Sec. 10.24.01.08. Procedure for Review of 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 review schedule has been published for a service, an application may be submitted 60 days after the filing of the letter of intent, unless a shorter period has been approved by the Executive Director.

(2) An application for which a review is scheduled may only be reviewed according to that schedule.

(3) If the Commission has not published a schedule for Certificate of Need review for a specified service, and the current State Health Plan does not preclude new capacity for that service in the relevant planning region, a letter of intent may be submitted at any time for that service. Notice shall be placed in the Maryland Register, and a 30-day period initiated for the submission of any other letters of intent for the same service in the same planning region to be included in the same review.

(4) 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 similar project.

B. Submission of Application.

(1) An application shall be submitted to the Health Facilities Coordination Office in accordance with the schedules set forth in §D(1) of this regulation.

(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."

(3) At the time of filing an application for a Certificate of Need or a modified application, an applicant shall submit six copies of the application to the Commission, unless the Commission requests that additional copies be filed, and shall send one copy to each other applicant in the review, to the local health department in each affected jurisdiction, and to any other person designated by the Commission, and shall certify delivery of the copies in writing to the Commission within 5 working days of the filing of the application with the Commission.

C. Completeness Review and Docketing.

(1) Within 10 business days of the filing of an application, the staff shall review the application for completeness to determine whether an application may be docketed for review.

(2) The staff shall schedule with the applicant an application review conference within the 10-day period for completeness review.

(3) The staff shall determine whether the application contains all the information required. Staff's requests for additional information to ensure that the application is complete shall specify in writing the information requested, which shall be submitted within 10 business days. 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 the staff's review of the application determines that the application is complete and conforms with the applicable docketing rules in the State Health Plan, staff shall docket the application for review as of 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 and return the application and proceed with the review. 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, for up to an additional 10 business days.

(6) The reviewer, staff, or the Commission 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, the Commission 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 for the simultaneous submission of applications.

(2) Within 10 business days, the Commission shall request that the Maryland Register publish notice of the receipt of an application and, when the application is complete, its docketing. The Commission shall also publish notice in a newspaper of general circulation in the area of the proposed project. This notice shall include:

(a) A citation to the Commission's enabling act and these regulations, 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 .10D of this chapter, the Commission shall provide notice to each person who has requested to be apprised of further proceedings on the application. The notice shall include a:

(a) Reference to the authority under which the hearing is to be held and the rules of procedure for the holding of an evidentiary hearing; and

(b) Statement that any person may attend the hearing.

E. Modifications to Letters of Intent and Applications.

(1) An applicant shall give written notice to the Health Facilities Coordination Office 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 or as a result of a project status conference held pursuant to Regulation .09A(2) of this chapter. After the 45th day, a modification to an application in a comparative review not made as the result of a project status conference requires the consent of each applicant. In a noncomparative review, modifications to an application to reduce capital or operating costs, reduce annual projected revenue, reduce the level or number of beds and services requested, or to respond to relevant changes in the State Health Plan review criteria, policies, or need projections, are permitted at any time.

(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) Changes to those portions of an application referring to facilities and services that are not subject to Certificate of Need review are not considered a modification to an application.

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

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

(b) Increases in the total licensed bed capacity beyond that permitted by Health-General Article §19-307.2, Annotated Code of Maryland, or medical service categories.

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 that the interested party wishes the Commission to consider in reviewing an application.

(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 or sworn affidavit, or both.

(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 shall have its comments on an applicant's conformance with State Health Plan standards and review criteria considered and analyzed by a reviewer in a proposed decision or by Commission staff in a staff report to an application.

(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 response may not be more than 25 pages, double-spaced, excluding attachments.

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

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

G. Criteria for Review of Application.

(1) In proceedings on a Certificate of Need application, the burden of proof that the project meets the applicable criteria for review, by a preponderance of the evidence, rests with the applicant.

(2) Issuance of a Certificate of Need by the Commission. In reviewing an application for a Certificate of Need, the Commission shall consider the applicant's submissions, the responses of each other applicant and interested party, the recommendation, if any, of the local health department, and the information gathered during the Commission's review of the application, to which each applicant and interested party shall have been afforded an opportunity to respond.

(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, policies, and criteria.

(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 unmet needs of the population to be served, and established that the proposed project meets those needs.

(c) Availability of More Cost-Effective Alternatives. The Commission shall compare the cost effectiveness of the proposed project with the cost effectiveness of providing the service through alternative existing facilities, or through an alternative facility that has submitted a competitive application as part of a comparative review.

(d) Viability of the Proposal. The Commission shall consider the availability of financial and nonfinancial resources, including community support, necessary to implement the project within the time frames set forth in the Commission's performance requirements, as well as the availability of resources necessary to sustain the project.

(e) Compliance with Conditions of Previous Certificates of Need. An applicant shall demonstrate compliance with all terms and conditions of each previous Certificate of Need granted to the applicant, and with all commitments made that earned preferences in obtaining each previous Certificate of Need, or provide the Commission with a written notice and explanation as to why the conditions or commitments were not met.

(f) Impact on Existing Providers and the Health Care Delivery System. An applicant shall provide information and analysis with respect to the impact of the proposed project on existing health care providers in the health planning region, including the impact on geographic and demographic access to services, on occupancy, on costs and charges of other providers, and on costs to the health care delivery system.