Expedited Review Process for Certain HRSA-Funded Projects Submitted by FQHCs
July 31, 2012
In an effort to facilitate the development of new FQHC capacity in New York State, the recently enacted SFY 2012-2013 State Budget (Ch. 56, L. 2012) includes an amendment to the Public Health Law (PHL) establishing a new Section 2807-z to provide for an expedited review process for FQHC capital projects funded in whole or in part with federal monies pursuant to Section 330 of the Public Health Service Act (PHSA), 42 USC 254b, or pursuant to the federal Capital Development-Building Capacity (CD-BC) Grant Program and Immediate Facility Improvements (CD-IFI) Grant Program.
This legislation does not apply to the establishment of new health care facility operators. Organizations that are not currently established to operate health care facilities must submit a Full Review – Establishment certificate-of-need (CON) application, using the normal process.
Projects with a Total Capital Cost of $3 Million or More
For FQHC capital projects funded through PHS Section 330, CD-BC, or CD-IFI with a total capital budget of $3 million dollars or more, the Department will expedite processing of the submitted Limited or Administrative Review construction application in the following manner:
- Within 30 days of receipt, the Department will deem such application complete or incomplete.
- If during such 30-day period the Department determines the application is incomplete or that more information is required, it will notify the applicant in writing and provide the applicant 20 business days to provide the necessary additional information or otherwise correct the deficiency in the application.
- Within 90 days of deeming the application complete, the Department will make a decision to approve or disapprove the application for such project. If the Department fails to take such action within the 90 days, the application will be deemed approved.
- If the Department determines to disapprove the project, the basis for such disapproval will be provided in writing.
- For an eligible capital project requiring Full Review by the Public Health and Health Planning Council (PHHPC), the certificate-of-need (CON) application will be placed on the next PHHPC agenda following the Department deeming the application complete.
- Where the Department requires the applicant to submit contingency material for an approved capital project pursuant to this initiative, it will have 30 days to review and approve or disapprove the contingency submission of the applicant. If the Department determines that the contingency submission is incomplete, it will so notify the applicant in writing and provide 10 business days to correct the deficiency or provide additional information. If the Department determines to disapprove the contingency submission, the basis for such disapproval will be provided in writing. Disapproval will not be based on the incompleteness of the application, if the Department has not notified the applicant that its submission is incomplete. Within 15 days of complete contingency satisfaction, the Department will transmit a letter to the applicant indicating that all contingencies have been satisfied.
- The Department will develop an expedited pre-opening survey process for capital projects approved pursuant to this initiative, with pre-opening survey reviews scheduled no later than 30 days after final approval, construction completion and notification of such completion to the Department by the FQHC. Applicants will be allowed to contact their respective Regional Office upon receipt of the all contingencies satisfied letter to have a pre-opening survey scheduled after they have completed construction. The Department will schedule a pre-opening survey no later than 30 after notification of construction completion.
For purposes of PHL Section 2807-z, "budget" is defined as "total project cost."
Projects of Up to $3 Million
Pursuant to PHL Section 2807-z, construction projects of existing FQHCs, funded in whole or in part through PHS Section 330, CD-BC, or CD-IFI with a budget of less than $3 million will not be subject to CON review. For purposes of section 2807-z, "budget" is defined as "total project cost." However, in order to operate and receive reimbursement as health care facilities, new and renovated facilities must obtain a valid operating certificate and comply with construction standards under 10 NYCRR.
Accordingly, existing FQHCs seeking to certify new extension clinics or renovate space in an existing site, with funding in whole or in part through PHSA Section 330, CD-BC, or CD-IFI, the Department will provide for an abbreviated submission process to permit licensure of the site or space and recognition of capital costs in facility rates.
For new extension site projects (which would otherwise be subject to an Administrative Review), this process will entail submission of schedules related to staffing, program, and architectural design and construction. Such projects will be exempt from public need and financial schedules, due to the nature of the NAP initiative and the provisions of PHL Section 2807-z. Applicants should include within the project narrative and cover letter a description of the source of funding for the project.
Therefore, the following schedules would need to be completed:
- Schedule 1 (General Information)
- Schedule 6 (Architectural Submission)
- Schedule 7 (Environmental Assessment)
- Schedule 8 (Summarized Project Cost)
- Schedule 13 (Assurances, Staffing, and Annual Operating Costs/Revenues)
- Schedule 17 (Program Information and Impact on Operating Certificate only)
Where NYSE-CON requires additional Schedules to complete the submission (i.e., Schedules 5, 9, 10, and 11), applicants will need to upload those documents with a notation that they are "Not Applicable".
For existing FQHCs seeking to add services to an existing site without any associated construction or capital expenses, the Department will seek to expedite the processing of Limited Review Applications ("service delivery") to add the service(s) to the facilities' operating certificates. Though the schedules will be the same as otherwise for a licensed entity to add minor services (i.e., LRA Schedules 1, 7, 8, 10 and 12, with Cover Sheet), the Department will strive to act upon such applications within 30 days of receipt.
FQHCs seeking to conduct renovations at an existing site that would otherwise require Administrative Review will, in most instances, submit a Limited Review Application ("minor construction") with the same schedules that are otherwise required for a licensed entity to perform minor construction (i.e., LRA Schedules 1, 2, 3, 4, 5 and 6, with Cover Sheet), though the Department will similarly strive to act upon such applications within 30 days of receipt.
One mechanism to assist the expedited processing of a capital construction project is through use of certifications by a NYS-licensed architect and/or engineer (A&E certification) affirming that the project has been designed and constructed in compliance with New York State's health care facility construction standards. The A&E certification is an alternative to a Department review of the architectural drawings. The certification allows for approval of a project without a drawing review; however, the pre-opening survey is scheduled and conducted as usual. The certification forms do not reduce or suspend the regulatory obligations of the applicant. The facility is expected to meet all NYS codes and regulations, the FGI 2010 Guidelines, the 2000 Life Safety Code, the NFPA codes and all other applicable codes listed in 10 NYCRR. If a request for a waiver of any such codes or regulations is needed, then the A&E certification cannot be used, and a drawing review will be required.
Projects Eligible for a Notice Submission
Effective January 20, 2012, Chapter 174 of the Laws of 2011 amends Article 28 of the Public Health law to eliminate requirements for Limited Review and CON review for projects confined to non-clinical infrastructure, repair and maintenance, and one-for-one equipment replacement, all regardless of cost. In place of the former limited review and CON requirements for these categories of projects, the amended Section 2802 requires the submission of only a written notice, applicable architect/engineer certification, and a plan for patient safety during construction. Though it is not anticipated that FQHC capital projects funded via this initiative will fall within this new processing category, any such projects can be processed via this recent change. More can be found relative to this change here: Construction Notices
As stated above, PHL Section 2807-z further requires that pre-opening surveys be scheduled no later than 30 days after final approval, construction completion and notification of such completion to the Department by the FQHC. To facilitate this scheduling, the Department will revise its "all contingencies satisfied" letters for projects pursuant to this initiative directing applicants to contact their Regional Office to schedule a pre-opening survey within 30 days of notifying the regional office of construction completion. The Department will also alert all Regional Offices that these surveys must be included on their schedule within 30 days of notification of construction completion, in order to expedite close-out of the submitted CON application and enable federal funding to commence.
To facilitate expedited review pursuant to Ch. 56, L.2012, the Department asks that applicants identify their applications within the narrative as HRSA Funded. This moniker will assist staff during the review process.
Should you have any questions regarding this letter, please do not hesitate to contact Charles P. Abel, Acting Director, Division of Health Facility Planning, at (518) 402-0967.
Richard M. Cook
Office of Health Systems Management