H.F. 2066 Section 1. NEW SECTION . 135Q.1 Definitions. 1 As used in this chapter, unless the context otherwise 2 requires: 3 1. “Ambulatory surgical center” means a distinct facility 4 that operates exclusively for the purpose of providing surgical 5 services to patients not requiring hospitalization and in which 6 the expected duration of services does not exceed twenty-four 7 hours following an admission. “Ambulatory surgical center” does 8 not include individual or group practice offices of private 9 physicians or podiatrists that do not contain a distinct area 10 used for outpatient surgical treatment on a regular basis, or 11 that only provide surgery routinely provided in a physician’s 12 or podiatrist’s office using local anesthesia or conscious 13 sedation; individual or group practice offices of private 14 dentists; or a portion of a licensed hospital designated for 15 outpatient surgical treatment. 16 2. “Department” means the department of inspections and 17 appeals. 18 Sec. 2. NEW SECTION . 135Q.2 Licenses —— application —— fees 19 —— expiration and renewal. 20 1. A person, acting severally or jointly with any other 21 person shall not establish, operate, or maintain an ambulatory 22 surgical center in this state without first meeting the 23 requirements and obtaining a license as provided in this 24 chapter. 25 2. a. An application for a license shall be on a form 26 prescribed by the department and shall require information the 27 department deems necessary. Each application for a license 28 shall be accompanied by a nonrefundable annual license fee as 29 determined by the department. The fees collected under this 30 section shall be considered repayment receipts as defined in 31 section 8.2 and shall be used by the department to administer 32 this chapter. 33 b. The ambulatory surgical center shall meet the criteria 34 adopted by rule of the department pursuant to section 135Q.4 35 -1- LSB 5566YH (8) 88 pf/rh 1/ 8

H.F. 2066 before a license is issued. The department is responsible 1 to provide the necessary personnel to inspect the ambulatory 2 surgical center to determine if the ambulatory surgical center 3 complies with necessary standards before a license is issued. 4 3. An ambulatory surgical center certified under the 5 Medicare program or accredited by an accrediting organization 6 authorized by the centers for Medicare and Medicaid services 7 with deeming authority, shall be licensed without inspection by 8 the department as provided in section 135Q.5. 9 4. A license shall be issued only for the premises and 10 persons named in the application. 11 5. A license is not transferable or assignable except with 12 the written approval of the department. 13 6. Separate licenses are not required for ambulatory 14 surgical center facilities that are maintained on the same 15 physical site and that have the same ownership or control. 16 Multiple buildings located on the same physical site under the 17 same ownership or control shall be considered one ambulatory 18 surgical center facility for purposes of this chapter and 19 section 135.61, subsection 1A, and may operate under one 20 license. 21 7. A license, unless sooner suspended or revoked, shall 22 expire on June 30 of each year and shall be renewed annually. 23 The department shall renew a license upon payment of a five 24 hundred dollar annual license renewal fee and filing of an 25 application for renewal at least thirty days prior to the 26 expiration of the existing license. The annual licensure fee 27 shall be considered a repayment receipt as defined in section 28 8.2 and dedicated to support the staffing necessary to conduct 29 the inspections and investigations provided in section 135Q.5. 30 Sec. 3. NEW SECTION . 135Q.3 Denial, suspension, or 31 revocation of license —— hearings and review. 32 1. The department may deny, suspend, or revoke a license in 33 any case where it finds there has been a substantial failure 34 to comply with this chapter or the rules and standards adopted 35 -2- LSB 5566YH (8) 88 pf/rh 2/ 8

H.F. 2066 under this chapter. 1 2. The denial, suspension, or revocation of a license by 2 the department and appeal from that action are governed by the 3 procedures for a contested case hearing under chapter 17A. 4 3. a. If the department finds, after providing notice of 5 noncompliance and a reasonable time for corrective action, that 6 an ambulatory surgical center is in repeated noncompliance with 7 this chapter or the department’s rules but that noncompliance 8 does not endanger public health or safety, the department may 9 issue a conditional license to the ambulatory surgical center 10 as an alternative to suspending or revoking the ambulatory 11 surgical center’s license. 12 b. The department shall provide notice of its intent to 13 issue a conditional license to the ambulatory surgical center 14 and of the items of noncompliance not less than ten days before 15 the date the conditional license is issued. 16 c. The department shall designate a period of not more 17 than one year during which the ambulatory surgical center may 18 operate under a conditional license. 19 d. During the period an ambulatory surgical center is 20 operating under a conditional license, the ambulatory surgical 21 center shall correct the items that are in noncompliance and 22 report the corrections to the department for approval. 23 4. The department may suspend or revoke the license of an 24 ambulatory surgical center that does not correct items that 25 are in noncompliance or that does not comply with this chapter 26 or the rules adopted under this chapter within the applicable 27 period. 28 5. The department may issue an emergency order to suspend 29 a license issued under this chapter if the department has 30 reasonable cause to believe that the conduct of the ambulatory 31 surgical center creates an immediate danger to the public 32 health and safety. An emergency suspension is effective 33 immediately without a hearing or notice to the licensee. On 34 written request of the licensee, the department shall conduct 35 -3- LSB 5566YH (8) 88 pf/rh 3/ 8

H.F. 2066 a hearing not earlier than the tenth day or later than the 1 thirtieth day after the date the hearing request is received 2 to determine if the emergency suspension is to be continued, 3 modified, or rescinded. The hearing and any appeal are 4 governed by the department’s rules for a contested case hearing 5 and chapter 17A. 6 Sec. 4. NEW SECTION . 135Q.4 Rules. 7 1. The department, with the advice and approval of the state 8 board of health, shall adopt rules specifying the standards 9 for ambulatory surgical centers to be licensed under this 10 chapter. The rules and standards shall be consistent with the 11 requirements of this chapter and the conditions for coverage 12 in the federal Medicare program for ambulatory surgical 13 centers under 42 C.F.R. pt. 416 including those related to 14 the administration of anesthesia and to a safe and sanitary 15 environment in which to perform surgical procedures. 16 2. The department shall adopt rules as the department deems 17 necessary to implement the provisions of this chapter relating 18 to the issuance, renewal, denial, suspension, and revocation 19 of a license to establish, operate, and maintain an ambulatory 20 surgical center. 21 3. An ambulatory surgical center which is in operation at 22 the time of adoption of any applicable rules or standards under 23 this chapter shall be given a reasonable time, not to exceed 24 one year from the date of adoption, within which to comply with 25 such rules and standards. 26 Sec. 5. NEW SECTION . 135Q.5 Inspections or investigations. 27 1. The department shall make or cause to be made inspections 28 or investigations of ambulatory surgical centers to determine 29 compliance with this chapter and applicable rules and 30 standards. The department shall perform inspections on a 31 schedule that is of the same frequency required for inspections 32 of Medicare-certified ambulatory surgical centers. 33 2. The department shall recognize, in lieu of its own 34 licensure inspection, the comparable inspection and inspection 35 -4- LSB 5566YH (8) 88 pf/rh 4/ 8

H.F. 2066 findings of a Medicare conditions for coverage survey completed 1 by the department, the joint commission, the health care 2 facilities accreditation program, or det norske veritas 3 healthcare, inc. 4 3. A department inspector shall not participate in an 5 inspection or investigation of an ambulatory surgical center in 6 which the inspector or a member of the inspector’s immediate 7 family works or has worked within the last two years or in 8 which the inspector or the inspector’s immediate family has 9 a financial ownership interest. For the purposes of this 10 section, “immediate family member” means a spouse, natural or 11 adoptive parent or grandparent, child, grandchild, sibling, 12 stepparent, stepchild, or stepsibling. 13 Sec. 6. NEW SECTION . 135Q.6 Confidentiality. 14 The department’s final findings with respect to compliance 15 by an ambulatory surgical center with requirements for 16 licensing shall be made available to the public in a readily 17 available form and place. Other information relating to 18 an ambulatory surgical center obtained by the department 19 which does not constitute the department’s findings from an 20 inspection of the ambulatory surgical center shall not be made 21 available to the public, except in proceedings involving the 22 denial, suspension, or revocation of a license under this 23 chapter. The name of a person who files a complaint with the 24 department shall remain confidential and shall not be subject 25 to discovery, subpoena, or other means of legal compulsion for 26 its release to a person other than department employees or 27 agents involved in the investigation of the complaint. 28 Sec. 7. NEW SECTION . 135Q.7 Injunction. 29 Notwithstanding the existence or pursuit of any other 30 remedy, the department may, in the manner provided by law, 31 maintain an action in the name of the state for injunction 32 or other process against any person to restrain or prevent 33 the establishment, operation, or maintenance of an ambulatory 34 surgical center without a license. 35 -5- LSB 5566YH (8) 88 pf/rh 5/ 8

H.F. 2066 Sec. 8. NEW SECTION . 135Q.8 Judicial review. 1 Judicial review of an action of the department may be sought 2 in accordance with chapter 17A. Notwithstanding the provisions 3 of chapter 17A, petitions for judicial review may be filed 4 in the district court of the county in which the ambulatory 5 surgical center is located or is to be located and the status 6 quo of the petitioner or licensee shall be preserved pending 7 final disposition of the judicial review matter. 8 Sec. 9. NEW SECTION . 135Q.9 Penalties. 9 Any person establishing, operating, or maintaining any 10 ambulatory surgical center without a license commits a serious 11 misdemeanor, and each day of continuing violation after 12 conviction shall be considered a separate offense. 13 Sec. 10. Section 135.61, Code 2020, is amended by adding the 14 following new subsection: 15 NEW SUBSECTION . 1A. “Ambulatory surgical center” means 16 ambulatory surgical center as defined in section 135Q.1. 17 Sec. 11. Section 135.61, subsection 14, paragraph d, Code 18 2020, is amended to read as follows: 19 d. An outpatient ambulatory surgical facility center . 20 Sec. 12. Section 135.61, subsection 21, Code 2020, is 21 amended by striking the subsection. 22 EXPLANATION 23 The inclusion of this explanation does not constitute agreement with 24 the explanation’s substance by the members of the general assembly. 25 This bill creates a new Code chapter to provide for the 26 licensing and regulation of ambulatory surgical centers. 27 The bill defines “ambulatory surgical center” as a distinct 28 facility that operates exclusively for the purpose of providing 29 surgical services to patients not requiring hospitalization 30 and in which the expected duration of services does not 31 exceed 24 hours following an admission. “Ambulatory surgical 32 center” does not include individual or group practice offices 33 of private physicians or podiatrists that do not contain a 34 distinct area used for outpatient surgical treatment on a 35 -6- LSB 5566YH (8) 88 pf/rh 6/ 8

H.F. 2066 regular basis, or that only provide surgery routinely provided 1 in a physician’s or podiatrist’s office using local anesthesia 2 or conscious sedation; individual or group practice offices of 3 dentists; or a portion of a licensed hospital designated for 4 outpatient surgical treatment. The department of inspections 5 and appeals (DIA) is designated to enforce the Code chapter. 6 The bill prohibits the establishment, operation, or 7 maintenance of an ambulatory surgical center in the state 8 without obtaining a license. 9 The bill provides for the application for licensure, the 10 issuance and renewal of a license, and the denial, suspension, 11 or revocation of a license, and the associated processes, and 12 for the imposition and payment of associated fees. 13 The bill directs DIA to adopt rules with the advice and 14 approval of the state board of health to specify the standards 15 for ambulatory surgical centers. The rules and standards are 16 required to be consistent with the requirements of the Code 17 chapter and the conditions for coverage in the federal Medicare 18 program for ambulatory surgical centers. DIA is also directed 19 to adopt rules relating to the issuance, renewal, denial, 20 suspension, and revocation of a license to establish, operate, 21 and maintain an ambulatory surgical center. If an ambulatory 22 surgical center is in operation at the time of adoption of 23 any applicable rules or standards, the center is to be given 24 a reasonable time, not to exceed one year from the date of 25 adoption, within which to comply with such rules and standards. 26 The bill provides for inspections or investigations of 27 ambulatory surgical centers, and directs that the DIA shall 28 perform inspections on a schedule that is of the same frequency 29 required for inspections of Medicare-certified ambulatory 30 surgical centers. The bill also requires the DIA to recognize, 31 in lieu of its own licensure inspection, the comparable 32 inspection and inspection findings of a Medicare conditions 33 for coverage survey completed by the department or a specified 34 national accreditation agency. 35 -7- LSB 5566YH (8) 88 pf/rh 7/ 8

H.F. 2066 The bill prohibits a DIA inspector from participating in an 1 inspection or investigation of an ambulatory surgical center in 2 which the inspector or a member of the inspector’s immediate 3 family works or has worked within the last two years or in 4 which the inspector or the inspector’s immediate family has a 5 financial ownership interest. 6 The bill provides confidentiality provisions relating to 7 ambulatory surgical center information. The final findings 8 with respect to compliance by an ambulatory surgical center 9 are to be made available to the public in a readily available 10 form and place. Other information relating to an ambulatory 11 surgical center shall not be made available to the public, 12 except in proceedings involving the denial, suspension, or 13 revocation of a license. The name of a person who files a 14 complaint with the DIA is required to remain confidential and 15 not be subject to discovery, subpoena, or other means of legal 16 compulsion. 17 The bill provides for injunctive relief and judicial review. 18 The bill provides that any person establishing, operating, 19 or maintaining an ambulatory surgical center without a license 20 commits a serious misdemeanor, and each day of continuing 21 violation after conviction shall be considered a separate 22 offense. A serious misdemeanor is punishable by confinement 23 for no more than one year and a fine of at least $315 but not 24 more than $1,875. 25 The bill makes conforming changes in the Code to reflect the 26 terminology of “ambulatory surgical center”. 27 -8- LSB 5566YH (8) 88 pf/rh 8/ 8