Senate Study Bill 3084 - Introduced SENATE FILE _____ BY (PROPOSED COMMITTEE ON HEALTH AND HUMAN SERVICES BILL BY CHAIRPERSON WARME) A BILL FOR An Act relating to the certificate of need process. 1 BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA: 2 TLSB 5717XC (13) 91 dg/ko
S.F. _____ Section 1. Section 135.61, subsection 1, paragraphs d and f, 1 Code 2026, are amended by striking the paragraphs. 2 Sec. 2. Section 135.61, subsection 12, paragraph e, Code 3 2026, is amended by striking the paragraph. 4 Sec. 3. Section 135.61, subsection 16, Code 2026, is amended 5 to read as follows: 6 16. “New institutional health service” or “changed 7 institutional health service” means any of the following: 8 a. The construction, development , or other establishment 9 of a new institutional health facility regardless of ownership 10 if completing the construction, development, or other 11 establishment requires more than the following amount: 12 (1) Beginning on or after January 1, 2027, and before 13 December 31, 2031, four million dollars. 14 (2) Beginning on or after January 1, 2032, and before 15 December 31, 2036, four million five hundred thousand dollars. 16 (3) Beginning on or after January 1, 2037, five million 17 dollars . 18 b. Relocation of an institutional health facility. 19 c. Any A capital expenditure , or lease , or donation by or 20 on behalf of an institutional health facility in excess of one 21 million five hundred thousand dollars the following amount 22 within a consecutive twelve-month period : 23 (1) Beginning on or after January 1, 2027, and before 24 December 31, 2031, four million dollars. 25 (2) Beginning on or after January 1, 2032, and before 26 December 31, 2036, four million five hundred thousand dollars. 27 (3) Beginning on or after January 1, 2037, five million 28 dollars . 29 d. A permanent change in the bed capacity, as determined 30 by the department, of an institutional health facility. For 31 purposes of this paragraph, a change is permanent if it is 32 intended to be effective for one year or more. 33 e. Any expenditure in excess of five hundred thousand 34 dollars by or on behalf of an institutional health facility for 35 -1- LSB 5717XC (13) 91 dg/ko 1/ 10
S.F. _____ health services which are or will be offered in or through an 1 institutional health facility at a specific time but which were 2 not offered on a regular basis in or through that institutional 3 health facility within the twelve-month period prior to that 4 time. 5 f. The deletion of one or more health services, previously 6 offered on a regular basis by an institutional health facility 7 or health maintenance organization or the relocation of one or 8 more health services from one physical facility to another. 9 g. Any acquisition by or on behalf of a health care provider 10 or a group of health care providers of any piece of replacement 11 equipment with a value in excess of one million five hundred 12 thousand dollars, whether acquired by purchase, lease, or 13 donation. 14 h. Any acquisition by or on behalf of a health care provider 15 or group of health care providers of any piece of equipment 16 with a value in excess of one million five hundred thousand 17 dollars, whether acquired by purchase, lease, or donation, 18 which results in the offering or development of a health 19 service not previously provided. A mobile service provided 20 on a contract basis is not considered to have been previously 21 provided by a health care provider or group of health care 22 providers. 23 i. Any acquisition by or on behalf of an institutional 24 health facility or a health maintenance organization of any 25 piece of replacement equipment with a value in excess of one 26 million five hundred thousand dollars, whether acquired by 27 purchase, lease, or donation. 28 j. Any acquisition by or on behalf of an institutional 29 health facility or health maintenance organization of any 30 piece of equipment with a value in excess of one million five 31 hundred thousand dollars, whether acquired by purchase, lease, 32 or donation, which results in the offering or development of 33 a health service not previously provided. A mobile service 34 provided on a contract basis is not considered to have been 35 -2- LSB 5717XC (13) 91 dg/ko 2/ 10
S.F. _____ previously provided by an institutional health facility. 1 k. Any air transportation service for transportation of 2 patients or medical personnel offered through an institutional 3 health facility at a specific time but which was not offered 4 on a regular basis in or through that institutional health 5 facility within the twelve-month period prior to the specific 6 time. 7 l. e. Any A mobile health service with a value in excess of 8 one four million five hundred thousand dollars. 9 m. Any of the following: 10 (1) Cardiac catheterization service. 11 (2) Open heart surgical service. 12 (3) Organ transplantation service. 13 (4) Radiation therapy service applying ionizing radiation 14 for the treatment of malignant disease using megavoltage 15 external beam equipment. 16 Sec. 4. Section 135.62, subsection 1, Code 2026, is amended 17 to read as follows: 18 1. a. A new institutional health service or changed 19 institutional health service shall not be offered or developed 20 in this state without prior application to the department 21 for , and receipt of , a certificate of need, pursuant to this 22 subchapter . 23 b. The application shall be made upon on forms furnished or 24 prescribed by the department and shall contain such information 25 as required by the department may require under this subchapter 26 by rule adopted pursuant to chapter 17A . 27 c. (1) The application shall be accompanied by a fee 28 equivalent to three-tenths of one percent of the anticipated 29 cost of the project with a minimum fee of six hundred dollars 30 and a maximum fee of twenty-one thousand dollars. The fee 31 shall be remitted by the department to the treasurer of state , 32 who shall place it for deposit in the general fund of the 33 state. An applicant for a new institutional health service or 34 a changed institutional health service offered or developed by 35 -3- LSB 5717XC (13) 91 dg/ko 3/ 10
S.F. _____ an intermediate care facility for persons with an intellectual 1 disability or an intermediate care facility for persons with 2 mental illness, as each of those terms are defined in section 3 135C.1, shall not be required to pay the application fee. 4 (2) If an application is voluntarily withdrawn within 5 thirty calendar days after submission, seventy-five percent 6 of the application fee shall be refunded ; if the application 7 is voluntarily withdrawn more than thirty but within sixty 8 days after submission, fifty percent of the application fee 9 shall be refunded; if the application is withdrawn voluntarily 10 more than sixty days after submission, twenty-five percent of 11 the application fee shall be refunded . Notwithstanding the 12 required payment of an application fee under this subsection , 13 an applicant for a new institutional health service or a 14 changed institutional health service offered or developed by 15 an intermediate care facility for persons with an intellectual 16 disability or an intermediate care facility for persons with 17 mental illness as defined pursuant to section 135C.1 is exempt 18 from payment of the application fee. 19 Sec. 5. Section 135.62, subsection 2, paragraphs a and e, 20 Code 2026, are amended to read as follows: 21 a. Private offices and private clinics of an individual 22 physician, dentist, or other practitioner or group of 23 health care providers, except as provided by section 135.61, 24 subsection 16 , paragraphs “g” , “h” , and “m” paragraph “f” , and 25 section 135.61, subsections 2 and 18 . 26 e. A health maintenance organization or combination of 27 health maintenance organizations or an institutional health 28 facility controlled directly or indirectly by a health 29 maintenance organization or combination of health maintenance 30 organizations, except when the health maintenance organization 31 or combination of health maintenance organizations does any of 32 the following: 33 (1) Constructs constructs , develops, renovates, relocates, 34 or otherwise establishes an institutional health facility. 35 -4- LSB 5717XC (13) 91 dg/ko 4/ 10
S.F. _____ (2) Acquires major medical equipment as provided by section 1 135.61, subsection 16 , paragraphs “i” and “j” . 2 Sec. 6. Section 135.62, subsection 2, paragraph h, 3 subparagraph (2), Code 2026, is amended to read as follows: 4 (2) If these conditions are not met, the institutional 5 health facility or health maintenance organization is subject 6 to review as a “new institutional health service” or “changed 7 institutional health service” under section 135.61, subsection 8 16 , paragraph “f” , and is subject to sanctions under section 9 135.72 . 10 Sec. 7. Section 135.63, subsection 2, paragraph b, Code 11 2026, is amended by striking the paragraph. 12 Sec. 8. Section 135.65, subsections 1, 2, and 4, Code 2026, 13 are amended to read as follows: 14 1. a. Within fifteen business days after receipt of the 15 date the department receives an application for a certificate 16 of need, the department shall examine the application for form 17 and completeness and accept or reject it. An application 18 shall be rejected only if it fails to provide all information 19 required by the department pursuant to section 135.62, 20 subsection 1 . The department shall promptly return to the 21 applicant any a rejected application , to the applicant with an 22 explanation of the reasons for its rejection. 23 b. Within thirty calendar days of the date the department 24 sends a rejected application to an applicant, the applicant may 25 revise and resubmit the application once for review without 26 submitting another application fee under section 135.62. 27 2. Upon acceptance of an application for a certificate 28 of need, the department shall promptly undertake to notify 29 all affected persons in writing that formal review of the 30 application has been initiated. Notification to those affected 31 persons who are consumers or third-party payers or other payers 32 for health services may be provided by electronic distribution 33 of the pertinent information to the news media . 34 4. a. When a hearing is to be held pursuant to subsection 35 -5- LSB 5717XC (13) 91 dg/ko 5/ 10
S.F. _____ 3 , paragraph “b” , the department shall give at least ten days’ 1 notice of the time and place of the hearing. At the hearing, 2 any 3 b. An affected person, or an affected person’s legal 4 representative, may submit written testimony in a manner 5 prescribed by the department from the date the department gives 6 notice of the hearing until end of business on the calendar day 7 immediately preceding the date of the hearing. 8 c. An affected person or that person’s designated 9 representative shall have the opportunity to may present 10 testimony at the hearing . 11 Sec. 9. Section 135.66, subsection 1, Code 2026, is amended 12 to read as follows: 13 1. The department may waive the letter of intent procedures 14 prescribed by section 135.64 and substitute conduct a summary 15 review procedure, which shall be established by rules of 16 adopted by the department, when it the department accepts an 17 application for a certificate of need for a project which that 18 meets any of the following criteria in paragraphs “a” through 19 “e” : 20 a. A project which is limited to repair or replacement of a 21 facility or equipment damaged or destroyed by a disaster, and 22 which will not expand the facility nor increase the services 23 provided beyond the level existing prior to the disaster. 24 b. A project necessary to enable the facility or service to 25 achieve or maintain compliance with federal, state, or other 26 appropriate licensing, certification, or safety requirements. 27 c. A project which will not change the existing bed capacity 28 of the applicant’s facility or service, as determined by the 29 department, by more than ten percent or ten beds, whichever is 30 less, over a two-year period. 31 d. A project the total cost of which will not exceed one 32 hundred fifty thousand dollars. 33 e. d. Any other project for which the applicant proposes 34 and the department agrees to summary review. 35 -6- LSB 5717XC (13) 91 dg/ko 6/ 10
S.F. _____ Sec. 10. Section 135.68, Code 2026, is amended to read as 1 follows: 2 135.68 Department to make final decision. 3 1. The department shall complete its formal review of 4 the application within ninety days after acceptance of 5 the application, except as otherwise provided by section 6 135.71, subsection 4 . Upon completion of the formal review, 7 the department shall approve or deny the application. The 8 department shall issue written findings stating the basis for 9 its decision on the application and shall send copies of the 10 decision and the written findings supporting the decision to 11 the applicant and to any other person who so requests. 12 2. Failure by the department to issue a written decision 13 on an application for a certificate of need within the time 14 required by this section shall constitute denial of and final 15 administrative action on the application. 16 Sec. 11. Section 135.71, subsection 4, Code 2026, is amended 17 to read as follows: 18 4. Criteria for determining when it is not feasible to 19 complete formal review of an application for a certificate of 20 need within the time limits limit specified in section 135.68 . 21 The rules adopted under this subsection shall include criteria 22 for determining whether an application proposes introduction 23 of technologically innovative equipment, and if so, procedures 24 to be followed in reviewing the application. However, a rule 25 adopted under this subsection shall not permit a deferral of 26 more than sixty thirty calendar days beyond the time when a 27 decision is required under section 135.68 , unless both the 28 applicant and the department agree to a longer deferment. 29 Sec. 12. Section 135P.1, subsection 3, Code 2026, is amended 30 to read as follows: 31 3. “Health facility” means an any of the following: 32 a. An institutional health facility as defined in section 33 135.61 , a . 34 b. A birth center as defined in section 135.131 , a . 35 -7- LSB 5717XC (13) 91 dg/ko 7/ 10
S.F. _____ c. A hospice licensed under chapter 135J , a . 1 d. A home health agency as defined in section 144D.1 , an . 2 e. An assisted living program certified under chapter 231C , 3 a . 4 f. A clinic , a . 5 g. A community health center , or the . 6 h. The university of Iowa hospitals and clinics , and 7 includes any . 8 i. A corporation, professional corporation, partnership, 9 limited liability company, limited liability partnership, or 10 other entity comprised of such health facilities. 11 Sec. 13. Section 135P.1, Code 2026, is amended by adding the 12 following new subsection: 13 NEW SUBSECTION . 3A. “Institutional health facility” means 14 any of the following without regard to whether the facility is 15 publicly or privately owned, organized for profit, or is part 16 of or sponsored by a health maintenance organization: 17 a. A hospital as defined in section 135B.1. 18 b. A health care facility as defined in section 135C.1. 19 c. An organized outpatient health facility as defined in 20 section 135.61. 21 d. An ambulatory surgical center as defined in section 22 135.61. 23 e. A community mental health center as defined in section 24 225A.1. 25 Sec. 14. REPEAL. Section 135.64, Code 2026, is repealed. 26 EXPLANATION 27 The inclusion of this explanation does not constitute agreement with 28 the explanation’s substance by the members of the general assembly. 29 This bill relates to the certificate of need (CON) process. 30 The bill removes from the definition of “affected person” an 31 institutional health facility (facility) or health maintenance 32 organization which, prior to the department health and human 33 services’ (HHS) receipt of an application for a CON, has 34 formally indicated to HHS an intent to furnish institutional 35 -8- LSB 5717XC (13) 91 dg/ko 8/ 10
S.F. _____ health services as described in the application. The bill also 1 removes payers and third-party payers for health services from 2 the definition of “affected persons”, and “a community mental 3 health facility” from the definition of “institutional health 4 facility”. 5 The bill limits the circumstances that require a health 6 care provider to submit a CON application to the following: 7 construction, development, or other establishment of a new 8 facility if completion requires more than a monetary amount 9 as specified in the bill; relocation of a facility; a capital 10 expenditure or lease by a facility in excess of a monetary 11 amount as specified in the bill; a permanent change in the bed 12 capacity of a facility; and a mobile health service with a 13 value in excess of $4 million. 14 The bill eliminates the requirement that a CON applicant 15 needs to show that any existing facilities providing 16 institutional health services similar to those being applied 17 for are being used in an appropriate and efficient manner. 18 The bill no longer allows HHS to refund application fees 19 if the CON application is voluntarily withdrawn more than 30 20 calendar days after submission. 21 The bill allows a CON applicant whose application is 22 rejected to resubmit a revised application once without an 23 additional application fee. 24 The bill allows HHS to notify all affected persons of 25 pertinent information regarding a formal review of a CON 26 application through electronic distribution instead of through 27 the news media. 28 The bill allows an affected person, or the affected person’s 29 legal representative, to submit written testimony for a hearing 30 on a CON application from the date HHS gives notice on the 31 hearing until end of business on the calendar day immediately 32 preceding the hearing. 33 Under current law, HHS’s failure to issue a written 34 decision on a CON application within 90 days of accepting the 35 -9- LSB 5717XC (13) 91 dg/ko 9/ 10
S.F. _____ application constitutes denial of the application. The bill 1 eliminates this denial. 2 Under current law, HHS may defer approval or denial of a CON 3 application for up to 60 days. The bill allows HHS to defer for 4 a maximum of 30 calendar days unless both the applicant and HHS 5 agree to a longer deferment. 6 The bill makes conforming changes to Code sections 135.66 7 (summary review procedure) and 135P.1 (adverse health care 8 incidents —— definitions). 9 The bill repeals Code section 135.64 (letter of intent to 10 precede application —— review and comment). 11 -10- LSB 5717XC (13) 91 dg/ko 10/ 10