4 I am happy to be of any help and am excited
for this time. Thank you.
6 MS. MILGRAM: Thanks so much. Just a couple
7 of followup questions.
8 You talk about supporting internal auditing
9 and reporting. What kind of information --
expand on
that a little bit of what that kind of internal audit
11 could look like.
12 DR. ARMAH: For instance, we have a
13 behavioral health, what we call our behavioral health
14 dashboard. So on it we're looking at things like
okay, are we looking at whether or not people have
16 done urine toxicology screens. So we're checking to
17 make sure that people aren't taking other medications
18 at the same time that could make it more dangerous for
19 them to be on a particular controlled medication.
We're looking at all of the information down the line.
21 Looking at how often have they been seen? Have they
22 been seen by anybody in person? Where are some of the
23 qualified health centers, so at least we do have our
24 primary care providers. It's possible they may have
been seen by them. Oftentimes they haven't as well
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1 unless it's absolutely necessary.
2 The other thing is, just looking at them as
3 a whole person. So they have a lot of other
4 medications that they may be one that are, their
medical map, and also just looking at laboratories.
6 So what are some of the labs that might lead us to be
7 a little bit worried. Notice something like there are
8 certain labs you can look at and see oh, there might
9 be a problem with alcohol here. Let me be careful.
Let me check beyond what maybe the usual urine
11 toxicology screens would look for.
12 MS. MILGRAM: I was going to ask you how you
13 handle the drug tox screens in the virtual setting?
14 In the pure virtual setting.
DR. ARMAH: We have a couple of things. We
16 do have some patients who are able to go to one of the
17 Quest centers, so that's one of the laboratories that
18 exists here in Connecticut. And they can go and get
19 their labs done there. Right next door to their
house, right next door to their job. Even if we're
21 two hours away from them, they're still able to access
22 that pretty easily. So that's one thing that we do.
23 Sometimes we will have patients come in
24 between their visits. So maybe they can't come in and
see us. There are for instance we had a patient who
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1 can never come in on any day but a Thursday and a
2 Friday, which are the only two days that I'm not
3 clinically there. So they can come and see somebody
4 else. They didn't want to, but they come in and they
see our RN, who has a visit with them, talks with
6 them. It's a delegated order, so I tell them all the
7 things that I want them to find out. They collect the
8 urine toxicology screen as well and do some other
9 things that will get triggered based on algorithms.
MS. MILGRAM: My last question. You talked
11 a little bit about audio only, and I just want to
12 clarify. Were you suggesting audio only for
13 initiation and continued care? Or one telehealth
14 visit or something. How is that working?
DR. ARMAH: Right, exactly. I think that
16 again, just employing the piece on clinical judgment.
17 So it's really hard to say in just 30 days we're going
18 to be able to get to the bottom of something or to
19 really help someone and eliminate some of the
obstacles. So I really think that really should be
21 that clinical judgment piece. Not an extended long
22 period of time, a year is going to be too long for
23 never having seen someone even by video. But you
24 could have, you know, partnered with someone who is
seeing them in person as well, who's local to that
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1 person.
2 Additionally, I think it would be helpful if
3 you were given the opportunity to sort of explain why
4 you feel like, you know what, in this case I do want
to continue this. And then if we can have some
6 additional safeguards to just make sure that it's
7 actually that person. I know there are safeguards at
8 the level of the pharmacy to say okay, this
9 prescription is for this person and they are seeing
someone in person and they won't hand those
11 medications out if it's not the person.
12 So I think there are some additional
13 safeguards down the road that can make sure that it is
14 the person that you were speaking to on the phone.
MR. PREVOZNIK: That's actually what I want
16 to ask you. What safeguards are you thinking down the
17 road?
18 DR. ARMAH: I could get some technical
19 person to help as well, but I think being able to --
just the one thing is, obviously I'm asking all of the
21 information about the patient, but if there could be
22 some additional systems in place for patients to be
23 able to identify themselves. I know there were some
24 pretty cool programs that got suggested to me in the
past. Sign up for this, all of your information will
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1 go to all of your doctors.
2 Right now we have something called All Of Us
3 that we are participating in where all of our
4 biometric information is stored in a particular place,
because the purpose is to make sure that research is
6 more inclusive. So they're gathering a lot of
7 information and integrating that and looking at the
8 electronic health records and seeing how people fare
9 over the course of time.
So we're sort of putting myself, my
11 information out there so that I can help research in
12 the future. But it will also help me potentially if
13 they find something. But they collect everything, you
14 know, they're swabbing me, everything under the sun.
Not that everybody feels comfortable with something
16 like that.
17 MR. STRAIT: Okay. Thank you very much, Dr.
18 Armah for your comments.
19 My production crew tells me we have four
more virtual presenters for the afternoon. I did want
21 to just acknowledge that our two additional in-person
22 presenters from this morning will follow directly
23 after.
24 So with that, let me now transition to
Virtual Presenter No. 11.
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1 DR. LUSINS: Good afternoon, my name is Dr.
2 John Lusins. I'm a psychiatrist --
and it's
3 L-U-S-I-N-S --
in private practice in Corpus Christi,
4 Texas. Thank you for inviting me. I was very
surprised, and I was honored to be selected to present
6 today.
7 When I saw this come across the
8 notification, the DEA email, I was first hesitant and
9 said, you know, as a person that owns a small private
practice in a third or fourth-ranked kind of city in
11 terms of size and who we are in the states, would they
12 want to hear the opinion of somebody like myself? And
13 so I thank you for this.
14 So I started out here about 10 years ago and
all in-person. I was doing in-patient in the morning
16 and out-patient in the afternoon. Over that time my
17 practice currently has three MDs and six nurse
18 practitioners in two different locations, including
19 San Antonio.
When the pandemic came we, of course,
21 switched as fast as we could over to virtual. I had
22 training in West Virginia University and ran rural
23 clinics down into the rural areas where there was such
24 a need that they couldn't get up to Morgantown.
And when we had a nurse on site, at that
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1 point of time that's how we ran them, in clinics where
2 they had to come in and visit, we saw much increased,
3 higher utilization, and in great success rates, and so
4 I believe in telemedicine, I believe in
telepsychiatry. I think that the whole idea of
6 optimizing care without compromising the patient's
7 safety and increasing outcomes, increasing
8 accessibility is truly the whole goal.
9 When this proposal came up to then cut off
the ability to do controlled substances, I thought
11 there would only be one certain aspect of it that I am
12 in agreement with in terms of how. What we've seen
13 and what bothered me to actually put my name into this
14 was the rise of many psychiatrists, and also nurse
practitioners, working together to create just virtual
16 companies where we've seen solely prescribing perhaps
17 some SSRIs, but truly just marketing towards
18 prescribing ADHD medications and stimulants only.
19 I'm not talking about things such as
Atomoxetine and Clonidine for kids. This is marketing
21 primarily for ADHD. Just five minute visits. I know
22 if you look on Instagram, if you look on the web, that
23 you will see these. It's not a hidden fact.
24 I think that my prior presenter, she had
amazing points. I agree with her about racial
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1 disparities, I agree with what she was saying that
2 there needs to be greater access for all of us;
3 however, when you now see a market where a
4 psychiatrist in Texas can supervise six, seven nurse
practitioners and get paid anywhere from $1,000 to
6 $1,200 per nurse practitioner and never truly have a
7 face to face supervision, and then those nurse
8 practitioners, through --
will sign these controlled
9 substances and that psychiatrist then can go on and
send them in, this is not what the system was set up
11 to provide. This is not how medicine should be
12 practiced in that aspect of it.
13 Are we checking the national databases? Are
14 we checking the DEA databases? Yes. Are they
integrated into emergency --
I'm sorry --
into
16 external electronic medical records? Yes, they are.
17 These things. I think that there are circumstances
18 that my office has now gone back to truly providing a
19 hybrid, where we ask if ultimately 100 percent
possible we can get you into the office to see you for
21 the first visit and then for the three month follow
22 up.
23 And if the provider has questions, then we
24 try to pull you in. We try to have people come in and
do random drug screens, sending people to Quest that
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1 they can randomly choose their own times, and they can
2 have a wash out time if there's other substances in
3 there and say that they got busy. We found that that
4 just doesn't work. We ask people to come in and see
them. We ask detailed medical history.
6 My child psychiatrist, I was talking to him
7 about this, but he was saying that truly observing a
8 child --
and this is what they're trained to do during
9 their fellowship --
and watching them throughout their
interaction, when you have just a camera, yes, we have
11 gotten so much better at that, but there is nothing
12 like that true visit at some point in time that you're
13 going to have them come into the office and see the
14 interaction between the parents and the child and
watch the children, hyperactivity or inattention, and
16 get a true history without the influence perhaps of
17 the parents at that point.
18 Now, certain situations, like the college
19 student that's here for the summer and then we have to
just continue to prescribe while they're away and we
21 see them back at Thanksgiving, or the teacher,
22 telemedicine, that we --
and telepsychiatry for police
23 and firefighters that have such great difficulty in
24 coming in, this has been fantastic, and we work with
people as much as possible; however, we've just seen a
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1 dangerous rise in diversion, we've seen a dangerous
2 rise in inability for pharmacies to continue to stock
3 these medications, and people truly calling again and
4 again.
In talking with my colleagues, I haven't
6 seen true research on this but I think it would be a
7 fantastic topic, to really look and see --
I've had
8 several --
I'm looking in physician forums about Board
9 complaints now about physicians, where they have been
reported because they didn't send in the script within
11 two or three days. That never happened with
12 somebody's Prozac. That never happened with
13 somebody's --
those are just as important, but with
14 the controlled substances you have a different type of
environment that it really, truly needs a face to face
16 visit to have a relationship and understand the need.
17 Why do they need these?
18 Methamphetamine is a huge problem down here
19 in south Texas. I'm not saying that the link is any
one, but between truly treating ADHD and then also
21 methamphetamines, but what we see is diversion. When
22 I'm talking with my patients in the hospital that --
23 when they can't get methamphetamines, which are very
24 available, then they're also taking these medications
from their brothers and sisters or they're sharing
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1 them amongst each other.
2 Lastly, I think that, and since talking
3 about other controlled substances, we haven't seen --
4 which I predicted we'd have seen more difficulties
with benzodiazepines, but what my major concern truly
6 is is the monetization of the ADHD diagnosis and the
7 too easy access now of local clinics, MDs, charging in
8 between visits cash for people to come and pick up
9 their ADHD script.
Because of the laxity that the rules have
11 provided, it's turned into an environment where I
12 think we all try to do our best and follow kind of
13 guidelines, but I think that at least should be
14 seriously looked at and tightened up, primarily for
stimulants, and stop these loopholes that are allowing
16 companies to take advantage of these aspects while
17 continuing to provide access and great care, because I
18 think that's the majority, but the minority argues in
19 these rules. Thank you.
MR. STRAIT: Thank you, Dr. Lusins.
21 Do we have any comments?
22 (No response.)
23 MR. STRAIT: I do not see any so I will say
24 thank you, and I will call upon Virtual Presenter
No. 12.
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1 MR. CHESTER: Hello, my name is Dr. Jeffrey
2 Chester, J-E-F-F-R-E-Y, C-H-E-S-T-E-R. I represent
3 those prescribing practitioners who treat patients
4 with chronic pain disorders, and with substance use
disorders, and with both conditions. I am an
6 outpatient solo practitioner full-time for nearly two
7 and a half decades on the island of Maui in the state
8 of Hawaii. In addition to my private practice, I've
9 owned, operated, and medically directed multiple
levels of outpatient programs for addiction treatment.
11 I maintain a total of three medical board
12 certifications, one by the American Board of Physical
13 Medicine and Rehabilitation, one by the American Board
14 of Addiction Medicine, and one in the subspecialty of
addiction medicine by the American Board of Preventive
16 Medicine.
17 As I prepared for this presentation today, I
18 wrote several versions, and as I've been listening to
19 the people that have come before me, I'm going to
scrap most of what I was going to say and talk about
21 this differently. I think part of the problem is
22 we're attempting to take chronic pain, addiction, and
23 various psychiatric diagnoses, like ADHD, and because
24 there's an overlap between the schedule of the
medication treatments that may be used, try to have
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1 one rule to govern how those medications are
2 prescribed and dispensed.
3 What I believe will not be helpful will be
4 to have a legal requirement for an in-person
evaluation either prior to, or within 30 days of, an
6 initial prescription of a C2 or C3 controlled
7 medication, and the reason for that is sometimes an
8 adequate physical examination was performed by the
9 referring doctor, by a physical therapist, fairly
recent to the initiation or subsequent prescription of
11 a controlled substance.
12 And the timing of a physical examination can
13 be crucial in determining what medications should, or
14 should not, be prescribed, but the timing has to do
with clinical changes that occur with the patient. In
16 other words, if there's a change in status, one might
17 gain a lot from a physical examination. If there's no
18 change in status, a physical examination, an in-person
19 visit, will not necessarily change a pain medication
treatment decision.
21 It is more likely that we're going to rely
22 more and more on laboratory testing, either blood or
23 urine, and different x-ray examinations such as
24 ultrasounds, x-rays, MRIs, CT scans, when looking for
precautions or adverse outcomes from our treatments.
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1 An example would be if one prescribed
2 Naltrexone. Naltrexone is a non-controlled substance
3 that is often used for opioid use disorder treatment,
4 alcohol use disorder treatment, and sometimes in other
conditions such as chronic pain. When prescribing
6 this non-controlled substance we look for liver damage
7 and that liver damage is more likely to be monitored
8 on blood laboratory testing or an ultrasound of
9 someone's liver than with a physical, in-person
examination to see if a liver is enlarged or not.
11 Bringing someone in to perform pill counts
12 is not necessarily helpful to detect diversion as it
13 was once thought to be. It is easy to fake those pill
14 counts with counterfeit pills. In order to help
reduce diversion, taking time to listen to the patient
16 during a medical encounter and hearing what wording
17 they use and how they are asking for the start of a
18 medication or continuation of a medication can be
19 quite helpful. That could be done through telemedicine
just as easily, if not more easily, than with an
21 in-person encounter.
22 Checking the state prescription drug
23 monitoring program is essential, but there are a few
24 limitations. One is our local methadone clinic here
does not need to be included in that prescription drug
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1 monitoring program, so someone coming to see me, for
2 instance, and receiving any type of controlled
3 substance for any type of reason might also be going
4 to the methadone clinic and therefore getting two
different prescriptions essentially.
6 So the prescription drug monitoring program
7 should include in the future methadone clinics, as
8 well as mentioned before, a federal registry would be
9 excellent because, as we know now, people travel from
state to state quite easily.
11 We, in this practice, have always checked
12 public legal websites. We check the Circuit Court
13 system and the Hawaii Criminal Justice Data System
14 prior to accepting a patient into our practice. If
there were more collaborations between law enforcement
16 and the medical community, then I believe prescribers
17 would be better able to detect if a potential patient
18 or one of their existing patients might be diverting
19 their medications.
We don't have that kind of access on an
21 ongoing basis, we rely on these public websites, but
22 if we had some sort of more input from law
23 enforcement, I think we'd better be able to identify
24 who might be drug dealing or otherwise illicitly doing
things with their medications prescribed.
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1 I do find it very helpful to take the time
2 to speak with our local pharmacists and often stop in
3 and actually show my face, and so they know who I am.
4 Most of us here on this small island of Maui can
identify each other by the sounds of our voices on the
6 phone, certainly by face, and that's been very
7 helpful, to have that sort of intimate relationship
8 with the pharmacists and with the patients.
9 We also utilize urine drug screens quite
often, sometimes through local laboratories --
that
11 has pros and cons --
and sometimes through our office
12 --
that also has pros and cons --
and we find that the
13 urine testing to be quite helpful to look for what we
14 call aberrant results or unexpected results, and that
would inform our future directions of prescribing.
16 However, we don't often test for certain
17 substances that are not Schedule II or Schedule III,
18 and some of those medications do have significant
19 implications, such as gabapentin, where misuse and
diversion is quite common. And in certain states
21 there is mandatory reporting to the prescription drug
22 monitoring programs, but not in all states.
23 Also, there are medicines, such as Xanax,
24 and Soma, Valium, Ativan, Ambien, that also are often
a source of diversion and addiction and we don't
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1 necessarily treat those with as much respect as we
2 should when it comes to the C2 or the C3 medicines.
3 In-person evaluations come with some
4 disadvantages, including it's more costly for
patients. They necessarily will have to find
6 childcare or miss work. So there are definitely times
7 when telemedicine is better for the patient. Also
8 better for us, as practitioners. It can utilize fewer
9 resources for us. In Hawaii there are different
islands and sometimes people move from island to
11 island and I can still treat them even though they
12 are, necessarily, a plane ride away.
13 In summary, I don't think that mandating a
14 specific timing of an in-person evaluation will be
helpful in decreasing diversion. I do believe that
16 more communication with law enforcement and expanding
17 prescription monitoring programs to be federal and
18 include methadone clinics will be quite helpful.
19 So I want to thank you for inviting me.
It's been my pleasure. And if there are any questions
21 or comments for me, I'll be happy to field those out.
22 MR. STRAIT: Thank you, Dr. Chester.
23 Let me turn to the group. We're good?
24 (No response.)
MR. STRAIT: Okay. Well, let's see. It's
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1 six hours behind so you're still in morning time so
2 hopefully you can get to patient care.
3 We will move on now to Virtual Presenter
4 No. 13.
MR. COHAN: Good afternoon, everyone, my
6 name is Jerome Cohan, J-E-R-O-M-E, C-O-H-A-N. I am
7 the facility director and nurse practitioner at
8 Catalyst Health Solutions which operates in northeast
9 Tennessee and southwest Virginia out of four
locations. In Virginia, we are considered an OBAT,
11 which is office-based addiction treatment, in
12 Tennessee, an OBOT, which is office-based opioid
13 treatment. The clinic's been open for 10 years fully.
14 I represent five physicians who are all
board-certified in addiction. Two are addiction
16 psychiatrists. We have six nurse practitioners in
17 total and 11 Master level social workers, or
18 counselors.
19 In northeast Tennessee and southwest
Virginia --
before I read what I've wrote, after
21 listening to a lot of the presenters, it kind of fills
22 me with a little bit of positivity because all I've
23 witnessed for the last eight years here in these
24 mountains has been a nightmare: a nightmare of
methamphetamine, a nightmare of benzodiazepines, and a
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1 nightmare of dysfunctional homes, families being
2 broken up, and the Department of Children's Services
3 going crazy with methamphetamine.
4 And so it's really comforting to hear that
other people are having a better experience with
6 telemedicine. My experience has been nothing short of
7 pretty much a nightmare in regards to what we're
8 trying to deal with or tackle here, in our community.
9 So I'm not saying that to be argumentative
or try to start a conflict with other people who are
11 in support of telemedicine, I just want to make sure
12 that, at least from where I'm from and what we're
13 dealing with, without controls and regulations on
14 people who are only interested in making money, our
community will continue to suffer because of
16 polysubstance abuse.
17 So, with that said, I'm going to go ahead
18 and read what I wrote here. In the addiction field,
19 we've experienced a nightmare with the proliferation
of telehealth services in northeast Tennessee and
21 southwest Virginia. A hallmark of addiction is
22 dysfunction in the structure and accountability of a
23 person's life.
24 In the wake of COVID, online buprenorphine
prescribers started popping up pretty much everywhere
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1 and providing all addiction services over the
2 internet, including the prescribing of controlled
3 substances. From our clinical experience,
4 polysubstance abuse has not been addressed with this
approach, especially when it pertains to
6 methamphetamine abuse, addiction, trafficking, et
7 cetera, et cetera.
8 From the onset of the telehealth explosion,
9 the providers at our clinics, NPs, MDs, and social
workers, immediately realized the negative
11 implications of this if not put in check and kept in
12 control. We put in place internally on our own
13 protocols to resist the use of telemedicine services
14 for most of our patients suffering from meth, benzos,
alcohol addiction. Most were still at greater risk of
16 overdose. Some of them actually did overdose under
17 telehealth from polysubstance issues related to
18 worsening polysubstance abuse being missed with
19 inadequate accountability online.
Many of our patients tried online services
21 because of the convenience, only to return to face to
22 face visits often related to substance --
other
23 substances of abuse other than OUD, opioid use
24 disorder, suboxone, suboxone, suboxone.
Behaviors we are concerned about, we,
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1 Catalyst, and all the providers, include behaviors
2 such as altering urine drug screens, which often we
3 see are --
devices hidden on or inside someone's body
4 with another person's urine in it to try to falsify a
test. And, of course, we're not law enforcement so we
6 use that as an opportunity to provide compassionate
7 care, to let them know that's how sick their brain has
8 gotten, that they're going to hide somebody else's
9 urine inside their body to give fake information to
us.
11 Simply put, trauma-informed witness urine
12 drug screens save people's lives. One study in the VA
13 found that by implementing witness urine drug screens,
14 by implementing --
there's drug screens were positive,
it basically increased from 25 percent to 41 percent.
16 Now, the clinical implications of that are --
is now
17 that you can catch things, or at least observe things
18 --
I don't want to use the word catch, but at least
19 clinically observe things, that now you can talk to a
patient about to give them accurate information. We
21 advise the use of telehealth services for only
22 well-established patients, use sparingly, and regular
23 face to face visits.
24 The final thought from me, and some of the
other providers mentioned it on this call, is that the
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1 importance of physical exams --
and maybe it's just
2 the nurse in me, maybe it's just for 20 years I've
3 just been touching people, caring for people --
that
4 the idea of not doing a physical exam for somebody who
has polysubstance abuse is madness to me.
6 So part of that is looking for track marks.
7 Often these track marks are infected. We've sent
8 people to get things lanced, we use antibiotics to
9 treat infections that are up and down people's arms,
often in their necks, in their groin, in their feet.
11 And so the other thing is I commonly do is assess
12 people's nasal cavities for cavernous type activity
13 there, septum erosion from snorting of all kinds of
14 substances. Not just suboxone, but methamphetamine,
benzos, you name it.
16 Part of the face to face thing for me is
17 that I read once in passing that the opposite of
18 addiction is relationships. My contention is it's
19 very hard to have a meaningful relationship through a
computer screen with somebody who's suffering from
21 polysubstance abuse problems or addictions.
22 So I came here today, which I truly am
23 grateful for you all listening to this, to urge any
24 policy makers or people of influence to consider the
negative effects of telehealth activities in the
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1 context of our realities. I can only speak to
2 northeast Tennessee and southwest Virginia. Our
3 reality is that we are in a polysubstance abuse
4 epidemic. It's polysubstance. It's not just OUD,
it's just people want to escape from --
somehow.
6 And the majority of what we're seeing, 70
7 percent of the patients that show up for new intake
8 admissions are positive for methamphetamine, positive
9 for benzos, positive for ETG, which is a metabolite
for alcohol.
11 It's very, very, very, very, very rare for
12 us to see an opioid use disorder problem by itself. I
13 can't recall the last time I saw a new patient, or
14 neither can any of the other providers, where somebody
came in with a pure opioid use disorder problem that
16 buprenorphine is wonderful at taking care of. But if
17 that were the case, then buprenorphine for everybody,
18 but unfortunately, quite often, buprenorphine can make
19 things worse for folks that are suffering from
polysubstance abuse.
21 So some of the suggestions that I have,
22 again, is just --
I'm not really sure about
23 regulations and how to prevent it. I do think that
24 personal when it comes to addiction treatment,
polysubstance abuse, personal, face to face visits are
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1 vital to care for the entire person. I think
2 telemedicine gives people a free pass to ignore
3 problems that potentially can kill whole families
4 called methamphetamine. And even if people are still
breathing, the families are still destroyed. Talk to
6 any DCS worker and they'll tell you about it.
7 So, again, not trying to sound
8 self-righteous. I'm a little passionate about it
9 because it can get out of control very, very quickly.
The telemedicine products that we see pop up, in my
11 opinion, have questionable intentions and motives. I
12 just want to put a little plug in for Dr. Kevin Duane,
13 as well as Ms. Jodi Sullivan, for the DEA folks. In
14 my opinion, as a provider who sees patients and have
been doing this a long time, those two people spoke
16 some very deep truths and reality of what's going on
17 at the point of service care for polysubstance abuse
18 which we are engaged in every day.
19 So that's pretty much all I have to say, and
I really appreciate the opportunity to speak my mind
21 here from east Tennessee on our behalf.
22 MS. MILGRAM: Thanks so much for joining us.
23 Can I ask a couple of follow up questions?
24 MR. COHAN: Sure.
MS. MILGRAM: I mean, I don't know if you
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1 have this information, but just to try to clarify,
2 what percentage of the folks that you see are
3 polysubstance right now? Do you know?
4 MR. COHAN: Eighty, 85. Honestly, I cannot
remember. And I even queried before this talk some of
6 my nurse practitioner buddies and the physician I work
7 with. It's just very rare to find somebody who's just
8 purely opioid use disorder. That's why I just, like,
9 am, like, surprised when the president of ASAM was
talking about opioid use disorder, opioid use
11 disorder. I mean, wow, that would be nice, to just
12 talk about that, but we can't. We cannot go a day
13 without taking care of meth, benzos, alcohol.
14 And you can't really assess that without
seeing somebody in person and getting a
16 trauma-informed urine drug screen. I apologize. Go
17 ahead.
18 MS. MILGRAM: No, not at all. Just to
19 follow up on it, you said that BU can make it worse.
I just want to clarify. You said something like BU
21 can make it worse for someone who's polysubstance.
22 Can you just elaborate a little?
23 MR. COHAN: Yes, ma'am. One, whenever
24 buprenorphine contributes to somebody's death it's
almost always mixed with something else: benzos,
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1 alcohol, et cetera. The other thing is that it's a
2 cultural phenomenon. There's a great paper I'll share
3 with you guys. We had some anthropologists embedded
4 in our clinic for a while to study the culture in
southwest Virginia out of the University of Virginia
6 the culture of suboxone, diversion, use, or as a
7 currency somewhat.
8 And the point is if you have methamphetamine
9 involved --
and I'm convinced of this not only from my
own family members and friends who are in recovery,
11 but patient, after patient, after patient --
that if
12 methamphetamine is involved, you can pretty much be
13 assured the diversion of buprenorphine is involved.
14 At least in our area, it just goes hand in hand.
The other thing is that buprenorphine, in my
16 professional opinion, and my partner, Dr. Smyth's
17 professional opinion, buprenorphine is a very potent
18 partial opioid, right, but it has side effects
19 associated with it, including depression, anxiety,
insomnia.
21 If you look at buprenorphine products that
22 are measured in the micrograms for the treatment of
23 chronic severe pain, such as Belbuca, those side
24 effects aren't on the medication probile (phonetic) at
lower doses, so keeping somebody at high doses of
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1 buprenorphine for extended and ridiculous periods of
2 time, in our opinion, sometimes is not the best
3 approach. People often feel better once their lives
4 get cleaned up and they start obtaining life goals on
lower doses of buprenorphine to avoid the unpleasant
6 side effects associated with such a potent medication.
7 So there's a cultural nuance to it, but,
8 again, addiction is defined as a psycho social
9 phenomenon, right? So when you start mixing other
controlled substances in there, including
11 buprenorphine, it can often make life situations, as
12 well as physical situations, worse. So I hope that
13 answered your question, boss.
14 MS. MILGRAM: Yes. Thank you so much.
MR. STRAIT: Yeah, thank you Administrator
16 Milgram.
17 And thank you, Mr. Cohan. Appreciate your
18 comments and your candor.
19 I will now turn to our last virtual
presenter, Virtual Presenter No. 14, and, like I said,
21 we'll then transition over to our last in-person
22 presenters before we wrap up.
23 MR. PRATT: Good afternoon. My name is Tony
24 Pratt, T-O-N-Y, P-R-A-T-T. I'm with Piedmont Access
to Health Services, a Federally Qualified Health
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1 Center in south central Virginia.
2 And while I encourage steps to improve
3 access to care, particularly valuable health and
4 substance abuse treatment, as a practicing pharmacist,
I'm concerned about the impact that this rule could
6 have on pharmacies. At present, pharmacists are held
7 to what seems to be an almost arbitrary and nearly
8 impossible standard of ensuring a valid patient
9 provide a relationship exists before a prescription
can be dispensed, and this standard became of
11 particular concern and note as the opioid crisis was
12 unfolding.
13 While pharmacists are typically comfortable
14 with the practices of our own local providers, it has
become increasingly difficult to maintain this
16 standard with the growth of out-of-town referrals to
17 specialists and even more so with telehealth. It is
18 not physically nor fiscally possible for a pharmacy to
19 verify every prescription that comes to them, and if
we are now responsible for policing whether a patient
21 has also had the required in-person visit in a timely
22 fashion, it will increase the already excessive
23 burdens on a noble work profession.
24 The need for telehealth clearly exists.
However, prior to instituting regulations, no matter
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1 how well intentioned, due consideration must be given
2 to those regulations' impact on every facet of the
3 healthcare industry.
4 Pharmacies have historically been the de
facto enforcers of many DEA regulations. However, our
6 industry is at a breaking point. Independent
7 pharmacies are going out of business daily because of
8 unfair reimbursements often tied to unobtainable
9 clinical measures. Chain pharmacies survive by
demanding more productivity from their pharmacists
11 than is reasonable or safely conceivable. And
12 pharmacy errors are occurring at alarming frequency
13 because of these external pressures, putting our
14 patients at risk.
Adding yet another level of recordkeeping
16 and policing the activities of patients and providers
17 runs the risk of further exacerbating an already
18 critical problem.
19 Again, I encourage improved access, but I
implore those responsible for formalizing the rules to
21 carefully consider the potential burdens that the
22 regulations may create in a pharmacy and strive to
23 minimize that impact lest a greater impact limits the
24 pharmacy access to the many patients who are already
at risk of losing access.
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1 And I would like to add to that that the
2 question was raised earlier about what you would like
3 to see in a federal PMP. The one thing that I would
4 like to add to that presenter's comments would be that
it would be an actual live-in-time issue where we can
6 send a claim to an insurance company and get a
7 response back in three minutes as to whether or not
8 that prescription is valid to be filled. We need to
9 be able to see that on the pharmacy side too. It
would be extremely beneficial to us to know that a
11 patient just walked down the street 15 minutes ago as
12 opposed to having a one or two or sometimes even three
13 days or, in some places, at some point, it used to be
14 as much as a week delay in what was actually submitted
to the PMPs.
16 And much like Mr. Cohan, I applaud the
17 frankness of those who have spoken out that are
18 actually in day-to-day practice. While the group
19 presenters gave some very valid points, really, I
think the DEA needs to be talking to the people that
21 are in day-to-day practice to really see how the rules
22 are going to impact the practices and the individual
23 patients. There will be some benefits to every
24 situation, but there are also going to be some very
concerning limitations at times, and we need to be
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1 coherent and --
or cognizant of those concerns.
2 And with that, I'll end, and I'm happy to
3 answer any questions that you may have.
4 MR. STRAIT: No? Okay. Thank you very
much, Mr. Pratt. No further questions or comments.
6 So I will now call up to the stage our
7 in-person Commenter No. 14.
8 DR. KAFTARIAN: Thank you very much. My
9 name is Dr. Edward Kaftarian. My first name is
spelled E-D-W-A-R-D, last name, K-A-F-T-A-R-I-A-N.
11 And I'm with Orbit Health Telepsychiatry.
12 Good afternoon, ladies and gentlemen. I'm
13 Dr. Edward Kaftarian, a triple Board-certified
14 psychiatrist with specializations in general
psychiatry, forensic psychiatry, and addiction
16 medicine.
17 I've had the privilege of serving as the
18 former Vice Chair of Mental Health for the American
19 Telemedicine Association and am an active longstanding
member of the Telepsychiatry Committee for the
21 American Psychiatric Association. I've written books,
22 book chapters, and articles on the subject of
23 telepsychiatry and speak extensively around the nation
24 on the rules and regulations of telepsychiatry.
I'm a physician leader at Psych Congress,
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1 and I've also developed the largest correctional
2 telepsychiatry program in the nation overseeing 30
3 California prisons. And I'm Johns Hopkins trained.
4 Today, I also represent Orbit Health, a
national telepsychiatry organization committed to
6 delivering high-quality mental healthcare through
7 innovative technology. Our mission is to make mental
8 health services accessible and effective, and we do so
9 by partnering with a wide array of healthcare
facilities ranging from hospitals and outpatient
11 clinics to youth homes and correctional institutions.
12 Our team comprises highly qualified
13 psychiatrists, psychiatric nurse practitioners,
14 psychologists, social workers, and licensed marriage
and family therapists. Together, we strive to offer
16 comprehensive mental health solutions to both public
17 and private sectors.
18 As we navigate the complexities of mental
19 health in today's world, the role of telepsychiatry
becomes increasingly vital. The primary focus of
21 Orbit Health is on quality. We only partner with
22 high-quality institutions and work with high-quality
23 clinicians and providers, and our reputation has grown
24 and we're considered by many as the telepsychiatry
company with the highest degree of quality,
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1 reliability, and ethics.
2 I'd like to first discuss the critical role
3 of telehealth in enhancing access to mental
4 healthcare. Telehealth has emerged as an invaluable
resource for treating various mental health conditions
6 that often require controlled substances for effective
7 management. Specifically, conditions like opioid use
8 disorders, ADHD, and certain severe anxiety cases have
9 shown significant improvement with telehealth
interventions. The technology is especially
11 beneficial for populations that face barriers to
12 traditional healthcare access, such as those in rural
13 or low-income areas.
14 Envision this. A life hanging in the
balance ensnared by the unforgiving clutches of opioid
16 addiction. The individual is isolated not just by
17 societal stigma but also by the insurmountable
18 distance from a treatment center.
19 In my own practice, I've seen firsthand how
telehealth acts as a revolutionary lifeline,
21 shattering those barriers as if they are mere
22 illusions.
23 The evidence is compelling, almost shouting
24 from the rooftops that telehealth exponentially
amplifies access to life-saving medication for opioid
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1 use disorders. This is not a mere coincidence and
2 it's not a mere convenience. It's a seismic shift
3 that annihilates the dual barriers of distance and
4 societal judgment. Telehealth doesn't just offer a
treatment pathway. It offers a road to redemption.
6 This is not just an alternative, it's a life-saving
7 revolution.
8 Now let's shift our gaze to the
9 transformative power of telehealth in the realm of
ADHD. I've personally treated countless children, and
11 the results are nothing short of miraculous.
12 Telehealth is not merely opening doors, it's
13 obliterating barriers. When children are precisely
14 diagnosed and judiciously treated with stimulant
medication, the metamorphosis is awe-inspiring. We're
16 talking about a seismic shift that elevates academic
17 performance, refines behavior, and creates a ripple
18 effect of focus and discipline that uplifts not just
19 the individual but the entire classroom.
And the benefits don't end in the classroom.
21 These children, when treated appropriately, are far
22 less likely to descend into the abyss of substance
23 abuse later in life. The societal impact is
24 monumental, reducing the crippling costs associated
with academic failure and juvenile delinquency. This
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1 isn't just healthcare. This is a societal
2 renaissance.
3 Appropriate treatment of opioid use
4 disorders, ADHD, and anxiety with controlled
substances can sometimes mean the difference between
6 life and death, and qualified practitioners should be
7 able to prescribe these medications without having to
8 overcome overly restrictive or cumbersome regulations,
9 whether it's in person or via telehealth. Mental
healthcare save lives, regardless of whether it's in
11 person or via telehealth.
12 In regulating controlled substances, the DEA
13 should focus on two main issues. First, verifying
14 patient identity is essential to prevent illegal
access to medication. While advanced technologies
16 exist, simple identification should suffice. We leave
17 it up to the DEA to specify acceptable forms of
18 identification.
19 The second issue for DEA to focus would be
ensuring qualified practitioners evaluate patients
21 before dispensing controlled substances. We see no
22 difference --
we see no need to differentiate between
23 telehealth and in-person visits. Both should require
24 proper evaluation for a valid medical condition.
Adding extra hurdles for telehealth lacks a public
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1 safety rationale.
2 For years, I personally have immersed myself
3 in the complexities of the Ryan Haight Act, a law
4 conceived from a heart-wrenching tragedy. Ryan Haight
lost his life because he secured controlled substances
6 online without ever seeing a physician or a provider.
7 This Act, the Ryan Haight Act, was designed with a
8 laser-focused aim, to mandate that patients must see a
9 provider before receiving such potent medications.
But let's contextualize this. Back in 2008,
11 telehealth was barely a blip on the radar. At that
12 time, seeing a doctor meant an in-person visit in most
13 cases.
14 Fast-forward to today and the landscape has
dramatically changed. If Ryan Haight was alive today
16 and obtained pills, the focus would be whether he saw
17 a qualified physician or provider either in person or
18 via telehealth to ensure legitimate medical use. If
19 no consultation occurred, those supplying the
medications should be held accountable. But
21 consultation methods should be treated equally in
22 legislation.
23 Let's shift the narrative here. Instead of
24 launching an assault on telehealth, a modality that is
rapidly filling gaps in clinical care, why not zero in
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1 on the real culprit, those ill-intentioned providers
2 who exploit the system for their own personal gain,
3 whether they lurk in the corridors of brick-and-mortar
4 clinics or behind the screens of telehealth platforms.
They are the ones that should be held accountable.
6 Let's not tarnish an entire medical
7 revolution because of a few bad apples. It's time to
8 focus our regulatory cross-hairs on those who truly
9 deserve scrutiny, irrespective of the medium they use
to practice. This isn't just a call to action. It's
11 a clarion call for justice in healthcare.
12 I foresee that within the next decade, as
13 telehealth becomes an integral part of our healthcare
14 system, the government will come to realize that
imposing arbitrary restrictions on telehealth is not
16 only counterproductive but inexplicable.
17 We in the medical community struggle to
18 understand the DEA's rationale for singling out
19 telemedicine when it comes to prescribing controlled
substances. Telehealth is not merely an extension of
21 traditional healthcare. It is on track to become
22 indistinguishable from healthcare itself. I firmly
23 believe that the government will eventually recognize
24 that stifling the growth of telehealth doesn't prevent
abuse. Rather, it deprives communities of essential,
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1 sometimes life-saving treatments.
2 My aspiration is that a single DEA number
3 will suffice to prescribe controlled substances via
4 telemedicine or in person, thereby streamlining the
process and broadening access to healthcare.
6 If our request seems too ambitious or
7 progressive and the DEA opts for stricter telemedicine
8 regulation, we urge the establishment of a streamlined
9 special registration process based on evidence. This
should be nationwide to maximize telemedicine's
11 benefit and avoid healthcare fragmentation. Dual
12 state registration for practitioners is unnecessary
13 and only adds red tape. Special registration should
14 be open to all medical specialties competent in
prescribing controlled substances.
16 I propose that regardless of what
17 regulations are put in place the DEA should allow at
18 minimum a 90-day period for the practitioner to
19 prescribe the medication. This would enable a safe
tapering process, reducing the risk of withdrawal
21 symptoms and ensuring a smoother transition in the
22 treatment plan. I ask that you include this as an
23 exception to any other mandate that would prevent the
24 provider from being able to safely manage such a
patient.
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1 Moreover, irrespective of the final
2 regulatory landscape, I implore the DEA on behalf of
3 the entire psychiatric community to maintain the
4 confidentiality of practitioners' home office
addresses. This isn't merely a formality, it's a
6 critical safety measure. Exposing us and our families
7 to the potential risks posed by dissatisfied or
8 unstable patients who might seek to confront us in our
9 residences is just not unfair only, but it's also a
breach of our personal security and peace of mind.
11 In closing, I want to remind you that the
12 opioid crisis was ignited not by telehealth but by
13 in-person mills, pill mills. So what was our
14 response? Did we outlaw face-to-face medical
consultations? Of course not. The issue was
16 addressed through education, awareness, and holding
17 the culpable parties accountable, not by banning an
18 entire mode of healthcare delivery.
19 Let's not forget that the DEA's mandate is
not to micromanage the intricacies of medical
21 practice. That's the purview of the state medical
22 boards. When a qualified licensed provider determines
23 that a telehealth consultation provides sufficient
24 grounds for prescribing controlled substances, that
decision should be respected as their professional
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1 judgment.
2 We do recognize and deeply respect the DEA's
3 indispensable role in thwarting the illicit spread of
4 controlled substances. However, if the sword of
regulation must fall upon telehealth, let it be
6 surgically precise, targeting only two critical
7 issues, the verification of patient identity and the
8 evaluation by qualified providers for legitimate
9 medical needs.
To venture beyond these boundaries is not
11 merely an over-extension of regulatory power, it's a
12 betrayal of healthcare's very soul, a jeopardizing of
13 patient lives, and a barricade to essential care.
14 This is not a mere request. It's an impassioned plea
echoing from the core of medical ethics, a clarion
16 call for the sanctity and integrity of a practice that
17 holds lives in its hands.
18 Thank you.
19 (Applause.)
MR. STRAIT: Thank you so much. Let me just
21 ask if there's any questions.
22 Do we have any questions?
23 (No response.)
24 MR. STRAIT: Okay, thank you.
DR. KAFTARIAN: Thank you very much.
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1 MR. STRAIT: Okay. And I will follow up
2 with our commenter, in-person Commenter No. 15 and our
3 last for the day.
4 DR. ROTELLA: Well, good afternoon. You
made it to your last presenter of the day, and I
6 personally thank you for finding space for me after my
7 morning flight was canceled. It would have broken my
8 heart not to have this chance to talk to you today, so
9 thank you so much.
My name is Dr. Joe Rotella, J-O-E,
11 R-O-T-E-L-L-A. And I am the Chief Medical Officer of
12 the American Academy of Hospice and Palliative
13 Medicine. AAHPM is the national professional
14 organization for physicians who specialize in hospice
and palliative medicine. Our membership also includes
16 nurses, social workers, spiritual care providers,
17 researchers, and other health professionals deeply
18 committed to improving quality of life for the
19 expanding and diverse population of patients of all
ages living with serious illness, as well as their
21 families and caregivers. Together, we strive to
22 ensure that patients across all communities and
23 geographies have access to high-quality, safe, and
24 equitable palliative care at any stage of a serious
illness and hospice care for those nearing the end of
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1 life.
2 The timely and effective management of pain
3 and other distressing symptoms is central to providing
4 high-quality palliative care to patients with serious
illness. and opioid analgesics and other controlled
6 substances are critical tools in alleviating their
7 suffering.
8 AAHPM appreciates the intention of the
9 proposed rules to advance public safety and urges
taking a balanced approach that also prioritizes
11 access to care and relief of suffering.
12 Therefore, we believe it is imperative for
13 DEA and the Department of Health & Human Services to
14 account for the unique needs of seriously ill
patients, including those near the end of life, when
16 finalizing policies related to the prescribing of
17 controlled substances via telemedicine.
18 In particular, my comments today focus on
19 three main areas: the need to clarify that in-person
requirements for prescribing of Schedule II through V
21 controlled substances do not apply to patients
22 enrolled in hospice.
23 Secondly, the need to establish a special
24 telemedicine registration to allow that qualifying
practitioners may prescribe Schedule II through V
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1 controlled substances without conducting an in-person
2 medical evaluation to enable ready access to
3 controlled medications for patients with serious
4 illness who are not all in hospice care.
And, third, the need to extend telemedicine
6 prescribing flexibilities for controlled substances
7 that have been in place in response to the public
8 health emergency for COVID-19 through at least
9 calendar year 2024 to provide for a reasonable
transition period while a special telemedicine
11 registration process is implemented.
12 DEA asks if there are any circumstances in
13 which telemedicine prescribing of Schedule II
14 medications should be permitted and, if so, what
safeguards stakeholders would recommend. AAHPM
16 asserts that telemedicine prescribing of Schedule II
17 medications should be permitted in cases where
18 patients have elected to enroll in hospice.
19 Likewise, telemedicine prescribing should be
permitted in cases where patients outside of hospice
21 are truly identified as having a serious illness and
22 uncontrolled symptoms, with the added safeguard that
23 the prescriber has demonstrated training and expertise
24 in pain management or palliative care and met any
qualifications for a special registration.
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1 We understand that in-person evaluation
2 requirements are intended to ensure that an
3 established patient/physician relationship is in place
4 prior to the prescribing of controlled substances via
the internet.
6 The Academy takes the position that a proper
7 physician/patient relationship can be created and that
8 sufficient safeguards are in place to support
9 telemedicine prescribing without an in-person
evaluation when a patient is certified as having a
11 terminal illness and enrolled in a hospice program.
12 Under the Medicare hospice benefit, hospice patients
13 must be certified to be terminally ill by two
14 physicians who each attest the patient has an
estimated life expectancy of six months or less.
16 Once enrolled, the hospice model of care
17 creates the equivalent of a physician/patient
18 relationship in the form of care provided by an
19 interdisciplinary hospice team under the supervision
of a hospice physician. This team includes advanced
21 practice registered nurses, physician assistants,
22 nurses, social workers, chaplains, and others based on
23 need, and they conduct comprehensive skilled admission
24 assessments and are in regular face-to-face contact
with patients, including through frequent home visits,
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1 extensive education and supervision, and 24/7
2 availability, making them better equipped to detect
3 and address drug diversion and safety concerns than a
4 physician in a typical outpatient clinic. They're
there. They're there with the patient on many, many
6 occasions.
7 In addition to these guardrails, inherent
8 to the structure and processes of hospice care that
9 protect against diversion or misuse, we know that
hospice patients have a particularly urgent need for
11 ready access to opioids and other pain medications.
12 As they contend with terminal illness, they often
13 develop pain or symptom crises which represent a true
14 medical emergency. Hospice programs must be able to
prescribe and administer medications for pain and
16 other severe symptoms quickly, including Schedule II
17 controlled substances when indicated.
18 Requiring hospice patients to obtain an
19 in-person evaluation with a prescriber could delay
treatment by hours or days, prolong suffering, and
21 drive many to go to the emergency department or
22 hospital even when their primary goal for their care
23 is to remain comfortable at home.
24 So, given the wrap-around hospice care
management structure as defined by the Medicare
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1 hospice benefit conditions of participation, as well
2 as the high clinical need for urgent management of
3 pain and symptoms in a home setting, it's clear that
4 the benefits of telemedicine prescribing of controlled
substances outweigh the risks for patients enrolled in
6 hospice. We therefore respectfully request that DEA
7 provide clarification that specifies that in-person
8 evaluation requirements for telemedicine prescribing
9 does not apply to hospice patients.
AAHPM also believes that other non-hospice
11 patients with serious illness should likewise not have
12 to face unnecessary barriers in accessing medications
13 to address their pain, including Schedule II
14 controlled substances.
Patients with serious illness often
16 experience significant challenges in accessing
17 in-person care, including mobility, cognitive issues,
18 pain, frailty, medical instability, and they
19 disproportionately have to rely on caregivers to
assist in their transportation. These challenges and
21 burdens underscore the need to allow telemedicine
22 prescribing of controlled substances without in-person
23 evaluation for this high-need population.
24 For example, imagine an 86-year-old
homebound woman with moderate dementia and a flare-up
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1 of bone pain due to metastatic breast cancer who
2 receives oral chemotherapy and accesses all of her
3 cancer and palliative care from her home via
4 telehealth. It's highly unlikely that a physician
home visit would be available to her on an emergency
6 basis. Transporting her to an emergency department or
7 outpatient clinic for an in-person evaluation just to
8 prescribe pain medication would be extremely
9 challenging for her and her caregivers and would only
add to her distress.
11 Timely access to a palliative care
12 specialist to manage distressing symptoms is an even
13 bigger challenge for pediatric patients with serious
14 illness. It's not unusual for a child suffering from
a life-limiting rare childhood disease to receive
16 their specialty care from a tertiary care hospital
17 many hours away by car. Local medical resources are
18 often unavailable, unwilling, or incapable of
19 prescribing controlled substances for such complex
patients. It would be inhumane to subject that child
21 and family to a long car or ambulance transport to the
22 specialized medical center simply to access a
23 prescription for a controlled substance that could
24 otherwise be managed safely and effectively at home.
To provide safeguards while supporting
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1 access to urgent symptom management for people with
2 serious illness, AAHPM recommends that DEA implement a
3 telemedicine special registration process enabling
4 qualified practitioners to prescribe Schedule II
through V controlled substances via telemedicine
6 without a prior in-person medical evaluation.
7 We support robust requirements for special
8 registration, for example, demonstration of
9 specialized training in palliative care or pain
management, and would be happy to work with DEA on
11 identifying appropriate qualifications specifically
12 for those caring for people with serious illness.
13 Finally, we appreciate that Congress
14 extended Medicare telehealth flexibilities through
calendar year 2024. AAHPM urges DEA to likewise
16 extend the telemedicine prescribing flexibilities for
17 controlled substances through at least the end of 2024
18 while it implements a telemedicine special
19 registration process.
While we appreciate that DEA extended
21 flexibilities for six months after the Public Health
22 Emergency for COVID-19 and for an additional year
23 thereafter for relationships established between the
24 start of the PHE and November 11, 2024, we believe
that the flexibilities should be extended more
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1 broadly, including for all telemedicine encounters for
2 new and established patients, including for hospice
3 patients if they are not clarified to be exempt,
4 through the end of 2024.
Thank you so much for considering our
6 comments in support of patients with serious illness
7 and their families and caregivers.
8 (Applause.)
9 MR. STRAIT: Any questions?
(No response.)
11 MR. STRAIT: Okay. Thank you.
12 DR. ROTELLA: Thank you.
13 MR. STRAIT: Thank you so much.
14 Well, this does conclude our session. I
would first like to just say a couple thanks to
16 Administrator Milgram and Assistant Administrator
17 Prevoznik for making your time. I know you have a
18 hard stop at 4:00, so I would welcome you --
thank
19 you.
For those of you that are still here, either
21 watching us in person or virtually, I do want to say a
22 hearty thanks on behalf of all of us at DEA for making
23 time out of your busy schedules to be here, to be
24 present, and in many cases to be heard. I think the
comments we heard today were absolutely wonderful and
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1 really give us some really great perspective as we
2 move forward with our important regulation-drafting in
3 this effort.
4 I do want to just say that --
I want to give
a special shout-out to our production company, which
6 is Real Impact. They made this effort look completely
7 seamless, I hope, for the virtual presenters who got a
8 chance to watch this. All understanding that I had
9 was that this thing went really well today from a
production standpoint, and there's no way we could
11 have done it without Real Impact, so I do want to
12 extend hy hearty thanks to you all.
13 I also know that we have stenography
14 services being provided by Heritage Reporting
Corporation, which again will become part of the
16 administrative record for our rulemaking in this
17 space, so I want to give a hearty thanks to our
18 stenographer for being here, and I'm sure they have
19 their work cut out for them trying to interpret
everything and all the technical words that were said
21 during today's discussion.
22 With that in mind, we will close our session
23 for today. We're going to begin tomorrow at 9 a.m.
24 We're going to flip the script, so we'll have our
virtual presenters in our morning session, and then
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1 we'll close our afternoon session with in-person
2 presenters. I welcome you all to come back, and,
3 again, thank you for being here.
4 (Whereupon, at 4:00 p.m., the listening
session in the above-entitled matter adjourned, to
6 reconvene at 9 a.m. the following day, Wednesday,
7 September 13, 2023.)
8 //
9 //
//
11 //
12 //
13 //
14 //
//
16 //
17 //
18 //
19 //
//
21 //
22 //
23 //
24 //
//
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REPORTER'S CERTIFICATE
DOCKET NO.: --
CASE TITLE: DEA Telemedicine Listening Session
HEARING DATE: September 12, 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 13, 2023
Angela Brown
Official Reporter
Heritage Reporting Corporation
Suite 206
1220 L Street, N.W.
Washington, D.C. 20005-4018
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