Md. Code Regs. 10.24.01.08

Current through Register Vol. 51, No. 22, November 1, 2024

Section 10.24.01.08 - Procedure for Review of CON Applications

A. Review Schedule.

(1) An application shall be submitted in accordance with the published review schedule established by the Commission in accordance with §D(1) of this regulation, but if no applicable review schedule has been published, an application may be submitted at any time 60 days after the filing of the letter of intent but no more than 180 days after the filing of the letter of intent, unless a shorter period has been approved by the Executive Director.

(2) In a case when need for additional service capacity is projected, the Commission may not docket an application until it has made a final decision on each previously docketed application for a comparable project, unless the most recently published need projections or State Health Plan would support the approval of both projects.

B. Submission of Application.

(1) An application for a CON shall be submitted to the Commission's Center for Health Care Facilities Planning and Development in the form and manner prescribed by the Commission.

(2) The application, and all information supplementing the application, shall be signed by at least one principal of the applicant, who shall sign a statement as follows: "I solemnly affirm under penalties of perjury that the contents of the application (or the supplementary information) are true to the best of my knowledge, information, and belief."

C. Completeness Review and Docketing.

(1) Prior to docketing an application for review, Commission staff shall review the application for completeness:

(a) Within 20 business days for projects involving the establishment of a health care facility, the relocation of a health care facility or the introduction by a hospital of cardiac surgery or organ transplantation; and

(b) Within 15 business days for all other projects.

(2) Commission staff may schedule a conference with the applicant within the completeness review period prescribed in §C(1) of this regulation.

(3) Commission staff shall determine whether the application contains all the information requested in the application. If staff determines that the application is not complete, the staff shall make one written request for additional information that specifies the information requested and the 15-business-day deadline for the applicant to supply the requested information. For good cause, staff may make one additional request for information, to which the applicant shall have 10 business days to respond. Additional information may be requested by staff beyond that required to make the application complete, which shall also be subject to a time limit for the applicant to supply the requested information.

(4) If Commission staff determines, based on staff's review of the application and any additional information provided in response to a staff request for additional information, that the application is complete and conforms with the applicable docketing rules in the State Health Plan, the staff shall docket the application for review and publish notice of the docketing on the next available publication date of the Maryland Register.

(5) If an applicant fails to supply the required information within the specified time limit, staff may dismiss the application. Staff may, at its discretion, extend the response time for an applicant in a noncomparative review, or, with the consent of all applicants, for an applicant in a comparative review, up to an additional 10 business days, or more upon a demonstration of good cause for the additional extension.

(6) Commission staff or a reviewer may:

(a) Request information from the applicant supplementing an otherwise complete application at any time during the review of an application; and

(b) Set reasonable time limits for the applicant to supply the requested information.

D. Notice to the Public.

(1) At least once each year, Commission staff shall publish in the Maryland Register a schedule for conducting reviews of applications for designated services by health planning region, as follows:

(a) The schedule shall include the status of applicable need forecasts found in the State Health Plan or published elsewhere as required by the State Health Plan for conducting the reviews of the designated services by health planning region;

(b) The schedule shall establish application submission dates not sooner than 3 months following the publication of the proposed schedule; and

(c) The schedule shall identify scheduled reviews by health planning region and shall state the dates for the receipt of letters of intent and the submission of applications.

(2) Within 10 business days of receiving a complete application, Commission staff shall request that the Maryland Register publish notice to the public of the docketing of an application. The Commission shall also publish notice in a newspaper of general circulation in the area of the proposed project. Notices shall comply with State Government Article, §10-207, Annotated Code of Maryland, and shall include:

(a) A citation to the Commission's enabling act and this chapter, the name of the applicant, the matter or docket number, and a general description of the project containing the information required in letters of intent;

(b) An explanation that a person who meets the definition of "interested party" in Regulation .01B of this chapter may become an interested party to the review of this application by submitting written comments on the application within 30 days of its docketing; and

(c) A statement that a person may request in writing that the Commission advise them of further notices of the proceedings on the application, and that any further notice of proceedings will only be sent to persons who have submitted a written request.

(3) If an evidentiary hearing is held in accordance with Regulation .11 of this chapter, the Commission shall provide notice to each person who has requested to be apprised of further proceedings on the application.

E. Modifications to Letters of Intent and Applications.

(1) An applicant shall give written notice to the Center for Health Care Facilities Planning and Development of any modifications to the applicant's letter of intent before submitting an application.

(2) An application may be modified until the 45th day after docketing. After the 45th day of docketing, an application may only be modified as a result of a project status conference held pursuant to Regulation .09A(2) of this chapter or upon a showing of good cause.

(3) If an application is modified:

(a) The Commission shall provide:

(i) Notice of the changes by a dated posting on the Commission's website and in a newspaper of general circulation in the affected jurisdiction; and

(ii) A 10-business-day period following the website posting for comments on the changes; and

(b) Each applicant in the review will be deemed to have waived the right to a final decision by the Commission within the statutorily prescribed time.

(4) The following modifications to a proposed project require a new Certificate of Need application:

(a) Changes in the fundamental nature of a proposed facility or the medical services to be provided;

(b) Increases in the total bed capacity of a proposed facility; or

(c) A change in the site of a proposed facility.

F. Comments by a Person Seeking Interested Party Status or by a Participating Entity and Applicant's Response.

(1) Written Comments by a Person Seeking Interested Party Status.

(a) A person seeking interested party status shall file written comments on an application within 30 days of docketing.

(b) The comments shall include information sufficient to establish interested party status, as defined in Regulation .01B of this chapter.

(c) If a person seeking interested party status is opposing an application, the comments shall state with particularity the State Health Plan standards or the review criteria in §G of this regulation that the person seeking interested party status believes have not been met by the applicant and the reasons why the applicant does not meet those standards or criteria.

(d) Factual assertions made in comments by a person seeking interested party status that are not included in the record shall be accompanied by appropriate documentation and sworn affidavit.

(e) In a review with only one applicant, the comments shall be 25 pages or fewer, double-spaced, excluding attachments.

(f) In a comparative review, the comments shall be 35 pages or fewer, double-spaced, excluding attachments.

(2) Written Comments by a Person Seeking Participating Entity Status.

(a) A person seeking participating entity status shall file written comments on an application within 30 days of docketing that:

(i) Include information that the participating entity wishes the Commission to consider; and

(ii) State with particularity the State Health Plan standards or review criteria in §G of this regulation that it believes have not been met by the applicant, and the reasons why the applicant does not meet those standards or criteria.

(b) A person granted participating entity status shall be copied on Commission documents in the review of the application.

(c) A person granted participating entity status is not an interested party and has no right to judicial review of a final Commission decision.

(3) Response to Comments.

(a) An applicant is permitted to make one written filing responding to all written comments on its application within 15 days of receipt of those comments.

(b) The applicant's response may not be more than 25 pages, double-spaced, excluding attachments.

(c) In a comparative review, the applicant's response may not be more than 35 pages, double-spaced, excluding attachments.

(d) Factual assertions in an applicant's response that are not included in the record shall be accompanied by appropriate documentation and sworn affidavit.

G. Criteria for Review of Application.

(1) In a Certificate of Need review, the applicant carries the burden of proving by a preponderance of the evidence that the project meets the applicable criteria for review.

(2) In reviewing an application for a CON, the Commission shall consider the applicant's submissions, the comments, if any, of interested parties, participating entities, the local health department, and information gathered during the Commission's review of the application, to which each applicant and interested party has been afforded the opportunity to respond. In a comparative review the Commission shall award a CON to the applicant, or applicants, that best meet the review criteria in §G(3) of this regulation.

(3) Criteria for Review of an Application for Certificate of Need.

(a) State Health Plan. An application for a Certificate of Need shall be evaluated according to all relevant State Health Plan standards.

(b) Need. The Commission shall consider the applicable need analysis in the State Health Plan. If no State Health Plan need analysis is applicable, the Commission shall consider whether the applicant has demonstrated a need for the proposed project.

(c) Alternatives to the Project. The Commission shall consider the alternative approaches to meeting the need identified for the project that were considered by the applicant in planning the project and the basis for the applicant's choice of the project among considered alternatives. In a comparative review of applications within the same review cycle, the Commission shall compare the costs and the likely effectiveness of alternative projects in meeting identified needs, improving the availability and accessibility of care, and improving the quality of care.

(d) Project Financial Feasibility and Facility or Program Viability. The Commission shall consider the availability of resources necessary to implement the project and the availability of revenue sources and demand for the proposed services adequate to ensure ongoing viability and sustainability of the facility to be established or modified or the service to be introduced or expanded.

(e) Compliance with Terms and Conditions of Previous Certificates of Need. An applicant shall demonstrate compliance with all terms and conditions of each previous CON granted to the applicant.

(f) Project Impact. The Commission shall consider the impact of the proposed project on the costs and charges of existing providers of the facilities and services included in the project and on access to those facilities and services in the service area of the project.

(g) Health Equity. The Commission shall consider how a proposed project will address health care disparities in availability, accessibility, and quality of care among different populations within the service area. The Commission shall consider how social determinants of health within the service area of the proposed project create disparities in the delivery of health care.

(h) Character and Competence. The Commission shall assess the character and competence of an applicant based upon experience and past performance, including any records of violation in operating a health care service or facility.

Md. Code Regs. 10.24.01.08

Regulations .08 amended effective February 4, 1976 (3:3 Md. R. 151)
Regulations .08A, C amended as an emergency provision effective July 1, 1978 (5:17 Md. R. 1321); adopted permanently effective December 15, 1978 (5:25 Md. R. 1855)
Regulation .08C amended effective November 17, 1986 (13:23 Md. R. 2480); August 3, 1992 (19:15 Md. R. 1390)
Regulations .08 adopted effective November 6, 1995 (22:22 Md. R. 1658)
Regulation .08 amended effective April 11, 2005 (32:7 Md. R. 680)
Regulation .08C, E amended effective April 10, 2006 (33:7 Md. R. 672)
Regulation .08D, F amended effective April 9, 2007 (34:7 Md. R. 699)
Regulation .08E, G amended as an emergency provision effective November 9, 1995 (22:24 Md. R. 1874); amended permanently effective March 11, 1996 (23:5 Md. R. 379); adopted effective 50:22 Md. R. 975, eff. 12/1/2023