[Federal Register Volume 83, Number 140 (Friday, July 20, 2018)]
[Notices]
[Pages 34593-34594]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-15466]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier CMS-10675]
Agency Information Collection Activities: Proposed Collection;
Comment Request
AGENCY: Centers for Medicare & Medicaid Services, HHS.
ACTION: Notice.
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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 (the 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 60 days for public
comment on the proposed action. Interested persons are invited to send
comments regarding our burden estimates 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 must be received by September 18, 2018.
ADDRESSES: When commenting, please reference the document identifier or
OMB control number. To be assured consideration, comments and
recommendations must be submitted in any one of the following ways:
1. Electronically. You may send your comments electronically to
http://www.regulations.gov. Follow the instructions for ``Comment or
Submission'' or ``More Search Options'' to find the information
collection document(s) that are accepting comments.
2. By regular mail. You may mail written comments to the following
address: CMS, Office of Strategic Operations and Regulatory Affairs,
Division of Regulations Development, Attention: Document Identifier/OMB
Control Number __, Room C4-26-05, 7500 Security Boulevard, Baltimore,
Maryland 21244-1850.
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:
Contents
This notice sets out a summary of the use and burden associated
with the following information collections. More detailed information
can be found in each collection's supporting statement and associated
materials (see ADDRESSES).
CMS-10675 Evaluation of the CMS Quality Improvement Organizations:
Medication Safety and Adverse Drug Event Prevention
Under the 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 requires federal agencies
to publish a 60-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.
Information Collection
1. Type of Information Collection Request: New Collection of
Information Request; 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
pharmacists, physicians, and nursing home administrators or directors
of nursing at nursing homes 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
[[Page 34594]]
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, physicians, and nursing home
administrators or directors of nursing in nursing homes. 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 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. 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: July 16, 2018.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2018-15466 Filed 7-19-18; 8:45 am]
BILLING CODE 4120-01-P