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Summary of CTAAB Recommendations

Provider/Technology Name

Background and Recommendation

Project
Date

Proposal

Final outcome

9/19/11 United Memorial Medical Center proposed to construct a wound care center in renovated space.
8/18/11 Unity Hospital of Rochester proposes to acquire a daVinci SI robot.

CTAAB concluded there is need for the surgical robot:
·         
Patient and provider demand for robotic surgery continues to increase.
·         
Indications for robotic surgery are expanding.
·         
Available surgical robots in the region are operating close to capacity.
·         
Unity has 12 surgeons trained in robotic surgery, eight of whom are currently performing such surgeries at other area hospitals.
The surgical robot is expected to be operational in the third quarter of 2012.

8/3/11 Rochester General Health System proposes to build and operate an advanced wound care center in conjunction with St. Ann’s of Greater Rochester on the campus of St. Ann’s Community. Withdrawn
7/7/11 Strong Memorial Hospital proposes to establish a wound care extension clinic at 160 Sawgrass Drive, Rochester. Grandfathered
7/6/11 Geneva General Hospital proposes to acquire a daVinci robot. Withdrawn
5/19/11 Highland Hospital proposes to add a second daVinci robot.

CTAAB concluded there is need for the second surgical robot:
·        
Patient and provider demand for robotic surgery continues to increase.
·        
Indications for robotic surgery are expanding.
·        
Available surgical robots in the region are operating close to capacity.
·        
Highland Hospital has an established robotic surgery program with a dedicated surgical team.
The surgical robot is expected to be installed and ready for use by the end of 2011.

3/24/11 URMC Department of Imaging Sciences proposes to add an MRI machine in the Sports Medicine Building being constructed on Nine Mile Point Road in Penfield, NY.

CTAAB concluded there is not a need for the proposed services:
There is not a community need for additional MRI capacity.

Appeal:  CTAAB received an appeal from the applicant.  Based on additional information presented, CTAAB made no recommendation on the need for the service.

3/24/11 Geneva General Hospital proposes to expand its sleep laboratory from four to six beds.

CTAAB concluded there is need for the additional beds:
·         
As presently operated (six beds, four nights per week), the capacity being utilized is the same as that previously available (four beds, six nights per week).
·         
The present operation provides for more stable staffing patterns.
·         
The specification of an operational date is moot; the number of sleep beds has already been expanded.

The following conditions were also recommended by CTAAB:

·         
The applicant return to CTAAB for approval before expanding into additional nights’ use of the six-bed capacity.
The applicant provide annual monitoring data for Finger Lakes Health Systems Agency staff such that there is a measure of use of the six-bed unit.

3/24/11 Sleep & Wellness Center of Western New York proposes to open a sleep center in Brockport, NY.

CTAAB concluded there is need for the proposed services:   
·         
The sleep center will nominally serve areas, primarily in Orleans County, which experience less access to sleep diagnostic services than other areas in the region.
·         
There are extensive wait times at existing services that could potentially serve these areas.
·         
The sleep center and consulting sleep specialist physician accept all insurances, including Medicaid.
·         
The specification of an operational date is moot; the sleep center is currently operational.  

CTAAB also addressed concerns that the sleep facility was built and marketed to the community prior to CTAAB review.  In the context of that discussion the applicant offered to identify for the payers patients who received sleep services prior to the May 17 CTAAB approval of the sleep center and will forgo reimbursement for services to these patients.
2/8/11 Rochester General Hospital proposes to establish an imaging center at 214 Alexander Park, Rochester, to include general x-ray, dexa scanning, ultrasound, CT, and digital mammography.

CTAAB concluded there is need for proposed services:   
·         
Imaging services are not available at Alexander Park, where there is a substantial number of physician practices and more practices are expected to locate. 
·         
The proposed center would expand geographic access to care. 
·         
Approximately 35% of revenue would be derived from Medicaid.
·         
When CT scanning services are available at the Alexander Park site, use of the oldest and least used of the three CT scanners currently on site at Rochester General Hospital will be discontinued.  The two CT scanners remaining in operation at Rochester General Hospital will be sufficient to handle the volume of scans for inpatients, emergency department patients, and outpatients continuing to use the hospital imaging services.
·         
The anticipated operational date for the imaging center is the end of the first quarter 2012.  

If the applicant makes a future request for a CT scanner at the hospital site, it must demonstrate that all possible efforts have been made to move outpatient scans to the Alexander Park site.
12/21/10 Rochester Radiology proposes to place a fixed PET/CT unit at 1255 Portland Avenue, Rochester, replacing a mobile unit currently in use.

CTAAB concluded there is need for the fixed PET-CT:
·         
Clinical need for PET scanning continues to expand.
·         
Clinical quality and patient comfort and safety will likely be improved.
Anticipated project completion date is six to nine months.

10/27/10 Medina Memorial Health Care System proposes to certify MRI as a service to be provided through a mobile unit.

CTAAB concluded there is a need for the proposed MRI.
·         
The proposed service would add MRI services to a hospital where it does not currently exist.
·         
The proposed service would add geographic access.
The hospital is projecting appropriate levels of access for financially disadvantaged patient groups.

   2/4/10 The Exigence Group proposes to locate a CT scanner in a new urgent care center at 2745 West Ridge Road, Greece. Withdrawn
11/11/09 Newark-Wayne Community Hospital proposes relocation and renovation of its endoscopy suite.

CTAAB concluded there is need for the relocation and renovation:

·          There presently is a low rate of appropriate screening for colorectal cancer in Wayne County, the hospital’s primary service area.

·          The proposed renovation will support colorectal screening and other endoscopic activities with clinically efficient settings, will correct present violations of hospital building codes, and will bring the suite up to industry standards.

The total project will be completed in the first quarter of 2013.
11/11/09 Highland Hospital proposes the creation of a twenty-two bed neuromedicine unit.

CTAAB concluded there is need for the creation of the neuromedicine unit:

·          The proposed unit would provide some beds now to meet present need for beds as calculated by the 2020 Commission.  Those beds, potentially not needed in the future as effective demand management initiatives are implemented, should be acknowledged as part of the existing bed complement of the URMC/Strong Health system as the area hospitals develop their current and future bed projects.

·          The grouping of neuromedicine patients should lead to improvements in quality of care through development of specialized nursing skills and application of specialized technology.

·          The creation of the unit would renovate an older section of the hospital and provide private patient rooms.

·          Anticipated project completion date is July 2011.

9/24/09 Highland Hospital proposes to add two new operating rooms, renovate pre-surgical screening, and expand the sterile processing department.

CTAAB concluded there is need for the additional ORs:

  While there is no current community-wide need for additional surgery capacity, Highland Hospital has demonstrated an institutional need for additional OR capacity based on established criteria that reflect high usage rates of existing capacity.

Anticipated project operational date is January 2012.
7/20/2009 Newark-Wayne Community Hospital proposes to renovate its Emergency Department.

CTAAB concluded there is need for the renovation:
·         
There is need to replace or modernize the existing ED based on both functionality and capacity.
·         
Quality of patient care will be enhanced.
·         
The design offers the opportunity to provide lower intensity care in a more efficient setting.  

CTAAB recommended that the hospital provide bilingual-bicultural staff within the ED and the hospital at large in accordance with New York State regulations.   

CTAAB further recommended that the hospital be an active participant in a collaborative, regional planning process to assure effective and non-duplicative investment in the region’s and subarea’s health care delivery system.

3/6/2009 Clifton Springs Hospital proposes to convert a mobile MRI to a fixed in-house MRI.

CTAAB concluded there is a need for the fixed MRI:
·         
The proposed fixed unit will increase the timely availability, accessibility, and quality of MRI services to the patients at the hospital, including its rural patient base.
·         
The large bore unit will provide clinical benefit to some overweight and claustrophobic patients.
         There is only a small cost difference between the present part-time service and the proposed full-time service.

2/2/2009 Geneva General Hospital proposes to renovate and construct an addition to the facility:  reconfigure medical/surgical patient rooms to create and construct 24 private rooms, expand the emergency department, replace the operating suites, create a replacement ICU, expand radiology and cardiology, and create a nursing education center.

CTAAB concluded there is a need for the proposed modernization, with the contingency that the number of Emergency Department stations be reduced to 16 and that the number of pre-admission stations be reduced as FLHSA staff determines based on additional information from Geneva General Hospital.

·         Use of radiology services has increased.  Increased demand for cardiology services is expected following the addition of two hospital-based cardiologists.

·         The rooms in the current intensive care unit (ICU) are small and outdated; no new ICU beds will be added during the renovation.  Given current demand, the current number of ten beds is needed to have an ICU bed available 99% of the time.

·         The current operating suites are small and outdated; no new operating rooms will be added.

·         Based on available utilization data, the emergency department needs 16 stations.  There are no utilization standards for pre-admission stations; FLHSA staff will work with the applicant to determine an appropriate number of stations.

·         Modernization of the applicant’s hospital rooms is important; current standards for acute care hospitals call for single patient rooms.  The applicant’s renovation of current hospital rooms to create 17 single rooms and construction of 24 new single rooms will help the hospital meet these standards.  

CTAAB recognized the importance of community planning and expressed support for a community planning process, addressing, in particular, hospital bed capacity in the region.  This sentiment is shared among key stakeholders.
12/17/2008 Unity Hospital proposes to add a third cardiac catheterization laboratory.

CTAAB concluded there is need for the laboratory:
·         
Monroe County facilities, including Unity Hospital’s, are used at a rate well above state standards.
·         
Literature supports the use of non-surgical approaches to treating cardiac problems.

11/25/2008 Rochester General Hospital proposes to build a four-bed sleep lab on the RGH campus.  Newark Wayne Community Hospital proposes to a four-bed sleep lab on the NWCH campus.          Withdrawn
10/29/2008 Sleep Insights proposes to add a second sleep center in Gates.

CTAAB concluded there is need for the six sleep beds:
·         
There is an extensive wait time to obtain sleep consultations and diagnostic testing.
      The occupancy rate at existing sleep facilities based on six nights of operation 50 weeks a year was over 95%.

10/06/2008 Nicholas H. Noyes Memorial Hospital proposes to add at 16-slice CT scanner at the Livingston Health Services Extension.  CTAAB concluded there is need for the CT scanner:
·         
The current CT scanner is at or above its volume capacity.
·         
Access to CT scanning will be improved with the placement of a unit in Geneseo.
Anticipated project operational date is six months after the certificate of need approval.
6/24/2008 F.F. Thompson proposes to expand and improve its laboratory, rehabilitation units, dietary facility, operating rooms, and ambulatory procedures unit.  CTAAB concluded there is need for the proposed modernization:
·         
The areas proposed for renovation do not meet contemporary quality standards.
·         
The existing procedure rooms are operating at capacity, and the need for colonoscopies will increase as the population ages.

Anticipated project operational date is June 2012.

4/4/2008 Unity Hospital proposes to construct and modernize its facility; certify 72 medical/surgical beds, seven intensive care unit beds, six coronary care unit beds, four physical medicine and rehabilitation beds, 19 traumatic brain injury beds, and two coma recovery beds; decertify a five psychiatric bed service; decertify four physical medicine and rehabilitation beds, 24 traumatic brain injury beds, and five coma recovery beds at St. Mary’s Campus.  
1/11/2008 Rochester General Hospital proposes to undertake major modernization and renovation, including adding 36 net new medical/surgical beds and a 16-slice CT scanner.  
1/8/2008 Highland Hospital proposes to purchase a daVinci robot.

CTAAB concluded there is a need for the proposed robot:

  • Highland Hospital does not have a robotic system.
  • Demand for this type of surgery will continue to grow.
  • The proposed unit will not add to community cost from a reimbursement perspective.
  • Quality of care is improved.
Anticipated project operational date is January 2009.

Geneva MRI
2007

Background:

Geneva MRI proposes to provide mobile MRI service, followed by fixed magnet service, in Geneva, NY.

 

Recommendations:

CTAAB concluded there is no need for the proposed MRI services:

  • Community MRI capacity is sufficient to meet current and projected demand.

Beverly Prince , MD
2007

Background:

Beverly Prince, MD, (Warsaw ENT) proposes to build and operate a two-bed sleep lab.

 

Recommendations:

  • Application was withdrawn.

 

Geneva General Hospital

2007

Background:

Geneva General Hospital proposes to replace a 1.5T mobile MRI with a 1.5T fixed MRI.

 

Recommendations:

CTAAB concluded there is need for the proposed MRI:

·       The change from a mobile to a fixed unit will afford improvements in quality; and

·       MRI ownership will enable greater scheduling flexibility and extended coverage, as needed, and thus improve access.

·       Anticipated project completion date is within one year of approval of the Certificate of Need application.

 

Radiologists of the University of Rochester

2007

Background:

Radiologists of the University of Rochester propose to use the PET-CT at Science Park on a full-time basis.

 

Recommendations:

CTAAB concluded there is need for recognition of the full-time use of the PET-CT:   

·       Although there is not community need for additional PET capacity, the RUR unit is nearing full utilization of its “approved” capacity of 0.6 full-time-equivalent use; and

·       With consideration of the machine’s use for research applications, movement to “full-time” use represents minimal expansion of capacity.

Strong Memorial Hospital

2007

Background:

Strong Memorial Hospital proposes to build an off-site hospital-based ambulatory surgery (outpatient) center.

 

Recommendations:

CTAAB concluded there is need for the proposed ambulatory surgery center:

·       Although there is no community-wide need for additional operating room capacity, Strong Memorial Hospital (SMH) has demonstrated institution-specific need;

·       Development of hospital-sponsored capacity will maintain and may increase financial access to care;

·       The requirements of medical education and training and recruitment of physicians will be served by a hospital-sponsored ambulatory surgery center;

·       The ambulatory surgery center will be located on Sawgrass Drive; anticipated project completion date is April 2009 (assuming New York State Department of Health approval).

University Medical Imaging

2007

Background:

University Medical Imaging proposes to purchase and install a fourth MRI, which will be a 3T.

 

Recommendation:

CTAAB concluded there is need for the 3.0 Tesla MRI:

·       Although there is not a current community-wide need for additional MRI capacity, UMI is operating its MRIs significantly above CTAAB’s benchmark for scanner utilization;

·       The 3.0T MRI currently available in the community is fully utilized; and

·       Given UMI’s overall MRI volume, it is reasonable to add a specialized scanner to its mix of capabilities when adding incremental capacity.

·       Anticipated project completion date is March 2008

Soldiers & Sailors Memorial Hospital

2007

Background:

Soldiers & Sailors Memorial Hospital proposes to expand and upgrade its Emergency Department, Rehabilitation Services, and Cardiology department.

 

Recommendation:

CTAAB concluded there is need for the proposed renovation and reconfiguration:

·          The project will improve function in the Emergency Department;

·          The project will improve accessibility and function of a number of high-traffic services;

·          The project will improve the facility’s infrastructure;

·          Anticipated project date is third quarter 2009.

 

Finger Lakes Radiology

2007

Background:

Finger Lakes Radiology proposes to purchase a 1.5T MRI and make it a fixed unit in Geneva General Hospital .

 

Recommendation:

Application was withdrawn.

Strong Memorial Hospital

2007

Background:

Strong Memorial Hospital proposes to add an extension clinic certified for outpatient medical oncology infusion services at Highland Hospital; this clinic would consolidate the Highland Hospital infusion center within the Wilmot Cancer Center and would expand the services at the Highland Hospital site.

 

Recommendation:

CTAAB concluded there is need for the proposed outpatient medical infusion center at Highland Hospital :

·          Cancer chemotherapy volume continues to increase;

·          The change in auspice will enable qualification for 340b “best federal price” purchase of pharmaceuticals;

  • Anticipated operational date is third quarter 2008. 

United Memorial Medical Center

2007

Background:

United Memorial Medical Center proposes to construct an outpatient diagnostic radiology center and add a 40-slice CT scanner and ultrasound and EKG services at its Bank Street Campus (the former St. Jerome’s Hospital) in Batavia, Genesee County.

 

Recommendation:

CTAAB concluded there is need for UMMC’s proposed 40-slice CT scanner:

  • Evidence supports institutional need despite the lack of community-wide need for an additional CT scanner;
  • The proposed CT scanner is technologically superior to the existing scanner and will improve quality of care; 
  • UMMC received NYSDOH approval and HEAL funding for the proposal;
  • Anticipated operational date is second quarter 2008.

Strong Memorial Hospital

2007

Background:

Strong Memorial Hospital proposes to add an incremental linear accelerator within the Wilmot Cancer Center .

 

Recommendation:

CTAAB concluded there is need for the proposed radiosurgery linear accelerator:

·       Indications for radiosurgery are increasing;

·       Radiosurgery appears to be less costly than the alternative treatment (invasive surgery) for many tumors;

·       Radiosurgery permits treatment of some tumors that are otherwise not treatable;

·       Anticipated project completion date is the end of the calendar year 2008.

Elizabeth Wende Breast Clinic

2007

Background:

Elizabeth Wende Breast Clinic proposes to obtain a 1.5T MRI to replace the mobile unit currently in use part-time.

 

Recommendation:

CTAAB concluded there is need for the proposed fixed MRI unit:

  • General community MRI capacity is fully utilized; while other centers could provide the service, capacity to perform breast MRIs is presently limited;
  • Clinical indications for breast MRI are increasing;
  • Delay or lack of MRI appears to negatively impact the course of clinical care for some patients;
  • Operating cost of the proposed unit is similar to the operating cost of the present mobile arrangement;
  • The applicant states the MRI should be operational in the third quarter of 2007.

Rochester General Hospital

2007

Background:

Rochester General Hospital proposes to obtain an additional linear accelerator.

 

Recommendation:

CTAAB concluded there is need for the proposed linear accelerator::

·       Rochester General Hospital ’s radiation therapy units are currently operating above benchmark volume levels, suggesting the need to increase capacity;

·       The project will decompress the medical oncology services, enhancing patient privacy;

·       The project will reduce wait times to initiate cancer treatment;

·       The project will increase capacity to relatively underserved portions of the city of Rochester and Monroe County ;

·       The project will be sited at Linden Oaks; anticipated project completion date is June 2008.

Thompson Health

2007

Background:

Thompson Health proposes to expand its Sleep Center from two to four beds.

 

Recommendation:

CTAAB concluded there is need for F.F. Thompson to expand its sleep beds, with the further proviso that physician availability be improved at the earliest possible time:

  • Thompson’s existing capacity is maximally used;
  • Wait times for services are up to six months;
  • Expansion will be completed within 180 days of the State’s approval of the certificate of need application.

Rochester General Hospital

2007

Background:

Rochester General Hospital proposes to add a 64-channel CT scanner unit in conjunction with the expansion of its Emergency Department.

 

Recommendation:

CTAAB concluded there is need for the proposed 64-slice CT scanner:

  • There is evidence supporting an institutional need despite the lack of community-wide need for additional CT scanner capacity.  Specifically, current RGH CT scanners are utilized beyond benchmark levels and additional growth in CT volume is reasonably anticipated;
  • The need for the proposed unit is not premised on cardiac imaging;
  • Anticipated project operational date is first quarter 2008.

 

Rochester General Hospital

2007

Background:

Rochester General Hospital proposes to provide in-house mobile lithotripsy in an existing operating room in the hospital.

 

Recommendation:

CTAAB concluded there is no community need for the proposed lithotripter:

  • The units that are currently available are not fully utilized;
  • The proposed service would duplicate existing resources and increase community cost;
  • There is no compelling evidence the proposed unit would provide improved quality of care.

    Appeal:

    Following an appeal, CTAAB recommended approval of the proposed lithotripter for two half days per week:

    ·         Extracorporeal shock wave lithotripsy appears to be the standard of care for treating kidney stones.

    ·         No supply-induced demand is expected to result from the additional lithotripter.

    ·         Concern regarding additional community costs is not significant.

    ·         A mobile unit would allow flexibility in responding to demand.

    Anticipated project operational date is January 2009.

 

Strong Memorial Hospital

2007

Background:

Strong Memorial Hospital proposes to add a 64-slice CT scanner and a 1.0T open MRI.

 

Recommendation:

CTAAB concluded there is need for the proposed 64-slice CT scanner:

  • There is evidence supporting an institutional need despite the lack of community-wide need for additional CT scanner capacity;
  • The need for the proposed unit is not premised on cardiac imaging;
  • Anticipated project operational date is first quarter 2008.

 

CTAAB concluded there is need for an open MRI unit at Strong Memorial Hospital (SMH):

  • Certain classes of patients (obese, pediatric, ICU) would experience improved quality of imaging and improved safety with the use of an open MRI;
  • There are few community alternatives to provide open MRI services to SMH patients;
  • Anticipated operational date is first quarter 2008.

 

University Cardiovascular Associates

2007

Background:

University Cardiovascular Associates proposes to install a 64-slice multidetector CT scanner at its office.

 

Recommendation:

CTAAB concluded there is no community need for the proposed 64-slice CT scanner:

There is adequate available community capacity of CT scanners capable of performing cardiac CT angiography

University Medical Imaging

2007

Background:

University Medical Imaging proposes to install a second Computed Tomography (CT) scanner.

 

Recommendation:

CTAAB concluded there is need for the proposed 64-slice CT scanner:

  • There is evidence supporting an institutional need despite the lack of community-wide need for additional CT scanner capacity.  Specifically, the existing UMI CT scanner is utilized well beyond benchmark levels;
  • The need for the proposed unit is not premised on cardiac imaging;
  • Anticipated project operational date is first quarter 2008.

 

Pluta Cancer Center

2007

Background:

Pluta Cancer Center proposes to add a second linear accelerator.

 

Recommendation:

CTAAB concluded there is need for the proposed linear accelerator:

  • While Monroe County facilities are utilized at benchmark levels, Pluta Cancer Center is over-utilized; its volume greatly exceeds benchmarks;
  • Pluta Cancer Center is the only program in the region without treatment capacity redundancy, either on site or at an affiliated site, leaving its patients at risk of treatment interruption;
  • Pluta Cancer Center is the natural service area for Southeast Rochester and Monroe County which have received less than average radiation therapy, compared with the local average adjusted for age/sex/race and cancer incidence (based on information provided by the New York State);
  • The second linear accelerator is expected to be functional by April 1, 2008 .

Cardiac CT Angiography

2007

Background:

Cardiac CT Angiography:  Using CT scans to visualize coronary arteries has been receiving increasing attention.  Although insurers have considered this technique investigational, the published scientific evidence has been growing. 

 

Recommendation:

Based on its review of the Technical Advisory Committee (TAC) report on Cardiac CT Angiography, CTAAB recommends to insurers that:

·         Cardiac-related CT angiography by advanced CT scanners (CTA) should be accepted for insurance coverage.  Coverage should be limited, however:

a.       Cardiac CT angiography should be approved and reimbursed when careful clinical assessment by a cardiologist finds that the patient has a low to moderate pre-test risk of coronary artery disease and the test will resolve clinical uncertainty;

b.       Cardiac CT angiography should not be approved or reimbursed when the test is done for screening purposes;

c.   Cardiac CT angiography will only be reimbursed when ordered by a cardiologist.

·         Calcium scoring should be reimbursed when performed as part of a contrast enhanced cardiac CT angiography study which is otherwise clinically indicated;

·         The quality of machine and training requirements of those interpreting cardiac CT angiography tests should be further evaluated by the insurers.

 

Consistent with the TAC Cardiac CT Angiography Report, CTAAB has established as operating policies to:

·         Review all requests for increase in the number of CT scanners.  As part of the analysis of such a proposal, review the ICD-9 or other diagnostic codes to determine if the current and/or projected volume of scans is justified only on the basis of cardiac-related procedures;

·         Permit current CT providers to continue to replace units one-for-one with the level of unit they believe is appropriate.

 

 

Provider/Technology Name

Background and Recommendation

Strong Memorial Hospital
2006
 

 

Background:

Strong Memorial Hospital proposes to add a facility with four exam/sleep rooms to accommodate the evaluation and treatment of sleep disorders in children.

 Recommendation:

CTAAB concluded there is need for the proposed expansion:

·     Existing space is nearing its limits; wait times are long; and there is a backlog of pediatric patients needing sleep studies.

·     Specialized pediatric staff, increased staff-to-patient ratio and pediatric-friendly environment promote quality of care.

·     The anticipated project completion date is March 2007.


Strong
Memorial Hospital

2006

Background:

Strong Memorial Hospital proposes to add an electrophysiology lab and to replace and renovate an existing electrophysiology lab.  

Recommendations:

CTAAB concluded there is a need for the proposed electrophysiology lab addition and renovations:

·      EP patient volume is increasing as a result of new indications, aging of the population, and increasing referrals.

·      The projected volume and time demand on the existing labs will exceed the present capacity.

·      The anticipated project completion date is July 2007.  


Park Ridge
Hospital

2006

Background:

Park Ridge Hospital proposes to relocate its Sleep Disorders Center to 919 Westfall Road , Rochester ; this site will accommodate an additional two beds.  

Recommendations:

CTAAB concluded there is a need for the proposed relocation and expansion:

·      There is high occupancy at the Unity Sleep Center and other sleep centers in the community.

·      Patient volume is growing substantially and cannot be accommodated in the existing capacity.

·      Patients experience long wait times for appointments.

·      The anticipated project completion date is January 2007.  


Nicholas
Noyes Memorial Hospital
2006

Background:

Nicholas Noyes Memorial Hospital proposes to open a 12-station chronic renal dialysis center in Geneseo.  

Recommendations:

CTAAB concluded there is a need for the proposed dialysis unit:

·      There is need in the region for new capacity.

·      The proposed unit will increase geographic access for Livingston County patients.

·      There is strong support from county government.

·      The anticipated project completion date is June 2007.


Strong
Memorial Hospital
2006

Background:

Strong Memorial Hospital proposes to renovate existing space to allow (1) the reopening of ten licensed medical/surgical beds in a unit that will be designed to accommodate patients with behavioral problems and (2) the relocation of a psychiatric outpatient program.  

Recommendations:

CTAAB concluded there is a need for the proposed renovation:

·      The specialty unit would be designed and staffed to care for medical-surgical patients with mental health overlays.

·      Present occupancy level at the hospital is excessive.

·      The anticipated project completion date is April 2007.


Highland
Hospital
2006

Background:

Highland Hospital proposes to relocate a Breast Care Center from the hospital to Red Creek Drive.  

Recommendations:

CTAAB concluded there is a need for the proposed relocation:

·      The Breast Care Center needs relief from the space constraints of the hospital site in order to expand in size and abilities.

·      Screening services will continue to be available at the hospital for those patients who cannot, or do not want to, go to the new center.  Bus service is available to the new site, and the sponsor will seek improvements in service as needed.

·     There is a potential for increase in geographic access to care.

·      The project does not appear to add to community cost except through increases in patient volume.

·       The anticipated project completion date is February 2007.    

This recommendation is for approval of the relocation of the center and is not an approval or denial of any specific technology.


Strong
Memorial Hospital
 
2006

Background:

Strong Memorial Hospital proposes to add a da Vinci robot for use in the operating room.  

Recommendations:

CTAAB concluded there is a need for the proposed da Vinci robot:

·       The volume of robotically-assisted surgery at SMH is approaching the capacity of the existing system.

·      Access to this capacity is maintained with the addition of a second robot.

·      Quality of care is improved with minimally-invasive surgery.

·      The robot will be operational in six to twelve months (i.e., by June 2007).  


Strong
Memorial Hospital
 
2006

Background:

Strong Memorial Hospital proposes to renovate medical adult intensive care units.  

Recommendations:

CTAAB concluded there is a need for the proposed ICU renovations:

·      The present unit is outdated and undersized, without a sufficient number of private rooms.

·      ICU utilization at SMH justifies an increase in functional capacity.

·      The project does not appear to have an inflationary financial impact.

·      Quality of care will improve with improved facilities.

·      The anticipated project completion date is July 2007.  


Rochester General Hospital 2006

 

Background:

Rochester General Hospital proposes to add a 1.5 Tesla MRI magnet in the hospital.  

Recommendations:

CTAAB concluded there is a need for the proposed MRI:

·      The machine will provide improved access for inpatients and ED patients.

·      Patient safety will be improved.

·      The MRI will be operational by the fourth quarter of 2007.  


Thompson Health 2006

 

 

Background:

Thompson Health requests an expedited review of approval to own, operate, and maintain a second MRI within FF Thompson Hospital.  

Recommendations:

CTAAB recognizes Thompson Health System’s need for comprehensive radiology services, including 24/7 access to MRI services, and supports Thompson’s proceeding to application for New York State Certificate of Need (CON) approval for an MRI. 

Consistent with precedent, CTAAB sees the capacity approval as site specific; therefore, any additional MRI capacity on the Thompson campus is seen as excess.


Rochester General
Hospital
 
2006

Background:

Rochester General Hospital proposes to construct a new endovascular suite, including an operating room, within the hospital.  

Recommendations:

CTAAB concluded that there is a community need for the endovascular suite, based on the following rationale:

·       The hospital does not have sufficient operating room capacity of appropriate size to accommodate the desired equipment.

·       Growth in patient volume appropriate for the proposed facility is likely due to the decreased risk associated with the proposed surgical technology.

·      The proposal is cost neutral except for growth in volume.

·      The proposed unit will be funded with donor contributions or other cash.

·       Quality of care would increase with the proposed unit. 


Highland
Hospital
2006

Backgound:

Highland Hospital proposes to expand and renovate its Emergency Department and relocate and renovate its Ambulatory Procedures Center .  

Recommendations:

CTAAB concluded there is a community need for the proposed renovations:

·      Growth in patient volumes supports the proposed expansion in ED size. 

·      The present ED exhibits functional deficits, the resolution of which will lead to increases in service efficiency, patient privacy, and perhaps patient satisfaction.

·      Functional issues will be ameliorated with the proposed APC, although its size will stay the same.


The Ide Group
2005

Background:  
The Ide Group proposed to place a fixed PET-CT unit at its Clinton Crossings site in place of its current mobile unit.

Recommendation:
CTAAB concluded that there was not a community need for the proposed fixed PET-CT, based on the following rationale:

  •   The present PET-CT capacity is more than adequate to meet current and projected demand.  A fixed unit available five days per week would create additional excess capacity in the community.

  •  There is no clear evidence the images provided by a fixed PET-CT unit result in clinical differences in patient outcomes.

Appeal:  CTAAB received an appeal from the applicant.  Based on additional information presented, CTAAB concluded it would recommend approval of the application:

·   The proponent indicated they are willing to accept a limitation on days, hours, and use of the fixed PET-CT in order to remain within the approved capacity of 0.5 FTE.

·   Patient comfort and convenience are enhanced through the reduced scan time of the fixed machine and increased machine reliability in terms of downtime.

CTAAB recommended approval of the application for a fixed PET-CT for 2.5 specified days per week, the same days every week, as determined in conjunction with the payers.  The intent of CTAAB with this approval is to cap the usage of this capacity and not facilitate de facto utilization beyond the 2.5 days.

 


Strong
Memorial Hospital
2005

Background:
Strong Memorial Hospital proposed to renovate surgical adult intensive care units and intermediate care units.

Recommendation:
CTAAB concluded that there is a community need for the proposed renovations, based on the following rationale:

·  The beds to be renovated are considered to be functionally obsolete.

·  The number of staffed ICU beds will remain within the hospital’s current licensed ICU capacity.

CTAAB’s recommendation included a suggestion that Strong Memorial Hospital be required to provide a detailed plan on how the unit will be staffed and how the needed staff will be recruited or developed.

 


Strong
Memorial Hospital
2005

Background:
Strong Memorial Hospital proposed to construct a four-story building to house the James P. Wilmot Cancer Center, which will include all adult outpatient cancer care services (including radiation oncology, hematology-oncology, and chemo infusion therapy); translational, clinical trial, and cancer research programs; and medical education and administrative space.  This facility will accommodate a growing patient population and enhanced services.

Recommendation:
CTAAB concluded that there was a community need for the proposed building, based on the following rationale:

·     The existing facilities are functionally obsolete and scattered in a manner both inefficient and burdensome to patients.  

·     While the staff analysis did not indicate the projected visit volume will be achieved in the time frame projected, there is good reason to believe it will be achieved in a reasonable time.

·     The proposed space program appears to be appropriate to the identified needs and would represent a more efficient, more intensive use of space than at present.

·     The financial impact of the proposed facility does not appear to be adverse to community efforts to control cost.

The co-location of clinical and research spaces and integration of medical, surgical and radiation treatment modalities in one location will support high quality of care.

 


Nicholas
Noyes Memorial Hospital
2005

Background:
Nicholas Noyes Memorial Hospital submitted a CON application for the expansion of its surgical services center and ICU.

Recommendation:
CTAAB found that community need supported approval of the expansion/renovation of the ICU and OR service areas.


Sleep Telemedicine Services
2005

Background:
Sleep Telemedicine Services (NY D.B.A. Associated Sleep Centers) proposed to place a sleep center in
Warsaw , NY .

Recommendation:
CTAAB found that community need supported approval of the proposed
Warsaw , NY sleep center based on access to care.

 


Barry Rosenberg, MD, PC, in conjunction with
United Memorial Medical Center
2005

Background:
Barry Rosenberg, MD, PC, in conjunction with Alliance Imaging, proposed to place a dedicated mobile PET scanner at
United Memorial Medical Center in Batavia , NY .

Recommendation:
CTAAB found community need supported approval of one day per week mobile PET scanning at
United Memorial Medical Center based on access to care.


The Ide Group
2005

Background:
The Ide Group proposed to limit use of their open-MRI system at their Clinton Crossings location along with the upgrade and relocation of an existing MRI unit to Linden Oaks (from Clinton Crossings site).  

Recommendation:
CTAAB found community need supported approval of the existing open MRI for up to 0.3 FTE, with the understanding that:

·       The open magnet is to be used on a limited basis for two specific classes of patients: bariatric patients (large body size or weight) and patients with claustrophobia; -

This does not constitute a resource which can be replaced by another MRI unit; and Any replacement of such unit must be reviewed by CTAAB in the context of community need at the time of review.

 


Park Ridge
Hospital

2005

Background:
Park Ridge Hospital proposed to place a second catheterization lab adjacent to existing catheterization lab, which is scheduled to be replaced as part of their Emergency Center Expansion Project due to steady growth in the scope and volume of cardiac services over the past several years.

Recommendation:
CTAAB concluded that there is a community need for the proposed laboratory based on the following rationale:

·  Monroe County cardiac catheterization labs are used at a rate well above state standards, even when approved expansions are considered.
· 
Park Ridge Hospital uses its present cath lab in excess of state standards.

The Park Ridge cardiac cath program has remained strong and has grown.

 


Sleep Insights of Rochester
2004
Background:
Sleep Insights of Rochester proposes to place a clinical sleep center at One Eastgate Square, Victor, NY.

Recommendation:
CTAAB found that community need did not support a sleep disorders center for the proposed location.

Appeal: CTAAB concluded that there is not a community need for the proposed sleep center, based on the following rationale:

  • There is no clearly defined community need for the proposed capacity which is consistent with what was determined before;
  • Current centers have access to neurologic sleep services; and
  • Current providers are not fully utilizing dedicated sleep center bed for neurologic sleep disorders.

CTAAB's original recommendation for disapproval remains.


Medical Imaging Physicians of Greater Rochester at Linden Oaks
2004
Background:
Medical Imaging Physicians of Greater Rochester propose to place a 1.5T magnet at the Linden Oaks campus in Rochester, NY.

Recommendation:
CTAAB found community need did not support the addition of a MRI unit at the Linden Oaks location.


Borg Imaging at White Spruce Blvd.
2004
Background:
Borg Imaging proposes to place a high field (1.5 Tesla) MRI magnet at the 200 White Spruce Blvd. office location.

Recommendation:
CTAAB found that community need supported the addition of one 1.5 Tesla MRI unit. CTAAB further determined that the application of Borg Imaging Group should be recommended for approval based on CTAAB's review of the FLHSA needs analysis, all of the application materials submitted, as well as all of the presentations provided to the board.


FF Thompson CON application transportable lithotripsy services
2004
Background:
FF Thompson Hospital CON application for the provision of transportable lithotripsy services in the central Finger Lakes region.

Recommendation:
CTAAB found that community need supported the implementation of the proposed services.


3.0 Tesla MRI magnet at Rochester Science Park
2004
Background:
University of Rochester Medical Center proposes to place an incremental 3.0 Tesla MRI magnet at the Rochester Science Park location.

Recommendation:
CTAAB found that community need supported the addition of one 3.0 Tesla MRI unit.


Ide Group at Linden Oaks
2004
Background:
The Ide Group proposes to place a high field strength MRI at their Linden Oaks Imaging Center location.

Recommendation:
CTAAB found community need did not support the addition of a MRI unit at the Linden Oaks location.


Clifton Springs Hospital CON application for lithotripsy services
2004
Background:
Clifton Springs Hospital CON application for the provision of lithotripsy services in the central Finger Lakes region.

Recommendation:
CTAAB found that community need supported the implementation of the proposed services.


Rochester General Hospital CON renovation project
2004
Background:
Rochester General Hospital CON application for the renovation of the Emergency Department, Rochester Heart Institute Entrance and additon, Ambulatory Procedures (Endoscopy) Center, and Patient Access Pavilion

Recommendation:
CTAAB found that community need supported the proposed major renovation and expansion project.


The Greater Rochester Digestive & Liver Diseases Center ASC
2004
Background:
The Greater Rochester Digestive & Liver Diseases Center, LLC and William Y. Chey, MD, D.Sc. & Associates for Digestive and Liver Diseases, PLLC submit a Certificate of Need (CON) application, in the name of the Center, for a gastrointestinal diagnostic and therapeutic office facilities to become a single specialty Ambulatory Surgery Center (ASC). The facilities have been part of a practice in gastroenterology and hepatology at 222 Alexander Streeter, Rochester, NY, since June of 2000. The proposed Center will remain on this former Genesee Hospital complex in the heart of the City of Rochester.

Recommendation:
CTAAB found that there is not a community need for the proposed capacity.

CTAAB received an appeal from the proponent. CTAAB reversed its original recommendation based upon new data provided by the proponent and the FLHSA. CTAAB found that community need supported the proposed change in capacity for procedure rooms only.


Dent Neurological Institute Sleep Center
2004
Background:
Dent Neurological Institute seeks to establish a sleep center. The proposed new site/location is for two different sites: one located at 2060 Five Mile Line Road, Fairport, NY and another site at New Medical Center at Colonial Plaza, 485 Spencerport, Road, Gates, NY.

Recommendation:
CTAAB found that community need did not support a sleep disorders center for proposed east and west suburb locations.


Highland Hospital CON renovation project
2004
Background:
Highland Hospital CON application for the renovation of the 6th floor of the East wing to accommodate the addition of 21 new inpatient beds.

Recommendation:
CTAAB found that community need supported the redevelopment of the 21 acute care inpatient beds. CTAAB recommends approval of the application.


Park Ridge Hospital Major Renovations and Construction
2004

 

Background:
Park Ridge proposes to expand and renovate the Emergency Department (ED), to renovate the surgical suite, to replace cardiac catherization equipment, to add CT scanning, to provide supportive spaces for hospital-based physicians, and to expand parking and related site development,

Recommendation:
CTAAB concluded community need supported the proposed renovation and construction project. The ED expansion/ renovation, including development of a Special Care Unit, will decrease crowding in the ED and diversion of ED volume to other area hospitals and will support projected increases in ED volumes, including peak volume, while improving staffing and operational efficiencies. The additional and upgraded OR capacity in the hospital setting will be beneficial to the community. The impact of the proposal on community cost does not appear to be excesive. The proposal satisfies community access objectives.


Culver Park Surgicenter
2004

 

Background:
Culver Park Surgicenter, LLC, proposes to establish, construct, and operate a multi-specialty ambulatory surgery diagnostic & treatment center at 2615 Culver Road, Rochester.

Recommendation:
 CTAAB found no evidence supporting community need for the proposed capacity:
OR shortages, to the extent they exist, are found in hospital settings.
New freestanding surgery center capacities have not yet been absorbed by the community.
There is adequate specialty capacity to perform GI surgical procedures.
The proposed center would add to community cost.


Highland Hospital OR Renovation

2004

 

Background:
Highland Hospital proposes to add two operating rooms.

Recommendation:
CTAAB concluded the need for additional OR capacity in the hospital setting would be beneficial to the community.


Ventricular Assist Devices
2004
Background:
Ventricular assist devices (VADs) have been developed to sustain patients awaiting heart transplantation and to provide short- or long-term circulatory support to allow myocardial recovery in patients suffering from reversible cardiac dysfunction. Recently, VADs have also been investigated as permanent, or "destination" therapy for patients with end-stage CHF who are not candidates for transplantation.

Recommendation:
Based on the information reviewed, CTAAB found that the use of Ventricular Assist Device (VAD) as destination therapy should be made available with the use of the following criteria: patient selection based upon CMS approved criteria; assessment of patient compliance prior to patient selection for VAD implantation; appropriate and complete informed consent; limit implantation of VAD's in those centers that are CMS approved; and proper infection control protocols implemented and adhered to at the clinical site.

Borg Imaging at Linden Oaks Office Park
2003
Background:
Borg Imaging proposes to place a MRI scanner at 400 Linden Oaks Office Park.

Recommendation:
CTAAB found community need did not support the addition of a MRI unit at the Linden Oaks location.

Ide Group on Park Ridge Campus
2003
Background:
Ide Group proposes to place a MRI scanner at 1561 Long Pond Road, location on Park Ridge campus.

Recommendation:
CTAAB found that community need supported the addition of one MRI unit, and that given the high volume of scans currently being performed at the Park Ridge Hospital campus, they were the most appropriate choice for the expansion of capacity. Site-specific approval was granted to the Park Ridge Hospital campus application.

Geneva General Hospital CON Application
2003
Background:
Geneva General Hospital CON application to place a cardiac cath lab.

Recommendation:
CTAAB found that community need did not support a cardiac cath lab at Geneva General Hospital.

Strong Memorial Hospital and Borg Imaging
2003
Background:
Strong Memorial Hospital and Borg Imaging propose a collaborative contractual agreement for a PET-CT center to be located at Rochester Science Park.

Recommendation:
CTAAB found that community need supported the addition of this new technology (pet-ct) to the region for patient care. The collaborative agreement between Borg Imaging and Strong Memorial Hospital was approved for Borg to provide two days of pet-ct; Strong Memorial Hospital to provide two days of pet-ct, in exchange for their two days of mobile pet, with one day of research.

Cardiac Cath Lab for Strong Memorial Hospital
2003
Background:
Strong Memorial Hospital proposes an additional cardiac cath lab to current space.

Recommendation:
CTAAB found that community need supported the addition of a cardiac cath lab due to current and anticipated future demand.

Strong Memorial Hospital Adding Observation Beds
2003
Background:
Strong Memorial Hospital CON application to add observation beds to the Emergency Department.

Recommendation:
CTAAB found that community need supported the addition of observation beds to the Emergency Department due to current and anticipated future demand.

Borg Imaging at Linden Oaks Office Park
2003
Background:
Borg Imaging proposes to place a MRI scanner at 400 Linden Oaks Office Park.

Recommendation:
CTAAB found community need did not support the addition of a MRI unit at the Linden Oaks location.

Radiation Oncology Department Expansion at Rochester General Hospital
2003
Background:
Rochester General Hospital CON application for expansion of the Radiation Oncology Department.

Recommendation:
CTAAB found that community need supported the renovation of existing space to meet current and anticipated future demand.

Advanced Medical Imaging at Linden Oaks Office Park
2003
Background:
Advanced Medical Imaging of Western New York proposes an addition to current MRI capacity at Linden Oaks Office Park.

Recommendation:
CTAAB found community need did not support the addition of a MRI unit at the Linden Oaks location.

Medical Imaging Physicians of Greater Rochester at Willow Pond Way
2003
Background:
Medical Imaging Physicians of Greater Rochester proposes to place a MRI scanner at Willow Pond Way, Penfield, NY.

Recommendation:
CTAAB found community need did not support the addition of a MRI unit at the Willow Pond Way location.

Canandaigua Orthopaedic Associates Propose MRI at Farmington, NY
2003
Background:
Canandaigua Orthopaedic Associates, P.C. proposes to place an extremity MRI system at their satellite office located at 1160 Corporate Drive, Farmington, NY.

Recommendation:
CTAAB found community need did not support the addition of an extremity MRI unit at the Farmington location.

Extension Clinic with ENT Services for Strong Memorial Hospital
2003
Background:
Strong Memorial Hospital proposes to add an extension clinic that provides Otolaryngology (ENT), Speech-Language Pathology, and Audiology outpatient services which are anticipated to be located at 2365 South Clinton Avenue.

Recommendation:
Closed.

Fourth Floor Addition for Lakeside Memorial Hospital
2003
Background:
Lakeside Memorial Hospital proposes to construct a 4th floor addition to the hospital and relocate surgery services to that area to include 3 OR's now, with space for a 4th OR at a later time. The existing 1st floor surgery service to be renovated to provide 4 new LDRP rooms, a delivery room, as well as maternity support spaces, a new corridor for improved circulation, and future space for ambulatory surgery.

Recommendation:
Based on the information reviewed, CTAAB found that community need supported the upgrade of existing surgical and obstetric spaces to improve functionality.

Replace ICU at Strong Memorial Hospital
2003
Background:
Strong Memorial Hospital to replace the current Intensive Care Unit to new space to be built over the new Emergency Department.

Recommendation:
CTAAB found that community need supported the adult ICU renovation due to current and anticipated future demand.

Additional CT Unit for Strong Memorial Hospital
2003
Background:
Strong Memorial Hospital is requesting an additional CT unit for the Emergency Department.

Recommendation:
CTAAB found that community need supported the addition of an incremental CT scanner for the Emergency Department due to current and anticipated future demand.

After Hours Imaging at Buell Road
2003
Background:
After Hours Imaging proposes to provide mobile imaging services for CAT and MRI at their Buell Road location.

Recommendation:
Closed.

Advanced Imaging Associates at Genesee Country Mall
2003
Background:
Advanced Imaging Associates, PC proposes to place a fixed MRI unit at their Genesee Country Mall location.

Recommendation:
CTAAB found that community need did not support an additional MRI unit in the Batavia area.

Vantage Mobile Services in Lower Western New York
2003
Background:
Vantage Mobile Services proposes to provide lithotripsy service to health care facilities in lower western New York/Finger Lakes region.

Recommendation:
Closed.

The Ide Group at Clinton Crossing
2003
Background:
The Ide Group proposes to place a fixed PET-CT scanner at their Clinton Crossing facility site.

Recommendation:
CTAAB found that community need supported the addition of this new technology (pet-ct) to the region for patient care. CTAAB recommends that current PET operators be allowed to upgrade their equipment to pet-ct for the same number of days as previously approved by CTAAB; no additional days shall be added for pet-ct services provided by IDE radiology.

Fixed PET-CT in Rochester Science Park
2003
Background:
The Radiologists of the University of Rochester propose to place a fixed PET/CT scanner in Rochester Science Park (adjacent to Highland Park) with an attached cyclotron.

Recommendation:
Application is superseded by NT130.

CT Unit for Highland Hospital Campus
2003
Background:
Highland Hospital proposes the placement of a CT unit on their campus.

Recommendation:
CTAAB found that community need supported the addition of an incremental CT scanner to the Emergency Department due to current and anticipated future demand.

Borg Imaging at Calkins Corporate Park
2003
Background:
Borg Imaging proposes the placement of a CT/PET scanner to be located at Calkins Corporate Park in Henrietta, NY.

Recommendation:
Application is superseded by NT130.

Ambulatory Surgery Extension Clinic at Linden Oaks
2003
Background:
Lindsay House Surgery Center to add an Ambulatory Surgery Extension Clinit at Linden Oaks Medical Campus in Rochester.

Recommendation:
CTAAB found that community need supported the extension clinic of the Lindsay House Surgery Center at the Linden Oaks Medical Campus due to current and anticipated future surgical demand.

Rochester Diagnostic Imaging at Hudson Avenue
2003
Background:
Rochester Diagnostic Imaging proposes the placement of an additional MRI unit at 1432 Hudson Avenue, Rochester, NY

Recommendation:
CTAAB found community need supported approval of the existing open MRI for up to 0.3 FTE, with the understanding that: - The open magnet is to be used on a limited basis for three specific classes of patients: RGH inpatient and ED patients who require clinical support or monitoring devices while the scan is being performed, bariatric patients (large body size or weight), and patients with claustrophobia; - This does not constitute a resource which can be replaced by another MRI unit; and Any replacement of such unit must be reviewed by CTAAB in the context of community need at the time of review.

Advanced Medical Imaging Capacity
2002
Background:
Advanced Medical Imaging of Western New York proposes an addition to current MRI capacity at a site to be determined.

Recommendation:
CTAAB found no evidence to support the need for additional MRI units at this time. Capacity will be re-looked at in 6-9 months.

Borg Imaging in the Finger Lakes
2002
Background:
Borg Imaging proposes the placement of an additional MRI unit in the Finger Lakes Region.

Recommendation:
Application denied without prejudice. CTAAB will again review at the request of the applicant at a future meeting. CTAAB further recommends that additional capacity be developed with existing units.

Magnetic Resonaance Imaging (MRI) on Ridge Road East
2002
Background:
The IDE Group, P.C. proposes the placement of an MRI machine on Ridge Road East, Rochester, NY

Recommendation:
Application denied without prejudice. CTAAB will again review at the request of the applicant at a future meeting. CTAAB further recommends that additional capacity be developed with existing units.

Breast Magnetic Resonance Imaging for Use in Breast Disease
2002
Background:
Magnetic resonance imaging is a tool used in the diagnosis of injury or disease. One novel use of this technology is the imaging of breast tissue to diagnose disease.

Recommendation:
Based on the information reviewed, CTAAB found that the use of breast MRI may be used for the following indications: determine extent of disease, distinguishing scar from recurrence, detect occult tumors, and follow-up after induction chemotherapy. CTAAB found no evidence to support the use of breast MRI in the following clinical situation: equivocal physical exam, mammography, and ultrasound. In addition, CTAAB found no evidence to support the need for additional MRI units at this time.

Strong Memorial Hospital CON Application 2002 Background:
CTAAB reviewed a request to replace the current Pediatric Intensive Care Unit (PICU) and Intermediate Care beds to new space to be built over the new Emergency Department.

Recommendation:
Based on the information reviewed, CTAAB found that community need supported the renovation of existing spaces due to current inadequacy of space to care for current and projected growth.

F.F. Thompson Hospital CON Application 2002 Background:
CTAAB reviewed a request for expansion of the emergency department, diagnostic imaging, nutrition services, as well as mechanical upgrades in 67,000 square feet of new construction and 32,500 square feet of renovated space.

Recommendation:
Based on the information reviewed, CTAAB found that community need supported the expansion and renovation of current spaces due to current inadequacy of space as a result of growth in patient volume and projected future growth.

Magnetic Resonance Imaging Capacity 2002 Background:
A review for the increase in the number of MRI machines in the Rochester area was reviewed.

Recommendation:
Based on the information reviewed, CTAAB found no evidence to support the need for additional MRI units at this time. CTAAB further recommends that additional capacity be developed with existing units. Capacity will be re-looked at in 6-9 months.

Positron Emission Tomography (PET) Scanners in the Finger Lakes 2001 Background:
CTAAB reviewed a request for a mobile PET scan unit to be parked at one-day-per-week basis.

Recommendation:
Based on the information reviewed, CTAAB found that a mobile PET unit at Clifton Springs Hospital on a one-day-per-week basis is an appropriate addition to PET scan capacity. Further increases to capacity will be reviewed through the established CTAAB process.

Positron Emission Tomography (PET) Scanners
2000
Background:
CTAAB reviewed two requests for the addition of PET scan services in the Rochester area. One application was presented as a joint effort between two radiological groups for a two-site mobile unit to be used two days per week. A second application was presented for a fixed unit with cyclotron services to be used on a full time basis.

Recommendation:
Based on the information reviewed, CTAAB concluded that the current need for PET scan services is best met by the mobile unit. This proposal meets the community needs in terms of increased access, cooperative health planning, ability to increase capacity on an as needed basis and limited capital expenditure.

CTAAB's expectation is that this unit will have the widest possible use in the community to provide for the betterment of the entire community.

Monolayer Pap Smear Technology
2000
Background:
CTAAB reviewed monolayer pap smear technologies for efficacy and cost effectiveness.

Recommendation:
CTAAB found that the cost of this technology relative to the benefits does not warrant its widespread use at this time.

Magnetic Resonance Imaging Capacity (MRI)
2000
Background:
CTAAB reviewed two requests for increased MRI capacity in the community.

Recommendation:
CTAAB found that both units were needed given the current demand and expected future demand. CTAAB committed to monitoring the results of this decision with further analysis in early 2001.

Monolayer Pap Smear Technology
2000
Background:
CTAAB reviewed monolayer pap smear technologies for efficacy and cost effectiveness.

Recommendation:
CTAAB found that the cost of this technology relative to the benefits does not warrant its widespread use at this time.

Magnetic Resonance Imaging (MRI) Capacity
1999
Background:
A review for an increase in the number of MRI machines in the Rochester area was reviewed.

Recommendation:
CTAAB concluded that the addition of one MRI unit in the community is an appropriate addition to the MRI capacity.

Breast Magnetic Resonance
Imaging (MRI) For Use in Breast Disease
1999
Background:
Magnetic resonance imaging is a tool used in the diagnosis of injury or disease. One novel use of this technology is in the imaging of breast tissue to diagnose disease.

Recommendation:
CTAAB concluded that:

  • The demonstrated benefits for magnetic resonance imaging of the breast are uncertain.
  • More rigorous scientific studies are needed.
  • While MRI of the breast may eventually be shown to be a valuable diagnostic test, the current literature is not yet sufficiently strong to support its use.
Rotavirus Vaccine
1999
Background:
Rotavirus is the most common cause of severe diarrhea, affecting almost every child by the age of four. The Rotavirus vaccine was developed to prevent this.

Recommendation:
CTAAB found that the vaccine meets a patient care need. They concurred with the American Academy of Pediatrics (AAP) and recommended the vaccine for use based on safety and efficacy studies.

Request for Grandfathering
1998
Background:
The Board reviewed a request to consider whether an MRI that was operated until July, 1991 would qualify for replacement or upgrade under CTAAB's grandfathering policy.

Recommendation:
The Board confirmed that the intent of the grandfathering policy is to avoid penalizing owners of technology that was actively used for patient diagnosis or treatment when CTAAB was established on 3/30/93. Given that the MRI was deactivated in July 1991, the Board denied the request.

FDG Imaging Using Molecular Coincidence Detection (MCD)
1998
Background:
A molecular coincidence detector is a modified SPECT camera that produces images like those produced by a positron emitting tomography (PET) scanner.

Recommendation:
CTAAB concluded that:

  • It is uncertain what the demonstrated risks and benefits of MCD is relative to dedicated PET.
  • More studies are needed to identify the trade-offs between PET and molecular coincidence imaging.

In addition, CTAAB indicated that the proponent may resubmit a proposal to the Preview Committee to endorse community funding of a clinical study to assess the efficacy of MCD or to reapply outlining under what specific circumstances the technology should be used.

Viagra (sildenafil citrate) for Erectile Dysfunction
1998
Background:
Viagra is the first oral medication for the use of erectile dysfunction.

Recommendation:

CTAAB found that the lack of cost-effectiveness literature regarding Viagra makes it uncertain what level of expenditure is justified by community need at this time.

New Technologies to Improve the Accuracy of Pap Smears
1998
Background:
ThinPrep, PAPNET and AutoPap are technologies designed to reduce the rate of false negative Pap smears.

Recommendation:
CTAAB found that currently the cost of these technologies, relative to their benefits to the Rochester area does not warrant widespread use. CTAAB recommended redoubling community efforts aimed at increasing the rate of conventional cervical cancer screening using Pap smears among both insured and uninsured women.

Stereotactic Large Core Needle Breast Biopsy (update)
1997
Background:
Payers asked CTAAB to revisit its 1993 recommendation on the subject.

Recommendation:
CTAAB reaffirmed its previous recommendation that a maximum of two stereotactic large core needle breast biopsy machines is sufficient.

Transurethral Needle Ablation (TUNA) and Microwave
Thermotherapy for the Treatment of Benign Prostatic Hypertrophy
1997
Background:
Microwave thermotherapy and TUNA of the prostate are new techniques that destroy prostate tissue to relieve moderate symptoms of benign prostatic hyperplasia (BPH), a chronic, progressive condition often seen in middle aged and older men.

Recommendation:
CTAAB recommended to:

  • Encourage continued research of microwave thermotherapy at Strong Memorial Hospital using a device under FDA review.
  • Encourage community acquisition of one FDA approved device in a most efficient, accessible setting, and
  • Develop findings on capacity.
Need for Additional MRI Capacity
1997
Background:
CTAAB reviewed two separate requests to bring additional MRI units to the Rochester area.

Recommendation:
CTAAB found that there is no need for additional MRI capacity at this time.

Partial Ventriculectomy
1996
Background:
A new untested procedure to treat end-stage cardiac failure, partial ventriculectomy involves removing a section of muscle from an over-stretched heart to enable the heart to pump more efficiently.

Recommendation:
The board recommended not paying for procedures until there is a controlled study demonstrating efficacy.

Mobile Lithotripsy Update
1996
Background:
CTAAB received a second request for a mobile unit (see 1995).

Recommendation:
CTAAB upheld its 1995 finding of no need for an additional lithotripsy unit in the Rochester area.

Magnetic Resonance Angiography (MRA) for Sites Below the Neck
1996
Background:
Special software enables improved MRI imaging of the vasculature.

Recommendation:
CTAAB recommended that MRA below the neck is acceptable for persons with dye intolerance/allergy problems and should be offered as an option to patients fearful of the risks of conventional angiography.

Bone Densitometry for Menopausal Women
1995
Background:
CTAAB had been following this issue since 1993. In late 1995, FDA approved Fosamax to treat osteoporosis; evidence shows that test results from bone densitometry can aid in medical decision making, rendering the test (DEXA or QCT) valuable.

Recommendation:
Insurance coverage needed for some testing; capacity in region (as of 11/95) is adequate, and no additional capacity (DEXA scanners or QCT) is needed.

Universal Hepatitis B Vaccine
1995
Background:
CTAAB studied newly issued recommendations of the American Academy of Pediatrics and the Advisory Committee on Immunization Practices; noted that younger children are easier to vaccine due to compliance factors.

Recommendation:
All children up to, and including age 12 should be vaccinated. Adolescents should be vaccinated if presumed at risk.

Excimer Laser for Phototherapeutic Keratectomy
1995
Background:
With FDA approval of the Summit Excimer Laser, CTAAB found that this laser performs well, and for some patients, avoids a corneal transplant.

Recommendation:
Only one unit is needed; volume of procedures expected to be very small.

Ultrasonic Bone Fracture Healing Device
1995
Background:
This technology uses ultrasound to hasten healing of certain fractures, but benefits do not justify cost.

Recommendation:
No need for this device.

PET Rubidium 82 Studies of the Coronary Arteries
1995
Background:
CTAAB compared PET to SPECT and coronary angiography and found that PET provides useful data, but SPECT provides same data at lower cost.

Recommendation:
No need for PET to study coronary artery status.

Varicella Vaccine
1995
Background:
Advisory Committee on Immunization Practices supports universal vaccine.

Recommendation:
Vaccine should be made available to adolescents and young adults at risk for chicken pox.

Cryo-Surgical Ablation of the Prostate
1995
Background:
Very little published literature supports the use of this technique, although early reports are promising.

Recommendation:
Upheld previous finding (1994): effectiveness of procedure unknown.

Mobile Lithotripsy
1995
Background:
Lithotripters destroy kidney stones; a mobile unit can travel between hospitals. The lithotripsy unit already located in Rochester is under-utilized and scheduled for upgrading to become state-of-the-art like the one proposed.

Recommendation:
No need for an additional unit in the region.

Open MRI
1994
Background:
This is a very low field strength MRI, housed inside an open structure, enabling easier viewing of very large or claustrophobic patients. Reliability of testing is questionable. Technique not preferred, except in extreme situations. There is at least one MRI locally that can accommodate most patients who cannot tolerate conventional MRI. The few patients who can only use Open MRI can travel to sites in Buffalo and Syracuse.

Recommendation:
No need for an additional MRI unit in the region.

Universal Hepatitis B Vaccine
For Adolescents
1994
Background:
Because the recommendations of the American Academy of Pediatrics and the Centers for Disease Control were different, CTAAB agreed to review the issue and make a recommendation.

Recommendation:
CTAAB recommended following the guidelines developed by the CDC which endorsed selective immunization of high risk persons and universal immunization of infants.

Radiation Oncology in the Finger Lakes
1994
Background:
CTAAB received two proposals to increase the number of radiation oncology treatments centers in the Finger Lakes. The proposed centers would be less than 12 miles apart.

Recommendation:
With help from Finger Lakes Health Systems Agency, CTAAB found that one unit could be justified, based on evidence provided and utilization standards defining need. CTAAB recommended one of the two units be supported, and that it be the least costly one.

Cryosurgical Ablation of the Prostate
1994
Background:
Alternative treatment for prostate cancer, using technology that freezes cancerous tissue to render it inert.

Recommendation:
Although the treatment holds promise, the published literature on the safety and effectiveness of this is insufficient. CTAAB recommended no need for this.

Portable Sleep Study Monitors for Sleep Apnea
1993
Background:
Diagnostic apparatus that enables sleep study to be performed in the patient's home, not at a sleep disorders center.

Recommendation:
CTAAB found no evidence substantiating claims that this technology provides information as useful as in the sleep disorders center.

Positron Emission Tomography (PET)
1993
Background:
PET is an imaging technique using special radioisotopes to image cellular activity.

Recommendation:
CTAAB found no substantial need for PET locally. Nearest site in Buffalo appears to be adequate for Rochester region's needs.

Magnetic Resonance Angiography
1993
Background:
Special software enables improved MRI imaging of the vasculature.

Recommendation:
CTAAB recommended guidelines for sites in the head and neck, but did not recommend MRA for sites below the neck.

Bone Densitometry
1993
Background:
Diagnostic test that can be performed either by CT or DEXA to determine whether bone loss has occurred, and if so, how much has been lost.

Recommendation:
No treatment exists to reverse peri- and post-menopausal bone loss. Therefore, the results of the test cannot change patient outcome. CTAAB found no need for this.

Stereotactic Large Core Needle Breast Biopsy
1993
Background:
Device consists of treatment table, stereotactic mammography and needle "gun;" enables core biopsies to be taken from deep breast tissue instead of the convention method of wire-guided open surgical biopsy.

Recommendation:
CTAAB found this technique to be as reliable as open surgical biopsy, but is less disfiguring, time consuming and costly. CTAAB recommended a limit of no more than two of these devices in the region, until more is known about how they will be used.


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