Supporting Statement – Part B for the Information Collection Requirements in

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Supporting Statement for Conditions of Coverage (CfC)
for Portable X-Ray Suppliers (CMS-R-43/OMB Control No. 0938-0338)


A.  Background

The purpose of this package is to request reinstatement without change of the information collections (ICs) for the Conditions of Coverage (CfCs) for Portable X-ray Suppliers that expired on September 30, 2025.

Portable X-ray services are basic radiology studies (predominately chest and extremity X-rays) that are performed on residents in Skilled Nursing Facilities (SNFs) or Long-term Care Facilities (LTCs) or those who are homebound and unable to travel to an outpatient radiology facility. Portable X-ray suppliers must comply with health and safety requirements under Title 42 Code of Regulations (CFR) Section 486, Subpart C in order to receive payment for services from the Medicare and Medicaid programs. The Centers for Medicare and Medicaid Services (CMS) use the ICs to ensure suppliers are in compliance. 

The previous iteration of this package was approved on September 29, 2022, with an estimated burden of 324 hours at a cost of $12,312 for 506 suppliers.1 For this reinstatement, CMS estimates the incremental annual burden is 340 hours with an annual cost of $14,960 for 540 portable X-ray suppliers. (See Table 5). The 4.9% increase in burden hours is due to the increase in suppliers (from 506 to 540). For a detailed explanation, see Section 15.

B.  Justification
1.  Need and Legal Basis

Sections 1861(s)(3) and (4) of the Social Security Act (the Act)(Title 42 of United States Code Section 1395x) set forth the statutory qualifications and requirements for X-ray services to be reimbursed by the Medicare and Medicaid programs. Per Sections 1102 and 1871 of the Act, portable X-ray suppliers must be certified and designated by the Secretary and must meet performance-related standards prescribed by the Secretary, which are set forth in the Conditions of Coverage (CfCs) in order to receive payment under Medicaid and Medicare. The CfCs are found at Title 42 Code of Federal Regulations (CFR) Part 486 (Conditions for Coverage of Specialized Services Furnished by suppliers), Subpart C (Conditions for Coverage: Portable X-Ray Services).2  


2.  Information Users

CMS uses the ICs to ensure portable X-ray suppliers comply with Medicare and Medicaid CfCs in order to protect patient health and safety. The ICs are collected by surveyors, who are employed by state agencies under agreement with Medicare. Surveyors conduct in-person on-site visits at the time of initial certification and re-certifications, which are done on a cyclical basis. Surveyors use the ICs as part of their survey and certify the suppliers who meet their certification requirements.3

3.  Improved Information Technology

CMS does not require the use of any specific technology or format so long as the required ICs are readily available for review by State surveyors at the time of the on-site survey. Suppliers may use any available information technology to collect and maintain the required ICs as long as the methods comply with applicable privacy rules, including the Health Insurance Portability and Accountability Act of 1996 (HIPAA). The use of electronic or other technological collection techniques is encouraged when such methods would reduce burden and are consistent with portable X-ray suppliers’ operations.

4.  Duplication of Information

There is no duplication of information collection. The ICs are designed to be sufficiently general, allowing suppliers flexibility in substance and format within their existing recordkeeping practices. If portable X-ray suppliers already maintain records that satisfy the ICs, regardless of format (electronic or paper), they are in compliance.

5.  Small Business

These ICs affect small businesses. However, CMS minimizes the impact on small businesses by allowing suppliers flexibility to record and store the ICs in ways that are consistent with their existing operations.

6.  Less Frequent Collection

CMS does not collect the ICs from portable X-ray suppliers. Instead, surveyors review the ICs during on-site visits to determine if a supplier meets the CfCs for Medicare certification. Less frequent information collection could limit CMS’s ability to ensure compliance with the Medicare CfCs, which could potentially compromise patient health and safety. 

7.  Special Circumstances

There are no special circumstances.

8.  Federal Register Notice/Outside Consultation

The 60-day Federal Register notice published on April 10, 2026 (91 FR 18462). There were no public comments received.

The 30-day Federal Register notice published on June 16, 2026 (91 FR 36144).

9.  Payments/Gifts to Respondents

No payments or gifts will be provided to respondents  as part of this information collection.

10.  Confidentiality

Any information collected will be used only for stated purposes and disclosed only as permitted by law. Protected Health Information (“PHI”) will be kept confidential as required by the Privacy Act of 1974 (5 USC §552a) and HIPAA (45 CFR §§160, 164). 

11.  Sensitive Question

There are no questions of a sensitive nature associated with this information collection.

12.  Burden Estimates (Hours & Wages)

Part 12-A: Assumptions
This section is broken out into the following four parts, Part 12-A, 12-B, 12-C, and Part 12-D. Part 12-A explains the general assumptions we use to estimate hourly burden and costs. Part 12-B explains the data collections in detail and describes the methodology used to estimate the annual hourly burden and cost. Part 12-C explains which ICs are exempt from the PRA and Part 12-D summarizes the burden hours and costs for the industry.

Number of Portable X-ray suppliers Impacted by ICs
Below are the global assumptions used to estimate the annual hourly burden and costs to portable X-ray suppliers. 

Suppliers Impacted
The burden for the ICs described in Part 12-B uses data for currently certified portable X-ray suppliers as reported by CMS’ Certification and the Survey Provider Enhanced Reporting (CASPER). As shown in Table 1, there was an average of 540 active suppliers for Calendar Years (CY) 2023 and 2025.4  For purposes of estimation, we assume a simple average projection methodology and assume the total number of X-ray suppliers will remain the same in the next three-year period (2026, 2027, and 2028).

Table 1. Number of Portable X-ray Suppliers Impacted5

Actual
3-year Avg.
Projected
# of X-ray suppliers
CY
2023 -2025
CY
2026
CY
2027
CY
2028
Currently Certified
540
540
540
540

Labor Wages
The burden cost for the ICs described in Part 12-B is based on hourly wage costs presented in Table 2 below. This salary data is derived from the U.S. Department of Labor, Bureau of Labor Statistics (BLS), May 2024 Cross-Industry Occupational Employment and Wage Estimates (OEWS).6

Table 2. Hourly Labor Wage Data7
Personnel
BLS Labor Title
BLS Labor Code

May 2024 Hourly Mean Wage


Wages w/Benefit



(a) 
(b = a x 2)
Office Assistant
Medical Secretaries and Administrative Assistants
43-6013
$21.91 
$44

To develop the estimates, CMS first identified typical positions employed within X-ray suppliers and then matched those positions with their equivalent labor titles as listed in the OEWS. For example, we assume an office assistant in a supplier’s main office who is responsible for organizing the records for services in different locations is staffed by a Medical Secretary/Administrative Assistant, which corresponds to the BLS Labor Code 43-6013 in OEWS. CMS then identified the hourly mean salary wage for each applicable labor category and applied a 100 percent markup to account for fringe and overhead costs. The resulting wage rates were rounded up to the nearest whole dollar.

Part 12-B: Burden Estimates
This section discusses the burden estimates for the ICs embedded into the CfCs for portable X-ray suppliers as codified in Title 42 CFR §§486.100 to 486.110.  

As we noted in prior information collection requests for portable X-ray suppliers, the majority of the activities required by the CfCs, such as inspecting equipment and keeping employee records, should be considered part of normal operations of any medical supplier. However, because these suppliers must comply with specific requirements under the CfCs to be certified by CMS as well as undergo ongoing compliance reviews, we include below estimates for the incremental annual burden for the ICs associated with the following two CfCs: IC-1: §486.104(c) - CfC: Qualifications, orientation and health of technical personnel; IC-2: §486.110 - CfC: Inspection of equipment. The burdens associated with all other CfCs are exempt from the PRA as detailed in Section 12-C.

For a summary of the total estimated burden and costs to the industry for both ICs, see Part 12-D and Table 5.

Conditions for Coverage: Portable X-Ray Services

IC-1: §486.104(c) -  Document Training and Qualifications in Employees Records
Per sections 486.104(a) and (b), portable X-ray services must be provided by staff who have specific training and experience and completed a detailed orientation. Section 486.104(c) requires suppliers to document and maintain evidence of their employees’ qualifications (including training and experience) and supervision. 

For purposes of estimating the incremental burden for this IC, we assume currently certified suppliers have an average of 6 employees (technical and non-technical staff) and that it would require an additional 5 minutes per employee per year, or 30 minutes (6 employees x 5 minutes) for an Administrative Assistant to collect and ensure that every employee’s record includes evidence of their qualifications and training per §486.104(a) and (b). Thus, for each supplier, the incremental annual burden would require a total of 0.5 hours (30 minutes) for an Administrative Assistant at an associated cost of $22 (0.5 hr. x $44) to maintain the specific information in employees’ records. For all 540 portable X-ray suppliers, the incremental annual burden is 270 hours (0.5 hour x 540 suppliers) with an associated cost of $11,880 ($22 x 540 suppliers or 270 hours x $44). See Table 3.

  Table 3. IC-1, §486.104(c) - Document Qualifications & Training in Employee Records
Burden to Document Qualifications and Training in Employee Records
Loaded
Hourly Mean
Wage
Incremental Annual
Burden
Hours
/supplier
Incremental Annual
Burden
Cost/
supplier

(a)
(b)
(c = a x b)
Administrative Assistant (BLS Occ Code: 43-6013)
$44
0.5
$22
Total Incremental Burden Hours and Cost for all 540 Portable X-Ray suppliers

270
$11,880





IC-2: §486.110 - Maintain Inspection Records
Per Section 486.110(a), each portable X-ray supplier must have their X-ray equipment and shielding inspected by a radiation specialist employed by a local or state government agency at least every two years. Section 486.110(b) requires suppliers to maintain “records of current inspections that include the extent to which equipment and shielding are in compliance with the safety standards outlined in §486.108.” For purposes of estimating the incremental burden for this IC, we assume currently certified suppliers must ensure inspections of their equipment and shielding are conducted at least every two years and that they keep detailed records of when the inspections occurred, the results of the inspection, and if required, that any corrective action needed to meet safety standards are taken. We assume these activities would take an additional 16 minutes every two years for an Administrative Assistant to document that all x-ray equipment and shielding had been inspected and met safety standards as required by this CfC. Thus, the incremental annual burden for each supplier is 0.13 hours (8 minutes over 2 years/2) for an Administrative Assistant at a loaded hourly wage of $44 to maintain the required inspection records. For all 540 portable X-ray suppliers, the incremental annual burden is 70 hours (0.13 hr. x 540 suppliers) with an associated cost of $3,080 (70 hrs. x $44). See Table 4.

Table 4. IC-2, §486.110 – Maintain inspection records
Burden to Maintain Inspection Records
Loaded
Hourly Mean
Wage
Incremental Annual
Burden
Hours/supplier
Incremental Annual
Burden
Cost/
supplier


(a)
(b)
(c = a x b)
Administrative Assistant (BLS Occ Code: 43-6013)
$44
0.13
(8 min./year)
$5.70
Total Burden Hours and Cost for all 540 Portable X-ray suppliers

70
$3,080


Part 12-C: Exemptions from Paperwork Burden
The ICs associated with the following CfCs are exempt from the Paperwork Reduction Act (PRA) because the requirement falls into one of these categories: 1) Usual and customary business practice per 5 CFR §1320.3(b)(2); 2) Impacts fewer than 10 suppliers per year 5 CFR §1320.3(c)(4) or; 3) Required by other federal, state or local laws per 5 CFR §1320.3(b)(3).

§486.100 - Compliance with Federal, State, and local laws and regulations 
    • Requirement: Suppliers must comply with Federal, State, and local laws relating to licensing and safety standards
    • Exemption: 5 CFR §1320.3(b)(3) – IC required by other laws
    • Rationale: Suppliers must meet local and state licensing standards to operate their business

§486.102 - Supervision by a qualified physician
    • Requirement: Services must be provided under physician supervision, with annual certification of equipment and personnel checks
    • Exemption: 5 CFR §1320.3(b)(2) – usual and customary business practice
    • Rationale: Ensuring staff are trained and equipment is safe and in working order prior to use is a standard business practice

§486.104(a) and (b) - Staff Qualifications and Orientation
    • Requirement: Staff must be trained and undergo orientation
    • Exemption: 5 CFR §1320.3(b)(2) - Usual and customary business practice
    • Rationale: Training staff is standard business practice (only the recordkeeping in §486.104(c) has PRA burden)

§486.106 - Referral for service and preservation of records
    • Requirement: X-ray suppliers must: (a) document that their services were provided based on an order of a treating licensed physician or nonphysician and why they ordered the x-ray per 42 CFR §410.32 and (b) maintain this detailed documentation (not just the x-ray) for a minimum of 2 years.8
    • Exemption: 5 CFR §1320.3(b)(2) – usual and customary business practice
    • Rationale: Maintaining records for services provided is standard business practice for healthcare suppliers

§486.108 - Safety standards
    • Requirement: X-ray suppliers must test and maintain records to prove their equipment meets safety standards.
    • Exemption: 5 CFR §1320.3(b)(2) – usual and customary business practice
    • Rationale: Testing and maintaining records to prove medical equipment complies with safety standards is standard practice






Part 12-D: Burden Summary
As shown in Table 5 below, we estimate that the total incremental annual burden hours to industry for IC-1 and IC-2 is 340 hours at an annual cost of $14,960.

Table 5. Total Incremental Annual Burden Hours and Costs for                                      all Portable X-ray suppliers
Information Collection No.
42 CFR Section
Respondents
Responses
Incremental
Annual
Burden Hours
Incremental
Annual
Burden Cost
IC-1: Document Qualifications & Training in Employee Records
§486.104(c)
540
540
270
$11,880
IC-2: Maintain Inspection Records
§486.110
540
540
70
$3,080
Burden Hours and Costs
for all Impacted Portable X-ray suppliers
n/a
540
1,080
340
$14,960


13.  Capital Costs

There are no capital costs associated with this information collection.

14.  Cost to Federal Government

The estimated burden and costs to the federal government for these ICs include the time spent by surveyors, employed by State Survey Agencies under contract with CMS, to complete in-person compliance evaluations. As discussed in Section 2 above, portable X-ray suppliers undergo compliance reviews at the time of initial application for Medicare approval and for ongoing compliance. Because X-ray suppliers are surveyed every 6 years, we estimate 90 suppliers per year (540 suppliers/6 years) undergo compliance reviews for purposes of estimating the burden to the federal government. 

The burden for completing these activities was calculated using a loaded hourly mean wage of $71 per hour for a surveyor (BLS, Occupation Title: “Survey Researcher,” BLS Occupation Code: 19-3022).9 For ongoing compliance reviews for suppliers, CMS estimates that it takes 0.5 hours (30 minutes) per IC, resulting in a cost of $36 per IC (0.5 hours x $71).

As shown in Table 6, the annual burden to the federal government for each applicable IC is calculated based on the number of facilities impacted by that IC. The total annual burden for the federal government to conduct the required compliance reviews for IC-1 and IC-2 is 90 hours, at a cost of $6,390.

Table 6. Total Burden and Cost Estimates for Federal Government
Information Collection No.
42 CFR Section
# of X-ray suppliers surveyed per year

Loaded
Hourly Mean
Wage10

Burden
Hrs./ Supplier


Total  Burden Hrs.

Total  Burden Costs



(a)
(b)
(c)
(d = a x c)
(e = b x d)
IC-1: Document Qualifications & Training in Employee Records
§486.104(c)
90
$71
0.5
45
$3,195 
IC-2: Maintain Inspection Records
§486.110
90
$71
0.5
45
$3,195 
Burden Hours and Costs for Federal Government
n/a
90
$71
1.0
90
$6,390 


15.  Changes to Burden

As shown in Table 5, the estimated annual burden hours to the industry increased from 324 to 340 hours, a 4.9% increase because the number of suppliers increased from 506 to 540. The annual cost increased from $12,312 to $14,960, a 21.5% increase due to the increased number of suppliers and higher hourly wage due to inflation (from $38 to $44).

16.  Publication/Tabulation Dates

There are no plans to publish the information collected.

17.  Expiration Date

CMS will publish a notice in the Federal Register to inform the public of both the approval and the expiration date of this information collection. The public may also view the expiration date by searching for the OMB control number on OMB’s website.

18.  Certification Statement

There are no exceptions to the certification statement requirements.