On February 22, 2024, the Maryland Medical Board unanimously approved a final rule that makes significant changes to the Rules of Procedure for Health Care Facilities and Services. Notably, the Commission did not receive any comments on the published proposed regulations, and no additional modifications were made to the proposed language prior to approval.
This adoption is the final step in a multi-year renewal process. 
Certificate of Necessity (CON) regulations must comply with significant legal changes that have occurred since the regulations were last updated. Below is a summary of the newly adopted final regulations that amend COMAR 10.24.10.
Post-approval requirements
The final regulations also require projects that were not previously required to undergo a full certificate of need review to comply with many of the post-approval requirements for projects to undergo a full CON review.
The Commission maintains that this is not a change from the current interpretation of the regulation and that the new language only serves to clarify existing requirements. Previously, commenters disagreed and argued that this was a significant change. However, no additional comments were made prior to approval.
The final regulations establish project implementation schedules and submit progress reports to the commission for projects that are exempt from required certificate review, such as converting a hospital to a free-standing medical facility or consolidating a medical facility. Meet specific deadlines and seek approval for specific project changes through the project change request process established for Certificate of Need projects.
It is the Commission’s position that this is already required, and therefore projects operating under the exemption will be considered by the Commission to be subject to these additional reporting requirements. You need to be aware of that.
Additionally, the final regulations permit the Commission to place limits on approved exemption applications.
Timeline flexibility
The previous regulations set strict implementation schedules for approved projects and did not provide the flexibility needed for projects of different sizes. The final regulations require each applicant to propose a reasonable schedule for implementing the project described in the application.
Additionally, the final regulations allow the Commission to develop guidance for calculating allowable inflation, which is intended to reduce the number of project change requests submitted to the Commission as a result of rising construction costs.
Other changes
The final rule includes additional measures, including imposing timeliness requirements for MHCC staff to conduct integrity reviews of required certificate applications and limiting the number of follow-up questions that may be asked during integrity reviews. Changes have been made.
The final rule also limits who qualifies as an interested party, allowing them to intervene in an applicant’s CON review process and object to the application. The pre-revised regulations did not require interested parties to demonstrate an adverse impact on their health care facilities.
The final regulations require prospective stakeholders to demonstrate that the quality of care at their health care facility will be materially affected or that the project will significantly deplete needed personnel or other resources. Desired.
Additionally, under the final regulations, the Commission will consider the project’s impact on health equity and the applicant’s character and abilities when reviewing proposals.
Barry F. Rosen is chairman and CEO of the law firm of Gordon Feinblatt LLC and head of the law firm’s healthcare practice group and can be reached at 410-576-4224 or [email protected]. Darci M. Smith is a consultant in Gordon Feinblatt’s Medical Practice Group and can be reached at 410-576-4153 or [email protected].
