On Feb. 22, 2024, the Maryland Health Care Commission unanimously approved final regulations making significant changes to the Procedural Regulations for Health Care Facilities and Services. Notably, the commission did not receive any comments on the published proposed regulations, and there were no additional amendments made to the proposed language prior to approval.
This adoption marks the last step in a multi-year process aimed at updating 
the certificate of need certificate of need (CON) regulations to conform with significant statutory changes that have occurred since the regulations were last updated, and the following is a summary of the newly adopted final regulations amending COMAR 10.24.10.
Post-approval requirements
The final regulations will 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 undergoing 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. Commentors 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 into freestanding medical facilities and consolidations of health care facilities, to develop a project implementation schedule, provide the commission with progress reports, make capital expenditure obligations by certain deadlines, and seek approval of certain project changes through the project change request process established for certificate of need projects.
Since it is the commission’s position that this is already required, projects operating under an exemption should be aware that the commission believes those projects are currently subject to these extra reporting requirements.
Additionally, the final regulations allow the commission to place restrictions on an approved exemption request.
Timeline flexibility
Prior to amendment, the regulations established strict implementation timelines for approved projects that did not provide for the flexibility needed for projects of differing scale. The final regulations will require each applicant to propose a reasonable schedule to implement the project in its application.
Additionally, 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 escalating construction costs.
Other changes
The final regulations make additional changes, such as imposing timeliness requirements for the MHCC staff to conduct its completeness review of a certificate of need application, and limiting the rounds of follow-up questions that may be asked during the completeness review.
The final regulations also limit who qualifies as an interested party, and is thereby able to intervene in an applicant’s CON review process and to object to the application. Prior to amendment, the regulations did not require that an interested party demonstrate a negative impact to its health care facility.
The final regulations will require a person who wants to be an interested party to demonstrate that the quality of care at its health care facility would be materially affected, or that the project would result in a substantial depletion of essential personnel or other resources.
Additionally, under the final regulations, the commission will now consider a project’s impact on health equity, and the character and competence of applicants when reviewing proposals.
Barry F. Rosen is the chairman & CEO of the law firm of Gordon Feinblatt LLC, heads the firm’s health care practice group, and can be reached at 410-576-4224 or [email protected]. Darci M. Smith is counsel in Gordon Feinblatt’s health care practice group, and can be reached at 410-576-4153 or [email protected].
