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###### Department of Health and Human Services

###### Centers for Medicare & Medicaid Services

          - [Document Identifiers CMS-10224, CMS-222-17, CMS-216-94, and CMS-265-11]

# 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 October 30, 2017.

# 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:                         *OIRA_submission@omb.eop.gov*.                    

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' Web site 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                         *Paperwork@cms.hhs.gov.*

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:*                     Extension 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 codeset has been                           ( print page 45590)                        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 codeset 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.                     *Form Number:*                     CMS-10224 (OMB control number: 0938-1042);                     *Frequency:*                     Annually;                     *Affected Public:*                     Private Sector: Business or other for-profit, Not-for-profit institutions;                     *Number of Respondents:*                     100;                     *Total Annual Responses:*                     100;                     *Total Annual Hours:*                     1100. (For policy questions regarding this collection contact Kimberley Combs-Miller at 410-786-6707).                

                    2.                     *Type of Information Collection Request:*                     Revision of a currently approved collection;                     *Title of Information Collection:*                     Independent Rural Health Clinics/Freestanding Federally Qualified Health Clinics Cost Report;                     *Use:*                     Providers of services participating in the Medicare program are required under sections 1815(a), 1833(e) and 1861(v)(1)(A) of the Social Security Act (42 U.S.C. 1395g) to submit annual information to achieve settlement of costs for health care services rendered to Medicare beneficiaries. In addition, regulations at 42 CFR 413.20 and 413.24 require adequate cost data and cost reports from providers on an annual basis. The Form CMS-222-17 cost report is needed to determine a provider's reasonable costs incurred in furnishing medical services to Medicare beneficiaries and reimbursement due to or from a provider.                     *Form Number:*                     CMS-222-17 (OMB control number: 0938-0107);                     *Frequency:*                     Annually;                     *Affected Public:*                     Private Sector: Business or other for-profit, Not-for-profit institutions;                     *Number of Respondents:*                     1,744;                     *Total Annual Responses:*                     1,744;                     *Total Annual Hours:*                     95,920. (For policy questions regarding this collection contact Yaakov Feinstein at 410-786-3137).                

                    3.                     *Type of Information Collection Request:*                     Extension of a currently approved collection;                     *Title of Information Collection:*                     Organ Procurement Organization/Histocompatibility Laboratory Cost Report;                     *Use:*                     Providers of services participating in the Medicare program are required under sections 1815(a) and 1861(v)(1)(A) of the Social Security Act (42 U.S.C. 1395g) to submit annual information to achieve settlement of costs for health care services rendered to Medicare beneficiaries. In addition, regulations at 42 CFR 413.20 and 413.24 require adequate cost data and cost reports from providers on an annual basis. The Form CMS-216-94 cost report is needed to determine a provider's reasonable costs incurred in furnishing medical services to Medicare beneficiaries and reimbursement due to or due from a provider.                     *Form Number:*                     CMS-216-94 (OMB control number: 0938-0102);                     *Frequency:*                     Annually;                     *Affected Public:*                     Private Sector: Business or other for-profit, Not-for-profit institutions;                     *Number of Respondents:*                     102;                     *Total Annual Responses:*                     102;                     *Total Annual Hours:*                     4590. (For policy questions regarding this collection contact Amelia Citerone at 410-786-3901).                

                    4.                     *Type of Information Collection Request:*                     Extension of a currently approved collection;                     *Title of Information Collection:*                     Providers of services participating in the Medicare program are required under sections 1815(a) and 1861(v)(1)(A) of the Social Security Act (42 U.S.C. 1395g) to submit annual information to achieve settlement of costs for health care services rendered to Medicare beneficiaries. In addition, regulations at 42 CFR 413.20 and 413.24 require adequate cost data and cost reports from providers on an annual basis. The Form CMS-265-11 cost report is needed to determine a provider's reasonable costs incurred in furnishing medical services to Medicare beneficiaries.                     *Form Number:*                     CMS-265-11 (OMB control number: 0938-0236);                     *Frequency:*                     Annually;                     *Affected Public:*                     Private Sector: Business or other for-profit, Not-for-profit institutions;                     *Number of Respondents:*                     6,821;                     *Total Annual Responses:*                     6,821;                     *Total Annual Hours:*                     443,365. (For policy questions regarding this collection contact Gail Duncan at 410-786-7278).                

Dated: September 26, 2017.

William N. Parham, III,

Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs.

[FR Doc. 2017-20921 Filed 9-28-17; 8:45 am]

BILLING CODE 4120-01-P