HSB 48 (LSB 1638YC (2) 85)

HOUSE FILE _____

BY  (PROPOSED COMMITTEE ON HUMAN RESOURCES BILL BY CHAIRPERSON MILLER)

A BILL FOR

An Act relating to the licensure of ambulatory surgical centers, providing fees and penalties, and including effective date provisions.
BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA:

    Section 1.  NEW SECTION.  135P.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” does not include individual or group practice offices of private physicians, podiatrists, or dentists 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, podiatrist’s, or dentist’s office using local anesthesia or conscious sedation; 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.  135P.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.  135P.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.  135P.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.
  a.  An application for an initial license for an ambulatory surgical center that is in existence and Medicare-certified prior to July 1, 2014, shall be accompanied by a fee of fifty dollars.
   b.  An application for an initial license for an ambulatory surgical center established on or after July 1, 2014, shall be accompanied by a fee sufficient to cover the costs of performing the inspection required in section 135P.8 in an amount as provided in rules adopted by the department.
    Sec. 5.  NEW SECTION.  135P.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, subsection 21, and may operate under one license.
   6.  A license, unless sooner suspended or revoked, shall expire on December 31 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 dedicated to support the staffing necessary to conduct the inspections and investigations provided in section 135P.8.
    Sec. 6.  NEW SECTION.  135P.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.  135P.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.  135P.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.
   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.  135P.9  Employee background checks.
   1.  An ambulatory surgical center shall comply with child and dependent adult abuse information and criminal record checks and evaluations in the same manner as provided in section 135B.34, except that the authorization of an exemption under section 135B.34, subsection 4, paragraph “b”, from requirements for reevaluation of the latest record checks by the department of human services relative to a person being considered for employment in an ambulatory surgical center is subject to all of the following provisions:
   a.  The position with the ambulatory surgical center is substantially the same or has the same job responsibilities as the position for which the previous evaluation was performed.
   b.  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 employment in the ambulatory surgical center.
   c.  The person subject to the record checks has maintained a copy of the previous evaluation and provides the evaluation to the ambulatory surgical center or the previous employer 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 ambulatory surgical center, the record checks shall be reevaluated.
   d.  Although an exemption may be authorized, the ambulatory surgical center may instead request a reevaluation of the record checks and may employ the person while the reevaluation is being performed.
   2.  An ambulatory surgical center licensed in this state 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.  135P.10  Confidentiality.
   The department’s final findings or the final survey findings of an accrediting body with respect to compliance by an ambulatory surgical center with requirements for licensing or accreditation 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 or the final survey findings of the accrediting body 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.  135P.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.  135P.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.  135P.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 2013, is amended by adding the following new subsection:
   NEW SUBSECTION.  32.  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.  EFFECTIVE DATE.  This Act takes effect July 1, 2014.
EXPLANATION
   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” does not include individual or group practice offices of private physicians, podiatrists, or dentists 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, podiatrist’s, or dentist’s office using local anesthesia or conscious sedation; or a portion of a licensed hospital designated for outpatient surgical treatment. The department of inspections and appeals 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 for an ambulatory surgical center that is in existence and Medicare-certified prior to July 1, 2014, is required to be accompanied by a fee of $50. An application for an initial license for an ambulatory surgical center established on or after July 1, 2014, is required to be accompanied by a fee sufficient to cover the costs of performing the required inspection in an amount provided in rules adopted by the department. 
   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 the department; and is required to be posted in a conspicuous place on the licensed premises as prescribed by rule of the department. 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 shall be 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 December 31 of each year and are required to be renewed annually. The bill directs the department to renew a license upon payment of a $500 annual license renewal fee and filing of an application for renewal at least 30 days prior to the expiration of the existing license. The annual licensure fee is to be dedicated to support the staffing necessary to conduct the inspections and investigations under the Code chapter.
   The bill provides for denial, suspension, or revocation of licenses. A license may be denied, suspended, or revoked if the department finds there has been a substantial failure to comply with the Code chapter or the rules and standards adopted under the Code chapter. 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 Code chapter 17A. The bill authorizes the department, 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 the department to issue an emergency order to suspend a license if the department 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, the department 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 the department’s rules for a contested case hearing and Code chapter 17A. 
   The bill directs the department 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 Code chapter and the conditions for coverage in the federal Medicare program for ambulatory surgical centers. The department is also directed to adopt rules relating to provisions of the 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 the department 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 department 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 department 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 in the same manner as provided for hospitals, but specifically provides that the authorization of an exemption from a reevaluation of the person’s criminal or abuse record prior to commencing employment is subject to specific provisions. The bill also authorizes an ambulatory surgical center to access the single contact repository established by the department as necessary for the ambulatory surgical center to perform record checks of persons employed or being considered for employment by the ambulatory surgical center.
   The bill provides confidentiality provisions relating to ambulatory surgical center information. The final findings or the final survey findings of an accrediting body 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 department 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 $315 but not more than $1,875.
   The bill also directs the department of public health to 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. However, the rules are not to 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.
   The bill takes effect July 1, 2014.