Agency Information Collection Activities: Proposed Collection; Comment Request, 48145-48148 [2019-19711]

Download as PDF Federal Register / Vol. 84, No. 177 / Thursday, September 12, 2019 / Notices Federal Deposit Insurance Corporation Valerie Best, Assistant Executive Secretary. [FR Doc. 2019–19715 Filed 9–11–19; 8:45 am] BILLING CODE 6714–01–P FEDERAL MARITIME COMMISSION Notice of Agreements Filed The Commission hereby gives notice of the filing of the following agreement under the Shipping Act of 1984. Interested parties may submit comments on the agreements to the Secretary by email at Secretary@fmc.gov, or by mail, Federal Maritime Commission, Washington, DC 20573, within twelve days of the date this notice appears in the Federal Register. Copies of agreements are available through the Commission’s website (www.fmc.gov) or by contacting the Office of Agreements at (202)-523–5793 or tradeanalysis@ fmc.gov. Agreement No.: 012056–001. Agreement Name: WWOcean/EUKOR Joint Operating Agreement. Parties: Wallenius Wilhelmsen Ocean AS and EUKOR Car Carriers, Inc. Filing Party: Wayne Rohde; Cozen O’Connor. Synopsis: The amendment changes name of the WW party to the Agreement; updates addresses of the parties; updates the description of corporate relationship between parties; and revises officials of agreement and delegations of authority. Proposed Effective Date: 9/5/2019. Location: https://www2.fmc.gov/ FMC.Agreements.Web/Public/ AgreementHistory/2021. Dated: September 9, 2019. Rachel Dickon, Secretary. owned by the bank holding company, including the companies listed below. The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The applications will also be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843). Unless otherwise noted, nonbanking activities will be conducted throughout the United States. Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than October 15, 2019. A. Federal Reserve Bank of Dallas (Robert L. Triplett III, Senior Vice President) 2200 North Pearl Street, Dallas, Texas 75201–2272: 1. Kidd Partners, Ltd., Tyler, Texas; to acquire up to 11.74 percent of the voting shares of Spirit of Texas Bancshares, Inc., Conroe, Texas, and thereby indirectly acquire shares of Spirit of Texas Bank, SSB, College Station, Texas. 2. Spirit of Texas Bancshares, Inc., Conroe, Texas; to acquire 100 percent of the voting shares of Chandler Bancorp, Inc., Tyler, Texas, and thereby indirectly acquire shares of Chandler Bancorp of Nevada, Inc., Carson City, Nevada, and Citizens State Bank, Tyler, Texas. Board of Governors of the Federal Reserve System, September 9, 2019. Yao-Chin Chao, Assistant Secretary of the Board. [FR Doc. 2019–19749 Filed 9–11–19; 8:45 am] BILLING CODE 6731–AA–P [FR Doc. 2019–19788 Filed 9–11–19; 8:45 am] BILLING CODE P jbell on DSK3GLQ082PROD with NOTICES FEDERAL RESERVE SYSTEM Formations of, Acquisitions by, and Mergers of Bank Holding Companies DEPARTMENT OF HEALTH AND HUMAN SERVICES The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841 et seq.) (BHC Act), Regulation Y (12 CFR part 225), and all other applicable statutes and regulations to become a bank holding company and/or to acquire the assets or the ownership of, control of, or the power to vote shares of a bank or bank holding company and all of the banks and nonbanking companies Centers for Medicare & Medicaid Services VerDate Sep<11>2014 17:27 Sep 11, 2019 Jkt 247001 [Document Identifier: CMS–1500/1490S, CMS–10221, CMS–10237, CMS–R–5, CMS– 10224 and CMS–287–19] Agency Information Collection Activities: Proposed Collection; Comment Request Centers for Medicare & Medicaid Services, HHS. AGENCY: PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 ACTION: 48145 Notice. 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 November 12, 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 https:// 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 ll, 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-andGuidance/Legislation/ PaperworkReductionActof1995/PRAListing.html. 2. Email your request, including your address, phone number, OMB number, and CMS document identifier, to Paperwork@cms.hhs.gov. SUMMARY: E:\FR\FM\12SEN1.SGM 12SEN1 48146 Federal Register / Vol. 84, No. 177 / Thursday, September 12, 2019 / Notices 3. Call the Reports Clearance Office at (410) 786–1326. FOR FURTHER INFORMATION CONTACT: William N. Parham at (410) 786–4669. SUPPLEMENTARY INFORMATION: jbell on DSK3GLQ082PROD with NOTICES 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–1500/1490S Health Insurance Common Claims Form CMS–10221 Independent Diagnostic Testing Facilities (IDTFs) Site Investigation Form Revisions CMS–10237 Applications for Part C Medicare Advantage, 1876 Cost Plans, and Employer Group Waiver Plans to Provide Part C Benefits CMS–R–5 Physician Certifications/ Recertification’s in Skilled Nursing Facilities Manual Instructions CMS–10224 Healthcare Common Procedure Coding System (HCPCS)—Level II Code Modification Request Process CMS–287–19 Home Office Cost Statement 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: Extension of a currently approved collection; Title of Information Collection: Health Insurance Common Claims Form and Supporting Regulations at 42 CFR part 424, subpart C (CMS–1500 and CMS– 1490S); Use: The CMS–1500 and the CMS–1490S forms are used to deliver information to CMS in order for CMS to reimburse for provided services. Medicare Administrative Contractors VerDate Sep<11>2014 17:27 Sep 11, 2019 Jkt 247001 use the data collected on the CMS–1500 and the CMS–1490S to determine the proper amount of reimbursement for Part B medical and other health services (as listed in section 1861(s) of the Social Security Act) provided by physicians and suppliers to beneficiaries. The CMS–1500 is submitted by physicians/ suppliers for all Part B Medicare. Serving as a common claim form, the CMS–1500 can be used by other thirdparty payers (commercial and nonprofit health insurers) and other Federal programs (e.g., TRICARE, RRB, and Medicaid). The CMS–1490S (Patient’s Request for Medical Payment) was explicitly developed for easy use by beneficiaries who file their own claims. Form Number: CMS–1500/1490S (OMB control number: 0938–1197); Frequency: Yearly; Affected Public: State, Local, or Tribal Governments; Number of Respondents: 2,029,505; Total Annual Responses: 1,033,839,906; Total Annual Hours: 18,847,500. (For policy questions regarding this collection contact Charlene Parks at 410–786–8684.) 2. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Independent Diagnostic Testing Facilities (IDTFs) Site Investigation Form Revisions; Use: The data collection is used by Medicare contractors and/or their subcontractors on site visits to verify compliance with required IDTF performance standards. If a subcontractor is used, the subcontractor collects the information from the IDTF through an interview and forwards it to the Medicare contractor for evaluation. The collection and verification of this information defends and protects our beneficiaries from illegitimate IDTFs. These procedures also protect the Medicare Trust Fund against fraud. The data collected also ensures that the applicant has the necessary credentials to provide the health care services for which they intend to bill Medicare. Form Number: CMS–10221 (OMB control number: 0938–1029); Frequency: Occasionally; Affected Public: Private Sector (Business or other for-profit and Not-for-profit institutions); Number of Respondents: 727; Total Annual Responses: 727; Total Annual Hours: 1,454. (For policy questions regarding this collection contact Kimberly McPhillips at 410– 786–5374.) 3. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Applications for Part C Medicare Advantage, 1876 Cost Plans, and Employer Group Waiver Plans to Provide Part C Benefits; Use: This information collection includes the PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 process for organizations wishing to provide healthcare services under MA plans. These organizations must complete an application annually (if required), file a bid, and receive final approval from CMS. The MA application process has two options for applicants that include (1) request for new MA product or (2) request for expanding the service area of an existing product. CMS utilizes the application process as the means to review, assess and determine if applicants are compliant with the current requirements for participation in the MA program and to make a decision related to contract award. This collection process is the only mechanism for organizations to complete the required MA application process. The application process is open to all health plans that want to participate in the MA program. The application is distinct and separate from the bid process, and CMS issues a determination on the application prior to bid submissions, or before the first Monday in June. Collection of this information is mandated by the Code of Federal Regulations, MMA, and CMS regulations at 42 CFR 422, subpart K, in ‘‘Application Procedures and Contracts for Medicare Advantage Organizations.’’ In addition, the Medicare Improvement for Patients and Providers Act of 2008 (MIPPA) further amended titles XVII and XIX of the Social Security Act. Form Number: CMS–10237 (OMB control number: 0938–0935); Frequency: Occasionally; Affected Public: Private Sector (Business or other for-profit and Not-for-profit institutions); Number of Respondents: 435; Total Annual Responses: 435; Total Annual Hours: 6,754. (For policy questions regarding this collection contact Keith Penn-Jones at 410–786–3104.) 4. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Physician Certifications/Recertifications in Skilled Nursing Facilities Manual Instructions; Use: Section 1814(a) of the Social Security Act (the Act) requires specific certifications in order for Medicare payments to be made for certain services. Before the enactment of the Omnibus Budget Reconciliation Act of 1989 (OBRA1989, Pub. L. 101–239), section 1814(a)(2) of the Act required that, in the case of post-hospital extended care services, a physician certify that the services are or were required to be given because the individual needs or needed, on a daily basis, skilled nursing care (provided directly by or requiring the supervision E:\FR\FM\12SEN1.SGM 12SEN1 jbell on DSK3GLQ082PROD with NOTICES Federal Register / Vol. 84, No. 177 / Thursday, September 12, 2019 / Notices of skilled nursing personnel) or other skilled rehabilitation services that, as a practical matter, can only be provided in a SNF on an inpatient basis. The physician certification requirements were included in the law to ensure that patients require a level of care that is covered by the Medicare program and because the physician is a key figure in determining the utilization of health services. In addition, it set forth qualification requirements that a nurse practitioner or clinical nurse specialist must meet in order to sign certification or recertification statements (these requirements were later revised in the Balanced Budget Act of 1997). Effective with items and services furnished on or after January 1, 2011, section 3108 of the Affordable Care Act added physician assistants to the existing authority for nurse practitioners and clinical nurse specialists. Regulations implementing this provision were promulgated in the calendar year (CY) 2011 Medicare Physician Fee Schedule (MPFS) final rule with comment period (75 FR 73387, 73602, 73626–27, November 29, 2010). The requirements at 42 CFR 424.20(a) and (b) concern the initial certification of a beneficiary’s need for a SNF level of care, which must be made upon admission or as soon thereafter as is reasonable and practicable. The requirements at 42 CFR 424.20(c) and (d) concern recertification of a beneficiary’s need for continued SNF level of care, and also require an estimate of the time the individual will need to remain in the SNF, plans for home treatment, and, if appropriate, whether continued services are needed for a condition that occurred after admission to the SNF and while still receiving treatment for the condition for which he or she had received inpatient hospital services. These sections require recertification at specific intervals (the initial recertification must occur no later than the 14th day of SNF care, with subsequent recertification at least every 30 days thereafter) that posthospital SNF care is or was required because the individual needs or needed skilled care on a daily basis. The following CMS internet-Only Manuals provide more detailed instructions regarding the required certification and recertification of covered post-hospital extended care services for a Medicare beneficiary: Chapter 4, sections 40ff and 80 in the Medicare General Information, Eligibility, and Entitlement Manual (CMS Pub. 100–01), chapter 8, sections 40ff. in the Medicare Benefit Policy Manual (CMS Pub. 100–02), and chapter 6, section 6.3 in the Medicare Program Integrity Manual (CMS Pub. 100–08). VerDate Sep<11>2014 17:27 Sep 11, 2019 Jkt 247001 Form Number: CMS–R–5 (OMB control number: 0938–0454); Frequency: Occasionally; Affected Public: Private Sector (Not-for-profit institutions); Number of Respondents: 2,746,550; Total Annual Responses: 2,746,550; Total Annual Hours: 615,149. (For policy questions regarding this collection contact Kia Sidbury at 410– 786–7816.) 5. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Healthcare Common Procedure Coding System (HCPCS)—Level II Code Modification Request Process; Use: In October 2003, the Secretary of Health and Human Services (HHS) delegated authority under the Health Insurance Portability and Accountability Act (HIPAA) legislation to Centers for Medicare and Medicaid Services (CMS) to maintain and distribute HCPCS Level II Codes. As stated in 42 CFR Sec. 414.40 (a) CMS establishes uniform national definitions of services, codes to represent services, and payment modifiers to the codes. The HCPCS code set has been maintained and distributed via modifications of codes, modifiers and descriptions, as a direct result of data received from applicants. Thus, information collected in the application is significant to codeset maintenance. The HCPCS code set maintenance is an ongoing process, as changes are implemented and updated annually; therefore, the process requires continual collection of information from applicants on an annual basis. As new technology evolves and new devices, drugs and supplies are introduced to the market, applicants submit applications to CMS requesting modifications to the HCPCS Level II codeset. Applications have been received prior to HIPAA implementation and must continue to be collected to ensure quality decisionmaking. The HIPAA of 1996 required CMS to adopt standards for coding systems that are used for reporting health care transactions. The regulation that CMS published on August 17, 2000 (45 CFR 162.10002) to implement the HIPAA requirement for standardized coding systems established the HCPCS Level II codes as the standardized coding system for describing and identifying health care equipment and supplies in health care transactions. HCPCS Level II was selected as the standardized coding system because of its wide acceptance among both public and private insurers. Public and private insurers were required to be in compliance with the August 2000 regulation by October 1, 2002. PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 48147 Modifications to the HCPCS are initiated via application form submitted by any interested stakeholder. These applications have been received on an on-going basis with an annual deadline for each cycle. The purpose of the data provided is to educate the decisionmaking body about products and services for which a modification is requested so that an informed decision can be reached in response to the recommended coding. Form Number: CMS–10224 (OMB control number: 0938–1042); Frequency: Annually; Affected Public: Private Sector (Business or other for-profit and Not-for-profit institutions); Number of Respondents: 100; Total Annual Responses: 100; Total Annual Hours: 1,100. (For policy questions regarding this collection contact Kimberlee Combs Miller at 410– 786–6707.) 6. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Home Office Cost Statement; Use: Home offices of chain organizations vary greatly in size, number of locations, staff, mode of operations, and services furnished to the facilities in the chain. The home office of a chain is not in itself certified by Medicare. The relationship of the home office is that of a related organization to participating providers (See 42 CFR 413.17). When a provider claims costs on its cost report that are allocated from a home office, the Home Office Cost Statement constitutes the documentary support required of the provider to be reimbursed for home office costs in the provider’s cost report. Each contractor servicing a provider in a chain must be furnished with a detailed Home Office Cost Statement as a basis for reimbursing the provider for cost allocations from a home office or chain organization. Home offices usually furnish central management and administrative services, e.g., centralized accounting, purchasing, personnel services, management direction and control, and other services. To the extent that the home office furnishes services related to patient care to a provider, the reasonable costs of such services are included in the provider’s cost report and are reimbursable as part of the provider’s costs. If the home office of the chain provides no services related to patient care, the costs of the home office may not be recognized in determining the allowable costs of the providers in the chain. Under the authority of sections 1815(a) and 1833(e) of the Social Security Act (42 U.S.C. 1395g), CMS requires that providers of services participating in the E:\FR\FM\12SEN1.SGM 12SEN1 48148 Federal Register / Vol. 84, No. 177 / Thursday, September 12, 2019 / Notices 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. Providers receiving Medicare reimbursement must provide adequate cost data based on financial and statistical records, which can be verified by qualified auditors. The Form CMS– 287–19 home office cost statement is needed to determine a provider’s reasonable cost incurred in furnishing medical services to Medicare beneficiaries and reimbursement due to or from a provider. Form Number: CMS–287–19 (OMB control number: 0938–0202); Frequency: Annually; Affected Public: Private Sector (Business or other for-profit and Not-for-profit institutions); Number of Respondents: 1,507; Total Annual Responses: 1,507; Total Annual Hours: 702,262. (For policy questions regarding this collection contact Yaakov Feinstein at 410–786–3137.) Dated: September 6, 2019. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2019–19711 Filed 9–11–19; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2019–N–3885] Agency Information Collection Activities; Proposed Collection; Comment Request; Center for Tobacco Products, Food and Drug Administration Funded Trainee/ Scholar Survey AGENCY: Food and Drug Administration, HHS. ACTION: Notice. jbell on DSK3GLQ082PROD with NOTICES 17:27 Sep 11, 2019 Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). Written/Paper Submissions The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 and to allow 60 days for public comment in SUMMARY: VerDate Sep<11>2014 response to the notice. This notice solicits comments on ‘‘Center for Tobacco Products, Food and Drug Administration Funded Trainee/Scholar Survey.’’ DATES: Submit either electronic or written comments on the collection of information by November 12, 2019. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before November 12, 2019. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of November 12, 2019. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. Jkt 247001 Submit written/paper submissions as follows: • Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA– 2019–N–3885 for ‘‘Center for Tobacco Products, Food and Drug Administration Funded Trainee/Scholar Survey.’’ Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 E:\FR\FM\12SEN1.SGM 12SEN1

Agencies

[Federal Register Volume 84, Number 177 (Thursday, September 12, 2019)]
[Notices]
[Pages 48145-48148]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-19711]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-1500/1490S, CMS-10221, CMS-10237, CMS-R-5, 
CMS-10224 and CMS-287-19]


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 November 12, 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 
https://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].

[[Page 48146]]

    3. Call the Reports Clearance Office at (410) 786-1326.

FOR FURTHER INFORMATION CONTACT: William N. 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-1500/1490S Health Insurance Common Claims Form
CMS-10221 Independent Diagnostic Testing Facilities (IDTFs) Site 
Investigation Form Revisions
CMS-10237 Applications for Part C Medicare Advantage, 1876 Cost Plans, 
and Employer Group Waiver Plans to Provide Part C Benefits
CMS-R-5 Physician Certifications/Recertification's in Skilled Nursing 
Facilities Manual Instructions
CMS-10224 Healthcare Common Procedure Coding System (HCPCS)--Level II 
Code Modification Request Process
CMS-287-19 Home Office Cost Statement

    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: Extension of a currently 
approved collection; Title of Information Collection: Health Insurance 
Common Claims Form and Supporting Regulations at 42 CFR part 424, 
subpart C (CMS-1500 and CMS-1490S); Use: The CMS-1500 and the CMS-1490S 
forms are used to deliver information to CMS in order for CMS to 
reimburse for provided services. Medicare Administrative Contractors 
use the data collected on the CMS-1500 and the CMS-1490S to determine 
the proper amount of reimbursement for Part B medical and other health 
services (as listed in section 1861(s) of the Social Security Act) 
provided by physicians and suppliers to beneficiaries. The CMS-1500 is 
submitted by physicians/suppliers for all Part B Medicare. Serving as a 
common claim form, the CMS-1500 can be used by other third-party payers 
(commercial and nonprofit health insurers) and other Federal programs 
(e.g., TRICARE, RRB, and Medicaid). The CMS-1490S (Patient's Request 
for Medical Payment) was explicitly developed for easy use by 
beneficiaries who file their own claims. Form Number: CMS-1500/1490S 
(OMB control number: 0938-1197); Frequency: Yearly; Affected Public: 
State, Local, or Tribal Governments; Number of Respondents: 2,029,505; 
Total Annual Responses: 1,033,839,906; Total Annual Hours: 18,847,500. 
(For policy questions regarding this collection contact Charlene Parks 
at 410-786-8684.)
    2. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Independent 
Diagnostic Testing Facilities (IDTFs) Site Investigation Form 
Revisions; Use: The data collection is used by Medicare contractors 
and/or their subcontractors on site visits to verify compliance with 
required IDTF performance standards. If a subcontractor is used, the 
subcontractor collects the information from the IDTF through an 
interview and forwards it to the Medicare contractor for evaluation. 
The collection and verification of this information defends and 
protects our beneficiaries from illegitimate IDTFs. These procedures 
also protect the Medicare Trust Fund against fraud. The data collected 
also ensures that the applicant has the necessary credentials to 
provide the health care services for which they intend to bill 
Medicare. Form Number: CMS-10221 (OMB control number: 0938-1029); 
Frequency: Occasionally; Affected Public: Private Sector (Business or 
other for-profit and Not-for-profit institutions); Number of 
Respondents: 727; Total Annual Responses: 727; Total Annual Hours: 
1,454. (For policy questions regarding this collection contact Kimberly 
McPhillips at 410-786-5374.)
    3. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Applications for 
Part C Medicare Advantage, 1876 Cost Plans, and Employer Group Waiver 
Plans to Provide Part C Benefits; Use: This information collection 
includes the process for organizations wishing to provide healthcare 
services under MA plans. These organizations must complete an 
application annually (if required), file a bid, and receive final 
approval from CMS. The MA application process has two options for 
applicants that include (1) request for new MA product or (2) request 
for expanding the service area of an existing product. CMS utilizes the 
application process as the means to review, assess and determine if 
applicants are compliant with the current requirements for 
participation in the MA program and to make a decision related to 
contract award. This collection process is the only mechanism for 
organizations to complete the required MA application process. The 
application process is open to all health plans that want to 
participate in the MA program. The application is distinct and separate 
from the bid process, and CMS issues a determination on the application 
prior to bid submissions, or before the first Monday in June.
    Collection of this information is mandated by the Code of Federal 
Regulations, MMA, and CMS regulations at 42 CFR 422, subpart K, in 
``Application Procedures and Contracts for Medicare Advantage 
Organizations.'' In addition, the Medicare Improvement for Patients and 
Providers Act of 2008 (MIPPA) further amended titles XVII and XIX of 
the Social Security Act. Form Number: CMS-10237 (OMB control number: 
0938-0935); Frequency: Occasionally; Affected Public: Private Sector 
(Business or other for-profit and Not-for-profit institutions); Number 
of Respondents: 435; Total Annual Responses: 435; Total Annual Hours: 
6,754. (For policy questions regarding this collection contact Keith 
Penn-Jones at 410-786-3104.)
    4. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Physician 
Certifications/Recertifications in Skilled Nursing Facilities Manual 
Instructions; Use: Section 1814(a) of the Social Security Act (the Act) 
requires specific certifications in order for Medicare payments to be 
made for certain services. Before the enactment of the Omnibus Budget 
Reconciliation Act of 1989 (OBRA1989, Pub. L. 101-239), section 
1814(a)(2) of the Act required that, in the case of post-hospital 
extended care services, a physician certify that the services are or 
were required to be given because the individual needs or needed, on a 
daily basis, skilled nursing care (provided directly by or requiring 
the supervision

[[Page 48147]]

of skilled nursing personnel) or other skilled rehabilitation services 
that, as a practical matter, can only be provided in a SNF on an 
inpatient basis. The physician certification requirements were included 
in the law to ensure that patients require a level of care that is 
covered by the Medicare program and because the physician is a key 
figure in determining the utilization of health services. In addition, 
it set forth qualification requirements that a nurse practitioner or 
clinical nurse specialist must meet in order to sign certification or 
recertification statements (these requirements were later revised in 
the Balanced Budget Act of 1997). Effective with items and services 
furnished on or after January 1, 2011, section 3108 of the Affordable 
Care Act added physician assistants to the existing authority for nurse 
practitioners and clinical nurse specialists. Regulations implementing 
this provision were promulgated in the calendar year (CY) 2011 Medicare 
Physician Fee Schedule (MPFS) final rule with comment period (75 FR 
73387, 73602, 73626-27, November 29, 2010). The requirements at 42 CFR 
424.20(a) and (b) concern the initial certification of a beneficiary's 
need for a SNF level of care, which must be made upon admission or as 
soon thereafter as is reasonable and practicable. The requirements at 
42 CFR 424.20(c) and (d) concern recertification of a beneficiary's 
need for continued SNF level of care, and also require an estimate of 
the time the individual will need to remain in the SNF, plans for home 
treatment, and, if appropriate, whether continued services are needed 
for a condition that occurred after admission to the SNF and while 
still receiving treatment for the condition for which he or she had 
received inpatient hospital services. These sections require 
recertification at specific intervals (the initial recertification must 
occur no later than the 14th day of SNF care, with subsequent 
recertification at least every 30 days thereafter) that posthospital 
SNF care is or was required because the individual needs or needed 
skilled care on a daily basis. The following CMS internet-Only Manuals 
provide more detailed instructions regarding the required certification 
and recertification of covered post-hospital extended care services for 
a Medicare beneficiary: Chapter 4, sections 40ff and 80 in the Medicare 
General Information, Eligibility, and Entitlement Manual (CMS Pub. 100-
01), chapter 8, sections 40ff. in the Medicare Benefit Policy Manual 
(CMS Pub. 100-02), and chapter 6, section 6.3 in the Medicare Program 
Integrity Manual (CMS Pub. 100-08). Form Number: CMS-R-5 (OMB control 
number: 0938-0454); Frequency: Occasionally; Affected Public: Private 
Sector (Not-for-profit institutions); Number of Respondents: 2,746,550; 
Total Annual Responses: 2,746,550; Total Annual Hours: 615,149. (For 
policy questions regarding this collection contact Kia Sidbury at 410-
786-7816.)
    5. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Healthcare Common 
Procedure Coding System (HCPCS)--Level II Code Modification Request 
Process; Use: In October 2003, the Secretary of Health and Human 
Services (HHS) delegated authority under the Health Insurance 
Portability and Accountability Act (HIPAA) legislation to Centers for 
Medicare and Medicaid Services (CMS) to maintain and distribute HCPCS 
Level II Codes. As stated in 42 CFR Sec. 414.40 (a) CMS establishes 
uniform national definitions of services, codes to represent services, 
and payment modifiers to the codes. The HCPCS code set has been 
maintained and distributed via modifications of codes, modifiers and 
descriptions, as a direct result of data received from applicants. 
Thus, information collected in the application is significant to 
codeset maintenance. The HCPCS code set maintenance is an ongoing 
process, as changes are implemented and updated annually; therefore, 
the process requires continual collection of information from 
applicants on an annual basis. As new technology evolves and new 
devices, drugs and supplies are introduced to the market, applicants 
submit applications to CMS requesting modifications to the HCPCS Level 
II codeset. Applications have been received prior to HIPAA 
implementation and must continue to be collected to ensure quality 
decision-making. The HIPAA of 1996 required CMS to adopt standards for 
coding systems that are used for reporting health care transactions. 
The regulation that CMS published on August 17, 2000 (45 CFR 162.10002) 
to implement the HIPAA requirement for standardized coding systems 
established the HCPCS Level II codes as the standardized coding system 
for describing and identifying health care equipment and supplies in 
health care transactions. HCPCS Level II was selected as the 
standardized coding system because of its wide acceptance among both 
public and private insurers. Public and private insurers were required 
to be in compliance with the August 2000 regulation by October 1, 2002. 
Modifications to the HCPCS are initiated via application form submitted 
by any interested stakeholder. These applications have been received on 
an on-going basis with an annual deadline for each cycle. The purpose 
of the data provided is to educate the decision-making body about 
products and services for which a modification is requested so that an 
informed decision can be reached in response to the recommended coding. 
Form Number: CMS-10224 (OMB control number: 0938-1042); Frequency: 
Annually; Affected Public: Private Sector (Business or other for-profit 
and Not-for-profit institutions); Number of Respondents: 100; Total 
Annual Responses: 100; Total Annual Hours: 1,100. (For policy questions 
regarding this collection contact Kimberlee Combs Miller at 410-786-
6707.)
    6. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Home Office Cost 
Statement; Use: Home offices of chain organizations vary greatly in 
size, number of locations, staff, mode of operations, and services 
furnished to the facilities in the chain. The home office of a chain is 
not in itself certified by Medicare. The relationship of the home 
office is that of a related organization to participating providers 
(See 42 CFR 413.17). When a provider claims costs on its cost report 
that are allocated from a home office, the Home Office Cost Statement 
constitutes the documentary support required of the provider to be 
reimbursed for home office costs in the provider's cost report. Each 
contractor servicing a provider in a chain must be furnished with a 
detailed Home Office Cost Statement as a basis for reimbursing the 
provider for cost allocations from a home office or chain organization. 
Home offices usually furnish central management and administrative 
services, e.g., centralized accounting, purchasing, personnel services, 
management direction and control, and other services. To the extent 
that the home office furnishes services related to patient care to a 
provider, the reasonable costs of such services are included in the 
provider's cost report and are reimbursable as part of the provider's 
costs. If the home office of the chain provides no services related to 
patient care, the costs of the home office may not be recognized in 
determining the allowable costs of the providers in the chain. Under 
the authority of sections 1815(a) and 1833(e) of the Social Security 
Act (42 U.S.C. 1395g), CMS requires that providers of services 
participating in the

[[Page 48148]]

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. Providers receiving 
Medicare reimbursement must provide adequate cost data based on 
financial and statistical records, which can be verified by qualified 
auditors. The Form CMS-287-19 home office cost statement is needed to 
determine a provider's reasonable cost incurred in furnishing medical 
services to Medicare beneficiaries and reimbursement due to or from a 
provider. Form Number: CMS-287-19 (OMB control number: 0938-0202); 
Frequency: Annually; Affected Public: Private Sector (Business or other 
for-profit and Not-for-profit institutions); Number of Respondents: 
1,507; Total Annual Responses: 1,507; Total Annual Hours: 702,262. (For 
policy questions regarding this collection contact Yaakov Feinstein at 
410-786-3137.)

    Dated: September 6, 2019.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2019-19711 Filed 9-11-19; 8:45 am]
BILLING CODE 4120-01-P


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