PURSUANT TO THE PROVISIONS OF THE State Administrative Procedure Act, NOTICE is hereby given of the following proposed rule:
Proposed Action:
Amendment of section 710.1(c)(3) and (5) of Title 10 NYCRR.
Statutory authority:
Public Health Law, section 2802
Subject:
Relocation of Extension Clinics.
Purpose:
Substitute prior limited review for administrative CON review of relocations of extension clinics within the same service area.
Text of proposed rule:
Clause (h) of subparagraph (i) of paragraph (3) of subdivision (c) of Section 710.1 is amended to read as follows:
(3) Proposals eligible for administrative review.
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(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.
Existing clause (a) of subparagraph (i) of paragraph (5) of subdivision (c) of Section 710.1 is amended to read as follows:
(5) Proposals requiring a prior review limited to architectural and engineering matters.
(i)(a) Proposals where total project cost does not exceed [$1,000,000] $3,000,000, and for which a certificate of need is not otherwise required under this Part, shall be subject to review under Article 28 of the Public Health Law limited to a determination of whether the proposal is consistent with applicable statutes, codes, rules and regulations relating to the structural, architectural, engineering, environmental, safety and sanitary requirements of licensed medical facilities where the proposal relates to the acquisition, relocation, installation or modification of:
* * *
Existing clause (b) of subparagraph (i) of paragraph (5) of subdivision (c) of Section 710.1 is renumbered as (c) and a new clause (b) is added:
(b) A proposal for 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 twenty-five (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 where total project cost does not exceed $3,000,000, shall be subject to review under Article 28 of the Public Health Law limited to a determination of whether the proposal is consistent with applicable statutes, codes, rules and regulations relating to the structural, architectural, engineering, environmental, safety and sanitary requirements of licensed medical facilities.
[(b)] (c) Notwithstanding anything in this Title to the contrary, proposals for the reallocation, relocation or redistribution of the following equipment and related services from one hospital to another hospital within the same established Article 28 network shall be subject to review under Article 28 of the Public Health Law limited to a determination of whether the proposal is consistent with applicable statutes, codes, rules and regulations related to the structural, architectural, engineering, environmental, safety and sanitary requirements of licensed medical facilities. This clause shall apply to the following equipment and related services:
(1) magnetic resonance imagers (MRI);
(2) CT scanners;
(3) extracorporeal shockwave lithotripters; and
(4) linear accelerators as replacements for cobalt units.
Text of proposed rule and any required statements and analyses may be obtained from:
Katherine Ceroalo, DOH, Bureau of House Counsel, Regulatory Affairs Unit, Room 2438, ESP, Tower Building, Albany, NY 12237, (518) 473-7488, email: regsqna@health.state.ny.us
Data, views or arguments may be submitted to:
Same as above.
Public comment will be received until:
45 days after publication of this notice.
Regulatory Impact Statement
Statutory Authority
The authority for the proposed revision to 10 NYCRR Parts 710 is section 2803(2)(a) of the Public Health Law (PHL), which authorizes the State Hospital Review and Planning Council (SHRPC) to adopt and amend rules and regulations, subject to the approval of the Commissioner of Health, to effectuate the provisions and purposes of Article 28 of the PHL with respect to hospitals, including but not limited to, requirements for construction projects subject to Certificate of Need (CON) review.
Legislative Objectives
Article 28 of the PHL seeks to ensure that hospitals and related services are of the highest quality, efficiently provided and properly utilized at a reasonable cost. Consistent with this legislative intent, the Department seeks to focus staff effort and other resources on the analysis of CON applications where considerations of public need, financial feasibility and quality of care are most pertinent. The Department has found that Article 28 construction projects involving relocation of extension clinics and having total project costs of $3 million or less rarely involve these larger and more fundamental CON concerns. Accordingly, the proposed amendment would remove this category of projects from CON review and subject them to only prior limited review.
Current Requirements
10 NYCRR Part 710 sets forth criteria governing the types of medical facility construction projects that require CON review. These criteria relate to a variety of factors, including the nature of the service, type of equipment, change in physical plant, and increase in overall service capacity. The CON approval process governed by this section takes two forms: administrative review and full review. Both entail a determination of public need for the proposed service, as well as a review of the project's financial feasibility. Projects subject to administrative review may be approved by the Commissioner alone, while those subject to full review require prior examination by the State Hospital Review and Planning Council (SHRPC).
Section 710.1(c)(3) subjects the relocation of an extension clinic to administrative CON review. This applies regardless of the cost of the relocation (unless the cost exceeds the $10 million threshold for full review) and without respect to the distance from the current site of the extension clinic to the proposed new site. This requirement for administrative CON review also pertains even if the relocation involves no change in services or clinical capacity between the current site and the new location.
Need and Benefits
From time to time, hospitals and D & T centers relocate extension clinics within their service areas. This often occurs as the providers seek to serve changing populations within their communities but also comes about because of matters related to building and physical plant, such as the expiration of a lease or the operator's need to convert the existing site to other uses. As more and more services are delivered on an ambulatory basis, the need for extension clinics and the periodic relocation of these community-oriented sites of service is only likely to grow. This trend will be given added impetus with the implementation of the recommendations of the Commission on Health Care Facilities in the Twenty-First Century ("the Commission"), many of which call for the reduction of beds and inpatient services in favor of community-oriented primary and ambulatory care.
In a rapidly changing health care system, the need to undergo administrative CON review for the simple relocation of a clinic, often involving a move of only a short distance, undermines the ability of providers to respond quickly to changing health care needs in their communities. It also often complicates situations where unforeseen circumstances require the quick vacating of an existing site (e.g., a sudden escalation in rental fees) and where the finalization of arrangements at a new site is contingent upon CON approval. The additional time required for CON review may also temporarily jeopardize access to care by local residents.
The purpose of administrative CON review of the relocation of an extension clinic is to ensure that the operation of the clinic at the new site will continue to meet a public need for the services offered; that the costs of the relocation, including any associated construction, are financially feasible; and that the physical plant at the new site complies with applicable components of the medical facilities construction code. These are important considerations. However, the Department believes that the first of these criteria need not be examined for the relocation of a clinic, when the relocation involves no increase in services or capacity; and when the relocation is proposed to occur from a location in which a significant number of the clinic's current patients reside to another such area. In these instances, the use of the clinic by area residents attests to its need. And as long as the costs of the relocation do not exceed a $3 million CON administrative review threshold, the Department believes that review for financial feasibility is not required. The Department proposes instead that these types of relocations be subject only to limited review pertaining to architectural and engineering matters. The retention of an architectural and engineering review requirement for these transactions is necessary to ensure that the new clinic site complies with applicable life safety and construction codes.
COSTS
Costs to the Department of Health
The proposed amendment would impose no new costs on the Department and would actually result in savings by eliminating the additional staff time required to process administrative review CON applications compared to applications that are subject only to prior limited review.
Costs to Other State Agencies
There are no costs to other State agencies or offices of State government.
Costs to Local Government
There are no costs to local government.
Costs to Private Regulated Parties
Because the proposed amendment imposes no new burdensome requirements, duties or responsibilities on any entity subject to Article 28 of the PHL, there are no costs to private regulated parties. The amendment will, in fact, result in savings to regulated parties by eliminating the $1,250 CON application fee associated with those projects that will no longer be subject to administrative CON review.
Local Government Mandates
The proposed amendment does not impose any new programs, services, duties or responsibilities upon any county, city, town, village, school district, fire district or other special district.
Paperwork
The proposed amendment imposes no new reporting requirements, forms or other paperwork. The amendment will actually reduce paperwork by removing the requirement for the filing of a CON application for affected projects.
Duplication
There are no relevant State or Federal rules which duplicate, overlap or conflict with the proposed amendment.
Alternatives
The Department considered requiring only a letter of notification, as provided for in section 710.1(c)(4), for the relocation of extension clinics within the same service area. However, the need to ensure that the site of the relocation complies with applicable medical facilities construction codes requires that these changes of clinic venue still be subject to some form of review. The proposed requirement for review under section 710.1(c)(5) serves this purpose.
Federal Standards
The proposed amendment does not exceed any minimum standards of the Federal government. There are no Federal rules currently addressing the CON process for the relocation of extension clinics.
Compliance Schedule
It is anticipated that the proposed amendment will be announced within one month of the effective date through the posting of an announcement on the Department of Health's Internet site.
The proposed amendment will be effective upon publication of a Notice of Adoption in the New York State Register. There is no schedule of compliance, since the proposed amendment only indicates how applications will be processed within the Department of Health.
Regulatory Flexibility Analysis
No regulatory flexibility analysis is required pursuant to section 202-(b)(3)(a) of the State Administrative Procedure Act. The proposed amendment does not impose an adverse economic impact on small businesses or local governments, and it does not impose reporting, record keeping or other compliance requirements on small businesses or local governments.
Rural Area Flexibility Analysis
No rural area flexibility analysis is required pursuant to section 202-bb(4)(a) of the State Administrative Procedure Act. The proposed amendment does not impose an adverse impact on facilities in rural areas, and it does not impose reporting, record keeping or other compliance requirements on facilities in rural areas.
Job Impact Statement
No Job Impact Statement is required pursuant to section 201 a(2)(a) of the State Administrative Procedure Act. It is apparent, from the nature of the proposed amendment, that it will not have a substantial adverse impact on jobs and employment opportunities.
