Non-Substantive Justification

Non-Substantive Change Request to CMS-10054, OMB 0938-0860

This is a non-substantive change request to Centers for Medicare and Medicaid Services (CMS) New Technology Services for Ambulatory Payment Classifications (APC) under the Outpatient Prospective Payment System Application Form (CMS-10054) to allow CMS to receive and process New Technology APC applications in an electronic application intake system on the CMS-10054 form. The Form (CMS-10054) is currently near completion and is anticipated to go live in the electronic application in-take system in mid-March, 2022.

The electronic form is essentially identical to the paper application form (CMS-10054, OMB 0938-0860) except for a few minor, non-substantive changes to either accommodate the web format or further provide simplification or clarification of the existing questions. We are not requesting any new information. The modifications to the form include:

(1) Other information as CMS may require to evaluate specific requests or that the applicant believes CMS may need to evaluate the application. Provides capability to add reference

documents as attachments in addition to entered data

(2) Yes/No questions added due to potential overlap in applications in MEARIS: 1) Have you applied for a Healthcare Common Procedure Coding System (HCPCS) code? 2) Have you completed other MEARIS applications for this technology?

(3) Text area which provides 2000 characters to describe the service

Please refer to our crosswalk document for a more detailed comparison of the differences between the paper and electronic application. We consider all of the changes to be non-substantive since they do not constitute changes to the intent or substance of the New Technology APC application, but only simplify or clarify the content and streamline the reporting process. These changes have no impact on the previously stated burden associated with this collection.