83 FR 61383 - Agency Information Collection Activities: Submission for OMB Review; Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services Federal Register Volume 83, Issue 230 (November 29, 2018)
Centers for Medicare & Medicaid Services
Federal Register Volume 83, Issue 230 (November 29, 2018)
| Page Range | 61383-61385 | |
| FR Document | 2018-25978 |
[Federal Register Volume 83, Number 230 (Thursday, November 29, 2018)] [Notices] [Pages 61383-61385] From the Federal Register Online [www.thefederalregister.org] [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
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they cannot benefit from the federal through AHRQ’s PSO website: https:// To obtain copies of a supporting
confidentiality and privilege protections pso.ahrq.gov/. statement and any related forms for the
of the Patient Safety Act. proposed collection(s) summarized in
Francis D. Chesley, Jr.,
Since February 2005, AHRQ has this notice, you may make your request
Acting Deputy Director. using one of following:
convened the Federal Patient Safety [FR Doc. 2018–25971 Filed 11–28–18; 8:45 am] 1. Access CMS’ website address at
Work Group (PSWG) to assist with BILLING CODE 4160–90–P https://www.cms.gov/Regulations-and-
developing and maintaining the Guidance/Legislation/Paperwork
Common Formats. The PSWG includes ReductionActof1995/PRA-Listing.html.
major health agencies within HHS as DEPARTMENT OF HEALTH AND 2. Email your request, including your
well as the Departments of Defense and HUMAN SERVICES address, phone number, OMB number,
Veterans Affairs. The PSWG helps and CMS document identifier, to
assure the consistency of definitions/ Centers for Medicare & Medicaid
Paperwork@cms.hhs.gov.
formats with those of relevant Services
3. Call the Reports Clearance Office at
government agencies. In addition, (410) 786–1326.
[Document Identifiers CMS–10137 and
AHRQ has solicited comments from the CMS–10675] FOR FURTHER INFORMATION CONTACT:
private and public sectors regarding William Parham at (410) 786–4669.
proposed versions of the Common Agency Information Collection SUPPLEMENTARY INFORMATION: Under the
Formats through a contract, since 2008, Activities: Submission for OMB Paperwork Reduction Act of 1995 (PRA)
with the National Quality Forum (NQF), Review; Comment Request (44 U.S.C. 3501–3520), federal agencies
which is a non-profit organization must obtain approval from the Office of
focused on health care quality. After AGENCY: Centers for Medicare &
Medicaid Services, HHS. Management and Budget (OMB) for each
receiving comments, the NQF solicits collection of information they conduct
review of the formats by its Common ACTION: Notice. or sponsor. The term ‘‘collection of
Formats Expert Panel. Subsequently, SUMMARY: The Centers for Medicare & information’’ is defined in 44 U.S.C.
NQF provides this input to AHRQ who Medicaid Services (CMS) is announcing 3502(3) and 5 CFR 1320.3(c) and
then uses it to refine the formats. an opportunity for the public to includes agency requests or
Previously, AHRQ’s primary focus comment on CMS’ intention to collect requirements that members of the public
with the Common Formats has been to information from the public. Under the submit reports, keep records, or provide
Paperwork Reduction Act of 1995 information to a third party. Section
support traditional event reporting. For
(PRA), federal agencies are required to 3506(c)(2)(A) of the PRA (44 U.S.C.
the Common Formats, it should be
publish notice in the Federal Register 3506(c)(2)(A)) requires federal agencies
noted that AHRQ uses the term
concerning each proposed collection of to publish a 30-day notice in the
‘‘surveillance’’ to refer to the improved Federal Register concerning each
detection of events and calculation of information, including each proposed
extension or reinstatement of an existing proposed collection of information,
adverse event rates in populations including each proposed extension or
reviewed that will allow for collection collection of information, and to allow
a second opportunity for public reinstatement of an existing collection
of comparable performance data over of information, before submitting the
time and across settings. These formats comment on the notice. Interested
persons are invited to send comments collection to OMB for approval. To
are designed to provide, through comply with this requirement, CMS is
regarding the burden estimate or any
retrospective review of medical records, publishing this notice that summarizes
other aspect of this collection of
information that is complementary to the following proposed collection(s) of
information, including the necessity and
that derived from event reporting utility of the proposed information information for public comment:
systems. For more information on collection for the proper performance of 1. Type of Information Collection
AHRQ’s efforts measuring patient safety the agency’s functions, the accuracy of Request: Revision of a currently
in this area, please go to: https:// the estimated burden, ways to enhance approved collection; Title of
www.ahrq.gov/news/blog/ahrqviews/ the quality, utility, and clarity of the Information Collection: Solicitation for
new-system-aims-to-improve-patient- information to be collected, and the use Applications for Medicare Prescription
safety-monitoring.html. of automated collection techniques or Drug Plan 2020 Contracts; Use: Coverage
other forms of information technology to for the prescription drug benefit is
AHRQ announced the availability of
minimize the information collection provided through contracted
the, Common Formats for prescription drug plans (PDPs) or
Surveillance—Hospital Version 0.2 burden.
through Medicare Advantage (MA)
Beta, for review and comment on May DATES: Comments on the collection(s) of plans that offer integrated prescription
9, 2018 in the Federal Register (83 FR information must be received by the drug and health care coverage (MA–PD
21295–21296). After obtaining feedback, OMB desk officer by December 31, 2018. plans). Cost Plans that are regulated
the Agency revised and finalized the ADDRESSES: When commenting on the under Section 1876 of the Social
formats through the development of proposed information collections, Security Act, and Employer Group
event descriptions which are definitions please reference the document identifier Waiver Plans (EGWP) may also provide
of patient safety events, near misses, or OMB control number. To be assured a Part D benefit. Organizations wishing
and unsafe conditions. The Common consideration, comments and to provide services under the
khammond on DSK30JT082PROD with NOTICES
Formats for Surveillance—Hospital recommendations must be received by Prescription Drug Benefit Program must
Version 0.2 Beta will be posted at the the OMB desk officer via one of the complete an application, negotiate rates,
PSOPPC website: https:// following transmissions: OMB, Office of and receive final approval from CMS.
www.psoppc.org/psoppc_web. Information and Regulatory Affairs, Existing Part D Sponsors may also
Additional information about the Attention: CMS Desk Officer, Fax expand their contracted service area by
Number: (202) 395–5806 OR, Email: completing the Service Area Expansion
Common Formats can be obtained
OIRA_submission@omb.eop.gov. (SAE) application. The information will
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is an essential component of this section 423(a), the allotment ALLOTMENT—Continued
analytic method. percentages are one of the factors used
The information collected through the in the computation of the Federal grants State Percentage
survey will complement the existing awarded under the Program.
data by helping identify factors Utah ...................................... 57.96
DATES: The allotment percentages will
associated with ADE outcomes of Vermont ................................ 49.37
be effective for Federal Fiscal Years Virginia .................................. 46.44
interest from existing data sets such as 2020 and 2021. Washington ........................... 44.42
Medicare claims. For example, claims FOR FURTHER INFORMATION CONTACT: West Virginia ........................ 62.68
data can provide information on Daniel Jackson, Grants Fiscal Wisconsin ............................. 52.48
whether the number of prescriptions for Management Specialist, Office of Grants Wyoming ............................... 43.49
opioids has decreased, but not what has Management, Office of Administration, America Samoa .................... 70.00
helped to facilitate the decrease. Guam .................................... 70.00
Administration for Children and Puerto Rico ........................... 70.00
Subsequent to the 60-day Federal Families, 330 C St. SW, Washington, DC N. Mariana Islands ............... 70.00
Register notice which published on July 20201. Telephone: (202) 401–3446. Virgin Islands ........................ 70.00
20, 2018 (83 FR 34593), the collection Email: daniel.jackson@acf.hhs.gov.
instrument was revised to clarify SUPPLEMENTARY INFORMATION: The
wording on questions, adjust the Statutory Authority: Section 423(c) of the
allotment percentage for each State is Social Security Act (42 U.S.C. 623(c)).
methods for measuring attribution, and determined on the basis of paragraphs
nursing homes were removed from the (b) and (c) of section 423 of the Social Elizabeth Leo,
originally-proposed sample. These Security Act. These figures are available Grants Policy Specialist, Division of Grants
changes did not result in changes to on the ACF internet homepage at Policy, Office of Administration.
burden, as additional respondents will https://www.acf.hhs.gov/cb. The [FR Doc. 2018–25932 Filed 11–28–18; 8:45 am]
be recruited from the pharmacy and allotment percentage for each State is as BILLING CODE 4184–01–P
practice settings. Form Number: CMS– follows:
10675 (OMB control number: 0938–
NEW); Frequency: Annually; Affected ALLOTMENT DEPARTMENT OF HEALTH AND
Public: Private sector (Business or other HUMAN SERVICES
for-profits); Number of Respondents: State Percentage
1,200; Total Annual Responses: 1,200; Food and Drug Administration
Total Annual Hours: 300. (For policy Alabama ................................ 60.54 [Docket No. FDA–2018–N–4337]
questions regarding this collection Alaska ................................... 43.36
contact Nancy Sonnenfeld at 410–786– Arizona .................................. 59.19 Prescription Drug User Fee Act of
1294.) Arkansas ............................... 60.16 2017; Electronic Submissions and Data
California ............................... 42.50
Dated: November 26, 2018. Colorado ............................... 47.06
Standards; Announcement of Public
William N. Parham, III, Connecticut ........................... 30.25 Meeting; Request for Comments
Director, Paperwork Reduction Staff, Office Delaware ............................... 51.62 AGENCY: Food and Drug Administration,
of Strategic Operations and Regulatory District of Columbia .............. 30.00 HHS.
Affairs. Florida ................................... 53.73
Georgia ................................. 57.38 ACTION: Notice of public meeting;
[FR Doc. 2018–25978 Filed 11–28–18; 8:45 am] request for comments.
Hawaii ................................... 49.16
BILLING CODE 4120–01–P Idaho ..................................... 59.41
Illinois .................................... 47.37 SUMMARY: The Food and Drug
Indiana .................................. 56.44 Administration (FDA or Agency) is
DEPARTMENT OF HEALTH AND Iowa ...................................... 53.57 announcing the following public
HUMAN SERVICES Kansas .................................. 52.37 meeting entitled ‘‘Prescription Drug
Kentucky ............................... 60.43 User Fee Act of 2017; Electronic
Administration for Children and Louisiana .............................. 57.09 Submissions and Data Standards.’’ FDA
Families Maine .................................... 55.15 is also requesting public comments on
Maryland ............................... 41.34 the subject. The purpose of the meeting
Notice of Allotment Percentages to Massachusetts ...................... 34.73
Michigan ............................... 55.31 and the request for comments is to
States for Child Welfare Services State fulfill FDA’s commitment to seek
Minnesota ............................. 47.14
Grants; CFDA Number: 93.645 Mississippi ............................ 64.24 stakeholder input related to data
AGENCY: Children’s Bureau, Missouri ................................ 56.32 standards and the electronic submission
Administration on Children, Youth and Montana ................................ 55.77 system’s past performance, future
Nebraska .............................. 49.84 targets, emerging industry needs, and
Families, Administration for Children Nevada ................................. 55.23
and Families, Department of Health and technology initiatives. FDA will use the
New Hampshire .................... 42.83 information from the public meeting as
Human Services. New Jersey ........................... 37.84
well as from comments submitted to the
ACTION: Notice of biennial publication of New Mexico .......................... 61.06
New York .............................. 38.63 docket to provide input into data
allotment percentages for States under
North Carolina ...................... 57.20 standards initiatives, the FDA
the Title IV–B subpart 1, Stephanie
North Dakota ........................ 47.32 Information Technology (IT) Strategic
Tubbs Jones Child Welfare Services
Ohio ...................................... 54.67 Plan, and electronic submissions
khammond on DSK30JT082PROD with NOTICES
Program. Oklahoma ............................. 56.55 gateway target timeframes.
SUMMARY: As required by section 423(c) Oregon .................................. 53.59 DATES: The public meeting will be held
Pennsylvania ........................ 48.50
of the Social Security Act, the Rhode Island ........................ 48.88
on April 10, 2019, from 9 a.m. to 4 p.m.
Department is publishing the allotment South Carolina ...................... 59.65 Submit either electronic or written
percentage for each State under the Title South Dakota ........................ 51.47 comments by April 10, 2019. See the
IV–B Subpart 1, Stephanie Tubbs Jones Tennessee ............................ 56.03 SUPPLEMENTARY INFORMATION section for
Child Welfare Services Program. Under Texas .................................... 53.39 registration date and information.
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Document Created: 2018-11-28 23:44:36
Document Modified: 2018-11-28 23:44:36
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Comments on the collection(s) of information must be received by the OMB desk officer by December 31, 2018. | |
| Contact | William Parham at (410) 786-4669. | |
| FR Citation | 83 FR 61383 |
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