Supplemental Evidence and Data Request on Malnutrition in Hospitalized Adults, 71902-71904 [2020-24968]
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Federal Register / Vol. 85, No. 219 / Thursday, November 12, 2020 / Notices
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[FR Doc. 2020–25035 Filed 11–10–20; 8:45 am]
BILLING CODE 6750–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Supplemental Evidence and Data
Request on Malnutrition in
Hospitalized Adults
Agency for Healthcare Research
and Quality (AHRQ), HHS.
ACTION: Request for supplemental
evidence and data submissions.
jbell on DSKJLSW7X2PROD with NOTICES
AGENCY:
The Agency for Healthcare
Research and Quality (AHRQ) is seeking
scientific information submissions from
SUMMARY:
VerDate Sep<11>2014
17:07 Nov 10, 2020
Jkt 253001
the public. Scientific information is
being solicited to inform our review on
Malnutrition in Hospitalized Adults,
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published and unpublished pertinent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 14, 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.
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 Malnutrition in
Hospitalized Adults. 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 Malnutrition in
Hospitalized Adults, including those
that describe adverse events. The entire
research protocol is available online at:
https://effectivehealthcare.ahrq.gov/
products/malnutrition-hospitalizedadults/protocol.
This is to notify the public that the
EPC Program would find the following
information on Malnutrition in
Hospitalized Adults 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.
PO 00000
Frm 00028
Fmt 4703
Sfmt 4703
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
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)
Key Question 1. What is the
association between malnutrition and
clinical outcomes among hospitalized
patients?
a. How do outcomes vary depending
on measures or tools used to detect
malnutrition?
b. Are patient-related risk factors,
such as increased age or certain preexisting health conditions, associated
with poorer clinical outcomes?
E:\FR\FM\12NON1.SGM
12NON1
Federal Register / Vol. 85, No. 219 / Thursday, November 12, 2020 / Notices
Key Question 2. What is the
effectiveness of screening or diagnostic
assessment for malnutrition among
hospitalized adults?
a. In studies that report on clinical
outcomes, what is the diagnostic
accuracy of screening or diagnostic
assessment for malnutrition?
b. In studies that report on clinical
outcomes, what is the effectiveness of
screening or diagnostic assessment on
measures of nutrition (nutritional
stores)?
c. What is the impact of screening or
diagnostic assessment on clinical
outcomes?
71903
Key Question 3. Among patients
diagnosed with malnutrition, what is
the effectiveness of hospital-initiated
interventions used to treat malnutrition
on clinical outcomes?
PICOTS (POPULATION, INTERVENTION, COMPARATOR, OUTCOME, TIMING, SETTING)
Category
Definition
Population .......................................
Key Question 1 and 2: Hospitalized adults aged 18 years or older (see Methods section for exceptions).
Key Question 1b subgroups include adults with no risk of malnutrition, adults with risk of malnutrition, and
adults with baseline malnutrition. Risk factors of interest to this report include:
• Older patients (>65 years)
• Racial and ethnic minorities
• Low income (e.g. Medicaid beneficiaries)
• Patients with malignancy
• Patients with gastrointestinal disease and subsequent malabsorption, including ulcerative colitis and
Crohn’s disease
• Patients with chronic liver disease
• Patients with stroke
• Patients with chronic kidney disease
• Patients with dementia
• Patients with critical illness
• Sepsis/infection
Key Question 3: Adults diagnosed with protein-energy malnutrition.
Key Question 1: Positive screening for nutrition risk and/or diagnosis of malnutrition vs no malnutrition.
Key Question 2: Malnutrition screening and diagnostic assessment tools (utilized within the U.S., Australia,
New Zealand, Canada, and Europe). Examples of tools of interest include:
Screening:
• Malnutrition Screening Tool (MST)
• Malnutrition Universal Screening Tool (MUST)
• Nutritional Risk Index (NRI)
• Nutrition Risk in Critically Ill (NUTRIC) score
Diagnostic Assessment:
• Subjective Global Assessment (SGA)
• Patient Generated Subjective Global Assessment (PS–SGA)
• Mini Nutritional Assessment (MNA)
• AND (Academy of Nutrition and Dietetics)–ASPEN (American Society for Parenteral and Enteral Nutrition) Malnutrition Consensus Criteria (MCC)
• Global Leadership Initiative on Malnutrition (GLIM)
Key Question 3: Hospital-initiated malnutrition interventions. Examples of interventions include:
• Parenteral nutrition
• Enteral nutrition
• Oral nutrition supplements
• Nutrition team consultation, includes dietitian counseling
• Pharmacologic interventions
Key Question 1: Hospitalized patients without malnutrition, or direct comparisons of different definitions of
malnutrition.
Key Questions 2: Radiographic imaging or SGA will be used as the reference standard.
Key Question 3: Usual care or another hospital-initiated malnutrition-related intervention.
Clinical Outcomes (All Key Questions):
• Mortality (inpatient and 30-day)
• Length of stay
• 30-day readmission
• Quality of life
• Functional status, includes gate speed, Karnofsky Index, handgrip strength, days on ventilator
• Activities of daily
• Hospital Acquired Condition (HAC)
• Wound healing
• Discharge disposition
Intermediate Outcomes (KQ 2):
Diagnostic accuracy outcomes:
• Sensitivity
• Specificity
• Predictive value
• Area under the curve
Intermediate Outcomes (KQ 2 or KQ 3):
Nutrition Stores: Direct measures of nutrition status (nutrition stores) during and post hospitalization. Examples include:
• Cross-sectional areas for lumbar skeletal muscle and adipose tissue
• Skeletal Muscle Index
Interventions/Exposures ..................
Comparators ...................................
jbell on DSKJLSW7X2PROD with NOTICES
Outcomes ........................................
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71904
Federal Register / Vol. 85, No. 219 / Thursday, November 12, 2020 / Notices
PICOTS (POPULATION, INTERVENTION, COMPARATOR, OUTCOME, TIMING, SETTING)—Continued
Category
Definition
Timing .............................................
Setting .............................................
• Regional or total fat mass and muscle mass assessed using validated gold standard methods, such
as body composition measures derived through Computed Tomography (CT) scans, Dual X-ray
Absorptiometry (DXA), and Magnetic Resonance Imaging (MRI)
Up to 30 days post-discharge
Acute care hospitalizations
Dated: November 5, 2020.
Marquita N. Cullom,
Associate Director.
amount of $4.20, $6.00, $7.80, $9.60 or
$10.20, respectively.
DATES: The premium and related
amounts announced in this notice are
effective on January 1, 2021.
FOR FURTHER INFORMATION CONTACT: M.
Kent Clemens, (410) 786–6391.
SUPPLEMENTARY INFORMATION:
[FR Doc. 2020–24968 Filed 11–10–20; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–8076–N]
RIN 0938–AU16
Medicare Program; Medicare Part B
Monthly Actuarial Rates, Premium
Rates, and Annual Deductible
Beginning January 1, 2021
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice.
AGENCY:
This notice announces the
monthly actuarial rates for aged (age 65
and over) and disabled (under age 65)
beneficiaries enrolled in Part B of the
Medicare Supplementary Medical
Insurance (SMI) program beginning
January 1, 2021. In addition, this notice
announces the monthly premium for
aged and disabled beneficiaries, the
deductible for 2021, and the incomerelated monthly adjustment amounts to
be paid by beneficiaries with modified
adjusted gross income above certain
threshold amounts. The monthly
actuarial rates for 2021 are $291.00 for
aged enrollees and $349.90 for disabled
enrollees. The standard monthly Part B
premium rate for all enrollees for 2021
is $148.50, which is equal to 50 percent
of the monthly actuarial rate for aged
enrollees (or approximately 25 percent
of the expected average total cost of Part
B coverage for aged enrollees) plus the
$3.00 repayment amount required under
current law. (The 2020 standard
premium rate was $144.60, which
included the $3.00 repayment amount.)
The Part B deductible for 2021 is
$203.00 for all Part B beneficiaries. If a
beneficiary has to pay an income-related
monthly adjustment, he or she will have
to pay a total monthly premium of about
35, 50, 65, 80 or 85 percent of the total
cost of Part B coverage plus a repayment
jbell on DSKJLSW7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:07 Nov 10, 2020
Jkt 253001
I. Background
Part B is the voluntary portion of the
Medicare program that pays all or part
of the costs for physicians’ services;
outpatient hospital services; certain
home health services; services furnished
by rural health clinics, ambulatory
surgical centers, and comprehensive
outpatient rehabilitation facilities; and
certain other medical and health
services not covered by Medicare Part
A, Hospital Insurance. Medicare Part B
is available to individuals who are
entitled to Medicare Part A, as well as
to U.S. residents who have attained age
65 and are citizens and to aliens who
were lawfully admitted for permanent
residence and have resided in the
United States for 5 consecutive years.
Part B requires enrollment and payment
of monthly premiums, as described in
42 CFR part 407, subpart B, and part
408, respectively. The premiums paid
by (or on behalf of) all enrollees fund
approximately one-fourth of the total
incurred costs, and transfers from the
general fund of the Treasury pay
approximately three-fourths of these
costs.
The Secretary of the Department of
Health and Human Services (the
Secretary) is required by section 1839 of
the Social Security Act (the Act) to
announce the Part B monthly actuarial
rates for aged and disabled beneficiaries
as well as the monthly Part B premium.
The Part B annual deductible is
included because its determination is
directly linked to the aged actuarial rate.
The monthly actuarial rates for aged
and disabled enrollees are used to
determine the correct amount of general
revenue financing per beneficiary each
month. These amounts, according to
actuarial estimates, will equal,
respectively, one-half of the expected
average monthly cost of Part B for each
aged enrollee (age 65 or over) and onehalf of the expected average monthly
PO 00000
Frm 00030
Fmt 4703
Sfmt 4703
cost of Part B for each disabled enrollee
(under age 65).
The Part B deductible to be paid by
enrollees is also announced. Prior to the
Medicare Prescription Drug,
Improvement, and Modernization Act of
2003 (MMA) (Pub. L. 108–173), the Part
B deductible was set in statute. After
setting the 2005 deductible amount at
$110, section 629 of the MMA
(amending section 1833(b) of the Act)
required that the Part B deductible be
indexed beginning in 2006. The
inflation factor to be used each year is
the annual percentage increase in the
Part B actuarial rate for enrollees age 65
and over. Specifically, the 2021 Part B
deductible is calculated by multiplying
the 2020 deductible by the ratio of the
2021 aged actuarial rate to the 2020 aged
actuarial rate. The amount determined
under this formula is then rounded to
the nearest $1.
The monthly Part B premium rate to
be paid by aged and disabled enrollees
is also announced. (Although the costs
to the program per disabled enrollee are
different than for the aged, the statute
provides that the two groups pay the
same premium amount.) Beginning with
the passage of section 203 of the Social
Security Amendments of 1972 (Pub. L.
92–603), the premium rate, which was
determined on a fiscal-year basis, was
limited to the lesser of the actuarial rate
for aged enrollees, or the current
monthly premium rate increased by the
same percentage as the most recent
general increase in monthly Title II
Social Security benefits.
However, the passage of section 124
of the Tax Equity and Fiscal
Responsibility Act of 1982 (TEFRA)
(Pub. L. 97–248) suspended this
premium determination process.
Section 124 of TEFRA changed the
premium basis to 50 percent of the
monthly actuarial rate for aged enrollees
(that is, 25 percent of program costs for
aged enrollees). Section 606 of the
Social Security Amendments of 1983
(Pub. L. 98–21), section 2302 of the
Deficit Reduction Act of 1984 (DEFRA
84) (Pub. L. 98–369), section 9313 of the
Consolidated Omnibus Budget
Reconciliation Act of 1985 (COBRA 85)
(Pub. L. 99–272), section 4080 of the
Omnibus Budget Reconciliation Act of
E:\FR\FM\12NON1.SGM
12NON1
]]>Agencies
[Federal Register Volume 85, Number 219 (Thursday, November 12, 2020)]
[Notices]
[Pages 71902-71904]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-24968]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Supplemental Evidence and Data Request on Malnutrition in
Hospitalized Adults
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 Malnutrition in
Hospitalized Adults, 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 14, 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 Malnutrition in
Hospitalized Adults. 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 Malnutrition in Hospitalized Adults, including those
that describe adverse events. The entire research protocol is available
online at: https://effectivehealthcare.ahrq.gov/products/malnutrition-hospitalized-adults/protocol.
This is to notify the public that the EPC Program would find the
following information on Malnutrition in Hospitalized Adults 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 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)
Key Question 1. What is the association between malnutrition and
clinical outcomes among hospitalized patients?
a. How do outcomes vary depending on measures or tools used to
detect malnutrition?
b. Are patient-related risk factors, such as increased age or
certain pre-existing health conditions, associated with poorer clinical
outcomes?
[[Page 71903]]
Key Question 2. What is the effectiveness of screening or
diagnostic assessment for malnutrition among hospitalized adults?
a. In studies that report on clinical outcomes, what is the
diagnostic accuracy of screening or diagnostic assessment for
malnutrition?
b. In studies that report on clinical outcomes, what is the
effectiveness of screening or diagnostic assessment on measures of
nutrition (nutritional stores)?
c. What is the impact of screening or diagnostic assessment on
clinical outcomes?
Key Question 3. Among patients diagnosed with malnutrition, what is
the effectiveness of hospital-initiated interventions used to treat
malnutrition on clinical outcomes?
PICOTS (Population, Intervention, Comparator, Outcome, Timing, Setting)
------------------------------------------------------------------------
Category Definition
------------------------------------------------------------------------
Population........................ Key Question 1 and 2: Hospitalized
adults aged 18 years or older (see
Methods section for exceptions).
Key Question 1b subgroups include
adults with no risk of
malnutrition, adults with risk of
malnutrition, and adults with
baseline malnutrition. Risk factors
of interest to this report include:
Older patients (>65
years)
Racial and ethnic
minorities
Low income (e.g.
Medicaid beneficiaries)
Patients with malignancy
Patients with
gastrointestinal disease and
subsequent malabsorption,
including ulcerative colitis and
Crohn's disease
Patients with chronic
liver disease
Patients with stroke
Patients with chronic
kidney disease
Patients with dementia
Patients with critical
illness
Sepsis/infection
Key Question 3: Adults diagnosed
with protein-energy malnutrition.
Interventions/Exposures........... Key Question 1: Positive screening
for nutrition risk and/or diagnosis
of malnutrition vs no malnutrition.
Key Question 2: Malnutrition
screening and diagnostic assessment
tools (utilized within the U.S.,
Australia, New Zealand, Canada, and
Europe). Examples of tools of
interest include:
Screening:
Malnutrition Screening
Tool (MST)
Malnutrition Universal
Screening Tool (MUST)
Nutritional Risk Index
(NRI)
Nutrition Risk in
Critically Ill (NUTRIC) score
Diagnostic Assessment:
Subjective Global
Assessment (SGA)
Patient Generated
Subjective Global Assessment (PS-
SGA)
Mini Nutritional
Assessment (MNA)
AND (Academy of
Nutrition and Dietetics)-ASPEN
(American Society for Parenteral
and Enteral Nutrition)
Malnutrition Consensus Criteria
(MCC)
Global Leadership
Initiative on Malnutrition
(GLIM)
Key Question 3: Hospital-initiated
malnutrition interventions.
Examples of interventions include:
Parenteral nutrition
Enteral nutrition
Oral nutrition
supplements
Nutrition team
consultation, includes dietitian
counseling
Pharmacologic
interventions
Comparators....................... Key Question 1: Hospitalized
patients without malnutrition, or
direct comparisons of different
definitions of malnutrition.
Key Questions 2: Radiographic
imaging or SGA will be used as the
reference standard.
Key Question 3: Usual care or
another hospital-initiated
malnutrition-related intervention.
Outcomes.......................... Clinical Outcomes (All Key
Questions):
Mortality (inpatient and
30-day)
Length of stay
30-day readmission
Quality of life
Functional status,
includes gate speed, Karnofsky
Index, handgrip strength, days
on ventilator
Activities of daily
Hospital Acquired
Condition (HAC)
Wound healing
Discharge disposition
Intermediate Outcomes (KQ 2):
Diagnostic accuracy outcomes:
Sensitivity
Specificity
Predictive value
Area under the curve
Intermediate Outcomes (KQ 2 or KQ
3):
Nutrition Stores: Direct measures of
nutrition status (nutrition stores)
during and post hospitalization.
Examples include:
Cross-sectional areas
for lumbar skeletal muscle and
adipose tissue
Skeletal Muscle Index
[[Page 71904]]
Regional or total fat
mass and muscle mass assessed
using validated gold standard
methods, such as body
composition measures derived
through Computed Tomography (CT)
scans, Dual X-ray Absorptiometry
(DXA), and Magnetic Resonance
Imaging (MRI)
Timing............................ Up to 30 days post-discharge
Setting........................... Acute care hospitalizations
------------------------------------------------------------------------
Dated: November 5, 2020.
Marquita N. Cullom,
Associate Director.
[FR Doc. 2020-24968 Filed 11-10-20; 8:45 am]
BILLING CODE 4160-90-P
