Notice2022-02802
Proposed 2022 CDC Clinical Practice Guideline for Prescribing Opioids
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
February 10, 2022
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Abstract
The Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS), announces the opening of a docket to obtain comment on the proposed clinical practice guideline, CDC Clinical Practice Guideline for Prescribing Opioids--United States, 2022 (the clinical practice guideline). The clinical practice guideline updates and expands the CDC Guideline for Prescribing Opioids for Chronic Pain--United States, 2016, 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 3 months or more), not including sickle cell disease-related pain management, cancer pain treatment, palliative care, and end-of-life care. The 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). This voluntary clinical practice guideline provides recommendations and does not require mandatory compliance; and the clinical practice guideline is intended to be flexible so as to support, not supplant, clinical judgment and individualized, patient-centered decision-making.
Full Text
<html>
<head>
<title>Federal Register, Volume 87 Issue 28 (Thursday, February 10, 2022)</title>
</head>
<body><pre>
[Federal Register Volume 87, Number 28 (Thursday, February 10, 2022)]
[Notices]
[Pages 7838-7840]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-02802]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Docket No. CDC-2022-0024]
Proposed 2022 CDC Clinical Practice Guideline for Prescribing
Opioids
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice with comment period.
-----------------------------------------------------------------------
SUMMARY: The Centers for Disease Control and Prevention (CDC) within
the Department of Health and Human Services (HHS), announces the
opening of a docket to obtain comment on the proposed clinical practice
guideline, CDC Clinical Practice Guideline for
[[Page 7839]]
Prescribing Opioids--United States, 2022 (the clinical practice
guideline). The clinical practice guideline updates and expands the CDC
Guideline for Prescribing Opioids for Chronic Pain--United States,
2016, 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 3
months or more), not including sickle cell disease-related pain
management, cancer pain treatment, palliative care, and end-of-life
care. The 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). This
voluntary clinical practice guideline provides recommendations and does
not require mandatory compliance; and the clinical practice guideline
is intended to be flexible so as to support, not supplant, clinical
judgment and individualized, patient-centered decision-making.
DATES: Written comments must be received on or before April 11, 2022.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2022-
0024, by either of the following methods.
<bullet> Federal eRulemaking Portal: <a href="http://www.regulations.gov">http://www.regulations.gov</a>.
Follow the instructions for submitting comments.
<bullet> Mail: National Center for Injury Prevention and Control,
Centers for Disease Control and Prevention, 4770 Buford Highway NE,
Mailstop S106-9, Atlanta, GA 30341, Attn: Docket No. CDC-2022-0024.
Instructions: All submissions received must include the agency name
and Docket Number. All relevant comments received will be posted
without change to <a href="http://regulations.gov">http://regulations.gov</a>, including any personal
information provided. Do not submit comments by email. CDC does not
accept comments by email. For access to the docket to read background
documents or comments received, go to <a href="http://www.regulations.gov">http://www.regulations.gov</a>.
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: <a href="/cdn-cgi/l/email-protection#2b445b4244424f586b484f48054c445d"><span class="__cf_email__" data-cfemail="bad5cad3d5d3dec9fad9ded994ddd5cc">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
Public Participation
Interested persons or organizations are invited to participate by
submitting written views, recommendations, and data. Please note that
comments received, including attachments and other supporting
materials, are part of the public record and are subject to public
disclosure. Comments will be posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Therefore, do not include any information in your comment or supporting
materials that you consider confidential or inappropriate for public
disclosure. If you include your name, contact information, or other
information that identifies you in the body of your comments, that
information will be on public display. Do not submit comments by email.
CDC does not accept comments by email. CDC will review all submissions
and may choose to redact, or withhold, submissions containing private
or proprietary information such as Social Security numbers, medical
information, inappropriate language, or duplicate/near duplicate
examples of a mass-mail campaign.
Background
In the CDC Guideline for Prescribing Opioids for Chronic Pain--
United States, 2016, CDC communicated the intent to evaluate and
reassess evidence and recommendations 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 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 upon the new evidence
described in these reviews, an update to the CDC Guideline for
Prescribing Opioids for Chronic Pain--United States, 2016 was
warranted.
CDC developed the clinical practice guideline 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; patients', caregivers', and clinicians'
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 clinical practice
guideline focused on assisting clinicians in determining whether to
initiate opioids for pain; opioid selection and dosage; opioid duration
and follow-up; and assessing risk and addressing potential harms of
opioid use.
This clinical practice guideline is voluntary; it provides
recommendations and does not require mandatory compliance. It is
intended to be flexible to support, not supplant, clinical judgment and
individualized, patient-centered decision-making. This clinical
practice guideline 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 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 a reduction in the risks associated
with long-term opioid therapy, including opioid use disorder, overdose,
and death.
To help assure the clinical practice guideline's integrity,
credibility, and consideration of patients', caregivers', and
providers' values and preferences, CDC obtained input from patients,
caregivers, experts, clinicians, the public, and a federally chartered
advisory committee, the Board of Scientific Counselors of the National
Center for Injury Prevention and Control (BSC/NCIPC). CDC is also
currently obtaining feedback from a panel of external peer reviewers
who are experts in topic areas related to opioid prescribing. The panel
of external peer reviewers' feedback will be addressed and incorporated
into the final clinical practice guideline at the same time that public
comments received in response to this Notice are considered.
For more information about the clinical practice guideline or the
process of updating it, please visit <a href="https://www.cdc.gov/opioids/guideline-update/index.html">https://www.cdc.gov/opioids/guideline-update/index.html</a>.
Supporting and Related Material in the Docket
The docket contains the following supporting and related materials
to help
[[Page 7840]]
inform public comment: (1) The draft clinical practice guideline; (2)
the GRADE tables; (3) 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 (4) an Overview of Community Engagement and Public
Comment Opportunities, which describes key themes that emerged about
stakeholders' 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 the initial draft clinical practice
guideline as 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,
transparent input to the BSC/NCIPC on the diverse and complex issues
addressed in the 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 of the clinical practice guideline. The Overview of
Community Engagement and Public Comment Opportunities document provides
a summary of efforts implemented throughout the clinical practice
guideline update process to better understand the lived experiences and
perspectives of community members that we serve and to ensure
additional input from patients, caregivers, clinicians, and the public.
CDC's response to the themes and findings that emerged throughout the
community engagement and public comment opportunities describes how CDC
carefully considered and incorporated diverse perspectives and input
from multiple sources and stakeholders into the clinical practice
guideline.
Dated: February 7, 2022.
Angela K. Oliver,
Executive Secretary, Centers for Disease Control and Prevention.
[FR Doc. 2022-02802 Filed 2-9-22; 8:45 am]
BILLING CODE 4163-18-P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on February 10, 2022.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.