HF 117 (LSB 2074YH (1) 89)

HOUSE FILE 117

BY  BRINK

A BILL FOR

An Act relating to the licensure of ambulatory surgical centers, providing for fees to be considered repayment receipts, and providing penalties.
BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA:

    Section 1.  NEW SECTION.  135Q.1  Definitions.
   As used in this chapter, unless the context otherwise requires:
   1.  “Ambulatory surgical center” means a distinct facility that operates exclusively for the purpose of providing surgical services to patients not requiring hospitalization and in which the expected duration of services does not exceed twenty-four hours following an admission. “Ambulatory surgical center” includes a facility that otherwise meets the definition of an ambulatory surgical center whether or not licensed, certified, or accredited as an ambulatory surgical center and which may or may not operate on a partially cash-only or completely cash-only basis. “Ambulatory surgical center” does not include individual or group practice offices of private physicians or podiatrists that do not contain a distinct area used for outpatient surgical treatment on a regular basis, or that only provide surgery routinely provided in a physician’s or podiatrist’s office using local anesthesia or conscious sedation; individual or group practice offices of private dentists; or a portion of a licensed hospital designated for outpatient surgical treatment. 
   2.  “Department” means the department of inspections and appeals. 
    Sec. 2.  NEW SECTION.  135Q.2  Purpose.
   The purposes of this chapter is to protect the public health, safety, and welfare by providing for the licensing and regulation of ambulatory surgical centers.
    Sec. 3.  NEW SECTION.  135Q.3  Licenses —— application —— fees —— expiration and renewal.
   1.  A person, acting severally or jointly with any other person shall not establish, operate, or maintain an ambulatory surgical center in this state without first meeting the requirements and obtaining a license as provided in this chapter.
   2.  a.  An application for a license shall be on a form prescribed by the department and shall require information the department deems necessary. An application for an initial license for an ambulatory surgical center shall be accompanied by a nonrefundable fee of fifty dollars. The fees collected under this section shall be considered repayment receipts as defined in section 8.2 and shall be used by the department to administer this chapter.
   b.  The ambulatory surgical center shall meet the criteria adopted by rule of the department pursuant to section 135Q.5 before a license is issued. The department is responsible to provide the necessary personnel to inspect the ambulatory surgical center to determine if the ambulatory surgical center complies with necessary standards before a license is issued. 
   3.  An ambulatory surgical center certified under the Medicare program or accredited by an accrediting organization authorized by the centers for Medicare and Medicaid services with deeming authority, shall be licensed without inspection by the department as provided in section 135Q.6.
   4.  A license shall be issued only for the premises and persons named in the application.
   5.  A license is not transferable or assignable except with the written approval of the department. 
   6.  A license shall be posted in a conspicuous place on the licensed premises as prescribed by rule of the department.
   7.  Separate licenses are not required for ambulatory surgical center facilities that are maintained on the same physical site and that have the same ownership or control. Multiple buildings located on the same physical site under the same ownership or control shall be considered one ambulatory surgical center and may operate under one license.
   8.  A license, unless sooner suspended or revoked, shall expire on June 30 of each year and shall be renewed annually. The department shall renew a license upon payment of a fifty dollar annual license renewal fee and filing of an application for renewal at least thirty days prior to the expiration of the existing license. The annual licensure fee shall be considered a repayment receipt as defined in section 8.2 and dedicated to support the staffing necessary to conduct the inspections and investigations provided in section 135Q.6.
    Sec. 4.  NEW SECTION.  135Q.4  Denial, suspension, or revocation of license —— hearings and review.
   1.  The department may deny, suspend, or revoke a license in any case where it finds there has been a substantial failure to comply with this chapter or the rules and standards adopted under this chapter.
   2.  The denial, suspension, or revocation of a license by the department and appeal from that action are governed by the procedures for a contested case hearing under chapter 17A.
   3.  a.  If the department finds, after providing notice of noncompliance and a reasonable time for corrective action, that an ambulatory surgical center is in repeated noncompliance with this chapter or the department’s rules but that noncompliance does not endanger public health or safety, the department may issue a conditional license to the ambulatory surgical center as an alternative to suspending or revoking the ambulatory surgical center’s license.
   b.  The department shall provide notice of its intent to issue a conditional license to the ambulatory surgical center and of the items of noncompliance not less than ten days before the date the conditional license is issued.
   c.  The department shall designate a period of not more than one year during which the ambulatory surgical center may operate under a conditional license.
   d.  During the period an ambulatory surgical center is operating under a conditional license, the ambulatory surgical center shall correct the items that are in noncompliance and report the corrections to the department for approval.
   4.  The department may suspend or revoke the license of an ambulatory surgical center that does not correct items that are in noncompliance or that does not comply with this chapter or the rules adopted under this chapter within the applicable period.
   5.  The department may issue an emergency order to suspend a license issued under this chapter if the department has reasonable cause to believe that the conduct of the ambulatory surgical center creates an immediate danger to the public health and safety. An emergency suspension is effective immediately without a hearing or notice to the licensee. On written request of the licensee, the department shall conduct a hearing not earlier than the tenth day or later than the thirtieth day after the date the hearing request is received to determine if the emergency suspension is to be continued, modified, or rescinded. The hearing and any appeal are governed by the department’s rules for a contested case hearing and chapter 17A. 
    Sec. 5.  NEW SECTION.  135Q.5  Rules.
   1.  The department, with the advice and approval of the state board of health, shall adopt rules specifying the standards for ambulatory surgical centers to be licensed under this chapter. The rules and standards shall be consistent with the requirements of this chapter and the conditions for coverage in the federal Medicare program for ambulatory surgical centers under 42 C.F.R. pt. 416 including those related to the administration of anesthesia and to a safe and sanitary environment in which to perform surgical procedures.
   2.  The department shall adopt rules as the department deems necessary to implement the provisions of this chapter relating to the issuance, renewal, denial, suspension, and revocation of a license to establish, operate, and maintain an ambulatory surgical center. 
   3.  An ambulatory surgical center which is in operation at the time of adoption of any applicable rules or standards under this chapter shall be given a reasonable time, not to exceed one year from the date of adoption, within which to comply with such rules and standards.
    Sec. 6.  NEW SECTION.  135Q.6  Inspections or investigations.
   1.  The department shall make or cause to be made inspections or investigations of ambulatory surgical centers to determine compliance with this chapter and applicable rules and standards. The department shall perform inspections on a schedule that is of the same frequency required for inspections of Medicare-certified ambulatory surgical centers.
   2.  The department shall recognize, in lieu of its own licensure inspection, the comparable inspection and inspection findings of a Medicare conditions for coverage survey completed by the department, or an accrediting organization authorized by the centers for Medicare and Medicaid services of the United States department of health and human services.
   3.  A department inspector shall not participate in an inspection or investigation of an ambulatory surgical center in which the inspector or a member of the inspector’s immediate family works or has worked within the last two years or in which the inspector or the inspector’s immediate family has a financial ownership interest. For the purposes of this section, “immediate family member” means a spouse, natural or adoptive parent or grandparent, child, grandchild, sibling, stepparent, stepchild, or stepsibling.
    Sec. 7.  NEW SECTION.  135Q.7  Ambulatory surgical center employees —— criminal history and abuse record checks.
   The department shall adopt rules pursuant to chapter 17A to provide for the performance of criminal record checks and founded child abuse or dependent adult abuse record checks applicable to prospective employees of an ambulatory surgical center in substantial conformance with the provisions of section 135B.34 and section 135C.33.
    Sec. 8.  NEW SECTION.  135Q.8  Confidentiality.
   The department’s final findings with respect to compliance by an ambulatory surgical center with requirements for licensing shall be made available to the public in a readily available form and place. Other information relating to an ambulatory surgical center obtained by the department which does not constitute the department’s findings from an inspection of the ambulatory surgical center shall not be made available to the public, except in proceedings involving the denial, suspension, or revocation of a license under this chapter. The name of a person who files a complaint with the department shall remain confidential and shall not be subject to discovery, subpoena, or other means of legal compulsion for its release to a person other than department employees or agents involved in the investigation of the complaint.
    Sec. 9.  NEW SECTION.  135Q.9  Injunction.
   Notwithstanding the existence or pursuit of any other remedy, the department may, in the manner provided by law, maintain an action in the name of the state for injunction or other process against any person to restrain or prevent the establishment, operation, or maintenance of an ambulatory surgical center without a license. 
    Sec. 10.  NEW SECTION.  135Q.10  Judicial review.
   Judicial review of an action of the department may be sought in accordance with chapter 17A. Notwithstanding the provisions of chapter 17A, petitions for judicial review may be filed in the district court of the county in which the ambulatory surgical center is located or is to be located and the status quo of the petitioner or licensee shall be preserved pending final disposition of the judicial review matter.
    Sec. 11.  NEW SECTION.  135Q.11  Penalties.
   Any person establishing, operating, or maintaining any ambulatory surgical center without a license commits a serious misdemeanor, and each day of continuing violation after conviction shall be considered a separate offense. 
EXPLANATION
The inclusion of this explanation does not constitute agreement with
the explanation’s substance by the members of the general assembly.
   This bill creates a new Code chapter to provide for the licensing and regulation of ambulatory surgical centers.
   The bill defines “ambulatory surgical center” as a distinct facility that operates exclusively for the purpose of providing surgical services to patients not requiring hospitalization and in which the expected duration of services does not exceed 24 hours following an admission. “Ambulatory surgical center” includes a facility that otherwise meets the definition of an ambulatory surgical center whether or not licensed, certified, or accredited as an ambulatory surgical center and which may or may not operate on a partially cash-only or completely cash-only basis. “Ambulatory surgical center” does not include individual or group practice offices of private physicians or podiatrists that do not contain a distinct area used for outpatient surgical treatment on a regular basis, or that only provide surgery routinely provided in a physician’s or podiatrist’s office using local anesthesia or conscious sedation; individual or group practice offices of dentists; or a portion of a licensed hospital designated for outpatient surgical treatment. 
   The bill prohibits the establishment, operation, or maintenance of an ambulatory surgical center in the state without meeting the requirements of the new Code chapter and obtaining a license.
   The bill provides for the application for licensure, the issuance and renewal of a license, and the denial, suspension, or revocation of a license, and the associated processes, and for the imposition and payment of associated fees.
   The bill directs the department of inspections and appeals (DIA) to adopt rules with the advice and approval of the state board of health to specify the standards for ambulatory surgical centers. The rules and standards are required to be consistent with the requirements of the Code chapter and the conditions for coverage in the federal Medicare program for ambulatory surgical centers. DIA is also directed to adopt rules relating to the issuance, renewal, denial, suspension, and revocation of a license to establish, operate, and maintain an ambulatory surgical center. If an ambulatory surgical center is in operation at the time of adoption of any applicable rules or standards, the center is to be given a reasonable time, not to exceed one year from the date of adoption, within which to comply with such rules and standards.
   The bill provides for inspections or investigations of ambulatory surgical centers, and directs that the DIA shall perform inspections on a schedule that is of the same frequency required for inspections of Medicare-certified ambulatory surgical centers. The bill also requires the DIA to recognize, in lieu of its own licensure inspection, the comparable inspection and inspection findings of a Medicare conditions for coverage survey completed by the department or a national accreditation agency authorized by the centers for Medicare and Medicaid services of the United States department of health and human services.
   The bill prohibits a DIA inspector from participating in an inspection or investigation of an ambulatory surgical center in which the inspector or a member of the inspector’s immediate family works or has worked within the last two years or in which the inspector or the inspector’s immediate family has a financial ownership interest.
   The bill requires DIA to adopt administrative rules to provide for the performance of criminal record checks and founded child abuse or dependent adult abuse record checks applicable to employees of an ambulatory surgical center in substantial conformance with the record checks applicable to facilities and providers under Code sections 135B.34 (hospital employees —— criminal history and abuse record checks —— penalty) and 135C.33 (employees and certified nurse aide trainees —— child or dependent adult abuse information and criminal record checks —— evaluations —— application to other providers —— penalty).
   The bill provides confidentiality provisions relating to ambulatory surgical center information. The final findings with respect to compliance by an ambulatory surgical center are to be made available to the public in a readily available form and place. Other information relating to an ambulatory surgical center shall not be made available to the public, except in proceedings involving the denial, suspension, or revocation of a license. The name of a person who files a complaint with the DIA is required to remain confidential and not be subject to discovery, subpoena, or other means of legal compulsion. 
   The bill provides for injunctive relief and judicial review.
   The bill provides that any person establishing, operating, or maintaining an ambulatory surgical center without a license commits a serious misdemeanor, and each day of continuing violation after conviction shall be considered a separate offense. A serious misdemeanor is punishable by confinement for no more than one year and a fine of at least $430 but not more than $2,560.