[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]


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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.

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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 (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

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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 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

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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