is CEO of Integra Connect, West Palm Beach FL provider of technologies and services for value-based specialty care. Integra Connect partners with large groups in the U.S. focused on oncology and urology, as well as with other key health care constituents.

With 2018 behind us, it is a natural time to reflect on the major developments that took place in health care in general and urology specifically. For many, it will be remembered as the year that value-based care became a reality. Just over a year ago, 

only one-fourth of urologists understood the choices available to them

 as part of the Merit-based Incentive Payment System (MIPS) and alternative payment model (APM) programs created by CMS (Dec. 2017, page 1).

Fortunately, some of that confusion has since dissipated. With only a couple of urology practices participating in an APM-the Oncology Care Model-and no urology-specific candidates yet approved, most urologists are experiencing value-based care through MIPS.

What 2019 MIPS changes mean for your practice

With the first MIPS results released last November, urologists began to better understand the clinical, financial, and operational inputs that would positively or negatively affect their MIPS performance. One area of focus: the suitability of the technology tools and infrastructure on which their offices depend. Around the same time, we sat down with the leadership of 25 prominent urology practices nationwide to talk about the tools they were looking for in a value-based world.

During the fee-for-service era, the electronic health record established itself as the central technology of many urology practices, and with good reason. It was designed specifically to document patient encounters in the office setting, with an eye on the billing and collections workflow to follow. However, as MIPS has evolved-specifically, with the introduction of cost as 10% of the overall MIPS score for performance year 2018-it has become increasingly important for urologists to manage their patients more holistically, across all care settings and comorbidities.

The urology practices in our group said they need access at the point of care to information and insights that draw from an array of clinical and financial inputs, across entire care teams. Legacy EHRs, with their notoriously closed architectures and difficult data access, were simply not built for these value-based requirements.

As a result, more than half of the practices in our group said that in the next year they either will change their EHR (19%) or are actively looking to change it (35%). Interestingly, nearly all of those wanting a new EHR solution espoused the need for new requirements, driven by value-based considerations. They specifically want to take the opportunity of an EHR replacement to help them positively change their clinical operations and reduce treatment variability. Fifty percent say they want to make major changes, while another 42% seek modest changes.

When asked what kinds of value-based capabilities will be important, they pointed to: integrated care pathways, including tracking of deviations (54%); a historic patient timeline for an at-a-glance, longitudinal overview (43%); and real-time alerts on gaps in care/actions to complete for patients (39%). This vision for a value-based EHR goes beyond the scope of what existing legacy solutions provide.

If the EHR was a technology linchpin for fee-for-service billing models, it is transitioning to become just one component-albeit a critical one-sitting atop a new data foundation needed to power value-based care success. The ability to support cross-functional, team-based care across settings and venues, during and in between office visits, with access to rich clinical and financial patient data, requires the integration and harmonization of data from disparate sources that have not traditionally talked to one another. This may take the form of a practice-level health information exchange that can aggregate, integrate, and exchange population-based information, including medical claims, clinical, lab, prescriptions, and sociodemographic and bio-genomic data.

Value-based care also necessitates a redoubled focus on the quality and consistency of all data. We recently studied the data requirements for a selection of urology-specific MIPS measures and found that while most inputs resided in the EHR, more than two-thirds were unstructured-for example, captured in narrative notes with an elevated risk of errors, duplication, or even omission. Many practices found that they needed to manually abstract and curate charts in order to submit measures properly.

Medicare final rule: How E/M changes help urologists

Practices are looking for this investment in new technology capabilities and protocols to pay off in the form of a new generation of analytics that can drive both insights and action for MIPS and future APMs. Urology groups told us their wish list includes new clinical, financial, and population health analytics:

When asked for the top capabilities they needed on the clinical side, urology practices pointed to gaps in clinical care and care continuity (38%), patient identification for clinical action and/or research (23%), and the ability to track and analyze a patient’s entire care journey (19%). Most importantly, urology practices were unanimous in looking to add predictive capabilities to their analytics, so they could anticipate outliers or adverse events before they happened, design appropriate interventions, and ultimately improve their value-based performance in terms of outcomes and cost. Nearly 90% described it as “extremely” or “very” important.

While many urology practices are satisfied with the analytics that pertain to their fee-for-service revenue cycle, they are rightfully looking for new tools that will better connect clinical decisions with financial implications. These include areas such as utilization of services (32%) and episode of care costs (20%). As the cost component of MIPS increases and urology-specific APMs arise, this will be joined by the need for advanced support for care bundles, risk management, capitation, and more.

While population health management has evolved more quickly in specialties with major APM programs that involve accountability for episode costs-such as the Oncology Care Model in oncology-urology practices are increasingly incentivized to manage their patient panels more holistically. The increased shift of risk to providers points them toward adopting the population health tools and analytics familiar to payers, including patient risk stratification and condition and case management-all the way through to patient engagement metrics that attest to the success of their interventions.

While the emerging requirements of value-based care will necessitate changes to urology practice infrastructure and tools, it is important to recognize that a larger transformation will also be essential as well. In parallel, practices must expect to embark on a journey to adopt a broader, more holistic patient view; a new array of financial and clinical considerations; and a cultural commitment as they assume risk. Value-based incentives have the ability to determine the future sustainability of most practices, with the inevitable addition of APMs-either from CMS or commercial payers-as a further accelerant.

The combination of practice transformation with suitable enabling technologies will be an important determinant in which fork in the road urologists ultimately follow.

Articles

Practices must embark on a journey that goes beyond new technology.

Tools urologists need to thrive in a value-based world

My New Year’s resolution was to get my financial house in better order. Where is a good starting point?

While not comprehensive, here is a checklist to get you started. There are certain to be other items you will want to address, but getting these financial items in place is a good start.

Set short- and long-term financial goals.

 Whether you want to be debt-free in 10 years or own a home in 5, you are more inclined to save if you have specific goals. Factor these goals into a budget and figure out where you can squeeze the extra money from to make these goals realities.

 Every effective financial plan starts with a budget. Identify necessary spending and savings items. Give yourself a little leeway but stick close to the guidelines you’ve created throughout 2019.

How to make sense of the IRA aggregation rule

 We have seen clients saved by their emergency funds numerous times. A sudden job loss, major surprise expense, or unexpected health issue can change your financial picture quickly. The general rule of thumb is to maintain an emergency fund equal to three to six times your monthly living expenses.

 Some forms of debt such as a mortgage on a house may be perfectly acceptable due to the tax deductibility of the interest. However, you should do your best to reduce your other debt, especially if you are paying interest at relatively high rates such as those on credit cards.

 If you already contribute to an employer plan such as a 401(k) or 403(b), keep it going. The IRS increased the contribution amount for 2019 to $19,000 ($25,000 if over age 50). 401(k)s and 403(b)s should be maxed out before utilizing other tax-advantaged retirement accounts because they are protected by federal law from malpractice lawsuits and creditors. If you own your practice, determine if you are utilizing the best type of retirement plan for your specific situation.

Traditional and Roth IRAs, disability and life insurance

 If you are already maxing out employer provided retirement accounts and wish to save additional amounts toward retirement, consider contributing to a traditional or Roth IRA. These accounts also offer excellent tax-advantaged growth and are protected in most states from malpractice lawsuits. The contribution limit increased to $6,000 per year for 2019 ($7,000 if over age 50).

Often overlooked, disability and life insurance are actually very important components of financial security. Disability insurance supplements a portion of your income in the event you are sick or disabled and unable to work. In the event of a long-term disability, it could ensure you stay in your home and/or are still able to save for financial goals like retirement. All eligible physicians should have comprehensive disability coverage.

Life insurance is slightly more situational, but if you own a home with a mortgage or have any other debts that would not be absolved at your death, have children whose college educations you would want to guarantee, or have an individual or organization you would want to provide for in the event of your death, then life insurance should be considered.

Flexible spending vs. health savings accounts: How to choose

 The complexity of an estate plan may vary based on your assets and needs, but having basic estate planning strategies in place is important. Work with an estate planning attorney to review whether you need wills, powers of attorney, trusts, etc.

These are important items to have in place and will give you a good foundation to start moving toward a financially secure future. I recommend speaking with your financial adviser about other areas that could use improvement.

Is there anything I can do at the beginning of the year to prepare my investments for the year ahead?

Assuming you have an investment strategy in place that includes an asset allocation mix that is appropriate based on your risk and return objectives and you have investments that fit into these asset classes, then a good item to review at the beginning of the year is portfolio rebalancing. Over the course of the past year, certain asset classes will have outperformed, and others will have underperformed. That may have caused the asset classes to stray from their target percentages.

Your portfolio is a moving target that you must keep an eye on. If an asset class has moved too far away from its target, then rebalancing the portfolio and getting it back in line to start the year is a good idea.

Mr. Witz is educational program director at MEDIQUS Asset Advisors, Inc. in Chicago. He welcome readers’ questions and can be reached at 800-883-8555 or 

The information in this column is designed to be authoritative. The publisher is not engaged in rendering legal, investment, or tax advice.

Include disability insurance and estate planning on your financial checklist for this year, advises Jeff Witz, CFP.

2019 ‘to-do list’: Reduce debt, contribute to retirement plans

The U.S. Department of Health and Human Services Office for Civil Rights, as of this writing, has 412 cases of breaches of unsecured protected health care information involving more than 500 individuals who are under investigation 

 Most of these involve health care providers, most involve hacking or an IT incident, and most involve information in email. These statistics serve as a sobering reminder that medical practices remain an attractive target for hackers, possibly because many are small businesses with no dedicated IT professionals on staff.

On Dec. 28, 2018, HHS released a set of publications intended to help medical practices of all sizes confront this very real threat 

 In this article, I will summarize the threats and recommended practices for cybersecurity in your practice.

According to HHS, the five most common cybersecurity threats in health care are:

 These consist of attempts to deceive someone into giving out sensitive information via email. A common scenario might involve an email to an employee that appears to come from a legitimate source, and directs the employee to enter their login credentials. Those credentials are then hijacked to access other systems. This is the most common threat in medical practices leading to reported breaches.

 According to HHS, “Ransomware is a type of malware (malicious software) distinct from other malware; its defining characteristic is that it attempts to deny access to a user’s data, usually by encrypting the data with a key known only to the hacker who deployed the malware, until a ransom is paid. After the user’s data is encrypted, the ransomware directs the user to pay the ransom to the hacker (usually in a cryptocurrency, such as Bitcoin) in order to receive a decryption key.”

 The concern here is that the stolen equipment may contain unencrypted, unsecured protected health information. This is the third most common cause of data breaches reported to HHS.

Insider, accidental, or intentional data loss

Attacks against connected medical devices that may affect patient safety. 

Connected devices in a urology practice may include x-ray equipment, urodynamic machines, and other lab equipment. These interfaced devices typically contain protected health information and are vulnerable.

Disaster preparation: Make sure your practice is ready

The HHS report, “Health Industry Cybersecurity Practices: Managing Threats and Protecting Patients,” 

 recommends 10 cybersecurity practices to address these five threats, and the recommendations are tailored to the size of the practice (small, medium, and large). The report is accompanied by technical “how-to” volumes 

 that facilitate the implementation of these practices. I highly recommend that every practice download the section of the volume pertinent to your practice size and implement these best practices. For example, the table below, from the technical volume for small practices 

 provides recommendations for safeguarding your practice from phishing attacks.

Bottom line: Cybersecurity threats in a urology practice are real and can result in harm to patients-and your business. HHS has released a valuable toolkit that can be adopted by practices of any size with minimal effort. Follow these 10 basic practices and put your practice on the best cybersecurity footing for 2019.

HHS toolkit outlines basic practices to combat phishing, ransomware attacks.

Cybersecurity: How to safeguard your practice against threats

We continue to see a high percentage of errors in the hundreds of audits we perform each year. Fortunately, in the last few years, we have performed more audits to assist practices in billing accurately to improve income than to assist them in decreasing “take backs.”

In a series of articles, we plan to address in detail the documentation and communication that needs to occur in order to bill for different services, such as the procedure that was much more difficult and took a lot longer than the average procedure. How should you bill for services on the same day or during the global period? Many services have specific codes for specific variations of the procedure; how do you know you’ve picked the correct code? We’ll cover most of the problematic issues that we have seen that stem from problems with documentation, communication, and/or coding.

Accurate billing starts with documentation, communication

For this first installment, we will focus on the –22 modifier. (Note: We will target these articles to those who have at least some knowledge. If you need some more basic knowledge to understand this article, please feel free to contact us and we can provide you with options.)

Stating a case is difficult not sufficient for applying modifier

We will start with the complicated surgical case that took you a lot longer to perform than usual; for example, a cystectomy on an obese patient who had previous radiation and has lots of adhesions. Dictating that it was a tough case that was much more difficult than usual is not adequate documentation to satisfy the requirements for using the –22 modifier, the most accurate way to request and receive increased payment in most cases.

This is the CPT definition of the –22 modifier: Increased Procedural Services: When the work required to provide a service is substantially greater than typically required, it may be identified by adding modifier 22 to the usual procedure code. Documentation must support the substantial additional work and the reason for the additional work (ie, increased intensity, time, technical difficulty of procedure, severity of patient’s condition, physical and mental effort required). Note: This modifier should not be appended to an evaluation/management service.

The appropriate documentation should include:

the reason it required extra time (patient was obese, multiple adhesions from prior surgery/radiation, etc.). This information should be included in the body of the operative note relating to the performance of the procedure.

the increased degree of difficulty for that surgery. This information is more subjective and should be included in a summary or the “findings” section.

the extra amount of time that the procedure required in relation to an average procedure (such as twice the amount of time it usually takes). This should also be included in the summary of the procedure or “findings” section of the procedure note. It can also be included in the body of the operative note in a more granular notation.

any additional information that would inform a medical director or an auditor as to the difficulty and the extra time required. This should also be included in the summary or “findings” section of the operative note. You can also include non-clinical but relevant issues that complicated the performance of the case. Documenting that you were up all night, had a hangover, or equipment malfunctioned would not qualify for extra payments.

"The –22 modifier requires medical review by the payer in nearly all cases"

The –22 modifier requires medical review by the payer in nearly all cases. The process of review will slow payment of the claim. Additionally, the modifier is by definition for services that are substantially greater than what is required normally. It should also be said that the use of the –22 modifier, even with excellent supporting documentation, does not guarantee increased payment. Therefore, the modifier should not be added to a procedure unless the extra work and time were significant and the documentation supports the work.

Payments for each procedure are considered to be based on the average procedure. As “average” represents a range of time and effort, also consider placing a threshold on when to report the modifier. As a general guideline, we have seen mention of a 25% variation up and down as still considered within the range of average.

Does opting out of Medicare affect locum tenens billing?

For example, a procedure noted as more difficult than average but completed with within 145 minutes compared to the normal 120 minutes (120% of normal time) may not warrant extra payment consideration and the modifier is not used. On the other end, a very difficult case requiring 170 minutes for the same procedure (142% of the normal time) should warrant extra payment consideration and the use of the –22 modifier.

Finally, we have found through the Physician Reimbursement Services outsourced billing service and through discussion with other practices that submission of the operative note with the claim when first sent to the payer saves time and significantly improves your chances of being paid at a higher rate. Your billing staff should monitor all claims. Monitoring claims for which the –22 modifier requires extra attention, and if claims are denied, they should be appealed with additional documentation. In short, if you are hoping to be paid more with the –22 modifier, make sure you are committed to both the documentation and the follow-up.

In the second installment of this series, we plan to discuss the proper documentation to support payment for E/M services on the same day as a procedure.

The information in this column is designed to be authoritative, and every effort has been made to ensure its accuracy at the time it was written. However, readers are encouraged to check with their individual carrier or private payers for updates and to confirm that this information conforms to their specific rules.

"If you are hoping to be paid more with the –22 modifier, make sure you are committed to both the documentation and the follow-up," write Ray Painter, MD, and Mark Painter.

How to get reimbursed when using –22 modifier

According to the updated report from the Prostate Cancer Intervention versus Observation Trial (PIVOT), radical prostatectomy had no significant benefit over observation for reducing mortality among men with clinically localized disease.

The appropriateness of applying those findings to patients seen in daily practice is questionable, however, considering information from an analysis assessing the external validity of PIVOT, said Firas Abdollah, MD, at the 2018 AUA annual meeting in San Francisco.

To evaluate the generalizability of the PIVOT results, Dr. Abdollah and colleagues compared the characteristics of its patient population with those of 

 patients within three nationwide databases-the Surveillance, Epidemiology, and End-Results (SEER) population-based registry, the National Cancer Database (NCDB) hospital based-registry, and the Prostate, Lung, Colorectal and Ovarian (PLCO) trial.

Relative to all three external populations, men in PIVOT were older and had more comorbidities, the authors found. The differences between cohorts in age and general health might explain why the all-cause mortality rate was also much higher in PIVOT compared with the other prostate cancer patient populations, said Dr. Abdollah, fellow in uro-oncology and robotic surgery, Henry Ford Health System, Detroit.

“Our findings point to a sampling bias in PIVOT and indicate that the men who enrolled in PIVOT are not representative of those we are seeing in clinical practice. Clinically localized prostate cancer has a protracted course, and perhaps the older, sicker men in PIVOT did not have a long enough life expectancy to benefit from treatment,” added Dr. Abdollah, working with Mani Menon, MD, and colleagues.

Men from the external databases were included for the comparisons if they had characteristics matching those used for the PIVOT inclusion criteria: age ≤75 years, T1-T2NxM0 prostate cancer, PSA <50 ng/mL, and life expectancy ≥10 years.

Bone marker data support mCRPC combination Tx

PIVOT included 731 men enrolled between 1994 and 2002. The comparator groups were comprised of 2,847 men enrolled in the PLCO trial between 1993 and 2001, 60,089 men entered into SEER between 2000 and 2004, and 63,303 men registered in the NCDB between 2004 and 2005.

“The databases that we used capture a wide variety of clinical settings and are very representative of men seen in clinical practice,” Dr. Abdollah told 

The mean age at diagnosis was 67 years for men in PIVOT, which was older than for the SEER, NCDB, and PLCO cohorts (61.3, 60.2, and 65.8 years, respectively), and the between-group difference was statistically significant comparing PIVOT with the SEER and NCDB populations. Charlson comorbidity index (CCI) was not reported in SEER, but the proportion of men with no comorbidities (CCI of 0) was significantly smaller in PIVOT than in the NCDB and PLCO databases (56% vs. 96.4% and 94%, respectively).

The overall mortality rates in the PIVOT, SEER, NCDB, and PLCO cohorts were 64%, 23%, 9%, and 8.1%, respectively. Dr. Abdollah noted that the median follow-up in PIVOT, which was 12.7 years, is similar to that for the SEER database (12.3 years), whereas the median follow-up for men in the PLCO trial and NCDB was only 7.5 and 9 years, respectively.

“The shorter follow-up for the latter two cohorts could only partly explain their lower overall mortality rates,” said Dr. Abdollah.

Latin-American PCa patients less likely to receive definitive treatment

“Interestingly, the overall mortality rate for a subgroup of men from SEER that we excluded from our comparative analysis because they had not been given a recommendation for surgery was 50%. Presumably, these individuals were not recommended definitive treatment because of pre-existing conditions, and yet their mortality rate was still lower than that reported in PIVOT.”

Findings question validity of large PCa trial

While the relative value units (RVUs) associated with urologic procedures are generally in line with the surgical complexity and outcomes associated with them, there are four outliers that may warrant a closer look, results of a recent investigation show.

Two procedures that had work RVUs lower than expected based on the combination of operating time, morbidity, and length of stay were retroperitoneal lymph node dissection and cystectomy with bilateral pelvic lymph node dissection, according to the analysis, which was presented at the 2018 American College of Surgeons clinical congress in ­Boston.

By contrast, laparoscopic partial nephrectomy and laparoscopic ureteral reimplantation had work RVUs that could be adjusted downward, based on a model including three variables, said investigator Case Wood, MD, a urology resident with the University of North Carolina, Chapel Hill.

“It’s a relatively thoughtful system and I think it’s well intended, but looking at some of these specific numbers would probably do all surgical fields some benefit,” said Dr. Wood, working with Raj Pruthi, MD, and colleagues.

To gauge how well RVUs track with surgical complexity and physician workload, the authors queried the ACS National Surgical Quality Improvement Program database using 56 CPT codes for a wide range of urologic surgery procedures. They identified more than 190,000 non-emergent urologic procedures performed between 2012 and 2016.

Work RVUs for those procedures ranged from a low of 4.64 for transurethral resection of small bladder tumor, up to 44.26 for radical cystectomy with neobladder.

Lymph node dissection should be more than 10 units higher

Retroperitoneal lymph node dissection had an RVU value of 17.7, but should actually be around 10.6 units higher, going by a multivariable model the authors built based on three variables, including length of stay, operating time, and patient morbidity.

Likewise, cystectomy with bilateral pelvic lymph node dissection was 34.1 RVUs, which could be increased by 6.5 units, based on the modeling.

By contrast, laparoscopic partial nephrectomy had an RVU value of 27.4 that would be decreased by 6.8 based on this model, while laparoscopic ureteral reimplantation would go from an RVU value of 25.7 that would be revised downward by 6.7. That’s a net increase of about 3.5 RVUs, just looking at this set of four procedures, according to Dr. Wood.

App review: UpToDate earns high marks for accessibility

“Certainly, our outcomes are limited by the variables that we’ve defined to represent complexity and workload, but we were surprised to see as good of a correlation as we did, to be quite honest,” he said.

Length of stay, operative time, and morbidity were used to create the multivariable model because they had strong correlations with RVUs at the individual variable level, with R2 values of 0.80, 0.87, and 0.75, respectively, Dr. Wood said.

Based on these findings, RVUs for individual CPT codes should be reassigned using a “data-driven approach,” he said.

While the relative value units associated with urologic procedures are generally in line with the surgical complexity and outcomes associated with them, there are four outliers that may warrant a closer look, results of a recent investigation show.

Some urology RVUs do not track with complexity, outcomes

Persistent disparities in outcomes between men and women with bladder cancer highlight areas of needed improvement in the delivery of oncologic care. There were approximately 81,190 new cases of bladder cancer in the United States in 2018, and the majority of these cases were in men. While males are three to four times more likely to develop the disease, women tend to present with advanced stage, experience differences in quality of life following treatment, and suffer worse cancer-specific mortality (Surveillance, Epidemiology, and End Results [SEER] Program Populations [1992-2018], 

Based on Surveillance, Epidemiology, and End Results (SEER) data, women appear to have better cancer-specific mortality for most malignancies; however, this does not appear to be the case for bladder cancer 

 Epidemiologic and biologic explanations have been offered, but our incomplete understanding of the issue suggests numerous contributing factors.

In this article, we examine these factors, with a focus on current research that elucidates their role in the bladder cancer gender disparity. The table provides a summary of these research findings.

Perhaps the most evident disparity confronting female patients with bladder cancer relates to timely evaluation and diagnosis. The reasons for this are multifaceted and reflect differences in how female patients with hematuria progress through the health care system. Interpretation of hematuria in the female patient can be challenging for primary care physicians. While hematuria is certainly concerning for malignancy, it is also present in a number of benign conditions, including urinary tract infections, which are common in postmenopausal females.

Noninvasive bladder Ca test performs favorably compared to cystoscopy

In a large population study performed by Cohn and colleagues, women presenting with hematuria who were ultimately diagnosed with bladder cancer were far more likely to be treated for a suspected urinary tract infection during initial evaluation than males 

 Similarly, evaluation of practice patterns of primary care physicians by Buteau and colleagues demonstrated that women presenting with hematuria often underwent three or more pre-referral consultations with their primary care provider for the same complaint before referral for urologic evaluation (OR: 2.31, 95% CI: 1.98–2.69) 

It is possible that these barriers are the result of conflicting guidelines regarding the evaluation of asymptomatic microscopic hematuria. While the AUA defines microscopic hematuria as greater than 3 red blood cells per high powered field as the trigger for further diagnostic evaluation, 2017 guidelines from the American College of Obstetricians and Gynecologists favor a cutoff of 25 red blood cells per high powered field for non-smoking women under 50 years of age. This may lead to confusion for primary care physicians as to when referral is appropriate. Similarly, women who present to their gynecologist for evaluation of microscopic hematuria may experience delays in urologic referral.

While individually, these factors likely play only a small role in the overall delay in evaluation, the effect is notable. Cohn and colleagues demonstrated that women were more likely to experience a delay in time to diagnosis when compared to men (85.4 days vs. 73.6 days; 

<.001) and a higher rate of >6-month delay in diagnosis (17.3% vs. 14.1%; 

 It has been well documented that delays in diagnosis translate to poorer cancer-specific outcomes 

Even after diagnosis, female patients with bladder cancer continue to suffer worse outcomes than males following definitive treatment. While it has been proposed that advanced stage presentation in women may be to blame, this does not fully explain differences in overall survival. An analysis of 5-year survival between men and women with bladder cancer found that women fared worse across all stages 

 This would suggest that gender continues to play a role even after diagnosis.

Pre-op variables may predict post-cystectomy complication risk

The evidence for nonmuscle-invasive bladder cancer is mixed and somewhat limited. One single-institution series suggests that women were less likely to receive intravesical therapy for nonmuscle-invasive disease, but larger population cohorts have failed to demonstrate this 

Several studies have examined the use of treatment modalities and associated outcomes in women with muscle-invasive bladder cancer. An analysis of SEER data that examined the use of radical cystectomy or radiotherapy in patients with muscle-invasive bladder cancer revealed that while men were more likely to receive radiotherapy, there were no differences in the use of radical cystectomy between men and women 

Neoadjuvant PD-L1 inhibitor therapy found safe, effective

Similarly, it has been demonstrated that female patients do not experience significant differences in surgical margin status and lymph node count at the time of cystectomy 

 Outcomes regarding cancer-specific survival following cystectomy have unfortunately been conflicting. While older series demonstrated female gender as an independent risk factor for worse cancer-specific survival, newer series suggest the gender gap may be closing 

 While more studies are needed to confirm this new trend, it is encouraging. This may in part be due to heightened awareness of historical disparities in the diagnosis and treatment of bladder cancer in women.

Differences in urinary diversion utilization and HRQoL

Despite equivalent use of radical cystectomy between men and women, the use of continent diversions is underutilized in the female population. A recent review of radical cystectomies performed in the United States revealed that while the use of continent urinary diversions has declined, male patients still received continent diversions at more than twice the rate of female patients 

 It has been demonstrated that women suffer worse health-related quality of life outcomes following ileal conduit when compared to men 

Marital status linked to bladder Ca survival

While patient perception of body image and the results of surgery impact a number of quality of life measures in all patients, several studies have suggested this may be improved with the use of continent diversion. In a meta-analysis performed by Cerruto et al, 65% of men who had an orthotopic neobladder following radical cystectomy showed improved quality of life measures when compared to those who received an ileal conduit 

Few studies have compared health-related quality of life measures in men and women following cystectomy. In one study of 73 female patients who underwent radical cystectomy, those who received an orthotopic neobladder were more likely to experience improvements in future perspective of their illness, perceptions of body image, and sexual function than those who received an ileal conduit 

 2018 [In press]). The factors driving the underutilization of orthotopic neobladder use in females are unclear, but may be related to gender-specific complications and adverse outcomes following urinary diversion. A study of urinary functional outcomes in women receiving an orthotopic neobladder revealed that hypercontinence rates may be as high as 44.6% in female patients 

Many low-risk PCa patients on AS may be lost to follow-up

There is a paucity of data comparing men to women in terms of daytime incontinence, nighttime incontinence, hypercontinence, and sexual function following orthotopic diversion. Lack of standardization of questionnaires, varying definitions of continence, under-sampling of female patients, and variable assessments of sexual function are mostly to blame. Further assessment of gender differences in this area is needed.

The role of sex steroids and the hormonal axis have been investigated as a potential biologic explanation for the gender divide in bladder cancer. Population analyses have shown that bladder cancer is more common in postmenopausal women than in premenopausal women 

 This has led several investigators to assess the role of sex steroid receptors in bladder tumors.

The primary points of interest have been the expression of androgen receptor (AR) and estrogen receptor (ER) and their association with pathologic stage. In an analysis of 188 tumors, Miyamoto and colleagues showed that loss of AR and ERÎ± and increases in ERÎ² were associated with an increase in tumor grade and stage 

RCC 2018: Top advances in treatment of localized, advanced disease

It also appears that modulating estrogen receptors may inhibit the growth of urothelial cell carcinoma. In a study conducted by Sonpavde and colleagues, raloxifene (Evista), an estrogen receptor modulator, was found to inhibit the growth of urothelial cell carcinoma in an in vivo model 

 2007; 69:1221-6). The implications of androgen and estrogen receptors as drivers of tumorigenesis are profound. The role of tamoxifen (Nolvadex), a selective estrogen receptor modulator (SERM), is currently under investigation for the treatment of low- and intermediate-risk bladder cancer (NCT02197897). Further study is needed to determine the role of androgens in the treatment of bladder cancer.

Gender disparity in bladder cancer is a complex issue that likely stems from diagnostic delays, therapeutic differences, and possibly biologic factors. Each of these areas provides opportunities for improvement and for the eventual elimination of the gender divide. Partnerships with primary care providers and gynecologists should remain a priority to improve education and understanding of the importance of timely evaluation of hematuria in the female patient. Hopefully, continued understanding of the biologic drivers of urothelial carcinoma will provide novel therapeutic targets for both male and female patients with bladder cancer.

 are professors in the department of urology, Loyola University Stritch School of Medicine, Maywood, IL. 

Section Editor Christopher M. Gonzalez, MD, MBA,

 is professor and chair of the department of urology at Loyola University Chicago Stritch School of Medicine, Maywood, IL.

Poor outcomes in women may stem from diagnostic, therapeutic, and biologic factors.

Gender disparities in bladder cancer management

Once its first documented use in the early 1800s, endoscopy has evolved to be an essential part of the urologist’s toolkit. The subsequent century saw multiple engineering and clinical use advances that led to the evolution of modern endoscopes. These changes have revolutionized the way clinicians diagnose and treat a variety of urologic pathologies. Combined with an increased interest and accessibility of surgical robots, multiple novel endoscopic robotic platforms are being developed to potentially improve outcomes, ease performance and learning challenges, and improve surgical ergonomics.

This article highlights some of the emerging endoscopic robotic systems in urology.

Current challenges of endoscopic surgery

Despite being fundamental to the diagnosis and treatment of many urologic diseases, some challenges exist during endoscopic surgeries. Adequate visibility stands as a central pillar of endoscopy. Although fiberoptic scopes have improved significantly since their first documented use in the 1960s, their “honeycomb”-like image, as well as fiber deterioration over time, can lead to impaired visibility. Camera systems have continued to evolve, incorporating advances in image capture and display.

How artificial intelligence may reshape urologic practice

Recent advances have favored imaging chips at the scope tip over traditional fiberoptic bundles. Though digital scopes provide a clearer image, the imaging chip requires a larger scope tip, with most being 7.7F to 9.7F. This increase in size in flexible scopes, however, exemplifies another challenge of endoscopic surgery: endoscopic accessibility. The caliber of the working instrument, the number of previous scope usages, and the patient’s upper tract anatomy can complicate maneuverability during flexible ureteroscopy. In the lower urinary tract, anatomic variability (ie, capacious bladders or significant intravesical lobes) can impede routine cystoscopic evaluations or transurethral procedures.

These factors, which can affect endoscopic accessibility and the time length of increasingly complex procedures, highlight another challenge of endoscopic surgery: surgeon ergonomics. Factors leading to surgeon fatigue and potential injury are multifactorial, variable, and dependent on the procedure being performed. However, they are further compounded by decreased visibility and maneuverability when performing endoscopic cases, increasing surgeon discomfort, and decreasing intraoperative efficiency, likely impacting physician dexterity over time. Though surgical experience can certainly help overcome difficulties when performing endoscopic procedures, new endoscopic robotic systems attempt to improve on these challenges.

Urologists developed the first transurethral robotic system to perform transurethral resection of the prostate in the 1980s, but this did not meet with commercial development 

 With the increased acceptance of surgical robotics for laparoscopy over the last two decades, multiple engineering groups and companies have been developing new transurethral robots.

Noting some of resource and time limitations of bladder cancer surveillance, Soper et al developed an automated, ultrathin scanning-fiber endoscope of small diameter (1.5 mm) for bladder cancer surveillance. The system allows for machine-controlled surveillance and uses a spiral cam motion to map the entire surface of the bladder, which they demonstrated ex vivo in a pig bladder 

 Given the small size of the scanning fiber as well as the automated nature of the motion, the potential advantages of this technology could be increased patient comfort, performance by ancillary clinic staff, and improved detection by use of image analysis and confirmation of full surface scanning.

More recently, our engineering-based research team at Vanderbilt has been developing a transurethral robot platform (ie, TURBot) for bladder tumor resection 

 Transurethral resection of bladder tumor can be a technically challenging procedure given anatomic constraints using rigid instruments, as well as difficulty monitoring resection depth to minimize risk of perforation while ensuring adequate tissue for treatment and staging. The TURBot system uses a flexible, multi-backbone continuum robot, fitted with three 1.8-mm working channels, allowing for visualization and laser ablation or resection across the entire bladder surface (figure 1).

The technology has successfully been evaluated in vivo in porcine experiments. Though en bloc tumor laser resection was achieved in these models, it was complicated by lack of depth perception and limited degrees of freedom of the working components (figure 2). Current efforts are aimed at improving these limitations in future prototype systems.

An additional rigid endoscopic system using bendable, concentric tube robotic platform tools is being developed to perform prostate and endoscopic surgery including holmium laser enucleation of the prostate (HoLEP) 

 Although this procedure has been shown to be durable with good patient outcomes, the learning curve has limited its wide acceptance. The robotic platform comprises a user interface and computer control to manipulate the concentric tube tools and allows for two-plus tools to dexterously interact through a 27F scope (figure 3).

The platform has shown to have 65% improvement in accessible areas compared to rigid endoscopes in simulations and has successfully been demonstrated in a cadaveric model. The potential of complex surgical maneuvers including retraction and enhanced tissue manipulation is part of the ongoing development of this system.

Several investigational robotic flexible endoscopic systems have been developed with the intention to potentially treat urolithiasis and perform upper tract endoscopy. The initial foray into robotic control was use of the Sensei and the Magellan systems by Hansen Medical. These systems utilized robotically controlled catheters that were actively manipulated to passively maneuver the shaft of the ureteroscope. The passive manipulation of the scope lead to limited maneuverability in the upper tract, however 

 Auris Health ultimately acquired Hansen Medical in 2016 and has been developing the Monarch robotic system for bronchoscopy. Given the size similarity to ureteroscopes, such a system may be applicable to upper tract urologic endoscopy. 

The Avicenna Roboflex system from ELMED Medical Systems has been developed and clinically evaluated since 2010. The system comprises multiple features, including a finely tuned robotic platform designed to control insertion, rotation, and flexion of a standard ureteroscope in the field. The system has a surgeon control console where the surgeon is seated outside of the radiation field and allows for adjustment of seat and arm height for comfort. The console adds a touch screen-activated irrigation pump, touch screen laser-fiber control, and pedals to control fluoroscopy; laser activation is integrated into the system.

Currently, any commercially available ureteroscope can be used with the Avicenna Roboflex, as well as any laser type. There is, however, no integration of a basket or grasper, although these can be controlled by a bedside assistant. Multiple clinical studies have evaluated the system in Europe. Most recently, a multicenter phase II study was performed by Klein et al 

 2016; 195[suppl]:e406-7 [abs. PD18-08]). The group was able to demonstrate the safety and efficacy of the platform in 266 patients with a mean stone size of 1.4 cm. They were able to successfully perform fragmentation, dusting, and extraction of stone fragments. Total operative time was 96 minutes, with mean console and robotic docking times of 65 minutes and 4 minutes, respectively. FDA approval of the device is still pending.

The field of urology has been at the forefront of the scientific evolution of surgical robotics and minimally invasive surgery. Novel endoscopic robotic systems open the door for a new set of diagnostic and therapeutic possibilities to offer patients. Further studies on improvements in patient and disease outcomes, as well as cost considerations, will ultimately drive how these robotic systems are integrated into clinical practice.

 is a minimally invasive surgery fellow and 

 is professor of urology, Vanderbilt University Medical Center, Nashville, TN. 

 Dr. Herrell is founder and a board member of, and owns stock in, Virtuoso Surgical; and receives grant funding from CSATS, BTG, and NIH.

Endoscopic robotic platforms: What the future holds

“Journal Article of the Month” is a new Urology Times section in which Badar M. Mian, MD (left), offers perspective on noteworthy research in the peer-reviewed literature.  Dr. Mian is professor of surgery in the division of urology at Albany Medical College, Albany, NY.

When addressing the treatment for high-risk prostate cancer, all of the guidelines recommend either surgery or radiation therapy as a valid option for initial treatment. In a recent analysis of Surveillance, Epidemiology, and End Results data, Huang et al report that prostatectomy was associated with improved cancer-specific and overall mortality when compared to primary radiation therapy in men age <60 years 

The authors analyzed data from the most recent SEER registry, focusing on younger men (<60 years) who had Gleason score 8-10 prostate cancer, without nodal or distant metastases. After excluding men with metastases or without initial surgery or radiation or short follow-up (<2 years), 2,228 men met the study criteria. The median age was 56 years and the median follow-up was 44 months.

Of these 2,228 men, 1,459 (65.5%) underwent surgery and 769 (34.5%) were treated with radiation therapy. Within the radiation therapy cohort, external beam alone was used in 583 (75.8%) and external beam plus brachytherapy was used in 186 (24.2%). Among the men treated with initial surgery, 266 (18.2%) required adjuvant radiation therapy. The surgery cohort was more likely to be somewhat younger, Caucasian, and with PSA <20 ng/mL.

The estimated 7-year cancer-specific mortality was lower in the surgery cohort compared to the radiation group-8.2% and 12.1% 

<.001), respectively. The 7-year overall mortality was similarly reduced in the surgery group-10.2% versus 21.2%, respectively. On multivariable analysis, prostatectomy was associated with a significant decrease in cancer-specific mortality and overall mortality, after controlling for age, Gleason score, clinical T stage, and PSA level 

=.001). In men undergoing surgery, there was a 16.5% decrease in cancer-specific mortality and a 40.6% decrease in overall mortality compared to initial radiation.

This study appropriately focused mostly on men in their 50s with high-risk disease who are likely to be healthier and with fewer competing causes of mortality. While a number of important clinical variables were included in the analysis, some of the most pertinent data were not available: comorbidities, use and duration of hormonal therapy, and the dose of radiation. It is possible that the lower mortality from surgery noted in this analysis may be due to selection of healthier patients for ­surgery.

Effects of hormonal therapy must be taken into account

Hormonal therapy, which has long been used in combination with radiation therapy of high-risk cancer, is associated with both short-term and long-term systemic toxicity. The adverse effects of hormonal therapy may be a significant contributing factor for the higher overall mortality noted with radiation therapy.

If history is our guide, it’s unlikely that a large, randomized controlled trial will be successfully conducted in the space of localized prostate cancer. We are then left to make the best use of available data from various sources such as SEER or other larger registries or single-institution experience. When counseling our younger patients about potential advantages of surgery, it’s essential to be cognizant of the limitations and confounding factors listed above.

Surgery was associated with improved cancer-specific and overall mortality compared with radiation therapy, according to a recent study.

Vol. 47 No. 2

Tools urologists need to thrive in a value-based world

2019 ‘to-do list’: Reduce debt, contribute to retirement plans

Cybersecurity: How to safeguard your practice against threats

How to get reimbursed when using –22 modifier

Findings question validity of large PCa trial

Some urology RVUs do not track with complexity, outcomes

Gender disparities in bladder cancer management

Endoscopic robotic platforms: What the future holds

High-risk prostate Ca: New study sheds light on RP vs. RT

75% of urologic surgery patients have unused opioids

Undetected kidney tumor leads to lawsuit

APPs play multifaceted role as urology team members