[Federal Register Volume 87, Number 223 (Monday, November 21, 2022)]
[Notices]
[Pages 70823-70827]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-25264]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Docket No. CDC-2022-0024]


CDC Clinical Practice Guideline for Prescribing Opioids for 
Pain--United States, 2022

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice.

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SUMMARY: The Centers for Disease Control and Prevention (CDC) within 
the Department of Health and Human Services (HHS), announces the 
availability of the CDC Clinical Practice Guideline for Prescribing 
Opioids for Pain--United States, 2022 (2022 Clinical Practice 
Guideline). The 2022 Clinical Practice Guideline updates and expands 
the CDC Guideline for Prescribing Opioids for Chronic Pain--United 
States, 2016 (2016 Guideline) and provides evidence-based 
recommendations for clinicians who provide pain care, including those 
prescribing opioids, for outpatients age 18 years and older with: acute 
pain (duration less than 1 month), subacute pain (duration of 1-3 
months), or chronic pain (duration of more than 3 months). The 
recommendations in the 2022 Clinical Practice Guideline do not apply to 
pain management related to sickle cell disease, cancer-related pain 
treatment, palliative care, or end-of-life care. The 2022 Clinical 
Practice Guideline finalizes the draft clinical practice guideline 
issued on February 10, 2022.

DATES: The 2022 Clinical Practice Guideline is available November 21, 
2022.

FOR FURTHER INFORMATION CONTACT: Arlene I. Greenspan, National Center 
for Injury Prevention and Control, Centers for Disease Control and 
Prevention, 4770 Buford Highway NE, MS S106-9, Atlanta, GA 30341; 
Telephone: 770-488-4696. Email: [email protected].

SUPPLEMENTARY INFORMATION:

[[Page 70824]]

Background

    In the 2016 Guideline, CDC communicated the intent to evaluate and 
reassess evidence and recommendations for opioid prescribing for adult 
patients as new evidence became available and to determine when new 
evidence would prompt an update. To achieve these aims, CDC funded the 
Evidence-based Practice Centers at the Agency for Healthcare Research 
and Quality (AHRQ) to conduct systematic reviews of the scientific 
evidence in the following five areas: (1) noninvasive (e.g., exercise, 
physical therapy, psychological therapies), nonpharmacological 
treatments for chronic pain; (2) nonopioid pharmacologic treatments for 
chronic pain; (3) opioid treatments for chronic pain; (4) treatments 
for acute pain; and (5) acute treatments for episodic migraine. Based 
on the evidence described in these reviews, an update to the 2016 
Guideline was warranted.
    CDC developed the 2022 Clinical Practice Guideline recommendations 
using the Grading of Recommendations, Assessment, Development, and 
Evaluation (GRADE) framework, which specifies the systematic review of 
scientific evidence and offers a transparent approach to grading 
quality of evidence and strength of recommendations. Recommendations 
were made based on systematic reviews of the available scientific 
evidence while considering benefits and harms; patient, caregiver, and 
clinician values and preferences for pain treatment; and resource 
allocation (e.g., costs to patients or health systems, including 
clinician time). CDC drafted recommendation statements in the 2022 
Clinical Practice Guideline to assist clinicians in determining whether 
or not to initiate opioids for pain, selecting opioids and determining 
opioid dosages, deciding duration of initial opioid prescription and 
conducting follow-up, and assessing risk and addressing potential harms 
of opioid use.
    The 2022 Clinical Practice Guideline includes recommendations for 
primary care clinicians (including physicians, nurse practitioners, and 
physician assistants) as well as for outpatient clinicians in other 
specialties (including those managing dental and postsurgical pain in 
outpatient settings and emergency clinicians providing pain management 
for patients being discharged from emergency departments).
    The 2022 Clinical Practice Guideline is not a regulation or a law. 
It is a set of voluntary recommendations intended to support clinicians 
as they work in consultation with their patients to address pain. It is 
intended to be flexible to support, not supplant, clinical judgment and 
individualized, patient-centered decision-making. It is not intended to 
be applied as inflexible standards of care across patient populations 
by healthcare professionals, health systems, third-party payers, 
organizations, or governmental jurisdictions. The 2022 Clinical 
Practice Guideline is intended to achieve the following: improved 
communication between clinicians and patients about the risks and 
benefits of pain treatment, including opioid therapy for pain; improved 
safety and effectiveness for pain treatment, resulting in improved 
function and quality of life for patients experiencing pain; and 
reduction in the risks associated with long-term opioid therapy, 
including opioid use disorder, overdose, and death.
    To help ensure the 2022 Clinical Practice Guideline's integrity, 
credibility, and consideration of patient, caregiver, and clinician 
values and preferences, CDC obtained input through individual 
conversations with patients, caregivers, experts, clinicians, through 
public comment opportunities, and a federally chartered advisory 
committee, the Board of Scientific Counselors of the National Center 
for Injury Prevention and Control (BSC/NCIPC). CDC also obtained 
feedback from a panel of external peer reviewers who are experts in 
topics related to opioid prescribing.

Summary of Public Comment and CDC Response

    On February 10, 2022, CDC published a notice in the Federal 
Register announcing the availability of the draft clinical practice 
guideline (87 FR 7838). The notice gave the public an opportunity to 
submit comments by April 10, 2022. CDC received approximately 5,500 
unique comments (including one comment submitted with 28,322 additional 
signatories) from the public, including patients with acute and chronic 
pain, caregivers, and clinicians. Comments also included organizational 
perspectives from medical associations, professional organizations, 
academic institutions, state and local governments, and advocacy and 
industry groups.
    CDC carefully catalogued, reviewed, and qualitatively analyzed all 
comments submitted by members of the public. All public comments were 
carefully reviewed and considered when revising the draft clinical 
practice guideline. Most comments submitted to the public docket for 
the draft clinical practice guideline were submitted by individuals 
living with pain and their caregivers, families, and friends.
    CDC highly values insights gained from these public comments and 
especially thanks those patients living with pain who shared their 
personal experiences in this public forum.
    Themes from the comments included: (1) concerns about the 2016 
Guideline; (2) overall considerations for the 2022 Clinical Practice 
Guideline; (3) considerations for Recommendation Statements in the 2022 
Clinical Practice Guideline; and (4) suggestions for scientific 
articles to include in supporting rationales to supplement information 
from the systematic reviews about acute and chronic pain management.

(1) Concerns about the 2016 Guideline

    Respondents shared their personal experiences with pain care, 
including with misinterpretation and misapplication of the 2016 
Guideline. In particular, they mentioned issues with misapplication 
related to prescribed dosing limits and forced tapers.

CDC Response

     CDC added language to the 2022 Clinical Practice Guideline 
emphasizing that it provides voluntary clinical practice 
recommendations that are not intended to be inflexible standards of 
care or implemented as absolute limits of policy or practice for 
patients by clinicians, healthcare systems, or government entities.
     CDC added language throughout the document that further 
emphasizes that both the benefits and the risks of continuing opioid 
therapy should be considered by clinicians when providing pain care for 
patients.
     CDC added discussion throughout the document pertaining to 
changes related to dosage thresholds and appropriate application. For 
example, the following was added to the Rationale:
    Importantly, to discourage the misapplication of opioid pain 
medication dosage thresholds as inflexible standards, revised 
recommendation statement language emphasizes principles such as 
avoiding increasing dosage above levels likely to yield diminishing 
returns in benefits relative to risks to patients. More specific 
considerations related to dosage have been moved to implementation 
considerations that follow each recommendation statement, where more 
nuance is offered to inform clinical decision-making and individualized 
patient care.

[[Page 70825]]

(2) Overall Considerations for the 2022 Clinical Practice Guideline

    Respondents focused on the importance of clinician judgment that 
promotes flexible opioid prescribing practices focused on the 
individual patient. They were appreciative of CDC's inclusion of 
language emphasizing open communication between patients and clinicians 
and updated language to discourage forced tapers. Regarding the latter, 
respondents encouraged CDC to further emphasize and strengthen this 
language.
    Many respondents expressed concern that mention of specific 
morphine milligram equivalents in the 2022 Clinical Practice Guideline 
would lead to hard limits on opioid prescriptions. Respondents also 
were concerned that specific pain conditions were called out as 
conditions to which the draft clinical practice guideline was not 
applicable while others went unmentioned.
    Respondents noted that the length of the draft clinical practice 
guideline was a barrier to end users. However, respondents also noted 
that several organizational features of the draft clinical practice 
guideline were helpful, such as a call-out box that summarizes its 
intended use, including conditions for which it is not applicable. 
Respondents suggested that additional detail in these boxes would be 
beneficial for those who may not read beyond this content. In addition, 
professional organizations suggested the development of supplemental 
one-pagers and supporting materials to further increase the utility of 
the document.
    Finally, some respondents providing comments on behalf on 
individuals with non-pain related conditions that use opioids for 
treatment (e.g., ostomy-related conditions and restless leg syndrome 
[RLS]) proposed that the 2022 Clinical Practice Guideline title should 
be adjusted to better reflect its content and intended use.

CDC Response

     CDC added language throughout the document to emphasize 
that the 2022 Clinical Practice Guideline provides voluntary clinical 
practice recommendations that are not intended to be inflexible 
standards of care or implemented as absolute limits of policy or 
practice for patients by clinicians, healthcare systems, or government 
entities.
     CDC added discussion throughout the document pertaining to 
changes related to dosage thresholds and appropriate application. For 
example, the following was added to the Rationale:
    Importantly, to discourage the misapplication of opioid pain 
medication dosage thresholds as inflexible standards, revised 
recommendation statement language emphasizes principles such as 
avoiding increasing dosage above levels likely to yield diminishing 
returns in benefits relative to risks to patients. More specific 
considerations related to dosage have been moved to the Implementation 
Considerations that follow each recommendation statement, where more 
nuance is offered to inform clinical decision-making and individualized 
patient care.
     CDC revised language in the scope and audience section to 
further emphasize that all types of pain need effective treatment:
    Although some principles in this clinical practice guideline might 
be helpful in the management of pain related to sickle cell disease, 
cancer-related pain treatment, palliative care, and end-of-life care, 
some recommendations might not be relevant for pain management in these 
contexts. Other guidelines more specifically address pain management in 
these situations; therefore, this clinical practice guideline does not 
apply to patients experiencing pain associated with these conditions or 
types of care. This does not imply that any other types of pain are 
more or less worthy of effective treatment, only that clinicians are 
referred to existing clinical guidelines that more specifically address 
unique considerations for management of pain related to sickle cell 
disease, cancer-related pain treatment, palliative care, and end-of-
life care.
     CDC added call-out boxes to the document to highlight 
critical information:
    [cir] Box 1. Executive summary of the CDC Clinical Practice 
Guideline for Prescribing Opioids for Pain-United States, 2022
    [cir] Box 2. Intended use of CDC's Clinical Practice Guideline for 
Prescribing Opioids for Pain-United States, 2022
    [cir] Box 3. Recommendations for prescribing opioids for 
outpatients with pain, excluding pain management for sickle cell 
disease, cancer-related pain treatment, palliative care, and end-of-
life care; recommendation categories; and evidence types, CDC Clinical 
Practice Guideline for Prescribing Opioids for Pain-United States, 2022
    [cir] Box 4. Guiding principles for implementation of the CDC 
Clinical Practice Guideline for Prescribing Opioids for Pain-United 
States, 2022 recommendations
    [cir] Box 5. Areas for additional research to build the evidence 
base for optimal pain management
     CDC is developing translation and communication materials 
to support accurate implementation of the 2022 Clinical Practice 
Guideline. These resources will be short references and ``at-a-glance'' 
materials to support appropriate application and interpretation.
     CDC changed the name of the document from the CDC Clinical 
Practice Guideline for Prescribing Opioids to the CDC Clinical Practice 
Guideline for Prescribing Opioids for Pain to further emphasize its 
focus on prescription opioids for the treatment of pain.

(3) Considerations for Recommendation Statements in the 2022 Clinical 
Practice Guideline

    Respondents noted that frequent follow-up appointments, office 
visits, and drug screening requirements were barriers to care and 
health equity. They also expressed concern about stigma related to 
toxicology testing.

CDC Response

     CDC added language to address health equity and additional 
considerations and context related to health equity, such as language 
about using virtual follow-up visits for patients for whom virtual 
visits are part of standard care (e.g., in remote areas where distance 
or other context makes follow-up visits challenging) or for patients 
for whom in-person follow-up visits are challenging (e.g., frail 
patients) under Recommendation 7's implementation considerations and 
supporting text.
     The second sentence of Recommendation 7 has been changed 
from ``Clinicians should evaluate benefits and risks of continued 
therapy with patients every 3 months or more frequently'' to 
``Clinicians should regularly reevaluate benefits and risks of 
continued opioid therapy with patients.'' Of note, the more specific 
``3-month'' time frame is still discussed in the Implementation 
Considerations and Supporting Rationale, where more nuanced 
considerations for flexibility are discussed.
     CDC augmented language in the implementation 
considerations for Recommendation 10 to state:
    Toxicology testing should not be used in a punitive manner but 
should be used in the context of other clinical information to inform 
and improve patient care. Clinicians should not

[[Page 70826]]

dismiss patients from care on the basis of a toxicology test result. 
Dismissal could have adverse consequences for patient safety, 
potentially including the patient obtaining opioids or other drugs from 
alternative sources and the clinician missing opportunities to 
facilitate treatment for substance use disorder.

(4) Suggestions for Scientific Articles About Acute and Chronic Pain 
Management

    Some respondents submitted scientific articles about acute and 
chronic pain management for CDC to consider citing as additional 
informative references in the supporting rationales. CDC carefully 
reviewed each submitted comment and made edits or added additional 
citations to the draft clinical practice guideline where appropriate. 
Some examples of recommended sources and revisions are below.
     To demonstrate the undertreatment of sickle cell disease 
due to stigma and racism, the organization Sick Cells recommended that 
CDC cite this reference: Phillips S, Chen Y, Masese R, Noisette L, 
Jordan K, et al. (2022) Perspectives of individuals with sickle cell 
disease on barriers to care. PLOS ONE 17(3): e0265342. https://doi.org/10.1371/journal.pone.026534.
     The Michigan Opioid Prescribing Engagement Network 
suggested that CDC cite its OPEN Prescribing Recommendations as an 
additional reference for Recommendation 1. This reference was already 
included in the document: Michigan Opioid Prescribing Engagement 
Network. Prescribing recommendations. Ann Arbor, MI: Michigan Opioid 
Prescribing Engagement Network. https://michigan-open.org/prescribing-recommendations.
     The American Geriatric Society noted that a reference to 
its 2009 American Geriatric Society Recommendations for Chronic Pain 
Medications in Older Adults (AGS Guideline) was not current and 
recommended CDC cite different sources for its discussion of the use of 
acetaminophen for the treatment of pain among adults aged 18 and over.
     The National Pain Advocacy Center stated that several 
studies finding adverse outcomes after opioid stoppage, dose reduction, 
or dose variation were not cited or were cited inaccurately.
     The American Academy of Addiction Psychiatry recommended 
the inclusion of the Alcohol Use Disorders Identification Consumption 
Test (AUDIT-C), as done by the Veterans Health Administration, instead 
of the full Alcohol Use Disorders Identification Test (AUDIT).
     The American College of Obstetrics and Gynecology (ACOG) 
recommended that other critical concepts regarding family planning and 
contraceptive counseling from additional resources be included in the 
document. ACOG also recommended an additional reference with safety 
data regarding buprenorphine/naloxone combination use in pregnancy: 
Link HM, Jones H, Miller L, Kaltenbach K, Seligman N. Buprenorphine-
naloxone use in pregnancy: a systematic review and metaanalysis. Am J 
Obstet Gynecol MFM. 2020 Aug;2(3):100179. doi: 10.1016/
j.ajogmf.2020.100179. Epub 2020 Jul 3. PMID: 33345863.

CDC Response

     CDC included Phillips et. al. in the references section.
     CDC added a citation to the Open Prescribing 
Recommendations again in reference to Recommendation 1.
     CDC deleted reference to the 2009 American Geriatric 
Society Guideline throughout the document.
     CDC added the references from the National Pain Advocacy 
Center. Several recommended references were already included in the 
draft clinical practice guideline.
    [cir] Hallvik SE, El Ibrahimi S, Johnston K, et al. Patient 
outcomes after opioid dose reduction among patients with chronic opioid 
therapy. Pain. 2022;163(1):83-90.
    [cir] Binswanger IA, Glanz JM, Faul M, et al. The Association 
between Opioid Discontinuation and Heroin Use: A Nested Case-Control 
Study. Drug and Alcohol Dependence. 2020;217:108248.
    [cir] Perez HR, Buonora M, Cunningham CO, Heo M, Starrels JL. 
Opioid Taper Is Associated with Subsequent Termination of Care: a 
Retrospective Cohort Study. J Gen Intern Med. 2020;35(1):36-42.
     CDC modified its inclusion from full AUDIT to AUDIT-C in 
the Supporting Rationale for Recommendation 7.
     CDC added additional family planning and contraceptive 
planning concepts and the following sources:
    [cir] ACOG Committee Opinion No. 762. American College of 
Obstetricians and Gynecologists. Obstet Gynecol 2019;133:e78-89.
    [cir] Patient-Centered Contraceptive Counseling. Committee 
Statement No. 1. American College of Obstetricians and Gynecologists. 
Obstet Gynecol 2022;139:349-53.
    [cir] Interpregnancy care. Obstetric Care Consensus No. 8. American 
College of Obstetricians and Gynecologists. Obstet Gynecol 
2019;133:e51-72.
     CDC added Link. et al.
    For more information about CDC's response to peer reviewers' and 
public comments, please see the Supporting & Related Materials tab of 
this docket.
    For more information about the 2022 Clinical Practice Guideline or 
the process of updating it, please visit https://www.cdc.gov/opioids/guideline-update/index.html.

Supporting and Related Material in the Docket

    The docket contains the following supporting and related materials: 
(1) the 2022 Clinical Practice Guideline; (2) the GRADE tables; (3) 
CDC's response to peer review of the draft clinical practice guideline; 
(4) CDC's response to public comments on the draft clinical practice 
guideline; (5) the draft clinical practice guideline released for 
public comment on February 10, 2022; (6) the Opioid Workgroup (OWG) 
Report, prepared at the request of the BSC/NCIPC and which the BSC/
NCIPC unanimously voted to have CDC adopt, and CDC's response to 
observations outlined in the OWG Report; and (7) an Overview of 
Community Engagement and Public Comment Opportunities, which describes 
key themes that emerged about participant values and preferences 
regarding pain management, as well as CDC's response to input obtained 
from these efforts.
    The GRADE tables include clinical evidence review ratings of the 
evidence for the key clinical questions. The OWG Report describes the 
workgroup's findings and observations about an initial draft clinical 
practice guideline presented to the BSC/NCIPC at a public meeting on 
July 16, 2021. The OWG, comprising three BSC/NCIPC members in 
accordance with federal advisory committee policy, as well as patients 
with pain, caregivers, and family members of patients with pain, and 
clinicians and subject matter experts with a variety of relevant pain 
management expertise, was designed to provide independent, broad, 
external, and transparent input to the BSC/NCIPC on the diverse and 
complex issues addressed in the draft clinical practice guideline. OWG 
meetings were coordinated by an NCIPC subject matter expert who served 
as the Designated Federal Official. CDC's response to the OWG Report 
reflects and describes how CDC incorporated OWG observations and 
comments in the revised draft clinical practice guideline.
    The Overview of Community Engagement and Public Comment 
Opportunities document provides a summary of efforts implemented 
throughout the clinical practice

[[Page 70827]]

guideline update process to better understand the lived experiences and 
perspectives of community members and to ensure additional input from 
patients, caregivers, clinicians, and the public. This document also 
summarizes CDC's response to the themes and findings that emerged 
throughout the community engagement and public comment opportunities 
and describes how CDC carefully considered and incorporated diverse 
perspectives and input from multiple sources into the draft clinical 
practice guideline that was posted for public comment.

Availability of the 2022 Clinical Practice Guideline

    The CDC Clinical Practice Guideline for Prescribing Opioids for 
Pain--United States, 2022 can be found in the Supporting & Related 
Materials tab of this docket on the Federal eRulemaking Portal: 
identified by Docket No. CDC-2022-0024 and at https://www.cdc.gov/mmwr/volumes/71/rr/rr7103a1.htm?s_cid=rr7103a1_w.

Angela K. Oliver,
Executive Secretary, Centers for Disease Control and Prevention.
[FR Doc. 2022-25264 Filed 11-18-22; 8:45 am]
BILLING CODE 4163-18-P