NORTHWESTERN UNIVERSITY MEDINF 403-DL: MEDICAL INFORMATICS Business Case: Virtual Colonoscopy Professor Vikram Sheshadri Eric Abbott, Marla Kouche, Chris Davis and Jeremiah Rothschild 5/9/2010 Contents Project / Investment Description ................................................................................................................... 3 Business Need ........................................................................................................................................... 3 Alternatives ............................................................................................................................................... 3 Business Risks/Impacts If Not Performed ................................................................................................ 4 Business Sponsor and Stakeholder Expectations .......................................................................................... 5 Alignment to Strategic Objectives ............................................................................................................ 5 Executive Sponsor and Stakeholders ........................................................................................................ 5 Expected Benefits ..................................................................................................................................... 6 Purpose and Acquisition Strategy ................................................................................................................. 6 Technology Acquisition ............................................................................................................................ 6 Risks and Dependencies........................................................................................................................ 8 Resources .............................................................................................................................................. 8 Table 1. Estimated Costs ................................................................................................................. 9 Risks / Issues ......................................................................................................................................... 9 Benefits Realization .................................................................................................................................... 10 Economic Benefit.................................................................................................................................... 10 Patient Care ............................................................................................................................................. 12 Quality .................................................................................................................................................... 12 Market Value .......................................................................................................................................... 12 Industry Standards .................................................................................................................................. 12 Financial Analysis....................................................................................................................................... 13 Recommendation ........................................................................................................................................ 14 Works Cited ................................................................................................................................................ 15 Project / Investment Description Business Need A colonoscopy is an invaluable procedure used in the early detection, intervention, and treatment of colon abnormalities such as lesions and polyps that may degenerate into deadly cancerous growths. While there are less invasive procedures (such as sigmoidoscopy and fecal occult blood tests), colonoscopies are considered the optimal method for the aforementioned clinical evaluations (Northwestern University MED INF 403, 2010). In the U.S., there are an estimated 130,000 new cases of colorectal cancer and 60,000 deaths from it each year (Northwestern University MED INF 403, 2010). Furthermore, the cancer risk increases with age, a family history of colorectal cancer, and the size and age of colon polyps (if present). Given that early detection and treatment has a 90% cure rate, the intrinsic value of a colonoscopy is self-evident (Northwestern University MED INF 403, 2010). Traditionally, there has been only one way to perform a colonoscopy. Inserting an optical colonoscopy (OC) consisting of a long, flexible tube that has an integral camera in a sedated patient’s rectum to inspect the colon. This approach, while still considered the ‘gold-standard’, has many drawbacks and potential complications that are enumerated in subsequent sections below. More recently, a new method called virtual colonoscopy (VC) is available that instead uses sophisticated imaging processing software to construct a three-dimensional visualization of a patient’s bowel using hundreds of images obtained from a computed tomography (CT) scanner. The inherent advantages of this method are many, but none is more fundamental than promoting and encouraging pertinent demographics (i.e., “at risks patients”) to elect to undergo a colonoscopy. Alternatives As explained above, the closest alternative to a VC is an OC. While the comparative efficacy of the two approaches has been heavily debated, most investigators are satisfied that VC is clinically comparable to that of an OC in terms of the detection of colon abnormalities (National Institutes of Health, 2010). That said, each procedure has advantages and disadvantages. VC predominately eliminates the need to sedate a patient, thus greatly shortening the duration of a clinical visit and reducing overall costs. Importantly, a VC minimizes the risk of a bowel perforation compared to an OC procedure. On the other hand, the OC alternative is necessary for visual confirmation and polyp removal if the VC procedure detects abnormalities. Furthermore, an OC procedure is less costly than a VC procedure (by approximately $300 per procedure), and unlike VC, it is covered by Medicare and most private insurance health programs (Northwestern University MED INF 403, 2010, Inview, 2010). As well, it does not expose the patient to consequential radiation (from the CT scanner), and has the capability of removing any found polyps concurrent with its discovery. There is much evidentiary disagreement about the comparative effectiveness of detecting small polyps (especially those that are less than 6mm in diameter) by either method. Some researchers claim that the OC method misses as many as 18% of polyps 6mm and larger (Northwestern University MED INF 403, 2010). Conversely, others claim that the VC method is unreliable in detecting polyps of 6mm diameter and smaller (National Institutes of Health, 2010, UCSF, 2004, Pfau, 2007). If polyp size (and its corresponding proportional relevance in terms of cancer risk potential) were solely the decision criteria based on the above claims, then the OC method would seemingly be at a disadvantage relative to the VC method. Nonetheless, the OC procedure remains a much more popular choice with clinicians for the primary reasons above and the fact that the VC is a relatively new, higher-cost procedural option not widely covered by government medical insurance plans. Business Risks/Impacts If Not Performed There are two ways to view the business risks of not offering VC as an alternative to OC procedures. The clinically-based argument is that VC is a viable option to certain categories of patients for whom an OC procedure either is not palatable or medically possible (i.e., a herniated bowel). Moreover, given that the VC procedure may be used as a filter for the more complicated OC procedure, it represents a reduction in risk from a medical liability standpoint associated with complications arising from a poorly-performed OC procedure. Examples of the latter include bowel perforation, missed polyp detection, and incomplete bowel analysis. The business-based argument is that since the VC procedure has been shown to be clinically comparable to that of an OC, its availability gives a healthcare facility a clear marketing advantage over other facilities that don’t offer VC as a choice. This is especially relevant as educated patients seek alternative and advanced care options, and a facility that doesn’t offer VC as an option may be deemed or judged as antiquated or deficient in terms of its approach to the delivery of modern healthcare. Business Sponsor and Stakeholder Expectations Alignment to Strategic Objectives In a leading health system, patients must be offered the latest and most effective options for colon cancer screening. Despite limited reimbursement from insurance providers, it has been shown that competitors have adopted this modern VC as an elective option. Many patients who would not ordinarily be screened for colon cancer are now opting for the VC procedure, as it is faster and less invasive. While the VC has limitations in comparison to the optical colonoscopy, it allows a healthcare provider to attract a different market segment that would not traditionally undergo a colonoscopy. As a private health system with a responsibility to the community, offering VC as an option, on a trial basis, allows a healthcare provider to test the market and phase in the technology based on demand. Executive Sponsor and Stakeholders Although the Food and Drug Administration has approved use of the VC as an alternative for detection of colon cancer, public insurance plans such as Medicare and Medicaid do not currently provide reimbursement. However, there are private insurance companies that reimburse for VCs in an effort to encourage patient screening. Primary stakeholder groups affected by the introduction of this new preventative testing option include: Patients Patients seek the most convenient and effective testing options to maintain quality of life near their place of residence Hospital Administrators Administrators seek to provide effective testing options that meet the needs of their patients where revenue for the procedure exceeds the cost of offering the option Clinicians, Gastroenterologists, Radiologists Clinicians seek to have access to the latest technology that advances the ability to diagnose and treat colorectal cancer. As with any new technology, adoption takes time. Given the near equal effectiveness to the gold standard colonoscopy, it is only a matter of proving success before all the stakeholders embrace the VC option. As volumes increase, then insurance companies will be forced to reimburse for the option and the cost for the procedure will approach the cost for the traditional option. Hospital administrators and clinicians are eager to use new technologies that improve health outcomes. The VC is a great screening tool for patients that eliminate the need for an invasive procedure except in cases where polyps are detected. Expected Benefits To be considered a Center of Excellence in the diagnosis and treatment of colorectal cancer, a leading healthcare facility must have the latest technologies to maintain the level of care expected from such a facility. The benefits of offering this testing option is not just associated with the test and treatment itself, but also the marketing awareness of how advanced such a hosting facility is perceived compared to competitors. Further, having such an option serves as input in the decision process of a prospective patient, when evaluating care facilities for their health needs. Purpose and Acquisition Strategy Technology Acquisition The purpose of VC is to provide an effective, minimally invasive, rapid, and more comfortable way to screen for colon cancer without the need for sedation. This procedure is less embarrassing for the patient and relieves some of the anxiety of having a colonoscopy. Studies have shown that patients prefer VC over OC for routine screening which may improve compliance with repeat exams (Svensson, et al, 2002, Angtuaco, et al, 2001, Gluecker, et al, 2003). VC is able to provide more information about the proximal side of a lesion that is not visible with OC. Additionally, the use of CT technology also allows for the detection of other intra-abdominal pathology not seen with OC. The scope of this acquisition is to add one VC workstation to the hospital radiology department for use with an existing high resolution 64 slice CT scanner. The technology employed will be the Viatronix V3D Colon turnkey system (Viatronix, Inc., 2010). This includes all hardware and software components needed to interact with existing CT scanners to capture the images. The V3D Medical Imaging Workstation consists of a 3D processor which receives the 2D DICOM images from a medical image acquisition device (CT) and generates a 3D model of the scan. The V3D viewer receives this 3D model created by the processor and utilizes advanced graphical algorithms to display both the 3D model and the original 2D images in different anatomical imaging planes. The V3D viewer allows the user to interactively fly through the organ of interest and provide task-specific 3D medical imaging, analysis and measurement tools. Additional equipment includes a CO2 insufflator to dilate the colon during the exam. Figure 1. Medical Image Acquisition Device Source: (Viatronix, Inc., 2010). Risks and Dependencies A key dependency includes being able to schedule additional studies on the existing CT equipment. If CT exam times are not available, or if demand of this new technique exceeds capacity, an additional CT scanner may need to be purchased. A policy must be in place in the endoscopy lab to ensure OC can be performed on patients with abnormal findings on the same day in order to prevent repeat bowel prep for a future exam. The time available to schedule the CT resource for VC must be early morning to accommodate this workflow for patients with abnormal exams to provide OC on the same day. Resources Resources for implementation include IT installation and testing, training for CT technologists to perform the exam and training for radiologists to interpret the exams. Fewer staffing resources are needed to perform VC. Conventional OC requires a nurse for pre-procedure check-in and prep, a nurse and/or tech to assist during the procedure including administering sedation, and a post-procedure recovery nurse to care for the patient until the sedation has worn off. VC only requires a CT technologist to perform the exam. No sedation is required for VC; therefore, no recovery time is required after the exam is completed. A high resolution 64 slice CT scanner is an additional resource required to perform the exam. Table 1. Estimated Costs Equipment Type (Hardware / Software) Unit Price One Time Cost Viatronic V3D software and hardware: $100,000 (estimated) CO2 Insufflators: $15,000 Training Included in the price of software for both CT techs and radiologists Maintenance and Operations Service contract/maintenance: 18% Additional maintenance on CT scanner: None – included in CT service contract. Risks / Issues Medicare does not routinely cover the cost of VC for screening purposes (Centers for Medicare and Medicaid Services, 2010). While both Tricare and MediCal will not cover for routine screening regardless of risk factors (with prior authorization), VC is covered for diagnostic reasons where OC is medically contraindicated, such as patients on chronic anticoagulation therapy that cannot be interrupted or where OC cannot be completed due to a known colonic lesion, structural abnormality, or other technical difficulty that prevents adequate visualization of the entire colon (Tricare, 2010, MediCal Policy Department Clinical Affairs Division, 2010). According to an article published on PR Newswire, March 2, 2010, private insurance companies are starting to cover the cost for VC, including CIGNA, United HeathCare, and Anthem Blue Cross Blue Shield. Those with Flexible Spending Plans can also use this money to cover (PR Newswire, March 2, 2010). Benefits Realization In order to evaluate the benefits derived from the adoption of this procedure, a benefits analysis has been performed in the following areas: Economic Benefit, Patient Care, Quality, Market Acceptability and Industry Standards. Economic Benefit 1. Revenue/Reimbursement Impact: The net annual projected benefit of shifting procedures to VC from a standard of OC indicates a potential growth of $900,000. Annually, the hospital performs ~7,100 colonoscopies (hypothetical) with a net recovery rate of $2.8 mm under the traditional OC method (represents reimbursement less costs of complication). (Refer to “Notes” within Financial Modal, Pg14). Although VCs are only reimbursed partially (not through Medicare, but certain private and managed care companies will reimburse under the right circumstances and proper CPT coding mechanisms (Payer Mix and the Adoption of HIT, April 2007), the actual reimbursed cost of a VC is higher ($1,200 versus $900 for an OC). (Virtual Colonoscopy Shapes the Future, MedInf 403). Additionally, VC rarely has the number of complications due to perforation (creating costs that must be absorbed by the hospital). VC implies a generated “net” reimbursement of $3.8 mm under like conditions. The following table delineates the calculations of the Revenue/Reimbursement Impact: Table 2. Revenue/Reimbursement Impact Procedural Cost Recovery (Nationwide): Medicare cost # of Colonoscopies Performed OC $ Annual Cost of Procedure 12,780,000,000 Cost of Complication Annual Complications 50,000 142,000 Annual Cost of Complication Secondary Procedure: Therapeutic C Cost of Procedure Incidence of 2ndary procedure Cost of secondary procedure Total Healthcare Cost VC $ 900 14,200,000 Variance f(u) 300 17,040,000,000 4,260,000,000 - 1.000% 7,100,000,000 - n/a 1,100 1,420,000 1,562,000,000 - $ 19,880,000,000 1,200 14,200,000 $ 18,602,000,000 1,278,000,000 Not considered: Reduction in cost over time… Impact on JEMC Hospital: # of Colosopies Performed Annual Pricing Expected Reimbursement 7,100 6,390,000 8,520,000 100% Cost of Complications 35% VC partially covered 3,550,000 Cost of Secondary Procedure Estimated JEMC Cost Recovery 7,100 - $ 2,840,000 Assumed not covered by insurance 781,000 Assumed to be covered by insurance $ 3,763,000 Net Top Line Benefit of VC over OC $ 923,000 (Refer also to “Notes” within Financial Modal, Pg14) 2. Increase in number of procedures performed: A VC takes 10-15 minutes to perform, versus an OC that will take procedural resources and clinician involvement more than an hour (American Cancer Society website). As a result, a VC is 4 times more efficient to perform than an OC. Changing to VC will free resources (people and equipment) to perform other value added services. Assuming a conservative 10% improvement in efficiency, this could add the potential of $280,000 of incremental annual billable activity. 3. General volume increase of colonoscopies: Since VC has not been adopted by competitors within our community, volume could grow to achieve a 20% shift of market share. This would increase this hospital’s volume by ~2,800 or $1.6mm in annual new reimbursement. Patient Care Colorectal cancer is the second leading cause of cancer death in the United States with 130,200 newly diagnosed cases and 56,300 deaths in 2000. 152,000 newly diagnosed cases and 57,000 deaths in 2002 are predicted. Since it takes up to 10 years for a colonic polyp to grow to a size with a high likelihood of invasive cancer, timely and accurate patient screening with subsequent polyp removal can prevent over 90% of malignant colorectal cancers. Early detection of colorectal cancer can reduce mortality by over 50%. Early detection can reduce by 30 incidences annually. (American Cancer Society Website) Patient Friendliness: As opposed to the invasive approach, VC is a much less invasive procedure without the need for sedatives and is relatively shorter than an OC. This patient friendly technique in turn helps to convince patients to undergo the procedure regularly. It is noted, however, that patients will continue to have to undergo the preliminary “bowel cleansing” as a preparatory measure. Quality VC not only can cover a greater area of the colon (typical VC misses roughly 15%), the technique renders the colon a green color for examined areas and red as missed path. These qualitative measures greatly improve the ease of testing. (Virtual Colonoscopy, MedInf 403) Market Value VC aligns to a strategy of being perceived as on the “cutting edge” acute care facility. As we build out a marketing campaign, VC gives this hospital a chance to take a progressive approach within the community. Demonstrating the adoption of incremental new technologies help this hospital gain community appeal, recruit top-tier clinical resources, and drive strategic long-term objectives. Industry Standards Due to its effectiveness, VC has been approved by the U.S. Food and Drug Administration as a screening tool for colon polyps and cancer. It is quickly becoming a mainstream technology in many markets. Financial Analysis Table 3. Financial Analysis Project Name: Virtual Colonoscopy A) Investment Detail ($) Description Capital Item 1 2 2 3 4 5 6 Hardware/software: Viatronix* CO2 Insuflator* Development interface engine Development storage Maintainence & Support Subtotal Sales Tax/Shipping Investment 100,000 15,000 20,000 25,000 6.58% Amount Year 2 Year 1 Total Year 3 Year 4 100,000 24,300 24,786 25,282 25,787 20,000 25,000 100,155 - 160,000 10,528 24,300 1,599 24,786 1,631 25,282 1,664 25,787 1,697 245,155 17,118 170,528 25,899 26,417 26,945 27,484 262,273 Other Capitalizable Cost (installation, testing, preparation for use) Total Investment - * Obtained from Viatronix, VC vendor. Pricing range $50-150k, depending upon options. B) Investment Impact on Operations ($) Year 0 Year 1 Year 2 Year 3 Year 4 Year 5 1) Revenue Enhancement (Incremental Sales) 1 2 Revenue Reimbursement Incremental Market Capture Net Sales Increase (driven by investment) - 92300 160000 230750 400000 461500 800000 461500 800000 461500 800000 252,300 630,750 1,261,500 1,261,500 1,261,500 Assumes a 10% adoption in Year 1, 25% in Year 2, 50% in Year 3 and 100% in Years 4 & 5. 2) Incremental Cost Change (a) Incremental Savings/Cost Avoidance 1 Efficiency Savings Total 28,000 70,000 140,000 280,000 280,000 28,000 70,000 140,000 280,000 280,000 (b) Incremental Expenses 1 2 3 Depreciation Labor/Direct Costs of Testing Maintenance/Support 4 Training & Implementation Costs 5 Market Awareness Launch 6 7 Physician Advocacy Program Parallel/Pilot Considerations 8 Facility/Space Needs - 9 Malpractice Insurance - Total (c) Total Incr. Savings/(Expense) -- (a)+(b) Net Financial Impact - (56,843) (56,843) (56,843) (56,843) (56,843) (300,000) (300,000) (300,000) (300,000) (300,000) (25,899) (26,417) (26,945) (27,484) (262,273) (50,000) (40,000) (25,000) (25,000) (20,000) (100,000) (100,000) (75,000) (75,000) (74,999) (30,000) (30,000) (30,000) (30,000) (30,000) (200,000) (100,000) - - - - - - - - - - - - (762,742) (653,260) (513,788) (514,327) (744,115) - (734,742) (583,260) (373,788) (234,327) (464,115) (482,442) 47,490 887,712 1,027,173 Base Case Worst Case Best Case 797,385 Range Net Present Value (3 Year) $315,237 $252,190 $378,285 $200-400k Net Present Value (5 Year) Payback Period $1,667,387 2.5 $1,333,910 2.0 $2,000,865 $1.4-2mm 3.0 2-3 Years Years Notes on Financial Analysis: 1. In order to provide quantifiable benefits, we needed to make assumptions about a hypothetical hospital that is looking to purchase this solution. We assumed that the hospital was a typical, standalone, 250 bed acute care facility operating in a competitive community. 2. It is assumed that the community in which this hypothetical hospital resides also has two other competing hospitals. 3. Equipment data is obtained from a VC vendor, Viatronix Systems. Recommendation The evaluation team recommends investment in the VC technology to differentiate this hospital’s health system by providing an effective option for colorectal cancer screening. The business case indicates a likely return on investment, and the pilot approach will mitigate organizational risk during adoption. The next steps are to initiate a project team to support the sourcing process and begin development of an implementation and deployment plan. Works Cited American Cancer Society. Retrieved May 1, 2010 from http://www.americancancersociety.org Angtuaco TL; Banaad-Omiotek GD; Howden CW. (March 2001). Differing attitudes toward virtual and conventional colonoscopy for colorectal cancer screening: surveys among primary care physicians and potential patients. Am J Gastroenterology, 96(3):887-93. Centers for Medicare and Medicaid Services. Retrieved April 25, 2010 from http://www.cms.gov/mcd/viewdecisionmemo.asp?from2=viewdecisionmemo.asp&id=220& Gluecker TM; Johnson CD; Harmsen WS; Offord KP; Harris AM; Wilson LA; Ahlquist DA. (May 2003). Colorectal cancer screening with CT colonography, colonoscopy, and double-contrast barium enema examination: prospective assessment of patient perceptions and preferences. Radiology, 227(2):378-84. InView Imaging. Virtual Colonoscopy. Retrieved April 20, 2010 from http://www.inviewimaging.com/virtual-colonoscopy.htm Kim, D, Pcikhardt, P., Taylor, A., Leung, W., Winter, T., Hinshaw, L., Gopal, D., Reichelderfer, M., Hsu, R., Pfau, P. (Oct. 4., 2007). CT Colonoscopy versus Colonoscopy for the Detection of Advanced Neoplasia. The New England Journal of Medicine, 375:14, 1401-1412. Medical Policy Department Clinical Affairs Division. Virtual Colonoscopy (CT Colonography). Retrieved April 25, 2010 from https://www.medicalcardsystem.com/NR/rdonlyres/AE4768DD-0B5D-4066-A46674A13B4B0720/3774/VirtualColonoscopy1.pdf Virtual Colonoscopy Shapes the Future, MedInf 403, Handout from Dr. Shesadri National Institutes of Health. Computer-Aided Polyp Detection Software in Combination with Virtual Colonoscopy is as Effective as Traditional Colonoscopy. Retrieved April 20, 2010 from http://nih.gov/news/pr/dec2005/cc-01.htm PR Newswire (March 2, 2010). President Obama Gets Virtual Colonoscopy (CT Colonography) But Medicare Denies CTC Coverage to Seniors. Retrieved April 25, 2010 from http://www.prnewswire.com/news-releases/president-obama-gets-virtual-colonoscopy-ctcolonography-but-medicare-denies-ctc-coverage-to-seniors-85954667.html Svensson MH; Svensson E; Lasson A; Hellstrom M. (February 2002). Patient acceptance of CT colonography and conventional colonoscopy: prospective comparative study in patients with or suspected of having colorectal disease. Radiology, 222(2):337-45 Tricare. Covered Services. Retrieved April 25, 2010 from http://www.tricare.mil/mybenefit/jsp/Medical/IsItCovered.do?kw=Colonoscopy&topic=Men Viatronix. Products: V3D-System. Retrieved April 25, 2010 from http://www.viatronix.com/3d-medical-imaging.asp Virtual Colonoscopy. Retrieved April 20, 2010 from http://digestive.niddk.nih.gov/ddiseases/pubs/virtualcolonoscopy/ Vosmer, Corrine, Payer Mix and Adoption of HIT, Georgetown Pub Policy Inst, Washington, April 2007. Wong, K. (2004). Study finds virtual colonoscopy not ready for widespread use. University of California at San Francisco. Retrieved April 20, 2010 from http://news.uscf.edu/releases/study-finds-virtual-colonoscopy-not-ready-for-widespread-use/