CMS-10164 Supporting Statement MAK 12-03-2018 ver 4-a

Statement for Medicare Electronic Data Interchange (EDI) Registration and Electronic Data Interchange Enrollment Form

1. Background

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 Enrollment Form and the Medicare Registration Forms are completed by Medicare providers/suppliers and submitted to Medicare contractors.

Authorization is needed for providers/suppliers to send/receive Health Insurance Portability and Accountability Act (HIPAA) standard transactions directly (or through a designated 3^rd party) to/from Medicare contractors. Medicare contractors will use the information for initial set-up and maintenance of the access privileges. The use of the standard form provides an efficient uniform means by which Medicare could capture 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.

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 lack of uniformity for EDI Registration has made it difficult to exchange information efficiently thereby reducing the efficiencies and savings for health care providers and health plans that could be realized if this information was standardized. Adopting a standard form for Medicare EDI Registration and Enrollment forms greatly decreases the burden on health care providers and their billing services and standardizes the data content needed to drive Medicare EDI security and EDI access privileges.

The Medicare 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 3^rd party) to/from Medicare contractors.

CMS-10164 expired 6/30/2016. CMS is requesting for reinstatement of a previously approved collection. The lapse in the renewal of the package was caused by administrative issues.

2. Justification

1. Need and Legal Basis

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 sets. 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, Medicare contractors 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 common form that is sufficient to address all HIPAA transactions.

2. Information Users

The information collected by this form 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.

3. Use of Information Technology

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.

4. Duplication of Similar Information

This is not a duplicative collection of information. No other collections can substitute for this.

5. Small Businesses

This has no impact or burden to small businesses.

6. Less Frequent Collection

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 this Form. The security and privacy of our Medicare electronic commerce remains potentially at risk without this collection or with less frequent collections.

7. Special Circumstance

No special circumstances.

8. Federal Register Notice/Outside Consultation

The 60-day Federal Register notice for this collection published on November 09, 2018 (83FR56085) and the 30-day notice published on January 3, 2019 (84FR734) with no comments received.

9. Payment/Gift to Respondent

There will be no payments/gifts to respondents.

10. Confidentiality

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.

11. Sensitive Questions

There are no sensitive questions arising from this data collection.

12. Burden Estimate (Hours & Wages)

CMS estimates the time to complete and forward the forms for Medicare EDI Registration and Electronic Data Interchange (EDI) Enrollment is 20 minutes per EDI provider/supplier on an ongoing basis annually. The totals below include a breakdown by CMS Medicare Administrative Contractors (MACs). We expect to see changes to existing enrollments/registrations and new enrollments occurring at a frequency of 193,268 provider/suppliers per year. This is the calculated average from existing CMS combined yearly totals of existing enrollments/registrations and new enrollments from the following calendar years:

2013 - 156,907; 2014 - 169,396;
2015 - 199,203;
2016 - 241,693; and
2017 - 199,140
Number of CMS MACs:	16
Estimated Number of Registrations per Year:	193,268
Estimated Number of Registrations per MAC:	12,079
Estimated Annual Hours per Year:	64,423
Estimate cost per Hour:	$ 15.81
Estimated Cost per MAC:	$ 127,315.95
Total Annual Cost per Year:	$ 1,018,527.63
Total respondent cost estimate accounting for fringe & overhead benefits:	$ 2,037,055.26

For the current submission, CMS estimates 193,268 (2013-2017/5) registrations per year, for a total of 64,423 annual hours per year @ $15.81 per hour= $1,018,527.63. Adding fringe and overhead at 100 % =

$2,037,055.26. “We have added 100% of the mean hourly wage to account for fringe and overhead benefits”

** Please see the Bureau of Labor Statistics website for wage information:

http://www.bls.gov/oes/current/oes_md.htm ** 43-4051 Customer Service Representatives **

13. Capital Costs

There are no additional capital costs to respondents or to record keepers.

14. Cost to Federal Government

There are no costs to the Federal Government.

15. Program/Burden Changes

This is a request for reinstatement of a previously approved request. Estimated labor costs have been updated.

	Total Requested	Change Due to Agency Estimate	Currently Approved
Annual Responses	193,268	-46,732	240,000
Annual Hour Burden	64,423 hours	-15,577 hours	80,000 hours
Annual Cost Burden	$2,037,055.26	+$1,157,055.26	$880,000

16. Publication and Tabulation Dates

There are no publication and tabulation dates associated with this collection.

17. Expiration Date

An expiration date placeholder has been added to the bottom of both forms.

18. Certification Statement

There are no exceptions to the certification statement.

3. Collections of Information Employing Statistical Methods

This collection of information does not employ statistical methods.