Supplemental Evidence and Data Request on Integrated Pain Management Programs, 73710-73712 [2020-25451]
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Federal Register / Vol. 85, No. 224 / Thursday, November 19, 2020 / Notices
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[FR Doc. 2020–25582 Filed 11–18–20; 8:45 am]
BILLING CODE 6210–01–P
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[FR Doc. 2020–25569 Filed 11–18–20; 8:45 am]
BILLING CODE 6210–01–P
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Jkt 253001
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Supplemental Evidence and Data
Request on Integrated Pain
Management Programs
Agency for Healthcare Research
and Quality (AHRQ), HHS.
ACTION: Request for Supplemental
Evidence and Data Submissions.
AGENCY:
The Agency for Healthcare
Research and Quality (AHRQ) is seeking
scientific information submissions from
the public. Scientific information is
being solicited to inform our review on
Integrated Pain Management Programs,
which is currently being conducted by
the AHRQ’s Evidence-based Practice
Centers (EPC) Program. Access to
published and unpublished pertinent
scientific information will improve the
quality of this review.
DATES: Submission Deadline on or
before December 21, 2020.
ADDRESSES:
Email submissions: epc@
ahrq.hhs.gov.
Print submissions:
Mailing Address: Center for Evidence
and Practice Improvement, Agency for
Healthcare Research and Quality,
ATTN: EPC SEADs Coordinator, 5600
Fishers Lane, Mail Stop 06E53A,
Rockville, MD 20857.
SUMMARY:
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Shipping Address (FedEx, UPS, etc.):
Center for Evidence and Practice
Improvement, Agency for Healthcare
Research and Quality, ATTN: EPC
SEADs Coordinator, 5600 Fishers Lane,
Mail Stop 06E77D, Rockville, MD
20857.
FOR FURTHER INFORMATION CONTACT:
Jenae Benns, Telephone: 301–427–1496
or Email: epc@ahrq.hhs.gov.
SUPPLEMENTARY INFORMATION: The
Agency for Healthcare Research and
Quality has commissioned the
Evidence-based Practice Centers (EPC)
Program to complete a review of the
evidence for Integrated Pain
Management Programs. AHRQ is
conducting this systematic review
pursuant to Section 902 of the Public
Health Service Act, 42 U.S.C. 299a.
The EPC Program is dedicated to
identifying as many studies as possible
that are relevant to the questions for
each of its reviews. In order to do so, we
are supplementing the usual manual
and electronic database searches of the
literature by requesting information
from the public (e.g., details of studies
conducted). We are looking for studies
that report on Integrated Pain
Management Programs, including those
that describe adverse events. The entire
research protocol is available online at:
https://effectivehealthcare.ahrq.gov/
products/integrated-pain-management/
protocol.
This is to notify the public that the
EPC Program would find the following
information on Integrated Pain
Management Programs helpful:
D A list of completed studies that
your organization has sponsored for this
indication. In the list, please indicate
whether results are available on
ClinicalTrials.gov along with the
ClinicalTrials.gov trial number.
D For completed studies that do not
have results on ClinicalTrials.gov, a
summary, including the following
elements: Study number, study period,
design, methodology, indication and
diagnosis, proper use instructions,
inclusion and exclusion criteria,
primary and secondary outcomes,
baseline characteristics, number of
patients screened/eligible/enrolled/lost
to follow-up/withdrawn/analyzed,
effectiveness/efficacy, and safety results.
D A list of ongoing studies that your
organization has sponsored for this
indication. In the list, please provide the
ClinicalTrials.gov trial number or, if the
trial is not registered, the protocol for
the study including a study number, the
study period, design, methodology,
indication and diagnosis, proper use
instructions, inclusion and exclusion
E:\FR\FM\19NON1.SGM
19NON1
Federal Register / Vol. 85, No. 224 / Thursday, November 19, 2020 / Notices
criteria, and primary and secondary
outcomes.
D Description of whether the above
studies constitute ALL Phase II and
above clinical trials sponsored by your
organization for this indication and an
index outlining the relevant information
in each submitted file.
Your contribution is very beneficial to
the Program. Materials submitted must
be publicly available or able to be made
public. Materials that are considered
confidential; marketing materials; study
types not included in the review; or
information on indications not included
in the review cannot be used by the EPC
Program. This is a voluntary request for
information, and all costs for complying
with this request must be borne by the
submitter.
The draft of this review will be posted
on AHRQ’s EPC Program website and
available for public comment for a
period of 4 weeks. If you would like to
be notified when the draft is posted,
please sign up for the email list at:
https://
www.effectivehealthcare.ahrq.gov/
email-updates.
The systematic review will answer the
following questions. This information is
provided as background. AHRQ is not
requesting that the public provide
answers to these questions.
Key Questions (KQs)
KQ1: What are the effectiveness and
harms of integrated or comprehensive
pain management programs for
Medicare beneficiaries with complex
acute/subacute pain or chronic, nonactive cancer pain? Population
subgroups of interest include those with
disabilities (including ESRD), prior
substance use disorder, psychological
co-morbidities (including suicidal
behaviors), and degree of nociplasticity.
KQ2: Have any of the following
factors been evaluated and/or shown to
impact outcomes in studies of
comprehensive or integrated pain
management models?
a. Treatment delivery including
session formats (group, one-on-one),
73711
duration, intensity and frequency of
sessions, number of sessions; general
structure and scope of sessions.
b. Treatment components (e.g.,
medication review and/or management,
including transition from opioid to
nonopioid medications; psychological
support or mental health services;
physical reconditioning, such as
physical therapy and occupational
therapy; use of complementary and
integrative medicine treatments; patient
education; use of medical procedures or
devices).
c. Care provision.
i. Care coordination methods or
decision support
ii. Provider types involved
iii. Personalization, care pathways
d. Program characteristics.
i. Program emphasis/goals
ii. Target population
iii. Referral sources
iv. Staffing characteristics (e.g., turn
over)
PICOTS (POPULATIONS, INTERVENTIONS, COMPARATORS, OUTCOMES, TIMING, SETTINGS)
PICOTS
Inclusion
Exclusion
Population ............................
Medicare beneficiaries (i.e., adults ≥65 years old and
those under 65 years old who qualify for Medicare
due to disability including ESRD) with complex acute/
subacute pain a or chronic non-active cancer pain.b In
the absence of publications in Medicare populations,
studies of adults with these types of pain will be considered.
Population subgroups of interest include those with disabilities (including ESRD), prior substance use disorder, psychological co-morbidities (including suicidal
behaviors), degree of nociplasticity.c
Pain management programs that address the biopsychosocial model of pain and include:
• Multidisciplinary (interdisciplinary) teams that at
a minimum have the following components available: Pharmacotherapy review and/or management, psychological care (mental health services), and physical reconditioning (e.g., PT, OT);
studies may also include other components in
addition to these; and
• Description of care coordination, case management or mechanisms of multidisciplinary, interdisciplinary collaboration and communication.
Integrated pain management programs (IPMPs) will be
defined as those that include the above and are
based in primary care. Comprehensive pain management programs (CPMPs) will be defined as those including the above but are not based in primary care.
Any.
Patient oriented outcomes:
• Primary: Pain, function (focus on ‘‘success’’ if reported), opioid use.
• Secondary: HRQOL, emotional function (e.g.,
depression, anxiety), patient satisfaction, global
improvement.
Harms, adverse events, unintended consequences Program-related outcomes:
• Utilization (e.g., pain-related hospital/ED visits or
short-term skilled nursing facility use, long term
care facility or institutional care transfer, Medicaid enrollment).
• Patients undergoing end-of-life care, terminally ill
(e.g., hospice) patients; those under supervised palliative care.
• Young, non-disabled populations.
Intervention ..........................
Comparator ..........................
Outcome ...............................
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• Unimodal pain management.
• Pain management confined to a single provider type,
practice, or isolated method of management.
• Programs focused on functional restoration and/or
occupational health focused on return to work such
as work hardening programs, unless they are specifically done in a Medicare eligible population or are
clearly applicable to the Medicare population.
• Programs in very young and non-disabled populations (e.g., military populations).
• Studies evaluating incremental value of adding a single treatment modality to another single treatment
modality (e.g., addition of CBT to PT).
• Post-operative or post-trauma rehabilitation programs.
None.
Patient-oriented outcomes:
• Non-validated instruments for outcomes (e.g.,
pain, function, HRQOL, depression, etc.)
• Intermediate outcomes (e.g., range of motion,
physical strength, etc.).
E:\FR\FM\19NON1.SGM
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Federal Register / Vol. 85, No. 224 / Thursday, November 19, 2020 / Notices
PICOTS (POPULATIONS, INTERVENTIONS, COMPARATORS, OUTCOMES, TIMING, SETTINGS)—Continued
PICOTS
Inclusion
Timing ..................................
Duration of follow up: Focus on persistence of effects
evaluated short term (1 to <6 months), intermediate
term (≥6 to <12 months) and long term (≥12 months)
following intervention.
Outpatient, inpatient, institutional residence.
Setting ..................................
Study design, publication
type.
Exclusion
Inclusion will focus on RCTs. Prospective cohort studies that control for confounding will be considered if
RCTs are not available. Comparative cohorts that do
not control for confounding will be considered if cohorts controlling for confounding are not available. In
the absence of comparative studies, single arm (e.g.,
case series, pre-post studies) will be considered if
they are clearly relevant to the Medicare population.
• Inpatient or outpatient settings exclusively providing
treatment for SUD/OUD or tertiary care, hospice, or
similar settings.
• Case reports.
• Case series (unless no comparative studies).
• Case-control studies, cross-sectional studies.
• Conference proceedings, editorials, letters, white papers, citations that have not been peer-reviewed.
CBT = Cognitive Behavioral Therapy; ED = emergency department; ESDR = end stage renal disease; HRQOL = Health-related quality of life;
OT = occupational therapy; OUD = opioid use disorder; PICOTS = population, intervention, comparator, outcomes, timing, study design; PT =
physical therapy; RCT = randomized control trial; SUD = substance use disorder.
a Complex acute or subacute pain: Patients with acute pain (<6 weeks duration) or subacute pain (6 weeks to 12 weeks duration) who are at
risk of developing chronic pain).
b Chronic, nonactive cancer pain (based on Mersky 1994): Pain that persists for at least three months and is not associated with [active] malignant disease’’; pain could, however, be resultant from a previous malignancy that is no longer active.
c The term nociplasticity has been used to describe pain resulting from altered nociception without underlying tissue damage resulting in hypersensitivity (e.g., fibromyalgia). Many pain conditions may have a nociplastic component. Some additional terms used in the literature include centralized pain and amplified pain.
Dated: November 13, 2020.
Marquita Cullom,
Associate Director.
[FR Doc. 2020–25451 Filed 11–18–20; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[Docket No. CDC–2020–0117]
Advisory Committee on Immunization
Practices (ACIP)
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice of meeting and request
for comment.
AGENCY:
In accordance with the
Federal Advisory Committee Act, the
Centers for Disease Control and
Prevention (CDC), announces the
following meeting of the Advisory
Committee on Immunization Practices
(ACIP). This meeting is open to the
public. Time will be available for public
comment. The meeting will be webcast
live via the World Wide Web.
DATES: The meeting will be held on
November 23, 2020 from 12:00 p.m. to
5:00 p.m., EST (times subject to change).
Written comments must be received
on or before November 23, 2020.
ADDRESSES: For more information on
ACIP please visit the ACIP website:
SUMMARY:
VerDate Sep<11>2014
19:40 Nov 18, 2020
Jkt 253001
https://www.cdc.gov/vaccines/acip/
index.html.
You may submit comments, identified
by Docket No. CDC–2020–0117 by any
of the following methods:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
• Mail: Docket No. CDC–2020–0117,
c/o Attn: November 23, 2020 ACIP
Meeting, Centers for Disease Control
and Prevention, 1600 Clifton Road NE,
MS H24–8, Atlanta, GA 30329–4027.
Instructions: All submissions received
must include the Agency name and
Docket Number. All relevant comments
received in conformance with the
https://www.regulations.gov suitability
policy will be posted without change to
https://www.regulations.gov, including
any personal information provided. For
access to the docket to read background
documents or comments received, go to
https://www.regulations.gov.
Written public comments submitted
by 24 hours prior to the ACIP meeting
will be provided to ACIP members
before the meeting.
FOR FURTHER INFORMATION CONTACT:
Stephanie Thomas, ACIP Committee
Management Specialist, Centers for
Disease Control and Prevention,
National Center for Immunization and
Respiratory Diseases, 1600 Clifton Road,
NE, MS–H24–8, Atlanta, GA 30329–
4027; Telephone: 404–639–8367; Email:
ACIP@cdc.gov.
SUPPLEMENTARY INFORMATION:
Purpose: The committee is charged
with advising the Director, CDC, on the
use of immunizing agents. In addition,
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under 42 U.S.C. 1396s, the committee is
mandated to establish and periodically
review and, as appropriate, revise the
list of vaccines for administration to
vaccine-eligible children through the
Vaccines for Children (VFC) program,
along with schedules regarding dosing
interval, dosage, and contraindications
to administration of vaccines. Further,
under provisions of the Affordable Care
Act, section 2713 of the Public Health
Service Act, immunization
recommendations of the ACIP that have
been approved by the Director of the
Centers for Disease Control and
Prevention and appear on CDC
immunization schedules must be
covered by applicable health plans.
Matters To Be Considered: The agenda
will include discussions on COVID–19
vaccines. No recommendation vote is
scheduled for COVID–19 vaccines.
Agenda items are subject to change as
priorities dictate. For more information
on the meeting agenda visit https://
www.cdc.gov/vaccines/acip/meetings/
meetings-info.html.
Meeting Information: The meeting
will be webcast live via the World Wide
Web; for more information on ACIP
please visit the ACIP website: https://
www.cdc.gov/vaccines/acip/.
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
E:\FR\FM\19NON1.SGM
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]]>Agencies
[Federal Register Volume 85, Number 224 (Thursday, November 19, 2020)]
[Notices]
[Pages 73710-73712]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-25451]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Supplemental Evidence and Data Request on Integrated Pain
Management Programs
AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.
ACTION: Request for Supplemental Evidence and Data Submissions.
-----------------------------------------------------------------------
SUMMARY: The Agency for Healthcare Research and Quality (AHRQ) is
seeking scientific information submissions from the public. Scientific
information is being solicited to inform our review on Integrated Pain
Management Programs, which is currently being conducted by the AHRQ's
Evidence-based Practice Centers (EPC) Program. Access to published and
unpublished pertinent scientific information will improve the quality
of this review.
DATES: Submission Deadline on or before December 21, 2020.
ADDRESSES:
Email submissions: [email protected].
Print submissions:
Mailing Address: Center for Evidence and Practice Improvement,
Agency for Healthcare Research and Quality, ATTN: EPC SEADs
Coordinator, 5600 Fishers Lane, Mail Stop 06E53A, Rockville, MD 20857.
Shipping Address (FedEx, UPS, etc.): Center for Evidence and
Practice Improvement, Agency for Healthcare Research and Quality, ATTN:
EPC SEADs Coordinator, 5600 Fishers Lane, Mail Stop 06E77D, Rockville,
MD 20857.
FOR FURTHER INFORMATION CONTACT: Jenae Benns, Telephone: 301-427-1496
or Email: [email protected].
SUPPLEMENTARY INFORMATION: The Agency for Healthcare Research and
Quality has commissioned the Evidence-based Practice Centers (EPC)
Program to complete a review of the evidence for Integrated Pain
Management Programs. AHRQ is conducting this systematic review pursuant
to Section 902 of the Public Health Service Act, 42 U.S.C. 299a.
The EPC Program is dedicated to identifying as many studies as
possible that are relevant to the questions for each of its reviews. In
order to do so, we are supplementing the usual manual and electronic
database searches of the literature by requesting information from the
public (e.g., details of studies conducted). We are looking for studies
that report on Integrated Pain Management Programs, including those
that describe adverse events. The entire research protocol is available
online at: https://effectivehealthcare.ahrq.gov/products/integrated-pain-management/protocol.
This is to notify the public that the EPC Program would find the
following information on Integrated Pain Management Programs helpful:
[ssquf] A list of completed studies that your organization has
sponsored for this indication. In the list, please indicate whether
results are available on ClinicalTrials.gov along with the
ClinicalTrials.gov trial number.
[ssquf] For completed studies that do not have results on
ClinicalTrials.gov, a summary, including the following elements: Study
number, study period, design, methodology, indication and diagnosis,
proper use instructions, inclusion and exclusion criteria, primary and
secondary outcomes, baseline characteristics, number of patients
screened/eligible/enrolled/lost to follow-up/withdrawn/analyzed,
effectiveness/efficacy, and safety results.
[ssquf] A list of ongoing studies that your organization has
sponsored for this indication. In the list, please provide the
ClinicalTrials.gov trial number or, if the trial is not registered, the
protocol for the study including a study number, the study period,
design, methodology, indication and diagnosis, proper use instructions,
inclusion and exclusion
[[Page 73711]]
criteria, and primary and secondary outcomes.
[ssquf] Description of whether the above studies constitute ALL
Phase II and above clinical trials sponsored by your organization for
this indication and an index outlining the relevant information in each
submitted file.
Your contribution is very beneficial to the Program. Materials
submitted must be publicly available or able to be made public.
Materials that are considered confidential; marketing materials; study
types not included in the review; or information on indications not
included in the review cannot be used by the EPC Program. This is a
voluntary request for information, and all costs for complying with
this request must be borne by the submitter.
The draft of this review will be posted on AHRQ's EPC Program
website and available for public comment for a period of 4 weeks. If
you would like to be notified when the draft is posted, please sign up
for the email list at: https://www.effectivehealthcare.ahrq.gov/email-updates.
The systematic review will answer the following questions. This
information is provided as background. AHRQ is not requesting that the
public provide answers to these questions.
Key Questions (KQs)
KQ1: What are the effectiveness and harms of integrated or
comprehensive pain management programs for Medicare beneficiaries with
complex acute/subacute pain or chronic, non-active cancer pain?
Population subgroups of interest include those with disabilities
(including ESRD), prior substance use disorder, psychological co-
morbidities (including suicidal behaviors), and degree of
nociplasticity.
KQ2: Have any of the following factors been evaluated and/or shown
to impact outcomes in studies of comprehensive or integrated pain
management models?
a. Treatment delivery including session formats (group, one-on-
one), duration, intensity and frequency of sessions, number of
sessions; general structure and scope of sessions.
b. Treatment components (e.g., medication review and/or management,
including transition from opioid to nonopioid medications;
psychological support or mental health services; physical
reconditioning, such as physical therapy and occupational therapy; use
of complementary and integrative medicine treatments; patient
education; use of medical procedures or devices).
c. Care provision.
i. Care coordination methods or decision support
ii. Provider types involved
iii. Personalization, care pathways
d. Program characteristics.
i. Program emphasis/goals
ii. Target population
iii. Referral sources
iv. Staffing characteristics (e.g., turn over)
PICOTS (Populations, Interventions, Comparators, Outcomes, Timing, Settings)
----------------------------------------------------------------------------------------------------------------
PICOTS Inclusion Exclusion
----------------------------------------------------------------------------------------------------------------
Population........................... Medicare beneficiaries (i.e., adults >=65 Patients undergoing
years old and those under 65 years old end-of-life care, terminally
who qualify for Medicare due to ill (e.g., hospice)
disability including ESRD) with complex patients; those under
acute/subacute pain \a\ or chronic non- supervised palliative care.
active cancer pain.\b\ In the absence of Young, non-disabled
publications in Medicare populations, populations.
studies of adults with these types of
pain will be considered.
Population subgroups of interest include
those with disabilities (including ESRD),
prior substance use disorder,
psychological co-morbidities (including
suicidal behaviors), degree of
nociplasticity.\c\
Intervention......................... Pain management programs that address the Unimodal pain
biopsychosocial model of pain and management.
include: Pain management
Multidisciplinary confined to a single
(interdisciplinary) teams that at a provider type, practice, or
minimum have the following components isolated method of
available: Pharmacotherapy review and/or management.
management, psychological care (mental Programs focused on
health services), and physical functional restoration and/
reconditioning (e.g., PT, OT); studies or occupational health
may also include other components in focused on return to work
addition to these; and such as work hardening
Description of care coordination, programs, unless they are
case management or mechanisms of specifically done in a
multidisciplinary, interdisciplinary Medicare eligible population
collaboration and communication. or are clearly applicable to
Integrated pain management programs the Medicare population.
(IPMPs) will be defined as those that Programs in very
include the above and are based in young and non-disabled
primary care. Comprehensive pain populations (e.g., military
management programs (CPMPs) will be populations).
defined as those including the above but Studies evaluating
are not based in primary care. incremental value of adding
a single treatment modality
to another single treatment
modality (e.g., addition of
CBT to PT).
Post-operative or
post-trauma rehabilitation
programs.
Comparator........................... Any. None.
Outcome.............................. Patient oriented outcomes: Patient-oriented outcomes:
Primary: Pain, function (focus Non-validated
on ``success'' if reported), opioid instruments for outcomes
use. (e.g., pain, function,
Secondary: HRQOL, emotional HRQOL, depression, etc.)
function (e.g., depression, anxiety), Intermediate
patient satisfaction, global improvement. outcomes (e.g., range of
motion, physical strength,
etc.).
Harms, adverse events, unintended
consequences Program-related outcomes:
Utilization (e.g., pain-
related hospital/ED visits or short-
term skilled nursing facility use,
long term care facility or
institutional care transfer, Medicaid
enrollment).
[[Page 73712]]
Timing............................... Duration of follow up: Focus on
persistence of effects evaluated short
term (1 to <6 months), intermediate term
(>=6 to <12 months) and long term (>=12
months) following intervention.
Setting.............................. Outpatient, inpatient, institutional Inpatient or
residence. outpatient settings
exclusively providing
treatment for SUD/OUD or
tertiary care, hospice, or
similar settings.
Study design, publication type....... Inclusion will focus on RCTs. Prospective Case reports.
cohort studies that control for Case series (unless
confounding will be considered if RCTs no comparative studies).
are not available. Comparative cohorts Case-control
that do not control for confounding will studies, cross-sectional
be considered if cohorts controlling for studies.
confounding are not available. In the Conference
absence of comparative studies, single proceedings, editorials,
arm (e.g., case series, pre-post studies) letters, white papers,
will be considered if they are clearly citations that have not been
relevant to the Medicare population. peer-reviewed.
----------------------------------------------------------------------------------------------------------------
CBT = Cognitive Behavioral Therapy; ED = emergency department; ESDR = end stage renal disease; HRQOL = Health-
related quality of life; OT = occupational therapy; OUD = opioid use disorder; PICOTS = population,
intervention, comparator, outcomes, timing, study design; PT = physical therapy; RCT = randomized control
trial; SUD = substance use disorder.
\a\ Complex acute or subacute pain: Patients with acute pain (<6 weeks duration) or subacute pain (6 weeks to 12
weeks duration) who are at risk of developing chronic pain).
\b\ Chronic, nonactive cancer pain (based on Mersky 1994): Pain that persists for at least three months and is
not associated with [active] malignant disease''; pain could, however, be resultant from a previous malignancy
that is no longer active.
\c\ The term nociplasticity has been used to describe pain resulting from altered nociception without underlying
tissue damage resulting in hypersensitivity (e.g., fibromyalgia). Many pain conditions may have a nociplastic
component. Some additional terms used in the literature include centralized pain and amplified pain.
Dated: November 13, 2020.
Marquita Cullom,
Associate Director.
[FR Doc. 2020-25451 Filed 11-18-20; 8:45 am]
BILLING CODE 4160-90-P
