TITLE 410 INDIANA DEPARTMENT OF HEALTH
Notice of First Public Comment Period
LSA Document #24-370
RURAL EMERGENCY HOSPITAL LICENSURE
The Indiana Department of Health (department) is soliciting public comment on adding new rules at
410 IAC 15.2 to establish the process to obtain a license to operate a rural emergency hospital (REH) in Indiana and for the department to regulate REHs following licensure. The new rules are required by House Enrolled Act 1457, passed in 2023 (P.L. 147-2023). The department seeks comment on the affected citations listed and any other provisions of Title 410 that may be affected by this rulemaking.
Basic Purpose and Background
The Centers for Medicare and Medicaid Services (CMS) established federal Conditions of Participation for REHs on January 1, 2023. P.L. 147-2023 requires the department to license and regulate REHs. The proposed rule is necessary for Indiana to continue to have state jurisdiction over REHs and regulate this newly created type of institution.
The proposed rule provides for the orderly conversion of rural critical access hospitals to REHs. The rule establishes relevant definitions; a process for licensure of REHs; a mandate for compliance with federal and state law; the process for application for, review of, and approval or denial, or both, of an REH license; the issuance of an REH license; fees to be paid by applicants; notice requirements; enforcement actions the department may take against REHs; a process for probationary licenses; and a scheme for surveys to be performed by the department.
For purposes of
IC 4-22-2-28.1, small businesses affected by this rulemaking may contact the Small Business Regulatory Coordinator:
Ann Z. Knotek
Staff Attorney
Indiana Department of Health
2 North Meridian Street
Indianapolis, IN 46204
(317) 233-7874
aknotek@health.in.gov
Matthew Jaworowski
Small Business Ombudsman
Indiana Economic Development Corporation
One North Capitol, Suite 700
Indianapolis, IN 46204
(317) 650-0126
majaworowski@iedc.in.gov
Resources available to regulated entities through the small business ombudsman include the ombudsman's duties stated in
IC 5-28-17-6, specifically
IC 5-28-17-6(9), investigating and attempting to resolve any matter regarding compliance by a small business with a law, rule, or policy administered by a state agency, either as a party to a proceeding or as a mediator.
REQUEST FOR PUBLIC COMMENT
The department is soliciting public comment on the proposed rule. Comments may be submitted in one of the following ways:
(1) By mail or common carrier to the following address:
LSA Document #24-370 Rural Emergency Hospital Licensure
Cody Smith
Office of Legal Affairs
2 North Meridian Street
Indianapolis, IN 46204
(2) By email to aknotek@health.in.gov; reference 'Rural Emergency Hospital Rule COMMENT' in the subject line.
(3) Attend scheduled public hearing.
All comments must be postmarked or time stamped not later than October 25, 2024.
The rule, Regulatory Analysis, appendices referenced in the Regulatory Analysis, and materials incorporated by reference (if applicable) are on file at the Indiana Department of Health, 2 North Meridian Street, Indianapolis, Indiana and are available for public inspection. Copies of the rule, Regulatory Analysis, and appendices referenced in the Regulatory Analysis are available at the Indiana Department of Health office.
If the department does not receive substantive comments during the public comment period or public hearing, the rule may be adopted with text that is the same as or does not substantially differ from the text of the proposed rule published in this notice.
ARTICLE 15.2. RURAL EMERGENCY HOSPITALS
Rule 1. Definitions
Authority:
IC 16-19-3-4
Sec. 1. The definitions in this rule apply throughout this article.
(Indiana Department of Health; 410 IAC 15.2-1-1)
Authority:
IC 16-19-3-4
Sec. 2. "CMS" means the United States Centers for Medicare and Medicaid Services.
(Indiana Department of Health; 410 IAC 15.2-1-2)
Authority:
IC 16-19-3-4
Sec. 3. "Commissioner" means the state health commissioner or the state health commissioner's designee.
(Indiana Department of Health; 410 IAC 15.2-1-3)
Authority:
IC 16-19-3-4
Sec. 4. "Department" means the Indiana department of health.
(Indiana Department of Health; 410 IAC 15.2-1-4)
Authority:
IC 16-19-3-4
(Indiana Department of Health; 410 IAC 15.2-1-5)
410 IAC 15.2-1-6 "Rural emergency hospital" defined
Authority:
IC 16-19-3-4
Sec. 6. "Rural emergency hospital" has the meaning set forth in IC 16-18-2-320.5.
(Indiana Department of Health; 410 IAC 15.2-1-6)
Rule 2. Licensure of Rural Emergency Hospitals
Authority:
IC 16-19-3-4
Sec. 1. (a) A license must be obtained from the commissioner under IC 4-21.5-3-5 before:
(1) establishing;
(2) conducting;
(3) operating; or
(4) maintaining;
a rural emergency hospital (REH). An REH may not operate as a rural emergency hospital without a license issued by the commissioner.
(b) A license to operate an REH:
(1) expires two (2) years after the date of issuance unless otherwise stated in this article;
(2) is not assignable or transferable;
(3) is issued only for the premises named in the application; and
(4) must be posted in a conspicuous place in the facility.
(c) After an REH is closed, the license shall be returned to the department.
(Indiana Department of Health; 410 IAC 15.2-2-1)
410 IAC 15.2-2-2 Compliance with federal and state law
Authority:
IC 16-19-3-4
Sec. 2. (a) Rural emergency hospitals (REHs) shall comply with the following:
(1) The terms and participation requirements of REHs as set forth by CMS.
(2) Applicable Indiana statutes and regulations for hospitals relating to outpatient services the REH provides.
(b) An REH shall immediately notify the department if the REH is no longer operating as a rural emergency hospital under CMS.
(Indiana Department of Health; 410 IAC 15.2-2-2)
Authority:
IC 16-19-3-4
Sec. 3. (a) To obtain a license to operate a rural emergency hospital (REH), an application for a license to operate shall be submitted to the department within thirty (30) days after receiving certification as an REH by CMS.
(b) The license application must include the following:
(1) An application for a license to operate an REH on a form prescribed by the department.
(2) Documents required by the department as prescribed on the application for a license to operate an REH, including a copy of the documentation of REH status certification by CMS.
(3) The appropriate license fee.
(c) An eligible facility shall report on the application all outpatient services the REH will offer or will remain when the facility is licensed as an REH.
(Indiana Department of Health; 410 IAC 15.2-2-3)
410 IAC 15.2-2-4 Review and approval of license application
Authority:
IC 16-19-3-4
Sec. 4. (a) On determination by the commissioner that an applicant has complied with the licensing requirements for a rural emergency hospital (REH) under this article, the commissioner shall issue a license to operate an REH.
(b) A hospital license serves as the state license for the REH until the commissioner issues a license to operate as an REH. The effective date of the REH state license is the date CMS certifies the facility to be an REH. If an eligible facility is not licensed as a hospital at the time of applying to be an REH, a hospital license is not first required. A hospital license shall be revoked on the same date the REH state license becomes effective, if applicable.
(c) On determination by the commissioner that an applicant has failed to comply with this article, the commissioner may:
(1) request additional information concerning the application;
(2) conduct a further investigation to determine whether a provisional license may be granted; or
(3) deny the application.
(d) On determination by the commissioner that an applicant has complied with the provisional licensing requirements for an REH under this article, the commissioner may:
(1) provisionally approve the application for an REH; and
(2) issue a provisional license to operate an REH. The provisional license expires ninety (90) days after issue.
(e) After the REH opens and before the provisional license expires, the department shall conduct a licensing survey to ensure the REH is operating in compliance with this article.
(f) If the REH is found on the initial licensing survey to be in compliance with this article, the commissioner shall issue a full license to operate an REH. If the REH is not found to be in compliance with this article, the commissioner may extend the provisional license for up to ninety (90) days. If the provisional license is extended, a revisit survey will be conducted or additional documentation requested, or both, before the end of the provisional period to ensure compliance with this article. If the REH is found to be in compliance with this article, the commissioner shall issue a full license to operate an REH. If the REH is not found to be in compliance with this article after the extended provisional period, the commissioner may:
(1) request additional information concerning the application;
(2) conduct a further investigation to determine whether a provisional license may be granted; or
(3) deny the application.
(Indiana Department of Health; 410 IAC 15.2-2-4)
Authority:
IC 16-19-3-4
Sec. 5. The commissioner may deny a license to operate a rural emergency hospital (REH) for any of the following reasons:
(1) The licensee or licensees are not of reputable and responsible character.
(2) The REH is not in compliance with the minimum standards for an REH adopted under this article.
(3) Violating any of the applicable provisions of IC 16-21 or this article.
(4) Permitting, aiding, or abetting the commission of an illegal act in the REH.
(5) Knowingly collecting or attempting to collect from:
of a health maintenance organization as defined in IC 27-13-1-19 any amounts owed by the health maintenance organization.
(6) Conduct or practices of the REH are found to be detrimental to the welfare of the patients of the REH.
(7) The application for a license to operate an REH, or supporting documentation, provided inaccurate statements or information.
(Indiana Department of Health; 410 IAC 15.2-2-5)
Authority:
IC 16-19-3-4
Sec. 6. (a) A rural emergency hospital (REH) shall file an application that meets the requirements of this article for licensure on a biennial basis with the department thirty (30) days before the current license expires. The initial license may be issued for a period of less than two (2) years to ensure the REH is on the same two (2) year cycle as other REHs and hospitals.
(b) The initial REH license period for currently operating hospitals shall be for the remaining period of the hospital license.
(c) Reapplication shall be filed when a change of at least fifty percent (50%) ownership occurs.
(d) An application for license from a newly constructed REH may be obtained from the department and submitted after the physical plant plans have been approved under 410 IAC 15-1.5-8. After receiving a design release from the state building commissioner, an application may be submitted to the department on the form provided, along with the documents required by the application form.
(f) Fully or partially replacing the physical plant of an REH, an addition or a renovation to the physical plant of an REH, or acquiring additional buildings under the current license of an existing REH must meet the provisions of 410 IAC 15-1.5-8.
(Indiana Department of Health; 410 IAC 15.2-2-6)
410 IAC 15.2-2-7 Rural emergency hospital license fees
Authority:
IC 16-19-3-4;
IC 16-21-2-12;
IC 16-21-2-14
Sec. 7. (a) A rural emergency hospital (REH) licensed under IC 16-21-2 and this article shall pay a biennial renewal fee as directed by the department.
(b) An initial application for an REH license currently operating as a hospital does not require an accompanying licensing fee. The biennial renewal of an REH must be accompanied by a licensing fee at the rate set in the fee schedule in this subsection. Biennial renewal fees are due on biennial renewal of an REH's license based on total operating expenses, as reported to the department on the application form, which meet the requirements of this article. The fee schedule is as follows:
| | |
| | Total Operating Expenses | Fee |
| | 0 – $49,999,999 | $2,000 |
| | $50,000,000 – $99,999,999 | $4,000 |
| | $100,000,000 – $199,999,999 | $6,000 |
| | $200,000,000 – $299,999,999 | $8,000 |
| | $300,000,000 and above | $10,000 |
(c) A previously closed facility that applies to reopen as an REH shall pay an initial license fee of two thousand dollars ($2,000).
(Indiana Department of Health; 410 IAC 15.2-2-7)
Authority:
IC 16-19-3-4
Sec. 8. (a) An eligible facility shall give at least sixty (60) days written notice to the department that it intends to become certified as a rural emergency hospital by CMS, unless waived by the department, and a period less than sixty (60) days is permitted.
(b) The notice shall be written by the highest officer in charge of the eligible facility.
(c) The notice may be sent through United States mail or electronic means.
(Indiana Department of Health; 410 IAC 15.2-2-8)
Authority:
IC 16-19-3-4;
IC 16-21-3
Sec. 9. (a) The commissioner may take any of the following actions on any of the grounds listed in subsection (b):
(1) Issue a letter of correction.
(2) Issue a probationary license.
(3) Conduct a resurvey.
(4) Deny the renewal of a license.
(5) Revoke a license.
(6) Impose a civil penalty in an amount not to exceed ten thousand dollars ($10,000) per violation.
(b) The commissioner may take action under subsection (a) on any of the following grounds:
(1) Violating any provision of this article.
(2) Permitting, aiding, or abetting the commission of an illegal act in a rural emergency hospital (REH).
(3) Knowingly collecting or attempting to collect from:
of a health maintenance organization as defined in IC 27-13-1-19 any amounts owed by the health maintenance organization.
(4) Conduct or practice found by the department to be detrimental to the welfare of the patients of an REH.
(Indiana Department of Health; 410 IAC 15.2-2-9)
Authority:
IC 16-19-3-4;
IC 16-21-3
Sec. 10. A probationary license may be:
(1) issued for a period of three (3) months; and
(2) reissued;
but not more than three (3) probationary licenses may be issued during a twelve (12) month period. Issuing a probationary license results in the automatic expiration of any other license held under this article.
(Indiana Department of Health; 410 IAC 15.2-2-10)
Authority:
IC 16-19-3-4
Sec. 11. (a) The department shall conduct a licensing survey of each rural emergency hospital (REH) at least once every two (2) years. The licensing survey is conducted to ensure that an REH is operating in compliance with this article.
(b) The department shall notify the REH of the licensing survey results in writing.
(c) The REH may request the department to accept an accreditation or certification survey instead of a licensing survey. The department may accept an accreditation or certification survey report from a nationally recognized accreditation or certification agency, association, or organization determined by the department to have survey standards consistent with this article. On request by the REH, the department shall review the accreditation or certification survey report for the facility. If the department finds, based on the accreditation report, the REH was found to have substantially complied with the standards referenced in this subsection, the department shall accept the accreditation report as a licensing survey. If, based on the accreditation report, the REH failed to significantly comply with the standards regreened in this subsection, the department may:
(1) request a plan of correction; or
(2) conduct a licensing survey.
If the department accepts an accreditation or certification survey as a licensing survey, the department shall conduct at least one (1) licensing survey in a four (4) year period.
(Indiana Department of Health; 410 IAC 15.2-2-11)
Authority:
IC 16-19-3-4
Sec. 12. (a) The department shall investigate credible complaints received by the department that allege noncompliance with this article.
(b) Complaints will be assigned a priority for investigation under department policy.
(c) A licensing survey may be conducted simultaneously with and in addition to a complaint survey.
(d) The department shall notify the rural emergency hospital of the results of the complaint survey in writing.
(Indiana Department of Health; 410 IAC 15.2-2-12)
Authority:
IC 16-19-3-4
Sec. 13. (a) Rural emergency hospitals (REHs) shall fully cooperate with surveys conducted by representatives of the department.
(b) Documents, registers, reports, records, and minutes of an REH must be made available to the department on request for inspection and copying.
(c) An REH shall file an acceptable plan of correction with the department within ten (10) days after receiving a survey report that documents noncompliance with this article.
(Indiana Department of Health; 410 IAC 15.2-2-13)
Posted: 09/25/2024 by Legislative Services Agency
DIN: 20240925-IR-410240370FNA
Composed: Nov 07,2024 8:22:04PM EST
A
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