N.Y. Comp. Codes R. & Regs. tit. 10 § 710.1

Current through Register Vol. 46, No. 50, December 11, 2024

Section 710.1 - General provisions

(a) Medical facilities shall be planned to achieve efficiency and economy of operation and care of high quality.

(b)

(1) For purposes of this Part, total project cost(s) means total costs for construction, including but not limited to costs for demolition work, site preparation, design and construction contingencies, total costs for real property, for fixed and movable equipment, architectural and/or engineering fees, construction manager and/or consultant fees, construction loan interest costs, and other financing, professional and ancillary fees, charges and allowances. Such costs shall include the cost of all capital items associated with an acquisition, lease arrangement and/or construction. If any acquisition is to be financed through a leasing arrangement, the relevant cost shall be the cost of the asset, not the lease amount.

(2) For purposes of this Part, total basic cost(s) of construction means total project cost(s) less capitalized amounts of construction loan interest cost(s), and other financing fees and charges.

(3) For purposes of this Part, "general hospital" means a general hospital as defined in subdivision 10 of section 2801 of the public health law.

(4) - [Reserved]

(5) For purposes of this Part, cardiac catheterization laboratory center, PCI capable cardiac catheterization laboratory center, diagnostic cardiac catheterization service, and cardiac electrophysiology (EP) laboratory program shall have the same meanings as in section 405.29(a)(4) of this Title.

(c) The erection, building, acquisition, alteration, reconstruction, improvement, extension or modification of a medical facility, including its equipment and services, shall be governed by the following:

(1) Proposals requiring a certificate of need application. Any proposal which involves any of the following shall be the subject of an application submitted for review pursuant to the requirements of this Part and article 28 of the Public Health Law:

(i) the addition, modification or decertification of a licensed service other than the addition of a service or a decertification of a facility's services as provided for in paragraph (5) of this subdivision, or the addition or deletion of approval to operate part-time clinics, regardless of cost. The addition or deletion of part-time clinic services operated by the State Department of Health (other than as an extension of an article 28 hospital operated by the State Department of Health) or by the health department of a city or county as such terms are defined in section 614 of the Public Health Law shall not be subject to approval pursuant to this Part;

(ii) a change in the method of delivery of a licensed service, regardless of cost;

(iii) the initial acquisition or addition of any equipment, regardless of cost, utilized in the provision of a service listed in paragraph (2) of this subdivision, other than the acquisition or addition of equipment subject to paragraph (6) of this subdivision. A proposal for the replacement of existing equipment, regardless of cost, which meets the criteria contained therein, shall not require an application but shall be processed pursuant to paragraph (4)of this subdivision;

(iv) [Reserved]

(v) a conversion of beds, except as provided for in paragraph (5) of this subdivision or a change in the certified bed capacity of a facility, regardless of cost, other than a decertification of a facility's beds as provided for in paragraph (5) of this subdivision; or

(vi) any other construction, addition or replacement proposal involving a total project cost in excess of $15,000,000 for a general hospital or $6,000,000 for all other facilities, except non-clinical and health information technology projects subject to paragraph (4) of this subdivision.

(2) Proposals requiring a full review, including a recommendation of the State Hospital Review and Planning Council.

(i) Any proposal involving any of the activities set forth in paragraph (1) of this subdivision that falls within any of the following categories shall require a full review pursuant to the requirements of this Part and article 28 of the Public Health Law:

(a) the addition of beds, other than beds designated for patients with acquired immune deficiency syndrome (AIDS) which are eligible for administrative review under paragraph (3) of this subdivision, or the conversion of beds which establish a different level of care, regardless of cost;

(b) any proposal for the addition, modification or change in the method of delivery of the following services, including the initial acquisition of any equipment relating thereto, regardless of cost;

(1) therapeutic radiology other than the replacement of a cobalt unit with a linear accelerator by a facility which has been deemed appropriate to provide therapeutic radiology or radiation oncology pursuant to section 708.5 of this Title which may be eligible for administrative review under paragraph (3) of this subdivision;

(2) adult or pediatric cardiac surgery;

(3) cardiac catheterization, including the relocation of any Cardiac Catheterization Laboratory Center service within a network or to another site in a multi-site facility, as defined in Section 401.1 of this Title, and the addition of a PCI Capable Cardiac Catheterization Laboratory Center at a facility that is not already approved to provide cardiac catheterization services; provided however that the addition of a PCI Capable Cardiac Catheterization Laboratory Center or Cardiac EP Laboratory Program at a facility approved to provide cardiac catheterization services shall be reviewed pursuant to paragraph (3) of this subdivision, and the addition of a Cardiac EP Laboratory Program services at a facility approved to provide cardiac surgery shall be reviewed pursuant to paragraph (6) of this subdivision;

(4) kidney, heart, liver and bone marrow transplantation;

(5) burns care;

(6) acquired immune deficiency syndrome (AIDS) centers except as provided in paragraph (3) of this subdivision; and

(7) epilepsy service;

(c) any proposal involving total project cost in excess of $30,000,000 for a general hospital or $15,000,000 for all other facilities, except as otherwise provided under paragraph (3) of this subdivision;

(d) any other proposal not eligible for administrative review under this section;

(e) any proposal which would otherwise be eligible for administrative review but which exceeds a facility's administrative review limitation; or

(f) any proposal which would otherwise be eligible for administrative review but which is recommended for disapproval.

(ii) The addition of equipment utilized in the provision of a service set forth in subparagraph (i) of this paragraph by a medical facility already approved to provide such service shall be reviewed as follows:

(a) The addition of equipment utilized in the provision of Cardiac Catheterization Laboratory Center services shall be eligible for limited review pursuant to paragraph (6) of this subdivision, to the extent that it does not otherwise require an administrative or a full review under this Part;

(b) the addition of equipment utilized in the provision of all other services set forth in subparagraph (i) of this paragraph shall be eligible for administrative review pursuant to paragraph (3) of this subdivision, to the extent that it does not otherwise require a full review under this Part.

(iii) For any application subject to full review for which the total basic cost of construction does not exceed $15 million the commissioner may, in lieu of requiring some or all of the architectural information and documentation required by this Part, accept a written certification by an architect or engineer licensed by the State of New York that such project complies with Part 711 of this Title. The certification shall be attached to and made a part of the application. The costs of any subsequent corrections necessary to achieve compliance with the requirements of Part 711 of this Title, when the prior work was not completed properly and was not accurately certified, shall not be considered allowable costs for reimbursement under Part 86 of this Title. This subparagraph does not waive any of the requirements of section 5-1.22 of this Title.

(3) Proposals eligible for administrative review.

(i)The commissioner may administratively approve applications submitted pursuant to Article 28 of the Public Health Law and this Part without the recommendation of the Public Health and Health Planning Council when an application has not been recommended for disapproval by the health systems agency having jurisdiction, and where the total project cost does not exceed $30,000,000 for a general hospital or $15,000,000 for all other facilities. An application shall be eligible for administrative review even though total project costs exceed $30,000,000 for a general hospital or $15,000,000 for all other facilities, if:

(A) total project costs do not exceed 10% of the total operating costs of the facility for the fiscal year ended two years prior to the submission of the application; and

(B) total project costs do not exceed $100,000,000 for a general hospital or $25,000,000 for all other facilities. Notwithstanding anything in this Part to the contrary, any cost increase of a project in excess of $30,000,000 for general hospitals or $15,000,000 for all other facilities that is administratively reviewed under the subparagraph, resulting in total project costs in excess of the $100,000,000 for general hospitals or $25,000,000 for all other facilities, or in excess of 10% of the total operating costs of the facility for the fiscal year ended two years prior to the submission of the application, shall subject the application to full review. The following types of proposals are eligible for administrative review:

(a) the addition of a licensed service or the modification or change in the method of delivery of a licensed service, other than those set forth in paragraph (2) of this subdivision which require full review;

(b) the conversion of a diagnostic cardiac catheterization service as described in section 405.29(a)(4)(ii) of this Title into a PCI capable cardiac catheterization laboratory center as described in section 405.29(a)(4)(i) of this Title; and the addition of cardiac EP laboratory program services at a facility approved to provide cardiac catheterization laboratory center services that is not also approved to provide cardiac surgery services;

(c) the conversion of beds other than a conversion which would establish a different level of care which proposal would require a full review, including the approval of the Public Health Council, and except as provided for in paragraph (5) of this subdivision;

(d) additions to existing services not involving an additional site or beds;

(e) the correction of patient safety deficiencies, ordinary repairs and maintenance, energy conservation measures, or modernization in a medical facility or portion of a medical facility. Projects for the modernization (which may include new construction and/or renovation) of a medical facility or portion of a medical facility will be eligible for administrative review only if it will not substantively change the capacity or type of the service(s) involved and does not involve issues of public need;

(f) the addition, updating or modification of equipment utilized in the provision of a service listed in paragraph (2) of this subdivision, by a medical facility already approved to provide such service, except for the addition of equipment utilized in cardiac catheterization laboratory center services by a facility already approved to provide such service, which shall be subject to limited review pursuant to paragraph (6) of this subdivision;

(g) the addition or deletion of approval to operate part-time clinic services;

(h) the operation or relocation of an extension clinic as defined in section 401.1 of this Title, when such relocation is to a site outside the current service area of the extension clinic, as defined in paragraph (5) of this subdivision, and does not entail an increase in scope of services or clinical capacity.

(i) the expansion or the modernization of an emergency room;

(j) [Reserved]

(k) a change in bed capacity of an acquired immune deficiency syndrome (AIDS) center which does not result in a net increase in the certified bed capacity of the facility;

(l) the acquisition of magnetic resonance imagers (MRIs), provided that acquisitions of MRIs by a general hospital as defined in section 2801 of the Public Health Law may be reviewed under paragraph (5) of this subdivision;

(m) the addition of adult day health care services provided either in a residential health care facility or offsite by a residential health care facility that has been approved to provide the services onsite or the expansion of an existing adult day health care service;

(n) the addition of skilled nursing facility beds specifically designated for persons suffering with acquired immune deficiency syndrome (AIDS) by a residential health-care facility without any limitation of total project cost as set forth above;

(o) the addition of a methadone maintenance treatment program at either its main site or an extension clinic;

(p) the acquisition of CT scanners, provided that acquisitions of CT scanners by a general hospital as defined in article 28 of the Public Health Law may be reviewed under paragraph (5) of this subdivision;

(q) Reserved;

(r) the replacement of a cobalt unit with a linear accelerator by a facility which has been deemed appropriate to provide therapeutic radiology and radiation oncology pursuant to section 708.5(a) of this Title;

(s) the temporary addition of beds to a facility's certified capacity, for a period of time not to exceed one year, required to address high priority health care needs for which there is a demonstrated acute shortage;

(t) the addition of ventilator dependent service;

(u) Swing Bed Demonstration Program;

(v) the addition of chronic renal dialysis stations by a facility approved and operating dialysis stations. A facility approved to provide only chronic renal dialysis shall be deemed approved to provide:

(1) all modalities of chronic renal dialysis; and

(2) chronic renal dialysis services to patients at home, provided that a facility shall give the appropriate area office of the department at least 15 days' written notice prior to commencing or terminating the facility's program for the provision of chronic renal dialysis services to patients at home; and

(w) the addition of primary care sites meeting the following criteria:

(1) primary care services are comprehensive in nature and are developed consistent with section 85.44 of this Title; and

(2) total project costs do not exceed $15,000,000; and

(3) the proposed location is designated by the department and the health systems agency having jurisdiction as a low access to primary care area and access to primary care by residents will be enhanced. The local health systems agency, however, may provide the department with other relevant information addressing the unmet need for additional primary care capacity; and

(4) the number of projected new visits represents residents who are not currently receiving primary health care services from an existing designated preferred primary care provider (PPCP); and

(5) the proposed addition would not substantially adversely impact existing PPCPs relative to duplication of services and proximity of the proposed site; and

(6) existing PPCPs have achieved optimal utilization based on their physical plant and ability to retain an appropriate supply of practitioners; and

(7) neither the facility nor any part thereof, nor the project is currently or is proposed to be financed by bonds or other debt instruments insured, enhanced or guaranteed by any state or municipal agency or public benefit corporation. Notwithstanding anything in this Part to the contrary, any cost increase of a primary care services project resulting in total project costs in excess of the $30,000,000 threshold for general hospitals or the $15,000,000 threshold for all other facilities shall subject the application or amendment, as the case may be, to full review.

(ii)

(a) Each medical facility shall be limited in the total amount of, or extent to which, applications may be approved administratively, and such limit shall be based on the anticipated annual operating costs, including capital costs, generated by the activities which are the subject of the applications. Except with respect to an application under clause (i)(a), (c), (h) or (j) of this paragraph, or clause (b) of this subparagraph, a medical facility's application shall not be eligible for administrative review if, for any calendar year, the total anticipated annual increase in total operating costs, including capital costs, generated by the facility's applications that have already been approved administratively in the current calendar year exceeds or, including the subject application under review, would exceed an amount equal to one percent of the total allowable operating and capital costs of the base year used trended to determine the facility's Medicaid reimbursement rate pursuant to Part 86 of this Title for the year in which the application is expected to be acted on. For facilities which do not participate in the Medicaid program, the limitation imposed herein shall be an amount equal to one half of one percent of the facility's total annual operating and capital costs, incurred during the fiscal year utilized by Part 86 for participating facilities. Any unused portion of a facility's administrative review cap for any calendar year shall be carried forward to the following calendar year to be applied to any application(s) eligible for administrative review which has not been acted on, which is deemed complete and which was submitted on or before October 1st of the preceding year.

(b) Notwithstanding the administrative review limitation imposed by clause (a) of this subparagraph, the commissioner may, pursuant to the requirements and limitations of this clause, administratively approve an application for the correction of nonwaiverable requirements of construction under this Title or the replacement of existing equipment which has not exhausted at least 90 percent of the higher of its useful life pursuant to Part 86 of this Title or its estimated useful life according to the tables of estimated useful lives in the American Hospital Association's Estimated Useful Lives of Depreciable Hospital Assets, 2008 edition, as incorporated by reference in this clause, the total project cost of which does not exceed $15 million, when such correction or replacement proposal is essential for the continued operation of the facility in compliance with the requirements of this Title or the provision of necessary medical care and services. Equipment replacement proposals involving equipment which no longer meets the generally accepted operational standards for such equipment or has exhausted at least 90 percent of the higher of its useful life reported pursuant to Part 86 of this Title or its estimated useful life according to the tables of estimated useful lives in the American Hospital Association's Estimated Useful Lives of Depreciable Hospital Assets, 2008 edition, may be processed under paragraph (4) of this subdivision. Copies of the foregoing publication are available from the American Hospital Association, One North Franklin, Chicago, IL 60606-3421, www.aha.org and a copy is available for inspection and copying at the Regulatory Affairs Unit of the Department of Health, Empire State Plaza, Corning Tower, Albany, NY 12237. The anticipated annual increase in total operating costs, including capital costs, generated by an application eligible for administrative review under this clause, shall be charged against any unused portion of the applicant's administrative review limitation imposed by clause (a) of this subparagraph; however, an application eligible for administrative review under this clause may be processed administratively despite the fact that the administrative review limitation has been exhausted or may be exceeded as a result of approving the subject application.

(iii) Where an application is being processed administratively and consistency with applicable statutes, codes, rules and regulations relating to the structural, architectural, engineering, environmental, safety and sanitary requirements of a licensed medical facility is required:

(a) the applicant shall submit to the Bureau of Architectural and Engineering Review such information and documentation as is required under this Part to determine the acceptability of the proposal; or

(b) the commissioner may, as an alternative to the above, accept a written certification by an architect or engineer licensed by the State of New York that such project complies with Part 711 of this Title. The certification will be made available for review at the next onsite survey conducted by the department in accordance with article 28 of the Public Health Law. The costs of any subsequent corrections necessary to achieve compliance with the requirements of Part 711 of this Title when the prior work was not completed properly and was not accurately certified shall not be considered allowable costs for reimbursement under Part 86 of this Title. This clause does not waive any of the requirements of section 5-1.22 of this Title.

(4) Proposals not requiring an application.

(i) The following types of construction projects shall not require prior approval under this Part, regardless of cost, provided that a written notice has been submitted to the department prior to commencement of construction, together with, where indicated in this paragraph, a written certification by a New York State licensed architect or engineer that the project meets all applicable statutes, codes and regulations; and provided that the hospital shall implement a plan to protect patient safety during construction projects that implicate patient safety, consistent with section 711.2 of this Title and other applicable standards, and as otherwise required by the department:

(a) Any proposal for the correction of cited deficiencies, consistent with a plan of correction approved by the department; provided that the construction is limited to the correction of the deficiencies.

(b) Any proposal for the repair or maintenance of a medical facility, including routine purchases and the acquisition of minor equipment undertaken in the course of a medical facility's inventory control functions, provided that for proposals under this clause with a total cost of up to $6 million, including separate proposals which are programmatically related, no written notice shall be required. This subparagraph shall not apply to activities requiring a limited review under Article 28 of the Public Health Law pursuant to paragraph (5) of this subdivision.

(c) Any proposal to discontinue a part-time clinic site of a medical facility already authorized to operate part-time clinics pursuant to this Part shall not require the submission of an application pursuant to this Part, but compliance is required with the applicable notice provisions of section 703.6 of this Title.

(d) Any proposal for the replacement of existing equipment, regardless of cost, with another piece of equipment used for similar purposes but employing substantially equivalent current technology which, if subject to approval by the U.S. Food and Drug Administration, has received such approval. The facility"^TMs written notice to the department shall include a written certification by a New York State licensed architect or engineer that the project meets the applicable statutes, codes and regulations; and a plan to protect patient safety during replacement projects that implicate patient safety, consistent with section 711.2 of this Title and other applicable standards, and as otherwise required by the department. Upon completion of the project, the facility shall, where applicable, submit written certification by a New York State licensed architect, engineer and/or physicist that the replacement equipment as installed meets applicable statutes, codes and regulations; and such other close-out documents as may be required by the department.

(e) Subject to clause (d) of subparagraph (ii) of paragraph (5) of this subdivision, any proposal for a nonclinical infrastructure project with total project costs in excess of $6,000,000, including but not limited to replacement of heating, ventilating and air conditioning, fire alarm and call bell systems or components thereof, roofs, elevators, parking lots and garages, dietary, and solid waste and/or sewage disposal and upgrades of the exterior building envelope. The facility's written notice to the department shall include a written certification by a New York State licensed architect or engineer that the project meets the applicable statutes, codes and regulations; and shall include a plan to protect patient safety during construction consistent with section 711.2 of this part and other applicable standards, and as otherwise required by the department. Upon completion of the project, the facility shall, where applicable, submit written certification by a New York State licensed architect, engineer and/or physicist that the project as constructed or installed meets applicable statutes, codes and regulations; and such other close-out documents as may be specified by the department.

(f) Notwithstanding anything in this section to the contrary, from time to time the commissioner may, at the commissioner's discretion, approve capital expenditures that may be required in response to new State, municipal, or Federal code requirements. Such approval may only be considered when such code changes affect large numbers of hospitals (as such term is defined in article 28 of the Public Health Law) and where the commissioner finds that the capital expenditure is unlikely to create any risk to patient safety. Upon such determination, the commissioner shall notify affected hospitals of the opportunity to proceed with such capital expenditures based on a letter of notice to the department. The commissioner may impose a cap on anticipated individual project capital expenditures for such a waiver.

(g) Any proposal that relates to health information technology regardless of cost. For health information technology proposals involving the implementation of clinical information systems, electronic medical records, computerized physician order entry, radiology systems, lab ordering systems or other health information systems impacting patient care, the facility's written notice to the department shall include a certification of the technology's interoperability with other systems an d conformance with state and federal guidelines and regulations governing the use and exchange of information, including privacy and security, that is acceptable to the department.

(ii) Proposals for a nonclinical infrastructure project, including but not limited to replacement of heating, ventilating and air conditioning, fire alarm and call bell systems or components thereof, roofs, elevators, parking lots and garages, dietary, and solid waste and/or sewage disposal and upgrades of the exterior building envelope, where total project costs do not exceed $6,000,000, shall not require prior approval or written notice to the department under this Part, except as required by clause (d) of subparagraph (ii) of paragraph (5) of this subdivision.

(5) Proposals requiring a limited review. Proposals where total project cost does not exceed $15,000,000 for a general hospital or $6,000,000 for all other facilities, and for which a certificate of need is not otherwise required under this Part, shall be reviewed under this paragraph, except for proposals covered by paragraph (4) of this subdivision.

(i)

(a) Applicants shall submit all such requests for approval of proposals described in this paragraph through the electronic application submission process at the address posted on the department's website, including such information and documentation as the department requires to determine whether the proposal is acceptable.

(b) If the proposal involves the addition or decertification of a service or the conversion or decertification of beds subject to review under subparagraph (iv) of this paragraph, a copy shall also be sent to the health systems agency (HSA) having jurisdiction, if any. The HSA will have 10 days to respond to the department.

(c) If the department determines that the proposal complies with all pertinent statutory and regulatory requirements, the department shall notify the applicant, in writing, that the proposal is acceptable and, if applicable, an amended operating certificate will be issued.

(d) If the department determines that the proposal is not acceptable, the applicant shall be notified in writing of such determination and the bases thereof. If the applicant disagrees with the commissioner's determination, the applicant may submit a certificate of need application to be processed for full review in accordance with this Part.

(e) Applicants that submit proposals subject to review under clause (ii)(e) of this paragraph, or under subparagraph (iv) of this paragraph that do not require an architecture and engineering certification, shall be notified of the department's determination within 30 days of submission of all necessary information.

(ii) A review shall be conducted of the proposal's compliance with applicable statutes, codes, rules and regulations relating to the structural, architectural, engineering, environmental, safety and sanitary requirement of licensed medical facilities, where the proposal relates to the acquisition, relocation, installation or modification of:

(a) medical equipment involving ionizing radiation or magnetic resonance, including magnetic resonance imagers (MRIs) and CT scanners by a general hospital as defined in article 28 of the Public Health Law;

(b) facility areas relating to clinical services or surgical or other invasive procedures, not otherwise requiring approval under this section;

(c) inpatient units, including resident rooms in a residential health care facility and other spaces used by residents of residential health care facilities on a daily basis, relating to other than routine maintenance and repairs or routine purchase of equipment;

(d) heating, ventilating, air conditioning, plumbing, electrical, water supply and fire protection systems that involve modification or alteration of clinical space, services or equipment such as operating rooms, treatment and procedure rooms, and intensive care, cardiac care and other special care units (such as airborne infection isolation rooms and protective environment rooms), laboratories and special procedure rooms, and patient or resident rooms or other spaces used by residents of residential health care facilities on a daily basis. Projects involving routine maintenance or repairs or routine purchases affecting such systems shall not be subject to this subparagraph.

(e) the relocation of an extension clinic within the same service area, defined as:

(1) one or more postal zip code areas in each of which 25 percent or more of the extension clinic's patients reside; or

(2) the area within one mile of the current location of such extension clinic, which does not entail an increase in services or clinical capacity; and

(f) notwithstanding anything in this Title to the contrary, the reallocation, relocation or redistribution of linear accelerators as replacements for cobalt units and related services from one hospital to another hospital within the same established article 28 network.

(iii) The commissioner may, as an alternative to the submission of architectural and engineering documentation referenced above, accept a written certification by an architect or engineer licensed by the State of New York that such project complies with Part 711 of this Title. The certification will be made available for review at the next onsite survey conducted by the department in accordance with article 28 of the Public Health Law. The costs of any subsequent corrections necessary to achieve compliance with the requirements of Part 711 of this Title, when the prior work was not completed properly and was not accurately certified, shall not be considered allowable costs for reimbursement under Part 86 of this Title. This subparagraph does not waive any of the requirements of section 5-1.22 of this Title.

(iv) The following proposals shall also be subject to limited review under this paragraph for programmatic and/or public need purposes:

(a) Any proposal to decertify a facility's beds, for which a certificate of need application is not otherwise required under this Part. The applicant shall submit information indicating the number of beds to be decertified, where the beds to be decertified are physically located in the facility and what, if any, alternate use will be made of the space. Such proposed alternate use may require review pursuant to subparagraph (ii) of this paragraph.

(b) Any proposal solely to decertify services, other than those set forth in clause (2)(i)(b) of this subdivision. The applicant shall submit information indicating the services to be decertified, where the services to be decertified are physically provided in the facility and what, if any, alternate use will be made of the space. Such alternate use may require review pursuant to subparagraph (ii) of this paragraph.

(c) Any proposal to add services, other than those set forth in clause (2)(i)(b) and subparagraph (3)(i) of this subdivision, for which a certificate of need application is not otherwise required under this Part. The applicant shall submit information indicating the services to be certified, the additional staffing requirement, if any, where the services to be certified are physically provided in the facility and what, if any, construction will be required in the facility. If construction is required, the request may require review pursuant to subparagraph (ii) of this paragraph.

(d) Any proposal to convert beds from one category to another in the categories listed in this clause and for which the acute care inpatient facility is already a certified provider. The applicant shall submit information indicating the number of beds to be converted and the categories from which and to which the beds will be converted. This clause applies to beds in the following categories:

(1) medical/surgical;

(2) intensive care;

(3) coronary care;

(4) pediatric;

(5) pediatric intensive care;

(6) neonatal intensive care;

(7) neonatal intermediate care;

(8) neonatal continuing care;

(9) maternity; and

(10) chemical dependence-detoxification.

(e) Any proposal to operate, change services offered, change hours of operation, or relocate a part-time clinic site. Requests for approval shall be consistent with the provisions of section 703.6(b) of this Title. Notwithstanding any inconsistent provision of this section, if the proposal is acceptable to the department, the applicant shall be notified in writing within 45 days of acknowledgment of receipt of the request. If the proposal is not acceptable, the applicant shall be notified in writing within 45 days of such determination and the bases thereof. If the applicant disagrees with the commissioner's determination, the applicant may submit a certificate of need application to be processed for full review in accordance with this Part. If a proposal requests approval for an arrangement or services that are not permissible for a part-time clinic, the proposal will not be accepted for processing under this section.

(f) Notwithstanding anything in this Title to the contrary, any proposal for the reallocation, relocation or redistribution of acute care beds from one general hospital to another general hospital within the same established article 28 network shall be subject to a limited review under this section. The applicant shall submit information indicating the current and proposed certified bed capacity for each service and facility for which the reallocation, relocation or redistribution of beds is proposed.

(6) Cardiac catheterization proposals requiring a limited review.

(i) The following proposals related to the expansion or modification of cardiac catheterization laboratory center services and equipment shall be subject to review pursuant to this paragraph, provided that they do not involve a total project cost in excess of the amount set forth in paragraph (5) of this subdivision or otherwise require a certificate of need under this Part:

(a) any proposal to add or modify cardiac catheterization laboratories, facility areas or equipment to be utilized in the provision of approved cardiac catheterization laboratory center services by a facility already approved to provide PCI capable cardiac catheterization laboratory center services;

(b) any proposal to add or modify equipment in approved space by a facility already approved to provide diagnostic cardiac catheterization services; and

(c) any proposal to add cardiac EP laboratory program services at a facility that is already approved to provide cardiac surgery services.

(ii)

(a) Reviews under this paragraph shall include, but not be limited to, the proposal's compliance with applicable statutes, codes and rules and regulations relating to the structural, architectural, engineering, environmental, safety and sanitary requirements of licensed medical facilities and with Part 405.29 of this Title.

(b) Requests for approval of proposals described in this subparagraph shall be made through the electronic application submission process at the address posted on the department's website or any other means approved by the department, including information indicating the services to be provided, the facility areas to be utilized, and such other information as the Department may require. If construction is required, the requests hould include the cost of such construction and other information required by the Bureau of Architectural and Engineering Facility Planning under this Part. If the proposal involves the addition of Cardiac EP Laboratory Pro gram Services, the applicant shall also submit a copy to the local health systems agency (HSA) having jurisdiction, if any. The HSA shall have 10 days to make a recommendation to the department.

(c) If the proposal is acceptable to the department, the applicant will be notified in writing and, if appropriate, an amended operating certificate will be issued. If the proposal is not acceptable, the applicant shall be notified in writing of such determination and the basis thereof. If the applicant has not submitted an acceptable proposal within 30 days of such determination, then the proposal shall be deemed an application subject to full or administrative review pursuant to section 2802 of the Public Health Law.

(7) Medical facilities which will undertake during their fiscal year a number of construction and/or acquisition projects related programmatically, the aggregate total project cost of which during said period will exceed $6 million, shall submit for review a single application encompassing all such projects pursuant to the requirements of this Part and article 28 of the Public Health Law. If a subsequent audit reveals that during any such period a medical facility has undertaken several projects or submitted several proposals or applications, related programmatically, the total aggregate project cost of which exceeds $6 million, the facility's reimbursement rate may not reflect, or may be reduced to the extent it includes, the cost of the related projects. For the purposes of this paragraph, no such audit shall consider costs incurred in proposals or applications acknowledged or received prior to the effective date of this subdivision.

(8) Medical facilities shall maintain a record of all additions to property, plant and equipment made during the appropriate 12-month period reflected in their capital budget. Each addition, which is subject to paragraph (1) of this subdivision, must be supported by an application approved pursuant to article 28 of the Public Health Law and this Part. Each medical facility shall, as a matter of routine, submit with the annual certified cost reimbursement reporting forms required by the Office of Health Systems Management, beginning with the effective date of this section, identification of its annual capital expenditures, as provided for in the section entitled "Changes in financial positions," indicating separately the total amounts thereof involving projects in the following categories: below $6 million and over $6 million, which have received appropriate approvals pursuant to this Part, and the nature of each approval. The facilities shall also provide to the department annually, on forms provided by the department, a list of projects between $1 million and $6 million, which have been undertaken by the facility, although such projects do not require certificate of need approval.

(d) All drawings and specifications shall bear the seal and signature of an architect or engineer licensed to practice in New York State. The commissioner, at his discretion, may waive the above requirement when the construction is less than $10,000 in value, unless otherwise provided for in this Part.

(e) All construction in or of a medical facility shall have competent and adequate architectural and/or engineering inspection at the construction site to ensure that the completed work conforms with the approved plans and specifications.

(f) As a part of the application required for approval of the project, the applicant shall give the following assurances:

(1) that the applicant has or will have a fee simple or such other estate or interest in the site, including necessary easements and rights-of-way sufficient to assure use and possession for the purpose of the construction and operation of the facility;

(2) that the applicant will obtain the approval of the commissioner of all required submissions, which shall conform to the standards of construction and equipment of this Subchapter;

(3) that the applicant will submit to the commissioner final working drawings and specifications, which shall conform to the standards of construction and equipment of this Subchapter, prior to contracting for construction, unless otherwise provided for in section 710.7 of this Part;

(4) that the applicant will cause the project to be completed in accordance with the application and approved plans and specifications;

(5) that the applicant will provide and maintain competent and adequate architectural and/or engineering inspection at the construction site to insure that the completed work conforms with the approved plans and specifications;

(6) that if the project is an addition to a facility already in existence, upon completion of construction all patients shall be removed from areas of the facility which are not in compliance with sections 711.4 through 711.8 of this Title, or other pertinent provisions of this Subchapter, unless a waiver is granted to specific provisions by the commissioner, under section 711.9 of this Title;

(7) that the facility will be operated and maintained in accordance with the standards prescribed by law; and

(8) that the applicant will comply with the provisions of the Public Health Law and the applicable provisions of this Title with respect to the operation of all established, existing medical facilities in which the applicant has a controlling interest.

(g) The applicant shall be required to adequately equip the facility to assure its proper operation.

N.Y. Comp. Codes R. & Regs. Tit. 10 § 710.1

Amended New York State Register September 30, 2015/Volume XXXVII, Issue 39, eff. 9/30/2015

Amended New York State Register September 6, 2017/Volume XXXIX, Issue 36, eff. 9/6/2017