S.C. Code Regs. § § 61-91.100.103

Current through Register Vol. 48, No. 11, November 22, 2024

Section 61-91.100.103 - License Requirements (II)

A. License. No person, private or public organization, political subdivision, or governmental agency shall establish, operate, maintain, or represent itself (advertise/market) as an ambulatory surgical facility in S.C. without first obtaining a license from the Department. No such party shall provide care, treatment, procedures, surgery, and/or services to patients prior to the effective date of licensure. Upon the Department's determination that such party provides care, treatment, procedures, surgery, and/or services without a Department-issued license, the party shall cease operation immediately and ensure safety, health, and well-being of the patients. Current or previous violations of the S.C. Code and/or Department regulations may jeopardize the issuance of a license or licensing of another facility or addition to an existing facility owned or operated by the violating licensee. (I)

B. Compliance. An initial license shall not be issued to a proposed facility that has not been previously and continuously licensed under Department regulations until the licensee has demonstrated to the Department that the proposed facility is in substantial compliance with the licensing standards. In the event a licensee who already has a facility/activity licensed by the Department makes application for another facility or increase in licensed capacity, the currently licensed facility/activity shall be in substantial compliance with the applicable standards prior to the Department issuing a license to the proposed facility or an amended license to the existing facility. A copy of the licensing standards shall be maintained at the facility and accessible to all staff members. Facilities shall comply with applicable local, state, and federal laws, codes, and regulations.

C. Compliance with Structural Standards. Facilities possessing a license issued prior to January 1, 2016 are considered in compliance with Section 1703 without modification of its licensed structure.

D. Licensed Capacity. No facility that has been licensed for a set number of operating rooms or procedure rooms shall exceed that number of operating or procedure rooms or establish new care, treatment, procedures, surgery, and/or services without first obtaining authorization from the Department. (I)

E. Issuance and Terms of License.

1. A license is issued by the Department and shall be posted in a conspicuous place in a public area within the facility.

2. The issuance of a license does not guarantee adequacy of individual care, treatment, procedures, surgery, and/or services, personal safety, fire safety, or the well-being of any patient or occupant of a facility.

3. A license is not assignable or transferable and is subject to revocation at any time by the Department for the licensee's failure to comply with the laws and regulations of this State.

4. A license shall be effective for a specified facility, at a specific location(s), for a specified period following the date of issue as determined by the Department. A license shall remain in effect until the Department notifies the licensee of a change in that status.

5. Facilities owned by the same entity but not located on the same adjoining or contiguous property shall be separately licensed. Roads or local streets, except limited access, e.g., interstate highways, shall not be considered as dividing otherwise adjoining or contiguous property.

6. Separate licenses are not required, but may be issued, for separate buildings on the same or adjoining grounds where a single level or type of care is provided.

7. Multiple types of facilities on the same premises shall be licensed separately even though owned by the same entity.

8. A facility shall provide only the care, treatment, procedures, surgery, and/or services of which it is capable and equipped to provide, and has been authorized by the Department to provide pursuant to the definition in Section 101.E of this regulation.

9. Abortions shall not be performed in an ambulatory surgical facility unless it is also licensed as an abortion clinic pursuant to R.61-12.

F. Facility Name. No proposed facility shall be named nor shall any existing facility have its name changed to the same or similar name as any other facility licensed in S.C. The Department shall determine if names are similar. If the facility is part of a "chain operation" it shall then have the geographic area in which it is located as part of its name.

G. Application. Applicants for a license shall submit to the Department a completed application on a form prescribed and furnished by the Department prior to initial licensing and periodically thereafter at intervals determined by the Department. The application includes the applicant's oath, assuring that the contents of the application are accurate and true, and that the applicant will comply with this regulation. The application shall be signed by the owner(s) if an individual or partnership; in the case of a corporation, by two of its officers; or in the case of a governmental unit, by the head of the governmental department having jurisdiction. The application shall set forth the full name and address of the facility for which the license is sought and of the owner in the event his or her address is different from that of the facility, and the names of the persons in control of the facility. The Department may require additional information, including affirmative evidence of the applicant's ability to comply with these regulations. Corporations or partnerships shall be registered with the S.C. Office of the Secretary of State. Applicants shall make payment of all outstanding fees (initial licensure fees, annual licensure fees, inspection fees, construction fees, etc.) prior to the Department's issuance of a license.

H. Fees. The initial and annual license fee shall be $150.00 per operating/procedure room or $600.00, whichever is greater. All fees are non-refundable and shall be made payable to the Department via a secured portal or specific website.

I. Late Fee. Failure to submit a renewal application after the license expiration date may result in a late fee of 25% of the licensing fee amount, in addition to the licensing fee. Continual failure to submit completed and accurate renewal applications and/or fees by the time-period specified by the Department may result in an enforcement action.

J. License Renewal. To renew a license, an applicant shall file an application with the Department and pay a license fee. If the license renewal is delayed due to enforcement action, the renewal license shall be issued only when the matter has been resolved satisfactorily by the Department or when the adjudicatory process is completed, whichever is applicable. If an application is denied, a portion of the fee shall be refunded based upon the remaining months of the licensure year.

K. Change of License.

1. A facility shall request issuance of an amended license by application to the Department prior to any of the following circumstances:

a. Change of ownership;

b. Reallocation of types of operating or procedure rooms as shown on the license;

c. Change of facility location from one geographic site to another;

d. The addition or replacement of a surgical suite or any part thereof, or the deletion of operating or procedure rooms.

2. Changes in facility name or address (as notified by the post office) shall be accomplished by application or by letter from the licensee.

L. An ambulatory surgical facility license shall not be required for, nor shall such a license be issued to:

1. Facilities operated by the federal government;

2. Ambulatory surgical services or procedures provided in licensed hospitals (such services remain within the purview of R.61-16);

3. Private practices (see Section 101.JJ).

M. Exceptions to Licensing Standards. The Department has the authority to make exceptions to these standards where it is determined that the health, safety, and well-being of the patients are not compromised, and provided the standard is not specifically required by statute.

N. Indigent/Charity Care. Any Facility established or constructed after May 16, 2023, and which did not require a Certificate of Need, must provide indigent charity care as described below in Section 103.N.2 after it has been in operation for two calendar years:

1. Annual Reports: After being in operation for two calendar years, a Facility subject to Section 103.N shall submit annual reports in a form prescribed by the Department and located on the Department's website. Further, a Facility subject to Section 103.N shall submit the annual reports by a deadline set by the Department and indicated on the Department's website. The annual reports shall include, but not be limited to the following information:

a. Gross patient revenue;

b. Medicare contractual adjustments;

c. Medicaid contractual adjustments;

d. Other contractual adjustments;

e. Bad debt;

f. Indigent care gross charges;

g. Indigent care compensation;

h. Charity care gross charges;

i. Charity care compensation;

j. Other free care;

k. Other revenue; and

l. Total expenses.

2. Indigent/Charity Care requirements:

a. If the Facility provides care to Medicaid beneficiaries, it must provide uncompensated indigent/charity care to the underinsured or medically indigent in an amount equal to or greater than 2% of its adjusted gross revenue; or

b. If the Facility does not provide care to Medicaid beneficiaries, it must provide uncompensated indigent/charity care to the underinsured or medically indigent in an amount equal to or greater than 3% of its adjusted gross revenue.

c. Noncompliance with Section 103.N.2.a or -b shall result in a monetary penalty in the amount of the difference between the services which the Facility is required to provide and the amount it actually provided.

S.C. Code Regs. § 61-91.100.103

Amended by State Register Volume 39, Issue No. 06, eff. 6/26/2015; State Register Volume 48, Issue No. 06, eff. 6/28/2024.