CMS-10282.FINAL Supporting Statement Part A

Supporting Statement – Part A for the Information Collection Requirements in

42 CFR 485.50, 485.51, 485.54, 485.56, 485.58, 485.60, 485.62, 485.64, 485.66, 485.70, and 485.74

Comprehensive Outpatient Rehabilitation Facilities (CORFs)

Condition of Participation (CoP)

CMS-10282

INTRODUCTION

This information collection package is a request for a new information collection package with requirements for existing regulations at 485.50 - 485.74 that have never been reviewed and approved by OMB. Currently, no information collection requirements exist. This document represents the inclusion of all current and final CORF CoPs currently effective. Concurrently with this package, at CMS-1413-P and CMS-1413-FC, we proposed to revise regulatory requirements under 485.70 to reflect a change in the definition of respiratory therapist to conform to current respiratory therapy professional standards relative to training and the use of terms to identify professionals working in the field of respiratory therapy. This package reflects the paperwork burden for a total of 446 facilities as of March 1, 2009.

The current conditions of participation (CoPs) for CORFs that will have associated information collection requirements are 42 CFR 485.54(b), 485.56(b)(3), 485.56(c)(1), 485.56(d)(1), 485.56(d)(2)(i), 485.56(d)(2)(ii), 485.56(d)(2)(iii), 485.56(e)(1), 485.56(e)(2), 485.56(e)(3), 485.56(e)(4), 485.56(e)(5), 485.56(e)(6), 485.56(e)(7), 485.56(e)(8), 485.56(e)(9), 485.56(e)(10), 485.58(c)(1), 485.58(c)(2), 485.58(c)(3), 485.58(c)(4), 485.64(a)(1), 485.64(a)(2), 485.64(a)(3), 485.64(a)(4), 485.64(b)(1), 485.64(b)(2), 485.66(b)(1), 485.66(b)(2), 485.66(b)(3)(i), and 486.66(b)(3)(ii).

This package serves to quantify the information collection requirements and associated burden estimates that have never been reviewed and approved by OMB. We are not including burden associated with most patient-related activities (such as healthcare plans, patient records, and clinical records) in this package because these activities would take place in the absence of the Medicare and Medicaid programs.

1. BACKGROUND

The information collection requirements described herein are needed to implement the Medicare and Medicaid CoPs for a total of 446 CORFs.

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 2007, found at www.bls.gov. The salary estimates contained in this package are based on the following healthcare personnel:

“Administrator” refers to the BLS 2007 national average salary for accountants and auditors ($72.77 per hour, $151,370 per year) (i.e., $151,370 divided by 52 weeks per year divided by 40 hours per week).

“Clerical person” refers to the BLS 2007 national average salary for medical secretaries ($14.45 per hour, $30,050 per year).

“Physical therapist” refers to the BLS 2007 national average salary for a physical therapist ($34.39 per hour, annual salary $71,520).

“Social worker” refers to the BLS 2007 national average salary for a social worker, all others ($22.68 per hour, $47,170 per year) used in this report to provide cost estimates for social or psychological services professionals.

“Accountant” refers to the BLS 2007 national average salary for an accountant and auditors ($30.37 per hour, $63,180 per year).

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 the requirements are necessary for the health and safety of individuals who are furnished services by CORFs.

All 446 CORFs must meet the CoPs in order to receive program payment for services provided to Medicare or Medicaid patients. Currently, 446 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.

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.

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.

4. 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.

7. Special Circumstances

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 published as part of the proposed rule that published on July 13, 2009 (74 FR 33520). Similarly, the 30-day Federal Register notice published as part of the final rule that published November 25, 2009 (74 FR 61738). We republished a 30-day Federal Register notice on March 12, 2010 (75 FR 11890).

9. Payment/Gift to Respondent

We do not plan to provide any payment or gifts to respondents for the collection of this information.

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.

11. Burden Estimates

485.50 – Standard: Basis and scope

This subpart sets forth the conditions that facilities must meet to be certified as comprehensive outpatient rehabilitation facilities (CORFs) under section 1861(cc)(2) of the Social security Act and be accepted for participation in Medicare in accordance with part 489 of this chapter. There is no associated burden.

485.51 Definition

As used in this subpart, unless the context indicates otherwise, ``comprehensive outpatient rehabilitation facility'', ``CORF'', or ``facility'' means a nonresidential facility that--

(a) Is established and operated exclusively for the purpose of providing diagnostic, therapeutic, and restorative services to outpatients for the rehabilitation of injured, disabled, or sick persons, at a single fixed location, by or under the supervision of a

physician; and

(b) Meets all the requirements of this subpart.

There is no associated burden.

485.54(a) and (b) – Standard: Compliance with State and local laws.

The facility and all personnel who provide services must be in compliance with applicable State and local laws and regulations.

1. Standard: Licensure of facility. If State or local law provides for licensing, the facility must be currently licensed or approved as meeting the standards established for licensure.

We expect the Administrator would perform this task. However, we are not associating burden with this requirement since this task is necessary to for all CORFs to establish practice.

2. Standard: Licensure of personnel. Personnel that provide service must be licensed, certified, or registered in accordance with applicable State and local laws.

The Administrator or other appropriate person would have to contact the State or local authority for requirements for licensure and meet the standards established for such licensure. Also, the Administrator or other appropriate person would have to ensure that appropriate personnel are licensed, certified, or registered in accordance with applicable State and local laws. We expect the administrator could accomplish this task in 30 minutes and one clerical person could ensure such records within one 4 hour shift.

Hours/Est. Salary/ # of CORFs (446)	Annual Burden Hours	Annual Cost Estimate
1 Administrator @ 72.77/hr. X .50 hrs. X 1 a yr. X 446 CORFs	223.00	16,227.71
1 Clerical person @ $14.45/hr. X 4 hrs. X 1 a yr. X 446 CORFs	1,784.00	25,778.80
SUB-TOTAL	2,007.00	42,006.51

485.56 (b)(3), (c)(1), (d)(1) and (d)(2)(i), (ii), (iii), (e)(1), (2), (3), (4), (5), (6), (7), (10) - Standard: Governing body and administration

The facility must have a governing body that assumes full legal responsibility for establishing and implementing policies regarding the management and operation of the facility.

(b) Standard: Administrator. The governing body must appoint an administrator who--

(3) Designates, in writing, an individual who, in the absence of the administrator, acts on behalf of the administrator; and

We believe this is a one time task that would take approximately 15 minutes for the administrator to designate an individual and 15 minutes for a clerical person to put this in writing and disseminate to staff.

Hours/Est. Salary/ # of CORFs (446)	Annual Burden Hours	Annual Cost Estimate
b. 1 Administrator @ $72.77/hr. X .25 hrs. X 1 a yr. X 446 CORFs for designation	111.50	8,113.86
1 Clerical person @ $14.45/hr. X .25 hrs. X 1 a yr. X 446 CORFs for designation	111.50	1,611.18
SUB-TOTAL	223.00	9,725.04

(c) Standard: Group of professional personnel. The facility must have a group of professional personnel associated with the facility that--

(1) Develops and periodically reviews policies to govern the services provided by the facility; and

The administrator, along with, at a minimum, one physical therapist (PT) and one professional who provides social or psychological services, may take a combined total of 8 hours to develop such policies and another combined total of 4 hours for a periodic review potentially on an annual basis. One clerical person could be used to draft policies and to revise written policies as needed on an annual basis. We estimate it would take one clerical person per CORF 2 hours to put the developed policies into final form and one hour per CORF to finalize revisions to the policies on an annual basis. Thus, ultimately, we expect it will require a combined total of 10 hours for policy development per CORF and a combined total of 4 hours for policy revision per CORF for a combined total of 14 hours for policy development and revision per CORF.

Hours/Est. Salary/ # of CORFs (446)	Annual Burden Hours	Annual Cost Estimate
c. 1 Administrator @ $72.77/hr. x 4 hrs. X 1 a yr. X 446 CORFs for policy development	1,784.00	129,821.68
1 PT @ $34.39 X 2 hrs. X 1 a yr. X 446 CORFs for policy development	892.00	30,675.88
1 social or psychological services professional @ $22.68 X 2 hrs. X 1 a yr. X 446 CORFs for policy development	892.00	20,230.56
1 Clerical person @ $14.45/hr. X 2 hrs. X 1 a yr. X 446 CORFs for policy development	892.00	12,889.40
SUB-TOTAL	4,460.00	193,617.52
Hours/Est. Salary/ # of CORFs (446)	Annual Burden Hours	Annual Cost Estimate
c. 1 Administrator @ $72.77/hr. x 1 hr. X 1 a yr. X 446 CORFs for policy review	446.00	32,455.42
1 PT @ $34.39 X 1 hr. X 1 a yr. X 446 CORFs for policy review	446.00	15,337.94
1 social or psychological services professional @ $22.68 X 1 hr. X 1 a yr. X 446 CORFs for policy review	446.00	10,115.28
1 Clerical person @ $14.45/hr. X 1 hr. X 1 a yr. X 446 CORFs for policy review	446.00	6,444.70
SUB-TOTAL	1,784.00	64,353.34

(d) Standard: Institutional budget plan. The facility must have an institutional budget plan that meets the following conditions:

(1) It is prepared, under the direction of the governing body, by a committee consisting of representatives of the governing body and the administrative staff.

(2) It provides for--

(i) An annual operating budget prepared according to generally accepted accounting principles;

(ii) A 3-year capital expenditure plan if expenditures in excess of $100,000 are anticipated, for that period, for the acquisition of land; the improvement of land, buildings, and equipment; and the replacement,

modernization, and expansion of buildings and equipment; and

(iii) Annual review and updating by the governing body.

The Administrator, along with members of the governing body, would oversee and provide input into an accountant’s preparation of the annual operating budget and would participate in its review.

Hours/Est. Salary/ # of CORFs (446)	Annual Burden Hours	Annual Cost Estimate
d. 1 Administrator @ $72.77/hr. x 1 hrs. X 1 a yr. X 446 CORFs for oversight of accountant’s budget preparation	446.00	32,455.42
Governing body consisting of 1-PT @ $34.39 hr. X 1 hr. X 1 a yr. X 446 CORFs for oversight of accountant’s budget preparation	446.00	15,337.94
Governing body consisting of 1-social or psychological services prof. @ $22.68/hr. X 1 hr. X 1 a yr. X 446 CORFs for oversight of accountant’s budget preparation	446.00	10,115.28
1 Accountant @ $30.37/hr. X 4 hrs. X 1 a yr. X 446 CORFs for preparation of accountant’s budget	1,784.00	54,180.08
d. 1 Administrator @ $72.77/hr. x 1 hrs. X 1 a yr. X 446 CORFs for review of annual budget	446.00	32,455.42
Governing body consisting of 1-PT @ $34.39 hr. X 1 hr. X 1 a yr. X 446 CORFs for review of annual budget	446.00	15,337.94
Governing body consisting of 1-social or psychological services prof. @ $22.68/hr. X 1 hr. X 1 a yr. X 446 CORFs for review of annual budget	446.00	10,115.28
1 Accountant @ $30.37/hr. X 2 hrs. X 1 a yr. X 446 CORFs for review of annual budget	892.00	27,090.04
SUB-TOTAL	5,352.00	197,087.40

(e) Standard: Patient care policies. The facility must have written patient care policies that govern the services it furnishes. The patient care policies must include the following:

(1) A description of the services the facility furnishes through employees and those furnished under arrangements.

(2) Rules for and personnel responsibilities in handling medical emergencies.

(3) Rules for the storage, handling, and administration of drugs and biologicals.

(4) Criteria for patient admission, continuing care, and discharge.

(5) Procedures for preparing and maintaining clinical records on all patients.

(6) A procedure for explaining to the patient and the patient's family the extent and purpose of the services to be provided.

(7) A procedure to assist the referring physician in locating another level of care for--patients whose treatment has terminated and who are discharged.

(8) A requirement that patients accepted by the facility must be under the care of a physician.

(9) A requirement that there be a plan of treatment established by a physician for each patient.

(10) A procedure to ensure that the group of professional personnel reviews and takes appropriate action on recommendations from the utilization review committee regarding patient care policies.

We believe the Administrator or other appropriate person would establish and maintain adequate policies, including the aforementioned elements, in approximately 4 hrs. and one clerical person would put it into final form in 30 minutes.

Hours/Est. Salary/ # of CORFs (446)	Annual Burden Hours	Annual Cost Estimate
e. 1 Administrator @ $72.77/hr. x 4 hrs. X 1 a yr. X 446 CORFs establish and maintain policies	1,784.00	129,821.68
1 Clerical person @ $14.45/hr. X .50 hrs. X 1 a yr. X 446 CORFs for document finalization	223.00	3,222.35
SUB-TOTAL	2,007.00	133,044.03

Hours/Est. Salary/ # of CORFs (446)	Annual Burden Hours	Annual Cost Estimate
b. Designation of personnel	223.00	9,725.04
c. Policy development	6,244.00	257,970.86
d. Oversight of accountant’s annual operating budget	5,352.00	197,087.40
e. Establishment and maintenance of policies	2,007.00	133,044.03
TOTAL	13,826.00	597,827.33

485.58(c)(1), (2), (3), (4)- Standard: Comprehensive rehabilitation program

The facility must provide a coordinated rehabilitation program that includes, at a minimum, physicians' services, physical therapy services, and social or psychological services. The services must be furnished by personnel that meet the qualifications set forth in Sec. 485.70 and must be consistent with the plan of treatment and the results of

comprehensive patient assessments.

(c) Standard: Coordination of services. The facility must designate, in writing, a qualified professional to ensure that professional personnel coordinate their related activities and exchange information about each patient under their care. Mechanisms to assist in the coordination of services must include--

(1) Providing to all personnel associated with the facility, a schedule indicating the frequency and type of services provided at the facility;

(2) A procedure for communicating to all patient care personnel pertinent information concerning significant changes in the patient's status;

(3) Periodic clinical record entries, noting at least the patient's status in relationship to goal attainment; and

(4) Scheduling patient case review conferences for purposes of determining appropriateness of treatment, when indicated by the results of the initial comprehensive patient assessment, reassessment(s), the recommendation of the facility physician (or other physician who established the plan of treatment), or upon the recommendation of one of the professionals providing services.

We believe the CORF Administrator will designate a physical therapist to oversee the coordination of services. Designation of the physical therapist would take the Administrator 15 minutes to perform this task and the clerical person 15 minutes to put this in final form.

Hours/Est. Salary/ # of CORFs (446)	Annual Burden Hours	Annual Cost Estimate
c. 1 Administrator @ $72.77/hr. x .25 hrs. X 1 a yr. X 446 CORFs for designation of physical therapist	111.50	8,113.86
1 Clerical person @ $14.45/hr. X .25 hrs. X 1 a yr. X 446 CORFs for designation of physical therapist	111.50	1,611.18
SUB-TOTAL	223.00	9,725.04

485.60 (a)(1),(2),(3),(4),(5),(6),(7), (b), and (c) – Standard: Clinical records.

The facility must maintain clinical records on all patients in accordance with accepted professional standards and practice. The clinical records must be completely, promptly, and accurately documented, readily accessible, and systematically organized to

facilitate retrieval and compilation of information.

(a) Standard: Content. Each clinical record must contain sufficient information to identify the patient clearly and to justify the diagnosis and treatment. Entries in the clinical record must be made as frequently as is necessary to insure effective treatment and must be signed by personnel providing services. All entries made by assistant level personnel must be countersigned by the corresponding professional. Documentation on each patient must be consolidated into one clinical record that must contain--

(1) The initial assessment and subsequent reassessments of the patient's needs;

(2) Current plan of treatment;

(3) Identification data and consent or authorization forms;

(4) Pertinent medical history, past and present;

(5) A report of pertinent physical examinations if any;

(6) Progress notes or other documentation that reflect patient reaction to treatment, tests, or injury, or the need to change the established plan of treatment; and

(7) Upon discharge, a discharge summary including patient status relative to goal achievement, prognosis, and future treatment considerations.

(b) Standard: Protection of clinical record information. The facility must safeguard clinical record information against loss, destruction, or unauthorized use. The facility must have procedures that govern the use and removal of records and the conditions for release of information. The facility must obtain the patient's written consent before releasing information not required to be released by law.

(c) Standard: Retention and preservation. The facility must retain clinical record information for 5 years after patient discharge and must make provision for the maintenance of such records in the event that it is no longer able to treat patients.

We believe the maintenance of clinical records and all required contents, protection of clinical record information, and retention and preservation of such records reflect customary and usual business and medical practice. Thus, the burden is not subject to the PRA in accordance with §1320.3(b)(2).

485.62 (b)(1), (b) (2), (c)(1), and (c)(2) Standard: Physical environment

The facility must provide a physical environment that protects the health and safety or patients, personnel, and the public.

(b) Standard: Sanitary environment. The facility must maintain a sanitary environment and establish a program to identify, investigate, prevent, and control the cause of patient infections.

(1) The facility must establish written policies and procedures designed to control and prevent infection in the facility and to investigate and identify possible causes of infection.

(2) The facility must monitor the infection control program to ensure that the staff implement the policies and procedures and that the policies and procedures are consistent with current practices in the field.

(c) Standard: Maintenance of equipment, physical location, and grounds. The facility must establish a written preventive maintenance program to ensure that--

(1) All equipment is properly maintained and equipment needing periodic calibration is calibrated consistent with the manufacturer's recommendations; and

(2) The interior of the facility, the exterior of the physical structure housing the facility, and the exterior walkways and parking areas are clean and orderly and maintained free of any defects that are a hazard to patients, personnel, and the public.

Except as otherwise provided in this section, CORFs must meet the applicable provisions of the 2000 edition of the Life Safety Code of the National Fire Protection Association.

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 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 fire fighting 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 qualified 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 30 minutes 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 12 hours to develop the plan and 6 hrs. to maintain the plan (i.e., 18 hrs. in total).

Hours/Est. Salary/ # of CORFs (446)	Annual Burden Hours	Annual Cost Estimate
a. 1 Administrator @ $72.77/hr. x 4 hr. X 1 a yr. X 446 CORFs to develop the disaster plan	1,784.00	129,821.68
1 Physical therapist @ $34.39/hr. x 4 hr. X 1 a yr. X 446 CORFs to develop the disaster plan	1,784.00	61,351.76
1 Clerical person @ $14.45/hr. X 4 hr. X 1 a yr. X 446 CORFs to develop the plan	1,784.00	25,778.80
a. 1 Administrator @ $72.77/hr. x 2 hr. X 1 a yr. X 446 CORFs to maintain the disaster plan	892.00	64,910.84
1 Physical therapist @ $34.39/hr. x 2 hr. X 1 a yr. X 446 CORFs to maintain the disaster plan	892.00	30,675.88
1 Clerical person @ $14.45/hr. X 2 hr. X 1 a yr. X 446 CORFs to maintain the plan	892.00	12,889.40
SUB-TOTAL	8,028.00	325,428.36

(b) Standard: Drills and staff training.

(1) The facility must provide ongoing training and drills for all personnel associated with the facility in all aspects of disaster preparedness.

We believe the CORF physical therapist will provide ongoing training and drills for all personnel in collaboration with local qualified fire, safety, and other appropriate experts. We believe it will take one physical therapist two hours to provide ongoing training for all personnel in collaboration with qualified fire, safety, and other appropriate experts in the community.

Hours/Est. Salary/ # of CORFs (446)	Annual Burden Hours	Annual Cost Estimate
b(1). 1 Physical therapist @ $34.39/hr. x 2 hr. X 1 a yr. X 446 CORFs to provide ongoing disaster preparedness training	892.00	30,675.88
SUB-TOTAL	892.00	30,675.88

(2) All new personnel must be oriented and assigned specific responsibilities regarding the facility's disaster plan within two weeks of their first workday.

We believe the CORF physical therapist will provide new employee orientation and assign new employees specific responsibilities in the event of a disaster. We believe it will take one physical therapist 30 minutes to provide ongoing training and assign specific responsibilities to each new employee.

CMS does not capture data regarding the total or average number of personnel employed by a CORF. Thus, the burden associated with this requirement is difficult to quantify. We believe most CORFs are small facilities that have a small number of employees. We estimate an average of 10 employees with approximately three employees terminating and beginning employment at a CORF per year. Thus, we estimate the physical therapist will orient approximately three new employees each year on disaster preparedness and will assign these three employees specific responsibilities in disaster preparedness.

We estimate it will take the physical therapist 30 minutes per new employee to orient them on disaster preparedness and assign each new employee specific responsibilities. Thus, the physical therapist will take 1 ½ hrs. per CORF per year (i.e., 3 new employees X 30 minutes per new employee) to accomplish this task.

Hours/Est. Salary/ # of CORFs (446)	Annual Burden Hours	Annual Cost Estimate
b(2). 1 Physical therapist @ $34.39/hr. x 1.5hrs. X 1 a yr. X 446 CORFs to provide new employee orientation to disaster preparedness and assign specific responsibilities	669.00	23,006.91
SUB-TOTAL	669.00	23,006.91

Hours/Est. Salary/ # of CORFs (446)	Annual Burden Hours	Annual Cost Estimate
Provide ongoing disaster preparedness training	8,028.00	325,428.36
Provide new employee orientation to disaster preparedness and assign specific responsibilities	1,561.00	53,682.79
TOTAL	9,589.00	379,111.15

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 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 carry out the utilization review plan and one hour to review and revise the utilization review plan. One clerical person will take 30 minutes to put written documents in final form.

Hours/Est. Salary/ # of CORFs (446)	Annual Burden Hours	Annual Cost Estimate
1 Administrator @ $72.77/hr. x 2 hrs. X 1 a yr. X 446 CORFs for plan development	892.00	64,910.84
1 PT @ $34.39/hr. X 2 hrs. X 1 a yr. X 446 CORFs for plan development	892.00	30,675.88
1 social or psychological services professional @ $22.68 X 2 hrs. X 1 a yr. X 446 CORFs for plan development	892.00	20,230.56
1 Clerical person @ $14.45/hr. X .50 hrs. X 1 a yr. X 446 CORFs for plan development	223.00	3,222.35
1 Administrator @ $72.77/hr. x 1hr. X 1 a yr. X 446 CORFs for plan review and revision	446.00	32,455.42
1 PT @ $34.39/hr. X 1 hr. X 1 a yr. X 446 CORFs for plan review and revision	446.00	15,337.94
1 social or psychological services professional @ $22.68 X 1 hr. X 1 a yr. X 446 CORFs for plan review and revision	446.00	10,115.28
1 Clerical person @ $14.45/hr. X .50 hrs. X 1 a yr. X 446 CORFs for plan review and revision	223.00	3,222.35
SUB-TOTAL	4,460.00	180,170.62

485.70 – Standard: Personnel qualifications

This section sets forth the qualifications that must be met, as a condition of participation, under Sec. 485.58, and as a condition of coverage of services under Sec. 410.100 of this chapter.

There are no associated information collection requirements for this action or for any other requirements specific to personnel qualifications.

485.74 – Standard: Appeal rights.

The appeal provisions set forth in part 498 of this chapter, for providers, are applicable to any entity that is participating or seeks to participate in the Medicare program as a CORF.

There are no information collection requirements for the appeal of rights.

13. Capital Costs

There are no additional capital costs.

14. Cost to Federal Government

There are minimal costs associated with these requirements that are accrued at the Federal level and especially at the regional office (RO) levels. For example, RO staff is responsible for acting on the information collections requirements discussed in this package as it relates to CORF compliance. Once state survey agencies have completed their surveys and if a final decision to terminate a hospice for noncompliance is to be made, such decisions are made by the Central Office and the RO.

15. Changes to Burden

This is a new information collection.

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.

BURDEN ESTIMATES

Section	Annual Burden Hours	Cost Estimate
485.50	0	0
485.51	0	0
485.54(b)	2,007.00	42,006.51
485.56(b), (c), (d), (e)	13,826.00	597,827.33
485.58(c)	223.00	9,725.04
485.60(a), (b), (c)	0	0
485.62(b), (c)	0	0
485.64(a), (b)	9,589.00	379,111.15
485.66(b)	4,460.00	180,170.62
485.70	0	0
485.74	0	0
TOTAL	30,105.00	1,208,840.60

16