Oct 7, 2010

New Technology and Health Care Costs — The Case of Robot-Assisted Surgery


Technological innovation in health care is an important driver of cost growth. Doctors and patients often embrace new modes of treatment before their merits and weaknesses are fully understood. These technologies can lead to increases in costs, either because they are simply more expensive than previous treatments or because their introduction leads to an expansion in the types and numbers of patients treated. We examined these patterns as they apply to the case of robot-assisted surgery.

Robotic surgical devices allow a surgeon at a console to operate remote-controlled robotic arms, which may facilitate the performance of laparoscopic procedures. Laparoscopic surgery, in turn, is associated with shorter hospital stays than open surgery, as well as with less postoperative pain and scarring and lower risks of infection and need for blood transfusion.
Robotic technology has been adopted rapidly over the past 4 years in both the United States and Europe. The number of robot-assisted procedures that are performed worldwide has nearly tripled since 2007, from 80,000 to 205,000. Between 2007 and 2009, the number of da Vinci systems, the leading robotic technology, that were installed in U.S. hospitals grew by approximately 75%, from almost 800 to around 1400, and the number that were installed in other countries doubled, from 200 to nearly 400, according to Intuitive Surgical, da Vinci's manufacturer.
A wide range of procedures are now performed by means of robot-assisted surgery. Some of these procedures were already being performed laparoscopically before robots were introduced; the introduction of robotic technology affects expenditures associated with such procedures primarily by increasing the cost per procedure. For procedures that were more often performed as open surgeries, the introduction of robots may affect both the cost and the volume of surgeries performed.
Robotic surgical systems have high fixed costs, with prices ranging from $1 million to $2.5 million for each unit. Surgeons must perform 150 to 250 procedures to become adept in their use. The systems also require costly maintenance and demand the use of additional consumables (single-use robotic appliances). The use of robotic systems may also require more operating time than alternatives. In the case of procedures that had previously been performed as open surgery, however, some of the new costs will be offset by reductions in postoperative hospital costs and by productivity gains if patients recover more rapidly and can return to work and other activities sooner.
Estimates of the net per-procedure cost of robot assistance vary with assumptions about the frequency with which a robot will be used. We examined all the cost studies of robot-assisted procedures published since 2005 and found that, on average, across the full range of 20 types of surgery for which studies exist, the additional variable cost of using a robot-assisted procedure was about $1,600, or about 6% of the cost of the procedure in 2007. (For a detailed description of the methods, see the Supplementary Appendix, available with the full text of this article at NEJM.org.) When the amortized cost of the robot itself was included, the additional total cost of using a robot-assisted procedure rose to about $3,200, or about 13% of the cost of these procedures in 2007 (seetableProcedures Performed by Robot-Assisted Surgery, Current Cost per Procedure, and Estimates of Change in Cost, as Compared with Standard Procedure.). Intuitive Surgical is now the sole producer of robotic surgical devices; prices may decline in the future if there is more competition in the market for machines or related consumables.
This additional hospital spending is likely to affect the expenditures of public and private insurers — but only indirectly. New diagnosis-related and procedure codes now exist for robot-assisted surgery, but currently Medicare and most U.S. private insurers do not pay additional fees for this service. Instead, hospitals are likely to increase charges for procedures or diagnoses for which robots are used. Medicare and private-insurer reimbursement rates are computed on the basis of these charges. Thus, increases in charges for robot-associated diagnoses and procedures may eventually generate higher payments that are never explicitly linked to robot-assisted surgery.
Many procedures that can now be performed laparoscopically with robots used to be performed most often as open surgeries. Robot-facilitated substitution of laparoscopy for open surgery has occurred most prominently in the case of prostatectomy for localized prostate cancer.1
Various nonsurgical treatment alternatives for localized prostate cancer exist, with similar long-term outcomes and varying side effects, such as incontinence and impotence.2 Existing analyses suggest that as compared with open surgery, robot-assisted surgery does not diminish the frequency of these adverse effects.1 However, the substantial short-term benefits in terms of postoperative recovery that are associated with robot-assisted procedures may encourage patients with localized cancer to opt for surgical intervention rather than alternative nonsurgical interventions or watchful waiting.
Data from the Nationwide Inpatient Sample show an increase of more than 60% in the number of hospital discharges for prostatectomy (including both robotic and traditional procedures) in the United States between 2005 and 2008 (see graphProstatectomies in the United States, 2000–2008.).3 This increase occurred despite a decrease in the underlying incidence of prostate cancer4 and contemporaneously with a striking increase in the number of robot-assisted prostatectomies performed in the United States. The observed pattern matches evidence from the Surveillance, Epidemiology, and End Results Medicare database, which shows that Medicare beneficiaries (65 years of age or older) who received a diagnosis of prostate cancer in 2005 were about 14% more likely to have undergone surgery by 2007 than were their counterparts whose prostate cancer was diagnosed 3 years earlier.5 These patterns suggest that robotic technology may have contributed to the substitution of surgical for nonsurgical treatments for this disease. In this case, the introduction of the robotic technology may have increased both the cost per surgical procedure and the volume of cases treated surgically. However, the evidence suggests that despite the short-term benefits, robotic technology may not have improved patient outcomes or quality of life in the long run.
It is unlikely that robot-assisted surgeries will completely replace conventional surgeries for the full range of procedures for which cost studies have been done. If such a substitution did occur, however, it would generate nearly $1.5 billion in additional health care costs annually — excluding the (amortized) costs of the robots, which would bring the total to more than $2.5 billion. If robots also led to an increase in the volume of surgery performed, as suggested by the prostatectomy case, their effect on total annual expenditures would be even greater.
Who will consider these costs? The diffusion of robotic technology depends on fragmented, not centralized, decision making. Decisions to purchase robots are made not by payers but by hospitals, which compete with one another to attract surgeons and their patients. Hospitals, seeking surgical volume, find it difficult to resist surgeons' preferences, even without favorable direct reimbursement, and surgeons feel compelled to keep up with market demands so as not to lose patients.
Comparative-effectiveness research — often considered a corollary of regulatory cost containment — can play a critical role in this decentralized process. To date, there have been no large-scale randomized trials of robot-assisted surgery, and the limited observational evidence fails to show that the long-term outcomes of robot-assisted surgery are superior to those of conventional procedures.1 Evidence from well-designed, large-scale, multicenter trials or comparably rigorous nonrandomized evaluations is needed to determine which patients benefit from open surgical approaches and which from robot-assisted approaches. Hospitals could use this information in response to pressure from technophile surgeons; surgeons could use it in discussing treatment options with patients; patients could use it to make treatment choices; and payers could use it in negotiating reimbursements. An efficient health care system must enhance the ability of medical professionals and their patients to make informed choices about the adoption and use of new technologies, even when insurers do not explicitly provide reimbursement for these new technologies.

Oct 4, 2010

DaVinci surgery, how much does it really cost?

What is the real cost of a DaVinci system and how much does it cost to run it? It is probably not a suprise to learn that costs can be very high. 
The price for a single system, can be anything between 1.75 mUS$ in the US (1) to about 2 m€ in Italy (2,3).
The associated costs are annual service fees (approx. 10% of the initial investment/year) and disposable instruments for around 1500-2200 USD per use (4).
On top of that, manufacturer-provided training programs cost between 3000-3500 US$ per surgeon for a 1 or 2-day session. 
Interesting enough, surgeons need the same OR organisation as per a conventional laparoscopic approach, i.e. scrub nurse, OR nurse and, yes, a surgeon assistant !
Finally, there is a new learning curve associated with effective use the of da Vinci surgical system.
Break-even seems hard to reach, depending on the procedure type and number of cases per year, aditional costs per procedure can exceed 3000€ (2,4-7) vs. conventional laparoscopic approach.


4) Morino et al. in Mastery of endoscopic and laparoscopic surgery 
(NJ Soper, LL Swanström, WS Eubanks; Wolters Kluwer 2009)
6) G. Hubens, M. Ruppert, L. Balliu,W. Vaneerdeweg, What Have we Learnt after Two Years Working with the Da Vinci Robot System in Digestive Surgery? Acta chir belg, 2004, 104, 609-614 
7) Economic evaluations in The da Vinci Surgical Robotic System: A Review Of The Clinical And Cost- Effectiveness, HTIS 2008 (http://www.cadth.ca/media/pdf/htis/L0052%20daVinci%20Robotic%20Surgical%20System%20final.pdf)

Malfunction of the da Vinci Robotic System During Robot-Assisted Laparoscopic Prostatectomy: An International Survey

Dharam Kaushik, Robin High, Curtis J. Clark, Chad A. LaGrange. Journal of Endourology. April 2010, 24(4): 571-575.
Abstract
Purpose: To determine how urologists manage technical malfunction of the Da Vinci robotic system during robot-assisted radical prostatectomy (RARP).
Materials and Methods: A web-based survey was sent to urologists performing RARP. The survey questions were related to the stage of operation during which robotic malfunction occurred, management of malfunctions, and most common types of robotic malfunction. In addition, data were collected concerning surgical volume and training.
Results: One hundred (56.8%) of the 176 responding surgeons had experienced an irrecoverable intraoperative malfunction. Eighty respondents experienced mechanical failure before starting RARP, of which 46 (57.5%) rescheduled, 15 (18.8%) performed an open radical approach, 12 (15%) performed standard laparoscopic prostatectomy, and 4 (4.9%) docked another robot. Sixty-three respondents experienced mechanical failure before starting urethrovesical anastomosis, of which 26 (41.2%) converted to an open procedure, 20 (31.7%) converted to standard laparoscopy, 10 (15.8%) finished with one less arm, and 3 (4.7%) aborted the procedure. Thirty-two respondents experienced malfunction before completion of the anastomosis, of which 20 (62.5%) converted to standard laparoscopy, while 12 (37.5%) converted to open surgery. Fellowship trained surgeons were more likely to complete the prostatectomy using standard laparoscopy (P=0.05). No significant differences existed between surgeons performing a high volume or low volume of prostatectomies in regard to management of malfunctions.
Conclusion: Intraoperative breakdown of the Da Vinci robot is uncommon, but patients should be counseled preoperatively and a plan devised on how breakdown will be managed. Intracorporeal suturing skills allow conversion to a pure laparoscopic approach, if necessary. Consequently, standard laparoscopic suturing skills should remain in the residency curriculum.

Concerns About Rapid Adoption of Robotic Technology

Because robotic is rapidly emerging around the world (more than 80% of the prostatectomies in the US are performed with the daVinci robot), many health care providers are undergoing assessment of this new technology (HTA - Health Care Assessment).
They all have failed so far to show any benefit for the patient but are worried about the costs increase of the surgical procedures and the monopolistic position of Intuitive Surgical. Some interesting studies are given bellow. As a general conclusion, there is insufficient evidence to determine the efficacy or potential harmful effects of robotic surgery compared with conventional open or laparoscopic procedures but overall costs are much higher than any other surgical approach.

Please feel free to add any other relevant study and/or comment.


1) HTA report of the Belgian Health Care Authorities (Belgian Health Care Knowledge Centre) www.kce.fgov.be/Download.aspx?ID=1462the recommendations of this report are summarised as follows:

There is no clear evidence to prove or refute the superiority of robot- assisted surgery. Therefore, surgeons should refrain from presenting the use of robot-assistance as inherently better as this might induce unreasonable expectations in patients. 
Robot-assisted surgery has been shown to be reasonably safe and efficacious only when applied by surgical teams with adequate skills and experience with this technique. -There is also evidence that performance and patient outcomes improve with increasing experience. Therefore, it is recommended that robot-assisted surgery should only be performed by surgical teams specialised in performing the specific interventions using robot-assistance. Because of the limited absolute number of potential interventions in Belgium for each of the different disciplines, the number of these specialised teams should be limited, to enable those teams to build-up the required expertise. 


2) A comprehensive report on Robotic Surgery issued by the Canadian Coordinating Office for Health Technology Assessment (CCOHTA) has similar conclusions:
-Limited studies indicate the promise of these systems, which appear to be safe, but their efficacy is not fully established. In some procedures, the advantages they offer may also be achieved by newer non-computer assisted techniques. 
-Capital costs are high and cost-effectiveness has not been demonstrated.
-Diffusion of these systems can be expected to continue, but their place in surgical practice is not yet clear. They are most likely to be of value for centres undertaking specialized surgical services. 

3) In a canadian assessment in the field Gynecology performed by the University Hospital of Montreal, the authors have serious concerns about efficacy, patient outcome and and high costs: http://www.chumtl.qc.ca/userfiles/File/100531-robot-gynecologie.pdf

"Worldwide studies suggest that surgery performed with the Da Vinci robotic system have a comparable efficacy when compared to laparoscopy. 
However, economic studies indicate that the robotic assisted surgery is much more expensive than other available treatments. This is certainly due in part to the fact that only one supplier of this device (Da Vinci Robot) is operating in the market.  
Clear scientific evidence regarding the effectiveness and efficiency of the Da Vinci robotic system is not yet available (due to the absence of randomized clinical trials and economic evaluations) and it would be premature to undertake a wide dissemination of this technology. The superiority of robotic interventions remains to be demonstrated."

4) Another Canadian study published in the Canadian Urological Association Journal, strongly criticises the use of (Y. Fradet, Arguments against investing widely in robotic prostatectomy in Canada: a wrong focus on tool box rather than surgical expertise, Can Urol Assoc J. 2009 December; 3(6): 486–487): http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2792425/

5) Finally, a last comprehensive literature review on patients benefits with similar conclusions https://www.oxhp.com/secure/policy/robotic_assisted_surgery_610.html