Agency Information Collection Activities: Submission for OMB Review; Comment Request, 61383-61385 [2018-25978]
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Federal Register / Vol. 83, No. 230 / Thursday, November 29, 2018 / Notices
they cannot benefit from the federal
confidentiality and privilege protections
of the Patient Safety Act.
Since February 2005, AHRQ has
convened the Federal Patient Safety
Work Group (PSWG) to assist with
developing and maintaining the
Common Formats. The PSWG includes
major health agencies within HHS as
well as the Departments of Defense and
Veterans Affairs. The PSWG helps
assure the consistency of definitions/
formats with those of relevant
government agencies. In addition,
AHRQ has solicited comments from the
private and public sectors regarding
proposed versions of the Common
Formats through a contract, since 2008,
with the National Quality Forum (NQF),
which is a non-profit organization
focused on health care quality. After
receiving comments, the NQF solicits
review of the formats by its Common
Formats Expert Panel. Subsequently,
NQF provides this input to AHRQ who
then uses it to refine the formats.
Previously, AHRQ’s primary focus
with the Common Formats has been to
support traditional event reporting. For
the Common Formats, it should be
noted that AHRQ uses the term
‘‘surveillance’’ to refer to the improved
detection of events and calculation of
adverse event rates in populations
reviewed that will allow for collection
of comparable performance data over
time and across settings. These formats
are designed to provide, through
retrospective review of medical records,
information that is complementary to
that derived from event reporting
systems. For more information on
AHRQ’s efforts measuring patient safety
in this area, please go to: https://
www.ahrq.gov/news/blog/ahrqviews/
new-system-aims-to-improve-patientsafety-monitoring.html.
AHRQ announced the availability of
the, Common Formats for
Surveillance—Hospital Version 0.2
Beta, for review and comment on May
9, 2018 in the Federal Register (83 FR
21295–21296). After obtaining feedback,
the Agency revised and finalized the
formats through the development of
event descriptions which are definitions
of patient safety events, near misses,
and unsafe conditions. The Common
Formats for Surveillance—Hospital
Version 0.2 Beta will be posted at the
PSOPPC website: https://
www.psoppc.org/psoppc_web.
Additional information about the
Common Formats can be obtained
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through AHRQ’s PSO website: https://
pso.ahrq.gov/.
Francis D. Chesley, Jr.,
Acting Deputy Director.
[FR Doc. 2018–25971 Filed 11–28–18; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifiers CMS–10137 and
CMS–10675]
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Centers for Medicare &
Medicaid Services, HHS.
ACTION: Notice.
AGENCY:
The Centers for Medicare &
Medicaid Services (CMS) is announcing
an opportunity for the public to
comment on CMS’ intention to collect
information from the public. Under the
Paperwork Reduction Act of 1995
(PRA), federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension or reinstatement of an existing
collection of information, and to allow
a second opportunity for public
comment on the notice. Interested
persons are invited to send comments
regarding the burden estimate or any
other aspect of this collection of
information, including the necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions, the accuracy of
the estimated burden, ways to enhance
the quality, utility, and clarity of the
information to be collected, and the use
of automated collection techniques or
other forms of information technology to
minimize the information collection
burden.
SUMMARY:
Comments on the collection(s) of
information must be received by the
OMB desk officer by December 31, 2018.
ADDRESSES: When commenting on the
proposed information collections,
please reference the document identifier
or OMB control number. To be assured
consideration, comments and
recommendations must be received by
the OMB desk officer via one of the
following transmissions: OMB, Office of
Information and Regulatory Affairs,
Attention: CMS Desk Officer, Fax
Number: (202) 395–5806 OR, Email:
OIRA_submission@omb.eop.gov.
DATES:
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61383
To obtain copies of a supporting
statement and any related forms for the
proposed collection(s) summarized in
this notice, you may make your request
using one of following:
1. Access CMS’ website address at
https://www.cms.gov/Regulations-andGuidance/Legislation/Paperwork
ReductionActof1995/PRA-Listing.html.
2. Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov.
3. Call the Reports Clearance Office at
(410) 786–1326.
FOR FURTHER INFORMATION CONTACT:
William Parham at (410) 786–4669.
SUPPLEMENTARY INFORMATION: Under the
Paperwork Reduction Act of 1995 (PRA)
(44 U.S.C. 3501–3520), federal agencies
must obtain approval from the Office of
Management and Budget (OMB) for each
collection of information they conduct
or sponsor. The term ‘‘collection of
information’’ is defined in 44 U.S.C.
3502(3) and 5 CFR 1320.3(c) and
includes agency requests or
requirements that members of the public
submit reports, keep records, or provide
information to a third party. Section
3506(c)(2)(A) of the PRA (44 U.S.C.
3506(c)(2)(A)) requires federal agencies
to publish a 30-day notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension or
reinstatement of an existing collection
of information, before submitting the
collection to OMB for approval. To
comply with this requirement, CMS is
publishing this notice that summarizes
the following proposed collection(s) of
information for public comment:
1. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Solicitation for
Applications for Medicare Prescription
Drug Plan 2020 Contracts; Use: Coverage
for the prescription drug benefit is
provided through contracted
prescription drug plans (PDPs) or
through Medicare Advantage (MA)
plans that offer integrated prescription
drug and health care coverage (MA–PD
plans). Cost Plans that are regulated
under Section 1876 of the Social
Security Act, and Employer Group
Waiver Plans (EGWP) may also provide
a Part D benefit. Organizations wishing
to provide services under the
Prescription Drug Benefit Program must
complete an application, negotiate rates,
and receive final approval from CMS.
Existing Part D Sponsors may also
expand their contracted service area by
completing the Service Area Expansion
(SAE) application. The information will
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be collected under the solicitation of
proposals from PDP, MA–PD, Cost Plan,
Program of All Inclusive Care for the
Elderly (PACE), and EGWP applicants.
The collected information will be used
by CMS to: (1) Ensure that applicants
meet CMS requirements for offering Part
D plans (including network adequacy,
contracting requirements, and
compliance program requirements, as
described in the application), (2)
support the determination of contract
awards. Form Number: CMS–10137
(OMB control number: 0938–0936);
Frequency: Yearly; Affected Public:
Private Sector (Business or other forprofits, Not-for-Profit Institutions);
Number of Respondents: 243; Total
Annual Responses: 256; Total Annual
Hours: 2,351.08. (For policy questions
regarding this collection contact
Arianne Spaccarelli, at 410–786–5715.)
2. Type of Information Collection
Request: New c (Request for a new OMB
control number); Title of Information
Collection: Evaluation of the CMS
Quality Improvement Organizations:
Medication Safety and Adverse Drug
Event Prevention; Use: The purpose of
this Information Collection Request
(ICR) is to collect data to inform the
program evaluation of the Centers for
Medicare & Medicaid Services (CMS)
Quality Improvement Organizations
(QIO) current contract known as the
11th Scope of Work (SOW). The current
ICR focuses on evaluating one
component of the quality improvement
activities of the Quality Innovation
Network Quality Improvement
Organizations (QIN–QIOs) and is part of
a larger evaluation of the overall impact
of the QIO program. This ICR aims to
assess the QIN–QIO Task which focuses
on Medication Safety and Adverse Drug
Event Prevention. For this evaluation,
we are using a mixed-methods design to
compare quality improvement activities
of community-based pharmacists and
physician practices participating in the
QIN–QIO program (participating) with
those not participating in the QIN–QIO
program (non-participating).
As mandated by Sections 1152–1154
of the Social Security Act, CMS directs
the QIO program, which is one of the
largest federal programs dedicated to
improving health quality for Medicare
beneficiaries. QIOs are groups of health
quality experts, clinicians, and
consumers who work to assist Medicare
providers with quality improvement
throughout the spectrum of care and to
review quality concerns for the
protection of beneficiaries and the
Medicare Trust Fund. This program is a
key component of the U.S. Department
of Health and Human Services’ (HHS)
National Quality Strategy and the CMS
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Quality Strategy. The work is aligned
with the current HHS and CMS
administration priorities to empower
patients and doctors to make decisions
about their health care; usher in a new
era of state flexibility and local
leadership; support innovative
approaches to improve quality,
accessibility, and affordability; and
improve the CMS customer experience.
In the current SOW, 14 QIN–QIOs
coordinate the work in 53 U.S. states
and territories.
CMS evaluates the quality and
effectiveness of the QIO program as
authorized in Part B of Title XI of the
Social Security Act. CMS created the
Independent Evaluation Center (IEC) to
provide CMS and its stakeholders with
an independent and objective program
evaluation of the 11th SOW.
For the program to improve
medication safety and prevent adverse
drug events (ADEs), QIN–QIOs provide
technical assistance to providers,
practitioners, organizations offering
Medicare Advantage plans under
Medicare Part C, and prescription drug
sponsors offering drug plans under Part
D. ADEs are defined as ‘‘injury resulting
from medical intervention related to a
drug,’’ and cause the majority of
preventable deaths in hospitals. ADEs
escalate healthcare costs and utilization,
increasing admission and readmission
rates, emergency department (ED) visits,
and physician visits. ADEs are
particularly problematic for older adults
who have multiple chronic conditions
and interact with many care settings.
Opioid misuse and overdose is a
significant cause of ADEs and was
declared a public health emergency by
the White House in 2017. In 2016, over
14 million Medicare Part D beneficiaries
received opioid prescriptions, and many
of these beneficiaries received extreme
amounts of the drugs. The Medicare
population has one of the highest and
fastest-growing rates of diagnosed
opioid use disorder.
As part of the HHS Opioid Initiative
launched in March 2015, CMS
developed a multipronged approach to
combat misuse and promote programs
that support treatment and recovery
support services for clinicians,
beneficiaries, and families. CMS also
worked with HHS and other health
agencies to develop a National Action
Plan for Adverse Drug Prevention
(2014). In addition to opioids, the
Action Plan focused on ADEs caused by
other high-risk medication (HRM)
groups: Anticoagulants and diabetic
medications. Given the burden of ADEs
caused by these three classes of drugs,
focusing prevention efforts in these
areas could have a significant impact on
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reducing harm and improving
population health among Medicare
beneficiaries.
The QIO program provides technical
assistance to reduce ADEs in
beneficiaries resulting from
polypharmacy, specifically those who
use three or more medications including
a prescription in a HRM) drug groups.
In the 11th SOW, specific interventions
include training providers through
Learning Action Networks; developing
collaborations among local providers
across care settings; providing materials
and information resources; and helping
providers collect data to monitor
prescribing practices.
To evaluate the effectiveness of this
program, we will use a mixed method
evaluation combining secondary data
analysis of Medicare claims with a
community provider survey. We plan to
conduct an online survey of 1,200
community-based pharmacists and
physician practices. These participants
were selected based on their role in
prescribing HRM and treating ADEs.
The proposed survey assesses the
extent to which the National Action
Plan for Adverse Drug Prevention
strategies have been used, the level of
engagement with the QIO, and other
influences that can help explain
progress towards the goals of the QIN–
QIO SOW. The questions used for these
constructs related to program and nonprogram influences have been adopted
from previously used and/or validated
instruments, including the IEC Nursing
Home Survey that was approved under
OMB control number 0938–1330.
The survey will also provide
estimates of the attribution of the QIN–
QIO program for improving ADE
prevention, and reported impact of the
QIN–QIO program from the perspective
of healthcare providers. The perceived
influence on quality improvement
efforts will be quantified and, along
with econometric modeling methods,
will be used to assess program
attribution. Estimating attribution is a
contract requirement for the IEC and
helps provide evidence of impact of the
QIN–QIO program. Since current
analytical methods do not adequately
address the overlap of quality
improvement initiatives targeting
medication safety and ADE prevention,
the IEC developed an innovative
approach, combining survey input with
modeling, to estimate the relative
importance of the QIN–QIO program.
The concept is supported at the highest
level of administration for Quality
Improvement at CMS and has been
presented at national conferences and to
CMS/CCSQ leadership. The survey data
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Federal Register / Vol. 83, No. 230 / Thursday, November 29, 2018 / Notices
is an essential component of this
analytic method.
The information collected through the
survey will complement the existing
data by helping identify factors
associated with ADE outcomes of
interest from existing data sets such as
Medicare claims. For example, claims
data can provide information on
whether the number of prescriptions for
opioids has decreased, but not what has
helped to facilitate the decrease.
Subsequent to the 60-day Federal
Register notice which published on July
20, 2018 (83 FR 34593), the collection
instrument was revised to clarify
wording on questions, adjust the
methods for measuring attribution, and
nursing homes were removed from the
originally-proposed sample. These
changes did not result in changes to
burden, as additional respondents will
be recruited from the pharmacy and
practice settings. Form Number: CMS–
10675 (OMB control number: 0938–
NEW); Frequency: Annually; Affected
Public: Private sector (Business or other
for-profits); Number of Respondents:
1,200; Total Annual Responses: 1,200;
Total Annual Hours: 300. (For policy
questions regarding this collection
contact Nancy Sonnenfeld at 410–786–
1294.)
Dated: November 26, 2018.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2018–25978 Filed 11–28–18; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Notice of Allotment Percentages to
States for Child Welfare Services State
Grants; CFDA Number: 93.645
Children’s Bureau,
Administration on Children, Youth and
Families, Administration for Children
and Families, Department of Health and
Human Services.
ACTION: Notice of biennial publication of
allotment percentages for States under
the Title IV–B subpart 1, Stephanie
Tubbs Jones Child Welfare Services
Program.
khammond on DSK30JT082PROD with NOTICES
AGENCY:
As required by section 423(c)
of the Social Security Act, the
Department is publishing the allotment
percentage for each State under the Title
IV–B Subpart 1, Stephanie Tubbs Jones
Child Welfare Services Program. Under
SUMMARY:
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16:42 Nov 28, 2018
Jkt 247001
section 423(a), the allotment
percentages are one of the factors used
in the computation of the Federal grants
awarded under the Program.
DATES: The allotment percentages will
be effective for Federal Fiscal Years
2020 and 2021.
FOR FURTHER INFORMATION CONTACT:
Daniel Jackson, Grants Fiscal
Management Specialist, Office of Grants
Management, Office of Administration,
Administration for Children and
Families, 330 C St. SW, Washington, DC
20201. Telephone: (202) 401–3446.
Email: daniel.jackson@acf.hhs.gov.
SUPPLEMENTARY INFORMATION: The
allotment percentage for each State is
determined on the basis of paragraphs
(b) and (c) of section 423 of the Social
Security Act. These figures are available
on the ACF internet homepage at
https://www.acf.hhs.gov/cb. The
allotment percentage for each State is as
follows:
Percentage
Alabama ................................
Alaska ...................................
Arizona ..................................
Arkansas ...............................
California ...............................
Colorado ...............................
Connecticut ...........................
Delaware ...............................
District of Columbia ..............
Florida ...................................
Georgia .................................
Hawaii ...................................
Idaho .....................................
Illinois ....................................
Indiana ..................................
Iowa ......................................
Kansas ..................................
Kentucky ...............................
Louisiana ..............................
Maine ....................................
Maryland ...............................
Massachusetts ......................
Michigan ...............................
Minnesota .............................
Mississippi ............................
Missouri ................................
Montana ................................
Nebraska ..............................
Nevada .................................
New Hampshire ....................
New Jersey ...........................
New Mexico ..........................
New York ..............................
North Carolina ......................
North Dakota ........................
Ohio ......................................
Oklahoma .............................
Oregon ..................................
Pennsylvania ........................
Rhode Island ........................
South Carolina ......................
South Dakota ........................
Tennessee ............................
Texas ....................................
PO 00000
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Fmt 4703
Sfmt 4703
State
Percentage
Utah ......................................
Vermont ................................
Virginia ..................................
Washington ...........................
West Virginia ........................
Wisconsin .............................
Wyoming ...............................
America Samoa ....................
Guam ....................................
Puerto Rico ...........................
N. Mariana Islands ...............
Virgin Islands ........................
57.96
49.37
46.44
44.42
62.68
52.48
43.49
70.00
70.00
70.00
70.00
70.00
Statutory Authority: Section 423(c) of the
Social Security Act (42 U.S.C. 623(c)).
Elizabeth Leo,
Grants Policy Specialist, Division of Grants
Policy, Office of Administration.
[FR Doc. 2018–25932 Filed 11–28–18; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
ALLOTMENT
State
ALLOTMENT—Continued
60.54
43.36
59.19
60.16
42.50
47.06
30.25
51.62
30.00
53.73
57.38
49.16
59.41
47.37
56.44
53.57
52.37
60.43
57.09
55.15
41.34
34.73
55.31
47.14
64.24
56.32
55.77
49.84
55.23
42.83
37.84
61.06
38.63
57.20
47.32
54.67
56.55
53.59
48.50
48.88
59.65
51.47
56.03
53.39
Food and Drug Administration
[Docket No. FDA–2018–N–4337]
Prescription Drug User Fee Act of
2017; Electronic Submissions and Data
Standards; Announcement of Public
Meeting; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public meeting;
request for comments.
ACTION:
The Food and Drug
Administration (FDA or Agency) is
announcing the following public
meeting entitled ‘‘Prescription Drug
User Fee Act of 2017; Electronic
Submissions and Data Standards.’’ FDA
is also requesting public comments on
the subject. The purpose of the meeting
and the request for comments is to
fulfill FDA’s commitment to seek
stakeholder input related to data
standards and the electronic submission
system’s past performance, future
targets, emerging industry needs, and
technology initiatives. FDA will use the
information from the public meeting as
well as from comments submitted to the
docket to provide input into data
standards initiatives, the FDA
Information Technology (IT) Strategic
Plan, and electronic submissions
gateway target timeframes.
DATES: The public meeting will be held
on April 10, 2019, from 9 a.m. to 4 p.m.
Submit either electronic or written
comments by April 10, 2019. See the
SUPPLEMENTARY INFORMATION section for
registration date and information.
SUMMARY:
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]]>Agencies
[Federal Register Volume 83, Number 230 (Thursday, November 29, 2018)]
[Notices]
[Pages 61383-61385]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-25978]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifiers CMS-10137 and CMS-10675]
Agency Information Collection Activities: Submission for OMB
Review; Comment Request
AGENCY: Centers for Medicare & Medicaid Services, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Centers for Medicare & Medicaid Services (CMS) is
announcing an opportunity for the public to comment on CMS' intention
to collect information from the public. Under the Paperwork Reduction
Act of 1995 (PRA), federal agencies are required to publish notice in
the Federal Register concerning each proposed collection of
information, including each proposed extension or reinstatement of an
existing collection of information, and to allow a second opportunity
for public comment on the notice. Interested persons are invited to
send comments regarding the burden estimate or any other aspect of this
collection of information, including the necessity and utility of the
proposed information collection for the proper performance of the
agency's functions, the accuracy of the estimated burden, ways to
enhance the quality, utility, and clarity of the information to be
collected, and the use of automated collection techniques or other
forms of information technology to minimize the information collection
burden.
DATES: Comments on the collection(s) of information must be received by
the OMB desk officer by December 31, 2018.
ADDRESSES: When commenting on the proposed information collections,
please reference the document identifier or OMB control number. To be
assured consideration, comments and recommendations must be received by
the OMB desk officer via one of the following transmissions: OMB,
Office of Information and Regulatory Affairs, Attention: CMS Desk
Officer, Fax Number: (202) 395-5806 OR, Email:
[email protected].
To obtain copies of a supporting statement and any related forms
for the proposed collection(s) summarized in this notice, you may make
your request using one of following:
1. Access CMS' website address at https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.html.
2. Email your request, including your address, phone number, OMB
number, and CMS document identifier, to [email protected].
3. Call the Reports Clearance Office at (410) 786-1326.
FOR FURTHER INFORMATION CONTACT: William Parham at (410) 786-4669.
SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995
(PRA) (44 U.S.C. 3501-3520), federal agencies must obtain approval from
the Office of Management and Budget (OMB) for each collection of
information they conduct or sponsor. The term ``collection of
information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and
includes agency requests or requirements that members of the public
submit reports, keep records, or provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires
federal agencies to publish a 30-day notice in the Federal Register
concerning each proposed collection of information, including each
proposed extension or reinstatement of an existing collection of
information, before submitting the collection to OMB for approval. To
comply with this requirement, CMS is publishing this notice that
summarizes the following proposed collection(s) of information for
public comment:
1. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: Solicitation for
Applications for Medicare Prescription Drug Plan 2020 Contracts; Use:
Coverage for the prescription drug benefit is provided through
contracted prescription drug plans (PDPs) or through Medicare Advantage
(MA) plans that offer integrated prescription drug and health care
coverage (MA-PD plans). Cost Plans that are regulated under Section
1876 of the Social Security Act, and Employer Group Waiver Plans (EGWP)
may also provide a Part D benefit. Organizations wishing to provide
services under the Prescription Drug Benefit Program must complete an
application, negotiate rates, and receive final approval from CMS.
Existing Part D Sponsors may also expand their contracted service area
by completing the Service Area Expansion (SAE) application. The
information will
[[Page 61384]]
be collected under the solicitation of proposals from PDP, MA-PD, Cost
Plan, Program of All Inclusive Care for the Elderly (PACE), and EGWP
applicants. The collected information will be used by CMS to: (1)
Ensure that applicants meet CMS requirements for offering Part D plans
(including network adequacy, contracting requirements, and compliance
program requirements, as described in the application), (2) support the
determination of contract awards. Form Number: CMS-10137 (OMB control
number: 0938-0936); Frequency: Yearly; Affected Public: Private Sector
(Business or other for-profits, Not-for-Profit Institutions); Number of
Respondents: 243; Total Annual Responses: 256; Total Annual Hours:
2,351.08. (For policy questions regarding this collection contact
Arianne Spaccarelli, at 410-786-5715.)
2. Type of Information Collection Request: New c (Request for a new
OMB control number); Title of Information Collection: Evaluation of the
CMS Quality Improvement Organizations: Medication Safety and Adverse
Drug Event Prevention; Use: The purpose of this Information Collection
Request (ICR) is to collect data to inform the program evaluation of
the Centers for Medicare & Medicaid Services (CMS) Quality Improvement
Organizations (QIO) current contract known as the 11th Scope of Work
(SOW). The current ICR focuses on evaluating one component of the
quality improvement activities of the Quality Innovation Network
Quality Improvement Organizations (QIN-QIOs) and is part of a larger
evaluation of the overall impact of the QIO program. This ICR aims to
assess the QIN-QIO Task which focuses on Medication Safety and Adverse
Drug Event Prevention. For this evaluation, we are using a mixed-
methods design to compare quality improvement activities of community-
based pharmacists and physician practices participating in the QIN-QIO
program (participating) with those not participating in the QIN-QIO
program (non-participating).
As mandated by Sections 1152-1154 of the Social Security Act, CMS
directs the QIO program, which is one of the largest federal programs
dedicated to improving health quality for Medicare beneficiaries. QIOs
are groups of health quality experts, clinicians, and consumers who
work to assist Medicare providers with quality improvement throughout
the spectrum of care and to review quality concerns for the protection
of beneficiaries and the Medicare Trust Fund. This program is a key
component of the U.S. Department of Health and Human Services' (HHS)
National Quality Strategy and the CMS Quality Strategy. The work is
aligned with the current HHS and CMS administration priorities to
empower patients and doctors to make decisions about their health care;
usher in a new era of state flexibility and local leadership; support
innovative approaches to improve quality, accessibility, and
affordability; and improve the CMS customer experience. In the current
SOW, 14 QIN-QIOs coordinate the work in 53 U.S. states and territories.
CMS evaluates the quality and effectiveness of the QIO program as
authorized in Part B of Title XI of the Social Security Act. CMS
created the Independent Evaluation Center (IEC) to provide CMS and its
stakeholders with an independent and objective program evaluation of
the 11th SOW.
For the program to improve medication safety and prevent adverse
drug events (ADEs), QIN-QIOs provide technical assistance to providers,
practitioners, organizations offering Medicare Advantage plans under
Medicare Part C, and prescription drug sponsors offering drug plans
under Part D. ADEs are defined as ``injury resulting from medical
intervention related to a drug,'' and cause the majority of preventable
deaths in hospitals. ADEs escalate healthcare costs and utilization,
increasing admission and readmission rates, emergency department (ED)
visits, and physician visits. ADEs are particularly problematic for
older adults who have multiple chronic conditions and interact with
many care settings.
Opioid misuse and overdose is a significant cause of ADEs and was
declared a public health emergency by the White House in 2017. In 2016,
over 14 million Medicare Part D beneficiaries received opioid
prescriptions, and many of these beneficiaries received extreme amounts
of the drugs. The Medicare population has one of the highest and
fastest-growing rates of diagnosed opioid use disorder.
As part of the HHS Opioid Initiative launched in March 2015, CMS
developed a multipronged approach to combat misuse and promote programs
that support treatment and recovery support services for clinicians,
beneficiaries, and families. CMS also worked with HHS and other health
agencies to develop a National Action Plan for Adverse Drug Prevention
(2014). In addition to opioids, the Action Plan focused on ADEs caused
by other high-risk medication (HRM) groups: Anticoagulants and diabetic
medications. Given the burden of ADEs caused by these three classes of
drugs, focusing prevention efforts in these areas could have a
significant impact on reducing harm and improving population health
among Medicare beneficiaries.
The QIO program provides technical assistance to reduce ADEs in
beneficiaries resulting from polypharmacy, specifically those who use
three or more medications including a prescription in a HRM) drug
groups. In the 11th SOW, specific interventions include training
providers through Learning Action Networks; developing collaborations
among local providers across care settings; providing materials and
information resources; and helping providers collect data to monitor
prescribing practices.
To evaluate the effectiveness of this program, we will use a mixed
method evaluation combining secondary data analysis of Medicare claims
with a community provider survey. We plan to conduct an online survey
of 1,200 community-based pharmacists and physician practices. These
participants were selected based on their role in prescribing HRM and
treating ADEs.
The proposed survey assesses the extent to which the National
Action Plan for Adverse Drug Prevention strategies have been used, the
level of engagement with the QIO, and other influences that can help
explain progress towards the goals of the QIN-QIO SOW. The questions
used for these constructs related to program and non-program influences
have been adopted from previously used and/or validated instruments,
including the IEC Nursing Home Survey that was approved under OMB
control number 0938-1330.
The survey will also provide estimates of the attribution of the
QIN-QIO program for improving ADE prevention, and reported impact of
the QIN-QIO program from the perspective of healthcare providers. The
perceived influence on quality improvement efforts will be quantified
and, along with econometric modeling methods, will be used to assess
program attribution. Estimating attribution is a contract requirement
for the IEC and helps provide evidence of impact of the QIN-QIO
program. Since current analytical methods do not adequately address the
overlap of quality improvement initiatives targeting medication safety
and ADE prevention, the IEC developed an innovative approach, combining
survey input with modeling, to estimate the relative importance of the
QIN-QIO program. The concept is supported at the highest level of
administration for Quality Improvement at CMS and has been presented at
national conferences and to CMS/CCSQ leadership. The survey data
[[Page 61385]]
is an essential component of this analytic method.
The information collected through the survey will complement the
existing data by helping identify factors associated with ADE outcomes
of interest from existing data sets such as Medicare claims. For
example, claims data can provide information on whether the number of
prescriptions for opioids has decreased, but not what has helped to
facilitate the decrease. Subsequent to the 60-day Federal Register
notice which published on July 20, 2018 (83 FR 34593), the collection
instrument was revised to clarify wording on questions, adjust the
methods for measuring attribution, and nursing homes were removed from
the originally-proposed sample. These changes did not result in changes
to burden, as additional respondents will be recruited from the
pharmacy and practice settings. Form Number: CMS-10675 (OMB control
number: 0938-NEW); Frequency: Annually; Affected Public: Private sector
(Business or other for-profits); Number of Respondents: 1,200; Total
Annual Responses: 1,200; Total Annual Hours: 300. (For policy questions
regarding this collection contact Nancy Sonnenfeld at 410-786-1294.)
Dated: November 26, 2018.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2018-25978 Filed 11-28-18; 8:45 am]
BILLING CODE 4120-01-P
