CMS-10282 Supporting Statement 10-10-18 cleanX

Supporting Statement

Medicare and Medicaid Programs: Conditions of Participation for Comprehensive Outpatient Rehabilitation Facilities (CORFs) and Supporting regulations (CMS-10282)

1. 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.

The CoPs are written in regulation 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.

Additionally, CMS published revisions to certain CORF Conditions of Participation related to utilization review plans on September 20, 2018 (83 FR 47686).

2. JUSTIFICATION

1. Need and Legal Basis

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 188 CORFs must meet the CoPs in order to receive program payment for services provided to Medicare or Medicaid patients. Currently, 188 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 information users are the CORF administrators and State surveyors. CORFs use the written utilization review plan to assess the necessity of services and promote the most efficient use of services provided by the CORF. The types of information collected and analyzed by the CORFs include admission data, plan of treatment, clinical records, quality of services, etc. The State surveyors do not collect any information, however, they review the CORFs utilization review plan when performing a survey, as part of the CMS regulations that CORFs must complete to ensure they are meeting the CMS requirements for Medicare certification.

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. Facilities are free to take advantage of any technological advances that they find appropriate for their needs.

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.

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. 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. CORFs are surveyed once every five to seven years by the State survey agencies.

7. Special Circumstances

There are no special circumstances.

8. Federal Register Notice/Outside Consultation

This information collection request is associated with Regulatory Provisions to Promote Program Efficiency, Transparency, and Burden Reduction which published September 20, 2018 (83 FR 47686).

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

This package reflects the paperwork burden for a total of 188 facilities.

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, found at www.bls.gov/oes/current/oes_nat.htm. The salary estimates contained in this package are based on the May 2017 data for the following healthcare personnel:

“Administrator” refers to the national average salary for health services managers as $111,680 per year with a mean hourly wage of $54. We have factored in a benefits and overhead package equal to 100% of the annual salary, bringing the hourly wage to $108.

“Clerical person” refers to the national average salary for medical secretaries as $35,870 per year with a mean hourly wage of $17. We have factored in a benefits and overhead package equal to 100% of the annual salary, bringing the hourly wage to $34.

“Physical therapist” (PT) refers to the national average salary for physical therapists as $88,080 per year with a mean hourly wage of $42. We have factored in a benefits and overhead package equal to 100% of the annual salary, bringing the hourly wage to $84.

“Social worker” or “social or psychological services professional” refers to the national average salary for social workers as $51,630 per year with a mean hourly wage of $25. We have factored in a benefits and overhead package equal to 100% of the annual salary, bringing the hourly wage to $50.

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 to assess the necessity of services and promote the most efficient use of services provided by the facility.

2. 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--

   1. Assessing the quality of services provided; and

   2. 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 review, revise, and implement the utilization review plan annually. One clerical person will take two hours to put the developed documents in final typed format.

Table of Annual Burden Hours and Annual Cost Estimates

Hours/Est. Salary/# of CORFs	Annual Burden Hours	Annual Cost Estimate
1 Clerical person @ $34/hr. x 2 hr. x 1 a yr. x 188 CORFs for revising final typed document	376	$12,784
1 Administrator @ $108/hr. x 2 hrs. x 1 a yr. x 188 CORFs for plan review and implementation	376	$40,608
1 PT @ $84/hr. x 2 hrs. x 1 a yr x 188 CORFs for plan review and revision	376	$31,584
1 Social or psychological services professional @ $50 x 2 hrs. x 1 a yr. x 188 CORFs for plan review and revision	376	$18,800
Total	1,504	$103,776

Total Burden Estimate: $103,776

13. Capital Costs

There are no capital costs.

14. Cost to Federal Government

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 electronically.

15. Changes to Burden

The number of affected CORFs was adjusted from 235 to 188, and hourly wages were adjusted to reflect the latest (May 2017) data from BLS. In addition, the burden associated with developing utilization review plans has been removed and replaced by the ongoing review and revision burden.

The previous requirement for reviewing utilization review plans quarterly (§485.66) has been changed to an annual requirement, and the estimated burden associated with that review was adjusted to what we think is a more realistic level (30 minutes quarterly per personnel is now 2 hours annually per personnel).

The net result is a decrease in burden from 3,055 hours to 1,504 hours.

16. Publication/Tabulation Dates

We do not plan to publish any of 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. In addition, the public will be able to access the expiration date on OMB’s website by performing a search using the OMB control number.

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