Supporting Statement – Part A
This is a reinstatement with change of the information collection request previously approved under OMB control number 0938-0983.The purpose of this collection is to obtain information that will be subsequently used during transaction exchange for identification of Medicare providers/suppliers and authorization of requested electronic data interchange (EDI) functions. The EDI Registration Form and the Medicare Enrollment Forms are completed by Medicare providers/suppliers and submitted to CMS Medicare Administrative Contractors (MACs).
Authorization is needed for providers/suppliers to send/receive Health Insurance Portability and Accountability Act (HIPAA) standard transactions directly (or through a designated 3rd party) to/from Medicare contractors. Medicare contractors will use the information for initial set-up and maintenance of the access privileges. CMS has allowed each MAC to create their own organization specific forms given they are comparable in terms of content of forms 10164A and 10164B, to transmit data files electronically between themselves and their trading partners.
Due to an administrative oversight with changes to staff and management this EDI registration and enrollment forms package expired on March 31, 2022. CMS would like to reinstate this PRA package and redesignate CMS-10164A EDI registration form and CMS-10164B enrollment form as model/sample forms. The CMS IOM Publication 100-04 Chapter 24 Section 30 states the A/B MACs and CEDI must use these forms 10164A and 10164B, or their own organization specific forms given they are comparable in terms of content, to transmit data files electronically between themselves and their trading partners. CMS received confirmation from each MAC stating that currently each MAC uses their own organization specific forms that are comparable in terms of content of forms 10164A and 10164B.
The use of the MAC specific organization forms provides an efficient means by which Medicare captures the information necessary to drive Medicare EDI security and EDI access privileges. All EDI providers will complete and sign the EDI Enrollment Form along with the Medicare EDI Registration Form. They will also reconfirm their access privileges annually. The signature and contact information provides a level of attestation as to the supplied information in the form.
Each MAC specific EDI Registration Form captures information necessary to support implementation of the full suite of HIPAA transactions used by Medicare fee-for-service contractors and automates the application of Medicare EDI security and EDI access privileges. Providers/suppliers must register with Medicare contractors, via the form, to send/receive HIPAA standard transactions directly (or through a designated 3rd party) to/from Medicare contractors.
The Medicare contractor will ensure that the forms are complete, authenticated, and if requested EDI services are appropriate, update the Medicare EDI Registration File and send a confirmation to the requester. If the request is inappropriate, it will be returned with an explanation.
The CMS - Medicare EDI Registration and EDI Enrollment Form expired 3/31/2022. CMS is requesting a ‘Reinstatement with change of a previously approved collection’. The lapse in the renewal of the package was caused by administrative issues and the change is to renew forms 10164A and 10164B as sample/model forms only.
The Congress, recognizing the need to simplify the administration of health care transactions, enacted the Health Insurance Portability and Accountability Act of 1996 (HIPAA), Public Law 104-191, on August 21, 1996. Title II, Subtitle F of this legislation directs the Secretary of the Department of Health and Human Services to develop unique standards for specified electronic transactions and code sets for those transactions. The purpose of this Subtitle is to improve the Medicare and Medicaid programs in particular and the efficiency and effectiveness of the health care industry in general through the establishment of standards and requirements to facilitate the electronic transmission of certain health information.
This Subtitle also requires that the Secretary adopt standards for financial and administrative transactions, and data elements for those transactions to enable health information to be exchanged electronically.
The Standards for Electronic Transactions final rule, 45 CFR Part 162 Subpart K §162.1101 through Subpart R §162.1802, (hereinafter referred to as “Transactions Rule”) published August 17, 2000 adopted standards for health care transactions and code sets1. Subsequent to the Transactions Rule, CMS-0003-P and CMS-0005-P proposed modifications to the adopted standards essential to permit initial implementation of the standards throughout the entire healthcare industry.
Currently, MACs have a process in place to enroll providers for electronic billing and other EDI transactions. In support of the HIPAA Transactions Rule, the purpose of this Paperwork Reduction Act (PRA) request is to establish a prescribed amount of data that must be submitted by providers/suppliers that is sufficient to address all HIPAA transactions.
The information collected by the forms will be uploaded into Medicare contractor computer systems. Medicare contractors will store this information in a database accessed at the time of provider connection to the Medicare Data Contractor Network (MDCN). When authentication is successful and connectivity is established, transactions may be exchanged.
The information will be stored in a computer data base and used to authenticate the user on day-to- day electronic commerce, support the submitter and password administration function, and validate access relationships between providers/suppliers and their designated EDI submitter/receiver on a per transaction basis.
This is not a duplicative collection of information. No other collections can substitute for this.
This has no impact or burden to small businesses.
The frequency of collecting this information is determined by the provider/supplier as their business needs change, such as revisions to their relationship with business associates, application software and/or transactions they select to exchange electronically. Providers/suppliers will then communicate such changes to the appropriate contractor via the form. The security and privacy of our Medicare electronic commerce remains potentially at risk without this collection or with less frequent collections.
No special circumstances.
The 60-day Federal Register notice (89 FR 13721) for this collection published on February 23, 2024 and the 30-day Federal Register notice (89 FR 40485) published on May 10, 2024.
There will be no payments/gifts to respondents.
Respondent information will be kept in a physically secured area (electronic and paper). The computer system will be password protected for electronic information. Files containing the actual forms or information from these forms will be safeguarded. The information will be kept private to the extent provided by law.
There are no sensitive questions arising from this data collection.
To derive average costs, we used data from the U.S. Bureau of Labor Statistics’ May 2022 National Occupational Employment and Wage Estimates for all salary estimates (https://www.bls.gov/oes/current/oes434051.htm). In this regard, the following table presents the median hourly wage, the cost of fringe benefits which is 100% of the hourly wage, and the adjusted hourly wage.
Occupational Title |
Occupation Code |
Median Hourly Wage ($/hour)
|
Fringe Benefit ($/hour) |
Adjusted Hourly Wage ($/hour) |
Customer Service Representatives |
43-4051 |
$18.16 |
$18.16 |
Estimated Annual Burden Hours
2022 EDI Enrollment for Medicare Part A, Part B and Home Health and Hospice (HHH) provider/suppliers’ data was pulled from the MAC/CMS Data Exchange (MDX) Portal.
CMS estimates the time to complete and forward the forms for Medicare EDI Registration and Enrollment is 20 minutes per EDI provider/supplier on an ongoing basis annually.
2022 EDI Registration and Enrollment |
Time to Complete EDI Registration and Enrollment Forms |
Total Burden Hours |
1,181,209 |
20 minutes |
393,736 hours |
Labor Costs
Total Hours to Complete EDI Registration and Enrollment Forms |
Median Hourly Wage |
Fringe Benefit |
Adjusted Hourly Wage |
Total Labor Costs |
393,736 hours |
$18.16 |
$18.16 |
$36.32 |
$14,300,491.52 |
There are no additional capital costs to respondents or to record keepers.
The calculations for OIT employees’ hourly salary were obtained from the OPM website2, with an additional 100% to account for fringe benefits.
Hourly Wage: $62.83 + 100% fringe benefits = $125.66 per hour.
Task |
Estimated Cost |
Acquiring and Preparing the Required Data and Oversight |
Intentionally Blank |
1 GS-13: 1 x $125.66 x 20 hours |
$2,513.20 |
Total Costs to Government |
$2,513.20 |
There were no changes to the burden estimates or the required data elements; however, the total annual burden estimate was adjusted to account for an increase in the number of respondents. The annual cost burden was updated to reflect the current wage data that includes fringe and overhead benefits at 100%.
There are no publication and tabulation dates associated with this collection.
The OMB control number and expiration date will be listed on the model instruments; however, respondents are not required to use the model instruments to comply with this information collection request.
There are no exceptions to the certification statement.
1 https://www.federalregister.gov/documents/2000/08/17/00-20820/health-insurance-reform-standards-for-electronic-transactions
| File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
| File Title | Statement for Medicare Electronic Data Interchange (EDI) Registration and Electronic Data Interchange Enrollment Form |
| Subject | Statement for Medicare Electronic Data Interchange (EDI) Registration and Electronic Data Interchange Enrollment Form |
| Author | CMS |
| File Modified | 0000-00-00 |
| File Created | 2024-07-20 |