CMS-10932.Supporting Statement Part A

Supporting Statement for Paperwork Reduction Act Submissions

Accreditation of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Suppliers (OMB Control Number: 0938-New)

1. BACKGROUND

1. Introduction

Since 2006 – and pursuant to 42 Code of Federal Regulations (CFR) § 424.57 -- DMEPOS suppliers have been required to be accredited by a CMS-approved DMEPOS accreditation organization (AO) in order to enroll in Medicare. The accreditation process, which typically centers around the AO’s on-site survey of the DMEPOS supplier, is designed to help confirm that the supplier is compliant with the DMEPOS quality standards. (These standards pertain to, for instance, the DMEPOS supplier’s administration, financial management, customer service, and DMEPOS product safety.) To become and remain a DMEPOS AO – of which there currently are eight -- an organization must comply with the requirements of § 424.58. These requirements include, but are not limited to, submission of: (i) an initial application to CMS to become a DMEPOS AO; (ii) an application to CMS for reapproval as a DMEPOS AO; and (iii) periodic information to CMS about its DMEPOS accreditation program. These AO applications and data submissions do not follow a specific format and are not furnished on uniform OMB-approved forms -- akin to, for example, the Form CMS-855S DMEPOS supplier enrollment application (Medicare Enrollment Application - Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Suppliers; OMB Control Number: 0938-1056).

There are presently about 46,500 accredited DMEPOS suppliers.

2. OMB Approval

On August 16, 2006, CMS published in the Federal Register a notice that solicited interested entities to submit initial applications to become a CMS-approved DMEPOS AO (71 Federal Register (FR) 47230). The data to be furnished with these applications were outlined in this notice and largely mirrored that listed in existing § 424.58(b). We estimated in that notice that 10 entities would submit an initial application and that it would take each organization 20 hours to do so, resulting in a projected burden of 200 hours (10 x 20 hours). (No associated cost burden was prepared, though.) OMB approved this burden under OMB Control Number 0938-1005, pursuant to a CMS request for emergency OMB review of this information collection published in the Federal Register as CMS-10206 on August 4, 2006 (71 FR 44300). However, because this initial application process had been completed, OMB Control Number 0938-1005 and its associated burden were discontinued in 2007 at CMS’ request.

3. Calendar Year (CY) 2026 Home Health Proposed Rule

a. DMEPOS Accreditation Provisions

CMS on July 2, 2025, published in the Federal Register a proposed rule titled, “Medicare and Medicaid Programs; Calendar Year 2026 Home Health Prospective Payment System (HH PPS) Rate Update; Requirements for the HH Quality Reporting Program and the HH Value-Based Purchasing Expanded Model; Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program Updates; DMEPOS Accreditation Requirements; and Other Medicare and Medicaid Policies” (90 FR 29108) (CMS-1828-P). Among the proposals in this proposed rule were additional requirements that organizations must meet to become or remain a DMEPOS AO. These provisions would: (1) facilitate greater CMS oversight of the DMEPOS accreditation program in general and DMEPOS AOs in particular; and (2) help better ensure that DMEPOS AOs are adequately performing their accreditation and quality standard verification activities. These requirements would be included in revised § 424.58. As discussed in more detail in Section 12 of this Supporting Statement, the proposed requirements most pertinent to this ICR involve the AO’s submission – beyond the data that AOs must currently furnish under § 424.58 -- of additional information:

• As part of its initial application to become a DMEPOS AO

• As part of its application to request CMS re-approval of its status as a DMEPOS AO

• That reports its ongoing activities as a DMEPOS AO.

b. Provider Enrollment

Providers and suppliers must enroll in Medicare in order to receive Medicare payments. Part of this process involves the provider/supplier’s submission to its assigned Medicare Administrative Contractor (MAC) the applicable Form CMS-855 enrollment application containing information about the provider/supplier (e.g., identifying data, practice location(s), ownership, etc.) The provider enrollment process involves the MAC carefully screening the provider/supplier and its enrollment application to ensure the provider/supplier meets all Medicare program requirements and does not pose risks of fraud, waste, and abuse.

We also proposed in CMS-1828-P to make several revisions to our provider enrollment regulations in 42 CFR Part 424, Subpart P. One such proposal was that in new CMS, § 424.510(d)(2)(iii)(C) could require a provider/supplier to submit any documentation (that is, documentation beyond that currently required under § 424.510(d)(1)) to verify and confirm the information furnished on the enrollment application; this includes, but is not limited to, documentation regarding the provider’s or supplier’s ownership or management. The burden of this proposal is addressed in Section (B)(12)(b) of this Supporting Statement.

This PRA ICR seeks OMB approval for the aforementioned additional data collections, all of which we are finalizing in CMS-1828-F.

B. JUSTIFICATION

1. Need and Legal Basis

As already noted, the purpose of this ICR is to secure final OMB approval of our collection of the additional information referenced in CMS-1828-F. This data is needed: (1) so CMS can more closely scrutinize the qualifications, activities, and performances of DMEPOS AOs; and (2) to help verify certain data on the Form CMS-855. The most relevant statutes and regulations are as follows:

• Title XVII of the Act ensures that the data collected allows CMS to make correct payments to providers and suppliers in the Medicare program, including DMEPOS suppliers.

• Sections 1814(a), 1815(a), and 1833(e) of the Act require the submission of information necessary to determine the amounts due to a provider or other person.

• Under section 1834(a)(20) of the Act:

• Section 1834(a)(20)(A) requires DMEPOS suppliers to comply with the DMEPOS quality standards in order to bill Medicare.

• Section 1834(a)(20)(B) requires the Secretary to designate and approve one or more independent accreditation organizations for the purpose of confirming DMEPOS suppliers’ adherence to the DMEPOS quality standards.

• Section 1834(a)(20)(G)(i) allows certain Medicare supplier types to be exempt from the accreditation requirement.

• Section 1834(j) of the Act states that no payment may be made for items furnished by a DMEPOS supplier unless that supplier obtains, and renews at such intervals as we may require, a billing number. In order to issue a billing number, we need to collect information unique to that supplier.

• Section 1866(j) of the Act furnishes specific authority regarding the enrollment process for providers and suppliers.

• 42 CFR § 424.57 requires DMEPOS suppliers comply with 30 specific standards in order to receive and maintain Medicare billing privileges.

• 42 CFR § 424.58 requires DMEPOS suppliers to become accredited by a CMS-approved DMEPOS AO in order to enroll for the Medicare program.

• 5 U.S.C. 522(b)(4) requires privileged or confidential commercial or financial information be protected from public disclosure.

2. Information Users

CMS would use this additional data to:

• Help assess the credentials of prospective DMEPOS AOs, the performances of current ones, and the progress and success of the DMEPOS accreditation program in: (i) confirming DMEPOS suppliers’ compliance with the quality standards; and (ii) helping to ensure beneficiary health and safety; and (iii) preventing improper Medicare payments to non-compliant, unqualified, and fraudulent DMEPOS suppliers.

• Verify certain information on the Form CMS-855, most typically ownership data via the provider/supplier’s submission of documentation.

3. Improved Information Techniques

This collection lends itself to electronic collection methods in that DMEPOS AOs can submit certain data via e-mail.

4. Duplication and Similar Information

The additional data is new and not duplicated in any other CMS requirement.

5. Small Business

a. DMEPOS Suppliers

There are only eight existing DMEPOS AOs, and we project in CMS-1828-F that only two additional entities would apply for initial approval as a DMEPOS AO in the first 3 years of our provisions. As these would be the only entities affected by the data requirements addressed in this ICR, this collection will not have an impact on a substantial number of small businesses.

b. Provider Enrollment

We estimate in CMS-1828-F that approximately 5,000 providers/suppliers each year would be required to submit the additional documentation. Given that this is a very small percentage of the well over 2 million Medicare-enrolled providers and suppliers, new § 424.510(d)(2)(iii)(C) will not have an impact on a substantial number of small businesses.

6. Less Frequent Collections

As noted, there are several instances in which the aforementioned additional information would be requested:

1. Initial DMEPOS AO Application – Submitted only once.

2. Application for Reapproval as a DMEPOS AO – Submitted once every few years. (The timeframe would depend on the length of the AO’s CMS-assigned timeframe for initial approval or reapproval. Approval periods have a maximum of 6 years, though they can be for much shorter periods.)

3. Other data would be submitted: (i) monthly, (ii) per CMS request, or (iii) as otherwise required in § 424.58.

4. In certain instances, the provider/supplier’s submission of supporting documentation.

It is essential to collect this information for the reasons stated in Sections (B)(1) and (2) of this Supporting Statement. Due to the importance of maintaining stricter CMS oversight of the DMEPOS accreditation program and confirming the accuracy of certain enrollment information, the data in Section (B)(6)(a) through (d) cannot be collected less frequently.

7. Special Circumstances

There are no special circumstances associated with this collection.

8. Federal Register Notice/Outside Consultation

The 60-day notice published as part of the proposed rule that published in the Federal Register on August 28, 2025 (90 FR 41940). No comments were received.

The final rule published on December 2, 2025 (90 FR 55342).

No outside consultation was sought.

9. Payment/Gift to Respondents

No payments and/or gifts will be provided to respondents.

10. Confidentiality

CMS will comply with all Privacy Act, Freedom of Information laws and regulations that apply to this collection. Privileged or confidential commercial or financial information is protected from public disclosure by Federal law 5 U.S.C. 522(b)(4) and Executive Order 12600.

11. Sensitive Questions

There are no sensitive questions associated with this collection.

12. Burden Estimate (hours)

a. DMEPOS Accreditation

This Section (B)12 outlines the estimated hour and cost burdens associated with CMS’ additional DMEPOS AO data submission requirements in CMS-1828-F. These burdens reflect the projections made in the Collection of Information (COI) section of CMS-1828-P and CMS-1828-F. (We are finalizing without change the DMEPOS AO estimates we proposed.) As a baseline for calculating the cost burden, we will use the following median wage categories from the U.S. Bureau of Labor Statistics’ (BLS) May 2024 National Occupational Employment and Wage Estimates for all salary estimates (https://data.bls.gov/oes/#/industry/000000).

TABLE 1: NATIONAL OCCUPATIONAL EMPLOYMENT AND WAGE ESTIMATES

Occupation Title	Occupation Code	Median Hourly Wage ($/hr)	Fringe Benefits and Overhead ($/hr)	Adjusted Hourly Wage ($/hr)
Registered Nurses	29-1141	45.00	45.00	90.00
Medical and Health Services Managers	11-9111	56.71	56.71	113.42
Chief Executives	11-1011	99.24	99.24	198.48
Accountants and Auditors	13-2011	39.27	39.27	78.54

We reiterate that the data outlined in this Supporting Statement is additional information we would require beyond the data that DMEPOS AOs must currently submit under § 424.58.

i. Additional Data with AO’s Application for Initial Approval or Reapproval

Current § 424.58(b) (which will become new paragraphs (c) and (d) under CMS-1828-F) outlines information that organizations must submit when applying or reapplying to become a DMEPOS AO. We are finalizing in CMS-1828-F additional data that must be provided in these situations. These data elements are outlined in Table 2, which also lists our estimated hour burden of compiling, preparing, drafting, and submitting this information.

TABLE 2: NEW DATA SUBMISSION ELEMENTS FOR DMEPOS AO INITIAL APPLICATIONS AND REAPPROVAL APPLICATIONS

Data Element	Estimated Hour Burden Per Submission
Description of the AO’s survey process and other accreditation procedures	4
How the AO determines whether to perform a survey of a DMEPOS supplier (including sampling methodology)	2
AO’s policies/procedures for avoiding conflicts of interest (including consulting firewall policies)	2
AO’s policies/procedures for ensuring an adequate number of surveyors	2
AO’s process for identifying/addressing DMEPOS supplier deficiencies within its accreditation program	3
How the AO uses data to ensure compliance with Medicare program requirements	3
Outline of steps the AO would take in reviewing complaints against a DMEPOS supplier and determining compliance	3
Information demonstrating the AO’s DMEPOS knowledge/expertise/experience	2
Information on the AO’s ability to conduct timely application reviews	2
Description of the AO’s decision-making process (including approving/denying/terminating a DMEPOS supplier’s accreditation and the reasons for denial or termination)	4
AO’s policies/procedures for determining whether/when a survey of the DMEPOS supplier is performed and ensuring unannounced surveys	2
AO’s policies/procedures for determining when a corrective action should be applied to a DMEPOS supplier	4
Explanation of what the AO deems and defines as a DMEPOS supplier deficiency and levels thereof	2
AO’s processes for detecting/reporting fraud, waste, and abuse	3
AO’s submission of a signed statement agreeing to certain conditions and terms	6
AO’s submission of additional application information if requested by CMS	8
Total Hour Burden Per Application Submission	52

We believe that:

• Clinicians (such as nurses) and AO “Medical and Health Services Managers” will be most likely to prepare and submit the application.

• The AO’s chief executive officer (CEO) or someone with equivalent authority within the AO will sign the above-referenced statement agreeing to various terms and conditions

We previously mentioned that there are presently eight (8) CMS-approved DMEPOS AOs. For purposes of this ICR estimate only, we will assume that all 8 will apply for reapproval sometime within the next 3-year timeframe (which is the standard OMB approval period) and that two (2) organizations will initially apply for AO approval. This results in a total hour burden for this period of 520 hours (52 hours x 10 organizations). Of these 520 hours, 10 hours (or 1 hour for each of the 10 AOs) will involve the CEO’s review and signature of the statement, resulting in a cost of $1,985 (10 x $198.48).

As for the remaining 510 hours, we believe that nurses and the aforementioned managers will be equally involved in preparing the application. We will hence use a midpoint wage estimate of $101.71 (($90.00 + $113.42)/2). This results in a 3-year cost of $53,857 (($101.71 x 510 hours) + $1,985), with an annual burden of 173 hours and $17,952.

Except as otherwise noted, we will use the $101.71 wage figure for the remainder of our DMEPOS accreditation ICR estimates.

ii. Monthly Submission of Data

Existing § 424.58(c)(1) requires DMEPOS AOs to submit certain data to CMS on a monthly basis (for example, notice of accreditation decisions). CMS-1828-F that each AO must also – as part of its monthly submission to CMS -- furnish notice of: (1) the instances where the AO had the discretion to perform a survey of the DMEPOS AO but decided not to (including the reason for the AO’s decision); and (2) all currently resolved deficiencies among its DMEPOS suppliers. While we cannot determine how many DMEPOS AOs there will be over the next 3 years, we will use – solely for purposes of this ICR – the current number of 8 AOs.

We estimate it will take a DMEPOS AO a total of 6 hours each month to compile and submit the data in (1) and (2) in the previous paragraph. (That is, about 3 hours for each task.) This results in an ICR burden over 3 years of 1,728 hours (6 hours x 8 AOs x 12 months x 3 years) at a cost of $175,755 (1,728 hours x $101.71), with the annual burden being 576 hours and $58,585.

iii. CMS Ad-Hoc Data Requests

CMS-1828-F states that CMS may at any time request the DMEPOS AO to submit any of the information that § 424.58 requires to be furnished on a monthly basis. (In other words, CMS can request this information outside of the monthly reports the DMEPOS AO must submit.) We cannot predict the number of instances where CMS will request this data or the specific information that will be solicited. Strictly for purposes of this ICR, however, we estimate that we will request this data from each AO three times per year and that it will take the AO 3 hours to accumulate the data for each request. This results in a 3-year burden of 216 hours (3 hours x 3 requests x 8 AOs x 3 years) and $21,969 (216 x $101.71). The annual burden is 72 hours and $7,323.

iv. Notice to CMS of Changes to the AO’s Accreditation Standards, Requirements, or Survey Process

Among the monthly data a DMEPOS AO must submit under current § 424.58(c)(1)(v) is notice of any changes to the AO’s accreditation standards, requirements, or survey process. We are removing this provision in CMS-1828-F from the monthly reporting requirement and instead requiring the AO to: (1) report such changes to us 60 days before the planned effective date; and (2) submit detailed information about the changes, the rationale for them, and an accompanying crosswalk. We do not expect the 60-day requirement to impose an additional burden since the changes will still be reported to us, but we believe the additional information in (2) that must be furnished will present a burden.

Per our experience, each DMEPOS AO on average undertakes and reports these program revisions to us about twice per year. We estimate that the additional details that must be submitted will take 2 hours for the AO to compile. The resulting 3-year burden will thus be 96 hours (2 per year x 2 hours x 8 AOs x 3 years) and $9,764 (96 x $101.71), with the annual burden being 32 hours and $3,255.

v. Submission of Complaint Data

AOs under existing § 424.58(c)(1)(v) must report to CMS each month all complaints related to DMEPOS suppliers. In CMS-1828-F we are removing this requirement from § 424.58(c)(1)(v) and establishing a new paragraph (e)(3) devoted exclusively to complaints. There are two new ICR-related provisions therein:

• Upon receipt of a complaint, the AO must notify CMS in writing of the complaint within 5 calendar days of receiving it.

• Notify CMS in writing of the result of its review of the complaint, the result of the survey, or of any action the AO took against the supplier.

The more frequent reporting of complaints to CMS -- as well as notice of the results of the AO’s investigation – constitutes an additional ICR burden. Given the number of complaints currently reported to us on a monthly basis, we estimate that each AO will annually report approximately 50 complaints to us and, in turn, submit 50 investigation reports to us. We project that the former will take 1 hour to complete and submit and the latter 3 hours, for an average of 2 hours. This results in a 3-year burden of 4,800 hours ((50 complaint reports + 50 investigation reports)) x 2 hours x 8 AOs x 3 years) at a cost of $488,208 (4,800 x $101.71), with the annual burden being 1,600 hours and $162,736.

vi. Corrective Action Plans (CAPs)

CMS-1828-F will require AOs to notify CMS in writing of any decision to apply a CAP to a specific supplier within 10 calendar days of the decision. The notice must include: (1) the reason for the decision; (2) a detailed explanation and justification as to why the AO applied a CAP instead of revoking the supplier’s accreditation; and (3) the details of the supplier’s CAP. We believe that each AO will submit approximately 75 such notices to CMS per year and that each notice will take 2 hours to complete. The 3-year burden will therefore be 3,600 hours (75 submissions x 2 hours x 8 AOs x 3 years) and $366,156 (3,600 x $101.71). The annual burden will be 1,200 hours and $122,052.

vii. Denials and Terminations of DMEPOS Supplier’s Accreditation

CMS-1828-F requires the AO to notify CMS in writing of any decision to deny accreditation to (or terminate the accreditation of) a DMEPOS supplier within 5 calendar days of the decision; the notification must include the reason for the denial or termination. While AOs are currently required under § 424.58 to report DMEPOS supplier terminations to CMS on a monthly basis, CMS-1828-F will increase the frequency with which this information must be provided. We project that each AO will submit approximately 100 such reports to CMS each year. Each report will take 2 hours to prepare and submit. This results in a 3-year burden of 4,800 hours (100 reports x 8 AOs x 3 years x 2 hours) and $488,208 (4,800 x $101.71) and an annual burden of 1,600 hours and $162,736.

CMS-1828-F also states that an AO must: (1) deny or terminate a DMEPOS supplier’s accreditation if directed by CMS; and (2) notify CMS in writing that it has taken the directed action. We estimate that each year an AO will submit roughly 20 such notices to CMS and that it will take 0.5 hours for the AO to do so each time. The total 3-year burden will thus be 240 hours (20 reports x .0.5 x 8 AOs x 3 years) and $24,410 (240 hours x $101.71). The annual burden will be 80 hours and $8,137.

viii. Voluntary Termination of AO Approval

CMS-1828-F outlines procedures via which an AO can voluntarily withdraw from the DMEPOS accreditation program. Part of this process will involve: (1) notifying CMS in writing of its decision; and (2) provide written notice to each of its accredited DMEPOS suppliers. For purposes of this ICR only, we estimate that 1 DMEPOS AO over a 3-year period will voluntarily terminate its accreditation and that the tasks in (1) and (2) will take the AO 6 hours combined to complete at a cost of $610 (1 x 6 hours x $101.71). The annual burden will be 2 hours and $203.

ix. Involuntary Terminations

CMS states that an involuntarily terminated AO must provide written notice of the termination to each of its accredited DMEPOS suppliers. As with voluntary terminations, we estimate that 1 DMEPOS AO over a 3-year period will have its CMS approval terminated. We estimate it will take the AO 6 hours to notify its DMEPOS suppliers of the termination via a list-serv message. This will result in a 3-year burden of 6 hours at a cost of $610. The annual burden will be 2 hours and $203.

x. Acknowledgement of Suspension and Lifting Thereof

CMS-1828-F will require that if CMS notifies the AO that its DMEPOS accreditation program has been suspended, the AO must send CMS a written acknowledgment of CMS’ notice. Likewise, the AO must notify CMS in writing of its acknowledgment of a CMS notification that the suspension has been lifted. We project that 1 AO over a 3-year period will be suspended and that each of the two acknowledgments will take 1 hour to complete and submit. The 3-year burden will hence be 2 hours (1 hour x 2 acknowledgments) at a cost of $203. The annual burden will be 0.667 hours and $68.

xi. Conflicts of Interest and Consulting

New § 424.58(m) and (n) in CMS-1828-F establish requirements regarding AO consulting services and conflicts of interest. There are two principal ICR aspects of these requirements:

● The AO’s submission of a report upon CMS request regarding any consulting activities it has engaged or is engaging in.

• Submission to CMS -- upon a CMS request -- of the AO’s written consulting firewall polices.

We project that the first report will take an AO 2 hours to complete and submit and that CMS would request it twice per year. This results in a 3-year burden of 96 hours (2 reports per year x 2 hours x 8 AOs x 3 years) and $9,764 (96 x $101.71), or 32 hours and $3,255 annually. Regarding the firewall policies and procedures, we estimate that it would take the AO 2 hours to prepare and submit these policies and that CMS would request them once a year. The 3-year burden of this activity would be 48 hours (2 hours x 1 request per year x 8 AOs x 3 years) and $4,882, or 16 hours and $1,627 per year. The combined annual ICR burden of the requirements of paragraph (m) are 48 hours (32 + 16) and $4,882 ($3,255 + $1,627).

xii. AO Changes of Ownership

CMS-1828-F outlines procedures for which a DMEPOS AO can undergo a change of ownership. Said procedures will be those outlined in 42 CFR § 488.5(f). The latter section contains several actions that we believe will have ICR implications for an AO changing its ownership. Table 3 lists these actions and the estimated time burden of completing each of them:

TABLE 3 – NEW DATA SUBMISSION ELEMENTS IN PROPOSED § 424.58(o)

Regulatory Citation in § 488.5(f)	Action	Estimated Hour Burden Per Action
(f)(1)	DMEPOS AO contemplating or negotiating a change of ownership must notify CMS in writing.	2
(f)(2)(iii)	Prospective AO buyer must submit detailed data in its request for approval of transfer of AO’s current approval to the buyer (that is, identifying information, financial statements, transition plan, policies to avoid conflicts of interest)	135
(f)(3) and (4)(ii)	Prospective AO buyer’s submission of written acknowledgments to CMS.	2
(f)(4)(i) *	All parties to the transaction must notify all affected DMEPOS suppliers of any CMS approval of the transfer.	12
(f)(5)	Prospective AO buyer notifies CMS in writing that the change of ownership has occurred.	1
TOTAL		152

* Takes into account the aforementioned 6-hour supplier notification burden for voluntary and involuntary terminations.

As explained in CMS-1828-F, we believe that persons falling into the “Accountants and Auditors” BLS category in Table 1 above will assist nurses and medical health/services managers in preparing these AO change of ownership documents. We previously mentioned the wages for the nurse and medical health and services manager BLS category, $90.00 and $113.42. For accountants and auditors, the median wage with fringe benefits and overhead is $78.54. The average of these three figures is $93.99.

We will assume for purposes of this ICR that 1 DMEPOS AO over a 3-year period will undergo a change of ownership. Using our total hour burden from Table 3, this results in a 3-year burden of 152 hours and $14,286. The annual burden will be 51 hours and $4,762.

xiii. DMEPOS Supplier Change in Majority Ownership

We also stated in CMS-1828-F that a DMEPOS supplier that undergoes a change in majority ownership and that does not qualify for an exception must, among other things, enroll in Medicare as an initial DMEPOS supplier via the Form CMS-855S (Medicare Enrollment Application: Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Suppliers; OMB Control No. 0938-1056). This will require completion of an initial Form CMS-855S enrollment application. We address this burden as part of a separate PRA/ICR request (published in the Federal Register on August 18, 2025 (90 FR40073)) exclusively to the Form CMS-855S.

xiv. Totals

Table 4 outlines the annual ICR burdens associated with the DMEPOS accreditation provisions addressed in this Supporting Statement:

​ TABLE 4: ANNUAL ICR BURDEN ESTIMATES FOR DMEPOS AO REQUIREMENTS

	OMB Control No.	Number of Respondents	Number of Responses	Burden per Response (hours)	Total Annual Burden (hours)	Hourly Labor Cost of Reporting ($) (includes 100% fringe benefits)	Total Cost ($)
Submission of Additional Initial Application and Reapplication Data	0938-New	4	4	Varies	173	Varies	17,952
Submission of Additional Monthly Data	0938-New	8	96	6	576	101.71	58,585
Ad-Hoc CMS Data Requests	0938-New	8	24	3	72	101.71	7,323
Notice of Changes in AO’s Standards/Requirements	0938-New	8	16	2	32	101.71	3,255
Complaint Reports	0938-New	8	800	2 (average)	1,600	101.71	162,736
CAPs	0938-New	8	600	2	1,200	101.71	122,052
Denials/Terminations of Supplier’s Accreditation Reports to CMS	0938-New	8	800	2	1,600	101.71	162,736
Notice to CMS that AO Denied/Terminated Supplier’s Accreditation Per CMS Direction	0938-New	8	160	0.5	80	101.71	8,137
Voluntary Terminations – Notice to CMS and Suppliers	0938-New	0.333	0.333	6	2	101.71	203
Involuntary Termination – Notice to Suppliers	0938-New	0.333	0.333	6	2	101.71	203
Acknowledgment of Suspension and Lifting Thereof	0938-New	0.333	0.333	1	0.667	101.71	68
Fee-Based Consulting Data	0938-New	8	24	Varies	48	101.71	4,882
AO Changes of Ownership	0938-New	0.333	0.333	Varies	51	93.99	4,762
TOTALS (Rounded to Nearest Whole Dollar)	N/A	69	2,525	Varies	5,437	Varies	552,894

b. Provider Enrollment

In terms of cost, it has been our experience that Form CMS-855 applications are completed by the provider’s or supplier’s office staff. Accordingly, we will use the following wage category and hourly rate from the U.S. Bureau of Labor Statistics’ (BLS) May 2024 National Occupational Employment and Wage Estimates for all salary estimates (https://data.bls.gov/oes/#/industry/000000).

TABLE 5: NATIONAL OCCUPATIONAL EMPLOYMENT AND WAGE ESTIMATES – PROVIDER ENROLLMENT

Occupation Title	Occupation Code	Median Hourly Wage ($/hr)	Fringe Benefits and Overhead ($/hr)	Adjusted Hourly Wage ($/hr)
Office and Administrative Support Workers, All Other	43-9199	22.14	22.14	44.28

We stated in CMS-1828-P and CMS-1828-F that: (1) most of the requested documentation will be that which helps validate the provider’s or supplier’s ownership and management; (2) 5,000 providers and suppliers per year will have to secure and submit it; and (3) it would take the provider or supplier 15 minutes (0.25 hr) to do so. This results in an annual burden of 1,250 hours and $55,350 ($44.28 x 5,000 x 0.25).

c. Total

Table 6 outlines the total annual ICR burden of the aforementioned regulatory revisions:

TABLE 6: ANNUAL ICR BURDEN FOR CMS-1828-F REGULATORY PROVISIONS ADDRESSED IN THIS ICR PACKAGE ESTIMATES FOR

	OMB Control No.	Number of Respondents	Number of Responses	Burden per Response (hours)	Total Annual Burden (hours)	Hourly Labor Cost of Reporting ($) (includes 100% fringe benefits)	Total Cost ($)
DMEPOS Accreditation	0938-New	69	2,525	Varies	5,437	Varies	552,894
Provider Enrollment – Additional Documentation	0938-New	5,000	5,000	0.25	1,250	44.28	55,350
TOTAL	N/A	5,069	7,525	Varies	6,687	Varies	608,244

13. Cost to Respondents (Capital)

There are no capital costs associated with this collection.

14. Cost to Federal Government

We believe that the only costs to the federal government or its contractors would involve: (1) the PRA process (e.g., preparing the PRA package); (2) performing outreach as needed; and (3) reviewing the additional data that AOs would have to submit per CMS-1828-F. CMS employees would perform these tasks. The hourly wage of said employee is at a GS-13, Step 5 level (Washington/Baltimore/Arlington locality), or $65.48. (See https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/2025/general-schedule.) Over a 3-year period, we estimate that the first two tasks would take 150 hours total (mostly due to outreach) and the third would take 200 hours. This results in a total 3-year cost of $22,901 ((150 + 200) x $65.48), or 117 hours and $7,634 per year.

15. Changes in Burden/Program Changes

The ICR burdens described in this Supporting Statement are new and do not represent changes to current burden. As shown in the last row of Table 6 above, our requested ICR burdens are:

Number of Respondents	Number of Responses	Total Annual Burden (hours)	Total Cost ($)
5,069	7,525	6,687	608,244

16. Publication/Tabulation

There are no plans to publish the outcome of the data collection.

17. Expiration Date

We are requesting an expiration date of January 1, 2029, or 3 years after the anticipated effective date of the changes addressed in this ICR package.