Md. Code Regs. 10.24.01.13

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

Section 10.24.01.13 - Procedures for Certificate of Conformance and Certificate of Ongoing Performance Applications

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.

Md. Code Regs. 10.24.01.13

Regulations .13 amended effective February 4, 1976 (3:3 Md. R. 151)
Regulations .13 adopted effective November 6, 1995 (22:22 Md. R. 1658)
Regulation .13 amended effective April 11, 2005 (32:7 Md. R. 680)
Regulation .13B amended effective May 5, 1997 (24:9 Md. R. 657); adopted effective 50:22 Md. R. 975, eff. 12/1/2023