in-20240925-IR-410240370FNA: 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.

Notice of First Public Comment Period LSA Document #24-370 Sec. 1. The definitions in this rule apply throughout this article. Sec. 2. "CMS" means the United States Centers for Medicare and Medicaid Services. Sec. 3. "Commissioner" means the state health commissioner or the state health commissioner's designee. Sec. 4. "Department" means the Indiana department of health. Sec. 5. "Hospital" has the meaning set forth in IC 16-18-2-179(b). Sec. 6. "Rural emergency hospital" has the meaning set forth in IC 16-18-2-320.5. Sec. 1. (a) A license must be obtained from the commissioner under IC 4-21.5-3-5 before: (b) A license to operate an REH: (c) After an REH is closed, the license shall be returned to the department. Sec. 2. (a) Rural emergency hospitals (REHs) shall comply with the following: (b) An REH shall immediately notify the department if the REH is no longer operating as a rural emergency hospital under CMS. 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: (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. 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: (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: (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: Sec. 5. The commissioner may deny a license to operate a rural emergency hospital (REH) for any of the following reasons: 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. (e) REHs shall meet the provisions of 410 IAC 15-1.5-8. (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. 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: (c) A previously closed facility that applies to reopen as an REH shall pay an initial license fee of two thousand dollars ($2,000). 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. Sec. 9. (a) The commissioner may take any of the following actions on any of the grounds listed in subsection (b): (b) The commissioner may take action under subsection (a) on any of the following grounds: Sec. 10. A probationary license may be: 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: 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. 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.