83 FR 58572 - Agency Information Collection Activities: Proposed Collection; Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services Federal Register Volume 83, Issue 224 (November 20, 2018)
Centers for Medicare & Medicaid Services
Federal Register Volume 83, Issue 224 (November 20, 2018)
| Page Range | 58572-58574 | |
| FR Document | 2018-25312 |
[Federal Register Volume 83, Number 224 (Tuesday, November 20, 2018)] [Notices] [Pages 58572-58574] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-25312] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS-10511, CMS-10575, and CMS-2552-10] Agency Information Collection Activities: Proposed Collection; 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 (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 January 22, 2019. 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 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: Reports Clearance Office 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 [[Page 58573]] detailed information can be found in each collection's supporting statement and associated materials (see ADDRESSES). CMS-10511 Medicare Coverage of Items and Services in FDA Investigational Device Exemption Clinical Studies-Revision of Medicare Coverage CMS-10575 Generic Clearance for the Health Care Payment Learning and Action Network CMS-2552-10 Hospitals and Health Care Complex Cost Report 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: Reinstatement; Title of Information Collection: Medicare Coverage of Items and Services in FDA Investigational Device Exemption Clinical Studies--Revision of Medicare Coverage; Use: Section 1862(m) of the Social Security Act (and regulations at 42 CFR Subpart B (sections 405.201-405.215) allows for payment of the routine costs of care furnished to Medicare beneficiaries in a Category A investigational device exemption (IDE) study and authorizes the Secretary to establish criteria to ensure that Category A IDE trials conform to appropriate scientific and ethical standards. Medicare does not cover the Category A device itself because Category A (Experimental) devices do not satisfy the statutory requirement that Medicare pay for devices determined to be reasonable and necessary. Medicare may cover Category B (Non-experimental) devices, and associated routine costs of care, if they are considered reasonable and necessary and if all other applicable Medicare coverage requirements are met. Under the current centralized review process, interested parties (such as study sponsors) that wish to seek Medicare coverage related to Category A or B IDE studies have a centralized point of contact for submission, review and determination of Medicare coverage IDE study requests. In order for CMS (or its designated entity) to determine if the Medicare coverage criteria are met, as described in our regulations, CMS (or its designated entity) must review documents submitted by interested parties or study sponsors. Such information submitted will be a FDA IDE approval letter, IDE study protocol, IRB approval letter, National Clinical Trials (NCT) number, and Supporting materials as needed. Form Number: CMS-10511 (OMB control number: 0938- 1250); Frequency: Yearly; Affected Public: Private Sector (Business or other for-profits, Not-for-Profit Institutions); Number of Respondents: 100; Total Annual Responses: 100; Total Annual Hours: 200. (For policy questions regarding this collection contact Cheryl Gilbreath at 410- 786-5919.) 2. Type of Information Collection Request: Extension without change of a currently approved collection; Title of Information Collection: Generic Clearance for the Health Care Payment Learning and Action Network; Use: The Center for Medicare and Medicaid Services (CMS), through the Center for Medicare and Medicaid Innovation, develops and tests innovative new payment and service delivery models in accordance with the requirements of section 1115A and in consideration of the opportunities and factors set forth in section 1115A(b)(2) of the Act. To date, CMS has built a portfolio of models (in operation or already announced) that have attracted participation from a broad array of health care providers, states, payers, and other stakeholders. During the development of models, CMS builds on ideas received from stakeholders--consulting with clinical and analytical experts, as well as with representatives of relevant federal and state agencies. CMS will continue to partner with stakeholders across the health care system to catalyze transformation through the use of alternative payment models. To this end, CMS launched the Health Care Payment Learning and Action Network, an effort to accelerate the transition to alternative payment models, identify best practices in their implementation, collaborate with payers, providers, consumers, purchasers, and other stakeholders, and monitor the adoption of value- based alternative payment models across the health care system. A system wide transition to alternative payment models will strengthen the ability of CMS to implement existing models and design new models that improve quality and decrease costs for CMS beneficiaries. The information collected from LAN participants will be used by the CMS Innovation Center to potentially inform the design, selection, testing, modification, and expansion of innovative payment and service delivery models in accordance with the requirements of section 1115A, while monitoring the percentage of payments tied to alternative payment models across the U.S. health care system. In addition, the requested information will be made publically available so that LAN participants (payers, providers, consumers, employers, state agencies, and patients) can use the information to inform decision making and better understand market dynamics in relation to alternative payment models. Form Number: CMS-10575 (OMB control number: 0938-1297); Frequency: Occasionally; Affected Public: Individuals; Private Sector (Business or other For- profit and Not-for-profit institutions), State, Local and Tribal Governments; Number of Respondents: 30,110; Total Annual Responses: 23,110; Total Annual Hours: 25,917. (For policy questions regarding this collection contact Dustin Allison at 410-786-8830.) 3. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Hospitals and Health Care Complex Cost Report; Use: Under the authority of sections 1815(a) and 1833(e) of the Act, CMS requires that providers of services participating in the Medicare program submit information to determine costs for health care services rendered to Medicare beneficiaries. CMS requires that providers follow reasonable cost principles under 1861(v)(1)(A) of the Act when completing the Medicare cost report. Under the regulations at 42 CFR 413.20 and 413.24, CMS defines adequate cost data and requires cost reports from providers on an annual basis. The Form CMS-2552-10 cost report is needed to determine a provider's reasonable cost incurred in furnishing medical services to Medicare beneficiaries and calculate the hospital settlement amounts. These providers, paid under the inpatient prospective payment system (IPPS) and the outpatient prospective payment system (OPPS), may receive reimbursement outside of the PPS for hospital-specific adjustments such as Medicare reimbursable bad debts, disproportionate share, uncompensated care, direct and indirect medical education costs, and organ acquisition [[Page 58574]] costs. The Form CMS-2552-10 cost report is also used for rate setting and payment refinement activities, including developing a hospital market basket. Additionally, the Medicare Payment Advisory Commission (MedPAC) uses the hospital cost report data to calculate Medicare margins, to formulate recommendations to Congress regarding the IPPS and OPPS, and to conduct additional analysis of the IPPS and OPPS. Form Number: CMS-2552-10 (OMB control number: 0938-0050); Frequency: Yearly; Affected Public: Private Sector (Business or other For-profit and Not- for-profit institutions), State, Local and Tribal Governments, Federal Government; Number of Respondents: 6,088; Total Annual Responses: 6,088; Total Annual Hours: 4,097,224. (For policy questions regarding this collection contact Gail Duncan at 410-786-7278.) Dated: November 15, 2018. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2018-25312 Filed 11-19-18; 8:45 am] BILLING CODE 4120-01-P
![58572 Federal Register / Vol. 83, No. 224 / Tuesday, November 20, 2018 / Notices
incidence and higher mortality rates including residents of rural geographic of the study is rural healthcare
from TBI than do residents of urban areas, require special consideration providers; urban healthcare providers
areas, and that the prevalence of TBI- when it comes to researching TBI. will be included in this study to allow
related disability in rural geographical This is a New Information Collection for comparison in identifying the
areas is higher than in urban and Request for two years to collect distinct challenges and opportunities for
suburban areas. The obstacles information on challenges that rural rural healthcare providers. This study
healthcare providers and patients face healthcare providers face in diagnosing, has two data collection methods. A web
in rural areas are vastly different from treating, and managing TBI of all survey to gather quantitative data on the
severities and developing a knowledge unique challenges faced by rural
those in urban areas. There is little
base upon which we can begin to clinicians, and focus groups to gain
published research specifically related
address gaps in services to improve
to the challenges rural providers face in deeper insight into the context
clinical care and TBI outcomes in rural
TBI diagnosis and treatment, and even supporting and/or inhibiting access to
communities. The target population for
less examination into effective ways to the data collection effort includes comprehensive TBI evaluation and
address gaps in service and improve TBI physicians, nurse practitioners (NPs), treatment, the study will collect
outcomes. The National Center for and physician assistants (PAs) in qualitative data through focus groups
Injury Prevention and Control at the selected specialties (general or family with rural clinicians.
CDC, in a 2015 ‘‘Report to Congress on practice, emergency medicine, The total estimated annualized
TBI in the United States,’’ determined pediatrics) working in direct patient burden hours are 200. There is no cost
that certain population groups, care in rural and urban areas. The focus to respondents other than their time.
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per
Type of respondent Form name responses per
respondents response
respondent (in hrs)
Health care providers (Primary Care Physician, Emergency TBI Provider Survey .............. 600 1 15/60
Physician, Nurse Practitioner and Physician Assistant).
Focus group screener ............ 36 1 5/60
Focus group consent and 31 1 5/60
questionnaire.
Focus group discussion guide 31 1 85/60
Jeffrey M. Zirger, extension or reinstatement of an existing 2. By regular mail. You may mail
Acting Lead, Information Collection Review collection of information) and to allow written comments to the following
Office, Office of Scientific Integrity, Office 60 days for public comment on the address: CMS, Office of Strategic
of Science, Centers for Disease Control and proposed action. Interested persons are Operations and Regulatory Affairs,
Prevention. invited to send comments regarding our Division of Regulations Development,
[FR Doc. 2018–25274 Filed 11–19–18; 8:45 am] burden estimates or any other aspect of Attention: Document Identifier/OMB
BILLING CODE 4163–18–P this collection of information, including Control Number ll, Room C4–26–05,
the necessity and utility of the proposed 7500 Security Boulevard, Baltimore,
information collection for the proper Maryland 21244–1850.
DEPARTMENT OF HEALTH AND performance of the agency’s functions, To obtain copies of a supporting
HUMAN SERVICES the accuracy of the estimated burden, statement and any related forms for the
ways to enhance the quality, utility, and proposed collection(s) summarized in
Centers for Medicare & Medicaid this notice, you may make your request
Services clarity of the information to be
collected, and the use of automated using one of following:
[Document Identifier: CMS–10511, CMS– collection techniques or other forms of 1. Access CMS’ website address at
10575, and CMS–2552–10] information technology to minimize the website address at https://www.cms.gov/
information collection burden. Regulations-and-Guidance/Legislation/
Agency Information Collection PaperworkReductionActof1995/PRA-
Activities: Proposed Collection; DATES: Comments must be received by Listing.html.
Comment Request January 22, 2019. 2. Email your request, including your
AGENCY: Centers for Medicare & ADDRESSES: When commenting, please address, phone number, OMB number,
Medicaid Services, HHS. reference the document identifier or and CMS document identifier, to
OMB control number. To be assured Paperwork@cms.hhs.gov.
ACTION: Notice.
consideration, comments and 3. Call the Reports Clearance Office at
SUMMARY: The Centers for Medicare & recommendations must be submitted in (410) 786–1326.
Medicaid Services (CMS) is announcing any one of the following ways: FOR FURTHER INFORMATION CONTACT:
an opportunity for the public to 1. Electronically. You may send your Reports Clearance Office at (410) 786–
comment on CMS’ intention to collect comments electronically to http:// 4669.
information from the public. Under the www.regulations.gov. Follow the SUPPLEMENTARY INFORMATION:
Paperwork Reduction Act of 1995 (the instructions for ‘‘Comment or
PRA), federal agencies are required to Submission’’ or ‘‘More Search Options’’ Contents
publish notice in the Federal Register to find the information collection This notice sets out a summary of the
concerning each proposed collection of document(s) that are accepting use and burden associated with the
information (including each proposed comments. following information collections. More
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![58574 Federal Register / Vol. 83, No. 224 / Tuesday, November 20, 2018 / Notices
costs. The Form CMS–2552–10 cost DEPARTMENT OF HEALTH AND measures in six legislatively-mandated
report is also used for rate setting and HUMAN SERVICES benchmark areas; and conduct rigorous
payment refinement activities, evaluation activities to build the
including developing a hospital market Administration for Children and knowledge base on home visiting among
basket. Additionally, the Medicare Families Native populations.
Payment Advisory Commission Submission for OMB Review; The proposed data collection form is
(MedPAC) uses the hospital cost report Comment Request as follows: In order to continuously
data to calculate Medicare margins, to monitor, provide grant oversight, quality
formulate recommendations to Congress Title: Tribal Maternal, Infant, and improvement guidance, and technical
regarding the IPPS and OPPS, and to Early Childhood Home Visiting Program assistance to Tribal MIECHV grantees,
conduct additional analysis of the IPPS Quarterly Performance Reporting Form. ACF is seeking to collect services
and OPPS. Form Number: CMS–2552– OMB No.: New Collection. utilization data on a quarterly basis. The
Description: The Administration for
10 (OMB control number: 0938–0050); Tribal MIECHV Quarterly Data
Children and Families (ACF), Office of
Frequency: Yearly; Affected Public: Performance Reporting Form, is made
Child Care, in collaboration with the
Private Sector (Business or other For- up of five categories of data—program
Health Resources and Services
profit and Not-for-profit institutions), capacity, place-based services, family
Administration (HRSA), Maternal and
State, Local and Tribal Governments, engagement, staff recruitment and
Child Health Bureau, administers the
Federal Government; Number of Maternal, Infant, and Early Childhood retention and staff vacancies. This form
Respondents: 6,088; Total Annual Home Visiting (MIECHV) Program, as will be used by Tribal MIECHV grantees
Responses: 6,088; Total Annual Hours: authorized by Title V, Section 511 of the that receive grants under the Tribal
4,097,224. (For policy questions Social Security Act. The Administration MIECHV Program to collect data in
regarding this collection contact Gail for Children and Families administers order to determine the caseload capacity
Duncan at 410–786–7278.) the Tribal MIECHV Program while grantees are achieving, where services
HRSA administers the State/Territory are being delivered, the retention and
Dated: November 15, 2018. attrition of enrolled families, and the
MIECHV Program. Tribal MIECHV
William N. Parham, III, discretionary grants support cooperative retention and attrition of program staff
Director, Paperwork Reduction Staff, Office agreements to conduct community on a quarterly basis.
of Strategic Operations and Regulatory needs assessments; plan for and Respondents: Tribal Maternal, Infant,
Affairs. implement high-quality, culturally- and Early Childhood Home Visiting
[FR Doc. 2018–25312 Filed 11–19–18; 8:45 am] relevant, evidence-based home visiting Program Managers. The information
BILLING CODE 4120–01–P programs in at-risk tribal communities; collection does not include direct
establish, measure, and report on interaction with individuals or families
progress toward meeting performance that receive the services.
ANNUAL BURDEN ESTIMATES
Average
Number
Number of burden per Total burden
Type of respondent Form name responses per
respondents response hours
respondent (in hours)
Tribal MIECHV Grantees .................. Tribal MIECHV Quarterly Reporting 25 4 24 2,400
Form.
Total ........................................... ........................................................... ........................ ........................ ........................ 2,400
Estimated Total Annual Burden proposed information collection should DEPARTMENT OF HEALTH AND
Hours: 2,400. be sent directly to the following: Office HUMAN SERVICES
Additional Information: Copies of the of Management and Budget, Paperwork
proposed collection may be obtained by Reduction Project, Email: OIRA_ Food and Drug Administration
writing to the Administration for SUBMISSION@OMB.EOP.GOV, Attn: [Docket No. FDA–2018–N–3017]
Children and Families, Office of Desk Officer for the Administration for
Planning, Research and Evaluation, 330 Children and Families. Prescription Drug-Use-Related
C Street SW, Washington, DC 20201. Software; Establishment of a Public
Robert A. Sargis, Docket; Request for Comments
Attention Reports Clearance Officer. All
requests should be identified by the title Reports Clearance Officer.
[FR Doc. 2018–25214 Filed 11–19–18; 8:45 am]
AGENCY: Food and Drug Administration,
of the information collection. Email HHS.
address: infocollection@acf.hhs.gov. BILLING CODE 4184–01–P
ACTION: Notice; establishment of a
OMB Comment: OMB is required to public docket; request for comments.
make a decision concerning the
collection of information between 30 SUMMARY: The Food and Drug
and 60 days after publication of this Administration (FDA or the Agency) is
document in the Federal Register. announcing the establishment of a
Therefore, a comment is best assured of docket to solicit public comment on a
having its full effect if OMB receives it proposed framework for regulating
within 30 days of publication. Written software applications disseminated by
comments and recommendations for the or on behalf of drug sponsors for use
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Document Created: 2018-11-20 07:59:33
Document Modified: 2018-11-20 07:59:33
| 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 must be received by January 22, 2019. | |
| Contact | Reports Clearance Office at (410) 786- 4669. | |
| FR Citation | 83 FR 58572 |
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