900 KAR 6:125. Certificate of Need annual surveys, and registration requirements for new Magnetic Resonance Imaging units.

CABINET FOR HEALTH AND FAMILY SERVICES

Office of Health Policy

(As Amended at ARRS, March 12, 2012)

900 KAR 6:125. Certificate of Need annual surveys, and registration requirements for new Magnetic Resonance Imaging units.

RELATES TO: KRS 216B.010, 216B.020(2)(a), 216B.040

STATUTORY AUTHORITY: KRS 194A.030, 194A.050, 216B.040(2)(a)1

NECESSITY, FUNCTION, AND CONFORMITY: KRS 216B.040(2)(a)1 requires the Cabinet for Health and Family Services to administer Kentucky's Certificate of Need Program and to promulgate administrative regulations as necessary for the program. This administrative regulation establishes the requirements for[~~voluntary~~][~~the requirements for~~] registration of Magnetic Resonance Imaging units and the requirements for submission of annual survey data that are used to produce annual reports necessary for the orderly administration of the Certificate of Need Program.

Section 1. Definitions. (1) "Cabinet" is defined by KRS 216B.015(5).

(2) "Days" means calendar days, unless otherwise specified.

(3) "Exempt physicians" means physicians that operate a Magnetic Resonance Imaging unit pursuant to the exemption allowed in KRS 216B.020(2)(a).

(4) "Long term care facility" means any entity with licensed long term care beds including nursing facility, nursing home, intermediate care, Alzheimer’s, intermediate care facility for the mentally retarded, or personal care.

(5) "Office of Inspector General" means the office within the Cabinet for Health and Family Services that is responsible for licensing and regulatory functions of health facilities and services.

(6) "Owner" means a person as defined in KRS 216B.015(21) who is applying for the certificate of need and will become the licensee of the proposed health service or facility.

(7) "Year" means a calendar year from January 1 through December 31.

Section 2. Entities Completing Surveys. The following entities shall submit annual surveys:

(1) Licensed Ambulatory Surgery Centers;

(2) Licensed Hospitals performing ambulatory surgery services or performing outpatient surgical services;

(3) Licensed Home Health Agencies;

(4) Licensed Hospice Agencies;

(5) Licensed Hospitals;

(6) Licensed Private Duty Nursing Agencies;

(7) Facilities with licensed long term care beds;

(8) Entities that hold a certificate of need for MRI equipment;

(9) Facilities with Megavoltage Radiation equipment;

(10) Licensed Psychiatric Residential Treatment Facilities; and

(11) Facilities with Positron Emission Tomography equipment.

Section 3. Entities Completing Surveys on a Voluntary Basis. Exempt physicians that have MRI equipment may submit surveys on a voluntary basis.

Section 4. Annual Survey Submission. Entities Completing Surveys on a Voluntary Basis. Exempt physicians that have MRI equipment shall submit surveys on a voluntary basis. An annual survey shall be completed for the previous year and transmitted electronically by accessing the Office of Health Policy’s Web site at http://chfs.ky.gov/ohp.

Section 5. Surveys shall be submitted annually as follows:

(1) Annual Survey of Licensed Ambulatory Surgical Services;

(2) Annual Survey of Licensed Home Health Services;

(3) Annual Survey of Hospice Providers;

(4) Annual Survey of Licensed Hospitals;

(5) Annual Survey of Licensed Private Duty Nursing Agencies;

(6) Annual Survey of Long Term Care Facilities;

(7) Annual Survey of Magnetic Resonance Imaging (MRI) Equipment and Services;

(8) Annual Survey of Megavoltage Radiation Services;

(9) Annual Survey of Psychiatric Residential Treatment Facilities; and

(10) Annual Survey of Positron Emission Tomography (PET) Services.

Section 6. Annual surveys shall be completed and submitted no later than March 15th of each year. If the 15th falls on a weekend or holiday, the submission due date shall be the next working day.

Section 7. Extensions for Survey Submission. (1) A request for an extension for submission of data shall be made in writing or via email to the administrator of the specific survey.

(2) The request for an extension shall state the facility name, survey log-in identification number, contact person, contact phone number, contact email address, and a detailed reason for the requested extension.

(3) One (1) extension per survey of up to ten (10) [~~10 (ten)~~] days shall be granted.

(4) An additional extension shall only be granted if circumstances beyond the entity’s control prevents timely completion of a survey.

Section 8. Data Corrections to Draft Annual Reports Utilizing Data Submitted in the Annual Surveys. (1)(a) Prior to the release of draft reports to facilities for their review, the Office of Health Policy shall review data for completeness and accuracy.

(b) If an error is identified, the facility shall be contacted by the Office of Health Policy and allowed fourteen (14) days to make corrections.

(2)(a) Prior to publication of the reports, the Office of Health Policy shall publish draft reports available only to the entities included in each individual report.

(b) The facilities shall be notified of a website and provided with a login identification and password required to access each applicable draft report and shall have fourteen (14) days to review their data for errors.

(c) Corrections shall be submitted in writing or via email to the Office of Health Policy before the expiration of the fourteen (14) day review period.

(3)(a) After publication of the reports, reports shall not be revised as a result of data reported to the Office of Health Policy incorrectly by the facility.

(b) Corrections received after the fourteen (14) day review period shall not be reflected in the published report.

(c) Facilities may provide a note in the comments section for the following year’s report, referencing the mistake from the previous year.

Section 9. Annual Reports. (1) Utilizing data submitted in the annual surveys, the Office of Health Policy shall publish reports annually as follows:

(a) Kentucky Annual Ambulatory Surgical Services Report;

(b) Kentucky Annual Home Health Services Report;

(d) Kentucky Annual Hospital Utilization and Services Report;

(e) Kentucky Annual Private Duty Nursing Agency Report;

(f) Kentucky Annual Long Term Care Services Report:

(g) Kentucky Annual Magnetic Resonance Imaging Services Report;

(h) Kentucky Annual Megavoltage Radiation Services Report;

(i) Kentucky Annual Psychiatric Residential Treatment Facility Report; and

(j) Kentucky Annual Positron Emission Tomography Report.

(2) Electronic copies of annual reports may be obtained at no cost from the Office of Health Policy’s Web site at http://chfs.ky.gov/ohp. A paper copy may be obtained for a fee of twenty (20) dollars at the Cabinet for Health and Family Services, Office of Health Policy, 275 East Main Street 4WE, Frankfort, Kentucky 40621.

Section 10. Any facility, other than an exempt physician that has MRI equipment, that fails to complete a required annual survey shall be referred to the Office of Inspector General for further action which may impact the facility’s license renewal as provided for in 902 KAR 20:008, Section 2(6).

Section 11. Magnetic Resonance Imaging Equipment Registration on a Voluntary Basis by Exempt Physicians that have MRI Equipment.

(1) An exempt physician who uses a Magnetic Resonance Imaging unit (MRI) may register the MRI equipment by disclosing the following information by telephone contact and followed up in writing to the Cabinet for Health and Family Services:

(a) Name, address, and telephone number of the facility at which each unit is located or to be utilized;

(b) Identification of designated contact person or authorized agent of each facility;

(d) Date the unit became operational at each site; and

(e) Whether the unit is free-standing or mobile. If the unit is mobile, the submission shall also identify the number of days the unit is operational.

(2) Within thirty (30) days of a change in the facility’s address or the addition of another MRI unit as well as the discontinuation of any units, the designated contact person or authorized agent shall notify the Office of Health Policy in writing.

Section 12. Incorporation by Reference. (1) The following material is incorporated by reference:

(a) "2011[~~2010~~] Annual Survey of Licensed Ambulatory Surgical Services", revised January 2012;

(b) "2011[~~2010~~] Annual Survey of Licensed Home Health Services", revised January 2012;

(d) "2011[~~2010~~] Annual Survey of Licensed Hospitals", revised January 2012;

(e) "2011[~~2010~~] Annual Survey of Licensed Private Duty Nursing Agencies", revised January 2012;

(f) "2011[~~2010~~] Annual Survey of Long Term Care Facilities", revised January 2012;

(g) "2011[~~2010~~] Annual Survey of Magnetic Resonance Imaging (MRI) Equipment and Services", revised January 2012;

(h) "2011[~~2010~~] Annual Survey of Megavoltage Radiation Services", revised January 2012;

(i) "2011[~~2010~~] Annual Survey of Psychiatric Residential Treatment Facilities", revised January 2012; and

(j) "2011[~~2010~~] Annual Survey of Positron Emission Tomography (PET) Services", revised January 2012.

(2) This material may be inspected, copied, or obtained, subject to applicable copyright law, at the Cabinet for Health and Family Services, 275 East Main Street, Frankfort, Kentucky 40601, Monday through Friday, 8 a.m. to 4:30 p.m.

This is to certify that the Executive Director of the Office of Health Policy has reviewed and recommended this administrative regulation prior to its adoption, as required by KRS 156.070(4).

CARRIE BANAHAN, Executive Director

JANIE MILLER, Secretary

APPROVED BY AGENCY: December 14, 2011

FILED WITH LRC: December 15, 2011 at 9 a.m.

CONTACT PERSON: Jill Brown, Office of Legal Services, 275 East Main Street 5 W-B, Frankfort, Kentucky 40621, phone (502) 564-7905, fax (502) 564-7573.