CMS-10282 SuppStmt 7-12-13 PRA

Supporting Statement for the Paperwork Reduction Act Submission,
Medicare and Medicaid Programs: Conditions of Participation
for Comprehensive Outpatient Rehabilitation Facilities (CORFs) and
supporting regulations in 42 CFR Part 485
(CMS-10282, OMB 0938-1091)
A.

BACKGROUND

The purpose of this package is to request Office of Management and Budget (OMB)
approval of the collection of information requirements for the conditions of participation
(CoPs) that comprehensive outpatient rehabilitation facilities (CORFS) must meet to
participate in the Medicare Program. This document represents the inclusion of all
current CORF CoPs currently effective and applicable eligibility and survey report forms.
This package reflects the paperwork burden for a total of 274 facilities as of May 1, 2013.
The CoPs are based on criteria described in the law and are standards designed to ensure
that each CORF has a properly trained staff to provide the appropriate type and level of
care for that environment of patients. CMS needs the CoPs to certify health care facilities
wishing to participate in the Medicare and/or Medicaid programs.
To determine compliance with the CoPs, the Secretary has authorized States, through
contracts, to conduct surveys of health care providers. For Medicare purposes,
certification is based on the State survey agency’s recording of a provider or supplier’s
compliance or noncompliance with the health and safety requirements published in
regulations.
The currently approved information collection located at OMB Control Number 09380267 is being combined with this collection because the information will be more easily
tracked as one package in the future. OMB 0938-0267 covers the forms CMS-359 and 360. The certification form (CMS-359) is the form used in the initial stages of the
process to allow a provider to participate in the Medicare program. It establishes
necessary identification data for the provider for interaction with ASPEN and screens for
provider capacity to meet specifications which must be met before a provider can be
considered to participate in the Medicare program as a CORF. In order for the State
survey agency to report to CMS its generic findings on provider compliance with the
individual standards on which CMS determines certification, the agency completes the
CORF Survey Report Form (CMS-360). This form is a listing of the regulatory
conditions required for participation in the Medicare program. The surveyor reports on
each condition by checking a box alongside the condition or standard indicating whether
or not the State found that provider met the requirement.
B.

JUSTIFICATION

1.

Need and Legal Basis
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The regulations containing these information collection requirements are located at
42 CFR 485. These regulatory requirements implement section 1861(cc) of the Social
Security Act (the Act). CORFs receiving payment under Medicaid must meet the
Medicare CoPs. Section 1861(cc) of the Act authorizes promulgation of regulations in the
interest of the health and safety of individuals who are furnished services by a CORF.
The secretary may impose additional requirements if they are necessary for the health and
safety of individuals who are furnished services by CORFs.
All 274 CORFs must meet the CoPs in order to receive program payment for services
provided to Medicare or Medicaid patients. Currently, 274 are in compliance. We
believe many of the requirements applied to these CORFs will impose no burden since a
prudent rehabilitation facility would self-impose them in the normal course of doing
business. Regardless, we have attempted to estimate the associated burden for a CORF to
engage in these standard industry practices.
2.

Information Users

The CoPs and accompanying requirements specified in the regulations are used by our
surveyors as a basis for determining whether a CORF qualifies to be awarded a Medicare
provider agreement. CMS believes the health care industry practice demonstrates that the
patient clinical records and general content of records, which is referenced in these
regulations are necessary to ensure the well-being and safety of patients and professional
treatment accountability and are normal part of industry practice.
The request for certification and the survey form are used by CMS in making certification
decisions. When a provider initially expresses an interest in participating in the Medicare
program as a CORF, contact is made with the State agency that forwards the Request for
Certification (CMS-359) to the provider. The information on the completed form serves
as a screen for the State agency to determine whether the provider has the basic
capabilities to participate in the Medicare program and whether a provider survey is
appropriate. The basic identifying information from this form and individual compliance
codes from the survey form are coded into ASPEN and serve as the information base for
the creation of a record for future Federal certification for monitoring activity.
3.

Improved Information Technology

CORFs may use various information technologies to store and manage patient clinical
records as long as they are consistent with existing confidentiality in record-keeping
regulations at 485.60. This regulation in no way prescribes how the facility should
prepare or maintain these records. Facilities are free to take advantage of any
technological advances that they find appropriate for their needs.
The survey report form (CMS-360) serves primarily as a coding worksheet for inputting
minimal compliance information into the ASPEN. The standardized format and simple
check box method provide for consistent reporting by State survey agencies and easy

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automation of basic findings. Recording this information would be no easier for State
surveyors using direct access equipment. State reporting in this format avoids the need
for multiple systems and adaptation of numerous data files to CMS specifications.
4.

Duplication of Similar Information

These requirements are specified in a way that does not require a CORF to duplicate its
efforts. If a facility already maintains these general records, regardless of format they are
in compliance with this requirement. The general nature of these requirements makes
variations in the substance and format of these records from one facility to another
acceptable.
The survey and certification forms do not duplicate any information collection. The form
addresses specifically the unique regulatory conditions of participation directed to
CORFs for participating in the Medicare program. State survey agencies conduct these
reviews with Federal funds under contract with CMS. This form is a basic deliverable
under the contracts and is the only one of its kind collected by CMS for CORFs.
5.

Small Business

These requirements do affect small businesses. However, the general nature of the
requirements allows the flexibility for facilities to meet the requirements in a way
consistent with their existing operations.
6.

Less Frequent Collection

CMS does not collect this information, or require its collection, on a routine basis. Nor
does the rule prescribe the manner, timing, or frequency of the records or information
required to be available. CORF records are reviewed at the time of a survey for initial or
continued participation in the Medicare program. Less frequent information collection
would impede efforts to establish compliance with the Medicare CoPs.
State submission of provider survey forms depends on the frequency of provider surveys.
These submissions, in turn, depend on the frequency of surveys specified in regulations
and the availability of survey funds. It is a basic contract requirement that State
surveyors transmit their compliance findings for each survey they conduct.
7.

Special Circumstances

These requirements comply with all general information collection guidelines in 5 CFR
13320.6. Absent a legislative amendment, we are unable to anticipate any circumstances
that would change the requirements of this package.
8.

Federal Register Notice/Outside Consultation

The 60-day Federal Register notice was published on July 26, 2013.

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9.

Payment/Gift to Respondent

There are no payments or gifts associated with this collection.
10.

Confidentiality

Data collected will be kept confidential to the extent provided by law. Documents related
to the collection, use, or disclosure of individually identifiable or protected health
information pursuant to implementing these conditions of participation are subject to the
protections and standards of the Privacy Act of 1974 and the Health Insurance Portability
and Accountability Act (HIPAA) Privacy Rule.
11.

Sensitive Questions

There are no questions of a sensitive nature associated with this information collection.
12.

Burden Estimates

Salary data is based on the U.S. Department of Labor Bureau of Labor Statistics (BLS)
National Employment and Wage Data from the Occupational Employment Statistics
Survey, by Occupation, May 2012, found at www.bls.gov. The salary estimates
contained in this package are based on the following healthcare personnel:
“Administrator” refers to the BLS 2012 national average salary for health services
manager ($47.34 per hour, $98,460 per year) (i.e., $98,460 divided by 52 weeks per year
divided by 40 hours per week).
“Clerical person” refers to the BLS 2012 national average salary for medical secretaries
($14.63 per hour, $30,430 per year).
“Physical therapist” refers to the BLS 2012 national average salary for a physical
therapist ($38.99 per hour, annual salary $81,110).
“Social worker” refers to the BLS 2012 national average salary for a social worker, all
others ($27.29 per hour, $56,760 per year) used in this report to provide cost estimates for
social or psychological services professionals.
“Accountant” refers to the BLS 2012 national average salary for an accountant and
auditors ($36.44 per hour, $75,790 per year).
485.64 (a)(1), (2), (3), (4), (b)(1)and (2) - Standard: Disaster procedures
The facility must have written policies and procedures that specifically define the
handling of patients, personnel, records, and the public during disasters. All personnel

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associated with the facility must be knowledgeable with respect to these procedures, be
trained in their application, and be assigned specific responsibilities.
(a) Standard: Disaster plan. The facility's written disaster plan must be developed and
maintained with assistance of qualified fire, safety, and other appropriate experts. The
plan must include-(1) Procedures for prompt transfer of casualties and records;
(2) Procedures for notifying community emergency personnel (for example, fire
department, ambulance, etc.);
(3) Instructions regarding the location and use of alarm systems and signals and
firefighting equipment; and
(4) Specification of evacuation routes and procedures for leaving the facility.
We believe the CORF administrator and physical therapist will develop and maintain the
disaster plan in collaboration with local fire, safety, and other appropriate experts. We
believe it will take an administrator and one physical therapist four hours each per CORF
to develop a disaster plan and two hours each per CORF to maintain the plan in
collaboration with local qualified fire, safety, and other appropriate experts in the
community. It will take one clerical person two hours to put the plan into final written
form. Thus, we estimate it will take the team of administrator, physical therapist, and
clerical person a total of 10 hours to develop the plan and 6 hours to maintain the plan.
Hours/Est. Salary/ # of CORFs
(274)
a. 1 Administrator @ $47.34/hr.
x 4 hr. x 1 a yr. x 274 CORFs to
develop the disaster plan
1 Physical therapist @ $38.99/hr.
x 4 hr. x 1 a yr. x 274 CORFs to
develop the disaster plan
1 Clerical person @ $14.63/hr. x
2 hr. x 1 a yr. x 274 CORFs to
develop and maintain the plan
a. 1 Administrator @ $47.34/hr.
x 2 hr. x 1 a yr. x 274 CORFs to
maintain the disaster plan
1 Physical therapist @ $38.99/hr.
x 2 hr. x 1 a yr. x 274 CORFs to
maintain the disaster plan
1 Clerical person @ $14.63/hr. x
2 hr. x 1 a yr. x 274 CORFs to
maintain the plan
Total

Annual Burden Hours

Annual Cost Estimate

1,096

$51,884

1,096

$42,733

548

$8,017

548

$25,942

548

$21,366

548

$8,017

4,384

$157,959

485.66 (b)(1), (2), and (3) (i), (ii) – Standard: Utilization review plan
A CORF that participates in the Medicare and Medicaid programs must have in effect a
written utilization review plan that is implemented at least each quarter, to assess the
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necessity of services and promotes the most efficient use of services provided by the
facility.
(b) Standard: Utilization review plan. The utilization review plan must contain written
procedures for evaluating-(1) Admissions, continued care, and discharges using, at a minimum, the criteria
established in the patient care policies;
(2) The applicability of the plan of treatment to established goals; and
(3) The adequacy of clinical records with regard to-(i) Assessing the quality of services provided; and
(ii) Determining whether the facility's policies and clinical practices are compatible and
promote appropriate and efficient utilization of services.
We believe one administrator, one physical therapist, and one social or psychological
services provider will comprise the utilization review committee. It will take this
committee two hours to develop the utilization review plan and two hours to review and
implement the utilization review plan anually. One clerical person will take one hour to
put the developed documents in final typed format.

Hours/Est. Salary/ # of CORFs
(274)
1 Administrator @ $47.34/hr. x
2 hrs. x 1 a yr. x 274 CORFs for
plan development
1 PT @ $38.99/hr. x 2 hrs. x 1 a
yr. x 274 CORFs for plan
development
1 social or psychological services
professional @ $27.29 x 2 hrs. x 1
a yr. x 274 CORFs for plan
development
1 Clerical person @ $14.63/hr. x
1 hr. x 1 a yr. x 274 CORFs for
plan final document.
1 Administrator @ $47.34/hr. x
2 hrs.(4 qtrs @ 30 min) x 1 a yr. x
274 CORFs for plan review and
implementation
1 PT @ $38.99/hr. x 2 hr.(4 qtrs
@30 min) x 1 a yr. x 274 CORFs
for plan review and revision
1 social or psychological services
professional @ $27.29 x 2 hr.(4
qtrs @30 min) x 1 a yr. x 274
CORFs for plan review and

Annual Burden Hours

Annual Cost Estimate

548

$25,942

548

$21,366

548

$14,954

274

$4,008

548

$25,942

548

$21,366

548

$14,954

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revision
Total

3562

$128,532

Certification Form – CMS-359 – Based on past usage of this form and the general
nature of the questions, we estimate it takes approximately fifteen minutes to complete
this form. The burden for this is based on the 40 currently certified CORFs surveyed on
an annual basis.
Certification Form – CMS-360 – The survey report form is completed by the State
agency surveyor based on the results of his/her investigation of provider compliance with
each individual condition of participation. The surveyor compiles all information
pertaining to the provider’s compliance with health and safety requirements and
summarizes this on the survey form. The surveyor ascertains and documents, as
objectively as possible, whether the provider meets each requirement. In relation to each
standard on the form, the surveyor checks “met” or “not met.” The mere checking of
these blocks does not, in all cases, provide sufficient information to support a conclusion.
In these instances, brief statements will be needed to support a finding of compliance of
noncompliance with the conditions.
Since this form is completed by checking boxes either met or not met with a few
explanatory statements, we estimate that for experienced State agency surveyors to
prepare and complete the form as necessary, it would take approximately three hours per
survey report form. The burden for this request is based on the 40 currently certified
CORFs surveyed on an annual basis.

Certification Forms
Estimated Burden
CMS-359
CMS-360

Total

Reporting

Annual Cost Estimate

10 hours (15 min x 40 sites x
$47.34 per hour for
administrator)
120 hours (3 hrs x 40 sites x
$38.99 per hour for physical
therapist)
130 hours

$473
$4,678

$5,151

13. Capital Costs
There are no additional capital costs.
14. Cost to Federal Government

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There are minimal costs associated with these requirements for CORF facilities that
are accrued at the Federal level due to the ability for surveyors to view and complete
documentation and forms electronically.
15. Changes to Burden
Changes to the burden are a reflection of the decrease in number of Medicare
certified CORFs at this time compared to the previous collection and the changes in
current average hourly rate for medical professionals used in the calculations.
16. Publication/Tabulation Dates
We do not plan to publish any of the information collected.
17. Expiration Date
This collection does not lend itself to the displaying of an expiration date because
data collection and forms are used on a continual basis.

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