Pain Medicine, 20(4), 2019, 724–735

doi: 10.1093/pm/pny307
Advance Access Publication Date: 25 January 2019
Original Research Article

PRIMARY CARE & HEALTH SERVICES SECTION

Challenges with Implementing the Centers for Disease Control and

Prevention Opioid Guideline: A Consensus Panel Report

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Kurt Kroenke, MD,* Daniel P. Alford, MD, MPH,† Charles Argoff, MD,‡ Bernard Canlas, MD,§ Edward
Covington, MD,¶ Joseph W. Frank, MD, MPH,k Karl J. Haake, MD,kj Steven Hanling, MD,** W. Michael
Hooten, MD,†† Stefan G. Kertesz, MD, MSc,‡‡ Richard L. Kravitz, MD, MSPH,§§ Erin E. Krebs, MD,
MPH,¶¶ Steven P. Stanos, Jr., DO,kk and Mark Sullivan, MD, PhDkkj
*Indiana University School of Medicine, Indianapolis, Indiana; †Boston University School of Medicine, Boston, Massachusetts; ‡Albany Medical
§ ¶ k
College, Albany, New York; Veterans Affairs Puget Sound Health Care System, Seattle, Washington; Cleveland Clinic, Cleveland, Ohio; VA Eastern
kj
Colorado Health Care System, Denver, Colorado; Haake Medical Services, LLC, Shawnee Mission, Kansas; **Augusta University Medical Center,
†† ‡‡
Augusta, Georgia; Mayo Clinic College of Medicine, Rochester, Minnesota; Birmingham Veterans Affairs Medical Center, Birmingham, Alabama;
¶¶
§§
Department of Internal Medicine, University of California, Davis, California; Minneapolis Veterans Affairs Health Care System, Minneapolis,
kk kkj
Minnesota; Swedish Health System, Seattle, Washington; University of Washington School of Medicine, Seattle, Washington, USA

Correspondence to: Kurt Kroenke, MD, Regenstrief Institute, 1101 West Tenth Street, RF 221, Indianapolis, IN 46202-4800, USA. Tel: 317-
274-9046; Fax: 317-274-9304; E-mail: kkroenke@regenstrief.org.

Funding sources: Support for the Centers for Disease Control and Prevention (CDC) guideline consensus project of the American Academy of Pain
Medicine Foundation was received as unrestricted grants from Collegium Pharmaceutical, Inc., Daiichi Sankyo, Inc., Egalet, Jazz Pharmaceuticals,
Kaleo, and Nektar Therapeutics. The foundation provided travel reimbursement for participants to attend the December 2017 meeting in Chicago,
Illinois; J.W. Frank, S. Hanling, S.G. Kertesz, and E.E. Krebs declined this reimbursement. The authors did not receive honoraria.

Disclaimers: The findings and scientific conclusions in this report are those of the authors and do not reflect the position of any funding source or its
representatives, who were not present during panel discussions related to these findings and who had no input in the design, analysis, interpretation
of results, or preparation of this article and any and all products of this venture. For those authors holding positions with the US Department of
Veterans Affairs, the present statement reflects their personal views and does not represent the views or positions of the Department of Veterans
Affairs or any other agency of the US federal government.

Disclosures and conflicts of interest: D.P. Alford is a course director for safe opioid prescribing continuing medical education programs, funded by an
unrestricted educational grant awarded to the Boston University School of Medicine CME office by the Risk Evaluation and Mitigation Strategy (REMS)
Program Companies as part of the US Food and Drug Administration (FDA) extended-release and long-acting (ER/LA) Opioid REMS program. He did not
receive any direct compensation from industry for this activity. C. Argoff has served as a consultant for BioDelivery Sciences, Collegium, Daiichi
Sankyo, Egalet, Grünenthal, Kaleo, US WorldMeds, Pfizer, Eli Lilly, Novartis, Scilex, Teva, and Regeneron and has received honoraria for speaking from
Allergan, Daiichi Sankyo, Amgen, Teva, Eli Lilly, and Jazz Pharmaceuticals. B. Canlas has no relevant financial relationships to disclose. E. Covington
has served as a consultant for Inspirion, Endo Pharmaceuticals, AcelRx Pharmaceuticals, Intellipharmaceutics, Indivior, Braeburn Pharmaceuticals,
Trevena, and Franklin Bioscience. K.J. Haake has served as a consultant to Medtronic and Pfizer and currently serves as a consultant to the Centene
Corporation. S.G. Kertesz attests to ownership of stock in Abbott Pharmaceuticals and Merck, amounting for less than 3% of his assets, sold in 2017.
He has no other current or past consultancies, honoraria, or industry relationships to disclose. S.P. Stanos is a course director for safe opioid prescrib-
ing continuing medical education programs funded by unrestricted educational grants awarded to Miller Medical Communications by the REMS
Program Companies as part of the US Food and Drug Administration ER/LA Opioid REMS program. He did not receive any direct compensation from in-
dustry for these activities. He served as an invited consultant to the Opioid Guideline Workgroup for the 2016 CDC Guideline for Prescribing Opioids for
Chronic Pain. M. Sullivan has had research grants from Pfizer and Purdue and has provided consultation to Aetna and Chrono Therapeutics. J.W.
Frank, S.H. Hanling, W.M. Hooten, R.L. Kravitz, E.E. Krebs, and K. Kroenke have no relevant financial relationships to disclose.

Abstract
Background. A national crisis of opioid-related morbidity, mortality, and misuse has led to initiatives to address the
appropriate role of opioids to treat pain. Deployment of a guideline from the Centers for Disease Control and
Prevention to reduce the risks of opioid therapy has raised substantial clinical and public policy challenges. The
agency anticipated implementation challenges and committed to reevaluating the guideline for intended and

C 2019 American Academy of Pain Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com
V 724
Implementing the CDC Guideline 725

unintended effects on clinician and patient outcomes. Observations. A multidisciplinary expert panel met to review
the influence of the core recommendations of the guideline on pain management practices, principally regarding
the estimated 5 to 8 million Americans with chronic pain currently on opioids. The panel identified implementation
challenges, including application of dosage ceilings and prescription duration guidance, failure to appreciate the im-
portance of patient involvement in decisions to taper or discontinue opioids, barriers to diagnosis and treatment of
opioid use disorder, and impeded access to recommended comprehensive, multimodal pain care. Furthermore,
policy-making and regulatory bodies may misapply guideline recommendations without flexibility and, sometimes,
without full awareness of what the guideline contains. Conclusions and Relevance. The panel largely supported the
guideline, endorsing its focal points of safety and comprehensive assessment and monitoring. To mitigate clinical
and policy challenges identified with implementing the guideline, the panel discussed areas where viewpoints di-
verged and arrived at consensus proposals. The target audience includes the leaders and institutions that create pol-

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icy and influence guideline implementation to include regulatory agencies, legislators, public and private payers,
and health care systems.

Key Words: Treatment Guidelines; Opioids; Opioid Use Disorder; Consensus Panel

Introduction related to guideline implementation. Deliberations con-

A national crisis of opioid-related morbidity, mortality,
and misuse has led to initiatives to address the role of pri-
mary care physicians and other prescribing clinicians.
The 2016 release of the Centers for Disease Control and
Prevention (CDC) Guideline for Prescribing Opioids for
Chronic Pain outside of active cancer, palliative, and
end-of-life care was intended to enhance patient and
community safety by providing guidance on best clinical
practices [1].
As the guideline has been adopted, substantial chal-
lenges have emerged, including those related to appropri-
ate opioid use in patients with acute pain following
trauma and the 5 to 8 million patients [2] with chronic
pain presently being managed on long-term opioid ther-
apy (LTOT). Challenges in guideline implementation
were anticipated, with the CDC explicitly committed to
“evaluating the guideline to identify the impact of the
recommendations on clinician and patient outcomes,
both intended and unintended, and revising the recom-
mendations in future updates when warranted” [1]. The
purpose of this report is to discuss several challenges that
have emerged for prescribing clinicians who treat
patients with pain as a result of clinical guidance and
policy actions based on the CDC guideline.
Methods
To identify and address these challenges, the American
Academy of Pain Medicine Foundation convened a mul-
tidisciplinary panel of physician experts, reflecting a
spectrum of clinical, research, and academic experience.
In selecting invitees, foundation and physician leaders
aimed to form a working group of sufficient size (12–15
members) and specifically sought a wide range of perti-
nent viewpoints and professional experience. The panel
(Box A1) met in Chicago, Illinois, on December 9, 2017,
to review the core recommendations of the CDC guide-
line, discuss relevant literature, and identify challenges
tinued via electronic communication, in two conference
calls held in September 2018, and through several rounds
of manuscript drafts. The panel reached consensus on
proposals to address the challenges identified and recog-
nized divergent opinions on some topics.
Importance of the CDC Guideline
The CDC guideline is aimed at improving opioid
prescribing practices to ensure safe and effective chronic
pain treatment while reducing the risk of opioid use dis-
order (OUD), overdose, and death. The 12 core
recommendations of the CDC Guideline are shown in
Box A2 [1].
The panel commended many facets of the guideline,
including clinical reminders to:
• know that opioids are not firstline therapy for chronic pain;
• discuss the risks, benefits, and availability of nonopioid treat-
ments with patients;
• establish and measure goals for pain and function;
• emphasize patient-centeredness and individualized care;
• evaluate risk factors for opioid-related harms specific to the indi-
vidual patient;
• avoid concurrent benzodiazepine and opioid prescribing;
• prescribe opioids only in needed quantities and durations;
• initiate opioids at the lowest effective dose with frequent follow-
up and monitoring;
• ensure opioids, when indicated, are part of a comprehensive,
multimodal pain treatment plan;
• use prescription drug monitoring programs and urine drug test-
ing to monitor patient adherence to the treatment plan;
• reduce opioid dose or taper and discontinue if risks outweigh
benefits or if benefits do not outweigh harms;
• arrange treatment for OUD if indicated.
One noted potential benefit of the guideline may be
that fewer opioid-naı̈ve patients begin LTOT and that
those who do receive lower doses. While largely support-
ive of the guideline, the panel also identified implementa-
tion challenges with potential for untoward outcomes.
726
Guideline Implementation Challenges
The period following guideline release has seen clinical
and policy issues that may have gone beyond what was
originally intended by developers of the guideline. In par-
ticular, the appropriate role of regulatory and policy-
making bodies, including public and private payers,
requires clarification. The guideline was not meant to be
prescriptive but, at times, has been implemented without
flexibility, perhaps without full awareness of the guide-
line’s precise content and intent. One reason may be that
important clarifying information located in less promi-
nent sections of the guideline may be overlooked or un-
derappreciated by readers focused on the 12
recommendations.
Challenges caused by guideline misapplication identi-
fied by the panel include:
• inflexible application of recommended ceiling doses or prescrip-
tion durations as hard limits;
• abrupt opioid taper or cessation in physically dependent, opioid-
treated patients without regard for CDC emphasis on empathic-
ally reviewing benefits and risks of continued high-dosage ther-
apy and working collaboratively with patients on a tapering
plan;
• lack of availability and coverage for recommended comprehen-
sive, multimodal pain care;
• difficulty of OUD diagnosis and barriers to accessing evidence-
based OUD treatment;
• underutilization of naloxone;
• incomplete data in reporting of overdose death statistics.
The challenges are further described in Box A3 and in
the detailed discussion that follows.
Limits on Dosages
Concern was expressed that some policy-makers are
interpreting the CDC daily dosage thresholds as firm lim-
its without regard to CDC advice to individualize treat-
ment and work with patients. Policies to restrict daily
dose have been enacted in several states. Also, private
insurers have limited coverage to control and limit
dose [3].
One recent policy proposal, ultimately tempered,
would have capped opioid prescription coverage through
the Centers for Medicare and Medicaid Services (CMS)
at 90 morphine milligram equivalents (MME) per day
with the stated goal of concordance with the guideline
[4–7]. The final policy, instead, requires a pharmacist
who receives a prescription above the threshold to con-
firm it with the doctor and document the discussion [8].
In comments explaining its decision to hold back imple-
menting hard 90 MME safety thresholds for opioids,
CMS reported that [9]:
• physician groups expressed concerns about the risks for patients
of abrupt discontinuation or rapid taper of high doses;
• patients sent hundreds of letters describing fear of abrupt reduc-
tion or discontinuation of their long-time medication regimens
Kroenke et al.
“with sometimes extremely adverse outcomes, including depres-
sion, loss of function, quality of life, and suicide” [9];
• CMS plan sponsors and other organizations expressed support
for CMS’s goal to aggressively address opioid overuse but
requested to set their own MME thresholds.
This last point suggests that some plan sponsors may
make dosage a benchmark without fully considering the
CDC guideline’s intent to individualize treatment and
work with patients.
Some panel members believed that the CDC dosage
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thresholds could remain protective if clinicians were
allowed to individualize decisions after evaluating patient
factors that predict a higher risk of opioid-related death,
overdose, and other injuries. Such factors for evaluation
include pain etiology, response to therapy, medical
comorbidities, co-occurring psychological disorders, past
or previous substance use problems, history of opioid
misuse, and concomitant benzodiazepine use [1].
The panel agreed that any legislative, regulatory, or
payer policies enacted should make provisions for appro-
priately selected and monitored patients who need and
benefit from longer duration or higher dosage.
Opioid Taper or Cessation
Opioids may be tapered for several reasons, including in-
adequate analgesia or intolerable side effects, resolution
of pain, overall poor quality of life, or evidence of a pat-
tern of misuse or OUD.
There was concern that daily MME thresholds in
CDC Recommendation 5 are being rigidly applied in
some cases without adequate attention to the needs of
established or inherited patients who are already on
LTOT. Indeed, the guideline allows some flexibly when
it further states:
Established patients already prescribed high dosages of
opioids (90 MME/d), including patients transferring
from other clinicians, should be offered the opportunity
to reevaluate their continued use of opioids at high dos-
ages in light of recent evidence regarding the association
of opioid dosage and overdose risk. For patients who
agree to taper opioids to lower dosages, clinicians should
collaborate with the patient on a tapering plan [1].
Although the guideline does not support abrupt non-
collaborative opioid taper or cessation in patients on a
dose above a given target (90 MME or other), certain
panel members observed that some clinicians, policy-
makers, managed care administrators, and pharmacy
benefit managers have inferred an enforceable dose ceil-
ing as a de facto mandate [3,10,11]. Panelists described
patients who request providers to assume responsibility
for opioid prescribing after involuntary dismissal from
another practice without weaning or a treatment plan for
pain or OUD [10]. In addition, in an atmosphere of
heightened enforcement, clinicians and dispensing
Implementing the CDC Guideline
pharmacists may harbor professional concerns about po-
tential sanctions connected to prescribing patterns [10].
The panel held that, whenever possible, patient en-
gagement is preferred during opioid taper, as suggested
by the CDC guideline [1]. Some on the panel expressed
concern that some patients who are discontinued from
opioids abruptly or without their consent may go else-
where to a licit or illicit channel [12]. Separately, concern
was raised regarding patient deaths during or soon after
nonconsensual taper, events reported primarily in anec-
dotes or small case series describing suicidal ideation and
self-directed violence, medical deterioration, and, in
some instances, procurement of illicit market opioids
[13–16]. The rate of these events is not known, nor is it
clear that nonconsensual taper was the main or only
cause of the adverse outcomes. A further complication is
the lack of validated tapering protocols in patients on
opioids for chronic pain, although several guides to
providing safe and comfortable opioid tapering have
been published [13,17].
Although gradual and supported taper are believed to
be associated with improved pain outcomes, the evidence
base on opioid dose reduction and discontinuation is still
evolving. A recent systematic review found low-quality
but consistent evidence suggesting that several types of
opioid tapers may be effective and that pain, function,
and quality of life may improve for some patients with
consensual opioid dose reduction, especially with the
support of a multidisciplinary team [13]. A recent study
found that 62% of patients remained in a voluntary,
patient-centered opioid taper over four months, with me-
dian decreases in morphine equivalent daily dose from
288 mg to 150 mg [18]. Whereas a highly supported,
monitored taper can improve pain or quality of life in a
number of patients, a subset may experience worsened
pain.
The panel was unanimous that abrupt cessation of
opioids (and sedatives) is medically risky and outside the
intent of the CDC guideline. Furthermore, it is unaccept-
able practice to abruptly dismiss physically dependent
patients from care without an adequate plan for pain or
OUD treatment follow-up except in unusual circumstan-
ces, such as diversion. The CDC guideline provides de-
tailed discussion of the need for gentle and often slow
tapers [1]; however, some prescribers may be unaware of
this message. Recommendation 7 supports a decision on
the basis of individualized evaluation of harm vs benefit
and does not mandate taper to any target. Therefore, the
panel affirmed that providers should offer a gradual ta-
per while instituting alternative pain treatments or OUD
treatment as needed, or else refer the patient to a pro-
vider willing to provide these services [2,19].
Discussion of the potential harms of abrupt discontin-
uation should not be taken as blanket endorsement for
continuation. Given that the benefits of chronic opioids
often diminish over time while the risks do not, a deci-
sion to discontinue LTOT may be reasonable. Some
727
panel members favored a general opioid dose reduction
approach, given the association between higher doses
and adverse outcomes [1]. However, when low-risk
patients demonstrate improved comfort and function in
the absence of adverse effects and aberrant behaviors,
some panel members felt that there is little to be gained
by eliminating opioids, and there is the potential for
harm [20].
Although continuing treatments that are both ineffec-
tive and hazardous is unwarranted, the panel also agreed
that opioid cessation may not be the most appropriate
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target when patients maintained on high opioid doses for
years have developed what has been called “complex per-
sistent dependence,” an intermediate gray zone between
physiologic dependence and OUD [20]. These patients
may need to be transitioned to buprenorphine or reduced
full-agonist opioid doses to improve safety and, in some
cases, function and quality of life. Integrating behavioral
health and nonopioid pain therapies first may enhance
the therapeutic relationship and prepare the patient to
manage pain before initiating an opioid taper or dose re-
duction. In many instances, a re-evaluation of the under-
lying causes of the presenting pain complaint and
subsequent successful treatment integration may facili-
tate opioid reduction or discontinuation. Absent aggra-
vating circumstances, opioid taper and management of
behavioral, mental, and substance use problems need not
occur immediately, unless current medications pose im-
minent risk [21]. In summary, the panel emphasized the
CDC recommendation on gradual and supported taper
with patient engagement and cautioned that clinicians
should not interpret opioid reduction messages as the
need to automatically and immediately reduce or stop
LTOT or dismiss patients with risk factors from care.
Limits on Prescription Durations
The panel endorsed the CDC recommendation to limit
any medically necessary opioid prescriptions to the short-
est necessary duration for acute pain and to prescribe the
lowest effective dose. Furthermore, although the guide-
line is not intended to address postoperative pain, the
panel noted its potential impact on pain treatment after
surgical procedures. Evidence shows that excessive quan-
tities of opioid have often been given for acute pain when
a small supply would be sufficient, contributing to misuse
or diversionary risk [22,23]. Therefore, the panel agreed
that prudent prescription durations may reduce the risk
of redistribution and diversion.
Although CDC Recommendation 6 states that a pre-
scription duration longer than seven days will rarely be
needed for acute pain, the panel noted that accommoda-
tion must be made for patients who need longer duration
of opioid analgesia. Concern was raised by some panel
members that if the seven-day duration limit were inflexi-
bly applied as a hard limit, patients with severe pain per-
sisting more than a week and not controlled by
728
nonopioid therapies could lack access to needed analge-
sia. Furthermore, access challenges encountered by cer-
tain patients (e.g., newly diagnosed cancer patients and
elderly, rural, or other isolated patients) also must be
considered.
The issue of prescription duration limits is under-
scored because states began passing legislation to limit
opioid prescriptions in 2016, and by April 2018, 28
states had enacted such legislation, most frequently limit-
ing prescription durations, with a few also setting daily
dosage limits [11]. States do allow some common excep-
tions for chronic, cancer, and palliative pain, treatment
of substance use disorder (SUD), and, importantly, pro-
fessional judgment of the prescribing clinician, as long as
the rationale is carefully documented in the medical re-
cord [11]. These exceptions were deemed important for
all clinicians, payers, policy-makers, and other influences
of prescribing practices to note.
Although the CDC guideline specifically excludes cancer
treatment, palliative care, and end-of-life care and states
that postoperative pain management is beyond its scope,
concern was expressed that misapplication of
Recommendation 6 could promote unintended “drift” into
an increasing reluctance by providers to prescribe opioids
for these indications [19] and by pharmacists to fill prescrip-
tions. Overall, the panel supported reducing opioid pre-
scriptions for acute pain whenever possible and noted that
Enhanced Recovery After Surgery (ERAS) pathways, a
team-based approach that emphasizes pain control through
multimodal analgesia and limited reliance on opioids, have
reduced opioid use and improved outcomes [24].
Limited Comprehensive, Multimodal Pain Care
The CDC guideline and panelists agreed that if a clinician
determines that the potential benefits of opioids out-
weigh risks, their prescription should be part of a com-
prehensive, multidisciplinary, multimodal treatment plan
in which patients are assessed and closely monitored [1].
It was noted that clinical experience indicates that non-
opioid therapies that have previously “failed” can suc-
ceed when tried again with careful clinical evaluation
and follow-up using a comprehensive, multimodal ap-
proach. Unfortunately, integrated comprehensive pain
care models (i.e., multimodal, multidisciplinary, and in-
terdisciplinary rehabilitation programs) are neither
widely available nor sufficiently reimbursed despite dem-
onstrated long-term cost and health care utilization
advantages [25,26]. Telemedicine that includes access to
and payment for physicians and other health care pro-
viders may prove useful for reassessment if widely inte-
grated into workflows and reimbursed [27,28].
Difficulty of Diagnosing and Treating Opioid Use
Disorder
The panel noted that it can be challenging to distinguish
incipient OUD and complex persistent dependence from
Kroenke et al.
increasing pain due to the underlying pain condition,
worsening pain-related distress due to exacerbation of
medical, psychological, or social factors, or opioid-
induced hyperalgesia. However, it was also noted that
OUD can be a fatal disease whose recognition is vital to
instituting necessary treatment; therefore, clinicians who
prescribe LTOT should be required to demonstrate a ba-
sic knowledge of OUD diagnosis and treatment. This is
especially important where specialty consultation in ad-
diction medicine is inaccessible.
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A feature of any SUD is continued use of a substance
despite harm. Self-report of improvement with opioids is
problematic in the presence of physical dependence or
OUD and may be unreliable in the absence of improved
function and quality of life [29]. Thus, patients’ desire to
continue opioids cannot always be a reliable guide to ap-
propriate treatment; that is, tapers cannot always be con-
sensual [30]. “Adverse selection” [31] is a principle
describing the clinical phenomenon in which patients at
risk for worse outcomes due to mental disorders and
SUDs are the ones most likely to receive opioids and at
higher doses [32–34]. Further complicating clinical deci-
sions regarding opioid medications, chronic pain is
closely intertwined with comorbid mental health and
SUDs, as shown by a body of research:
• Chronic pain was reported by 87% of 589 participants with un-
healthy substance use identified in primary care [35].
• An analysis of opioid-related fatalities in Medicaid recipients
showed that most (61.5%) had chronic pain and were signifi-
cantly more likely than those without chronic pain to have been
diagnosed with depression, anxiety, or drug use, though not
OUD, during the last year of life [36].
• Other research indicates that pain increases the relative risk of
developing prescription-related OUD [37]. However, the major-
ity of patients on opioids for chronic pain do not develop an
OUD.
• Mental health conditions are among the patient characteristics
associated with “unintended prolonged opioid use,” which is
characterized by use of opioids beyond the intended short-term
course, for example, for minor surgery [38].
• Treatment-resistant depression is more common in people on
opioid therapy, and patients with mental health comorbidities
are more likely to receive opioids [32,39].
• Epidemiologic and functional imaging studies suggest that
chronic pain and mental health disorders have a bidirectional re-
lationship due in part to shared neural mechanisms [40].
When patients are clearly endangered or harmed by
their opioid treatment, clinicians are legally and ethically
obliged to work to mitigate the situation. Yet panelists
noted that patients who most need an opioid taper may
be least open to discussion or consensual taper and may
react belligerently.
Although the CDC recommends medication-assisted
treatment for OUD, the panel discussed the possibility
that a patient at high risk for opioid-related harm who
has pain and physical dependence but no diagnosed
OUD might also benefit from buprenorphine as a
Implementing the CDC Guideline
continuing treatment or bridge to eventual opioid discon-
tinuation. Many panel members shared a perspective
based on clinical observation that a subset of patients
may be candidates for off-label buprenorphine if the
patients are at heightened risk of dismissal from pain
care, even though they may not meet criteria for the
FDA-approved indication of OUD. The possibility that a
trial of buprenorphine in medication-assisted treatment
doses may be a safer option for these patients is suggested
by clinical experience reported by experts [20] and
mostly single-arm, poor-quality studies with variable
follow-up rather than clinical trials [41,42].
Others on the panel emphasized the need to continue to
consider and diagnose OUD in such patients when appro-
priate, to consider opioid taper to the lowest dose possible
in consensual fashion, or both. Thus, although it was
noted that certain patients who are not showing benefit
from opioids tolerate opioid taper poorly or not at all, no
consensus was reached on how to define or treat this sub-
set of patients. Supporting literature is inconclusive. In
people with prescription OUD, a voluntary taper was less
successful than ongoing maintenance with buprenorphine
in two high-quality randomized controlled trials [43,44].
Additionally, insurance will sometimes not authorize
or reimburse for buprenorphine formulation prepara-
tions indicated for OUD in patients lacking this diagno-
sis. The panel discussed the ethical challenge if a clinician
should falsely apply a clinical diagnosis of OUD in order
to meet payment or other criteria imposed by payers and
health systems. It was noted by some that patients may
experience stress or social stigma resulting from the ap-
plication of an OUD diagnosis for which they do not
qualify. The panel agreed that the use of buprenorphine
for care of patients with a history of opioid receipt for
pain requires scientific attention and policy deliberation.
All panelists concurred regarding the need to continue to
mitigate risk and conduct monitoring in conjunction
with buprenorphine treatment.
Naloxone Underutilization and Mortality Statistics
The panel agreed with the CDC emphasis on naloxone
for patients with risk factors for opioid overdose and fur-
ther expressed consensus that naloxone is insufficiently
available. States have passed laws intended to increase
naloxone distribution and reduce liability for laypersons,
first responders, and pharmacists [45,46]. Yet high costs
and variable access remain due to factors involving the
roles of manufacturers, state governments, private and
public insurers, pharmacy chains, and pharmacy benefit
managers [45,47].
Underutilization of naloxone also results in part from
uncertainty as to who should receive it. Polypharmacy,
mental disorders, SUDs, and high-dose opioids are
CDC-recognized risk factors that suggest naloxone co-
prescription [1]. Yet most opioid-related deaths are at-
tributable to illicitly obtained analgesics and recreational
729
drugs, such as heroin [48–50]. Recent data from
Massachusetts and Washington State indicate that
among persons suffering an opioid poisoning event, less
than 50% had received a prescription recently before the
overdose death [51,52]. In addition, the majority of opi-
oid fatalities involve multiple substances, particularly
sedatives such as benzodiazepines [51,53].
The confusion around sources of diverted opioids may
be exacerbated by media messages that foster the false
belief that most opioids are misused by people who were
prescribed them. In fact, the National Survey on Drug
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Use and Health reports that only 37% of adults who mis-
used opioids had a prescription, and 53% obtained their
most recent misused opioids from friends or relatives
[54]. The panel noted the association of SUDs with social
problems: For example, misuse and OUDs are most com-
mon in adults who are uninsured, unemployed, poor, or
suffering from behavioral health problems [55].
However, the panel further emphasized that no one is im-
mune from the ravages of SUD.
Although the panel did not achieve consensus on a
proposal regarding mortality statistics, some members
discerned a need to collect, conduct, and report more
complete, accurate opioid-related death statistics to facil-
itate the understanding of differences in lethality of spe-
cific licit and illicit opioid agents to better target
overdose death reduction initiatives, including naloxone
prescription. This would include efforts to examine and
quantify the contribution of diverted prescription opioids
to the current opioid harm crisis.
Panel Proposals
The panel devised consensus proposals (Box A4) to in-
crease guideline clarity and usefulness and to reach the
regulators, policy-makers, and payers who influence
guideline implementation. The panel further seeks to add
to the discussion and evidence base that will inform future
iterations of the guideline. An overarching principle for
the panel was to support efforts to reduce the overpre-
scribing of opioids that has led to opioid-related patient
and societal problems while at the same time using opioids
in an appropriate and reduced-risk fashion for acute pain
and in a small subset of patients with chronic pain.
Authors’ Contributions
All authors contributed to the consensus-building discus-
sions, analysis and interpretation of data, drafting or crit-
ical revision of the manuscript for scientific soundness
and intellectual content, and approval of the final
manuscript.
Acknowledgments
Beth Dove, of Dove Medical Communications, LLC, Salt
Lake City, Utah, helped with writing assistance and
730
editing this article in accordance with the guideline of the
International Committee of Medical Journal Editors
(ICMJE) defining the role of authors and contributors
and received payment for services from the foundation.
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Appendix
Box A1. CDC Guideline Implementation Consensus Panel

Chair

Kurt Kroenke, MD, Professor of Medicine, Indiana University School of Medicine, Indianapolis, Indiana; Research Scientist,
Regenstrief Institute, Inc., Indianapolis, Indiana.

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Panel

Daniel P. Alford, MD, MPH, Professor of Medicine, Associate Dean, Continuing Medical Education Office; Director, Safe and
Competent Opioid Prescribing Education (SCOPE of Pain) Program, Boston University School of Medicine; Director, Clinical
Addiction Research and Education (CARE) Unit, Boston Medical Center, Boston, Massachusetts.

Charles Argoff, MD, Director of Comprehensive Pain Center, Albany Medical College Albany, New York; President, American
Academy of Pain Medicine Foundation.

Bernard Canlas, MD, Medical Director, Pain Medicine (American Lake Division) and Functional Restoration Pain Programs
(Outpatient and Residential), Veterans Affairs Puget Sound Health Care System; Acting Assistant Professor, Department of
Anesthesiology and Pain Medicine, University of Washington School of Medicine, Seattle, Washington.

Edward Covington, MD, Former Director, Neurological Center for Pain, Cleveland Clinic, Cleveland, Ohio.

Joseph W. Frank, MD, MPH, VA Eastern Colorado Health Care System and Core Investigator, Center of Innovation for Veteran-
Centered and Value-Driven Care, Denver, Colorado; Assistant Professor, University of Colorado School of Medicine, Aurora,
Colorado.

Karl J. Haake, MD, Haake Medical Services, LLC, Shawnee Mission, Kansas; Consultant, Missouri Primary Care Association,
Jefferson City, Missouri.

Steven Hanling, MD, Director of Pain Medicine, Associate Professor, Augusta University Medical Center, Augusta, Georgia.

W. Michael Hooten, MD, Professor of Anesthesiology, Mayo Clinic College of Medicine, Rochester, Minnesota.

Stefan G. Kertesz, MD, MSc, Professor of Medicine, Birmingham Veterans Affairs Medical Center; Professor, University of
Alabama School of Medicine, Birmingham, Alabama.

Richard L. Kravitz, MD, MSPH, Professor and Co-vice Chair for Research, Department of Internal Medicine, University of
California, Davis, California.

Erin E. Krebs, MD, MPH, Women’s Health Medical Director, Minneapolis Veterans Affairs Health Care System; Associate
Professor of Medicine, University of Minnesota Medical School, Minneapolis, Minnesota.

Steven P. Stanos, Jr., DO, Medical Director, Swedish Pain Services and Occupational Medicine Services, Swedish Medical Center,
Seattle, Washington; President, American Academy of Pain Medicine.

Mark Sullivan, MD, PhD, Professor of Psychiatry and Behavioral Sciences, Adjunct Professor of Anesthesiology and Pain
Medicine, and Adjunct Professor of Bioethics and Humanities, University of Washington School of Medicine, Seattle, Washington.

Nonpanel Meeting Participants

Phil Saigh, Executive Director, American Academy of Pain Medicine (AAPM) and AAPM Foundation Chicago, Illinois.

Mary Kay Ams, Project Manager, AAPM and AAPM Foundation Chicago, Illinois.

Beth Dove, Medical Writer, Dove Medical Communications, LLC, Salt Lake City, Utah.
Implementing the CDC Guideline 733

Box A2. Centers for Disease Control and Prevention recommendations for prescribing opioids for chronic pain outside of active cancer, pallia-
tive, and end-of-life care

Determining When to Initiate or Continue Opioids for Chronic Pain

1. Nonpharmacologic therapy and nonopioid pharmacologic therapy are preferred for chronic pain. Clinicians should consider opioid
therapy only if expected benefits for both pain and function are anticipated to outweigh risks to the patient. If opioids are used, they
should be combined with nonpharmacologic therapy and nonopioid pharmacologic therapy, as appropriate.

2. Before starting opioid therapy for chronic pain, clinicians should establish treatment goals with all patients, including realistic goals

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for pain and function, and should consider how therapy will be discontinued if benefits do not outweigh risks. Clinicians should
continue opioid therapy only if there is clinically meaningful improvement in pain and function that outweighs risks to patient
safety.

3. Before starting and periodically during opioid therapy, clinicians should discuss with patients known risks and realistic benefits of
opioid therapy and patient and clinician responsibilities for managing therapy.

Opioid Selection, Dosage, Duration, Follow-up, and Discontinuation

4. When starting opioid therapy for chronic pain, clinicians should prescribe immediate-release opioids instead of extended-release/
long-acting (ER/LA) opioids.

5. When opioids are started, clinicians should prescribe the lowest effective dosage. Clinicians should use caution when prescribing
opioids at any dosage, should carefully reassess evidence of individual benefits and risks when increasing the dosage to 50 morphine
milligram equivalents (MME) or more per day, and should avoid increasing the dosage to 90 MME or more per day or carefully jus-
tify a decision to titrate dosage to 90 MME or more per day.

6. Long-term opioid use often begins with treatment of acute pain. When opioids are used for acute pain, clinicians should prescribe
the lowest effective dose of immediate-release opioids and should prescribe no greater a quantity than needed for the expected dura-
tion of pain severe enough to require opioids. Three days or less will often be sufficient; more than seven days will rarely be needed.

7. Clinicians should evaluate the benefits and harms with patients within one to four weeks of starting opioid therapy for chronic pain
or of dose escalation. Clinicians should evaluate the benefits and harms of continued therapy with patients every three months or
more frequently. If benefits do not outweigh harms of continued opioid therapy, clinicians should optimize therapies and work with
patients to taper opioids to lower dosages or to taper and discontinue opioids.

Assessing Risk and Addressing Harms of Opioid Use

8. Before starting and periodically during continuation of opioid therapy, clinicians should evaluate risk factors for opioid-related
harms. Clinicians should incorporate into the management plan strategies to mitigate risk, including considering offering naloxone
when factors that increase risk for opioid overdose, such as history of overdose, history of substance use disorder, higher opioid dos-
ages (  50 MME/d), or concurrent benzodiazepine use, are present.

9. Clinicians should review the patient’s history of controlled substance prescriptions using state prescription drug monitoring pro-
gram (PDMP) data to determine whether the patient is receiving opioid dosages or dangerous combinations that put him or her at
high risk for overdose. Clinicians should review PDMP data when starting opioid therapy for chronic pain and periodically during
opioid therapy for chronic pain, ranging from every prescription to every three months.

10. When prescribing opioids for chronic pain, clinicians should use urine drug testing before starting opioid therapy and consider urine
drug testing at least annually to assess for prescribed medications as well as other controlled prescription drugs and illicit drugs.

11. Clinicians should avoid prescribing opioid pain medication and benzodiazepines concurrently whenever possible.

12. Clinicians should offer or arrange evidence-based treatment (usually medication-assisted treatment with buprenorphine or metha-
done in combination with behavioral therapies) for patients with opioid use disorder.
734 Kroenke et al.

Box A3. Challenges identified in implementing the CDC guideline in clinical practice

• There is confusion in practice as to whether daily opioid dosage ceilings are to be universally applied, regardless of previous
opioid exposure.
• Daily dosage ceilings, if implemented as hard limits, may promote abrupt dose reductions in patients on high doses, which
risks withdrawal symptoms, hyperalgesia, and self-medication with more hazardous alternatives.
• Preferred practices regarding dosage ceilings are set as policy when payers make coverage and reimbursement decisions.
• The patient welfare consequences of an abrupt vs gradual and supported opioid tapers have not been clearly elucidated.
• A lack of access to resources has impeded a move toward integrated, multimodal, and comprehensive pain care, as espoused in

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the guideline.
• Naloxone co-prescribing is underutilized due to confusion around proper use and barriers to access.

CDC ¼ Centers for Disease Control and Prevention.

Box A4. Panel proposals addressed to government and private funders of research, public and private payers, and makers of health care law,
regulation, and policy

Appropriate Opioid Tapering

Facilitate interprovider communication and full reevaluation of harms and benefits in the care of patients on opioids who are
inherited from other practices.

Produce validated tapering protocols for patients on opioids for chronic pain.

Alert clinicians that it may be medically risky to abruptly discontinue opioids and other controlled substances in a patient who is
physically dependent without psychosocial management, focused care, gradual taper, and/or adjuvant therapies to treat with-
drawal symptoms.

Avoid misinterpreting the guideline by insisting on opioid reduction or cessation in pain conditions or treatment settings where
opioid use may still be warranted (e.g., palliative care, severe chronic pain when benefits outweigh risks) as the guideline does not
proscribe opioid use in these situations.

Prescription Dose and Duration Limits

Clarify the appropriate clinical application of the recommended dosage thresholds by acknowledging previous opioid exposure
and patient variability in risk factors for opioid-related overdose.

Fund more research to determine optimal dosage thresholds and improve understanding of potential differences in opioid metabo-
lism and response.

Fund more research to determine optimal prescription duration for acute pain care.

Toward Comprehensive, Multimodal Pain Care

Support a sufficient reimbursement and coverage structure to permit safe, effective pain treatment, including primary care access
to psychological and physical treatments and comprehensive pain management services when indicated.

Embrace the opportunity to work with insurance payers who exhibit interest in shifting to new reimbursement strategies that pri-
oritize comprehensive, multimodal pain care.

Support clinician training in a full range of available pain treatments and a team-based approach to pain care to include relevant
clinic staff and pharmacists.
Implementing the CDC Guideline 735

Disseminate programs to enhance prescriber competence in safer opioid prescribing.

In addition to dollars currently earmarked to fight the opioid problem, allocate funding to better study and support more compre-
hensive, multimodal pain care.

Acknowledge and reimburse some forms of telemedicine and virtual visits for follow-up and reassessment.

Protecting Patients from Unintended Consequences

Advise clinicians to avoid patient abandonment and that opioid failure does not preclude pain treatment.

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Consider revision to federal, state, or payer policies that treat opioid dose as the primary benchmark for quality of care without
adequate attention to maintaining pain control through alternative pain therapies.

Revise policies aimed at promoting dose tapering to ensure patient engagement, when possible, careful reevaluation of harms vs
benefits, and access to care.

Require the formal tracking of patient-level outcomes, favorable and unfavorable, of any interventions focused on prescription
reductions pursued by payers or regulators.

Toward Naloxene and OUD Treatment Optimization

Address access and cost barriers to naloxone distribution.

Support research and policy deliberation on how best to serve the patient subgroup that poorly tolerates an opioid taper but lacks
a formal OUD diagnosis, including clarifying the roles of opioid taper and possible buprenorphine administration.

Facilitate a clinic team focus with delegation of tasks to support staff to optimize both OUD and pain treatment.