Senate File 2459 - Introduced SENATE FILE 2459 BY COMMITTEE ON HEALTH AND HUMAN SERVICES (SUCCESSOR TO SSB 3084) 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 5717SV (3) 91 dg/ko
S.F. 2459 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. (1) The construction, development , or other 9 establishment of a new institutional health facility regardless 10 of ownership if completing the construction, development, or 11 other establishment requires more than the following amount: 12 (a) Beginning on or after January 1, 2027, and before 13 December 31, 2031, four million dollars . 14 (b) Beginning on or after January 1, 2032, and before 15 December 31, 2036, four million five hundred thousand dollars. 16 (c) Beginning on or after January 1, 2037, five million 17 dollars. 18 (2) If the new institutional health facility involves 19 the use of a leased building, the market value of the leased 20 building shall be used when calculating the value of completing 21 construction, development, or other establishment under 22 subparagraph (1). 23 b. Relocation of an institutional health facility. 24 c. Any A capital expenditure , or lease , or donation by or 25 on behalf of an institutional health facility in excess of one 26 million five hundred thousand dollars the following amount 27 within a consecutive twelve-month period : 28 (1) Beginning on or after January 1, 2027, and before 29 December 31, 2031, four million dollars. 30 (2) Beginning on or after January 1, 2032, and before 31 December 31, 2036, four million five hundred thousand dollars. 32 (3) Beginning on or after January 1, 2037, five million 33 dollars . 34 d. A permanent change in the bed capacity, as determined 35 -1- LSB 5717SV (3) 91 dg/ko 1/ 11
S.F. 2459 by the department, of an institutional health facility. For 1 purposes of this paragraph, a change is permanent if it is 2 intended to be effective for one year or more. 3 e. Any expenditure in excess of five hundred thousand 4 dollars by or on behalf of an institutional health facility for 5 health services which are or will be offered in or through an 6 institutional health facility at a specific time but which were 7 not offered on a regular basis in or through that institutional 8 health facility within the twelve-month period prior to that 9 time. 10 f. The deletion of one or more health services, previously 11 offered on a regular basis by an institutional health facility 12 or health maintenance organization or the relocation of one or 13 more health services from one physical facility to another. 14 g. Any acquisition by or on behalf of a health care provider 15 or a group of health care providers of any piece of replacement 16 equipment with a value in excess of one million five hundred 17 thousand dollars, whether acquired by purchase, lease, or 18 donation. 19 h. e. (1) Any acquisition by or on behalf of a health 20 care provider or group of health care providers of any piece of 21 equipment with a value in excess of one million five hundred 22 thousand dollars , whether acquired by purchase , or lease, or 23 donation, which results in the offering or development of a 24 health service not previously provided that has a value in 25 excess of the following amount: 26 (a) Beginning on or after January 1, 2027, and before 27 December 31, 2031, four million dollars . 28 (b) Beginning on or after January 1, 2032, and before 29 December 31, 2036, four million five hundred thousand dollars. 30 (c) Beginning on or after January 1, 2037, five million 31 dollars. 32 (2) A mobile health service provided on a contract basis 33 is not considered to have been previously provided by a health 34 care provider or group of health care providers. 35 -2- LSB 5717SV (3) 91 dg/ko 2/ 11
S.F. 2459 i. Any acquisition by or on behalf of an institutional 1 health facility or a health maintenance organization of any 2 piece of replacement equipment with a value in excess of one 3 million five hundred thousand dollars, whether acquired by 4 purchase, lease, or donation. 5 j. f. (1) Any acquisition by or on behalf of an 6 institutional health facility or health maintenance 7 organization of any piece of equipment with a value in excess 8 of one million five hundred thousand dollars , whether acquired 9 by purchase , or lease, or donation, which results in the 10 offering or development of a health service not previously 11 provided that has a value in excess of the following amount: 12 (a) Beginning on or after January 1, 2027, and before 13 December 31, 2031, four million dollars . 14 (b) Beginning on or after January 1, 2032, and before 15 December 31, 2036, four million five hundred thousand dollars. 16 (c) Beginning on or after January 1, 2037, five million 17 dollars. 18 (2) A mobile health service provided on a contract basis 19 is not considered to have been previously provided by an 20 institutional health facility. 21 k. Any air transportation service for transportation of 22 patients or medical personnel offered through an institutional 23 health facility at a specific time but which was not offered 24 on a regular basis in or through that institutional health 25 facility within the twelve-month period prior to the specific 26 time. 27 l. g. Any A mobile health service with a value in excess of 28 one four million five hundred thousand dollars. 29 m. Any of the following: 30 (1) Cardiac catheterization service. 31 (2) Open heart surgical service. 32 (3) Organ transplantation service. 33 (4) Radiation therapy service applying ionizing radiation 34 for the treatment of malignant disease using megavoltage 35 -3- LSB 5717SV (3) 91 dg/ko 3/ 11
S.F. 2459 external beam equipment. 1 Sec. 4. Section 135.62, subsection 1, Code 2026, is amended 2 to read as follows: 3 1. a. A new institutional health service or changed 4 institutional health service shall not be offered or developed 5 in this state without prior application to the department 6 for , and receipt of , a certificate of need, pursuant to this 7 subchapter . 8 b. The application shall be made upon on forms furnished or 9 prescribed by the department and shall contain such information 10 as required by the department may require under this subchapter 11 by rule adopted pursuant to chapter 17A . 12 c. (1) The application shall be accompanied by a fee 13 equivalent to three-tenths of one percent of the anticipated 14 cost of the project with a minimum fee of six hundred dollars 15 and a maximum fee of twenty-one thousand dollars. The fee 16 shall be remitted by the department to the treasurer of state , 17 who shall place it for deposit in the general fund of the 18 state. An applicant for a new institutional health service or 19 a changed institutional health service offered or developed by 20 an intermediate care facility for persons with an intellectual 21 disability or an intermediate care facility for persons with 22 mental illness, as each of those terms are defined in section 23 135C.1, shall not be required to pay the application fee. 24 (2) If an application is voluntarily withdrawn within 25 thirty calendar days after submission, seventy-five percent 26 of the application fee shall be refunded ; if the application 27 is voluntarily withdrawn more than thirty but within sixty 28 days after submission, fifty percent of the application fee 29 shall be refunded; if the application is withdrawn voluntarily 30 more than sixty days after submission, twenty-five percent of 31 the application fee shall be refunded . Notwithstanding the 32 required payment of an application fee under this subsection , 33 an applicant for a new institutional health service or a 34 changed institutional health service offered or developed by 35 -4- LSB 5717SV (3) 91 dg/ko 4/ 11
S.F. 2459 an intermediate care facility for persons with an intellectual 1 disability or an intermediate care facility for persons with 2 mental illness as defined pursuant to section 135C.1 is exempt 3 from payment of the application fee. 4 Sec. 5. Section 135.62, subsection 2, paragraphs a and e, 5 Code 2026, are amended to read as follows: 6 a. Private offices and private clinics of an individual 7 physician, dentist, or other practitioner or group of 8 health care providers, except as provided by section 135.61, 9 subsection 16 , paragraphs “g” , “h” , and “m” paragraph “e” , and 10 section 135.61, subsections 2 and 18 . 11 e. A health maintenance organization or combination of 12 health maintenance organizations or an institutional health 13 facility controlled directly or indirectly by a health 14 maintenance organization or combination of health maintenance 15 organizations, except when the health maintenance organization 16 or combination of health maintenance organizations does any of 17 the following: 18 (1) Constructs, develops, renovates, relocates, or 19 otherwise establishes an institutional health facility. 20 (2) Acquires major medical equipment as provided by section 21 135.61, subsection 16, paragraphs “i” and “j” paragraph “f” . 22 Sec. 6. Section 135.62, subsection 2, paragraph h, 23 subparagraph (2), Code 2026, is amended to read as follows: 24 (2) If these conditions are not met, the institutional 25 health facility or health maintenance organization is subject 26 to review as a “new institutional health service” or “changed 27 institutional health service” under section 135.61, subsection 28 16 , paragraph “f” , and is subject to sanctions under section 29 135.72 . 30 Sec. 7. Section 135.62, subsection 2, Code 2026, is amended 31 by adding the following new paragraphs: 32 NEW PARAGRAPH . r. An organized outpatient health 33 facility that provides behavioral health services as defined 34 by the department by rule, including but not limited to 35 -5- LSB 5717SV (3) 91 dg/ko 5/ 11
S.F. 2459 substitution-based treatment centers for opiate addiction. 1 NEW PARAGRAPH . s. Open heart surgical services. 2 NEW PARAGRAPH . t. Organ transplantation services. 3 NEW PARAGRAPH . u. Radiation therapy services. 4 Sec. 8. Section 135.63, subsection 2, paragraph b, Code 5 2026, is amended by striking the paragraph. 6 Sec. 9. Section 135.65, subsections 1 and 2, Code 2026, are 7 amended to read as follows: 8 1. a. Within fifteen business days after receipt of the 9 date the department receives an application for a certificate 10 of need, the department shall examine the application for form 11 and completeness and accept or reject it. An application 12 shall be rejected only if it fails to provide all information 13 required by the department pursuant to section 135.62, 14 subsection 1 . The department shall promptly return to the 15 applicant any a rejected application , to the applicant with an 16 explanation of the reasons for its rejection. 17 b. Within thirty calendar days of the date the department 18 sends a rejected application to an applicant, the applicant may 19 revise and resubmit the application once for review without 20 submitting another application fee under section 135.62. 21 2. Upon acceptance of an application for a certificate 22 of need, the department shall promptly undertake to notify 23 all affected persons in writing through electronic means 24 that formal review of the application has been initiated. 25 Notification to those affected persons who are consumers 26 or third-party payers or other payers for health services 27 may be provided by electronic distribution of the pertinent 28 information to the news media . 29 Sec. 10. Section 135.65, subsection 3, paragraph b, Code 30 2026, is amended to read as follows: 31 b. A period for the submission of written public hearing 32 comments from affected persons on the application, to be held 33 scheduled prior to completion of the evaluation required by 34 paragraph “a” . 35 -6- LSB 5717SV (3) 91 dg/ko 6/ 11
S.F. 2459 Sec. 11. Section 135.65, subsection 4, Code 2026, is amended 1 by striking the subsection. 2 Sec. 12. Section 135.66, subsection 1, Code 2026, is amended 3 to read as follows: 4 1. The department may waive the letter of intent procedures 5 prescribed by section 135.64 and substitute conduct a summary 6 review procedure, which shall be established by rules of 7 adopted by the department, when it the department accepts an 8 application for a certificate of need for a project which that 9 meets any of the following criteria in paragraphs “a” through 10 “e” : 11 a. A project which is limited to repair or replacement of a 12 facility or equipment damaged or destroyed by a disaster, and 13 which will not expand the facility nor increase the services 14 provided beyond the level existing prior to the disaster. 15 b. A project necessary to enable the facility or service to 16 achieve or maintain compliance with federal, state, or other 17 appropriate licensing, certification, or safety requirements. 18 c. A project which will not change the existing bed capacity 19 of the applicant’s facility or service, as determined by the 20 department, by more than ten percent or ten beds, whichever is 21 less, over a two-year period. 22 d. A project the total cost of which will not exceed one 23 hundred fifty thousand dollars. 24 e. d. Any other project for which the applicant proposes 25 and the department agrees to summary review. 26 Sec. 13. Section 135.70, subsection 2, Code 2026, is amended 27 to read as follows: 28 2. Upon expiration of a certificate of need, and prior to 29 extension of the certificate of need, any affected person shall 30 have the right to submit to the department information which 31 may be relevant to the question of granting an extension. The 32 department may call a public hearing for this purpose. 33 Sec. 14. Section 135.71, subsection 4, Code 2026, is amended 34 to read as follows: 35 -7- LSB 5717SV (3) 91 dg/ko 7/ 11
S.F. 2459 4. Criteria for determining when it is not feasible to 1 complete formal review of an application for a certificate of 2 need within the time limits limit specified in section 135.68 . 3 The rules adopted under this subsection shall include criteria 4 for determining whether an application proposes introduction 5 of technologically innovative equipment, and if so, procedures 6 to be followed in reviewing the application. However, a rule 7 adopted under this subsection shall not permit a deferral of 8 more than sixty thirty calendar days beyond the time when a 9 decision is required under section 135.68 , unless both the 10 applicant and the department agree to a longer deferment. 11 Sec. 15. Section 135P.1, subsection 3, Code 2026, is amended 12 to read as follows: 13 3. “Health facility” means an any of the following: 14 a. An institutional health facility as defined in section 15 135.61 , a . 16 b. A birth center as defined in section 135.131 , a . 17 c. A hospice licensed under chapter 135J , a . 18 d. A home health agency as defined in section 144D.1 , an . 19 e. An assisted living program certified under chapter 231C , 20 a . 21 f. A clinic , a . 22 g. A community health center , or the . 23 h. The university of Iowa hospitals and clinics , and 24 includes any . 25 i. A corporation, professional corporation, partnership, 26 limited liability company, limited liability partnership, or 27 other entity comprised of such health facilities. 28 Sec. 16. Section 135P.1, Code 2026, is amended by adding the 29 following new subsection: 30 NEW SUBSECTION . 3A. “Institutional health facility” means 31 any of the following without regard to whether the facility is 32 publicly or privately owned, organized for profit, or is part 33 of or sponsored by a health maintenance organization: 34 a. A hospital as defined in section 135B.1. 35 -8- LSB 5717SV (3) 91 dg/ko 8/ 11
S.F. 2459 b. A health care facility as defined in section 135C.1. 1 c. An organized outpatient health facility as defined in 2 section 135.61. 3 d. An ambulatory surgical center as defined in section 4 135.61. 5 e. A community mental health center as defined in section 6 225A.1. 7 Sec. 17. REPEAL. Section 135.64, Code 2026, is repealed. 8 EXPLANATION 9 The inclusion of this explanation does not constitute agreement with 10 the explanation’s substance by the members of the general assembly. 11 This bill relates to the certificate of need (CON) process. 12 The bill removes from the definition of “affected person” an 13 institutional health facility (facility) or health maintenance 14 organization which, prior to the department health and human 15 services’ (HHS) receipt of an application for a CON, has 16 formally indicated to HHS an intent to furnish institutional 17 health services as described in the application. The bill also 18 removes payers and third-party payers for health services from 19 the definition of “affected persons”, and “a community mental 20 health facility” from the definition of “institutional health 21 facility”. 22 The bill limits the circumstances that require a health 23 care provider to submit a CON application to the following: 24 construction, development, or other establishment of a new 25 facility if completion requires more than a monetary amount 26 as specified in the bill; relocation of a facility; a capital 27 expenditure or lease by a facility in excess of a monetary 28 amount as specified in the bill; a permanent change in the bed 29 capacity of a facility; an acquisition of a piece of equipment 30 by or on behalf of a health care provider or group of health 31 care providers; an acquisition of a piece of equipment by or 32 on behalf of an institutional health facility or a health 33 maintenance organization; and a mobile health service with a 34 value in excess of $4 million. 35 -9- LSB 5717SV (3) 91 dg/ko 9/ 11
S.F. 2459 For purposes of determining the cost of the construction, 1 development, or other establishment of a new facility that 2 involves the lease of a building, the bill includes the market 3 value of the leased building. 4 The bill exempts an organized outpatient health facility 5 that provides behavioral health services, open heart surgical 6 services, organ transplantation services, and radiation therapy 7 services from CON requirements. 8 The bill eliminates the requirement that a CON applicant 9 needs to show that any existing facilities providing 10 institutional health services similar to those being applied 11 for are being used in an appropriate and efficient manner. 12 The bill no longer allows HHS to refund application fees 13 if the CON application is voluntarily withdrawn more than 30 14 calendar days after submission. 15 The bill allows a CON applicant whose application is 16 rejected to resubmit a revised application once without an 17 additional application fee. 18 The bill allows HHS to notify all affected persons of 19 pertinent information regarding a formal review of a CON 20 application through electronic means instead of through the 21 news media. 22 Under current law, a formal review of each CON application 23 shall include a public hearing on the application where 24 affected persons, or their representatives, shall have the 25 opportunity to present testimony. The bill instead requires 26 a period for the submission of written comments from affected 27 persons on the application. 28 Under current law, HHS may call a public hearing to consider 29 whether to extend a CON. The bill eliminates HHS’s ability to 30 call such a public hearing. 31 Under current law, HHS may defer approval or denial of a CON 32 application for up to 60 days. The bill allows HHS to defer for 33 a maximum of 30 calendar days unless both the applicant and HHS 34 agree to a longer deferment. 35 -10- LSB 5717SV (3) 91 dg/ko 10/ 11
S.F. 2459 The bill makes conforming changes to Code sections 135.66 1 (summary review procedure) and 135P.1 (adverse health care 2 incidents —— definitions). 3 The bill repeals Code section 135.64 (letter of intent to 4 precede application —— review and comment). 5 -11- LSB 5717SV (3) 91 dg/ko 11/ 11