[Federal Register Volume 86, Number 137 (Wednesday, July 21, 2021)]
[Notices]
[Pages 38486-38488]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-15531]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-10774, CMS-10008 and CMS-10450]


Agency Information Collection Activities: Submission for OMB 
Review; 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 (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

[[Page 38487]]

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 August 20, 2021.

ADDRESSES: Written comments and recommendations for the proposed 
information collection should be sent within 30 days of publication of 
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular 
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function.
    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.

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: New collection (Request 
for a new OMB 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.)
    3. Type of Information Collection Request: Extension of a currently 
approved Information Collection; Title of Information Collection: 
Consumer Assessment of Healthcare Providers and

[[Page 38488]]

Systems (CAHPS) Survey for Merit-based Incentive Payment Systems 
(MIPS); Use: CMS is submitting updates to one information collection 
request associated with the CAHPS for MIPS survey. The CAHPS for MIPS 
survey is used in the Quality Payment Program (QPP) to collect data on 
fee-for-service Medicare beneficiaries' experiences of care with 
eligible clinicians participating in MIPS and is designed to gather 
only the necessary data that CMS needs for assessing physician quality 
performance, and related public reporting on physician performance, and 
should complement other data collection efforts. The survey consists of 
the core Agency for Healthcare Research and Quality (AHRQ) CAHPS 
Clinician & Group Survey, version 3.0, plus additional survey questions 
to meet CMS's information and program needs. The survey information is 
used for quality reporting, the Care Compare website, and annual 
statistical experience reports describing MIPS data for all MIPS 
eligible clinicians.
    This 2021 information collection request addresses changes to the 
CAHPS for MIPS Survey associated with the CY 2021 Physician Fee 
Schedule (PFS) final rule. In order to address the increased use of 
telehealth care due to the Public Health Emergency (PHE) for COVID-19, 
an additional question is added to the CAHPS for MIPS survey to 
integrate one telehealth item to assess the patient-reported usage of 
telehealth services. In addition, the cover page of the CAHPS for MIPS 
Survey is revised to include a reference to care in telehealth 
settings. The CAHPS for MIPS survey results in burden to three 
different types of entities: Groups and virtual groups, vendors, and 
beneficiaries associated with administering the survey. Virtual groups 
are subject to the same requirements as groups; therefore, we will 
refer only to groups as an inclusive term for both unless otherwise 
noted. The estimated time to administer the 2021 CAHPS for MIPS survey 
has increased from 12.9 minutes to 13.1 minutes; however, there was an 
overall decrease in burden as the number of respondents decreased. Form 
Number: CMS-10450 (OMB control number: 0938-1222); Frequency: Yearly; 
Affected Public: Business or other for-profits and Not-for-profit 
institutions and Individuals and Households; Number of Respondents: 
30,249; Total Annual Responses: 30,249; Total Annual Hours: 6,902 (For 
policy questions regarding this collection contact Alesia Hovatter at 
410-786-6861.)

    Dated: July 16, 2021.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2021-15531 Filed 7-20-21; 8:45 am]
BILLING CODE 4120-01-P