The New York State Department of Health (DOH) recently issued guidance on the new Certificate of Need (CON) licensure process for freestanding midwifery birth centers (also, MBCs). This guidance is the result of changes in law and regulation that seek to remove barriers that have historically restricted the establishment of freestanding birth centers led by licensed midwives.i This article provides a summary of the CON process developed by DOH as it relates to establishing and constructing midwifery birth centers.
What does New York’s CON application process generally entail?
As with all CON applications, in order to receive DOH approval to operate an MBC, applicants must submit, via the New York State Electronic Certificate of Need (NYSECON), a Full Review CON, which is reviewed by DOH staff for public need, financial feasibility, architectural and engineering standards, character and competence, and legal issues related to the organizational structure of the proposed operators and/or contractual arrangements.
Generally, upon completion of initial review, DOH staff submit a recommendation of approval to the Public Health and Health Planning Council (PHHPC), which is then responsible for reviewing and ultimately approving the applicant’s proposal. It is worth noting that, due to the COVID-19 pandemic, the PHHPC meetings from March 19, 2020, through June 4, 2020, have been canceled. The next PHHPC establishment committee meeting is scheduled to be held on July 16, 2020. As New York State forges ahead with its reopening plan in phases, DOH staff have resumed their review of submitted and pending licensure applications.
What specific items are needed to prepare and submit a CON application to become a licensed MBC provider?
As MBC is now considered an Article 28 healthcare facility, the CON process for MBCs is the same as for all other Article 28 entities. However, as indicated by DOH, as with other healthcare facilities, MBCs have requirements and standards that are specific to the program. Specifically, DOH has added new elements to the required CON submission relating to the operation and construction of MBCs, which include the following:
- Architectural and Engineering Submission Requirements. A new architectural schedule (Schedule 6) has been developed, outlining the architectural requirements for an MBC as well as a Birth Center Classifications matrix providing guidance on physical plant standards and project parameters for limited birth centers.
- MBC Programmatic Information. A new programmatic schedule (Schedule 24) has been developed for MBCs, requesting supporting information regarding community need, program information and program utilization. Applicants will be expected to demonstrate, in the form of a project narrative, their experience operating a program that is compliant with all state and federal laws and regulations relating to patient admissions, prenatal and intrapartum care, postpartum care, discharge and follow-up care, and on-site emergency care capabilities, as well as a description of how their proposal responds to and reflects the needs of the residents in the community they propose to serve.
It should be noted that, as a result of the COVID-19 Maternity Task Force’s six key recommendations to increase access to midwife-led birth centers, two providers have recently received emergency approvals through Executive Order 202 to establish and operate additional birthing surge sites. However, if these two providers wish to continue operation as licensed freestanding MBCs on a permanent basis, they will be required to submit for approval a CON application in the format described above.
Please contact Meghan McNamara at mmcnamara@manatt.com and/or Danielle Sokolov at dsokolov@manatt.com with any questions on the MBC CON process or if you need assistance preparing an application. Our New York licensing team works routinely with the New York State Department of Health to prepare and obtain approval of CON applications.
i On November 13, 2019, Title 10 of the New York Codes, Rules, and Regulations was amended to add a new Part 795 – Midwifery Birth Centers. This change was the result of Chapter 397 of the Laws of 2016, which amended the definition of the term “hospital” by including MBCs in the list of facilities or institutions engaged principally in providing services for the prevention, diagnosis or treatment of human disease, pain, injury, deformity or physical condition by or under the supervision of a midwife.