On February 22, 2024, the Maryland Health Care Commission unanimously approved final regulations making significant changes to the Rules of Procedure for Health Care Facilities and Services. Notably, the commission received no comments on the published proposed regulation and there were no additional amendments to the proposed language prior to approval.
This adoption is the last step in a multi-year process aimed at updating 
the certificate of need regulations certificate of need (CON) to adapt to the significant statutory changes that have occurred since the last update of the regulations, and the following is a summary of the new definitive regulations that modify the COMAR 10.24.10.
Post-approval requirements
The final regulations will require that projects that did not previously undergo a full certificate of need review meet many of the post-approval requirements of projects that undergo a full CON review.
The commission insists that this is not a change from its current interpretation of the regulations, and that the new language only serves to clarify an existing requirement. Commentators previously disagreed, arguing that this is a significant change; however, no additional comments were made prior to approval.
The final regulations explicitly require projects that are exempt from certificate of need review, such as conversions of hospitals to independent medical facilities and consolidations of assisted living facilities, to develop an implementation schedule of the project, provide the commission with progress reports, make capital expenditure obligations through certain deadlines, and request approval of certain project changes through the project change request process established for certificate projects of necessity
Because it is the commission’s position that this is already necessary, projects operating under an exemption should be aware that the commission believes that such projects are currently subject to these additional reporting requirements.
In addition, the final regulations allow the commission to place restrictions on an approved exemption request.
Temporal flexibility
Before the amendment, the regulations established strict implementation deadlines for approved projects that did not provide for the necessary flexibility for projects of different scale. The final regulations will require each applicant to propose a reasonable schedule for implementing the project in their application.
In addition, the final regulations would 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 increased construction costs.
Other changes
The final regulations make additional changes, such as imposing timeliness requirements for MHCC staff to conduct a completeness review of a certificate of need application and limiting the rounds of follow-up questions that can be asked during the integrity review.
The final regulations also limit who qualifies as an interested party and therefore may intervene in an applicant’s CON review process and oppose the application. Prior to the amendment, the regulations did not require an interested party to demonstrate a negative impact on their healthcare facility.
The final regulations will require that the person who wants to be an interested party demonstrate that the quality of care of their health center would be materially affected, or that the project would involve a substantial depletion of essential personnel or other resources.
In addition, according to the final regulations, the commission will now take into account the impact of the projects on health equity, and the character and competence of the applicants when reviewing the proposals.
Barry F. Rosen is the president and CEO of the law firm of Gordon Feinblatt LLC, leads the corporate health practice group, and can be reached at 410-576-4224 or [email protected]. Darci M. Smith is of counsel in Gordon Feinblatts Health Practice Group and can be reached at 410-576-4153 or [email protected].
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