[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