481—49.2(135R,10A) Application and licensing.
	49.2(1) Application and licensing. An ambulatory surgical center shall obtain a license from the department in accordance with Iowa Code section 135R.2.
	a. 	An ambulatory surgical center seeking licensure will make application on forms provided by the department or through the department’s online application system. Upon receipt of a completed application, including completion of the building and plan review set forth in paragraph 49.2(1)“b,” and receipt of the $50 fee set forth in Iowa Code section 135R.3(3), the application will be considered.
	b. 	An ambulatory surgical center applicant shall submit architectural technical documents, engineering documents, and plans and specifications to the department’s building and construction division in accordance with rule 661—300.4(103A) that demonstrate the applicant’s compliance with the construction and physical environment requirements of subrule 49.4(2). The submission may be completed by an authorized agent of the applicant or the responsible design professional, who shall certify that the building or building plans meet the construction and physical environment standards within subrule 49.4(2) or that a waiver has been granted by the department for any noncompliant standard. If the applicant was operating prior to and continuously since July 1, 2023, the applicant is permitted up to six months after submission of its license application to submit plans demonstrating compliance with subrule 49.4(1) or obtaining waivers for the construction and physical environment standards in accordance with subrule 49.4(2).
	49.2(2) Certificate of need. An ambulatory surgical center will be granted an initial license and is not required to obtain a new certificate of need solely because licensure is mandated by Iowa Code chapter 135R if the ambulatory surgical center was operating prior to and continuously since July 1, 2023. If an ambulatory surgical center beginning or modifying its operations on or after July 1, 2023, would be required to obtain a certificate of need from the health facilities council pursuant to Iowa Code chapter 10A, subchapter VII, part 2, it shall obtain a certificate of need from the health facilities council prior to submitting its license application to the department.
	49.2(3) Renewal, changes of ownership, and changes of information. A license issued pursuant to this chapter expires one year after the date of issuance or as indicated on the license.
	a. 	Renewal. To renew a license, a completed application form shall be submitted to the department 30 days prior to license expiration.
	b. 	Change of ownership. To request a change of ownership, a completed application form shall be submitted to the department for the new owner at least 30 days prior to the proposed effective date of the change of ownership. A change of ownership includes the purchase, transfer, assignment, or lease of the licensed ambulatory surgical center and includes a change in the management company responsible for the day-to-day operation of the ambulatory surgical center if the management company is ultimately responsible for any enforcement action taken by the department. For purposes of determining ownership and whether such changes constitute a change of ownership, the department adopts the Centers for Medicare and Medicaid Services (CMS) State Operations Manual sections 3210.1A and 3210.1D (Rev.	1, 05-21-04).
	c. 	Change of information. The department should be notified of any changes to an applicant’s or licensee’s application information within 30 days of the date the change occurs, including the cessation of operation.
	49.2(4) Public display. The license shall be displayed in a conspicuous place in the ambulatory surgical center viewed by the public.
[ARC 7886C, IAB 5/1/24, effective 6/5/24]