Part 709 - Determination of Public Need for Medical Facility Construction

Effective Date: 
Wednesday, September 25, 2019
Doc Status: 
Complete
Statutory Authority: 
Public Health Law, Section 2803

Section 709.1 - Determination of public need pursuant to section 2802 of the Public Health Law

Section 709.1 Determination of public need pursuant to section 2802 of the Public Health Law. (a) The factors for determining public need for health services and medical facilities shall include, but not be limited to:

(1) the current and projected population characteristics of the service area, including relevant health status indicators and socio-economic conditions of the population;

(2) normative criteria for age and sex specific utilization rates to correct for unnecessary utilization for health services;

(3) standards for facility and service utilization, comparing actual utilization to capacity, taking into consideration fluctuation of daily census for certain services, the geography of the service area, size of units, and specialized service networks;

(4) the patterns of in and out migration for specific services and patient preference or origin;

(5) the need that the population served or to be served has for the services proposed to be offered or expanded, and the extent to which all residents in the area, and in particular low-income persons, racial or ethnic minorities, women, handicapped persons, and other underserved groups and the elderly, will have access to those services;

(6) in cases involving the reduction or elimination of a service including those involving the relocation of a facility or service, the extent to which need will be met adequately and the effect of the reduction, elimination, or relocation of the service or facility on the ability of the low-income persons, racial and ethnic minorities, women, handicapped person, and other underserved groups, and the elderly, to obtain needed health care;

(7) the contribution of the proposed service or facility in meeting the health needs of members of medically underserved groups which have traditionally experienced difficulties in obtaining equal access to health services (for example, low-income persons, racial and ethnic minorities, women, and handicapped persons). For the purpose of determining the extent to which the proposed service or facility will be accessible to such persons, the following shall be considered:

(i) the extent to which medically underserved populations currently use the applicant's services in comparison to the percentage of the population in the applicant's service area which is medically underserved, and the extent to which medically underserved populations are expected to use the proposed services if approved;

(ii) the performance of the applicant in meeting its obligation under the applicable civil rights statutes prohibiting discrimination on the basis of race, color, national origin, handicap, sex and age;

(iii) the extent to which Medicare, Medicaid and medically indigent patients are served by the applicant; and

(iv) the extent to which the applicant offers a range of means by which a person will have access to its services.

(b) The evaluative procedure for review of public need pursuant to section 2802 of the Public Health Law shall include, but not be limited to:

(1) description of proposal as submitted by applicant for construction;

(2) identification of use rates in the service area for the service or services involved;

(3) identification of current and projected user population of the service area;

(4) identification of resulting estimate of future quantitative need as projected for a period of five years from last complete calendar year reported;

(5) identification of existing service(s) which are the same as those proposed by the applicant available in the service area;

(6) identification of existing service(s) which are the same as those proposed by the applicant which will be available to meet future need in the service area;

(7) identification of service(s) which are the same as those proposed by the applicant and which have been approved for construction but are not in operation in the service area;

(8) identification of resulting resource(s) available in service area five years in future to meet need;

(9) identification of percent of need met for proposed service(s) ;

(10) description of the current utilization for all service(s) which are the same as those proposed by applicant in the service area;

(11) description of the current utilization for allied or alternate services in the service area;

(12) description of any migration patterns for health care in the service area;

(13) description of any evidence of inappropriateness of placement in the service area for the subject service(s) and related service(s) ; and

(14) description of the distribution of service(s) in relation to the population's distribution.

(c) The public need analysis for each proposal will include a determination of the appropriate service area. The county in which the construction is proposed shall be the service area, unless the commissioner, upon consideration of the advice of the State Hospital Review and Planning Council, determines that a service area other than the county is more appropriate. The applicant or the health systems agency may delineate a service area other than the county together with evidence in support of such delineation. After reviewing the evidence, the commissioner, upon consideration of the advice of the council, may determine that the proposed service area is not acceptable. In cases wherein a service area other than the county is being proposed, the following shall be considered: (1) the patterns of in-and-out migration for specific services which are the same as those proposed by the applicant and patient preference or origin; and

(2) appropriateness of travel and referral patterns.

(d) Medical facilities shall be planned to achieve efficiency and economy of operation and care of high quality. In addition to the other pertinent provisions of this Part, the analysis to determine whether there is a public need for the proposed construction shall include consideration of additional factors as appropriate, including but not limited to the following:

(1) the condition of the facility's existing structures and equipment and the extent to which they are in compliance with the applicable standards of facility operation and construction under this Title;

(2) whether the architectural solutions proposed by the applicant to address the issues which are the subject of the application are:

(i) cost efficient with respect to the anticipated operational and capital cost impact of the proposal;

(ii) necessary to correct nonwaiverable requirements or standards of operation or construction under this Title;

(iii) necessary to address a problem or situation which will require corrective action within two years;

(3) reserved;

(4) whether the proposal is consistent with the applicant's long-range capital plan;

(5) whether the applicant will take advantage of opportunities for the efficient and economic reuse and recycling of existing physical plant resources, where feasible and appropriate;

(6) the life cycle incremental operational and capital cost effectiveness and efficiency of the proposal;

(7) whether the proposal could be adapted to accommodate changes in pertinent technology;

(8) whether the applicant will take advantage of opportunities to gain economies and improvements in the provision of services by entering into appropriate arrangements for sharing facilities, services or equipment with other facilities; and

(9) whether there are alternative methods or solutions available, which are more efficient, based on capital and operating costs, to address the subject problem or situation that will nevertheless ensure the provision of a level and quality of care and service that is in compliance with pertinent Federal and State statutes, rules and regulations.

(e) Any application for construction wherein a determination of public need is made pursuant to this section shall be subject to the following:

(1) The commissioner may, during the processing of an application, propose to disapprove the application solely on the basis of a determination of public need in advance of his consideration of the questions of the adequacy of financial resources, sources of future revenue and the character and competence of the applicant without, however, waiving his right to consider such criteria at a later date.

(2) In the event the commissioner upon the recommendation of the State Hospital Review and Planning Council proposes to disapprove an application solely on the basis of a lack of public need and the applicant then requests a hearing, the commissioner may direct the completion of the other required by Public Health Law, section 2802, the results of which shall be presented to the State Hospital Review and Planning Council for recommendations, which reviews may then be included as grounds for the proposed disapproval to be considered at the hearing. If the commissioner directs the completion of such reviews, a copy of the report containing the results of the reviews shall be mailed to the applicant at least 60 days prior to the date set for hearing.

(3) In the event the commissioner proposes to disapprove an application solely on the basis of no public need and the State Hospital Review and Planning Council does not concur with such proposed disapproval, the application shall be returned to the department without a formal recommendation. The commissioner shall then direct the completion of the other reviews required by Public Health Law, section 2802, and shall return the application to the State Hospital Review and Planning Council for its formal recommendation.
 

Effective Date: 
Wednesday, February 12, 1997
Doc Status: 
Complete

Section 709.2 - Acute care facilities

709.2 Acute care facilities. (a) The methodology will be utilized in the evaluation of certificate of need applications involving the construction or establishment of new or replacement beds in an acute care hospital and the need for acute care facilities and services. It is the intent of the State Hospital Review and Planning Council that this methodology, when used in conjunction with the planning standards and criteria set forth in Part 708 and section 709.1 of this Title become a statement of basic principles and planning/decision making tools for guiding and directing the development of hospital services throughout the State. Additionally, it is intended that the methodology will provide potential applicants with a framework to develop specific hospital feasibility studies submitted as a part of certificate of need applications while allowing health systems agencies sufficient flexibility to consider the unique and special characteristics of their respective areas in determining bed need. The methodology is conceptually based on the application of uniform planning objectives at the county and/or State level. Its purpose is to provide guidance, to insure flexibility, and to assist the health systems agencies, the Commissioner of Health and potential applicants in determining the future need for acute care beds as consistent with the certificate of need program. The goals and objectives of the methodology expressed in this section are expected to insure that an adequate institutional bed supply is available for normal and emergency needs. The methodology helps identify counties where the projection of future acute care bed need implies a potential for excess capacity and where significant issues of hospital access and viability may occur. The goals and objectives of this methodology also are expected to result in minimizing the need for costly inpatient care by encouraging the development and expansion of more desirable lower cost alternatives, as well as insuring that high quality care and an adequate institutional bed supply are available.

(b) For purposes of this methodology, the base year shall be 1991 and the planning target year shall be 1996. The planning area shall be the county.

(c) The methodology uses the following steps to estimate the need for medical/surgical and pediatric beds in the planning target year:

(1) The normative discharge utilization rates by county of patient residence for males and females ages 0-9, 10-14, 15-19, 20-44, 45-64, 65-74, 75-84 and 85 and over are derived for medical/surgical and pediatric services for the base year and the year five years previous to the base year as set forth in paragraphs (1) through (3) of subdivision (d) of this section.

(2) The population, males and females ages 0-9, 10-14, 15-19, 20-44, 45-64, 65-74, 75-84 and 85 and over, is estimated by county for the base year, the year five years previous to the base year and for the planning target year as set forth in paragraph (4) of subdivision (d) of this section.

(3) Normative discharge utilization rates per 1,000 population by county of patient residence and by peer groups of counties for males and females ages 0-9, 10-14, 15-19, 20-44, 45-64, 65-74, 75-84 and 85 and over are estimated for the planning target year as set forth in paragraphs (5) through (8) of subdivision (d) of this section.

(4) The number of expected discharges is derived by multiplying the utilization rates by county for males and females ages 0-9, 10-14, 15-19, 20-44, 45-64, 65-74, 75-84 and 85 and over for the planning target year by the estimated county population for the planning target year divided by 1,000.

(5) Total expected discharges by county of residence is the sum of the expected discharges as set forth in paragraph (4) of this subdivision.

(6) To derive the estimated number of discharges in the planning target year by county of hospitalization, the estimated number of expected discharges for the planning target year by county of residence is adjusted to reflect the migration of patients between counties in the State and for patients migrating from other states to New York as set forth in paragraphs (9) and (10) of subdivision (d) of this section.

(7) Discharges in the planning target year, by county of expected hospitalization, are distributed by Diagnostic Related Groups (DRG) and payor categories as set forth in paragraph (11) of subdivision (d) of this section.

(8) Actual average base year length of stay for discharges in the county of hospitalization for each DRG and payor group is compared to national experience in length of stay for each DRG and payor group as set forth in paragraph (12) of subdivision (d) of this section. The lowest length of stay, either the national experience or the county actual average base year length of stay for each DRG and payor group, is multiplied by the expected number of discharges for that DRG and payor group to derive expected days of hospitalization in the planning target year. Expected days of hospitalization in the planning target year by DRG and payor groups are summed to derive total expected days. (9) Days of care provided to adults and pediatric patients are separated from total expected days of hospitalization in the planning target year as set forth in paragraph (13) of subdivision (d) of this section. Medical/surgical bed need is derived from adult days and pediatric bed need is derived from pediatric days.

(10) Expected adult and pediatric days of hospitalization in the planning target year are divided by 365 to derive average daily census for each county.

(11) Estimated medical/surgical and pediatric beds needed in the planning target year for each county are calculated by dividing average daily census by the expected occupancy rate as set forth in paragraph (14) of subdivision (d) of this section.

(12) The estimates of public need for medical/surgical and pediatric beds for the planning target year for each county are adjusted, as set forth in paragraphs (15), (16) and (17) of subdivision (d) of this section, to reflect the use of these beds for alternate level of care patients and other extraordinary disease occurrences which were not adequately reflected in the historic use rate experience.

(d) The methodology for determining public need for acute care beds and the estimates of projected bed need by county for the planning target year shall be as follows:

(1) The initial data base for the base year and the year five years previous to the base year is extracted from the Statewide Planning and Research Cooperative System (SPARCS) for medical/surgical and pediatric discharges. Excluded are neonatal discharges, newborns, and discharges with non-medical/surgical DRGs of maternity, psychiatry, drug abuse, alcohol abuse, burns and medical rehabilitation. In the event other methodologies are developed by the Department of Health to project acute care bed need for extraordinary disease occurrences, these discharges also shall be removed from the base year and the year five years previous to the base year. For the purposes of this methodology, discharges with human immunodeficiency virus/acquired immune deficiency syndrome (HIV/AIDS) are excluded.

(2) Counties with similar demographic and socio-economic characteristics are grouped into peer groups for purposes of this methodology:

Group 1: Bronx, Kings, New York, Queens;

2: Dutchess, Nassau, Orange, Rockland, Suffolk, Richmond, Westchester;

3: Albany, Broome, Erie, Monroe, Niagara, Oneida, Onondaga;

4: Genesee, Madison, Montgomery, Ontario, Oswego, Rensselaer, Saratoga, Schenectady, Wayne;

5: Cattaraugus, Chautauqua, Chemung, Clinton, Cortland, Jefferson, Otsego, Steuben, Tompkins, Ulster, Warren;

6: Columbia, Greene, Hamilton, Herkimer, Livingston, Orleans, Putnam, Schoharie, Schuyler, Seneca, Washington, Wyoming, Yates;

7: Allegany, Cayuga, Chenango, Delaware, Essex, Franklin, Fulton, Lewis, St. Lawrence, Sullivan; 8: Tioga.

(3) To isolate health system changes that are occurring with the growth of hospital and free-standing ambulatory-surgery programs, discharges in the initial data base for the base year and the year five years previous to the base year are further classified based on their principal procedure code in SPARCS. Discharges whose principal procedure is included in the Department of Health's Ambulatory Surgery data base are classified as appropriate for ambulatory surgery. Exceptions to this classification include obstetric and newborn cases, deaths, transfers to acute care and long term care facilities and procedures done less than five percent of the time on an ambulatory basis.

(4) The population age 0-9, 10-14, 15-19, 20-44, 45-64, 65-74, 75-84 and 85 and older shall be estimated by county by sex for the base year, the year five years previous to the base year and the planning target year using linear interpolation of the population projections developed by the New York State Department of Economic Development and by population categories based on U.S. Census Bureau data. If the population projections for the planning target year are based on census data collected ten years or more before the planning target year, population projections for the planning target year shall be adjusted to account for the percent difference in the most recent year's actual census and the Department of Economic Development's population projection for that same year.

(5) A normative discharge utilization rate per 1,000 population by county of patient residence, for each sex, age group, and ambulatory-surgery category is calculated by dividing the number of discharges by the population for each sex and age group and multiplying this ratio by 1,000.

(6) For each peer grouping of counties, the number of discharges in each sex, age group, and ambulatory-surgery category are summed for a group total in the base year and the year five years previous to the base year. The population projection for the base year and the year five years previous to the base year for each sex and age group are summed for all counties in a peer group for a peer group population total. (7) A normative discharge utilization rate per 1,000 population by county peer group for each sex, age group, and ambulatory-surgery category is derived by dividing the sum of county discharges by the sum of county population estimates as set forth in paragraph (6) of this subdivision and multiplying by 1,000. An average annual rate of change is calculated for each sex, age group, and ambulatory-surgery category between the year five years previous to the base year and the base year.

(8) The projected utilization rate for the planning target year is calculated by applying the county peer group's average annual rate of change for each age group, sex and ambulatory-surgery category to each county's base year utilization rate and then each year thereafter up to the planning target year. This procedure shall be performed in all county peer groups, except groups 1 and 8, to derive a county estimated utilization rate for the planning target year. For group 8, the base year actual utilization rates shall be used for the planning target year. For group 1, the lowest actual average annual rate of change between the year five years previous to the base year and the base year for each age, sex and ambulatory-surgery category shall be applied to each county's base year rate and each year thereafter up to the planning target year.

(9) To account for the migration of patients from the county of residence to the county of hospitalization, the projected number of discharges by county of residence in the planning target year will be subdivided among the counties of hospitalization according to the same proportions as experienced by discharges in the base year. For example, if 50 percent of the base year discharges residing in county A were hospitalized in county B, then 50 percent of the projected planning target year discharges residing in county A shall be assumed hospitalized in county B. Discharges in the counties of hospitalization are summed to derive a total number of discharges by county of hospitalization.

(10) To account for the estimated number of non-New York State residents hospitalized in New York State counties in the planning target year, the actual number of non-New York State residents in the base year is added to the projected number of discharges in the planning target year as calculated in paragraph (9) of this subdivision. In the event that reliable information becomes available from the health systems agencies or other sources on migration pattern changes expected either within New York State counties or from non-New York State residents, then the migration patterns from the base year may be adjusted accordingly before being applied to the planning target year.

(11) For the purposes of this methodology, the 1991 federal grouping system of DRGs, as set forth in Appendix D-1, shall be used. The following four payor categories are used:

(i) Medicare,

(ii) Medicaid,

(iii) Blue Cross plus other commercial carriers, and

(iv) all other payors including self-pay. The percent distribution of discharges by DRG and payor group in the base year is applied to the number of discharges projected for the planning target year to derive the projected number of discharges by DRG and payor group by county of hospitalization.

(12) For the purposes of this methodology, the 75th percentile of national length of stay data, as set forth in Appendix D-2, shall be used. This national data is collected from inpatient discharge records submitted by hospitals participating in the Professional Activity Study. If a DRG is excluded from the national survey because it is no longer valid, ungroupable or inappropriate for length of stay determinations, then the actual New York State average length of stay by payor group in the base year shall be used for the expected length of stay in the target year.

(13) Pediatric days are defined as days for patients ages 0-14. The actual proportion of pediatric days as a percent of total medical/surgical and pediatric days combined for the base year is calculated for each county of hospitalization based on the age of the patients discharged. This actual base year percent distribution is multiplied by the projected number of total medical/surgical and pediatric days combined for the planning target year to derive projected pediatric days.

(14) The following occupancy levels are applied to project acute care bed need by county and bed type:
Bed Type Urban Rural__________________________________________
Medical/surgical .85 .80Pediatric .70 .65Obstetric .75 .70

For purposes of this methodology, the following counties are considered urban - Albany, Broome, Dutchess, Erie, Monroe, Nassau, Niagara, Oneida, Onondaga, Orange, Rockland, Suffolk, Westchester, Bronx, Kings, New York, Queens and Richmond. The rural occupancy proportions shall be applied in all other counties in New York State. (15) Patients who no longer require acute care but stay in the hospital pending discharge are termed alternate level of care (ALC) patients. Their bed use shall be added to the acute care bed need projected for the planning target year. The number of ALC days in the base year and the year five years previous to the base year is extracted from the SPARCS case-mix file by county of hospitalization for the following age groups - 0-44, 45-64, 65-74, 75-84 and 85 and older. The statewide average annual rate of change in the number of ALC days by age group is calculated between the year five years previous to the base year and the base year. This average annual rate of change is applied to the statewide actual number of ALC days by age group in the base year and each year thereafter to the planning target year. The total number of ALC days statewide for the planning target year by age group are then distributed to eachcounty of hospitalization according to the percent distribution of ALC days by county in the base year.

(16) Projected ALC days by county of hospitalization are summed across the age groups to derive a total number of expected ALC days by county. ALC days by county are divided by 365 to calculate an average daily census which is then added to the projected number of acute care beds needed in each county.

(17) The estimates of need for acute care beds as derived in the foregoing provisions of this section do not include estimates of need for acute care beds for patients with HIV/AIDS. Need for acute care beds to serve such patients shall be in addition to the estimates of need otherwise derived in this subdivision. If there are other patients with extraordinary disease occurrences whose acute care use is not adequately represented in the base year rate or in the rate for the year five years previous to the base year, an estimate of expected additional acute care bed need for the planning target year also shall be added to account for the needs of these patients.

(e) The methodology to derive an estimate for the need for obstetrical or maternity service beds in the planning target year shall be as follows:

(1) The number of expected live births for the planning target year is calculated by applying the projected age-specific birth rate for the planning target year as estimated by the New York State Department of Economic Development to the projected female population of child-bearing age (15-44 years) for the planning target year. If the projections of births for the planning target year are based on census data collected ten years or more before the planning target year, projections of births for the planning target year shall be adjusted to account for the percent difference in the most recent year's actual births and the Department of Economic Development's projection of births for that same year.

(2) An estimated rate of spontaneous fetal deaths and induced abortions is applied to the projected female population of child-bearing age (15-44 years) for the planning target year and then added to the expected number of live births to derive total expected obstetric discharges.

(3) To derive the estimated number of discharges in the planning target year by county of hospitalization, the estimated number of expected discharges for the planning target year by county of residence shall be adjusted to reflect the migration of patients between counties in the State and for patients migrating from other states to New York for the female population ages 15-44, as set forth in paragraphs (9) and (10) of subdivision (d) of this section.

(4) The number of estimated obstetric discharges for the planning target year is adjusted to account for the number of antenatal admissions, defined as admissions to obstetric beds which, while maternity related, do not result in a delivery. Examples of antenatal services are ectopic pregnancies, threatened abortions, miscarriages, false labor and maternity-related diagnostic procedures. The same proportion of antenatal discharges by county of hospitalization, in the base year is added to the estimated number of obstetric discharges in the planning target year.

(5) Expected discharges for the planning target year by obstetric-related diagnostic related group and payor are distributed as set forth in paragraph (11) of subdivision (d) of this section.

(6) The expected number of obstetric days for the planning target year is calculated by multiplying the number of projected discharges for each obstetric-related DRG and payor group by either the actual average county length of stay or the 75th percentile of national length of stay by DRG and payor group, as set forth in Appendix D-2, whichever is lower. Total obstetric days for the planning target year shall be further adjusted to reflect an expected length of stay for cesarean deliveries estimated by the Department of Health based on an analysis of the expected frequency and length of stay of cesarean section deliveries in New York State hospitals. (7) The expected number of obstetric days of hospitalization in the planning target year is divided by 365 to derive an average daily census for each county.

(8) The estimated number of obstetric beds needed in each county in the planningtarget year is calculated by dividing the average daily census by the expected occupancy rate as set forthin paragraph (14) of subdivision (d) of this section.

(f) Periodically, but at least every five years from the base year, the Department of Health, in conjunction with the health systems agencies and the State Hospital Review and Planning Council, shall review and update the methodology and projections established pursuant to this section to project acute care bed need to a new planning target year not to exceed five years from a new base year.

(g) The county acute care bed need totals for medical/surgical, pediatric and obstetric beds determined in accordance with subdivisions (c), (d) and (e) of this section shall constitute the estimated public need for medical/surgical, pediatric and obstetric beds in each county for the planning target year. Each health systems agency may review the estimated bed need of its region and, in conjunction with the Department of Health and the State Hospital Review and Planning Council, may:

(1) make recommendations for amending the need estimates developed in accordance with subdivisions (c), (d) and (e), of this section to reflect local characteristics. Factors that may be considered in this analysis include, but are not limited to, the following: an analysis of current utilization patterns as it relates to projected trends developed pursuant to the methodology for determining public need for acute care beds in subdivisions (c), (d), and (e) of this section, health status indices of the population, high and low variation discharge composition, ambulatory care sensitive discharge experience and trends in alternate level of care.

(2) identify counties at high risk of undergoing acute care system changes due to an estimated excess of medical/surgical, pediatric and/or obstetric bed capacity for the planning target year. Acute care system changes shall refer to any or all of the following occurrences: discontinuation of acute care services, conversion of all or a portion of the acute care beds, decertification of all or a portion of the acute care beds or hospital closure. A county at high risk of acute care system changes is one that meets at least one of the following criteria:

(i) the estimated acute care bed need in the county for the planning target year is less than 85 percent of existing capacity and there is at least one hospital in the county with fewer beds than the estimated excess in medical/surgical, pediatric, and/or obstetric beds for the county; or

(ii) the county is identified as being at high risk by the local health systems agency, subject to the approval of the Commissioner, when other factors are determined to result in acute care systems changes.

(h) The Department of Health in conjunction with the health systems agencies may develop institution-specific recommendations, with the concurrence of the State Hospital Review and Planning Council, for expected service needs and capital expenditure requirements. Commencing in 1994, and no more frequently than once a year, acute care facilities in counties identified as being at high risk pursuant to subdivision (g) of this section, may be required to submit to the Commissioner, on forms prescribed by the Commissioner, a summary assessment of the facility's service needs and capital expenditure requirements for at least the following five calendar years. Based on these five year plans and the estimated need for acute care beds in the county, the department, in consultation with the local health systems agencies, shall identify the need for appropriate changes in facility utilization and services provided to achieve the projected acute care bed need.

(i) Results of the acute care bed need methodology, as set forth in subdivisions (c), (d) and (e) of this section, together with any adjustments approved by the Commissioner in consultation with the State Hospital Review and Planning Council and developed in accordance with subdivision (g) of this section, shall be used when an application proposes one of the following:

(1) an increase in the facility's medical/surgical, pediatric or obstetric bed composition;

(2) a change in the operator of a hospital that requires a need review;

(3) a capital investment which meets at least one of the following criteria:

(i) the project is a Capital Architectural and Program Alternatives (CAPA) project with total basic costs of construction, as defined in section 710.1 of this Chapter, exceeding $25,000,000 or

(ii) the total basic costs of construction is an amount which is greater than fifty percent of the net depreciated value of the facility's total fixed assets used for hospital purposes.

(j) When submitting feasibility studies in support of applications which are subject to this section, applicants shall use the same discharge utilization rate calculations and trends as used in the acute care bed need methodology set forth in subdivisions (c), (d) and (e) of this section. Feasibility studies may not incorporate changes in hospital discharges based on market share changes except in the following instances: (1) acquisition of another hospital and consolidation of inpatient activity, (2) introduction of new services unavailable to the hospital service area population, or (3) continued increases in the market share between the year five years previous to the base year and the base year.

(k) The review of, and recommendations and decisions concerning, applications subject to this section shall be based upon the following:

(1) the estimated county acute care bed need as set forth in subdivisions (c), (d), (e) and (g) of this section; and

(2) the county's expected service needs and capital expenditure requirements, and the recommendations developed and need for changes identified in accordance with subdivision (h) of this section.

Effective Date: 
Wednesday, December 29, 1993
Doc Status: 
Complete

Section 709.3 - Residential health care facility beds

709.3 Residential health care facility beds.

(a) Notwithstanding the provisions of subdivisions (a), (b), and (c) of section 709.1 of this Part, the methodology and procedures in this section will be used in the evaluation of certificate of need applications involving the construction of new or replacement residential health care facility beds, the renovation of residential health care facilities, the sale or transfer of residential health care facility beds between facilities, or the establishment of residential health care facilities, including changes of ownership subject to review by the Public Health Council.

(b)(1) For purposes of this methodology, the base year shall be 2006 and the planning target year shall be 2016. The planning area shall be the county except as otherwise provided for in this section.

(2) Notwithstanding any other provision of this section, the estimates of public need for residential health care facility beds determined under this section for the planning target year shall continue to be the estimates of public need for such beds for years subsequent to the planning target year until a new bed need methodology is promulgated.

(c) The methodology uses the following steps to estimate the need for residential health care facility beds in the planning target year:

(1) The population age 0-64 is estimated by county for the base year and planning target year in paragraph (1) of subdivision (d) of this section.

(2) The number of functionally dependent individuals in the population age 65 and older is estimated by county for the base year and the planning target year in paragraph (2) of subdivision (d) of this section.

(3) The population age 0-64 and the number of functionally dependent individuals aged 65 and older in each county for the base year is summed in paragraph (3) of subdivision (d) of this section to derive the statewide totals for each age group.

(4) Statewide normative use rates for residential health care facilities, long term community based care and supportive housing are calculated in paragraphs (4), (5) and (6) of subdivision (d) of this section for the population age 0-64 and for the functionally dependent population age 65 and older.

(5) The statewide pattern need estimates for residential health care facility beds, long term community based services and supportive housing in the planning target year are calculated in paragraph (7) of subdivision (d) of this section by county by multiplying the statewide normative use rates by the appropriate population group.

(6) The need estimates for residential health care facility beds, long term community based services and supportive housing are summed to determine total long term care need for each county in paragraph (8) of subdivision (d) of this section.

(7) Local pattern need estimates for residential health care facility beds, long term community based services and supportive housing in the planning target year are calculated based on the local pattern distribution of long term care services in the base year in paragraph (9) of subdivision (d) of this section.

(8) The statewide pattern need estimates and the local pattern need estimates are averaged in paragraph (10) of subdivision (d) of this section to derive the blended need estimate for residential health care facility beds, long term community based care and supportive housing.

(9) The blended need estimates for residential health care facility beds are adjusted to reflect a 99% occupancy rate in paragraph (11) of subdivision (d) of this section.

(10) The residential health care facility bed need estimates are adjusted to reflect migration between counties in the State, to facilities outside the State and for patients migrating from other states to New York in paragraph (12) of subdivision (d) of this section.

(11) The relationship of the need estimates for residential health care facility beds to special populations is addressed in paragraphs (13) and (14) of subdivision (d) of this section.

(12) The requirement for the department to evaluate the residential health care facility bed need methodology and the appropriateness of certain assumptions set forth in this section is addressed in paragraph (15) of subdivision (d) of this section.

(13) The development of long term care plans by the health systems agencies and the types of adjustments to the need estimates that may be recommended in these plans is addressed in subdivision (e) of this section.

(14) Subdivision (f) of this section provides that the bed need estimates for the planning target year shall constitute the public need for residential health care facility beds in the planning area.

(15) Remaining need for construction of additional residential health care facility beds is calculated by county in subdivision (g) of this section.

(16) Factors which could be considered by the department to modify the need estimates developed in accordance with subdivision (d) of this section are described in subdivision (h) of this section.

(d) The methodology for determining the public need for residential health care facility beds and the estimates of projected need by county for the planning target year shall be as follows:

(1) The population age 0-64 shall be estimated by county for the base year and the planning target year using New York State Data Center projections.

(2)(i) The population age 65-74 and 75 and older shall be estimated by county for the base year and the planning target year using New York State Data Center projections.

(ii) The total number of functionally dependent individuals age 65 and older shall be estimated by county for the base year and planning target year based on the percentage of such individuals found in the population age 65 and older derived from U.S. Census Bureau data which identified those with a self-care limitation as those who resided in the community but report having a condition that makes activities of daily living difficult, plus those who resided in residential health care facilities. Estimating the functionally dependent population age 65 and older identifies a sub-set of the population age 65 and older of which a further sub-set will need long term care services from the formal support system, such as residential health care facility beds, supportive housing and long term community based services.

(3) The population estimates for those age 0-64 derived in accordance with paragraph (1) of this subdivision in each county and the population estimates of the functionally dependent individuals age 65 and older derived in accordance with paragraph (2) of this subdivision in each county for the base year shall be summed to derive the State total for each age group.

(4) The average daily census of persons served with long term care services in the base year shall be determined by age for the 0-64 age group and for those age 65 and older. Such data shall include, but not be limited to, the following long term care services:

(i) residential health care facility patients by county of origin including New York State residents served in out-of-state facilities;

(ii) persons served in the personal care program;

(iii) persons served in adult care facilities serving the frail elderly;

(iv) persons served by certified home health agencies with a length of stay of 90 days or longer;

(v) persons served by long term home health care programs;

(vi) persons served by managed long term care plans; and

(vii) patients in general hospitals on alternate level of care status with a length of stay on such status of seven days or more.

(5) For purposes of calculating appropriate normative use rates, the number of long term care patients served in the base year shall be summed by age group for the three long term care categories of residential health care facilities, long term community based care (including long term home health care programs, certified home health agency services to long term care patients, managed long term care plans and personal care programs) and supportive housing (including adult homes and enriched housing, programs). The number of patients on alternate level of care status shall be allocated between long-term community based care services and residential health care facilities.

(6) Statewide normative use rates shall be calculated for residential health care facilities, long term community based care and supportive housing for the population age 0-64 and for the functionally dependent population age 65 and older. Such statewide normative use rates shall be calculated by dividing the total patient population for residential health care facilities, long term community based services and supportive housing determined in accordance with paragraph (5) of this subdivision by the estimated base year population age 0-64 and the number of the functionally dependent age 65 and older.

(7) The statewide normative use rates derived in paragraph (6) of this subdivision shall be multiplied by the estimated county level population age 0-64 and estimated number of the functionally dependent age 65 and older for the planning target year to derive county level estimates of the need for residential health care facility beds, persons to be served in supportive housing and long term community based services needs. These need estimates shall be referred to as the statewide pattern need estimates.

(8) The total long term care need for each county is calculated by summing the need for residential health care facility beds, long term community based care and supportive housing. This sum represents an estimate of the total number of people in need of long term care services on a daily basis as represented by the statewide normative use rates.

(9) The local pattern of distribution of long term care services shall be calculated by county using the percentage distribution of resources in the county for residential health care facility beds, supportive housing and long term community based services in the base year. These percentages are multiplied by the total long term care need for the county derived in paragraph (8) of this subdivision to calculate the local pattern need estimates for residential health care facility beds, supportive housing and long term community based care.

(10) The need for residential health care facility beds calculated using the statewide pattern and the local pattern shall be averaged to estimate the blended need for each service category in the county for the planning target year.

(11) The residential health care facility beds in each county resulting from blending the statewide pattern need and the local pattern need in paragraph (10) of this subdivision shall be adjusted to reflect a 99% occupancy rate.

(12) The residential health care facility beds in each county resulting from the occupancy adjustment in paragraph (11) of this subdivision shall be adjusted to reflect migration between counties and to and from other states. In general, migration is estimated to be 50% voluntary and likely to continue regardless of the availability of resources in the county of origin and 50% involuntary resulting from the unavailability of resources in the county of origin. Migration adjustments shall be based on base year data and shall include:

(i) Migration from the county of origin to other New York State counties. Such migration adjustment shall be equal to 50% of the number of residential health care facility beds that would be required in the planning target year for residents who have migrated from another county for residential health care facility services calculated based on the proportion of county of origin patients migrating to the county of destination in the base year multiplied by the planning target year county of origin residential health care facility need.

(ii) Migration to facilities outside New York State. Such migration adjustment shall be equal to 50% of the Medicaid patients served outside New York State calculated based upon Medicaid claims data concerning out of state placements in the base year.

(iii) Out-of-state migration to New York State facilities. Such migration adjustment shall be equal to 100% of the patients reported by residential health care facilities in the base year.

(13) The estimates of need for residential health care facility beds determined in accordance with this subdivision do not include estimates of need for residential health care facility beds for special pediatric beds, ventilator beds, patients with acquired immune deficiency syndrome or those in need of long term rehabilitation for head injury. Need for residential health care facility beds to serve such patients shall be in addition to the estimates of need determined in accordance with paragraphs (1) through (12) of this subdivision.

(14) The estimates of need for residential health care facility beds determined in accordance with this subdivision include beds needed for dementia patients, e.g. Alzheimers disease and related disorders.

(15) The department shall conduct an evaluation of the residential health care facility bed need methodology set forth in this section by December 31, 2013.

(e)(1) The estimates of need for residential health care facility beds, supportive housing and long term community based services developed in accordance with subdivision (d) of this section shall serve as the basis for development of long term care plans by the health systems agencies that are operational. These need estimates may be modified in accordance with paragraph (4) of this subdivision.

(2) The long term care plans shall describe the steps that will be taken on a regional basis to develop the long term care system to meet the needs for residential health care facilities, long term community based services and supportive housing. These plans should be developed by the health systems agency in consultation with providers, consumers, local governments and other entities within the health systems agency region having an interest in long term care services. To be used by the department in reviewing certificate of need applications, the long term care plan must be approved by the Commissioner of Health with the advice of the State Hospital Review and Planning Council, provided, however, that if a long term care plan has not been developed by the health systems agency and approved by the Commissioner of Health with the advice of the State Hospital Review and Planning Council at the time an application is considered by the department, the need estimates shall be determined in accordance with subdivision (d) of this section without a long term care plan adjustment.

(3) The long term care plans developed by the health systems agencies shall include but need not be limited to:

(i) designation of long term care planning areas. Long term care planning areas may include a single county or two or more counties grouped together but may not include portions of a county. The criteria for establishing long term care planning areas shall be reflective of at least the following:

(a) voluntary patient migration patterns;

(b) travel patterns including driving time.

(4) The health systems agency long term care plans may make recommendation for amending the need estimates developed in accordance with subdivision (d) of this section to reflect local characteristics. Factors that may be considered in this analysis include, but are not limited to, the following:

(i) Adjustments for additional migration between health systems agency regions that is documented and agreed upon in writing by the affected health systems agencies;

(ii) Adjustments to the allocation of long term care services between components of the long term care service system - residential health care facilities, long term community based services and supportive housing. Factors that may be considered in reallocation of the need between components of the long term care service system may include issues related to geographic considerations or manpower availability. All such recommendations should clearly demonstrate why these adjustments are necessary and how they will benefit the planning area.

(f)(1) The bed need estimates developed pursuant to subdivision (d) of this section, together with any approved adjustments developed in accordance with subdivision (e) of this section, shall constitute the public need for residential health care facility beds in the planning areas defined subject to further adjustments in accordance with subdivision (h) of this section.

(2) For purposes of determining public need for residential health care facility beds in the City of New York, the public need estimates for each county in the City of New York, determined in accordance with this section, shall be summed. For the purposes of determining public need for residential health care facility beds in the counties in Nassau and Suffolk, the public need estimates for each of these two counties, determined in accordance with this section, shall be summed.

(3) Notwithstanding that there is an indication of need in a planning area for additional residential health care facility beds as determined in accordance with subdivisions (d) or (e) of this section, there shall be a rebuttable presumption that there is no need for any additional residential health care facility beds in such planning area if the overall occupancy rate for existing residential health care facility beds in such planning area is less than 97% based on the most recently available data. It shall be the responsibility of an applicant in such instances to demonstrate that there is a need for additional residential health care facility beds despite the less than 97% occupancy rate in the applicant's planning area utilizing the factors set forth in subdivision (h) of this section.

(g) The evaluative procedure for determining public need for residential health care facility beds in a planning area for the planning target year shall include, but not be limited to:

(1) identification of existing residential health care facility beds in the planning area;

(2) identification of residential health care facility beds that have been approved for construction but are not in operation in the planning area;

(3) identification of resulting total residential health care facility beds that will be available in the planning area;

(4) identification of remaining need in the planning area, based upon public need for residential health care facility beds in the planning area determined in accordance with subdivision (d) or (e) of this section or adjusted in accordance with subdivision (h) of this section.

(h
) Notwithstanding any other provision of this section, when the estimates of need for residential health care facility beds developed in accordance with subdivision (d) or (e) of this section indicate the need for additional residential health care facility beds, such estimates of additional need may be modified, based on information and data gathered from relevant sources relating to significant local factors pertaining to an applicant's service/planning area, or on statewide factors, where relevant, which factors may include, but not necessarily be limited to, those set forth in paragraphs (1) through (7) of this subdivision. When making recommendations to the State Hospital Review and Planning Council and Public Health Council concerning the impact of the factors set forth in this subdivision, the department shall, to the extent practicable, indicate the relative priority of such factors.

(1) the impact of requirements pertaining to placing persons with disabilities into the most integrated setting appropriate so as to enable persons with disabilities to interact with non-disabled persons to the fullest extent possible;

(2) the growth, availability and cost-effectiveness of long-term home and community-based services, other non-institutional residential programs and of other programs and services that may serve as a substitute for or prevent the need for residential health care facility placement;

(3) occupancy rates, and the trend of those rates of existing residential health care facilities in the planning area and in contiguous counties;

(4) patient migration patterns that vary from those included in the methodology set forth in subdivision (d) of this section;

(5) the health status of residents of the planning area or the state, as applicable;

(6) recommendations made by the local health systems agency, if applicable;

(7) documented evidence of the unduplicated number of patients on waiting lists who are appropriate for and desire admission to a residential health care facility who experience a long waiting time for placement and who cannot be served adequately in other settings.

(i) An applicant for residential health care facility beds should anticipate that the review of the certificate of need application will be on a competitive basis. Therefore, all information and factors that the applicant deems relevant to the Department's determination of public need must be included in the applicant's certificate of need submission. Review of the proposal as submitted by the applicant shall include:

(1) the proposal's responses to and consistency with priority considerations specified in any requests for proposals issued by the Department or the health systems agency;

(2) the relationship of the residential health care facility beds being proposed to any applicable regional or statewide plans;

(3) the proposal's consistency with the provisions of subdivision (d) of section 709.1 of this Part;

(4) the availability of less costly or more effective alternative methods of providing the residential health care facility beds being reviewed;

(5) whether the proposed residential health care facility beds would provide improvements or innovations in the financing and delivery of health services and serve to promote quality assurance and cost effectiveness;

(6) the quality of care provided by the residential health care facility in the past;

(7) in cases involving the reduction or elimination of residential health care facility beds including those cases involving the relocation of a facility or service, the extent to which need will be met adequately and the effect of the reduction, elimination, or relocation of the facility on the ability of low income persons, racial and ethnic minorities, and other underserved groups, to obtain needed long term care services;

(8) in cases involving a proposed service area which includes a neighboring planning area, the ability of residents of such neighboring planning area to access the residential health care facility beds proposed;

(9) the contribution the proposed residential health care facility would make in meeting the health needs of members of medically underserved groups which have traditionally experienced difficulties in obtaining equal access to residential health care facility beds (for example, low- income persons, racial and ethnic minorities, and patients on alternate level of care status in general hospitals). For the purpose of determining the extent to which the proposed facility will be accessible to such persons, the following shall be considered:

(i) the extent to which medically underserved populations currently use the applicant's services, where the applicant currently provides residential health care facility services, in comparison to the percentage of all users of the service in the applicant's planning area or to which they are found in the population in general, and the extent to which medically underserved populations are expected to use the proposed residential health care facility beds if approved;

(ii) the performance of the applicant, where the applicant currently provides residential health care facility services, in meeting its obligation under the applicable civil rights statutes prohibiting discrimination on the basis of race, color, national origin, handicap, sex and age; and

(iii) the extent to which Medicaid and medically indigent patients are or would be served by the applicant.

(10) When the remaining public need identified in subdivision (g) of this section is not sufficient to permit the approval of all applications for residential health care facility beds which are considered in the batch under consideration which otherwise meet all statutory and regulatory criteria specified under the Public Health Law, the proposals will be competitively reviewed. In the competitive review process consideration will be given to those proposals which meet any or all of the following:

(i) make a commitment to admit a percentage of patients who are Medicaid eligible or Medicare/Medicaid eligible in excess of that required under subdivision (m) of this section;

(ii) make a commitment to admit a percentage of patients who have been on alternate level of care status in a general hospital for more than 90 days. Additional consideration will be given to applications that:

(a) identify and agree to meet special program requirements for such patients; and

(b) demonstrate that they have written agreements with general hospitals for admission of alternate level of care patients;

(iii) agree in writing to participate in available local long term care case management programs. Existing written agreements with local case management programs should be documented in the application;

(iv) propose to establish or expand adult care facility beds or other supportive housing programs;

(v) provide an architectural design, as demonstrated through room-by-room single line drawings and project narrative, that offers innovative designs and other factors (such as interior finishes, lighting, decorating and furnishings) to enhance quality of life in the facility.

(j) Notwithstanding any inconsistent provision of this section, the applicant may propose a service area that includes a long term care planning area outside of that in which the facility or proposed facility is located. If any application is approved on this basis, the number of residential health care facility bed resources available in the external planning area determined in accordance with subdivision (g) of this section will be adjusted to reflect that portion of the facility's bed complement which will serve residents of the external planning area.

(k) Any application for construction wherein a determination of public need is made pursuant to this section shall be subject to he provisions of subdivision (e) of section 709.1 of this Part.

(l) Notwithstanding any other provision of this section to the contrary, up to 300 additional residential health care facility beds for the State as a whole may be approved, which shall be in addition to the total statewide number of residential health care facility beds otherwise estimated to be needed under this section. Such additional beds may be approved in response to applications to add a single bed or multiple beds to an existing facility, to add an extension unit to an existing facility or to construct a new facility. Such additional beds may be approved only to meet emergency situations or other unanticipated circumstances, which shall include, but not necessarily be limited to, the following:

(1) natural disasters, such as floods, fires and disease outbreaks,

(2) unanticipated changes in population migration patterns or census growth,

(3) unanticipated reduction in availability of alternative placement settings,

(4) unanticipated changes in population health or age group characteristics.

(m) Any residential health care facility or general hospital filing an application to add residential health care facility beds shall be subject to the following requirements which shall apply to all of the facility's existing and proposed certified residential health care beds:

(1) In determining the need for residential health care facilities, beds and services, consideration shall be given to the needs of persons who receive or are eligible to receive medical assistance benefits at the time of admission to a facility pursuant to title XIX of the Federal Social Security Act and title 11 of article 5 of the Social Services Law, hereafter referred to as Medicaid patients, and the extent to which the applicant serves or proposes to serve such persons, as reflected by factors including, but not necessarily limited to, the applicant's admissions policies and practices. An application by an applicant that is or will be a provider that participates in the medical assistance (Medicaid) program shall not be approved unless the applicant agrees to comply with the requirements of this subdivision. An applicant that, at the time of consideration of its application by the commissioner, proposes not to participate in the Medicaid program may be approved, provided all other review criteria have been met, upon the condition that if, in the future, it does participate in the Medicaid program, it would comply fully with the requirements of this subdivision.

(2) To ensure that the needs of Medicaid patients in an applicant's service area are met and that such patients have adequate access to appropriate residential health care facilities, beds and services, applicants shall be required to accept and admit at least a reasonable percentage of Medicaid patients as determined pursuant to this subdivision. Such reasonable percentage of Medicaid patient admissions, also referred to herein as the Medicaid patient admissions standard, shall be equal to 75 percent of the annual percentage of all residential health care facility admissions, in the long-term care planning area in which the applicant facility is located, that are Medicaid patients. The calculation of such planning area percentage shall not include admissions to residential health care facilities that have an average length of stay of 30 days or less. If there are four or fewer residential health care facilities in a planning area, the applicable Medicaid patient admissions standard for such planning area shall be equal to 75 percent of the planning area annual percentage of all residential health care facility admissions that are Medicaid patients or 75 percent of the annual percentage of all residential health care facility admissions, in the health systems agency area in which the facility is located, that are Medicaid patients, whichever is less. In calculating such percentages, the department will use the most current admissions data which have been received and analyzed by the department. An applicant will be required to make appropriate adjustments in its admissions policies and practices so that the proportion of its own annual Medicaid patient admissions is at least equal to 75 percent of the planning area percentage or health systems agency area percentage, whichever is applicable.

(3) The proportion of an applicant's admissions that must be Medicaid patients, as calculated under paragraph (2) of this subdivision, may be increased or decreased based on the following factors:

(i) the number of individuals within the planning area currently awaiting placement to a residential health care facility and the proportion of total individuals awaiting such placement that are Medicaid patients, provided that patients awaiting placement include, but need not be limited to, alternate level of care patients in general hospitals;

(ii) the proportion of the facility's total patient days that are Medicaid patient days and the length of time that the facility's patients who are admitted as private paying patients remain such before becoming Medicaid eligible;

(iii) the proportion of the facility's admissions who are Medicare patients or patients whose services are paid for under provisions of the Federal Veterans' Benefit Law;

(iv) the facility's patient case mix based on the intensity of care required by the facility's patients or the extent to which the facility provides services to patients with unique or specialized needs; and

(v) the financial impact on the facility due to an increase in Medicaid patient admissions.

(4)(i) An applicant shall submit a written plan, subject to the approval of the department, for reaching the Medicaid patient admissions standard required by this subdivision. The plan shall provide for reaching the standard within no longer than a two-year period and the facility shall give preference, as necessary, to Medicaid patients in order to reach the admissions standard within the prescribed time period.

(ii) Once the Medicaid patient admissions standard is reached, the facility shall not reduce its proportion of Medicaid patient admissions so as to go below the standard unless and until the applicant, in writing, requests the approval of the department to adjust the standard and the department's written approval is obtained. In reviewing requests to adjust a facility's Medicaid patient admissions standard, the department shall consider factors which may include, but need not be limited to, those factors set forth in paragraphs (2) and (3) of this subdivision.

(iii) After a facility's initial Medicaid patient admissions standard has been reached, the department may increase such facility's Medicaid patient admissions standard, based on the criteria set forth in this subdivision, if the percentage of Medicaid patients admitted by residential health care facilities in the facility's planning area or health systems agency area, as appropriate, increases due to factors other than an increase in Medicaid patient admissions by the applicant.

(5)(i) Subject to the provisions of subparagraph (ii) of this paragraph, after the phase-in period provided for in paragraph (4) of this subdivision, a facility shall be prohibited from failing, refusing or neglecting to accept or admit a Medicaid patient for whom it is otherwise able to provide care, regardless of whether the level of reimbursement received for such patient is less than the rate the facility charges private pay patients, unless the facility has reached and is maintaining compliance with the Medicaid patient admissions standard imposed by this subdivision. Compliance with the requirements of this subdivision shall be determined on the basis of a facility's total annual admissions, so that a facility may exercise its discretion in determining when during a year it will admit a sufficient number of Medicaid patients to maintain its Medicaid patient admissions standard.

(ii) A facility may be exempt from the requirement of admitting a Medicaid patient in order to meet or maintain its Medicaid patient admissions standard if it can demonstrate in writing to the satisfaction of the commissioner that the Medicaid patient was denied admission solely in order to admit another patient who had a greater need of residential health care facility services, as determined by the intensity of care anticipated to be required by such patient, and that there was only one bed available in the facility at the time of the admission decision to accommodate a new admission. Facilities shall not be required to obtain prior department approval in order to accept a non-Medicaid patient in place of a Medicaid patient pursuant to this subparagraph, but shall maintain sufficient documentation including, but not necessarily limited to, a copy of the patient review instrument for the patient admitted and the Medicaid patient denied admission in order to justify the admission decision. Copies of such documentation shall be provided to the department upon request.

(6) If any provision of this subdivision or the application thereof is held invalid, the remainder of this subdivision and the application thereof to other circumstances shall not be affected by such holding and shall remain in full force and effect.

Effective Date: 
Wednesday, July 21, 2010
Doc Status: 
Complete

Section 709.4 - End stage renal dialysis service

709.4 End stage renal dialysis service. (a) This methodology will be utilized in the evaluation of certificate of need applications involving the construction or establishment of new or replacement dialysis stations used in the treatment of End Stage Renal Disease. It is the intent of the State Hospital Review and Planning Council that this methodology, when used in conjunction with the planning standards and criteria set forth in section 709.1 of this Part, become a statement of basic principles and planning/decision making tools for guiding and directing the development of dialysis stations for End Stage Renal Disease services throughout the state. Additionally, it is intended that the methodology will provide the health systems agencies and potential applicants with sufficient flexibility to consider the unique characteristics of their respective areas in determining need. The goals and objectives of the methodology expressed herein are expected to ensure that an adequate supply of dialysis stations are available to provide access to care to all those in need of in-facility dialysis.

(b) The factors to be considered in determining the public need for dialysis stations shall include, but not be limited to, the following:

(1) evidence that the proposed dialysis services capacity proposed will be utilized sufficiently to be financially feasible as demonstrated by a five year analysis of projected costs and revenues associated with the program;

(2) evidence that the proposed service or additional capacity will enhance access to services by patients including members of medically underserved groups which have traditionally experienced difficulties in obtaining equal access to health services (for example, low-income persons, racial and ethnic minorities, women, and handicapped persons), and/or appropriate rural populations;

(3) evidence that the facility's hours of operation and admission policies will promote the availability of services which are acceptable to those in need of such services, in particular, operational hours that permit individuals in dialysis to continue employment.

(4) the facility's willingness and ability safely to serve dialysis patients; and

(5) when an existing provider proposes to add twelve or more stations, evidence, derived from analysis of factors including but not necessarily limited to both existing patient referral and use patterns and projected referral and use patterns which would result from addition of the proposed stations, indicating that approval of such stations will not jeopardize the quality of service provided at or the financial viability of other existing dialysis facilities or services within the applicant's planning area. However, a finding that the proposed facility would jeopardize the financial viability of such existing facilities will not, of itself, require a recommendation of disapproval of the application.

(c) Public need for a proposed facility or station shall be deemed to exist when review and consideration of evidence concerning each of the five factors set forth in subdivision (b) of this section results in an affirmative finding.
 

Effective Date: 
Wednesday, December 28, 1994
Doc Status: 
Complete

Section 709.5 - Ambulatory surgery services

709.5 Ambulatory surgery services. (a) This methodology will be utilized to evaluate certificate of need applications involving the construction or establishment of new ambulatory surgery centers or services or extension clinics of existing centers. It is the intent of the State Hospital Review and Planning Council that this methodology, when used in conjunction with the planning standards and criteria set forth in section 709.1(a) of this Title, become a statement of basic priniciples and planning/decision-making tools for guiding and directing the development of ambulatory surgery services and facilities throughout the state. This methodology is intended to promote the development of ambulatory surgery programs as a cost-effective alternative to inpatient surgery where appropriate. It is also intended that this methodology will provide potential applicants with sufficient flexibility to consider the unique characteristics of their prospective projects in determining need.

(b) Terms defined.

(1) Ambulatory surgery service, as set forth in section 755.1 of this Title, is a service organized to provide those surgical procedures which need to be performed for safety reasons in an operating room on anesthetized patients requiring a stay of less than 24 hours. A list of procedures appropriate for ambulatory surgery is set forth in section 86-4.40 of this Title. Ambulatory surgery services may be provided in a free-standing ambulatory surgery facility or a hospital-based ambulatory surgery facility. Ambulatory surgery facilities may be either single or multi-specialty.

(2) Hospital-based ambulatory surgery services, as set forth in section 405.20(d) of this Title, may be located at the same site as the hospital (on-site) or apart from the hospital (off-site).

(3) Free-standing ambulatory surgery services and facilities are certified to operate as diagnostic and treatment centers as set forth in section 600.8 of this Title.

(4) Extension clinics shall mean an extension clinic as defined in section 401.1 of this Title.

(c) Minimum requirements for ambulatory surgery services and facilities. Applicants for free-standing ambulatory surgery services or applicants for hospital-based off-site ambulatory surgery facilities must meet the following minimum requirements:

(1) all facilities must meet the minimum operating standards of free-standing ambulatory surgery services under Article 28 of the Public Health Law as set forth in Part 755 of this Title; and

(2) all facilities must meet the minimum construction standards of a diagnostic and treatment center under Article 28 of the Public Health Law as set forth in section 715.16 of this Title.

(d) Determination of public need in certificate of need applications. Factors to be considered in determining the public need for ambulatory surgery services and facilities shall include, but not be limited to, the following factors:

(1) written documentation that the proposed capacity of the ambulatory surgery service or facility will be utilized sufficiently to be financially feasible as demonstrated by a three year analysis of projected costs and revenues associated with the program. Written documentation of financial feasibility shall also include, but not be limited to, an analysis of expected demand for ambulatory surgery services and an explanation of how current and expected patient referral and use patterns will make the project financially feasible;

(2) written documentation that the proposed service or facility will enhance access to services by patients, including members of medically underserved groups which have traditionally experienced difficulties in obtaining equal access to health services (for example, low income persons, racial and ethnic minorities, women and handicapped persons) and/or rural populations;

(3) written documentation that the facility's hours of operation and admission policies will promote the availability of services to those in need of such services regardless of their ability to pay. This shall include, but not be limited to, a written policy to provide charity care and to promote access to services regardless of an individual's ability to pay. Charity care shall mean care provided at no charge or reduced charge for the services the facility is certified to provide to patients who are unable to pay full charges, are not eligible for covered benefits under Title XVIII or XIX of the Social Security Act or are not covered by private insurance; and

(4) written documentation of the facility's willingness and ability to safely serve ambulatory surgery patients including, but not limited to, such factors as control of infection, quality assessment and improvement, patient transfer, emergency care, credentialing and medical record keeping as set forth in Part 755 of this Title.

(e) Public need for a proposed facility shall be deemed to exist when review and consideration of evidence concerning each of the factors set forth in subdivision (d) of this section results in an affirmative finding.

(f) Determination of need for ambulatory surgery services in a health maintenance organization (HMO). Notwithstanding anything to the contrary in this section, the addition of ambulatory surgery services to be provided directly to an HMO-enrolled population shall be approved when the HMO can demonstrate to the satisfaction of the commissioner that the provision of services shall be cost-effective and accessible to plan enrollees.

Effective Date: 
Wednesday, March 11, 1998
Doc Status: 
Complete

Section 709.6 - Extracorporeal shockwave lithotripters

709.6 Extracorporeal shockwave lithotripters. (a) This methodology will be utilized to evaluate certificate of need applications involving the acquisition of extracorporeal shockwave lithotripters (ESWL). It is the intent of the State Hospital Review and Planning Council that this methodology, when used in conjunction with the planning standards and criteria set forth in section 709.1 of this Part, become a statement of planning principles and decisionmaking tools for directing the distribution of extracorporeal shockwave lithotripters. The goals and objectives of the methodology expressed herein are expected to insure that an adequate number of ESWL units are available to provide access to care and avoid the unnecessary duplication of resources.

(b) The factors and methodology for determining the public need for ESWL units shall include, but not be limited to the following:

(1) There shall be one ESWL unit of each 2.5 million residents within a health system agency's geographic area with a minimum of one unit in each health systems agency's geographic area.

(2) Each applicant must present evidence that an annual minimum utilization of 750 procedures shall be achieved within two years of initial operation, except those applicants located in a health systems agency whose geographic area contains less than 2.5 million residents.

(3) In addition, each applicant applying to acquire an ESWL unit must meet the following standards:

(i) Each applicant must demonstrate the availability of urologists who meet the definition of a qualified specialist. The applicant must also have competence in the provision of diagnostic, metabolic, and surgical services to patients with kidney stone disease. This shall include experience in the performance of renal surgery, percutaneous procedures and ureteroscopy for the removal of urinary calculi.

(ii) Each applicant must submit a plan to develop referral agreements with all facilities in the relevant service area.

(iii) Each applicant must submit a plan to evaluate ESWL compared to alternative therapeutic modalities in terms of clinical efficacy, utilization and costs.

(iv) Where public need is established herein, priority consideration will be given to applicants that agree to serve the medically indigent and patients regardless of source of payment.
 

Doc Status: 
Complete

Section 709.7 - Liver transplantation services

709.7 Liver transplantation services. (a) This methodology will be utilized to evaluate certificate of need applications involving the initiation of liver transplantation services. It is the intent of the State Hospital Review and Planning Council that this methodology, when used in conjunction with the planning standards and criteria set forth in section 709.1 of this Part, become a statement of planning principles and decisionmaking tools for directing the distribution of liver transplantation services. The goals and objectives of the methodology expressed herein are expected to insure that an adequate number of liver transplantation services are available to provide access to care and avoid the unnecessary duplication of resources.

(b) The factors and methodology for determining the public need for liver transplantation services shall include, but not be limited to, the following:

(1) The need for liver transplantation services will be planned for on a statewide basis based on an incidence rate of candidates for liver transplantation of 10 persons per one million population per year.

(2) There shall be one liver transplantation service center per five million population.

(3) Each applicant for a liver transplantation service must present evidence that a minimum of 20 transplants per year shall be achieved within two years of initial operation.

(4) There shall be no additional liver transplantation services approved until each existing transplantation service is performing 50 transplantations per year.

(5) Priority consideration will be given to applicants that propose to provide this service within the facility's current capacity.

(6) Where public need is established herein, priority consideration will be given to applicants that agree to serve the medically indigent and patients regardless of the source of payment.

(7) In addition, each applicant applying to initiate a liver transplantation service must meet the following standards:

(i) Each applicant must demonstrate the availability of a liver transplantation surgeon with board certification in general surgery or have equivalent experience and demonstrate the ability to perform liver transplantation as evidenced by clinical experience in an existing liver transplantation program.

(ii) Each applicant must demonstrate the availability of a liver transplantation team that includes qualified specialists in gastroenterology, hepatology, infectious disease, pulmonary medicine, immunology, hematology, pediatrics, neurology, neurosurgery and nephrology.

(iii) Each applicant must demonstrate its participation in a donor organ procurement system, or a donor organ harvesting program, or a written affiliation agreement with an existing approved or registered donor organ procurement or harvesting agency.
 

Doc Status: 
Complete

Section 709.8 - Bone marrow transplantation (BMT) services

709.8 Bone marrow transplantation (BMT) services. (a) This methodology will be utilized to evaluate certificate of need applications involving the initiation of allogeneic bone marrow transplantation services. It is the intent of the State Hospital Review and Planning Council that this methodology, when used in conjunction with the planning standards and criteria set forth in section 709.1 of this Part, become a statement of planning principles and decisionmaking tools for directing the distribution of bone marrow transplantation services. The goals and objectives of the methodology expressed herein are expected to insure that an adequate number of BMT services are available to provide access to care and avoid the unnecessary duplication of resources.

(b) The factors and methodology for determining the public need for allogeneic BMT services shall include, but not be limited to, the following:

(1) The need for BMT services shall be planned on a statewide basis.

(2) Based on the current status of BMT technology, the number of people expected to be candidates for BMT therapy is 13.2 per million population per year. This will be reviewed on an annual basis to determine if any adjustment is indicated.

(3) The capacity of each BMT bed is six patients/year.

(4) A BMT service shall have a minimum of four beds.

(5) Priority consideration will be given to applicants that propose to provide this service within the facility's current capacity.

(6) Where public need is established herein, priority consideration will be given to applicants that agree to serve the medically indigent and patients regardless of the source of payment.

(7) In addition, each applicant applying to initiate a BMT service must meet the following standards:

(i) Each applicant must demonstrate the availability of a bone marrow transplant team under the direction of a full-time medical director with training in immunology or hematology who had advanced training and experience in bone marrow transplantation.

(ii) The bone marrow transplant team shall include specialists in the following areas: chemotherapy, radiation therapy, social work, nursing, infectious disease control, immunology, oncology, hematology, and expertise in intensive cardiopulmonary medicine.

(iii) The transplant program shall be supported by a blood bank with a capacity to support four to six patients/day. This requires the availability of a blood separator, a central blood repository, and an irradiator for blood products.

(iv) The bone marrow transplantation program shall provide or make arrangements for the harvesting of bone marrow.

(v) The services of an immunogeneticist and a cytogeneticist shall be available to the transplant program.

(vi) The transplant program shall have available clinical laboratories possessing permits issued under article 5, title 5 of the Public Health Law, in the categories of: virology, diagnostic immunology, bacteriology, mycology, mycobacteriology, parasitology, cytogenetics, cellular immunology and histocompatibility.

(vii) There shall be an organized follow-up program for transplant patients following discharge, including data management resources to maintain records on the long-term survival of transplant patients.

(viii) Each facility providing BMT services shall agree to provide annual reports to the Department of Health on utilization levels and patient origin data.
 

Doc Status: 
Complete

Section 709.9 - Human heart transplantation services

709.9 Human heart transplantation services. (a) This methodology will be utilized to evaluate certificate of need applications involving the initiation of human heart transplantation services. It is the intent of the State Hospital Review and Planning Council that this methodology, when used in conjunction with the planning standards and criteria set forth in section 709.1 of this Part, become a statement of planning principles and decisionmaking tools for directing the distribution of human heart transplantation services. The goals and objectives of the methodology expressed herein are expected to insure that an adequate number of human heart transplantation services are available to provide access to care and avoid the unnecessary duplication of resources.

(b) The factors and methodology for determining the public need for human heart transplantation services shall include, but not be limited to the following:

(1) The need for human heart transplantation services will be planned initially on a statewide basis, based upon the need for two human heart transplantation centers.

(2) Each applicant for a human heart transplantation service must present evidence that a minimum of 14 transplants per year shall be achieved within two years of initial operation.

(3) There shall be no additional human heart transplantation services approved until each existing transplantation service is performing at least 30 transplantations per year at which time additional applications will be accepted and reviewed by the department.

(4) Priority consideration will be given to applicants that propose to provide this service within the facility's current capacity.

(5) Where public need is established herein, priority consideration will be given to applicants that agree to serve the medically indigent and patients regardless of the source of payment.

(6) In addition, each applicant applying to initiate a heart transplantation service must meet the following standards:

(i) Each applicant must demonstrate the availability of a heart transplantation surgeon with the ability to perform heart transplantation as evidenced by clinical experience in an existing heart transplantation program.

(ii) Each applicant must demonstrate the availability of a heart transplantation team that includes qualified specialists in cardiology, cardiovascular surgery, infectious disease, pulmonary medicine, pediatrics, neurosurgery, anesthesiology, psychiatry, immunologist, and pathologist.

(iii) Each applicant must demonstrate its participation in a donor organ procurement system, or a donor organ harvesting program, or a written affiliation agreement with an existing approved or registered donor organ procurement or harvesting agency.
 

Doc Status: 
Complete

Section 709.10 Reserved

Section 709.11 - Inpatient rehabilitation programs for traumatic brain-injured patients

709.11 Inpatient rehabilitation programs for traumatic brain-injured patients. (a) This methodology will be utilized to evaluate certificate of need applications involving the initiation of inpatient rehabilitation programs for traumatic brain-injured patients. It is the intent of the State Hospital Review and Planning Council that this methodology, when used in conjunction with the planning standards and criteria set forth in section 709.1 of this Part, become a statement of planning principles and decision making tools for directing the distribution of inpatient rehabilitation program for traumatic brain-injured patients. The goals and objectives of the methodology expressed herein are expected to ensure that an adequate number of inpatient traumatic brain-injured rehabilitation programs and beds are available to provide access to care and avoid the unnecessary duplication of resources.

(b) Inpatient rehabilitation programs for traumatic brain-injured patients are intensive rehabilitation programs designed to prevent and/or minimize chronic disabilities while restoring the individual to the optimal level of physical, cognitive, and behavioral functioning. These programs are applicable to those individuals who have severe disabling impairments of recent onset and are able to participate daily (at least five days per week) in multi-disciplinary programs for a minimum of three hours per day.

(c) The factors and methodology for determining the public need for inpatient rehabilitation programs for traumatic brain-injured patients shall include, but not be limited to, the following:

(1) The service area for determining the public need for inpatient rehabilitation programs for traumatic brain-injured patients shall be the designated health systems agency regions.

(2) The maximum number of inpatient rehabilitation beds for traumatic brain-injured patients in each health systems agency region required to meet the public need shall be determined by dividing the projected annual patient days for the service by three-hundred and sixty-five (365), and dividing the result by 0.90 to allow for ninety percent occupancy. The projected inpatient rehabilitation patient days for traumatic brain-injured patients used in this calculation shall be determined as follows:

(i) The diagnostic categories used in computing the need for inpatient rehabilitation beds for traumatic brain-injured patients shall be: brain dysfunction, traumatic brain dysfunction, and skull fracture.

(ii) The annual number of potential candidates for inpatient rehabilitation programs for the traumatic brain-injured shall be determined by calculating the total numbers of annual general hospital discharges from the categories considered, plus an additional ten percent, and multiplying the resulting figure by 0.155.

(iii) The number of potential candidates for inpatient rehabilitation programs for the traumatic brain-injured shall be multiplied by an 85-day rehabilitation length-of-stay to project the annual number of inpatient rehabilitation days for traumatic brain-injured patients.

(iv) A traumatic brain-injured rehabilitation program that is organized as a specialized unit within a comprehensive inpatient physical medicine and rehabilitation program shall have a minimum of ten beds. A traumatic brain-injury rehabilitation program that is organized as a freestanding inpatient rehabilitation program shall have a minimum of twenty beds.

(v) The Health Systems Agencies may make adjustments to these bed need estimates to address patient migration patterns and other regional planning issues.

(3) Where public need is established herein, and in addition to meeting the operating requirements of either subdivision 405.18(e) of this Title (traumatic head-injury programs of general hospitals) or section 415.36 of this Title (long term inpatient rehabilitiation program for head-injured residents in nursing homes), priority consideration will be given to applicants that:

(i) Demonstrate a commitment to developing and participating in an area-wide network of service organizations which provide and coordinate a full array of rehabilitation, support, education, vocational rehabilitation, recreation, housing, case management and social services for persons with traumatic brain-injuries.

(ii) Have a coma recovery care program for brain-injured patients who are unable to participate in an active rehabilitation program or have a transfer agreement with a facility that has a coma recovery care program for traumatic brain-injured patients. The number of coma recovery care beds needed in each health systems agency region shall be determined by the ratio of six (6) beds per 1.5 million population.

(iii) Have an extended care program for traumatic brain-injured patients who are unable to participate in an active rehabilitation program or a transfer agreement with a facility that has an extended care program for traumatic brain-injured patients. (iv) Will provide access to New York State Medicaid recipients or to patients or residents who are likely to become Medicaid-eligible.

(v) Demonstrate a commitment to serve the medically indigent and patients regardless of the source of payment.
 

Effective Date: 
Wednesday, May 5, 1993
Doc Status: 
Complete

Section 709.12 - Need methodology for acquisition of magnetic resonance imagers

709.12 Need methodology for acquisition of magnetic resonance imagers.

(a) This methodology will be utilized to evaluate certificate of need applications, submitted by facilities other than general hospitals, involving the acquisition of magnetic resonance imagers (MRI). It is the intent of the State Hospital Review and Planning Council that this methodology, when used in conjunction with the planning standards and criteria set forth in section 709.1 of this Part, become a statement of planning principles and decision making tools for directing the distribution of magnetic resonance imagers. The goals and objectives of the methodology expressed herein are expected to ensure that an adequate number of MRI units are available to provide access to care and avoid the unnecessary duplication of resources.

(b) The factors and methodology for determining the public need for MRI units shall include, but not be limited to the following:

(1) The need for MRI units will be planned for on a Health Systems Agency (HSA) region basis using a formula based on the number of CT scans performed in the region as follows:

(i) the total CT scans performed in an HSA region is reduced by fifteen percent to account for patients that are not suitable for MRI studies due to the presence of pacemakers and motion problems;

(ii) of the remaining number of CT scans, sixty percent will be deemed to be studies of the central nervous system (CNS);

(iii) fifty-five percent of the patients that receive CT scans of the CNS will be deemed to be candidates for an MRI scan;

(iv) the resulting number is increased by thirty percent to account for MRI studies of areas other than the CNS;

(v) each MRI has an annual capacity for 3,200 scans; and

(vi) the estimated number of MRI scans for the HSA region is divided by 3,200 to determine the number of MRI units which are needed.

(2) In addition, each applicant applying to acquire an MRI unit must meet the following standards:

(i) each applicant must demonstrate the availability of appropriate equipment in the areas of computed tomography, ultrasound, angiography, conventional radiography and nuclear medicine;

(ii) each applicant must demonstrate the availability of neurologists, neurosurgeons, orthopedists, oncologists and radiologists who meet the definition of qualified specialists;and

(iii) each applicant must submit a plan to develop referral agreements with all facilities in the relevant service area.

(3) When public need is established, priority consideration will be given to applicants who agree to serve the medically indigent and patients regardless of source of payment.
 

Effective Date: 
Wednesday, July 7, 2010
Doc Status: 
Complete

Section 709.13 - Adult day health-care programs

709.13 Adult day health-care programs. (a) This methodology will be utilized to evaluate certificate of need applications involving the initiation of adult day health-care programs. It is the intent of the State Hospital Review and Planning Council that this methodology, when used in conjunction with the planning standards and criteria set forth in section 709.1 of this Part, become a statement of planning principles and decisionmaking tools for directing the distribution of adult day health-care programs. The goals and objectives of the methodology expressed herein are expected to ensure that an adequate number of adult day health-care programs are available to provide access to care and avoid the unnecessary duplication of resources. Additionally it is intended that the methodology provide sufficient flexibility to consider additional circumstances that reflect on the need for adult day health care.

(b) The factors and methodology for determining the public need for adult day health care services in each county shall include, but not be limited to:

(1) An estimate of the capacity needed in adult day health-care programs to serve adult day health-care registrants. For purposes of this section, capacity means the number of registrants that an adult day health-care program can accommodate at one time based on factors such as availability of staff, furniture and equipment and the number and size of the rooms used for the program. This capacity is calculated using population estimates for each county projected five years in the future. This capacity shall be calculated using the following age cohorts and capacity measures:

(i) capacity for 0.04 registrants per 1,000 population aged 20-64;

(ii) capacity for 2.5 registrants per 1,000 population aged 65-74; and

(iii) capacity for 3.65 registrants per 1,000 population aged 75 and over.

(2) The estimates for each of the age cohorts shall be summed to derive the total capacity needed for adult day health-care services in a county.

(3) (i) To determine unmet need for adult day health-care program capacity in a county, capacity of the approved programs in such county shall be subtracted from the total capacity needed for such county.

(ii) The capacity of approved adult day health-care programs shall be deter mined as follows:

(a) for a program that was approved with a specific capacity, such approved capacity shall be utilized;

(b) for a program that was approved for a total number of registrants without a specific capacity, such number shall be divided by two to determine the program's capacity;

(c) for a program that was not approved with a specific capacity or for a total number of registrants, the department will determine, based on the most recently received and processed data, the total number of current registrants of such program and such number shall be divided by two to determine the program's capacity.

(iii) The number of registrants is divided by two in order to determine an approved program's capacity under clauses (ii) (b) and (c) of this paragraph, since it is estimated that each unit of adult day health-care program capacity will serve two registrants.

(4) In counties where the total capacity needed for adult day health-care services is less than the minimum capacity required in order to be approved under the operational standards set forth in Part 425 of this Title, one program may be approved despite such minimum capacity requirement, provided that all other criteria for approval are met.

(5) Notwithstanding that need may otherwise have been determined to be met under this section, additional adult day health-care program capacity may be ap proved within a county if:

(i) all existing programs within the county are operating at their approved capacities; and

(ii) there is evidence of further need for adult day health-care services as demonstrated by factors which include, but need not be limited to:

(a) waiting lists for adult day health-care services; and

(b) the number of people on alternate level of care in the county who could benefit from adult day health-care services.
 

Doc Status: 
Complete

Section 709.14 - Cardiac services

709.14 Cardiac services. (a) These standards will be used to evaluate certificate of need applications for cardiac catheterization laboratory center services and cardiac surgery center services. It is the intent of the Public Health and Health Planning Council that these standards, when used in conjunction with the planning standards and criteria set forth in section 709.1 of this Part, become a statement of planning principles and decision-making tools for directing the distribution of cardiac catheterization laboratory center services and cardiac surgery center services. These planning principles and decision-making tools build on the existing regional resources that have been developed through the regulatory planning process. The goals and objectives of the standards expressed herein are expected to promote access to cardiac catheterization laboratory center services and cardiac surgery center services, and maintain provider and operator volumes associated with high quality care, and avoid the unnecessary duplication of resources while addressing the geographic distribution of services necessary to meet the needs of patients in need of emergency percutaneous coronary interventional (PCI) procedures. Additionally, it is intended that the methodology provide sufficient flexibility to consider additional circumstances that reflect on the need for cardiac services, including providing flexibility for regional health systems to provide cardiac services at sites that are convenient to patients in the communities they serve.

(b) Cardiac Surgery Centers. The factors for determining the public need for Cardiac Surgery Center services shall include, but not be limited to the following:

(1) The planning area for determining the public need for Cardiac Surgery Center services shall include the applicant's designated Health Systems Agency (HSA) region and the use area of the applicant facility. For purposes of determining Cardiac Surgery Center services need, the use area of a facility is defined as the area within a 100 mile radius of the applicant facility.

(2) Planning for cardiac surgery center services shall ensure that, to the extent possible, eighty percent of the total population of each HSA region resides within 100 miles of one or more facilities providing cardiac surgical services.

(3) A facility proposing to initiate an adult cardiac surgery center must document a cardiac patient base and current cardiac interventional referrals sufficient to support a projected annual volume of at least 500 cardiac surgery cases and a projected annual volume of at least 36 emergency PCI cases within two years of approval. The criteria for evaluating the need for additional adult cardiac surgery centers within the planning area shall include consideration of appropriate access and utilization, and the ability of existing services within the planning area to provide such services. Approval of additional adult cardiac surgery center services may be considered when each existing adult cardiac surgery center in the planning area is operating and expected to continue to operate at a level of at least 500 cardiac surgical procedures per year. Waiver of this planning area volume requirement may be considered if:

(i) the HSA region's age adjusted, population based use rate is less than the statewide average use rate; and

(ii) existing adult cardiac surgery centers in the applicant facility's planning area do not have the capacity or cannot adequately address the need for additional cardiac surgical procedures, such determinations to be based on factors including but not necessarily limited to analyses of recent volume trends, analyses of Cardiac Reporting System data, and review by the area Health Systems Agency(s); and

(iii) existing cardiac surgical referral patterns within the planning area indicate that approval of an additional service at the applicant facility will not jeopardize the minimum volume required at other existing cardiac surgical programs.

(4) No finding of need for the addition of Pediatric Cardiac Surgery Center services will be made unless each existing Pediatric Cardiac Surgery Center service in the planning area is operating and expected to continue to operate at a level of at least 200 pediatric cardiac surgical procedures per year, and unless such existing Pediatric Cardiac Surgery Center services do not have the further capacity to meet projected need for additional pediatric cardiac surgical procedures. Where public need is established herein, a facility proposing to provide pediatric cardiac surgical services must demonstrate the ability to perform a minimum of 200 pediatric cardiac surgical procedures per year by the end of the second full calendar year of operation or demonstrate the ability to perform a minimum of 50 cases a year on-site and operate as part of a coordinated program based on a fully executed written agreement, approved by the Commissioner, with another pediatric cardiac surgery program in accordance with standards at 405.29(d)(5)(ii). For hospitals seeking approval as part of a coordinated program, the agreement must be submitted with the certificate of need application and must be approved by the Department prior to initiation of the service.

(5) A facility proposing to provide Adult and or Pediatric Cardiac Surgery Center services shall:

(i) submit a written plan to the Department of Health which, when implemented, will ensure access to cardiac surgical services for all segments of the HSA region's population. Such plan shall provide a detailed plan to reach patients not currently served within the planning area, ensure continuity of care for patients transferred between facilities, and shall otherwise promote planning for cardiac services within the region; and

(ii) propose a hospital based heart disease prevention program that, when implemented, shall include:

(a) Treatment plans for cardiac inpatients with a principal diagnosis of ischemic heart disease. These patients are at high risk for development of adverse cardiovascular events and the program shall provide for the following in a comprehensive, systematic way:

(1) protocols shall be developed and implemented for the assessment of risk factors including lipid disorders, hypertension, diabetes, obesity, cigarette smoking, and sedentary lifestyle. Such protocols shall be in keeping with generally accepted standards;

(2) The hospital shall provide patient education that shall include, but not be limited to, information on the importance of assessing risk factors for heart disease in first-degree relatives, and the importance of cardiopulmonary (CPR) training for family members and care givers;

(3) Discharge plans must include:

(i) a request for consent to allow patient medical information to be shared with the patient’s primary care providers;

(ii) patient referral to their primary care provider with documentation of treatments provided by the hospital and follow-up care recommended by the hospital; and

(iii) patient referral to cardiac rehabilitation programs appropriate to their needs.

(b) professional education:

(1) The hospital shall sponsor or co-sponsor at least three professional education programs per year related to heart disease risk assessment and control and that are open to local community based health professionals.

(c) hospital-based heart health promotion:

(1) The program shall implement policies and health programs in the hospital and establish environments that promote heart-healthy behaviors among hospital staff, employees and visitors, including:

(i) prohibiting the sale and use of tobacco products on hospital premises;

(ii) offering and promoting, on a regular basis, healthful choices in hospital cafeterias and patient menus; and

(iii) offering employee wellness and fitness programs that provide opportunities for employees to make healthy choices.

(d) community based heart health promotion:

(1) The hospital shall organize or participate in a consortium of existing community-based organizations and key community leaders to engage in activities to improve cardiac health in the community; and

(2) organize or participate in at least one major community based campaign (not including health fairs) each year related to major heart disease risk factors.

(e) program administration:

(1) Hospitals shall identify a team within their organization to coordinate heart disease prevention activities. Members of the team shall include a broad range of expertise, including but not limited to: community organization, planning, and social marketing, public health skills and health education.

(6) When considering an application to meet public need for Adult and or Pediatric Cardiac Surgery Center services, priority consideration shall be given to the expansion of an existing service as opposed to the initiation of a new Cardiac Surgery Center.

(7) Where public need is established herein, priority consideration will be given to applicants that agree to serve the medically indigent and patients regardless of the source of payment.

(8) Applicants proposing to initiate an Adult and or Pediatric Cardiac Surgery Center service must:

(i) demonstrate the ability to comply with standards set forth in 405.29 (c), 405.29(d), and 711.4(h) of this Title; and

(ii) in addition, a facility providing Pediatric Cardiac Surgery Center services also must comply with the requirements specified in section 711.4(f) of this Title.

(9) All hospitals approved as Adult Cardiac Surgery Centers shall be approved as PCI Capable Cardiac Catheterization Laboratory Centers and must meet standards in Sections 405.29(c), 405.29(e)(1), and 405.29(e)(2) of this Title. All hospitals approved as Pediatric Cardiac Surgery Centers shall be approved as Pediatric Cardiac Catheterization Laboratory centers and must meet the standards at 405.29(c), 405.29(e)(1) and 405.29(e)(4) of this Title.

(c) For the purposes of this section the terms Cardiac Catheterization Laboratory Center, Percutaneous Coronary Intervention (PCI) Capable Cardiac Catheterization Laboratory Center, Cardiac Electrophysiology (EP) Laboratory Program and Pediatric Cardiac Catheterization Laboratory Center shall have the same meanings as in section 405.29 (a)(4) of this Title.

(d) Public need for cardiac catheterization laboratory centers:

(1) PCI capable cardiac catheterization laboratory centers. The factors and methodology for determining the public need for PCI capable cardiac laboratory centers shall include, but not be limited to the following:

(i) PCI capable cardiac catheterization laboratory centers at hospitals with a cardiac surgery center on site. Applicants approved as cardiac surgery centers are approved PCI capable cardiac catheterization laboratory centers as provided under section 709.14 (b)(9) of this Part and must meet standards at Sections 405.29(c), (e)(1) and (2) of this Title.

(ii) PCI capable cardiac catheterization laboratory centers at hospitals with no cardiac surgery on site. Determinations of public need for PCI capable cardiac catheterization laboratory centers at hospitals with no cardiac surgery on-site will be differentiated between: (A) hospitals that are established by the Public Health and Health Planning Council as co-operators with a hospital that is a cardiac surgery center as defined in section 405.29(a)(3) of this Title; and (B) hospitals that have a clinical sponsorship with a cardiac surgery center as defined in section 405.3(f)(3) of this Title and that are applying to be a PCI capable cardiac catheterization laboratory center. For the purposes of this section, clinical sponsorship shall mean that the hospital applying to be a PCI capable cardiac catheterization laboratory center has entered into a clinical sponsorship agreement with a cardiac surgery center acceptable to the department and in accordance with the standards established in section 405.29(c)(8)(i) of this Title.

(iii) For both co-operated hospitals and hospitals that are proposing to enter into a clinical sponsorship agreement, factors for determining public need shall  include, but are not limited to:

(a) the planning area for determining the public need for PCI capable cardiac catheterization laboratory centers at hospitals with no cardiac surgery on-site shall be the area within a one hour average surface travel time, as determined by the department of transportation and adjusted for typical weather conditions, of the applicant facility, unless otherwise determined by the Commissioner in accordance with section 709.1(c) of this title;

(b) documentation by the applicant must demonstrate the hospital’s ability to provide high quality appropriate care that would yield a minimum of 36 emergency PCI procedures per year within the first year of operation.

(1) Documentation of the number of cardiologists on staff at the proposed site, credentialed by the co-operated hospital, and/or employed by the clinical sponsorship hospital who currently perform percutaneous coronary interventions at other hospital sites and a summary of experience (including the most recent three years of volume and outcomes) for each.

(2) Documentation in support of volume projections for emergency PCI procedures must include, at a minimum: discharge data indicating the number of patients with a diagnosis of acute myocardial infarction (AMI) and/or other diagnoses associated with PCI, the number of doses of thrombolytic therapy ordered for acute MI patients in the applicant hospital’s emergency department (as documented through hospital pharmacy records), and documentation of transfers to existing PCI capable cardiac catheterization laboratory centers for PCI.

(3) Additional documentation that may be submitted in support of the need for a proposed PCI capable cardiac catheterization laboratory center include:

(i) the number of acute care beds at the applicant hospital and the range of acute care services provided;

(ii) documentation by the applicant of barriers that impact care experienced by specific population groups within the planning area and demonstration of cultural competency at the applicant site specific to the proposed populations to be served by the applicant;

(iii) documentation by the applicant demonstrating outreach to underserved populations that identifies potential new PCI cases within the service area;

(iv) emergency department discharge data;

(v) documentation by the applicant of regional demographics and transport patterns within the applicant's emergency medical service (EMS) region that impact the provision of cardiac care;

(vi) the geographic distribution of PCI capable cardiac catheterization laboratory center services and the ability of such existing centers to serve the patients in the applicant's service area;

(vii) letters from local physicians quantifying the number of PCI referrals from their practice and the portion of those that would have been treated at the applicant facility if PCI had been available;

(c) a written plan submitted by the applicant that demonstrates the hospital’s ability to comply with standards for PCI capable cardiac catheterization laboratory centers at sections 405.29(c), (e)(1) and (2) of this Title;

(d) a written plan submitted by the applicant that outlines staff training and demonstrates the hospital’s readiness to accommodate the needs of the PCI patients;

(e) a written plan has been submitted by the applicant which would promote access to cardiac catheterization laboratory center services for all segments of the hospital service area's population. The document shall include:

(1) a description of current and proposed initiatives for improving outcomes for patients with heart disease,

(2) a plan documenting the hospital's ability to maintain a comprehensive program in which high quality interventional procedures are provided as a component of a broad range of cardiovascular care within the hospital and within the community, to include an emphasis on processes of care and a description of how a patient will traverse through the system of care to be offered,

(3) a plan for ensuring continuity of care for patients transferred between facilities,

(4) documentation of outreach to regional EMS councils served by the applicant,

(5) documentation that EMS system capabilities have been taken into consideration in the delivery of cardiac services;

(6) a description of activities that promote planning for cardiac services within the region; and

(7) a description of current and proposed initiatives and strategies for reaching patients not currently served within the area.

(f) Comments and recommendations received from community organizations;

(g) The hospital shall propose and implement a hospital heart disease prevention program as set forth at subparagraph (b)(5)(ii) of this section;

(h) a description of existing and planned activities to serve the medically indigent and populations that experience health disparities.

(2) Cardiac EP Laboratory Programs. Factors for determining public need for Cardiac EP Laboratory Programs shall include but not be limited to the following:

(i) Each applicant for a Cardiac EP Laboratory Program shall be an approved PCI Capable Cardiac Catheterization Laboratory Center or an approved Diagnostic Cardiac Catheterization Service operating in compliance with standards at sections 405.29(c) and 405.29(e). Applicants for EP laboratory programs will also be considered in conjunction with requests for approval of PCI Capable Cardiac Catheterization Laboratory Center services.

(ii) Each applicant shall submit documentation, describing how the hospital will comply with standards at 405.29(e)(5) of this Title.

(iii) Each applicant shall submit documentation of existing referrals for cardiac electrophysiology patients treated by cardiologists on staff at the hospital.

(iv) Applicants for cardiac EP Laboratory Programs at hospitals with no Cardiac Surgery Center on-site must submit a copy of the patient selection criteria for the proposed program in accordance with the standards at section 405.29(e)(5)(iii) of this Title.

(v) Hospitals approved as cardiac surgery centers shall be deemed to have demonstrated public need to perform cardiac electrophysiology.

(3) Pediatric Cardiac Catheterization Laboratory Centers. Public need for a Pediatric Cardiac Catheterization Laboratory Center shall be determined only in conjunction with an application for a Pediatric Cardiac Surgery Center and when need has been demonstrated for Pediatric Cardiac Surgery Centers in accordance with standards at Section 709.14(b) of this Part.

(4) For co-operated hospitals under subdivision (d)(1)(ii) of this section:

(i) The application for PCI services must be submitted jointly by the applicant facility and the co-operated parent.

(ii) Documentation acceptable to the department must be submitted demonstrating that all cardiac catheterization laboratory centers within the co-operated parent’s system have staff sharing agreements that include, at a minimum, provisions for rotation and training of staff with the parent hospital and integration into the parent hospital’s quality and patient safety programs, quality assurance and peer review.

(iii) Documentation acceptable to the department must be submitted demonstrating that the co-operated parent hospital will be responsible for maintaining the competency of the cardiac interventionalist physicians, nursing, and technical staff performing services at the applicant facility.

(iv) Documentation acceptable to the department must be submitted demonstrating that the co-operated parent hospital will be responsible for ensuring that the applicant facility can provide PCI services on a 24 hour a day, 365 days a year basis and is capable of assembling a dedicated team within 30 minutes of the activation call to provide coronary interventions 24 hours a day and 365 days each year.

(v) If the co-operated parent is not in the planning area of the applicant facility, then the applicant facility must document that it has an emergency transfer agreement with a New York State Cardiac Surgery Center in the planning area that has an on-site cardiac surgery program.

(5) For applicant hospitals in a clinical sponsorship relationship with a New York State Cardiac Surgery Center:

(i) the application for PCI services must be submitted by the applicant hospital.

(ii) the sponsoring New York State Cardiac Surgery Center must be located in the same planning area as the applicant hospital.

(iii) the sponsoring New York State Cardiac Surgery Center must perform at a level of at least 600 PCI procedures per year.

(iv) a written and signed PCI clinical sponsorship agreement with the sponsoring New York State Cardiac Surgery Center, acceptable to the department and in accordance with standards at section 405.29(c)(8)(i) of this Title, must be submitted.  The PCI clinical sponsorship agreement must specify that the department shall be provided 60 days prior written notification of any proposed change, termination or expiration of the agreement, and any changes must be found acceptable to the department prior to implementation.  The agreement shall further provide that the parties agree that termination or expiration of the agreement shall result in closure of the applicant hospital’s cardiac catheterization laboratory center. 

(v) both the applicant hospital and the sponsoring hospital must submit written documentation demonstrating that the respective governing bodies have approved the clinical sponsorship agreement.

 

Effective Date: 
Wednesday, September 25, 2019
Doc Status: 
Complete

Section 709.15 REPEALED

Effective Date: 
Wednesday, July 7, 2010

Section 709.16 - Therapeutic radiology or radiation oncology

709.16 Therapeutic radiology or radiation oncology.

(a) This methodology will be utilized to evaluate certificate of need applications involving the acquisition of megavoltage (MEV) devices used in therapeutic radiology. It is the intent of the State Hospital Review and Planning Council that this methodology, when used in conjunction with the planning standards and criteria set forth in section 709.1 of this Part, become a statement of planning principles and decision making tools for directing the distribution of MEV devices. The goals and objectives of the methodology expressed herein are expected to ensure that an adequate number of therapeutic radiology units are available to provide access to care and avoid the unnecessary duplication of resources.

(b) The factors for determining the public need for MEV devices used in therapeutic radiology shall include, but not be limited to, the following:

(1) No equipment other than four or more MEV or cobalt teletherapy units with a source axis distance of 80 or more centimeters and rotational capabilities will be considered appropriate as the primary unit in a multi-unit radiotherapy service or as the sole unit in a smaller radiotherapeutic unit.

(2) Ninety-five percent of the total population of each health region is within a one-hour mean travel time, adjusted for weather conditions, of a facility providing therapeutic radiology services.

(3) The expected volume of utilization sufficient to support the need for an MEV machine shall be calculated as follows:

(i) Each applicant and MEV machine shall provide a minimum of 5,000 treatments per year and have the capacity to provide 6,500 treatments per year. These volumes may be adjusted for the expected case-mix of a specific facility.

(ii) Sixty percent of the annual incidence of cancer cases in a service area will be candidates for radiation therapy.

(iii) Fifty percent of radiation therapy patients will be treated for cure with an average course of treatment of 35 treatments and fifty percent of patients will be treated for palliation with an average course of treatment of 15 treatments. These estimates may be adjusted based on the case-mix of a specific facility.

Effective Date: 
Wednesday, October 5, 2005
Doc Status: 
Complete

Section 709.17 - Long-term ventilator beds

709.17 Long-term ventilator beds.

(a) This methodology will be utilized to evaluate certificate of need applications for the certification of long-term ventilator beds, which are operated in residential health care facilities for individuals experiencing respiratory failure who can be treated through mechanical ventilation. It is the intent of the State Hospital Review and Planning Council that this methodology, when used in conjunction with the planning standards and criteria set forth in section 709.1 of this Part, become a statement of planning principles and decision making tools for directing the distribution of long-term ventilator beds. The goals and objectives of the methodology expressed herein are expected to ensure that an adequate number of long-term ventilator beds are available to provide access to care and avoid the unnecessary duplication of resources.

(b) The factors for determining the public need for long-term ventilator beds shall include, but not be limited to, the following:

(1) The planning areas for determining the public need for long-term ventilator beds shall be the designated health systems regions.

(2) The number of long-term ventilator beds in each health systems region required to meet the public need shall be determined by dividing the projected annual patient days for the service by three hundred and sixty-five (365), and dividing the result by 0.95 to allow for a ninety-five percent occupancy rate. The projected long-term ventilator patient days used in this calculation shall be determined as follows:

(i) The annual number of potential candidates for long-term ventilator beds shall be determined by calculating the total number of annual general hospital discharges in the planning area for DRG 475 (respiratory system diagnosis with ventilator support), plus an additional ten percent, and multiplying the resulting figure by 0.32.

(ii) The number of potential candidates for long-term ventilator beds shall be multiplied by a 125-day length-of-stay to project the annual number of patient days for long-term ventilator patients.

(3) The review of certificate of need applications will consider the documented referral patterns in the planning area, the expected length-of-stay based on the case-mix of long-term and short-term patients, the ability of the applicant to successfully wean ventilator patients, and the ability and commitment of the applicant to accept the difficult-to-place ventilator patients (e.g. ventilator patients with hemodialysis needs or patients with bacterial infections).

(4) The long-term ventilator bed need methodology will be reviewed within three years from the effective date of this section.

(c) (1) The bed need estimates developed pursuant to subdivision (b) of this section shall constitute the public need for ventilator beds in the planning area subject to further adjustments in accordance with subdivision (d) of this section.

(2) Notwithstanding that there is an indication of need in a planning area for additional long-term ventilator beds as determined in accordance with subdivision (b) of this section, there shall be a rebuttable presumption that there is no need for any additional long-term ventilator beds in such planning area if the overall occupancy rate for existing long-term ventilator beds in such planning area is less than 95 percent based on the most recently available data. It shall be the responsibility of an applicant in such instances to demonstrate that there is a need for additional long-term ventilator beds despite the less than 95 percent occupancy rate in the planning area utilizing the factors set forth in subdivision (d) of this section.

(3) The Department shall evaluate the appropriateness of the 95 percent occupancy threshold criterion in this section, based on the most recent data available, within three years of the effective date of this section.

(d) Notwithstanding any other provision of this section, when the estimates of need for long-term ventilator beds developed in accordance with subdivision (b) of this section indicate the need for additional beds, such estimates of additional need may be modified, based on information and data gathered from relevant sources relating to significant local factors pertaining to the planning area, or on statewide factors, where relevant, which factors may include, but not necessarily be limited to, those set forth in paragraphs (1) through (3) of this subdivision. When making recommendations to the State Hospital Review and Planning Council and the Public Health Council concerning the impact of the factors set forth in this subdivision, the department shall, to the extent practicable, indicate the relative priority of such factors.

(1) the impact of requirements pertaining to placing persons with disabilities into the most integrated setting appropriate so as to enable persons with disabilities to interact with non-disabled persons to the fullest extent possible;

(2) recommendations made by the local health systems agency, if applicable;

(3) documented evidence of the unduplicated number of patients on waiting lists who are appropriate for admission to long-term ventilator care who experience a long stay in acute care facilities awaiting discharge to a residential health care facility for long-term ventilator care.

Effective Date: 
Wednesday, October 5, 2005
Doc Status: 
Complete

Appendix 709 - Diagnosis Related Groups

APPENDIX D-1 is available for inspection and/or copying at the NYS Department of Health, Bureau of Health Facility Planning, Hedley Building, 6th Floor, Troy, NY (518) 402-0966.

Doc Status: 
Complete

Appendix 709 - National Length of Stay by DRG and Payment Source, Average and 75th Percentile, 1991-1992

APPENDIX D-2 is available for inspection and/or copying at the NYS Department of Health, Bureau of Health Facility Planning, Hedley Building, 6th Floor, Troy, NY (518) 402-0966.

Doc Status: 
Complete