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

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

          - [Document Identifier: CMS-10638 and CMS-1500]

# 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 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 16, 2023.

# 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, please access the CMS PRA website by copying and pasting the following web address into your web browser:                         *https://www.cms.gov/​Regulations-and-Guidance/​Legislation/​PaperworkReductionActof1995/​PRA-Listing.*

# 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:*                     Revision of a currently approved collection;                     *Title of Information Collection:*                     Add-On Payments for New Medical Services and Technologies Paid Under the Inpatient Prospective Payment System (IPPS);                     *Use:*                     Sections 1886(d) (5) (K) and (L) of the Act establish a process of identifying and ensuring adequate payment for new medical services and technologies (sometimes collectively referred to in this section as “new technologies”) under the Inpatient Prospective Payment System (IPPS). Section 1886(d)(5)(K)(vi) of the Act specifies that a medical service or technology will be considered new if it meets criteria established by the Secretary after notice and opportunity for public comment. Section 1886(d)(5)(K)(ii)(I) of the Act specifies that a new medical service or technology may be considered for NTAP if, “based on the estimated costs incurred with respect to discharges involving such service or technology, the DRG prospective payment rate otherwise applicable to such discharges under this subsection is inadequate.”                

                    In order to qualify for NTAP under the traditional pathway, a specific technology must be “new” and demonstrate that they are not substantially similar to existing technologies under the requirements of § 412.87(b)(2) of our regulations. The statutory provision contemplated the special payment treatment for new technologies until such time as data are available to reflect the cost of the technology in the DRG weights through recalibration (no less than 2 years and no more than 3 years). Alternative pathway technologies must also be “new” but are considered not substantially similar to existing technologies. Responses to the questions in the application help CMS determine if and how the applicant meets the established.                     *Form Number:*                     CMS-10638 (OMB Control Number: 0938-1347);                     *Frequency:*                     Yearly;                     *Affected Public:*                     Private Sector, Business or other for-profits and Not-for-profits institutions;                     *Number of Respondents:*                     62;                     *Number of Responses:*                     62;                     *Total Annual Hours:*                     1,655. (For policy questions regarding this collection contact Sophia Chan at 410-786-8348.)                

                    2.                     *Type of Information Collection Request:*                     Extension of a currently approved collection of information;                     *Title of Information Collection:*                     Health Insurance Common Claims Form;                     *Use:*                     The CMS-1500 and the CMS-1490S forms are used to deliver information to CMS in order for CMS to reimburse for provided services. Medicare Administrative Contractors use the data collected on the CMS-1500 and the CMS-1490S to determine the proper amount of reimbursement for Part B medical and other health services (as listed in section 1861(s) of the Social Security Act) provided by physicians and suppliers to beneficiaries. The CMS-1500 is submitted by physicians/suppliers for all Part B Medicare.                           ( print page 63580)                        Serving as a common claim form, the CMS-1500 can be used by other third-party payers (commercial and nonprofit health insurers) and other Federal programs (                    *e.g.,*                     TRICARE, RRB, and Medicaid).                     *Form Number:*                     CMS-1500 (OMB Control Number: 0938-1197);                     *Frequency:*                     Occasionally;                     *Affected Public:*                     Private Sector, Business or other for-profit and not-for-profit institutions;                     *Number of Respondents:*                     2,451,781;                     *Number of Responses:*                     975,664,249;                     *Total Annual Hours:*                     17,163,310. (For policy questions regarding this collection contact Charlene Parks at 410-786-8684.)                

Dated: September 12, 2023.

William N. Parham, III,

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

[FR Doc. 2023-20041 Filed 9-14-23; 8:45 am]

BILLING CODE 4120-01-P