ARC 0618D

ARC 0618D

HUMAN SERVICES DEPARTMENT[441]

Notice of Intended Action

Proposing rulemaking related to certificate of need
and providing an opportunity for public comment

    The Department of Health and Human Services hereby proposes to amend Chapter 123, “Certificate of Need Program,” and Chapter 124, “Standards for Certificate of Need Review,” Iowa Administrative Code.

Legal Authority for Rulemaking

    This rulemaking is proposed under the authority provided in Iowa Code section 135.71.

State or Federal Law Implemented

    This rulemaking implements, in whole or in part, Iowa Code section 135.71 and 2026 Iowa Acts, House File 2635.

Purpose and Summary

    The purpose of this proposed rulemaking is to implement the provisions of 2026 Iowa Acts, House File 2635, which changes the requirements for obtaining a certificate of need by, among other things:

     ?   Eliminating the requirement to submit a letter of intent;

     ?   Eliminating the requirement for a public hearing; and

     ?   Excluding the following from the certificate of need requirement:

     ?   Cardiac catheterization service;

     ?   Open heart surgical service;

     ?   Organ transplantation service; and

     ?   Some radiation therapy services for the treatment of malignant disease.

Regulatory Analysis

    A Regulatory Analysis for this rulemaking was published in the Iowa Administrative Bulletin on August 19, 2026. A public hearing was held on the following date(s):

     ?   September 8, 2026

Fiscal Impact

     This rulemaking has no fiscal impact to the State of Iowa.

Jobs Impact

    After analysis and review of this rulemaking, no impact on jobs has been found.

Waivers

    Any person who believes that the application of the discretionary provisions of this rulemaking would result in hardship or injustice to that person may petition the Department for a waiver of the discretionary provisions, if any, pursuant to 441—Chapter 2504.

Public Comment

     Any interested person may submit written or oral comments concerning this proposed rulemaking, which must be received by the Department no later than 4:30 p.m. on October 20, 2026. Comments should be directed to:

Public Hearing

    A public hearing at which persons may present their views orally or in writing will be held as follows:

    Persons who wish to make oral comments at the public hearing may be asked to state their names for the record and to confine their remarks to the subject of this proposed rulemaking.

     Any persons who intend to attend the public hearing and have special requirements, such as those related to hearing or mobility impairments, should contact the Department and advise of specific needs.

Review by Administrative Rules Review Committee

    The Administrative Rules Review Committee, a bipartisan legislative committee which oversees rulemaking by executive branch agencies, may, on its own motion or on written request by any individual or group, review this rulemaking at its regular monthly meeting or at a special meeting. The Committee’s meetings are open to the public, and interested persons may be heard as provided in Iowa Code section 17A.8(6).

    The following rulemaking action is proposed:

    ITEM 1.  Amend rule 441—123.1(135) as follows:

441—123.1(135) Definitions Definition. For purposes of this chapter, the following definitions apply definition applies:

    “Long-term (acute) care hospital” means a hospital that has been approved to participate in the Title XVIII (Medicare) program as a long-term care hospital-prospective payment system (LTCH-PPS) hospital in accordance with 42 CFR Part 412 as amended to August 1, 2025.

“Radiation therapy service applying ionizing radiation for the treatment of malignant disease using megavoltage external beam equipment,” as the term applies to new or changed institutional health service in Iowa Code section 135.61(17)“m”(4), means the initiation or expansion of this service.

    ITEM 2.  Rescind rule 441—123.2(135).

    ITEM 3.  Amend rule 441—123.3(135) as follows:

441—123.3(135) Determination of reviewability. A sponsor of a proposed project may electronically submit a written request for a determination of reviewability as to whether the project requires a certificate of need.

    123.3(1) If it is determined that a certificate of need is required, the department will notify the sponsor and the request for nonreviewability will be considered the letter of intent for purposes of subrule 123.2(2) of the determination of renewability and the sponsor will be allowed to submit an electronic application immediately.

    123.3(2) No change.

    ITEM 4.  Renumber rules 441—123.3(135) to 441—123.12(135) as 441—123.2(135) to 441—123.11(135).

    ITEM 5.  Amend renumbered rule 441—123.3(135) as follows:

441—123.3(135) Submission of application.

    123.3(1) Application form.

    a.  A sponsor of a proposed project for a new or changed institutional health service will submit to the department an electronic application for certificate of need using the appropriate application form found on the certificate of need website. All information requested in the application form is required in the absence of a waiver by the department.

    b. and c. No change.

    123.3(2) No change.

    123.3(3) The notice of an accepted application issued pursuant to Iowa Code section 135.65(2) will inform the applicant and affected persons of the deadlines for the electronic submission to the department of written statements public comments or other materials.

    ITEM 6.  Amend renumbered subrule 123.4(2) as follows:

    123.4(2) Public comments on an application.

    a.  The department will receive written public comments on an application during a time frame prescribed by the department for each application. Oral comments will be received at a public hearing set by the department.

    b. No change.

    ITEM 7.  Amend renumbered subrules 123.5(1) to 123.5(3) as follows:

    123.5(1) An applicant will electronically submit a written request for summary review and a copy of the application and all attachments. An applicant is not required to submit a letter of intent pursuant to Iowa Code section 135.64 prior to submitting a written request for a summary review.

    123.5(2) The eligibility of an application for summary review pursuant to Iowa Code section 135.66 does not mandate or require such review. The department will make the decision as to whether an application will be reviewed in the summary review process will be at the department’s discretion.

    123.5(3) Upon receipt of a written request for summary review, an application, and the fee required by Iowa Code section 135.62(1), the department will notify the applicant in writing within 15 calendar days if the application is complete and if a summary review will be granted.

    ITEM 8.  Amend renumbered subrule 123.6(2) as follows:

    123.6(2) An extension by the department made pursuant to subrule 123.7(1) 123.6(1) will in no case be more than 60 30 calendar days beyond the time a decision is required under Iowa Code section 135.68 unless the applicant and the department agree.

    ITEM 9.  Amend renumbered subrule 123.7(1) as follows:

    123.7(1) An applicant or any affected person who has participated or sought unsuccessfully to participate in the formal review procedure prescribed in Iowa Code section 135.65 may, for good cause shown, electronically file an application for rehearing in writing with the department stating the specific grounds therefor and the relief sought within 20 calendar days after the date of the issuance of the final decision on an application for certificate of need.

    ITEM 10.  Amend renumbered rule 441—123.8(135) as follows:

441—123.8(135) Finality. The certificate of need application process is continuous beginning with submission of a letter of intent or request for waiver of a letter of intent an application through issuance of a final decision by the department subject to judicial review under Iowa Code chapter 17A.

    123.8(1) The following stages of the process are intermediate and subject to judicial review only to the extent the stages meet criteria for intermediate review under Iowa Code section 17A.19:

    a.  A decision by the department pursuant to rule 441—123.3(135) 441—123.2(135) that a proposed project does not require a certificate of need;

    b.  A decision by the department to waive submission of the letter of intent and substitute conduct summary review; and

    c. No change.

    123.8(2) No change.

    ITEM 11.  Amend renumbered subrule 123.10(1) as follows:

    123.10(1) Once a project has been approved by the department, no changes that vary from or alter the number of approved beds, the approved services or the approved cost by an amount indicated in subrule 123.11(2) 123.10(2) may be made unless requested by the applicant and approved by the department. Requests should be made in writing and filed with the department electronically.

    ITEM 12.  Rescind rule 441—124.1(135).

    ITEM 13.  Rescind rule 441—124.2(135).

    ITEM 14.  Rescind the definitions of “Active oncology service” and “Chemotherapy service” in subrule 124.3(2).

    ITEM 15.  Amend subparagraph 124.3(3)“a”(2) as follows:

    (2)  An applicant in an area with one or more scanners.

    1.  An applicant must meet the requirement of need described in subparagraph 124.4(3) 124.2(3)“a”(1), and

    2. No change.

    3.  University of Iowa Health Care is specifically exempted from consideration under numbered paragraph 124.3(3) 124.3(2)“a”(2)“2” because it has a service area that encompasses the entire state and adjoining states. The utilization statistics for scanners at the University of Nebraska Medical Center and Creighton University Medical Center – Bergan Mercy (both in Omaha) will not affect the need for scanners at hospitals in Council Bluffs.

    ITEM 16.  Renumber rules 441—124.3(135) to 441—124.6(135) as 441—124.1(135) to 441—124.4(135).

    ITEM 17.  Amend renumbered subparagraph 124.3(3)“b”(1) as follows:

    (1)  An applicant must meet the requirement of need described in paragraph 124.5(3) 124.3(3)“a,” and

    ITEM 18.  Amend renumbered subrule 124.4(3) as follows:

    124.4(3) Availability and need. (Iowa Code section 135.63(1)“c,” “d,” “e,” “g,” and “h”)

    a. No change.

    b.  An applicant in an area with one or more PET units currently in operation or approved by the certificate of need program for operation.

Existing PET units within the area (whether basic or enhanced) should have been operating at a minimum of 1,000 PET procedures during the most recent annual period as reported to the certificate of need program according to paragraph 124.6(4) 124.4(4)“e.”