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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:

Centers for Medicare & Medicaid Services, Health and Human 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                               ( print 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:                     *ICDProcedureCodeRequest@cms.hhs.gov. 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                           ( print 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