HLT-41-14-00002-A Certificate of Need (CON) Requirements

9/30/15 N.Y. St. Reg. HLT-41-14-00002-A

NEW YORK STATE REGISTER

VOLUME XXXVII, ISSUE 39

September 30, 2015

RULE MAKING ACTIVITIES

DEPARTMENT OF HEALTH

NOTICE OF ADOPTION

 

I.D No. HLT-41-14-00002-A

Filing No. 796

Filing Date. Sept. 15, 2015

Effective Date. Sept. 30, 2015

Certificate of Need (CON) Requirements

PURSUANT TO THE PROVISIONS OF THE State Administrative Procedure Act, NOTICE is hereby given of the following action:

Action taken:

Amendment of section 710.1 of Title 10 NYCRR.

Statutory authority:

Public Health Law, section 2802

Subject:

Certificate of Need (CON) Requirements.

Purpose:

Simplify CON review requirements for projects involving nonclinical infrastructure, equipment replacement and repair and maintenance.

Text or summary was published

in the October 15, 2014 issue of the Register, I.D. No. HLT-41-14-00002-P.

Final rule as compared with last published rule:

No changes.

Text of rule and any required statements and analyses may be obtained from:

Katherine Ceroalo, DOH, Bureau of House Counsel, Reg. Affairs Unit, Room 2438, ESP Tower Building, Albany, NY 12237, [phone], email: [e-mail]

Assessment of Public Comment

In commenting on the proposed rules, the Healthcare Association of New York State (HANYS) states that the proposed 710.1(c)(5)(ii)(d) is contrary to statute in its retention of limited review for the installation, replacement or modification of heating, ventilation and air conditioning systems and for other infrastructure projects that involve the modification or alteration of clinical space. It is HANYS’ position that the reference in PHL 2801 section 1-a to “non-clinical infrastructure,” which includes heating, ventilation and air conditioning (HVAC), plumbing, electrical and other systems, exempts such projects from approval by the State, regardless of the area of the hospital involved.

The Department agrees that PHL 2801 section 1-a exempts non-clinical infrastructure projects from CON review regardless of the area of the hospital involved, except when such projects also involve changes to actual clinical space, services or equipment. Accordingly, the proposed language of 710.1(c)(5)(ii)(d) retains the requirement for limited review of the installation, modification or replacement of HVAC, plumbing, electrical, water supply and fire protection systems “that involve modification or alteration of clinical space, services or equipment” (emphasis added). Projects for the modification or alteration of such spaces, services or equipment, even to accommodate infrastructure changes, cannot be deemed nonclinical, involving as they do areas, devices and services that have a direct impact on patient care. The Department therefore disagrees with HANYS’ suggestion that the proposed 710.1(c)(5)(ii)(d) be modified.

The Department wishes to emphasize that infrastructure projects that involve clinical areas but which do not propose to modify or alter clinical space, services or equipment would be exempt from review and subject only to submission of a notice under the proposed rules, as intended by PHL 2801 section 1-a. For example, a hospital’s proposed installation of a new HVAC system for the entire facility would obviously affect operating rooms, outpatient clinics and patient rooms, as well as the hospital’s nonclinical areas. However, unless the project involved the modification or alteration of clinical space, services or equipment, it would be considered nonclinical and would require only the submission of a notice, as provided for in PHL 2801 section 1-a. We note that the Department has already received notices for several such projects, some from facilities of considerable size, and has imposed no review requirements on these undertakings.

The Department also received comments on the proposed rules from Mid-Hudson Medical Group, P.C. Although as a professional corporation, physicians in this organization are not subject to Article 28 of the Public Health Law, they wrote in support of the proposed rules on behalf of those among their membership who have affiliated ambulatory surgery centers, which are subject to Article 28 requirements, stating that the replacement of a CON requirement with a notice requirement would permit operators of Article 28 facilities to implement needed projects more quickly.