CMS-R-43 2013 Supporting Statement Part A PRA edits 4-23-13_compliant 50

Supporting Statement
Conditions for Coverage for
Portable X-ray Suppliers
(42 CFR 486 Subpart C)
CMS-R-43
0938-0338
A.

BACKGROUND
The information is required to certify portable X-ray suppliers wishing to participate in
the Medicare program. This is standard medical practice and is necessary in order to help
to ensure the well-being, safety and quality professional medical treatment accountability
for each patient.
The recordkeeping requirements for which we are seeking approval are contained in 42
CFR sections 486.104, 486.106 and 486.110.
The Recordkeeping Requirements
o

Section 486.104 - Condition for coverage: Qualifications, orientation and health
of technical personnel.
(c) Standard: Employee records. Records are maintained and include evidence
that -(1) Each employee is qualified for his or her position by means of training
and experience; and
(2) Employees receive adequate health supervision.

o

Section 486.106 - Condition for coverage: Referral for service and preservation
of records.
All portable X-ray services performed for Medicare beneficiaries are ordered by a
physician or a nonphysician practitioner as provided in § 410.32(a) of this chapter
or by a nonphysician practitioner as provided in § 410.32(a)(2) and records are
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properly preserved.
(a) Standard—referral by a physician or nonphysician practitioners. Portable Xray examinations are performed only on the order of a physician licensed to
practice in the State or by a nonphysician practitioner acting within the scope of
State law. Such nonphysician practitioners may be treated the same as physicians
treating beneficiaries for the purpose of this paragraph. The supplier's records
show that:
(1)

The portable X-ray test was ordered by a licensed physician or a
nonphysician practitioner acting within the State scope of law; and

(2)

Such physician or nonphysician practitioner's written, signed order
specifies the reason a portable X-ray test is required, the area of the body to be
exposed, the number of radiographs to be obtained, and the views needed; it
also includes a statement concerning the condition of the patient which
indicates why portable X-ray services are necessary.

(b) Standard—records of examinations performed. The supplier makes for each
patient a record of the date of the portable X-ray examination, the name of the
patient, a description of the procedures ordered and performed, the referring
physician or nonphysician practitioner, the operator(s) of the portable X-ray
equipment who performed the examination, the physician to whom the radiograph
was sent, and the date it was sent.
(c) Standard—preservation of records. Such reports are maintained for a period of
at least 2 years, or for the period of time required by State law for such records (as
distinguished from requirements as to the radiograph itself), whichever is longer.
o

Section 486.110 - Condition for coverage: Inspection of equipment.
(b) Standard—records of inspection and scope of inspection. The supplier
maintains records of current inspections which include the extent to which
equipment and shielding are in compliance with the safety standards outlined in
§486.108.

B.

JUSTIFICATION
1. Need and Legal Basis

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These requirements are among other requirements classified as (or known as) Conditions
of Participation or Conditions for Coverage. These conditions are based on a provision
specified in law relating to diagnostic X-ray tests "furnished in a place of residence used
as the patient's home," and are designed to ensure that each supplier has properly trained
staff to provide the appropriate type and level of care; as well as, a safe physical
environment for patients. CMS uses these conditions to certify suppliers of portable Xray services wishing to participate in the Medicare program. To examine these
requirements, please see 42 CFR sections 486.104, 486.106 and 486.110. These
requirements are required by 42 USC 1395m(c).
2. Information Users
The information users are the suppliers and the State surveying agencies. CMS and the
health care industry believe that the availability of the type of records that this regulation
specifies is standard medical practice and is necessary in order to ensure the well-being
and safety of patients and professional treatment accountability. CMS uses these
conditions for coverage to certify portable X-ray suppliers wishing to participate in the
Medicare program. If CMS did not require this information, we would not be able to
carry out the statutory mandate to certify only those suppliers that meet appropriate health
and safety requirements.
3. Improved Information Technology
This collection does not prescribe how suppliers should prepare or maintain these
records. Suppliers are free to take advantage of any technological advances that they find
appropriate for their needs.
4. Duplication
These are unique requirements that are specified in such a way as not to duplicate existing
supplier practice. If a supplier already maintains these general records, regardless of
format, it is in compliance with this requirement.
5. Small Business
These requirements affect small businesses. However, the general nature of the
requirements allows flexibility for suppliers to meet the requirement in a way consistent
with their existing operations.
6. Less Frequent Collection
N/A. These are recordkeeping requirements.

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7. Special Circumstances
There are no special circumstances for requiring this information.
8. Federal Register Notice and Outside Consultation
The 60-day Federal Register notice was published on XXX. There was no outside
consultation.
9. Payment/Gift to Respondent
There will be no payment/gift to respondent.
10. Confidentiality
There are no assurances of confidentiality.
11. Sensitive Questions
There are no sensitive questions.
12. Burden Estimates
These requirements are self-imposed by the suppliers in accordance with good medical
practice; however, it is possible that some burden would be eliminated or reduced in the
absence of a CMS requirement. Therefore, for burden estimate purposes, we counted the
portion of time we believe the suppliers expend on CMS requirements. The burden for
this request is based on 578 portable X-ray suppliers.
486.104(c) --

*employee records
.5
x 578
289

hour per supplier
X-ray suppliers
burden hours

486.106(a)-(c) --*referral for service and preservation of records
1
x 578
578

hour per supplier
X-ray suppliers
burden hours

.14
x 578

hour per supplier
X-ray suppliers

486.110(b) --*records of inspection

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burden hours

*These requirements deal only with keeping records that are already available. We
believe that this is a minimal burden imposed on portable X-ray suppliers with these
requirements. These requirements are comparable to industry standards and would be in
place even in the absence of a Federal requirement. This estimate is, therefore, based on
only the incremental burden for the portion of time we believe the suppliers expend on
CMS requirements.
Total burden for portable X-ray suppliers is computed as:
486.104 – 289.00 hours
486.106 – 578.00 hours
486.110 – 81 hours
948 total burden hours or (578 respondents * 1.64 total hours)
There are 948 total burden hours. The cost to collect this information is estimated at
$16.90 per hour based on the average salary for an office administrative services staff
person in 2012. The total cost estimate to the respondent is $16,021.20.
13. Cost Estimate to Respondent or Record keeper
There are no capital costs.
14. Cost to Federal Government
There is no cost to the Federal Government.
15. Program Changes
There are no program changes. The change to burden is due to a decrease in the number
of respondents from 726 to 578. The burden hour decreased from 1815 to 948.
16. Publication and Tabulation Dates
There are no publication and tabulation dates.
17. Expiration Date
This does not lend itself to the displaying of an expiration date.

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