HF 2388 (LSB 5832HV (3) 89)

HOUSE FILE 2388

BY  COMMITTEE ON STATE GOVERNMENT

(SUCCESSOR TO HSB 606)

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 admission. “Ambulatory surgical center” includes a facility certified or seeking certification as an ambulatory surgical center under the federal Medicare program or under the medical assistance program established pursuant to chapter 249A. “Ambulatory surgical center” does not include the individual or group practice office of a private physician, podiatrist, or dentist who there engages in the lawful practice of surgery, or the 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 purpose 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  Licensure.
   A person, acting severally or jointly with any other person, shall not establish, operate, or maintain an ambulatory surgical center in this state without obtaining a license as provided under this chapter.
    Sec. 4.  NEW SECTION.  135Q.4  Application for license —— fee.
   1.  An applicant for an ambulatory surgical center license shall submit an application to the department. Applications shall be upon such forms and shall include such information as the department may reasonably require, which may include affirmative evidence of ability to comply with reasonable rules and standards prescribed under this chapter.
   2.  An application for an initial license for an ambulatory surgical center shall be accompanied by a fee of fifty dollars.
   3.  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.
    Sec. 5.  NEW SECTION.  135Q.5  Issuance and renewal of license.
   1.  Upon receipt of an application for license and the license fee, the department shall issue a license if the applicant and the ambulatory surgical center meet the requirements of this chapter and the rules adopted by the department.
   2.  A license shall be issued only for the premises and persons named in the application.
   3.  A license is not transferable or assignable except with the written approval of the department.
   4.  A license shall be posted in a conspicuous place on the licensed premises as prescribed by rule of the department.
   5.  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 facility for purposes of this chapter and section 135.61, and may operate under one license.
   6.  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 five hundred 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.8.
    Sec. 6.  NEW SECTION.  135Q.6  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. 7.  NEW SECTION.  135Q.7  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 shall be consistent with and shall not exceed 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.
   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.
   4.  The department shall enforce the rules. 
    Sec. 8.  NEW SECTION.  135Q.8  Inspections.
   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 with deeming authority.
   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. 9.  NEW SECTION.  135Q.9  Employee background checks penalty.
   1.  a.  Prior to employment of a person in an ambulatory surgical center, the ambulatory surgical center shall request that the department of public safety perform a criminal history check and the department of human services perform child and dependent adult abuse record checks of the person in this state. An ambulatory surgical center shall inform all persons prior to employment regarding the performance of the record checks and shall obtain from the persons a signed acknowledgment of the receipt of the information.
   b.  An ambulatory surgical center shall include the following inquiry in an application for employment:
  Do you have a record of founded child or dependent adult abuse or have you ever been convicted of a crime, in this state or any other state?

   2.  a.  If it is determined that a person being considered for employment in an ambulatory surgical center has been convicted of a crime, the department of public safety shall notify the ambulatory surgical center that upon the request of the ambulatory surgical center the department of human services will perform an evaluation to determine whether the crime warrants prohibition of the person’s employment in the ambulatory surgical center.
   b.  If a department of human services child or dependent adult abuse record check shows that the person has a record of founded child or dependent adult abuse, the department of human services shall notify the ambulatory surgical center that upon the request of the ambulatory surgical center the department of human services will perform an evaluation to determine whether the founded child or dependent adult abuse warrants prohibition of the person’s employment in the ambulatory surgical center.
   c.  An evaluation performed under this subsection shall be performed in accordance with procedures adopted for this purpose by the department of human services.
   d.  (1)  If a person owns or operates more than one ambulatory surgical center, and an employee of one of such ambulatory surgical centers is transferred to another such ambulatory surgical center without a lapse in employment, the ambulatory surgical center is not required to request additional criminal and child and dependent adult abuse record checks of that employee.
   (2)  If the ownership of an ambulatory surgical center is transferred, at the time of transfer the record checks required by this section shall be performed for each employee for whom there is no documentation that such record checks have been performed. The ambulatory surgical center may continue to employ such employee pending the performance of the record checks and any related evaluation.
   3.  In an evaluation, the department of human services shall consider the nature and seriousness of the crime or founded child or dependent adult abuse in relation to the position sought or held, the time elapsed since the commission of the crime or founded child or dependent adult abuse, the circumstances under which the crime or founded child or dependent adult abuse was committed, the degree of rehabilitation, the likelihood that the person will commit the crime or founded child or dependent adult abuse again, and the number of crimes or founded child or dependent adult abuses committed by the person involved. If the department of human services performs an evaluation for the purposes of this section, the department of human services has final authority in determining whether prohibition of the person’s employment is warranted.
   4.  a.  Except as provided in paragraph “b” and subsection 2, a person who has been convicted of a crime or has a record of founded child or dependent adult abuse shall not be employed in an ambulatory surgical center licensed under this chapter unless an evaluation has been performed by the department of human services.
   b.  A person with a criminal or abuse record who is or was employed by an ambulatory surgical center licensed under this chapter and is hired by an employer who is another licensee without a lapse in employment shall be subject to the criminal history and abuse record checks required pursuant to subsection 1. However, if an evaluation was previously performed by the department of human services concerning the person’s criminal or abuse record and it was determined that the record did not warrant prohibition of the person’s employment and the latest record checks do not indicate a crime was committed or founded abuse record was entered subsequent to that evaluation, the person may commence employment with the other licensee in accordance with the department of human services’ evaluation and an exemption from the requirements in paragraph “a” for reevaluation of the latest record checks is authorized. Otherwise, the requirements of paragraph “a” remain applicable to the person’s employment. Authorization of an exemption under this lettered paragraph “b” from requirements for reevaluation of the latest record checks by the department of human services is subject to all of the following provisions:
   (1)  The position with the subsequent employer is substantially the same or has the same job responsibilities as the position for which the previous evaluation was performed.
   (2)  Any restrictions placed on the person’s employment in the previous evaluation by the department of human services shall remain applicable in the person’s subsequent employment.
   (3)  The person subject to the record checks has maintained a copy of the previous evaluation and provides the evaluation to the subsequent employer or the previous licensee provides the previous evaluation from the person’s personnel file pursuant to the person’s authorization. If a physical copy of the previous evaluation is not provided to the subsequent employer the record checks shall be reevaluated.
   (4)  Although an exemption under this lettered paragraph “b” may be authorized, the subsequent employer may instead request a reevaluation of the record checks and may employ the person while the reevaluation is being performed.
   5.  a.  If a person employed by an ambulatory surgical center licensed under this chapter is convicted of a crime or has a record of founded child or dependent adult abuse entered in the abuse registry after the person’s employment application date, the person shall inform the ambulatory surgical center of such information within forty-eight hours of the criminal conviction or entry of the record of founded child or dependent adult abuse. The ambulatory surgical center shall act to verify the information within forty-eight hours of notification. If the information is verified, the requirements of subsections 2, 3, and 4 regarding employability and evaluations shall be applied by the ambulatory surgical center to determine whether or not the person’s employment is continued. The ambulatory surgical center may continue to employ the person pending the performance of an evaluation by the department of human services to determine whether prohibition of the person’s employment is warranted. A person who is required by this subsection to inform the ambulatory surgical center of a conviction or entry of an abuse record and fails to do so within the required period commits a serious misdemeanor.
   b.  If an ambulatory surgical center receives credible information, as determined by the ambulatory surgical center, that a person employed by the ambulatory surgical center has been convicted of a crime or a record of founded child or dependent adult abuse has been entered in the abuse registry after employment from a person other than the employee and the employee has not informed the ambulatory surgical center of such information within the period required under paragraph “a”, the ambulatory surgical center shall act to verify the credible information within forty-eight hours of receipt of the credible information. If the information is verified, the requirements of subsections 2, 3, and 4 regarding employability and evaluations shall be applied by the ambulatory surgical center to determine whether or not the person’s employment is continued.
   c.  The ambulatory surgical center may notify the county attorney for the county where the ambulatory surgical center is located of any violation or failure by an employee to notify the ambulatory surgical center of a criminal conviction or entry of an abuse record within the period required under paragraph “a”.
   6.  An ambulatory surgical center licensed under this chapter may access the single contact repository established by the department pursuant to section 135C.33 as necessary for the ambulatory surgical center to perform record checks of persons employed or being considered for employment by the ambulatory surgical center.
    Sec. 10.  NEW SECTION.  135Q.10  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. 11.  NEW SECTION.  135Q.11  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. 12.  NEW SECTION.  135Q.12  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. 13.  NEW SECTION.  135Q.13  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. 
    Sec. 14.  Section 135.11, Code 2022, is amended by adding the following new subsection:
   NEW SUBSECTION.  29.  Adopt rules requiring ambulatory surgical centers to report quality data to the department of public health that is consistent with the data required to be reported to the centers for Medicare and Medicaid services of the United States department of health and human services as authorized by the Medicare Improvements and Extension Act of 2006 under Title I of the Tax Relief and Health Care Act of 2006, Pub. L. No. 109-432, and the regulations adopted under such Acts. Notwithstanding any provision of law to the contrary, nothing in this subsection shall require an ambulatory surgical center to provide health data to the department of public health or any other public or private entity that is in addition to, different than, or exceeds the quality data required to be reported to the centers for Medicare and Medicaid services of the United States department of health and human services.
    Sec. 15.  Section 135.61, Code 2022, is amended by adding the following new subsection:
   NEW SUBSECTION.  1A.  “Ambulatory surgical center” means ambulatory surgical center as defined in section 135Q.1.
    Sec. 16.  Section 135.61, subsection 14, paragraph d, Code 2022, is amended to read as follows:
   d.  An outpatient ambulatory surgical facility center.
    Sec. 17.  Section 135.61, subsection 21, Code 2022, is amended by striking the subsection.
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 department of inspections and appeals (DIA) is designated to enforce the regulations.
   The bill provides that the purpose of the new Code chapter is to protect the public health, safety, and welfare by providing for the licensing and regulation of ambulatory surgical centers. The bill prohibits the establishment, operation, or maintenance of an ambulatory surgical center in the state without obtaining a license.
   The bill provides the process for application for licensure. An application for an initial license is required to be accompanied by a fee of $50. The fees collected are repayment receipts and are to be used by DIA to administer the new Code chapter.
   The bill provides for the issuance and renewal of licenses. A license is to be issued only for the premises and persons named in the application; is not transferable or assignable except with the written approval of DIA; and is required to be posted in a conspicuous place on the licensed premises as prescribed by rule of DIA. The bill provides that 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 are considered one ambulatory surgical center facility for purposes of the new Code chapter and Code chapter 135, division VI, relating to the health facilities council and certificate of need provisions, and are to be permitted to operate under one license. Licenses expire on June 30 of each year and are required to be renewed annually. The bill directs DIA to renew a license upon payment of a $500 annual license renewal fee and the filing of an application for renewal at least 30 days prior to the expiration of the existing license. The annual licensure fee is considered a repayment receipt and is to be dedicated to support the staffing necessary to conduct the inspections and investigations under the new Code chapter.
   The bill provides for denial, suspension, or revocation of licenses. A license may be denied, suspended, or revoked if DIA finds there has been a substantial failure to comply with the new Code chapter or the rules and standards adopted under the new Code chapter. The denial, suspension, or revocation of a license by DIA and appeal from that action are governed by the procedures for a contested case hearing under Code chapter 17A. The bill authorizes DIA, after providing notice of noncompliance and a reasonable time for corrective action, and if the noncompliance does not endanger public health or safety, to issue a conditional license to the ambulatory surgical center as an alternative to suspending or revoking its license.
   The bill also authorizes DIA to issue an emergency order to suspend a license if DIA has reasonable cause to believe that the conduct of the ambulatory surgical center creates an immediate danger to the public health or safety. On written request of the licensee, DIA is required to conduct a hearing to determine if the emergency suspension is to be continued, modified, or rescinded. The hearing and any appeal are governed by DIA’s rules for a contested case hearing and Code chapter 17A.
   The bill directs 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 are required to be consistent with and not exceed the requirements of the new 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 provisions of the new Code chapter 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 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 DIA to recognize, in lieu of its own licensure inspection, the comparable inspection and inspection findings of a Medicare conditions for coverage survey.
   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 an ambulatory surgical center to comply with child and dependent adult abuse information and criminal record checks and evaluations.
   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 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.
   The bill also directs the department of public health (DPH) to adopt rules requiring ambulatory surgical centers to report quality data to DPH that is consistent with the data required to be reported to the centers for Medicare and Medicaid services of the United States department of health and human services. However, the rules shall not require an ambulatory surgical center to provide health data to DPH or any other public or private entity that is in addition to, different than, or exceeds the quality data required to be reported to the centers for Medicare and Medicaid services of the United States department of health and human services.
   The bill makes conforming changes in the Code to reflect the terminology of “ambulatory surgical center”.