Agency Information Collection Activities: Proposed Collection; Comment Request

Published date11 May 2021
Citation86 FR 25872
Record Number2021-09908
SectionNotices
CourtCenters For Medicare & Medicaid Services,Health And Human Services Department
Federal Register, Volume 86 Issue 89 (Tuesday, May 11, 2021)
[Federal Register Volume 86, Number 89 (Tuesday, May 11, 2021)]
                [Notices]
                [Pages 25872-25873]
                From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
                [FR Doc No: 2021-09908]
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                DEPARTMENT OF HEALTH AND HUMAN SERVICES
                Centers for Medicare & Medicaid Services
                [Document Identifier: CMS-10774 & CMS-10008]
                Agency Information Collection Activities: Proposed Collection;
                Comment Request
                AGENCY: Centers for Medicare & Medicaid Services, Health and Human
                Services (HHS).
                ACTION: Notice.
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                SUMMARY: The Centers for Medicare & Medicaid Services (CMS) is
                announcing an opportunity for the public to comment on CMS' intention
                to collect information from the public. Under the Paperwork Reduction
                Act of 1995 (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 July 12, 2021.
                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: CMS-P-0015A, 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.
                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-10744--The International Classification of Diseases, 10th Revision,
                Procedure Coding System (ICD-10-PCS)
                CMS-10008--Transitional Pass through payments related to Drugs,
                Biologicals, and Radiopharmaceuticals to determine eligibility under
                the Outpatient Prospective Payment System
                 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.
                [[Page 25873]]
                Information Collection
                 1. Type of Information Collection Request: New collection (Request
                for a new control number); Title of Information Collection: The
                International Classification of Diseases, 10th Revision, Procedure
                Coding System (ICD-10-PCS); Use: The HIPAA Act of 1996 required CMS to
                adopt standards for coding systems that are used for reporting health
                care transactions. The Transactions and Code Sets final rule (65 FR
                50312) published in the Federal Register on August 17, 2000 adopted the
                International Classification of Diseases, 9th Revision, Clinical
                Modification (ICD-9-CM) Volumes 1 and 2 for diagnosis codes and ICD-9-
                CM Volume 3 for inpatient hospital services procedures as standard code
                sets for use by covered entities (health plans, health care
                clearinghouses, and those health care providers who transmit any health
                information in electronic form in connection with a transaction for
                which the Secretary has adopted a standard).
                 The ICD-10-PCS code set has been maintained, enhanced and expanded
                as a direct result of recommendations for updates (e.g., adding new
                codes, deleting codes, and editing descriptive material related to
                existing codes) received from interested stakeholders from both the
                public and private sectors. Thus, information collected in the
                application is significant to code set maintenance. The ICD-10-PCS code
                set maintenance is an ongoing process, as changes are implemented and
                updated; therefore, the process requires continual collection of
                information from applicants on a bi-annual basis. As new technology
                evolves and new complex medical procedures are developed, requests are
                submitted to CMS requesting modifications to the ICD-10-PCS code set.
                Requests have been received prior to HIPAA implementation and must
                continue to be collected to facilitate quality decision-making.
                 The Committee provides two meetings each year as a public forum to
                discuss proposed changes to ICD-10. Suggestions to CMS for ICD-10-PCS
                procedure code modifications come from both the public and private
                sectors. ICD-10-PCS modification requests can be proposals for new or
                revised procedure codes or requests for technical coding updates
                including but not limited to, enhancements to existing procedure code
                concepts, such as adding a new body part value or a new approach value.
                Requestors are asked to include a description of the procedure code or
                change being requested, and rationale for why the procedure code or
                change is needed. Supporting references and literature may also be
                submitted. Interested parties submit these ICD-10-PCS modification
                requests three months prior to a scheduled Spring or Fall C&M meeting
                via email to the following email address:
                [email protected]. Form Number: CMS-10744 (OMB
                control number: 0938-New); Frequency: Yearly; Affected Public: Business
                or other for-profits and Not-for-profit institutions and Private
                Sector; Number of Respondents: 80; Total Annual Responses: 80; Total
                Annual Hours: 800. (For policy questions regarding this collection
                contact Marilu Hue at 410-786-4510.)
                 2. Type of Information Collection Request: Revision of a currently
                approved collection; Title of Information Collection: Transitional Pass
                through payments related to Drugs, Biologicals, and
                Radiopharmaceuticals to determine eligibility under the Outpatient
                Prospective Payment System; Use: Section 201(b) of the BBRA 1999
                amended section 1833(t) of the Act by adding new section 1833(t)(6).
                This provision requires the Secretary to make additional payments to
                hospitals for a period of 2 to 3 years for certain drugs,
                radiopharmaceuticals, biological agents, medical devices and
                brachytherapy devices. Section 1833(t)(6)(A)(iv) establishes the
                criteria for determining the application of this provision to new
                items. Section 1833(t)(6)(C)(i) provides that the additional payment
                for drugs and biologicals be the amount by which the amount determined
                under section 1842(o) of the Act exceeds the portion of the otherwise
                applicable hospital outpatient department fee schedule amount that the
                Secretary determines to be associated with the drug or biological.
                 Interested parties such as hospitals, pharmaceutical companies, and
                physicians will apply for transitional pass-through payment for drugs,
                biologicals, and radiopharmaceuticals used with services covered under
                the hospital OPPS. After we receive all requested information, we will
                evaluate the information to determine if the criteria for making a
                transitional pass- through payment are met and if an interim healthcare
                common procedure coding system (HCPCS) code for a new drug, biological,
                or radiopharmaceutical is necessary. We will advise the applicant of
                our decision, and update the hospital OPPS during its next scheduled
                quarterly update to reflect any newly approved drug, biological, or
                radiopharmaceutical. We list below the information that we will require
                from all applicants. Form Number: CMS-10008 (OMB control number: 0938-
                0802); Frequency: Yearly; Affected Public: Private Sector; Number of
                Respondents: 30; Total Annual Responses: 30; Total Annual Hours: 480.
                (For policy questions regarding this collection contact Raymond A.
                Bulls at 410-786- 7267.)
                 Dated: May 5, 2021.
                William N. Parham, III,
                Director, Paperwork Reduction Staff, Office of Strategic Operations and
                Regulatory Affairs.
                [FR Doc. 2021-09908 Filed 5-10-21; 8:45 am]
                BILLING CODE 4120-01-P
                

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