Code of Maryland Regulations
Title 10 - MARYLAND DEPARTMENT OF HEALTH
Part 4
Subtitle 24 - MARYLAND HEALTH CARE COMMISSION
Chapter 10.24.01 - Procedural Regulations for Health Care Facilities and Services
Section 10.24.01.08 - Procedure for Review of CON Applications
Universal Citation: MD Code Reg 10.24.01.08
Current through Register Vol. 51, No. 19, September 20, 2024
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.
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