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 10.24.01.13 - Procedures for Certificate of Conformance and Certificate of Ongoing Performance Applications
Universal Citation: MD Code Reg 10.24.01.13
Current through Register Vol. 51, No. 19, September 20, 2024
A. Coverage.
(1) A certificate of conformance is required
to introduce primary or elective percutaneous coronary intervention services at
a hospital.
(2) A certificate of
ongoing performance is required and shall be periodically renewed to certify
that a hospital providing cardiac surgery services or percutaneous coronary
intervention services is maintaining an acceptable level of quality and
performance in its provision of those services.
(3) A hospital with newly established cardiac
surgery services or percutaneous coronary intervention services at an acute
general hospital may continue to provide services without a certificate of
ongoing performance until the Commission acts on the hospital's first
application for a certificate of ongoing performance.
B. Submission of Applications.
(1) An application for a certificate of
conformance or a certificate of ongoing performance shall be submitted to the
Commission in a form and manner prescribed by the Commission.
(2) An application shall be submitted in
accordance with a published review schedule established by the Commission under
§E of this regulation, except that applications to establish both primary
and elective percutaneous coronary intervention services based on insufficient
access under COMAR 10.24.17.04A(2)(b) may be filed at any time.
(3) 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 this application are true to the best
of my knowledge, information, and belief."
C. Completeness Review of Certificate of Conformance Applications.
(1) Commission
staff shall review a certificate of conformance application for completeness
within 15 business days.
(2) If
staff determines the application is not complete, staff may request additional
information to make the application complete within the 15-business-day period
to review the application. The applicant shall provide full and clear responses
to the completeness and additional information request within 15 business days
unless an extension is requested and granted.
(3) If Commission staff determines after
review of the application and information provided in response to staff's
request that the application is complete, staff shall notify the applicant of
its determination.
(4) If an
applicant fails to supply requested information within the specified time
limit, staff may dismiss and return the application.
D. Additional Information. Commission staff may:
(1) Request information from an applicant
supplementing an application at any time during the review of an application,
provided that such additional information is material to the determination of
whether the applicant has satisfied the criteria and standards for approval;
and
(2) Set reasonable time limits
for the applicant to supply the requested information.
E. Notice to the Public.
(1) At least once each year, the Commission
staff shall publish in the Maryland Register a schedule for reviews of:
(a) Certificate of conformance applications
to establish primary or elective percutaneous coronary intervention services;
and
(b) Certificate of ongoing
performance applications if at least one hospital is required to file an
application in the time period covered by the schedule.
(2) The Commission shall publish, on its
website, information on the receipt of applications for certificates of
conformance and certificates of ongoing performance.
F. The Commission shall act on an application for a certificate of conformance not later than 120 days after staff notified the applicant that the application is complete, except for applications reviewed in conjunction with a CON application in accordance with COMAR 10.24.17.04C.
G. Criteria for Review of Applications. Applicable criteria and standards for certificate of conformance reviews and certificate of ongoing performance reviews are specified in COMAR 10.24.17, the State Health Plan chapter for cardiac surgery and percutaneous coronary intervention services.
H. Staff Report and Recommendation. Commission staff shall review a certificate of conformance and certificate of ongoing performance applications and prepare a staff report and recommendation that contains the staff's conclusion as to whether the applicant has met each applicable criterion and standard in COMAR 10.24.17.
I. Exceptions.
(1) An applicant may submit exceptions to a
staff report and recommendation and present oral argument on its exceptions to
the Commission.
(2) Schedule.
(a) Staff's issuance of a staff report and
recommendation shall be accompanied by a notice that specifies the schedule for
the submission of exceptions and the date of the Commission meeting at which
the Commission shall hear oral argument on exceptions.
(b) Unless otherwise agreed by each applicant
and interested party, the schedule issued by Commission staff shall specify
that:
(i) A party filing exceptions has at
least 10 days to file exceptions; and
(ii) A party filing a response to exceptions
has at least 7 days to file a response.
(c) The Commission staff may shorten these
periods by agreement of the parties, or extend any deadlines set for good cause
shown.
(3) Exceptions
shall specifically identify each staff conclusion to which exception is taken,
citing those portions of the record on which each exception is based.
(4) Exceptions and any response to exceptions
shall be limited to 25 pages, double-spaced, excluding attachments.
(5) Commission staff may file a written
response to exceptions and present oral argument at the exceptions
hearing.
(6) Oral arguments on
exceptions to the staff report and recommendation and any response shall be
limited to 10 minutes per argument unless extended by the Chair of the
Commission.
J. Final Decision on an Application for Certificate of Conformance.
(1) A final decision on an application for a
certificate of conformance shall contain findings of fact and conclusions of
law and shall:
(a) Approve the
application;
(b) Approve the
application with conditions; or
(c)
Deny the application.
(2) A certificate of conformance issued by
the Commission for an approved application shall specify the period of time for
which the initial certificate is effective and the expected date by which the
hospital is expected to seek a certificate of ongoing performance for its
primary or elective percutaneous coronary intervention services or
both.
K. Final Decision on an Application for Certificate of Ongoing Performance.
(1) The Commission's final decision on an
application for a certificate of ongoing performance shall contain findings of
fact and conclusions of law and shall:
(a)
Approve the application;
(b)
Approve the application with conditions; or
(c) Deny the application or revoke the
Commission's approval for the involved services provided that all the steps in
COMAR 10.24.17 including performance of a focused review and an opportunity for
agreement upon and completion of a plan of correction have been provided to the
hospital.
(2) A
certificate of ongoing performance issued by the Commission shall specify the
period of time for which the certificate is effective and the expected date by
which the hospital is expected to seek a new certificate of ongoing performance
for its primary or elective percutaneous coronary intervention services or
both, as applicable, or for its cardiac surgery services.
(3) The duration of a certificate of ongoing
performance may be extended beyond the renewal deadline, if due to extenuating
circumstances, the Executive Director determines an extension is necessary and
appropriate, prior to staff producing a written report and recommendation to
the Commission regarding the hospital 's application for renewal of its
certificate of ongoing performance.
L. The decision of the Commission shall be by a majority of the quorum present and voting.
M. The decision of the Commission is subject to judicial review in accordance with Regulation .09F of this chapter.
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