Physician Onboarding Manual With Articles Jan 2021

EVIDENCE-BASED MEDICATION-ASSISTED TREATMENT WITH BUPRENORPHINE
“And do not forget to do good and to share with others, for with such sacrifices God is pleased” - Hebrews 13:16
www.bupe.me | info@bupe.me| 704-236-3019 | Last Revision 01/11/2021

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WELCOME
We would like to thank you for wanting to join Church Ekklasia Sozo in the fight against Opioid Dependency. CES is
a religious, non-profit medical outreach Telemedicine Program providing life-saving Opioid addiction treatment to
all patients of any religion and/or ethnicity utilizing the following methodologies:
• Medication Assisted Treatments

We offer a comprehensive Evidenced Based Medication Treatment Program with Buprenorphine. This
treatment aids in reducing symptoms of Opioid Dependency patients (Abstinence Syndrome).
• Telemedicine Services
Telemedicine provides health care services in situations where patient and Provider are in different
locations. It allows patients to receive medical treatment when they cannot go to a traditional program
due to lack of transportation, childcare, work schedules and financial restrictions. A particular focus of our
telemedicine methodology is to improve access to patients, not only in cities, but also in rural and remote
locations.
• Compliance
We consistently monitor patients by doing Pill Counts, Drug Testing and PMP Surveillance, which provides
peace of mind to our Providers.
• Education and support: Patients are required to participate in a weekly mandatory meeting presented by a
Psychotherapist, Family Practice Physician, Board Certified Counselor, and the Medical Managing Director.
Our ordained minister provides spiritual support on a one-on-one basis; this is not mandatory; however, it
is available to all participants.
INTRODUCTION
We have over 40 years of combined experience in addiction treatment. Our team utilizes a strong compliance
program and state-of-the-art technology, coupled with ease of access to provide medication assisted treatment to
patients. And for Providers, we greatly reduce the amount of time you need to focus on the program. We
accomplish this with our highly skilled medical team.
Our team will interview the patient, obtain a comprehensive history and determine whether the patient is eligible
for the program.
After acceptance, along with your guidance, a prescription is eligible to be sent to the patient’s pharmacy, not to
exceed 16 mgs of Buprenorphine per day. CES only requires you to review and sign the Admissions and Drug
Screens. Drug screens will be sent out as requested by CES to the patients. You will received the results to be read
by you, and you will have four (4) choices of how you to respond to the results. Drug screens may be received
approximately 1-2 per week or more, or there may be times you do not receive any in one week..
Because of the support we provide, the only documentation required by you is to review and sign the Admission
and Drug Screens.

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TABLE OF CONTENTS
A. PROGRAM OUTLINE Page 4
B. PATIENT REQUIREMENT POLICIES AND PROCEDURES Page 4-6
C. TREATMENT PLAN Page 6
D. MEDICATION POLICIES Page 7
E. PATIENT’S RIGHTS Page 7
F. STAFF MEMBERS Page 7-8
G. LEGAL DOCUMENTS Page 8-14
H. MEMORANDUM OF UNDERSTANDING Page 15-20
I. PROVIDER’S INFORMATION Page 21
J. ARTICLES OF INTEREST Page 22

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A. PROGRAM OUTLINE
The Program is organized into Intake and Maintenance. Originally, we had stressed Tapering as a goal. But the
recent announcements from the American Academy of Endocrinology and the association with Opioid Induced
Adrenal Insufficiency has provided sufficient reason to pause and await further information and guidance.
• Patient Intake: Intake is a multi-step process, which includes online registration, online agreement with the
Narcotics Agreement, online agreement with the Informed Consent, an asynchronous encounter with the
Prescribing Provider via Store and Forward Video, and a live Telemedicine encounter with the Medical
Staff.
• Patient Maintenance: Maintenance includes beginning all patients on 16 mgs daily of Buprenorphine. This
dosage has been associated with the lowest incidence of Relapse. Unless requested in writing by the
OB-Gyn, we do not utilize ANY monotherapy (Subutex). We will not go over 16 mgs per day. We do not
routinely honor early refill requests. We do not routinely replace lost or stolen medication.
Our Program policies and procedures have been carefully reviewed and approved by our Chief Compliance Officer
and follows the official guidelines of The U.S. Department of Health and Human Services (HHS).
B. PATIENT REQUIREMENT POLICIES AND PROCEDURES
• Medication Count Protocol: On a random but frequent basis, the patient will be sent a message
requesting a Pill Count. This Pill Count will require the patient to go to their pharmacy within 20 minutes
for a pill count done by the pharmacist. The protocol is provided as follows:
1. Pill counts are random. Results will appear in the Drug Screens.
2. All results are referred to the Medical Team. Every pill count will result in an appropriate video to
be sent to the patient and from the medical team, in a timely manner. Expected results will warrant
an asynchronous communication. Unexpected results will warrant an appropriate warning and
Informed asynchronous communication, along with counseling.
3. A pill count request NOT honored within the appropriate timeframe will be treated in the same
manner as an abnormal pill count.
• Toxicology (Drug Screens) Protocol: Currently, on a random but frequent basis, the patient will be
mailed a drug screen kit, with instructions, to be completed and results uploaded through the Patient
Portal. All toxicology results, whether expected or unexpected, will receive an appropriate response to
the patient. The protocol is provided as follows:
1. Drug Screens are completed within the standard program guidelines.

2. All results are referred to the Medical Team.

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3. Every Drug Screen will result in an appropriate video to be sent to the patient and from the Medical
Team, in a timely manner. Expected results will warrant an asynchronous communication.
Unexpected results will warrant an appropriate warning and Informed asynchronous
communication.
4. Drug screen results lacking in either buprenorphine or, the metabolite, norbuprenorphine, will
result in an immediate request for a repeat drug screen.
5. A Drug Screen request NOT honored within the appropriate timeframe will be treated in the same
manner as an illicit opioid.
• Prescription Drug Monitoring Program Protocol: The PMP for the appropriate state will be referenced
routinely. Aberrancy will be reported to the Medical Director and Provider for appropriate action.
• Counseling Policy: Counseling is a requirement in order to be compliant with this Practice. A live Podcast
by a licensed Counseling Professional is offered, at no charge to the patient, at least weekly. These
Podcasts are stored and available on our website. These Weekly Meetings are MANDATORY. A set of
questions associated with the Meetings are required to be answered and submitted and will be part of
the medical records.
• Intake Policy: Prior to a live interaction with the Medical Staff, each patient is required to undergo a
somewhat lengthy and informative intake process. This intake includes an extensive questioning as to:
• History of addiction
• Drugs abused
• Frequency of usage
• Last usage
• History of overdosing
• Treatment history
• Legal history
• Psychiatric history
• Medical history
• Family history
• Review of symptoms
The patient then reviews and signs agreement to the Narcotic Agreement and the Informed Consent. The
patient is also required to interact in a series of asynchronous telemedicine encounters outlining,
particularly, the proper usage of Buprenorphine. Only then will a patient participate in an encounter with
the Medical Staff. All patients with a diagnosis of opioid addiction/dependency are eligible to join the
program. If a patient has previously been with CHURCH EKKLASIA SOZO and left treatment for whatever
reason, they will be welcomed back into treatment. There is no limit to the number of times a patient may
restart.

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Intake Policy (Continued): The overwhelming majority of people whom start with us, and at the time of their
intake, are either in withdrawal or under the influence of Opioids and possibly other substances. Not
surprisingly, we have found their recall of the Intake Process to be somewhat lacking. They just don’t
remember much of the very important information with which we share. Thus, we are revising our Intake
Process into a combination of synchronous and asynchronous Telemedicine but spread out over a number of
days. We tell the new patient initially the basics covering safety, risk, and Informed Consent. We then are
providing a series of asynchronous encounters involving Video from the Prescriber and the Medical Team
and covering the additional information. This process is reinforced by a series of questions accompanying
each encounter. Properly answering these questions ensures an adequate understanding by the new
patient and becomes a part of the permanent medical record.
Periodic Provider Summary: On a periodic basis, a summary of the patient’s activities will be submitted to
the Provider for review. This summary includes the results, if any, of the compliance activities (pill counts,
toxicology, PMP monitoring, mandatory meetings, questioners, etc.). It is the requirement of the Provider to
sign, after reviewing the document, before it is entered into the permanent Electronic Medical Record.
Electronic Medical Record: It will be the responsibility of the Staff at CHURCH EKKLASIA SOZO to create and
maintain an Electronic Medical Record on each patient for a period of seven years should the patient cease
activities with CHURCH EKKLASIA SOZO for whatever reasons. This record will contain all pertinent details
and events of the patient’s interactions with the Staff and Providers while with CHURCH EKKLASIA SOZO.
C. TREATMENT PLAN
1. Initiate Maintenance Program Protocol.

2. Initiate Counseling Protocol.
3. Initiate Toxicology Protocol.
4. Initiate Pill Count Protocol.
5. Standard Prescription can be for 7, 15, or 30 days (unless Bunavail or Zubsolv): Buprenorphine/Naloxone
8/2 - 2 SL tablets QD with no refills. (May substitute Films if required by insurance.)
6. Initiate Monthly Prescription Monitoring Program Protocol.
7. Initiate Periodic Provider Compliance Report.

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D. MEDICATION POLICIES
• Maximum daily dosage of 16 mgs: We recognize Buprenorphine is FDA approved for up to 32 mg/day. We
further recognize some patients require higher dosages. However, this Practice has determined the highest
maximum daily dosage to be prescribed will be 16 mgs/day. Those patients requiring higher dosages will
need to seek another program. The standard starting prescription for all patients will be as follows:
• Buprenorphine/Naloxone 8/2 Tablets

• 1 tablet SL BID
• Dispense #60
As research has indicated that 16 mgs of Buprenorphine per day is associated with the lowest rate of
relapse, we have determined, for the safety of all patients, we shall make 16 mgs per day available to all
patients and at all times. We will not be prescribing over 16 mgs per day. A patient may choose for
themselves, at any time, to take a lower dosage. We have wording in our Informed Consent that 16 mgs per
day is associated with a lower rate of relapse. If a patient voluntarily wishes to taper their dosage, they do
so with the knowledge that tapering below 16 mgs per day, for some patients, has resulted in relapse and
death.
Subutex: This Practice will not be prescribing Subutex except in some cases of pregnancy/breast feeding
and requested in writing by the OB-Gyn.
E. PATIENT’S RIGHTS
We are helping our patients understand their rights as recently outlined by the Department of Justice and access to
Buprenorphine as per the Americans with Disabilities Act (ADA).
F. STAFF MEMBERS
• Executive Managing Director: The Executive Director is the Chairman of the Board. He leads and directs the
entire program and is responsible for governmental affairs.
• Financial Managing Director (Board Member): Oversees the financial aspects of the corporation, while
monitoring compliance of participants. Handles patient accounting relations.
• Medical Managing Director (Board Member): Oversees the medical operations and monitors patient care.
Responsible for Physician recruitment, state expansion, licensing and management of Physicians.
• IT Managing Director (Board Member): Owner and President of TechByPro provides State of the Art
Internet Technology, quality control and ensures strict HIPPA Compliance for CES.

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• Medical Director: The Medical Director is responsible for the Policies and Procedures and overseeing the
professional staff.
• Prescribing Waivered Provider: All Providers are SAMHSA waivered. They review patient records for
compliance and adherence to medication regime, as well as review PMP’s, Periodic Patient Reviews, and, if
appropriate, send prescriptions to the pharmacy for their treatment due to Opioid side effects.
• Nurses: Nurses play a dynamic and crucial role in our program. They are usually the first person a patient
interacts with. Nurses are responsible for assessing patients’ needs, assisting Providers and providing
patient care.
• Counseling Clinician: The Counseling Clinician is highly trained and readily available. Routine counseling
sessions are available daily.
• Ordained Minister: Our ordained minister provides non-denominational support upon a patient’s request.
• Chief Compliance Officer: Our CCO is primarily responsible for overseeing compliance within an
organization, and ensuring compliance with laws, regulatory requirements, policies and procedures.
• Administrative Staff: Administrative staff assist with correspondence to providers and others, as well as
organizing and compiling documents. Assist in scheduling appointments and attaching documentation to
patient files.
G. LEGAL DOCUMENTS
• Narcotics Agreement: This is a somewhat lengthy and detailed document required by the Practice. Of note,
included within this document are provisions wherein the patient grants to the Practice and its Providers
both, indemnify, release and hold harmless, and release of all liability provision and assignment of Absolute
Immunity status. CHURCH EKKLASIA SOZO has provided a Narcotics Agreement between the patient and
CHURCH EKKLASIA SOZO of great specificity. A potential patient is required to read and sign this Narcotic
Agreement before being accepted into the CHURCH EKKLASIA SOZO Treatment Program. An existing
patient is required to re-read and sign this Narcotics Agreement, and any changes, every 20 days for the
duration of the patient's time within the Program. Included within the Narcotics Agreement, the patient:
1. Agrees to grant CHURCH EKKLASIA SOZO, its staff and Providers Absolute Immunity.
2. Agrees to grant CHURCH EKKLASIA SOZO, its staff and Providers Indemnification and Release and
Hold Harmless.

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3. No New Patient will be allowed into the Program without agreeing to each and every aspect of the
Narcotics Agreement.
4. The purpose of the Narcotics Agreement is to document an understanding of critically important

information between the Patient and the Providers of Medical Care.
5. Such documentation, as a means of facilitating care, is meant to improve communication of

important messaging between Patients and Providers.
CHURCH EKKLASIA SOZO Patients’ agree to the following statements during our online registration process. This
information is documented, managed and controlled in our EMR:
1) I agree to keep appointments and let appropriate staff know if I will be unable to show up as scheduled.
2) I agree to report my history and symptoms honestly to CHURCH EKKLASIA SOZO physicians, nurses, and
counselors. I also agree to inform CHURCH EKKLASIA SOZO staff of all other physicians and dentists whom I
am seeing; of all prescription and non-prescription drugs I am taking; of any alcohol or street drugs I have
recently been using; and whether I have become pregnant or have developed hepatitis.
3) I agree to cooperate with witnessed drug testing whenever requested by CHURCH EKKLASIA SOZO staff to
confirm if I have been using any alcohol, prescription drugs, or street drugs.
4) I have been informed that the drug Buprenorphine (found in Suboxone, Bunavail, Zubsolv) is a narcotic
analgesic, and thus it can produce a 'high'. I know that taking this medication regularly can lead to physical
dependence and addiction, and if I were to abruptly stop taking this medication after a period of regular
use, I could experience symptoms of opiate withdrawal.
5) I have been informed that the Buprenorphine/Naloxone combination medication should be taken, as
described by CHURCH EKKLASIA SOZO Providers, and that this medication should never be used
intravenously (Injected).
6) I have been informed that Buprenorphine/Naloxone is a powerful medication and is to be respected, and
that supplies of it must be protected from theft or unauthorized use, since persons who want to get high by
using it or who want to sell it for profit may be motivated to steal my prescription of
Buprenorphine/Naloxone medication.
7) I have a means to store, under lock and key, take-home prescription supplies of Buprenorphine/Naloxone
medication safely, where it cannot be taken accidentally by children or pets or stolen by unauthorized
users. I further understand if one dose of this medication is mistakenly ingested by a child, it could lead to
death. I agree if my Buprenorphine/Naloxone is swallowed by anyone besides me, I will call 911 or Poison
Control at 1-800-222-1222 immediately.

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8) I agree if my CHURCH EKKLASIA SOZO Provider recommends my home supply of Buprenorphine/Naloxone
medication should be kept in the care of a responsible member of my family or another third party, I will
abide by such recommendations.
9) I will be careful with my prescription of Buprenorphine/Naloxone medication and agree I have been
informed that if I report my prescription has been lost or stolen, my Provider will not be requested or
expected to provide me with a make-up prescription. This means if I run out of my medication, it could
result in my experiencing symptoms of opiate withdrawal. Also, I agree if there has been a theft of my
medications, I will report this to the police and will provide a copy of the police report to CHURCH EKKLASIA
SOZO.
10) I agree to submit to all prescription medication counts requested by CHURCH EKKLASIA SOZO Provider so
that remaining supplies can be accounted for by CHURCH EKKLASIA SOZO.
11) I agree to take my Buprenorphine/Naloxone medication as prescribed, to not skip doses, and that I will not
adjust the dose without talking with my CHURCH EKKLASIA SOZO Provider so changes in orders can be
properly communicated by CHURCH EKKLASIA SOZO to my pharmacy.
12) I agree I will not drive a motor vehicle or use power tools or other dangerous machinery during my first
days of taking Buprenorphine/Naloxone medication, to make sure I can tolerate taking it without becoming
sleepy or clumsy as a side-effect.
13) I understand Buprenorphine/Naloxone medication assisted treatment is just one of several types of
treatments for Opioid Dependency; others include Methadone Treatment, in-patient treatment, and other
rehab programs. After careful consideration, I have chosen Buprenorphine/Naloxone medication as my
choice of treatment.
14) I have been informed it can be dangerous to mix Buprenorphine/Naloxone with alcohol or another sedative
drug such as Valium, Ativan, Xanax, Klonopin or any other benzodiazepine drug--so dangerous that it could
result in accidental overdose, over-sedation, coma, or death. I agree to use no alcoholic beverages and take
no sedative drugs at any time while being treated with Buprenorphine/Naloxone. I have been informed that
my CHURCH EKKLASIA SOZO doctor will almost certainly discontinue my Buprenorphine treatment with
Buprenorphine/Naloxone medication if I violate this agreement.
15) I want to be in recovery from addiction to all drugs, and I have been informed that any active addiction to
other drugs besides heroin and other opiates must be treated by counseling and other methods. I have
been informed Buprenorphine (found in Suboxone, Bunavail and Zubsolv) is a treatment designed to treat
Opiate Dependence, not addiction to other classes of drugs.

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16) I agree, with medication assisted treatment of addiction with Buprenorphine/Naloxone medication, to
remain compliant in the CHURCH EKKLASIA SOZO program; CHURCH EKKLASIA SOZO expects me to
participate in a regular program of counseling i.e.: one-on-one counseling, group counseling, or support
group counseling.
17) I agree and understand counseling, combined with the CHURCH EKKLASIA SOZO treatment program, has
the best results while I am pursuing my recovery and could prevent relapse and or death.
18) I agree to participate in a regular program of peer/self-help while being treated with
Buprenorphine/Naloxone. An appropriate peer/self-help program could include, but is not limited to, the
following: a 12-step program (either Alcoholics Anonymous or Narcotics Anonymous), SMART recovery, a
church-based group (e.g. Celebrate Recovery), an online/virtual recovery support community, synchronous
or asynchronous telemedicine-based counseling and/or therapy and in-office individual or group counseling
and/or therapy.
19) I agree it is usually best to let my loved ones know about my medication assisted treatment. I understand
that hiding treatment can cause problems in relationships and further perpetuate the cycles of deception
and lying that must be broken to achieve meaningful recovery.
20) I agree to grant Absolute Immunity to CHURCH EKKLASIA SOZO, its staff, personnel, and all associated
persons. This means that, no matter what the circumstances or outcomes, neither myself nor anyone
associated with me, including family members, can ever sue or seek damages from CHURCH EKKLASIA SOZO
or its associates.
21) I indemnify, release and hold harmless, and release of all liability CHURCH EKKLASIA SOZO, its staff,
personnel, and all associated persons from any and all outcomes that may arise from my condition, the
treatment of my condition, or any behaviors or actions I may take.
22) I agree to always report accurately the amount of medication I have remaining whenever a medication
count request is sent. I understand falsifying, ignoring or not responding to medication count requests,
regardless of the reason, constitutes non-compliance on my part and jeopardizes my standing in the
program.
23) I will always provide a drug test sample; I understand if I do not follow this program requirement, I will not
be in compliance with the program.
24) I will include the date my drug test was completed with my submission.

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25) I understand if my medication counts or toxicology tests generates an unexpected result, my CHURCH
EKKLASIA SOZO Provider(s) might change my treatment plan. Any changes will be at the sole discretion of
my Provider(s). These changes include, but are not be limited to, the following: new requirements on how
frequently I interact with Church Ekklasia Sozo counseling/therapy requirements; limiting the number of
days-worth of medication I am allowed to pick-up at a single time; increases in quantity and frequency of
medication counts and/or toxicology tests.
Informed Consent: This document is another legal requirement by CHURCH EKKLASIA SOZO. CHURCH
EKKLASIA SOZO has provided an Informed Consent between the patient and CHURCH EKKLASIA SOZO of great
specificity. A potential patient is required to read and sign this Informed Consent before being accepted into
the CHURCH EKKLASIA SOZO Treatment Program. An existing patient is required to re-read and sign this
Informed Consent, and any changes, every 20 days for the duration of the patient's time within the Program.
Our policy is as follows:
1. No New Patient will be allowed into the Program without agreeing to each and every aspect of the
Informed Consent.
2. No Established Patient will be allowed to remain in the Program without re-agreeing to the Informed
Consent every 20 days on average.
3. The purpose of the Informed Consent is to make every effort to be sure the Patient understands the
benefits, risks, and other options of Treatment.
CHURCH EKKLASIA SOZO Patients agree to the following statements during our online registration process. This
information is documented, managed and controlled in our EMR:
1. Buprenorphine is a medication approved by the Food and Drug Administration (FDA) for treatment of
people with Opioid Dependence. Buprenorphine can be used for detoxification or maintenance therapy.
Maintenance therapy can continue as long as medically necessary.
2. Buprenorphine itself is an opioid, but it is not as strong an opioid as heroin or morphine. Buprenorphine
treatment can result in physical dependence of the opiate type. Buprenorphine withdrawal is generally less
intense than with heroin or methadone. If Buprenorphine is suddenly discontinued, some patients have no
withdrawal symptoms; others have symptoms such as muscle aches, stomach cramps, or diarrhea lasting
several days. To minimize the possibility of opiate withdrawal, Buprenorphine should be discontinued
gradually, usually over several weeks or more.
3. If you are dependent on opiates, you should be in as much withdrawal as possible when you take the first
dose of Buprenorphine. If you are not in withdrawal, Buprenorphine may cause significant opioid
withdrawal. Some patients find it takes several days to get use to the transition from the opioid they had
been using to Buprenorphine. During that time, any use of other opioids may cause an increase in
symptoms. After you become stabilized on Buprenorphine, it is expected other opioids will have less effect.

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4. Attempts to override the Buprenorphine by taking more opioids could result in an opioid overdose.
5. You should not take any other medication without discussing it with the medical staff first. Combining
Buprenorphine with alcohol or some other medications may also be hazardous. The combination of
Buprenorphine with benzodiazepine medication such as Valium, Xanax, Klonopin, Librium, and Ativan has
resulted in deaths.
6. The form of Buprenorphine (Suboxone) you will be taking is a combination of Buprenorphine with a short-
acting opiate blocker (Naloxone). If the Suboxone tablet were dissolved and injected by someone taking
heroin or another strong opioid, it could cause severe opiate withdrawal.
7. Buprenorphine tablets must be held under the tongue until they dissolve completely. Buprenorphine is
then absorbed over the next 30 to 120 minutes from the tissue under the tongue. Buprenorphine will not
be absorbed from the stomach if it is swallowed.
8. Alternatives to Buprenorphine: Some hospitals that have specialized drug abuse treatment units can
provide detoxification and intensive counseling for drug abuse. Some outpatient drug abuse treatment
services also provide individual and group therapy, which may emphasize treatment that does not include
maintenance on buprenorphine or other opiate like medications. Other forms of opioid maintenance
therapy include methadone maintenance. Some opioid treatment programs use Naltrexone, a medication
that blocks the effects of opioids, but has no opioid effects of its own.
• Electronic Code of Federal Regulations:
1. Federal Law and Regulations protect the confidentiality of your substance use disorder patient
records.
2. Your participation in this program can be discussed or revealed to others only with your written
permission. This privacy is protected by a Federal Law.
3. Any violation of your privacy is considered a violation of a Federal Law.
4. Information related to a patient's commission of a crime on the premises of the program or against
personnel of the program is not protected.
5. Reports of suspected child abuse and neglect made under state law to appropriate state or local
authorities are not protected.
6. Federal and State Regulations require your permission for us to discuss your treatment with any
other entity. Your privacy is a priority to us. By agreeing with this statement, we have your
permission to discuss and share your treatment of Buprenorphine with your Pharmacy, the
Laboratory, Pastoral Care, and appropriate Counselors.

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7. Research has shown the Buprenorphine daily dosage of 16 mgs per day is associated with the
LOWEST incidence of relapse back to abused opioids. Dosages both lower and higher than 16 mgs
per day were associated with HIGHER rates of Opioid relapse. Research has shown that tapering off
Buprenorphine is associated with a risk of relapse back to abusing opioids. While this program
support those who have stabilized their lives and wish to attempt to wean down or even off the
Buprenorphine, Ethics of Informed Consent lead us to warn you of the risk of relapse and even
death associated with the weaning process.
• Provider's Risk Management: CHURCH EKKLASIA SOZO recognizes the Provider's intent to save lives in the
midst of the Opioid Crisis. But this heeding of the call should not place the Provider at any risk to
themselves or their licensing. CHURCH EKKLASIA SOZO has taken a number of steps to shield the Provider
from said risk. Furthermore, we dedicate to the continual striving to ever reduce all risk. Listed below are
the main steps taken by CHURCH EKKLASIA SOZO towards Risk Reduction and Risk Management.
• Federal / State Laws & Regulations: CHURCH EKKLASIA SOZO hereby attest it is the responsibility of
CHURCH EKKLASIA SOZO to ensure that all Policy & Procedures as outlined in this document and all actions
taken by CHURCH EKKLASIA SOZO on behalf of any and all Providers is in keeping with all Federal and State
Laws, Regulations, and Guidelines. Any inquiry, investigation, action towards CHURCH EKKLASIA SOZO and
its Providers will be the responsibility of CHURCH EKKLASIA SOZO in both the financial and legal sense, to
see through to a completion. By following these Policy & Procedures, and by acting in accordance with a
non-denominational religious non-profit organization, out-reaching into the communities in a time of a
Public Health Emergency and providing, what too many, is truly a lifesaving treatment, the Provider is
hereby indemnified, released and held harmless from any and all actions resulting from this outreach and
the treatment of the afflicted.
• Legal Actions Taken by a Patient, Patient Family, or Representative: By following these Policy &
Procedures, and by acting in accordance with a non-denominational religious non-profit organization, out-
reaching into the communities in a time of a Public Health Emergency and providing, what to many, is truly
a lifesaving treatment. The Provider is hereby indemnified, released and held harmless from any and all
actions taken by a patient, patient's family, or representative of a patient’s family.

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H. MEMORANDUM OF UNDERSTANDING
PATIENT CARE MEMORANDUM OF UNDERSTANDING BETWEEN:
___________________________________________
AND CHURCH EKKLASIA SOZO

As part of our Telemedicine, MAT model of care, ________________________ enters into this Memorandum of
Understanding (MOU) with CHURCH EKKLASIA SOZO to further our vision of optimizing health care delivery and
the overall health and well-being of our patients. The purpose of this MOU is to define goals and expectations for
the relationship between _____________________________________and CHURCH EKKLASIA SOZO as it
pertains to the care of patients who receive services from ________________. This MOU will provide a
framework for access to services, effective collaboration, and timely communication among CHURCH EKKLASIA
SOZO, and _____________________________________patients.
Goals for:
__________________________________
and CHURCH EKKLASIA SOZO
• Provide optimal health care for our patients. This includes care that is timely, high quality, and patient
centered.
• Improve collaboration, communication, coordination of services, and continuity of care by supporting
efficient, real-time communication of patient information among those caring for the patient.
• Foster healing relationships and patient engagement.
Expectations of CHURCH EKKLASIA SOZO
• New Patients will be adequately screened for substance abuse, psychiatric history, medical history,
current medications, current drugs of abuse, and suicidal ideation and suicidal history.
• New Patients will have an admitting diagnosis of Adult Assistance Syndrome.
• All Patients will participate in the Toxicology Protocol.
• All Patients will participate in the Pill Count Protocol.
• All Patients will be offered additional access to Counseling.
• All Patients are required to participate in the weekday mandatory meetings.
• All Patients will be offered access to Pastoral Care.

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Prepaid Malpractice Defense
CES has taken every effort possible to protect our Prescribers. Our Prescribers are those who have stepped
forward and heeded the call during a National Crisis. Our Prescribers are those who have marched TOWARDS the
sounds of the cannon. And they should be able to do so and without incurring risk.
First off, each and every patient, and on an initial, regular, and ongoing basis, agrees to grant to CES, its staff, and
all associated with CES, including the Prescribers, the following:
1) Absolute Immunity from any and all potential outcomes,
2) Sovereign Immunity from any and all potential outcomes,
3) To Release and Hold Harmless CES, its staff, associates, and all Prescribers from any and all liability as a direct
or indirect consequence from the treatment provided by CES, its staff, associates, and Prescribers.
This language is found in the Narcotics Agreement read and signed by the patient initially and thereafter on an
ongoing basis.
Expectations of The Provider
• The Provider is expected to maintain a waiver to treat Opioid Dependency under the DATA 2000.
• The Provider is expected to review and sign the Admissions & Drug Screens within 7 business days.
• The Provider gives permission to CES the ability to send prescriptions specifically and exclusively for
Buprenorphine, Suboxone, and Zubzolv for opioid dependent patients only.

Page 16 of 22
Quality of Care
Both CHURCH EKKLASIA SOZO and _____________________________________will furnish their services in a

manner that is consistent with, at a minimum, the prevailing standard of care, and the same professional
manner and pursuant to the same professional standards as are generally furnished to all patients, and in
accordance with all relevant federal, state and local laws and regulations, including, but not limited to, non-
discrimination laws. _________________ will accept all CHURCH EKKLASIA SOZO patients, subject to capacity
limitations (as CHURCH EKKLASIA SOZO may determine in its sole discretion). Each party will provide the other,
on request, with assurances that, during the life of this MOU, it and, as applicable, its individual health care
Providers are and will remain duly licensed, certified and/or otherwise qualified to Provider services hereunder,
with appropriate training, education and experience in their particular field: appropriately credentialed and
privileged, and eligible to participate in federal health care programs including Medicaid and Medicare.
Provider of Judgment and Freedom of Choice
All health and health-related professionals employed by or under contract with either Party shall retain sole and
complete discretion, subject to any valid restriction(s) imposed by participation in a managed care plan, to refer
patients to any and all Provider(s) that best meet the requirements of such patients. All such patients shall be
advised that, subject to any valid restriction(s) imposed by participation in a managed care plan, said patients
may request referral to any Provider(s) they choose.
Agreements with Other Parties
Both Parties retain the authority to contract with other Parties, if, and to the extent, they reasonably determine
such contracts are necessary in order to implement their policies and procedures, or as otherwise may be
necessary to ensure appropriate collaboration with other local Providers (as required by Section 330(k)(3)(8) of
the Public Health Services Act), to enhance patient freedom of choice, and/or to enhance accessibility,
availability, quality and comprehensiveness of care.
Volume or Value of Referrals
Nothing in this MOU requires, is intended to require, or provides payment or benefit of any kind (directly or
indirectly) for the referral of individuals or businesses to either Party by the other Party. Neither Party shall track
such referrals for purposes relating to setting the compensation of its professionals or influencing their choice.

Page 17 of 22
Confidentiality
The Parties (and their directors, officers, employees, agents, and contractors) shall maintain the privacy and
confidentiality of all information regarding the personal facts and circumstances of their patients in accordance
with all applicable federal and state laws and regulations (including, but not limited to, the Health Insurance
Portability and Accountability Act and its implementing regulations set forth at 45 C.F.R Part 160 and Part 164).
The Parties (and their directors, officers, employees, agents and contractors) shall not use or disclose patient
information, other than as permitted or required by this MOU for the proper performance of duties and
responsibilities hereunder. The Parties shall use appropriate safeguards to prevent use or disclosure of PHI, other
than as provided for under this MOU.
Termination
This MOU may be terminated by either Party without penalty or cause by giving written notice to the other Party.
Notices
All notices and other communications required or permitted under this MOU, unless otherwise stated, shall be
deemed duly given if in writing and delivered personally, via email or by First Class US Mail, postage prepaid.
Notices will be deemed given on the date of delivery. Either Party may change its notice address by giving the
other ten (10) days prior notice of such a change.
Dispute Resolution
If a dispute arises regarding this MOU, _____________________________________and CHURCH EKKLASIA SOZO

shall first attempt to resolve it by informal discussions between Parties, unless there are circumstances under
which an extended resolution procedure may endanger the health and safety of patients.
Relationship of the Parties
The Parties are and shall remain separate and independent entities. Neither Party shall be construed to be the
agent, partner, co-venture, employee or representative of the other Party.
Third Party Beneficiaries
Nothing herein is intended or shall be construed as creating any rights for any person or entity not a Party
hereto, including, but not limited to, employees or patients who are receiving services under this MOU.
Amendments
This MOU may be modified or amended in writing with the express written consent of both Parties.

Page 18 of 22
Financial Coverage and Responsibility
The Church Ekklasia Sozo agrees to bear all financial responsibility for the defense and outcome of any and all
actions which could arise from any agency, Department, Board, Patient, or Patient’s Family or Family
Representative related to activities taken on behalf of Church Ekklasia Sozo, its mission, and for its clients.
Said financial coverage and responsibility is pursuant to the following of the Policy & Procedures as set forth by
Church Ekklasia Sozo. To re-state, as long as an attempt is made to follow the Policy & Procedures as set forth in
this document, and even if said attempt falls short of full adherence, it is the Church Ekklasia Sozo that will bear
any and all financial burden. Our Providers were but stepping forward to help in a time of national crisis. No
harm nor penalties shall come their way for said good deeds.
Physician Payment Schedule
Compensation: The Church Ekklasia Sozo is highly appreciative of you, our Providers.
According to DEA 2010b delegated agents, such as CES, are permitted to transmit prescriptions for Schedule III,
IV, and V controlled substances, which allows you to continue to work your full-time job without
interruptions. CES only requires you to review and sign the Admissions and Drug Screens. Drug screens will be
sent out as requested by CES to the patients. You will received the results to be read by you, and you will have
four (4) choices of how you to respond to the results. Drug screens may be received approximately 1-2 per week
or more, or there may be times you do not receive any in one week. This should only take minimual
time. CES’ trained medical staff will handle everything else.
Compensation is never less than $200.00 per month, even if you have no patients.
Compensation is monthly for the preceding month based upon signed Admissions and signed Drug Screens.
Compensation is $25 per patient, and maximizes at $3,000.00 per month; however, if you are willing to be a
Collaborating Physician for Nurse Practitioners, you will be eligible to receive an additional $500.00 per month.
Governing Law
This MOU shall be construed and enforced in accordance with the state laws excluding the state’s choice-of-law
principles.

Page 19 of 22
IN WITNESS WHEREOF, the Parties here have executed this MOU as of the dates written below.
CES Representative Name: Name:
Signed: Signed:
Title: Title:
Date: Date:

Page 20 of 22
I. PROVIDER’S INFORMATION
PROVIDER’S INFORMATION – PLEASE PRINT
Full Name:
(Please provide a copy of your Driver License.)
Home Address:
Business Name if Applicable:
Business Address:
Preferred Mailing Address:
Email Address:
Cell Number and/or Home Number:
Medical Degree/Title:
Primary Specialty:
NPI Number:
SSN/EIN:
DEA# for each state you hold a license in; list

expiration(s) & provide copy of each license.
(DEAX) Suboxone License# with expiration; provide a
copy. What are you currently waivered for?
What state(s) are you currently licensed in? List
license(s)# & expiration(s) per license. Provide copy(ies).
What state(s) do you hold a Medicaid license in? List
license(s)# and expiration(s). Provide copy(ies).
In the past, what state(s) have you been licensed in?
Do you have a license in any compact states? If so, what
state(s)? List license(s)# & expiration(s); provide copy for
each state.
Are you willing to re-activate any license(s) that are not
active?
Are you willing to join the Nurse Compact to obtain
additional license(s)?
Above information is correct to the best of my knowledge.
Signature:______________________________________________Date:_________________________________

Page 21 of 22
J. ARTICLES OF INTEREST
1. Telemedicine and Prescribing Buprenorphine for the Treatment of Opioid Use Disorder
3 Pages
2. Justice Department Reaches Settlement with Selma Medical Associates Inc. to Resolve
ADA Violations
1 Page
3. Telemedicine’s Role in Addressing the Opioid Epidemic
5 Pages
4. Model Policy for the Appropriate Use of Telemedicine Technologies in the Practice of
Medicine
9 Pages
5. Epigenetic variation in OPRM1 gene in opioid-exposed mother-infant dyads.
2 Pages
6. Profound Increase in Epinephrine Concentration in Plasma and Cardiovascular Stimulation

after [micro sign]-Opioid Receptor Blockade in Opioid-addicted Patients during
Barbiturate-induced Anesthesia for Acute Detoxification 7 Pages
7. Opioid Induced Adrenal Insufficiency
3 Pages

Page 22 of 22
U.S. Department of Health and Human Services
Article of Interest - 1
Telemedicine and Prescribing Buprenorphine

for the Treatment of Opioid Use Disorder
September 2018
THE UNITED STATES is in the midst of an unprecedented crisis of prescription and illicit opioid misuse,
addiction, and overdose. To combat the epidemic HHS is working to prevent more people from becoming
addicted while also expanding access to treatment and recovery support services for those with opioid use
disorder. Improving access to medication-assisted treatment (MAT) for opioid use disorder, which
combines the use of medications (methadone, buprenorphine, and naltrexone) with psychosocial and other
behavioral health support services, is a critical component of the HHS Opioid Strategy.
Despite the well-documented effectiveness of MAT, the majority of Americans with opioid use disorder do
not receive this life-saving treatment. This is particularly true in some rural and remote areas of the country
where there are few clinicians available to provide MAT and patients often have to travel long distances to
receive care or go without care. One particular barrier to MAT access is the limited number of practitioners
with a Drug Addiction Treatment Act of 2000 (“DATA 2000”) waiver, which allows qualified practitioners to
prescribe buprenorphine, for the treatment of opioid use disorder in settings other than a federally regulated
opioid treatment program.
HHS remains committed to bringing the full extent of its resources to bear on the opioid crisis. Reflecting
this commitment, the Department is working with the Drug Enforcement Administration (DEA) to
understand how telemedicine (the use of electronic information and telecommunications technologies to
support and promote long-distance clinical health care) can best be leveraged to expand buprenorphine-
based MAT. On May 15, 2018, DEA issued a statement “Use of Telemedicine While Providing Medication
Assisted Treatment”, to clarify how practitioners can use telemedicine as a tool to expand
buprenorphine treatment for opioid use disorder under current DEA regulations.
According to the DEA’s Use of Telemedicine While Providing Medication Assisted Treatment (MAT)
statement, pursuant to the provisions of the Ryan Haight Act of 2008, DEA-registered practitioners acting
within the United States, which include DATA 2000-waivered practitioners, are exempt from the in-person
medical evaluation requirement as a prerequisite to prescribing or otherwise dispensing controlled
substances via the Internet if the practitioner is engaged in the “practice of telemedicine” as defined under
21 U.S.C. § 802(54). The “practice of telemedicine” entails, among other things, “the practice of medicine
in accordance with applicable Federal and State laws by a practitioner (other than a pharmacist) who is at a
location remote from the patient and is communicating with the patient, or health care professional who is
treating the patient, using a telecommunications system referred to in section 1395m(m) of Title 42,” and in
practices with certain features identified in 21 U.S.C. § 802(54). Practitioners should familiarize themselves
with all aspects of the “practice of telemedicine” definition provided in 21 U.S.C. § 802(54). 1
1
21 U.S.C. § 802(54) is available at: https://www.deadiversion.usdoj.gov/21cfr/21usc/802.htm.
|1
U.S. Department of Health and Human Services | page 2
EXAMPLE CLINICAL CASE SCENARIO2

HHS has developed the following case scenario to provide clinicians with an example of a clinical practice
engagement consistent with the DEA statement and applicable HHS administered authorities.
• A patient is being seen in a rural health clinic staffed by a nurse practitioner licensed in the state and
has a DEA registration consistent with the nurse practitioner’s scope of practice.
• The nurse practitioner conducts an examination of the patient and determines that treatment with
buprenorphine for opioid addiction is clinically indicated, and the patient agrees to treatment.
• The nurse practitioner does not have a DATA 2000 waiver to prescribe buprenorphine for the
treatment of opioid addiction, but the clinic has an agreement with an addiction specialist in a large
city in the same state (or in another state so long as the remote addiction specialist is also registered
with the DEA and licensed in the state where the patient is located)5 to provide remote telemedicine
services for addiction treatment.
• The remote addiction specialist has a DATA 2000 waiver to prescribe buprenorphine for the
treatment of opioid addiction and is licensed and DEA-registered in the state where the rural health
clinic is located.
• At the patient visit, the nurse practitioner connects the patient to the remote addiction specialist via
an appropriately safeguarded interactive telecommunications system.
• The addiction specialist, after engaging with the patient remotely concurs with the nurse practitioner
that buprenorphine is clinically indicated for this patient and issues a prescription for a specific
formulation and dosage of a buprenorphine product to be filled at the patient’s local pharmacy.
• After the initial encounter, the patient continues to have his/her buprenorphine treatment managed
by the remote DATA 2000-waived practitioner (who remains the buprenorphine prescriber of
record) in collaboration with the local nurse practitioner.
• The patient will be considered a patient of the DATA 2000-waived practitioner for purposes of 21
U.S.C. § 823(g)(2), and 42 C.F.R. Part 8, Subpart F when applicable.
Note that HHS programs like Medicare have additional Federal requirements in order for a practitioner to
be reimbursed for telehealth services, and Medicaid programs may have additional State requirements.
2
This clinical case scenario assumes that practitioners will maintain malpractice insurance per requirements in the state(s)
where they practice (including via telemedicine) and that the insurance will be of sufficient scope to cover the types of
services they provide. Practitioners must also maintain records related to patients treated under a DATA 2000 waiver per
DEA requirements (see footnote 6)
U.S. Department of Health and Human Services | page 3
ADDITIONAL RESOURCES
For additional information on obtaining a DATA 2000 waiver, which can be obtained by physicians, nurse
practitioners, and physician assistants, please go to:
https://www.samhsa.gov/programs-campaigns/medication-assisted-treatment/training-materials-
resources/buprenorphine-waiver
For additional information on the use of medications for the treatment of opioid use disorder please go to:
https://store.samhsa.gov/product/SMA18-5063FULLDOC
For additional information about telemedicine and telehealth please go to:
https://www.hrsa.gov/rural-health/telehealth/index.html
https://www.integration.samhsa.gov/operations-administration/telebehavioral-health
https://www.medicare.gov/coverage/telehealth.html
https://www.medicaid.gov/medicaid/benefits/telemed/index.html
8/30/2019 Justice Department Reaches Settlement with Selma Medical Associates Inc. to Resolve ADA Violations | OPA | Department of Justice
JUSTICE NEWS
Department of Justice
Office of Public Affairs
FOR IMMEDIATE RELEASE Thursday, January 31, 2019
Justice Department Reaches Settlement with Selma Medical Associates Inc. to

Resolve ADA Violations
The Justice Department today reached a settlement agreement with Selma Medical Associates Inc. (Selma Medical), a
privately owned medical facility located in Winchester, Virginia, that provides primary and specialty care to patients.
The settlement agreement resolves a complaint under Title III of the Americans with Disabilities Act (ADA) that Selma
Medical refused to accept a prospective new patient for an appointment because he takes Suboxone, a medication
used to treat opioid use disorder. The Justice Department’s investigation concluded that Selma Medical regularly turned
away prospective new patients who lawfully take controlled substances to treat their medical conditions.
Under the agreement, Selma Medical will not deny services on the basis of disability, including opioid use disorder, or
apply standards or criteria that screen out individuals with disabilities. The agreement also requires Selma Medical to
adopt non-discrimination policies, train staff on its non-discrimination obligations, and report on compliance. Selma
Medical will also pay $30,000 in damages to the complainant and a $10,000 civil penalty to the United States.
“This agreement ensures that people in recovery from an opioid use disorder do not face discriminatory barriers to
health care services,” said Assistant Attorney General Eric Dreiband of the Civil Rights Division. “Unlawfully denying
services to individuals with disabilities because of their medical conditions subjects these individuals to unwarranted
stigma and harm, and will not be tolerated by the Department of Justice.”
People interested in finding out more about the ADA or this settlement agreement can call the toll-free ADA Information
Line at 800-514-0301 or 800-514-0383 (TDD), or access the ADA website at http://www.ada.gov.
Topic(s):
Civil Rights
Component(s):
Civil Rights Division
Press Release Number:

19-47
Updated January 31, 2019
https://www.justice.gov/opa/pr/justice-department-reaches-settlement-selma-medical-associates-inc-resolve-ada-violations 1/1
8/30/2019 Telemedicine’s Role in Addressing the Opioid Epidemic - Mayo Clinic Proceedings
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Telemedicine’s Role in Addressing the Opioid Epidemic
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Article Outline
I. MAT via Telemedicine

II. Barriers Related Articles
III. Policy Recommendations for Expanding MAT via Telemedicine
IV. References
Emergency Video Telemedicine
Consultation for Newborn
Adverse health e ects of the opioid epidemic continue to climb. Opioid-related overdose deaths reached Resuscitations: The Mayo Clinic Experience
an all-time high of 42,249 in 2016,1 prompting President Trump to declare an opioid public health Mayo Clinic Proceedings, Vol. 91, Issue 12
emergency in 2017. From July 2016 to September 2017, emergency department visits associated with
opioid-related overdoses spiked about 30%.2 Those with opioid use disorders (OUDs) face dramatically
Telemedicine: An Application in Search of
increased risk of early death, typically from overdose. Provision of evidence-based medication-assisted Users
treatment (MAT), which can involve methadone, buprenorphine, or naltrexone, to those with OUDs has Mayo Clinic Proceedings, Vol. 71, Issue 4
been shown to reduce the risk of death by as much as 50%.3 Yet access to MAT remains severely
inadequate—notably in rural America, particularly hard hit by the epidemic. Policymakers generally agree
Successful Implementation of a
that more widespread access to MAT is desperately needed; the question remains: how? Telemedicine-Based Counseling Program
for High-Risk Patients With Breast Cancer
Prominent among strategies proposed to ramp-up MAT access is providing it via telemedicine. Mayo Clinic Proceedings, Vol. 88, Issue 1
Telemedicine, or the remote delivery of health care using telecommunications technology, has the
potential to increase access to MAT medicines and concurrent therapy in underserved, remote rural
Stroke Telemedicine
areas by providing direct-to-patient or specialty consultation services from afar. Although telemedicine to
Mayo Clinic Proceedings, Vol. 84, Issue 1
treat patients with OUDs has been piloted favorably, scaling up its provision is not as simple as
connecting a patient to a provider. Rather, stakeholders must surmount considerable regulatory,
logistical, and quality hurdles before telemedicine can help to mitigate the opioid epidemic. Telemedicine: A Glance Into the Future
Mayo Clinic Proceedings, Vol. 69, Issue 12
Jump to Section Go
MAT via Telemedicine View All
Programs capable of providing methadone to treat patients with OUD are concentrated in urban areas
(91%-99% of rural counties lack any) and often have extensive waiting lists.4 Such programs are heavily
regulated, typically required to supervise methadone administration, and have not expanded noticeably
in number in the past decades.4 Naltrexone’s e ectiveness is still being demonstrated, and the
requirement that patients be opioid-abstinent for 7 to 10 days before initiating treatment can limit the
treatment’s utility.5 In short, methadone and naltrexone are not presently the most viable candidates for
MAT expansion via telemedicine in rural America.
Buprenorphine, which can be prescribed in o ce-based settings, is a more realistic option for
telemedicine prescribing.6 Buprenorphine treatment has demonstrated e ectiveness in increasing
patient retention and in reducing opioid use, mortality, and transmission of HIV and hepatitis C.6
Although providers must obtain a federal waiver to prescribe buprenorphine, policy around these waivers
has relaxed in recent years and the number of buprenorphine prescribers continues to expand.6
https://www.mayoclinicproceedings.org/article/S0025-6196(18)30539-1/fulltext 1/5
Nevertheless, rural communities still face a severe shortage in buprenorphine prescribers, and the
average provider with a waiver to prescribe buprenorphine treats far fewer patients than allowed under
law.7
Pilot projects have demonstrated the clinical potential for prescribing buprenorphine via telemedicine.8, 9
For example, an initiative in Maryland provided buprenorphine to more than 300 rural Marylanders.8 A
chart review showed that 59% of patients remained in treatment after 3 months and 94% of those
patients still engaged in treatment at 3 months no longer used opioids illicitly.8 In a West Virginia pilot
study, a review of 2 years of clinic records revealed no signi cant statistical di erence between face-to-
face and telemedicine buprenorphine MAT treatment programs across 3 outcomes: additional substance
use, average time to achieve 30 and 90 consecutive days of abstinence, and treatment retention rates at
90 and 365 days.9 An Ontario, Canada, study demonstrated that 1 year of buprenorphine or methadone
therapy via telemedicine was strongly correlated with improved physical and mental health and reduced
illicit drug use, relapse, hospitalization, mortality, and illegal activity.10 Telemedicine can allow patients
with OUDs to stay in treatment and receive counseling to further recovery. Moreover, through enhanced
convenience, reduced travel time, and cost savings, telemedicine o ers additional bene ts for patients,
physicians, and the greater health care system.
Jump to Section Go
Barriers
Despite its great potential, substantial barriers hinder widescale adoption of telemedicine for MAT. In
2008, Congress enacted the Ryan Haight Online Pharmacy Consumer Protection Act (Haight Act). The
Haight Act prohibits providers from remotely prescribing any controlled substances through telemedicine
unless they rst conduct an in-person examination with the patient, or meet a “practice of telemedicine”
exception—for instance, if the patient is treated by and is physically located at a Drug Enforcement
Agency (DEA)-registered hospital or clinic.11 Congress passed the law to curb rogue Internet pharmacies
that proliferated in the late 1990s from selling controlled substances online.
Haight Act requirements now impede the ability of providers to prescribe buprenorphine, a controlled
substance, via telemedicine. The DEA, acting on behalf of the US Attorney General, has failed to follow
through on a Haight Act requirement that it pass regulations creating a “special registration” process for
certain prescribers, potentially of buprenorphine, relating to the practice of telemedicine. Although the
law allows remote prescribing of controlled substances during a public health emergency, both the
Secretary of Health and Human Services and the Attorney General must agree on which controlled
substances. No such agreement has been reached under the recently declared federal public health
emergency, and even if it were, this exemption would need to be renewed every 90 days.
State laws also regularly pose an impediment to telemedicine providers seeking to prescribe controlled
substances needed by their patients. However, at least 6 states currently allow telemedicine-controlled
substance prescribing without an in-person examination, and thereby lower the barriers for providers to
o er MAT and related care to their patients via telemedicine (see the Table). Indiana's telemedicine law is
particularly thoughtful because it not only expands OUD treatment options by allowing the remote
prescribing of buprenorphine (opioid partial agonist) but also attempts to address the opioid epidemic by
limiting remote access to most prescription opioids. These 6 state laws directly con ict with Haight Act
requirements, violations of which can carry penalties that include prison, nes, and temporary or
permanent loss of the prescriber’s DEA registration. The last documented case of enforcement of such a
Haight Act violation against a physician occurred in July 2011,18 although the threat remains as the DEA
recently reiterated its strict interpretation of Haight Act requirements.19
Table
State Laws Allowing Telemedicine-Controlled Substance Prescribing Without In-Person Examination
(as of June 15, 2018)
E ective
State Remote prescribing date
Delaware12 Treatment and consultation recommendations made in an online setting, July 7,

including issuing a prescription via electronic means, are held to the same 2015
standards of appropriate practice as those in traditional in-person settings.
Without a previous and proper doctor-patient relationship, providers are
prohibited from issuing prescriptions solely in response to an Internet
questionnaire, an Internet consult, or a telephone consult. Prescriptions made
through telemedicine under a valid doctor-patient relationship may include
controlled substances subject to any limitations as set by the Board of Medicine
Florida13 Controlled substances shall not be prescribed through the use of telemedicine March 7,
except for the treatment of psychiatric disorders, including addiction 2016
Indiana14 An Indiana provider may prescribe controlled substances via telemedicine, July 1,
without an in-person examination, if the prescriber satis es the conditions 2017
outlined and the following conditions are met:
The prescription is not for an opioid, unless the opioid is a partial agonist that is
used to treat or manage opioid dependence
The prescriber maintains a valid controlled substance registration
The patient has been examined in-person by a licensed Indiana health care
provider and the licensed health care provider has established a treatment plan
to assist the prescriber in the diagnosis of the patient
The prescriber has reviewed and approved that treatment plan and is
prescribing for the patient pursuant to that treatment plan
The prescriber complies with Indiana’s prescription drug monitoring program
The prescription for a controlled substance is prescribed and dispensed in

accordance with Code 35-48-7
Michigan15 A health care professional treating a patient via telehealth may prescribe a drug March
if both requirements are met: 31, 2017
The health professional is a prescriber acting within the scope of his or her
practice in prescribing the drug; and
If the health professional is prescribing a controlled substance, he or she meets

the requirements applicable to that health professional for prescribing a
controlled substance
Ohio16 An Ohio physician may prescribe controlled substances via telemedicine, March
without an in-person examination, if the physician satis es the steps outlined 23, 2017
and when one of the listed situations exists (largely mirror exceptions under the
federal Ryan Haight Act)
West Remote prescribing without a previous in-person examination is permitted, June 11,
Virginia17 including prescriptions for controlled substances, subject to certain limitations 2016
A physician who practices medicine to a patient solely through the utilization of

telemedicine technologies may not prescribe to that patient any Schedule II
controlled substances
A physician may not prescribe any pain-relieving controlled substance listed in

Schedules II through V as part of a course of treatment for chronic
nonmalignant pain solely on the basis of a telemedicine encounter
View Table in HTML
Logistical barriers to telemedicine for MAT include substantial start-up costs for technologies to be Health
Insurance Portability and Accountability Act–compliant for privacy and security, limited broadband access
in rural areas, and state clinical licensure and prescribing requirements. Although coverage of MAT
services by public and private payers has improved over time, health plans’ utilization criteria and
medication formularies pose persistent access and reimbursement hurdles associated with these
medications and services.
Quality-of-care concerns also warrant careful consideration, even though telemedicine has been shown
to increase treatment and improve outcomes for patients with OUD in many cases.20 Where telemedicine
infrastructure is inadequate, quality and continuity of care may su er. Because MAT typically involves
therapy and other supports, a lack of ability to maintain and share certain patient substance use
treatment records under 42 Code of Federal Regulations Part 2 for auxiliary services could in certain
cases hamper timely, integrated care. Moreover, given the level of alleged fraud currently plaguing
addiction treatment, it is possible that some providers could enter the telemedicine space for nancial
gains rather than to serve the best interests of their patients. Monitoring of patient outcomes and a
commitment to continuous quality improvement can help ensure that providers follow best and evolving
evidence-based practices for buprenorphine treatment via telemedicine.
Jump to Section Go
Policy Recommendations for Expanding MAT via

Telemedicine
Telemedicine represents an integral component to comprehensively tackling the opioid crisis. For this
modality to become a powerful tool, however, serious obstacles must be overcome. Congress must
update the Haight Act to allow addiction treatment centers and community mental health centers to
register with the DEA as clinics, enabling them to prescribe controlled substances via telemedicine
without a previous in-person examination. The DEA should activate the “special registration” provision,
authorizing qualifying providers to use telemedicine without a required in-person examination and
without the need for the patient to be present in a clinic. Several currently proposed bills attempt to
tackle these issues.
Prominent among them is the Opioid Crisis Response Act of 2018, advanced by the Senate Health
Education, Labor & Pensions Committee.21 This proposed legislation addresses a key issue with Haight
Act implementation, by proposing to require the Attorney General to initiate this special registration
process. Some stakeholders remain concerned as to whether it goes far enough in light of the magnitude
and complexity of the crisis.22 In addition, the US House’s “Substance Use-Disorder Prevention that
Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act” passed the full
House on June 22, 2018. Although the Congress is galvanized to act to mitigate the opioid crisis, it is
actively considering dozens of bills23 in this space, any of which requires considerable reconciliation to
resolve di erences and approval from both houses despite broad bipartisan support, as well as signature
by the president, before becoming law; therefore, it is unclear that legislation to facilitate telemedicine for
MAT will be enacted soon. Nevertheless, these initiatives in the Congress are to be strongly applauded
and their expeditious enactment broadly supported: such enactment into law would address many of the
challenges and barriers impeding alleviation of the opioid epidemic, and which we have delineated in the
present commentary.
States should also authorize buprenorphine prescribing by approved providers through telemedicine
without in-person examination. In addition, the Substance Abuse and Mental Health Services
Administration should train providers with a waiver to prescribe buprenorphine in best telemedicine
practices for MAT, as these standards evolve, to ensure both quality and continuity of care in this unique
setting. These changes, in combination with a coordinated national strategy and intelligent funding, could
help to expand OUD treatment in a meaningful way at the height of the opioid epidemic.
Jump to Section Go
References
1. Hedegaard, H., Warner, M., and Miniño, A.M. Drug overdose deaths in the United States, 1999–
2016. NCHS Data Brief, No. 294. National Center for Health Statistics, Hyattsville, MD; 2017
View in Article | Google Scholar
2. Vivolo-Kantor, A.M., Seth, P., Gladden, R.M. et al. Vital signs: trends in emergency department visits
for suspected opioid overdoses — United States, July 2016–September 2017. Morb Mortal Wkly Rep.
2018; 67: 279–285
View in Article | Crossref | PubMed | Google Scholar
3. Schwartz, R.P., Gryczynski, J., O’Grady, K.E. et al. Opioid agonist treatments and heroin overdose
deaths in Baltimore, Maryland, 1995-2009. Am J Public Health. 2013; 103: 917–922
View in Article | Crossref | PubMed | Scopus (98) | Google Scholar
4. Jones, C.M., Campopiano, M., Baldwin, G., and McCance-Katz, E. National and state treatment need
and capacity for opioid agonist medication-assisted treatment. Am J Public Health. 2015; 105: e55–
e63
5. Minozzi, S., Amato, L., Vecchi, S., Davoli, M., Kirchmayer, U., and Verster, A. Oral naltrexone
maintenance treatment for opioid dependence. Cochrane Database Syst Rev. 2011; : CD001333
6. Mattick, R.P., Kimber, J., Breen, C., and Davoli, M. Buprenorphine maintenance versus placebo or
methadone maintenance for opioid dependence. Cochrane Database Syst Rev. 2004; 3: CD002207
View in Article | PubMed | Google Scholar
7. Andrilla, C.H.A., Coultard, C., and Patterson, D.G. Prescribing practices of rural physicians waivered
to prescribe buprenorphine. Am J Prev Med. 2018; 54: S208–S214
View in Article | Abstract | Full Text | Full Text PDF | PubMed | Scopus (13) | Google Scholar
8. Weintraub, E., Chang, J., Currens, M., and Welsh, C. Expanding access to buprenorphine treatment
in rural areas with telemedicine. (Paper presented at: 49th Annual Conference of the American
Society of Addition Medicine; April 13, 2018; San Diego, CA) (Accessed May 18, 2018)
https://www.eventscribe.com/2018/ASAM/ajaxcalls/PosterInfo.asp?
efp=Tk5JV0RMTEEzNDgz&PosterID=134155&rnd=0.7671117
9. Zheng, W., Nickasch, M., Lander, L. et al. Treatment outcome comparison between telepsychiatry
and face-to-face buprenorphine medication-assisted treatment for opioid use disorder: a 2-year
retrospective data analysis. J Addict Med. 2017; 11: 138–144
10. Eibl, J.K., Gauthier, G., Pellegrini, D. et al. The e ectiveness of telemedicine-delivered opioid
agonist therapy in a supervised clinical setting. Drug Alcohol Depend. 2017; 176: 133–138
View in Article | Abstract | Full Text | Full Text PDF | PubMed | Scopus (10) | Google Scholar
11. 21 U.S.C. § 802(54)(A).

12. Del. Code tit. 24, §1769D.
13. Fla. Stat. §64B8-9.0141.
14. Ind. Code §25-1-9.5-7.
15. Mich. Comp. Laws §333.7104.
16. Ohio Rev. Code §4731-11-09; §7331-11-01.
17. W. Va. Code §30-3-13a; §30-14-12d.
18. Drug Enforcement Administration. Registrant actions – 2011. (Accessed May 18, 2018)
https://www.deadiversion.usdoj.gov/fed_regs/actions/2011/fr1011.htm
19. Drug Enforcement Administration, Diversion Control Division. Use of telemedicine while providing
medication assisted treatment (MAT). May 15, 2018. (Accessed May 18, 2018)
https://public.govdelivery.com/accounts/USDOJDEADCD/subscriber/new
20. Hilty, D.M., Ferrer, D.C., Parish, M.B., Johnston, B., Callahan, E.J., and Yellowlees, P.M. The
e ectiveness of telemental health: a 2013 review. Telemed J E Health. 2013; 19: 444–454
21. 115th Congress (2017-2018). S.2680 - Opioid Crisis Response Act of 2018. (Accessed June 18, 2018)
https://www.congress.gov/bill/115th-congress/senate-bill/2680/text
22. Meyer, H. Senate panel advances opioid response bill, but Democrats say more is needed.
Modern Healthcare. April 24, 2018. (Accessed May 18, 2018)
http://www.modernhealthcare.com/article/20180424/NEWS/180429959
23. House Energy and Commerce Committee. Combating the opioid crisis. (Accessed June 18, 2018)
https://energycommerce.house.gov/opioids/
Grant Support: The work was supported by a grant (E.W.) from the Robert Wood Johnson Clinical Scholars
Program and grant KL2TR002241 (R.L.H.) from the National Center for Advancing Translational Sciences of the
National Institutes of Health.
Potential Competing Interests: The authors report no competing interests.
© 2018 Mayo Foundation for Medical Education and Research
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MODEL POLICY FOR THE APPROPRIATE USE OF

TELEMEDICINE TECHNOLOGIES IN THE PRACTICE OF
MEDICINE
Report of the State Medical Boards’ Appropriate Regulation of
Telemedicine (SMART) Workgroup
Adopted as policy by the Federation of State Medical Boards in April 2014
INTRODUCTION
The Federation of State Medical Boards (FSMB) Chair, Jon V. Thomas, MD, MBA, appointed the State Medi-
cal Boards’ Appropriate Regulation of Telemedicine (SMART) Workgroup to review the “Model Guidelines for
the Appropriate Use of the Internet in Medical Practice” (HOD 2002)1 and other existing FSMB policies on
telemedicine and to offer recommendations to state medical and osteopathic boards (hereinafter referred
to as “medical boards” and/or “boards”) based on a thorough review of recent advances in technology and
the appropriate balance between enabling access to care while ensuring patient safety. The Workgroup was
charged with guiding the development of model guidelines for use by state medical boards in evaluating the
appropriateness of care as related to the use of telemedicine, or the practice of medicine using electronic
communication, information technology or other means, between a physician in one location and a patient
in another location with or without an intervening health care provider.
This new policy document provides guidance to state medical boards for regulating the use of telemedicine
technologies in the practice of medicine and educates licensees as to the appropriate standards of care
in the delivery of medical services directly to patients2 via telemedicine technologies. It is the intent of the
SMART Workgroup to offer a model policy for use by state medical boards in order to remove regulatory bar-
riers to widespread appropriate adoption of telemedicine technologies for delivering care while ensuring the
public health and safety.
In developing the guidelines that follow, the Workgroup conducted a comprehensive review of telemedicine
technologies currently in use and proposed/recommended standards of care, as well as identified and con-
sidered existing standards of care applicable to telemedicine developed and implemented by several state
medical boards.
1
The policy on the Appropriate Use of Telemedicine Technologies in the Practice of Medicine supersedes the Model Guidelines for the Appropriate Use of the Internet in
Medical Practice (HOD 2002).
2
The policy does not apply to the use of telemedicine when solely providing consulting services to another physician who maintains the physician-patient relationship with
the patient, the subject of the consultation.
Federation of State Medical Boards | www.fsmb.org 1

MODEL POLICY FOR THE APPROPRIATE USE OF TELEMEDICINE
TECHNOLOGIES IN THE PRACTICE OF MEDICINE
Model Guidelines for State Medical Boards’ Appropriate Regulation of Telemedicine
Section One. Preamble
The advancements and continued development of medical and communications technology have had a profound
impact on the practice of medicine and offer opportunities for improving the delivery and accessibility of health
care, particularly in the area of telemedicine, which is the practice of medicine using electronic communication,
information technology or other means of interaction between a licensee in one location and a patient in another
location with or without an intervening healthcare provider.3 However, state medical boards, in fulfilling their duty
to protect the public, face complex regulatory challenges and patient safety concerns in adapting regulations
and standards historically intended for the in-person provision of medical care to new delivery models involving
telemedicine technologies, including but not limited to: 1) determining when a physician-patient relationship is
established; 2) assuring privacy of patient data; 3) guaranteeing proper evaluation and treatment of the patient;
and 4) limiting the prescribing and dispensing of certain medications.
The [Name of Board] recognizes that using telemedicine technologies in the delivery of medical services offers
potential benefits in the provision of medical care. The appropriate application of these technologies can en-
hance medical care by facilitating communication with physicians and their patients or other health care provid-
ers, including prescribing medication, obtaining laboratory results, scheduling appointments, monitoring chronic
conditions, providing health care information, and clarifying medical advice.4
These guidelines should not be construed to alter the scope of practice of any health care provider or authorize
the delivery of health care services in a setting, or in a manner, not otherwise authorized by law. In fact, these
guidelines support a consistent standard of care and scope of practice notwithstanding the delivery tool or busi-
ness method in enabling Physician-to-Patient communications. For clarity, a physician using telemedicine tech-
nologies in the provision of medical services to a patient (whether existing or new) must take appropriate steps
to establish the physician-patient relationship and conduct all appropriate evaluations and history of the patient
consistent with traditional standards of care for the particular patient presentation. As such, some situations
and patient presentations are appropriate for the utilization of telemedicine technologies as a component of, or
in lieu of, in-person provision of medical care, while others are not.5
The Board has developed these guidelines to educate licensees as to the appropriate use of telemedicine tech-
nologies in the practice of medicine. The [Name of Board] is committed to assuring patient access to the conve-
nience and benefits afforded by telemedicine technologies, while promoting the responsible practice of medicine
by physicians.
It is the expectation of the Board that physicians who provide medical care, electronically or otherwise, maintain
the highest degree of professionalism and should:
• Place the welfare of patients first;

• Maintain acceptable and appropriate standards of practice;
3
See Center for Telehealth and eHealth Law (Ctel), http://ctel.org/ (last visited Dec. 17, 2013).
4
Id.
5
See Cal. Bus. & Prof. Code § 2290.5(d).

• Adhere to recognized ethical codes governing the medical profession;

• Properly supervise non-physician clinicians; and
• Protect patient confidentiality.
Section Two. Establishing the Physician-Patient Relationship
The health and well-being of patients depends upon a collaborative effort between the physician and patient.6
The relationship between the physician and patient is complex and is based on the mutual understanding of the
shared responsibility for the patient’s health care. Although the Board recognizes that it may be difficult in some
circumstances to precisely define the beginning of the physician-patient relationship, particularly when the physi-
cian and patient are in separate locations, it tends to begin when an individual with a health-related matter seeks
assistance from a physician who may provide assistance. However, the relationship is clearly established when
the physician agrees to undertake diagnosis and treatment of the patient, and the patient agrees to be treated,
whether or not there has been an encounter in person between the physician (or other appropriately supervised
health care practitioner) and patient.
The physician-patient relationship is fundamental to the provision of acceptable medical care. It is the expecta-
tion of the Board that physicians recognize the obligations, responsibilities, and patient rights associated with
establishing and maintaining a physician-patient relationship. A physician is discouraged from rendering medi-
cal advice and/or care using telemedicine technologies without (1) fully verifying and authenticating the location
and, to the extent possible, identifying the requesting patient; (2) disclosing and validating the provider’s identity
and applicable credential(s); and (3) obtaining appropriate consents from requesting patients after disclosures
regarding the delivery models and treatment methods or limitations, including any special informed consents
regarding the use of telemedicine technologies. An appropriate physician-patient relationship has not been es-
tablished when the identity of the physician may be unknown to the patient. Where appropriate, a patient must
be able to select an identified physician for telemedicine services and not be assigned to a physician at random.
Section Three. Definitions
For the purpose of these guidelines, the following definitions apply:
“Telemedicine” means the practice of medicine using electronic communications, information technology or
other means between a licensee in one location, and a patient in another location with or without an intervening
healthcare provider. Generally, telemedicine is not an audio-only, telephone conversation, e-mail/instant mes-
saging conversation, or fax. It typically involves the application of secure videoconferencing or store and forward
technology to provide or support healthcare delivery by replicating the interaction of a traditional, encounter in
person between a provider and a patient.7
“Telemedicine Technologies” means technologies and devices enabling secure electronic communications and
information exchange between a licensee in one location and a patient in another location with or without an
intervening healthcare provider.
6
American Medical Association, Council on Ethical and Judicial Affairs, Fundamental Elements of the Patient-Physician Relationship (1990), available at http://www.ama-
assn.org/resources/doc/code-medical-ethics/1001a.pdf.
7
See Ctel.

Section Four. Guidelines for the Appropriate Use of Telemedicine Technologies in Medical Practice
The [Name of Board] has adopted the following guidelines for physicians utilizing telemedicine technologies in
the delivery of patient care, regardless of an existing physician-patient relationship prior to an encounter:
Licensure:
A physician must be licensed, or under the jurisdiction, of the medical board of the state where the patient is
located. The practice of medicine occurs where the patient is located at the time telemedicine technologies are
used. Physicians who treat or prescribe through online services sites are practicing medicine and must possess
appropriate licensure in all jurisdictions where patients receive care.8
Establishment of a Physician-Patient Relationship:

Where an existing physician-patient relationship is not present, a physician must take appropriate steps to es-
tablish a physician-patient relationship consistent with the guidelines identified in Section Two, and, while each
circumstance is unique, such physician-patient relationships may be established using telemedicine technolo-
gies provided the standard of care is met.
Evaluation and Treatment of the Patient:

A documented medical evaluation and collection of relevant clinical history commensurate with the presentation
of the patient to establish diagnoses and identify underlying conditions and/or contra-indications to the treat-
ment recommended/provided must be obtained prior to providing treatment, including issuing prescriptions,
electronically or otherwise. Treatment and consultation recommendations made in an online setting, including
issuing a prescription via electronic means, will be held to the same standards of appropriate practice as those in
traditional (encounter in person) settings. Treatment, including issuing a prescription based solely on an online
questionnaire, does not constitute an acceptable standard of care.
Informed Consent:
Evidence documenting appropriate patient informed consent for the use of telemedicine technologies must be
obtained and maintained. Appropriate informed consent should, as a baseline, include the following terms:
• Identification of the patient, the physician and the physician’s credentials;

• Types of transmissions permitted using telemedicine technologies (e.g. prescription refills, appointment
scheduling, patient education, etc.);
• The patient agrees that the physician determines whether or not the condition being diagnosed and/or
treated is appropriate for a telemedicine encounter;
• Details on security measures taken with the use of telemedicine technologies, such as encrypting data,
password protected screen savers and data files, or utilizing other reliable authentication techniques,
as well as potential risks to privacy notwithstanding such measures;
• Hold harmless clause for information lost due to technical failures; and
• Requirement for express patient consent to forward patient-identifiable information to a third party.
8
Federation of State Medical Boards, A Model Act to Regulate the Practice of Medicine Across State Lines (April 1996), available at http://www.fsmb.org/pdf/1996_grpol_
telemedicine.pdf.

Continuity of Care:
Patients should be able to seek, with relative ease, follow-up care or information from the physician [or phy-
sician’s designee] who conducts an encounter using telemedicine technologies. Physicians solely providing
services using telemedicine technologies with no existing physician-patient relationship prior to the encounter
must make documentation of the encounter using telemedicine technologies easily available to the patient, and
subject to the patient’s consent, any identified care provider of the patient immediately after the encounter.
Referrals for Emergency Services:

An emergency plan is required and must be provided by the physician to the patient when the care provided us-
ing telemedicine technologies indicates that a referral to an acute care facility or ER for treatment is necessary
for the safety of the patient. The emergency plan should include a formal, written protocol appropriate to the
services being rendered via telemedicine technologies.
Medical Records:
The medical record should include, if applicable, copies of all patient-related electronic communications, includ-
ing patient-physician communication, prescriptions, laboratory and test results, evaluations and consultations,
records of past care, and instructions obtained or produced in connection with the utilization of telemedicine
technologies. Informed consents obtained in connection with an encounter involving telemedicine technologies
should also be filed in the medical record. The patient record established during the use of telemedicine technol-
ogies must be accessible and documented for both the physician and the patient, consistent with all established
laws and regulations governing patient healthcare records.
Privacy and Security of Patient Records & Exchange of Information:

Physicians should meet or exceed applicable federal and state legal requirements of medical/health informa-
tion privacy, including compliance with the Health Insurance Portability and Accountability Act (HIPAA) and state
privacy, confidentiality, security, and medical retention rules. Physicians are referred to “Standards for Privacy
of Individually Identifiable Health Information,” issued by the Department of Health and Human Services (HHS).9
Guidance documents are available on the HHS Office for Civil Rights Web site at: www.hhs.gov/ocr/hipaa.
Written policies and procedures should be maintained at the same standard as traditional face-to-face encoun-
ters for documentation, maintenance, and transmission of the records of the encounter using telemedicine
technologies. Such policies and procedures should address (1) privacy, (2) health-care personnel (in addition to
the physician addressee) who will process messages, (3) hours of operation, (4) types of transactions that will be
permitted electronically, (5) required patient information to be included in the communication, such as patient
name, identification number and type of transaction, (6) archival and retrieval, and (7) quality oversight mecha-
nisms. Policies and procedures should be periodically evaluated for currency and be maintained in an accessible
and readily available manner for review.
Sufficient privacy and security measures must be in place and documented to assure confidentiality and integ-
rity of patient-identifiable information. Transmissions, including patient e-mail, prescriptions, and laboratory
9
45 C.F.R. § 160, 164 (2000).

results must be secure within existing technology (i.e. password protected, encrypted electronic prescriptions, or
other reliable authentication techniques). All patient-physician e-mail, as well as other patient-related electronic
communications, should be stored and filed in the patient’s medical record, consistent with traditional record-
keeping policies and procedures.
Disclosures and Functionality on Online Services Making Available Telemedicine Technologies:

Online services used by physicians providing medical services using telemedicine technologies should clearly
disclose:
• Specific services provided;

• Contact information for physician;
• Licensure and qualifications of physician(s) and associated physicians;
• Fees for services and how payment is to be made;
• Financial interests, other than fees charged, in any information, products, or services provided by a
physician;
• Appropriate uses and limitations of the site, including emergency health situations;
• Uses and response times for e-mails, electronic messages and other communications transmitted via
telemedicine technologies;
• To whom patient health information may be disclosed and for what purpose;
• Rights of patients with respect to patient health information; and
• Information collected and any passive tracking mechanisms utilized.
Online services used by physicians providing medical services using telemedicine technologies should provide
patients a clear mechanism to:
• Access, supplement and amend patient-provided personal health information;

• Provide feedback regarding the site and the quality of information and services; and
• Register complaints, including information regarding filing a complaint with the applicable state medical
and osteopathic board(s).
Online services must have accurate and transparent information about the website owner/operator, location,
and contact information, including a domain name that accurately reflects the identity.
Advertising or promotion of goods or products from which the physician receives direct remuneration, benefits, or
incentives (other than the fees for the medical care services) is prohibited. Notwithstanding, online services may
provide links to general health information sites to enhance patient education; however, the physician should
not benefit financially from providing such links or from the services or products marketed by such links. When
providing links to other sites, physicians should be aware of the implied endorsement of the information, services
or products offered from such sites. The maintenance of preferred relationships with any pharmacy is prohibited.
Physicians shall not transmit prescriptions to a specific pharmacy, or recommend a pharmacy, in exchange for
any type of consideration or benefit form that pharmacy.

Prescribing:
Telemedicine technologies, where prescribing may be contemplated, must implement measures to uphold pa-
tient safety in the absence of traditional physical examination. Such measures should guarantee that the iden-
tity of the patient and provider is clearly established and that detailed documentation for the clinical evaluation
and resulting prescription is both enforced and independently kept. Measures to assure informed, accurate, and
error prevention prescribing practices (e.g. integration with e-Prescription systems) are encouraged. To further
assure patient safety in the absence of physical examination, telemedicine technologies should limit medication
formularies to ones that are deemed safe by [Name of Board].
Prescribing medications, in-person or via telemedicine, is at the professional discretion of the physician. The
indication, appropriateness, and safety considerations for each telemedicine visit prescription must be evaluated
by the physician in accordance with current standards of practice and consequently carry the same professional
accountability as prescriptions delivered during an encounter in person. However, where such measures are
upheld, and the appropriate clinical consideration is carried out and documented, physicians may exercise their
judgment and prescribe medications as part of telemedicine encounters.
Section Five. Parity of Professional and Ethical Standards

Physicians are encouraged to comply with nationally recognized health online service standards and codes of
ethics, such as those promulgated by the American Medical Association, American Osteopathic Association,
Health Ethics Initiative 2000, Health on the Net and the American Accreditation HealthCare Commission (URAC).
There should be parity of ethical and professional standards applied to all aspects of a physician’s practice.
A physician’s professional discretion as to the diagnoses, scope of care, or treatment should not be limited or
influenced by non-clinical considerations of telemedicine technologies, and physician remuneration or treatment
recommendations should not be materially based on the delivery of patient-desired outcomes (i.e. a prescription
or referral) or the utilization of telemedicine technologies.

REFERENCES
American Accreditation HealthCare Commission. Health Web Site Standards. July 2001.
AMA. Council on Ethical and Judicial Affairs. Code of Medical Ethics. 2000-2001.
AMA. Report of the Council on Medical Service. Medical Care Online. 4-A-01 (June 2001).
College of Physicians and Surgeons of Alberta. Policy Statement. Physician/Patient Relationships (February 2000).
Colorado Board of Medical Examiners. Policy Statement Concerning the Physician-Patient Relationship.
The Department of Health and Human Services, HIPPA Standards for Privacy of Individually Identifiable Health Informa-
tion. August 14, 2002.
FSMB. A Model Act to Regulate the Practice of Medicine Across State Lines. April 1996.
Health Ethics Initiative 2000. eHealth Code of Ethics. May 2000.
Health on the Net Foundation. Code of Medical Conduct for Medical and Health Web Sites. January 2000.
La. Admin. Code tit. 46, pt. XLV, § 7501-7521.
New York Board for Professional Medical Conduct. Statements on Telemedicine (draft document). October 2000.
North Carolina Medical Board. Position Statement. Documentation of the Physician-Patient Relationship. May 1,
1996.
Oklahoma Board of Medical Licensure. Policy on Internet Prescribing. November 2, 2000.
South Carolina Board of Medical Examiners. Policy Statement. Internet Prescribing. July 17, 2000.
Texas State Board of Medical Examiners. Internet Prescribing Policy. December 11, 1999.
Washington Board of Osteopathic Medicine and Surgery. Policy Statement. Prescribing Medication without Physician/
Patient Relationship. June 2, 2000.

SMART WORKGROUP
Kenneth B. Simons, MD, Chairman

Chair, State of Wisconsin Dept of Safety & Professional EX OFFICIOS
Services
Jon V. Thomas, MD, MBA
Michael R. Arambula, MD, PharmD Chair, FSMB
Member, Texas Medical Board
Donald H. Polk, DO
Michael J. Arnold, MBA Chair-elect, FSMB
Member, North Carolina Medical Board
Humayun J. Chaudhry, DO, MACP
Ronald R. Burns, DO President & CEO, FSMB
Chair, Florida Board of Osteopathic Medicine
Anna Earl, MD STAFF SUPPORT

Immediate Past President, Montana Board of Medical
Examiners Lisa A. Robin, MLA
Chief Advocacy Officer, FSMB
Gregory B. Snyder, MD
President, Minnesota Board of Medical Practice Shiri Hickman, JD
State Legislative & Policy Manager, FSMB
Jean Rawlings Sumner, MD
Past Chair & Current Medical Director, Georgia Composite
Medical Board
SUBJECT MATTER EXPERT
Elizabeth P. Hall
WellPoint, Inc.
Alexis S. Gilroy, JD
Jones Day LLP
Sherilyn Z. Pruitt, MPH

Director, HRSA Office for the Advancement of Telehealth
Roy Schoenberg, MD, PhD, MPH

President & CEO, American Well Systems
© Copyright 2014 by the Federation of State Medical Boards

(817) 868-4000 | www.fsmb.org

8/30/2019 Epigenetic variation in OPRM1 gene in opioid-exposed mother-infant dyads. - PubMed - NCBI
PubMed
Format: Abstract Full text links
Genes Brain Behav. 2018 Sep;17(7):e12476. doi: 10.1111/gbb.12476. Epub 2018 Apr 19.
Epigenetic variation in OPRM1 gene in opioid-exposed mother-infant

dyads.
Wachman EM1, Hayes MJ2, Shrestha H1, Nikita FNU3, Nolin A4, Hoyo L4, Daigle K5, Jones HE6,7,8, Nielsen
DA9.
Author information
Abstract
Neonatal abstinence syndrome (NAS) due to in-utero opioid exposure has significant variability of
severity. Preliminary studies have suggested that epigenetic variation within the μ-opioid receptor
(OPRM1) gene impacts NAS. We aimed to determine if DNA methylation in OPRM1 within opioid-
exposed mother-infant dyads is associated with differences in NAS severity in an independent
cohort. Full-term opioid-exposed newborns and their mothers (N = 68 pairs) were studied. A DNA
sample was obtained and then assessed for level of DNA methylation at 20 CpG sites within the
OPRM1 promoter region by next-generation sequencing. Infants were monitored for NAS and treated
with replacement opioids according to institutional protocol. The association between DNA
methylation level at each CpG site with NAS outcome measures was evaluated using linear and
logistic regression models. Higher methylation levels within the infants at the -18 (11.4% vs 4.4%, P
= .0001), -14 (46.1% vs 24.0%, P = .002) and +23 (26.3% vs 12.9%, P = .008) CpG sites were
associated with higher rates of infant pharmacologic treatment. Higher levels of methylation within
the mothers at the -169 (R = 0.43, P = .008), -152 (R = 0.40, P = .002) and +84 (R = 0.44, P = .006)
sites were associated point-wise with longer infant length of stay. Maternal associations remained
significant point-wise for -169 (β = 0.07, P = .007) and on an experiment-wise level for +84 (β =
-0.10, P = .003) using regression models. These results suggest an association of higher levels of
OPRM1 methylation at specific CpG sites and increased NAS severity, replicating prior findings.
These findings have important implications for personalized treatment regimens for infants at high
risk for severe NAS.
© 2018 John Wiley & Sons Ltd and International Behavioural and Neural Genetics Society.
KEYWORDS: DNA methylation; NAS; OPRM1; epigenetics; neonatal abstinence syndrome; opioids
PMID: 29575474 DOI: 10.1111/gbb.12476

[Indexed for MEDLINE]
https://www.ncbi.nlm.nih.gov/pubmed/29575474 1/2
8/30/2019 Epigenetic variation in OPRM1 gene in opioid-exposed mother-infant dyads. - PubMed - NCBI
Publication type, MeSH terms, Substances, Grant support
LinkOut - more resources
https://www.ncbi.nlm.nih.gov/pubmed/29575474 2/2
8/30/2019 Profound Increase in Epinephrine Concentration in Plasma and Cardiovascular Stimulation after [micro sign]-Opioid Receptor Blockade i…
(/)
Clinical Science | May 1998
Profound Increase in Epinephrine Concentration in Plasma and Cardiovascular Stimulation
after [micro sign]-Opioid Receptor Blockade in Opioid-addicted Patients during
Barbiturate-induced Anesthesia for Acute Detoxi cation
(Kienbaum) Research Fellow, Abteilung fur Anasthesiologie und Intensivmedizin.
(Thurauf) Staff Anesthesiologist, Abteilung fur Anasthesiologie und Intensivmedizin.
(Michel) Professor of Pharmacology, Biochemisches Forschungslabor, Abteilung fur Nieren-und Hochdruckkrankheiten.
(Scherbaum) Staff Psychiatrist, Klinik fur Allgemeine Psychiatrie.
(Gastpar) Professor of Psychiatry; Chairman, Klinik fur Allgemeine Psychiatrie.
(Peters) Professor of Anesthesiology and Intensive Care Therapy; Chairman, Abteilung fur Anasthesiologie und Intensivmedizin.
From the Abteilung fur Anasthesiologie und Intensivmedizin, Biochemisches Forschungslabor der Abteilung fur Nieren- und
Hochdruckkrankheiten, and Klinik fur Allgemeine Psychiatrie der Rheinischen Landes- und Hochschulklinik, Universitat GH Essen, Germany.
Submitted for publication August 26, 1997. Accepted for publication December 30, 1997. Supported in part by the Deutsche
Forschungsgemeinschaft (DFG Pe 301/3–1) and Lilly Deutschland GmbH. Presented in part at the Annual Meeting of the American Society of
Anesthesiologists, San Diego, California, October 18–22, 1997.
Address reprint requests to Dr. Kienbaum: Abteilung fur Anasthesiologie und Intensivmedizin, Universitat GH Essen, Hufelandstr. 55, D-
45122 Essen, Germany. Address electronic mail to: (peter.kienbaum@uni-essen.de).
Anesthesiology 5 1998, Vol.88, 1154-1161. doi:
A MAJOR goal in the treatment of opioid addiction is to achieve abstinence from the drug. Unfortunately, classic forms of treatment are costly and not
very effective, with patient drop-out rates as high as 30%. [1] These objections have encouraged many clinicians to look for innovative forms of treatment
to improve outcome. In particular, mitigation of opioid withdrawal symptoms is a desirable objective because these symptoms are thought to contribute to
termination of therapy by the patient. Recently, a new approach coined ultrarapid opioid detoxi cation has been described, with programs starting in
many hospitals worldwide. [2–6] The principle idea of this approach is to antagonize any opioid effects rapidly by the administration of large doses of
[micro sign]-opioid receptor antagonists. General anesthesia is induced before the start of opioid antagonization and maintained for several hours to
prevent perception of withdrawal symptoms by the patient.
This treatment represents a new clinical area of interest for anesthesiologists, and it also offers the unique opportunity to assess cardiovascular effects of
opioid receptor blockade during conditions of a chronically stimulated opioid receptor system in humans. In the current study, we tested the hypothesis
that [micro sign]-opioid receptor blockade by intravenous administration of naloxone (Curamed, Karlsruhe, Germany) results in signi cant cardiovascular
effects mediated by the sympathoadrenal system, despite barbiturate-induced anesthesia, and we assessed the clinical feasibility of this method.
Materials and Methods

The protocol of the study, including catheterization, blood sampling, administration of barbiturates to induce anesthesia, and the use of high doses of
naloxone, was approved by the ethics committee of the University GH Essen and is consistent with the Declarations of Helsinki. All patients were
informed that the treatment they would receive was not an established one, and they gave written informed consent before participating in this study.
Patients
All data are presented as mean +/- SD unless otherwise indicated. Ten patients (six women; 28 +/- 7 yr old; range, 20–39 yr old) were selected on a
voluntary basis from the local methadone out-patient care unit. All had a long history of opioid abuse (73 +/- 51 months; range, 13–180 months) and were
treated with orally administered methadone (96 +/- 57 mg/day; range, 50–130 mg/day for 19 +/- 19 months; range, 1–60 months). The patients were
admitted to the hospital at least 1 day before treatment and were screened by clinical history, physical examination, laboratory examination,
electrocardiogram, and chest radiography. Other than methadone, the patients reported that they did not consume other drugs, which was con rmed by
repeated urine toxicology screens before inclusion in the study. Patients did not suffer from any overt disease, except ve patients had serologic evidence
of exposure to the hepatitis B or C virus without clinical or laboratory signs of impaired liver function.
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8/30/2019 Profound Increase
The last dose of methadone in Epinephrine
was given Concentration
24 h before treatment withinnaloxone.
Plasma and Cardiovascular
Flunitrazepam Stimulation
(1 mg after [micro sign]-Opioid
orally; Rohypnol[registered Receptor
sign]; Roche, Blockade i…
Grenzach-
Wyhlen, Germany) was administered as a premedication before the patients were transferred to our intensive care unit.
Methods
After admission to the intensive care unit in the morning, a peripheral venous cannula and an arterial and a pulmonary artery catheter were inserted using
local anesthesia for uid replacement and hemodynamic monitoring. If required, mild sedation by midazolam (Dormicum[registered sign]; Roche) was
provided. For prophylaxis of infection and potential development of gastrointestinal ulcers during withdrawal, 2 g ceftriaxone (Elzogram[registered sign];
Lilly, Bad Homburg, Germany) and 20 mg famotidine (Pepdul[registered sign]; MSD Chibropharm, Haar, Germany) were given. Heparin
(Liquemin[registered sign]; Roche) was administered (625 U/h) for prophylaxis of thrombosis. The infusion rate of Ringer's lactate (460 +/- 98 ml/h) was
adjusted to keep right atrial and pulmonary artery occlusion pressures at baseline values (central venous pressure, 7 +/- 3 mmHg; pulmonary artery,
occlusion pressure, 8 +/- 3 mmHg.) Potassium chloride was infused as required (8 +/- 3 mmol/h) to maintain serum concentration of potassium close to the
baseline value.
After a resting period of 30–60 min, general anesthesia was induced by 2–4 mg/kg methohexital (Brevimytal [registered sign]; Lilly) and a single dose (0.1
mg/kg) of piperocuronium (Arpilon [registered sign]; Organon, Oberschleissheim, Germany) for muscle relaxation. The trachea was intubated, and the
patients were mechanically ventilated (fractional inspired oxygen concentration, 0.21–0.3; positive end-expiratory pressure [PEEP], 3 mmHg). In addition,
a gastric tube, a urinary catheter, and a rectal tube were placed. Anesthesia was maintained by continuous infusion of methohexial (74 +/- 44 micro gram
[center dot] kg-1[center dot] min-1) titrated to abolish corneal and glabella re exes. This dose also suppressed the response to painful stimuli such as
pinching of the skin, as studied in pilot patients. A minimum interval of 1 h was allowed to elapse before starting administration of naloxone to achieve a
cardiorespiratory and anesthetic steady state. Steady-state conditions after induction of anesthesia were assumed when heart rate, arterial pressures,
and cardiac index differed by < 10% between two measurements taken >or= to 30 min apart. Normocapnia was established and repeatedly con rmed by
analysis of arterial blood gas.
Measurements
Arterial pressures and pulmonary artery, central venous, and pulmonary artery occlusion pressures were measured by electromanometry relative to
barometric pressure with transducers referenced to the midaxillary line. Heart rate was determined from the electrocardiogram (lead two) of a ve-lead
electrocardiogram recording system, including ST segment analysis (Sirecust 1281; Siemens, Erlangen, Germany). Cardiac output was determined in
triplicate by thermodilution, injecting 10 ml of iced saline irrespective of the respiratory phase. [7,8] Calculations were performed with variables
normalized to body surface area and expressed as cardiac, stroke volume, and systemic vascular resistance indices using standard formulae.
Concentrations of Catecholamine in Plasma

Concentrations of norepinephrine and epinephrine in plasma were determined by high-performance liquid chromatography with electrochemical
detection (lower detection limit, 10 pg/ml; coef cient of variation, 6.2% for norepinephrine, 6.8% for epinephrine). Mixed venous blood drawn from the
pulmonary artery was sampled at speci ed intervals into chilled tubes with ethylenediaminetetraacetic acid, cooled to +4 [degree sign]C in ice water, and
immediately centrifuged. Plasma was stored at -80 [degree sign]C until analysis. [9]
Study Protocol
Treatment with naloxone was started after achieving steady-state conditions during anesthesia (see previous section) using a rst dose of 0.4 mg
administered intravenously. Four additional naloxone bolus doses of increasing dose amount (0.8, 1.6, 3.2, and 6.4 mg) were injected at 15-min intervals.
Accordingly, a total of 12.4 mg of naloxone was given during a 60-min period. This stepwise approach was chosen for safety reasons because
complications after injection of naloxone have been described, [10–16] and effects in our patients were considered unpredictable.
Seventy- ve minutes after the rst dose of naloxone, an infusion of naloxone was started in a dose of 0.8 mg/h for 24 h. [micro sign]-opioid receptor
blockade was continued with 50 mg/d naltrexon administered via the gastric tube starting 12 h after the rst injection of naloxone.
Cardiovascular variables were assessed before induction of anesthesia (patient awake), at least twice within the period before application of naloxone,
and 15 min after each bolus dose of naloxone, i.e., after 15, 30, 45, 60, and 75 min, and 120 and 180 min after the initial administration of naloxone. At the
same time, pulmonary arterial blood was collected for determination of concentrations of epinephrine and norepinephrine in plasma.
Continuous infusion of methohexital was stopped after the 180-min observation period. To attenuate withdrawal symptoms after anesthesia, clonidine
([nearly =] 2 micro gram [center dot] kg-1[center dot] h-1) was given intravenously until the patient was discharged to the psychiatric ward the next
morning, as required.
Statistical Analysis
Differences in mean values of variables over time were determined by one-way repeated-measures analysis of variance followed by Fisher's post hoc test.
The following a priori null hypotheses were tested: There is no difference in means of variables at baseline (before administration of naloxone) compared
with observations (1) after administration of naloxone and (2) before induction of anesthesia. A null hypothesis was rejected, and statistical signi cance
assumed with an alpha error (P value) < 0.05.
Results
ThisConcentrations
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8/30/2019
Concentration ofProfound Increase
epinephrine in Epinephrine
in plasma was 15 +/-Concentration in Plasma andofCardiovascular
9 pg/ml, and concentration norepinephrineStimulation after76
in plasma was [micro sign]-Opioid
+/- 44 pg/ml afterReceptor
achievingBlockade
steady- i…
state conditions after induction of anesthesia. Administration of naloxone induced a 30-fold increase in concentration of epinephrine in plasma (to 458 +/-
304 pg/ml and a threefold signi cant increase in concentration of norepinephrine in plasma (to 226 +/- 58 pg/ml). Peak concentrations were attained after
60–75 min and remained signi cantly increased compared with baseline values until the end of the observation period (Figure 1).
Figure 1. Concentrations of epinephrine and norepinephrine in plasma in the awake state before induction of anesthesia, during methohexital-induced anesthesia, and after
administration of the [micro sign]-opioid receptor antagonist naloxone. Administration of incremental bolus doses of naloxone is indicated by arrows (top). Seventy- ve minutes
after the rst injection of naloxone, a continuous infusion of naloxone (0.8 mg/h) was started. Concentrations of epinephrine in plasma increased 30-fold after administration of
naloxone, and concentration of norepinephrine in plasma signi cantly increased threefold. (dagger)P <0.05 versus baseline in the awake state before induction of anesthesia;*P <
0.05 versus methohexical-induced anesthesia before administration of naloxone.
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Cardiovascular Alterations
Administration of naloxone markedly increased heart rate within 1–2 min, from 89 +/- 16 to a plateau of 108 +/- 17 beats/min with no further increase.
Stroke volume index also increased from 31 +/- 8 to 45 +/- 11 ml [center dot] m-2(P < 0.05) but in a more gradual fashion. Increased heart rate and stroke
volume index resulted in a marked increase in cardiac index, from 2.7 +/- 0.41 to 4.7 +/- 1.7 min (-1)[center dot] m-2(+74%), reaching a plateau after [nearly
=] 45 min (Figure 2). In parallel, systemic vascular resistance index decreased from 2,484 +/- 762 to 1,495 +/- 539 dyne [center dot] s [center dot] cm-
5[center dot] m-2(P < 0.05;Figure 2).
Figure 2. Cardiovascular variables before induction of anesthesia, during methohexital-induced anesthesia, and after administration of the [micro sign]-opioid receptor antagonist
naloxone. Administration of incremental bolus doses of naloxone is indicated by arrows (top). Seventy- ve minutes after the rst injection of naloxone, a continuous infusion of
naloxone (0.8 mg/h) was started. Induction of anesthesia resulted in a signi cant decrease in stroke volume index and an increase in heart rate, whereas cardiac and systemic
vascular resistance indices did not change signi cantly. Injection of naloxone was associated with a marked increases in cardiac and stroke volume indices and heart rate, whereas
systemic vascular resistance index decreased. The observed effects of naloxone reached an apparent plateau within 60 min after the rst injection of naloxone. (dagger)P < 0.05
versus baseline in the awake state before induction of anesthesia;*P < 0.05 versus methohexital-induced anesthesia before administration of naloxone.
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Systolic arterial pressure signi cantly increased from 113 +/- 16 +/- 5 to 138 +/- 16 mmHg, reaching maximum 15–30 min after initiation of naloxone
administration, whereas diastolic arterial pressure remained unchanged (71 +/- 16 vs. 80 +/- 16 mmHg after administration of naloxone, P = 0.13;Figure
3).
Figure 3. Systolic and diastolic arterial pressures before induction of anesthesia, during methohexital-induced anesthesia, and after administration of the [micro sign]-opioid
receptor antagonist naloxone. Administration of incremental bolus doses of naloxone is indicated by arrows (top). Seventy- ve minutes after the rst injection of naloxone, a
continuous infusion of naloxone (0.8 mg/h) was started. Induction of anesthesia resulted in a signi cant decrease in systolic arterial pressure. Administration of naloxone induced a
22% increase in systolic arterial pressure, reaching a maximum at 30 min, whereas diastolic arterial pressure remained unchanged. (dagger)P < 0.05 versus baseline in the awake
state before induction of anesthesia;*P < 0.05 versus methohexital-induced anesthesia before administration of naloxone.
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Mean pulmonary artery pressure increased from 15 +/- 5 to 20 +/- 4 mmHg (P < 0.05) at 30 min, whereas pulmonary vascular resistance remained normal
and unchanged throughout the observation period.
Clinical Observations
The clinical signs of [micro sign]-opioid receptor blockade were observed in all patients: marked gastrointestinal secretion with 500–1,000 ml of uids
draining from the gastric tube and rectal discharges of 200–500 ml during the 180-min observation period.
None of the patients moved, coughed, or vomited during the observation period after administration of naloxone. Further, all patients showed miosis and
absence of the corneal and glabella re exes during anesthesia and administration of naloxone until sedation was terminated.
After discontinuation of methohexital 180 min after the rst dose of naloxone, patients started sweating, hyperventilating, moving, and coughing. Patients
were extubated 264 +/- 219 min after administration of methohexital was stopped. No complications attributable to treatment with naloxone were
observed.
Discussion
This study is the rst to assess concentrations of catecholamine in plasma and cardiovascular alterations after [micro sign]-opioid receptor blockade in
patients addicted to opioids. These results are clinically important for evaluation of potential cardiovascular risk and for guiding care and improving
patient safety during acute detoxi cation in those addicted to opioids. This study represents a unique setting for assessment of the effects of acute [micro
sign]-opioid receptor blockade in humans with a chronically stimulated opioid receptor system.
Most important, a 30-fold increase in concentration of epinephrine in plasma, a small increase in concentration of norepinephrine in plasma, and profound
cardiovascular alterations were observed after [micro sign]-opioid receptor blockade despite maintenance of general anesthesia. Because of the
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addicted to opioids should be performed by trained
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anesthesiologists or intensivists.
Critique of Methods
Sympathetic nervous system activity, concentrations of catecholamine in plasma, and cardiovascular variables are potentially in uenced by anesthesia,
altered cardiac lling, and changes in arterial blood gas tensions induced by mechanical ventilation. [10–12] Barbiturate-induced anesthesia abolished
corneal and glabella re exes. The absence of circulatory stress during anesthesia at baseline before administration of naloxone was indicated by
constantly decreased arterial pressure and stroke volume index and by low concentrations of catecholamine in plasma. [13,14] The increased heart rate
observed after induction of anesthesia by methohexital is most likely due to its parasympatholytic activity. [15,16] To minimize changes that may alter
sympathetic nervous system activity, central venous and pulmonary artery occlusion pressures were maintained by administration of Ringer's lactate
solution, and normocarbia was established.
Effects of receptor antagonists depend on concentrations of receptor agonist and antagonist. In our patients, [micro sign]-opioid receptor blockade
induced marked gastrointestinal secretion, indicating that effective doses of naloxone had been injected. Finally, when assessing the effect of long-term
opioid receptor stimulation and blockade in addicted patients, interference with other drugs must be considered. In our study, we carefully selected only
patients addicted to one opioid that was substituted with orally administered methadone and con rmed the absence of intake of other drugs by repeated
drug screening.
In anesthetic practice, the [micro sign]-opioid receptor antagonist naloxone is the drug of choice for reversing opioid-induced respiratory depression. Rare
but serious complications have been reported after [micro sign]-opioid receptor antagonization, however, including marked arterial hypertension,
pulmonary edema, and sudden death after administration of even small doses of naloxone. [17–23] The exact mechanisms responsible for these adverse
effects are unknown, and no data have been reported regarding cardiovascular alterations in patients addicted to opioids. Accordingly, to minimize
potential complications, we administered naloxone in a stepwise fashion.
Interpretation of Results
Conventional detoxi cation from long-term intake of opioids in addicted patients is accompanied by unpleasant withdrawal symptoms and drop-out rates
of up to 30% during initial therapy. [1] It is widely accepted that the severity of withdrawal symptoms during detoxi cation is positively correlated with the
frequency of unsuccessful therapy. Accordingly, general anesthesia is induced before [micro sign]-opioid receptor blockade in the approach described
here of acute opioid detoxi cation to prevent perception of withdrawal symptoms by the patient. The purpose of administering high doses of naloxone is
to terminate [micro sign]-opioid receptor stimulation rapidly and to prepare maintenance of prolonged [micro sign]-opioid receptor blockade by
naltrexone while minimizing withdrawal symptoms, e.g., by administration of the alpha2-receptor agonist clonidine. Studies with this new approach have
been aimed mainly at psychiatric variables, and, [2–6,23–25] to our knowledge, the cardiovascular effects of high-dose naloxone in patients addicted to
opioids have not been described previously.
Although naloxone, even when injected in high doses (0.15 mg/kg) in healthy volunteers, does not increase concentrations of epinephrine in plasma, [26–
28] heart rate, arterial or central venous pressures, or efferent sympathetic nerve activity to calf muscle in the absence of opioid receptor agonist
stimulation, [29,30] we observed a 30-fold increase in the concentration of epinephrine in plasma and a threefold signi cant increase in the concentration
of norepinephrine in plasma. Maximum concentrations of catecholamine in plasma were attained 45–60 min after the initial injection of naloxone with a
total dose of 2.8–6.0 mg naloxone administered. In parallel, cardiac output (+74%), heart rate (+24%), stroke volume (+44%), and systolic arterial pressure
(+22%) increased, whereas systemic vascular resistance decreased (-40%).
It is noteworthy that a similar pattern of changes in the concentrations of catecholamine in plasma was observed earlier in awake morphine-dependent
rats after administration of naloxone and was abolished by removal of the adrenal glands, suggesting that the increase in concentration of epinephrine in
plasma is due to increased adrenal release of epinephrine. [31,32]
Cardiovascular changes observed in our study are in line with beta-adrenoceptor effects of epinephrine and, accordingly, may be mediated by the
determined alterations in concentrations of catecholamine in plasma. This hypothesis is supported by other data.
Infusion of epinephrine in awake volunteers increased concentration of epinephrine in plasma from 50 to 480 pg/ml, i.e., to concentrations very similar to
those observed in our study after [micro sign]-opioid receptor blockade by naloxone; increased heart rate by 24%, cardiac output by 74%, and stroke
volume by 40%; and decreased systemic vascular resistance by 31%. [33] Most of these cardiovascular changes were attained at plasma concentrations of
260 pg/ml, with few additional changes when the concentration of epinephrine in plasma was further increased. [33] Concentrations of norepinephrine in
plasma also increased (by 60%) during infusion of epinephrine, possibly secondary to the decrease in systemic vascular resistance induced by epinephrine,
and this increase in concentration can be considered hemodynamically important. [33] Accordingly, these data taken together support the assumption
that cardiovascular stimulation observed in our study after [micro sign]-opioid receptor blockade is mediated to a major extent by increased
concentrations of epinephrine in plasma.
Although our study design does not allow us to pinpoint responsible mechanisms for the profound increase in the concentration of epinephrine in plasma
after [micro sign]-opioid receptor blockade by naloxone in patients addicted to opioids, potential mechanisms include direct effects of naloxone, [micro
sign]-opioid receptor antagonization on the adrenal medulla, [34] and neurally mediated changes of central sympathetic out ow, e.g., by disinhibition and
resetting of cardiopulmonary barore exes. [35] The 30-fold increase in the concentration of epinephrine in plasma in the absence of a quantitatively
similar increase in that for norepinephrine is rather atypical for a generalized activation of the sympathetic nervous system.
Despite maintenance of general anesthesia, [micro sign]-opioid receptor blockade in patients addicted to opioids undergoing methadone substitution
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infusion of epinephrine
8/30/2019 in healthy
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[microdetoxi cationReceptor
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Blockade i…
to opioids should be handled by trained anesthesiologists or intensivists.
The authors thank Matthias Steimer and the intensive care nursing staff for excellent nursing and assistance; Marc Achilles for assistance in performing
hemodynamic measurements and blood sampling; and the technicians of the biochemistry laboratory for determination of concentrations of
catecholamine in plasma.
REFERENCES
1. Mattick RP: Are detoxi cation programs effective? Lancet 1996; 347:97-100.
2. Loimer N, Schmid RW, Presslich O, Lenz K: Continuous naloxone administration suppresses opiate withdrawal symptoms in human opiate addicts during detoxi cation
treatment. J Psychiatr Res 1989; 23:81-6.
3. Loimer N, Schmidt R, Lenz K, Presslich O, Grunberger J: Acute blocking of naloxone-precipitated opiate withdrawal symptoms by methohexitone. Br J Psychiatry 1990;
157:748-52.
4. Loimer N, Hofmann P, Chaudhry H: Ultrashort noninvasive opiate detoxi cation. Am J Psychiatry 1993; 150:839.
5. Gossop M, Grif ths P, Bradley B, Strang J: Opiate withdrawal responses to 10-day and 21-day methadone withdrawal programs. Br J Psychiatry 1991; 148:1291-300.
6. Legarda JJ, Gossop M: A 24-h inpatient detoxi cation treatment for heroin addicts: A preliminary investigation. Drug Alcohol Depend 1994; 35:91-3.
7. Ganz W, Swan HJC: Measurement of blood ow by thermodilution. Am J Cardiol 1972; 29:241-6.
8. Jansen JRC, Schreuder JJ, Settels JJ, Kloek JJ, Versprille AA: An adequate strategy for the thermodilution technique during mechanical ventilation. Intensive Care Med
1990: 16:422-5.
9. Bauch HJ, Kelsch U, Hauss WH: Einfache, schnelle, selektive und quantitative Bestimmung von Adrenalin und Noradrenalin im Plasma durch Kombination von
Flussigkeitsextraktion, HPLC-Trennung und elektrochemischer Detektion. J Clin Chem Clin Biochem 1986; 24:651-8.
10. Victor RG, Leimbach WN Jr: Effects of lower body negative pressure on sympathetic discharge to leg muscles in humans. J Appl Physiol 1987; 63:2558-62.
11. Somers VK, Mark AL, Zavala DC, Abboud FM: Contrasting effects of hypoxia and hypercapnia on ventilation and sympathetic activity in humans. J Appl Physiol 1989;
67:2101-6.
12. Mace eld VG, Wallin BG: Modulation of muscle sympathetic activity during spontaneous and arti cial ventilation and apnoea in humans. J Autonom Nerv Syst 1995;
53:137-47.
13. Sellgren J, Ponten J, Wallin BG: Characteristics of muscle sympathetic activity during general anaesthesia in humans. Acta Anaesthesiol Scand 1992; 36:336-45.
14. Ebert TJ, Kanitz DD, Kampine JP: Inhibition of sympathetic neural out ow during thiopental anesthesia in humans. Anesth Analg 1990; 71:319-26.
15. Peiss CN, Manning JW: Effects of sodium pentobarbital on electrical and re ex activation of the cardiovascular system. Circ Res 1964; 14:228-35.
16. Inoue K, Amdt JO: Efferent vagal discharge and heart rate in response to methohexitone, althesin, ketamine and etomidate in cats. Br J Anaesth 1982; 54:1105-16.
17. Tanaka GY: Hypertensive reaction to naloxone. JAMA 1974; 228:25-6.
18. Flacke JW, Flacke WE, Williams GD: Acute pulmonary edema following reversal of high-dose morphine anesthesia. Anesthesiology 1977; 47:376-8.
19. Andree RA: Sudden death following naloxone administration. Anesth Analg 1980; 59:782-4.
20. Taff RH: Pulmonary edema following low-dose naloxone administration. Anesthesiology 1983; 59:576-7.
21. Partridge BL, Ward CF: Pulmonary edema following low-dose naloxone administration. Anesthesiology 1986; 65:709-10.
22. Johnson C, Mayer P, Grosz D: Pulmonary edema following naloxone administration in a healthy orthopedic patient. J Clin Anesth 1995; 7:356-7.
23. Pfab T, Hirtl C, Hibler A, Felgenheuer N, Chlistalla J, Zilker TH: Der Antagonist-induzierte, Narkose-gestutzte Opiat-Schnellentzug (AINOS). Munch Med Wochenschr
1996; 138:781-6.
24. Resnick RB, Kestenbaum RS, Washton A, Poole D: Naloxone-precipitated withdrawal: A method for rapid induction onto naltrexone. Clin Pharmacol Ther 1977; 21:409-
13.
25. Dettling M, Tretter F: Der Opiatentzug in Narkose (forcierter Narkosentzug, “Turboentzug”) bei Opiatabhangigkeit. Nervenarzt 1996; 67:805-10.
26. Estilo AE, Cottrell JE: Hemodynamic and catecholamine changes after administration of naloxone. Anesth Analg 1982; 61:349-53.
27. Mannelli M, Maggi M, De Feo ML, Cuomo S, Delitala G, Giusti G, Serio M: Effects of naloxone on catecholamine plasma levels in adult men: A dose-response study. Acta
Endocrinologica 1984; 106:357-61.
28. Bouloux PM, Grossman A, Al-Damluji S, Bailey T, Besser M: Enhancement of the sympathoadrenal response to the cold-pressure test by naloxone in man. Clin Sci 1985;
69:365-8.
29. Farrell PA, Ebert TJ, Kampine JP: Naloxone augments muscle sympathetic nerve activity during isometric exercise in humans. Am J Physiol 1991; 260:E379-88.
30. Schobel HP, Oren RM, Mark AAL, Ferguson DW: Naloxone potentiates cardiopulmonary barore ex sympathetic control in normal humans. Circ Res 1992; 70:172-83.
31. Delle M, Ricksten SE, Haggendal J, Olsson K, Skarphedinson JO, Thoren P: Regional changes in sympathetic nerve activity and baroreceptor re ex function and arterial
plasma levels of catecholamines, renin and vasopressin during naloxone-precipitated morphine withdrawal in rats. J Pharmacol Exp Ther 1990; 253:646-54.
32. Chang APL, Dioxon WR: Role of plasma catecholamines in eliciting cardiovascular changes seen during naloxone-precipitated withdrawal in conscious, unrestrained
morphine-dependent rats. J Pharmacol Exp Ther 1990; 254:857-63.
33. Stratton JR, Pfeifer MA, Ritcher JL, Halter JB: Hemodynamic effects of epinephrine: Concentration-effect study in humans. J Appl Physiol 1985; 58:1199-206.
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8/30/2019 Opioid induced adrenal insufficiency: what is new? : Current Opinion in Endocrinology, Diabetes and Obesity
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Opioid induced adrenal insufficiency

what is new?
Donegan, Diane
Current Opinion in Endocrinology, Diabetes and Obesity: June 2019 - Volume 26 - Issue 3 - p 133–
138
doi: 10.1097/MED.0000000000000474
ADRENAL CORTEX AND MEDULLA: Edited by Irina Bancos
Abstract Author Information

Authors Article Metrics
Metrics
Purpose of review Despite the declaration of an opioid epidemic, opioid use remains prevalent. Side-effects of chronic
opioid use continue to be problematic. Opioid-induced endocrinopathies have been well documented, yet opioid-
induced adrenal insufficiency (OIAI) remains underappreciated. This review summarizes what is currently known
regarding the prevalence, predictive factors for the development and effect of treatment of OIAI.
Recent findings Although several case reports have highlighted the development of adrenal crisis among those receiving
chronic opioids, only a few studies have systematically assessed patients for OIAI. The heterogeneity of these small
studies presents challenges when trying to assess prevalence of or potential risk factors for OIAI. The estimated
prevalence of OIAI among those treated with chronic opioids ranges from 8.3 to 29% and is more likely in those
receiving higher doses of opioids. Reduced health-related quality of life variables and altered pain perception has been
associated with lower cortisol levels; however, the effect of glucocorticoid replacement on the parameters remains
unknown.
Summary Further research is critical to better identify those at greatest risk and guide optimal management of OIAI.
Frontline providers should remain vigilant for possibility of OIAI among chronic opioid users.
Department of Endocrinology and Diabetes, Indiana University School of Medicine, Indiana, USA
Correspondence to Diane Donegan, MB, BCh, BAO, Department of Endocrinology and Diabetes, Indiana University
School of Medicine, IN 46202, USA. Tel: +1 317 274 1339/278 5090; fax: +1 317 278 0658; e-mail: diadoneg@iu.edu
Copyright © 2019 Wolters Kluwer Health, Inc. All rights reserved.

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EVIDENCE-BASED MEDICATION-ASSISTED TREATMENT WITH BUPRENORPHINE

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• Medication Assisted Treatments

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A. PROGRAM OUTLINE Page 4

B. PATIENT REQUIREMENT POLICIES AND PROCEDURES Page 4-6

C. TREATMENT PLAN Page 6

D. MEDICATION POLICIES Page 7

E. PATIENT’S RIGHTS Page 7

F. STAFF MEMBERS Page 7-8

G. LEGAL DOCUMENTS Page 8-14

H. MEMORANDUM OF UNDERSTANDING Page 15-20

I. PROVIDER’S INFORMATION Page 21

J. ARTICLES OF INTEREST Page 22

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B. PATIENT REQUIREMENT POLICIES AND PROCEDURES

1. Drug Screens are completed within the standard program guidelines.

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1. Initiate Maintenance Program Protocol.

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• Buprenorphine/Naloxone 8/2 Tablets

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4. The purpose of the Narcotics Agreement is to document an understanding of critically important

5. Such documentation, as a means of facilitating care, is meant to improve communication of

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• Electronic Code of Federal Regulations:

3. Any violation of your privacy is considered a violation of a Federal Law.

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PATIENT CARE MEMORANDUM OF UNDERSTANDING BETWEEN:

AND CHURCH EKKLASIA SOZO

and CHURCH EKKLASIA SOZO

Expectations of CHURCH EKKLASIA SOZO

• New Patients will have an admitting diagnosis of Adult Assistance Syndrome.

• All Patients will participate in the Toxicology Protocol.

• All Patients will participate in the Pill Count Protocol.

• All Patients will be offered additional access to Counseling.

• All Patients are required to participate in the weekday mandatory meetings.

• All Patients will be offered access to Pastoral Care.

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1) Absolute Immunity from any and all potential outcomes,

2) Sovereign Immunity from any and all potential outcomes,

Expectations of The Provider

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Both CHURCH EKKLASIA SOZO and _____________________________________will furnish their services in a

Provider of Judgment and Freedom of Choice

Agreements with Other Parties

Volume or Value of Referrals

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If a dispute arises regarding this MOU, _____________________________________and CHURCH EKKLASIA SOZO

Relationship of the Parties

Third Party Beneficiaries

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Physician Payment Schedule