Urology Times' 50th anniversary is this year, and we are celebrating by highlighting 50 pivotal innovations from the past 50 years. This week, we are spotlighting advances in testosterone therapy, with expert insight from Dr. Mohit Khera.

50th Anniversary Innovation Celebration: Testosterone Therapy

Philippe E. Spiess, MD, MS, FRCSC, FACS, 

discuss how the new Global Society of Rare Genitourinary Tumors plans to raise awareness and make an impact for the patients and clinicians in this specialty. Spiess and Necchi serve as President and Vice President of this organization. Spiess is a genitourinary oncologist and assistant chief of surgical services at the Moffitt Cancer Center in Tampa, Florida. Necchi is an associate professor at Vita-Salute Raffaele University and the head of genitourinary medical oncology at IRCCS San Raffaele Hospital and Scientific Institute in Milan, Italy.

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“The geographical discrepancies, the social discrepancies, and the impact of these discrepancies in the possibility for the patient to access any type of cure or surgical intervention is critical,” says Andrea Necchi, MD.

How the Global Society of Rare Genitourinary Tumors hopes to make a difference

Overactive bladder continues to be a major issue that negatively impacts the quality of life for urologic patients around the globe. Fortunately, the new drug vibegron (Gemtesa) continues to show promise in clinical trials for treatment of this condition.

Results of the recent phase 3 EMPOWUR extension study

 demonstrated efficacy and safety of vibegron in patients who suffer from overactive bladder, reports 

 Haag-Molkenteller is a chief medical officer at Urovant Sciences, Inc in Irvine, California.

Please discuss the background of the study.

This is another analysis of our EMPOWUR phase 3 study for vibegron , which is an approved treatment for overactive bladder. The first study results were published in 2019. And then we published several sub analyses, including in elderly patients, which is another very important aspect for overactive bladder. This analysis now combined the objective response of the parameters of overactive bladder as micturition frequency, which means how often you go to the bathroom in 24 hours, urge incontinence and urgency, which is one of the leading symptoms, and the patient response to the treatment. The patient voice is very important as well.

What were the findings of this study? And were any of them surprising to you?

First of all, we were very happy with our efficacy and safety results from the EMPOWUR study with the 75 mg of vibegron . This study, of course, showed and confirmed that the patient also perceives the so-called 'objective treatment effect' of their micturition frequency, urgency, [and] urge continence themselves as an improvement, which I think is very important because next to objective parameters, which you gather on the bladder diary, it's also important to hear the patient's voice—how the individual who is being treated feels about the improvement of their symptoms, and feels about the treatment benefit they're receiving. So, this analysis of this publication confirms the link between efficacy and the patient perception, and that the results are actually meaningful to the patients as well.

How will the results of this study impact your company’s clinical development programs for overactive bladder?

I am a chief medical officer of a pharma company. So, we lead the clinical development of drugs. We will always continue to include the patient's voice in our clinical development programs, which means we will have patient-reported outcomes, [or] PROs, in our clinical studies. The individual patient is very important to us at Urovant. So, how the individual patient responds to treatment is very important, and how they feel about the treatment is very important to us as we develop new drugs.

Is there further research on this topic planned? And if so, what will its focus be?

We will continue to read the patient feedback, and we will even focus more on meaningful patient-reported outcomes where the patient can really voice their opinion with the collection of the study results. We will always have, of course, efficacy and safety in a clinical study, but also the patient’s voice and what the treatment means to the patients or individuals. It’s not one group. It’s an individual person. We really strive to approach them as individuals and keep that in mind when we design our clinical studies because we want the patients to really benefit from the treatment and live their life to their fullest.

What is the take-home message for the practicing urologist?

I think for overactive bladder, the practicing urologist will employ the so-called ‘bladder diary.’ They will collect the objective symptoms, which as I said, were micturition frequency, urge incontinence, and urgency in overactive bladder. However, I do believe that all urologists do listen to their patients. It is important to ask the patient how they feel about the treatment. Do they feel that it really helps them? And when they see the results, of course, that is very important. This combination of the objective parameters of the patient's voice and what the treatment means to the patient is extremely important also for a treating urologist or urogynecologist prescribing medications for overactive bladder.

Is there anything else you feel our audience should know about this topic?

As I said before, integrating the patient's voice and what the treatment means to the patient next to objective parameters for any treatment, I think, is extremely important. Patients are human beings, and they're individuals. We need to understand what the treatment [means] to them as individuals, and how they perceive the benefit of the treatment.

1. Staskin D, Frankel J, Varano S, et al. Once-daily vibegron 75 mg for overactive bladder: Long-term safety and efficacy from a double-blind extension study of the international phase 3 trial (EMPOWUR)

 2021 May;205(5):1421-1429. Doi: 10.1097/JU0000000000001574. Epub 2020 December 28.

Articles

"This analysis of this publication confirms the link between efficacy and the patient perception, and that the results are actually meaningful to the patients as well," says Cornelia Haag-Molkenteller, MD, PhD.

Dr. Haag-Molkenteller on implications of vibegron phase 3 EMPOWUR extension study

discuss what is unique about the new Global Society of Rare Genitourinary Tumors, for which they serve as President and Vice President. Spiess is a genitourinary oncologist and assistant chief of surgical services at the Moffitt Cancer Center in Tampa, Florida. Necchi is an associate professor at Vita-Salute Raffaele University and the head of genitourinary medical oncology at IRCCS San Raffaele Hospital and Scientific Institute in Milan, Italy.

“I really foresee this becoming a very critical society in this area for many, many years to come,” says Philippe E. Spiess, MD, MS, FRCSC, FACS.

Global Society of Rare Genitourinary Tumors launches during pandemic

Experts at Cleveland Clinic have invested in research and technology designed to improve outcomes and the patient experience. From diagnosis and biopsy to surgical approaches and longer-term management—learn more about how the team is leading the way in prostate cancer.

Most prostate cancers are discovered through PSA-based screening. However, the test has several shortcomings. For example, it is not prostate-cancer specific; an elevated PSA is often caused by benign prostate hyperplasia.
Cleveland Clinic partnered with Cleveland Diagnostics to develop a blood test that detects and measures PSA-related proteins in the blood. The test, called IsoPSA, is more accurate in predicting high-grade prostate cancer, potentially reducing unnecessary biopsy.

Use of MRI in performing prostate biopsy allows precise targeting of areas of concern where cancer is most likely to be present. In the past, these biopsies were generally done transrectally, which is uncomfortable for patients and carries a finite risk of bacteremia and infection.

Cleveland Clinic urologists have found that passing the needle through the perineum is more accurate, carries a negligible risk of infection and can be done under local anesthesia, sedation or general anesthesia. Importantly, patients report no discomfort.

“Transperineal biopsies require dedicated equipment, special expertise and some experience, but I think the whole field will move this way in the next few years,” says Eric Klein, MD, Urologic oncologist and Chairman Emeritus of the Glickman Urological & Kidney Institute.

“We have preliminarily shown that micro ultrasound is as effective as MRI at finding high-grade cancers, and it may be better than MRI at finding tumors,” says Klein. “In the future, it may be possible to obtain an accurate prostate biopsy without MRI.”

Identifying candidates for active surveillance

Cleveland Clinic helped to develop several assays that use high-end genomic technology to identify which men may be good candidates for active surveillance, and who needs closer follow-up, early re-biopsy or immediate treatment. These tests allow assessment of tumor aggressiveness that is not visible using standard microscopes and serve as adjuncts to routine pathologic assessment.

Outpatient, noninvasive treatment of low-risk cancers

Cleveland Clinic is one of the first sites in the country to offer an improved form of high-intensity focused ultrasound (HIFU) using Focal One. The technology combines imaging and ablative techniques to target prostate tumors in a short, noninvasive outpatient procedure performed under MRI guidance. Unlike radical prostatectomy and radiation therapy, HIFU does not increase the risk for urinary or fecal incontinence. Since only part of the prostate is treated, it is better able to preserve potency. Patients return to normal activities in a few days.

At this time, HIFU is reserved for patients with a single tumor that is easily visible on MRI and located in a favorable anatomic position.

Single-port robotic radical prostatectomy

Robotic radical prostatectomy at Cleveland Clinic can be done through a single incision using a single-port robot. Performing the procedure extraperitoneally avoids bowel-related complications and adverse events that can occur during surgery, including optical nerve edema, congestion and respiratory problems. In select patients, this approach has become an outpatient procedure with minimal need for opioids for pain.

These research and technology breakthroughs are designed to improve outcomes and the patient experience.

Cleveland Clinic highlights 5 innovations that are changing the delivery of prostate cancer care

Dr. Gomella, a member of the Urology Times Editorial Council, is professor and chairman of urology at Thomas Jefferson University, Philadelphia.

I want to turn it over to Dr Sam Chang to talk about some of the aspects of how we’re diagnosing bladder cancer, the initial process from making the diagnosis—testing, imaging, biopsy—and how we interact with primary care doctors, urologists, and oncologists in this process. Again, Dr Chang has been very involved with guidelines on bladder cancer so he’ll be the perfect one to give us that background, Dr Chang.

 Thanks very much, Dr Gomella. It’s a real honor to be with such a learned panel. I know I’ll gain much more from this than I’ll be able to contribute. This initial evaluation and process of diagnosing bladder cancer is one, we think, it starts from the urologist but actually many times it starts with the primary care physicians. The AUA [American Urological Association] has actually just come up with updated guidelines regarding microscopic hematuria and its proper evaluation and diagnostic approach because we still are finding, I think, bladder cancers at a much later stage than we would like. The next stage of evaluating a patient is diagnose, usually with cystoscopy and biopsy, endoscopic resection (we call it by different names), transurethral resection, but that will give us an idea of not only the histopathologic characteristics but the stage and grade of the tumors that may be present.

Importantly, that will be essential in terms of trying to remove as much tumor that’s actually there. I think understanding everything that is accounted for is essential and Dr Chamie is going to go over kind of what that bladder cancer patient journey is like. I think not only importantly are the AUA guidelines in terms of microscopic hematuria, but as we’ll go through non-muscle invasive and invasive bladder cancer components, the AUA has recently updated their guidelines just last year to help kind of formulate an algorithm that can kind of pattern for our clinicians to help diagnose, treat, and survey our patients with bladder cancer. Dr Chamie?

 Thank you, Dr Chang. Thank you, Dr Gomella. This is obviously an honor here. Obviously, patients with bladder cancer it’s a significant burden, not only from the perspective of mortality, but one that’s associated with significant recurrences, financial toxicities, pain. Oftentimes, patients succumb to other diseases but in the meantime go through multiple endoscopic resections and treatments. Patients are oftentimes diagnosed with bladder cancer after an episode of gross hematuria or after lower urinary tract symptoms they’re referred to a urologist. We’ve actually examined the role of high-grade bladder cancer, non-muscle invasive bladder cancer and 70% of patients are actually initially diagnosed by community physicians.

These physicians usually do less than 12 transurethral resections a year, which counts to maybe 1 bladder tumor diagnosis per month. They’re often referred to the urologist. The urologist does the resection, and the initial treatments often take place in the community. It’s not until the tumors become more problematic, meaning that they start to recur more frequently or if currently with community physicians having less access to BCG [Bacillus Calmette-Guerin] or other agents, are they actually referred to other academic medical centers. When patients are usually diagnosed with bladder cancer, they tend to refer to urologists and then the referral to medical oncology tends to occur later on as the stage progresses or if they become more advanced. With regard to when patients are referred to medical oncology, Dr Chang when do you see that in your practice?

 Increasingly early. Number 1, the indications for starting systemic therapy has moved sooner and sooner in the disease process. It started with metastatic and more advanced disease but increasingly for our basic cancer patients they’ve become essential in terms of our evaluation of patients, not only prior to cystectomy but in a trimodal or multi-modality factor when we try to spare the bladder with invasive disease. But importantly, with non-muscle invasive disease as we get options now for those patients who don’t respond to BCG we call on our medical oncologist quite a lot. Not only for therapy—using immunotherapy—but to consider for trials that include immunotherapy and other IO [immuno-oncology] type agents.

When we’re talking about patients and their bladder cancer journey there’s obviously multiple phases. I mean we have phases where they initially get diagnosed and they’re undergoing ongoing treatment. And most of the time when we’re talking about non-muscle invasive bladder cancer, that’s usually managed by urologists because they have access to the cystoscopes and intravesical agents. Once patients complete therapy, once they’ve completed their BCG, most of the time, if we’re talking about non-muscle invasive bladder cancer again they’re usually just followed by just a urologist. But when the disease is out of control, obviously they get referred to medical oncology. That’s something that is going to be a tug of war in the future as urologists become maybe increasingly more comfortable giving some of these newer novel agents. Will they be referring to medical oncologists? Will they be doing it themselves? And obviously you have radiation oncologists that do their own cystoscopy so obviously there are ongoing shifts there.

The types of healthcare professionals who may play a role in evaluating and diagnosing bladder cancer.

Treatment Journey for a Patient With Bladder Cancer

Well, welcome everybody to our immunotherapies and the treatment of bladder cancer today. This is part of the Urology Times Viewpoint series. I’ll be the moderator for this session. I’m Dr Leonard Gomella. I’m the chairman of the Department of Urology at Thomas Jefferson University. I’m also the senior director for clinical affairs for the Sidney Kimmel Cancer Center, as well as enterprise vice president for urology for the Jefferson Health System. I am very honored to be here today with 4 very esteemed panelists, all who have a tremendous amount of clinical and research expertise in the field of bladder cancer. Our panelists are going to be Dr Sam Chang, who’s a professor and the chief of urological oncology and the chief surgical officer at the Vanderbilt-Ingram Cancer Center [Nashville, Tennessee]; Dr Matt Galsky from the Icahn School of Medicine at Mount Sinai [New York, New York], where he is professor of medicine and the director of the GU medical oncology unit; Dr Karim Chamie, who’s the associate professor of urology at UCLA [Los Angeles, California]; and lastly, Dr Petros Grivas, who’s the director of the GU oncology program at the University of Washington School of Medicine and Fred Hutchinson Cancer in Seattle. So again, I’m very honored to be here today with these esteemed colleagues.

We’re going to be talking today about these areas in each section. We’re going to cover the overview of bladder cancer diagnosis and patient management. We’re going to talk about some of the first-line treatment options for non-muscle invasive bladder cancer, as well as for nonmetastatic muscle invasive bladder cancer. We’re going to move then to the treatment of advanced and metastatic bladder cancer and then we’re going to talk about the future developments and some of the unmet needs. Our focus today is going to be primarily on immunotherapy, but we will also take the time to cover other key areas that might come along.

In the first part here, what I’d just like to do is talk a little bit about where we are with bladder cancer in the United States for 2021. Overall, we have about 83,000 cases of bladder, cancer with a preponderance of males—about 64,000 cases—and about 20,000 cases of bladder cancer in females. When you look at the data, it gets a little bit fuzzy because we have renal pelvis cancers that are mixed in with kidney cancers and we have ureter and other genitourinary cancers that are mixed in with urothelial carcinomas. So the number that we’re dealing with is actually probably much higher than just the bladder cancer number. If you look among men, the 5 most common types of cancer in 2021 were of course prostate cancer, lung cancer, colorectal cancer, with bladder cancer accounting for a large number of that—7% of cases of men with bladder cancer. In ladies it’s a little bit lower on the list, but then again, in females we are seeing more and more cases of urothelial carcinoma, bladder cancer as time goes along.

I know we have a very learned audience here about the common clinical signs of bladder cancer but we’re all aware that these tend to be gross hematuria and frequently painless. Every once in a while, micro-hematuria is a reason that a patient is diagnosed with bladder cancer. Irritation, irritative warning symptoms, urinary frequency, a constant need to urinate is another common presenting cancer symptom very often associated with carcinoma and CY2. Lastly, we see incidental renal masses on imaging are also a reason that sometimes we’re referred for patient with disease. Of course, risk factors: smoking, chemical exposure, race—Caucasians more likely to get bladder cancer than African Americans. It’s a disease of older individuals, male-predominant disease, and also a history of pelvic radiation may increase the risk. We’re going to focus on immunotherapies and again of course bladder cancer and BCG [Bacillus Calmette-Guerin] are the arch typical examples of immunotherapy. We’re going to be talking a little bit about BCG, but again the exciting things that are going on with immunotherapy in bladder cancer are really going to be the focus of our discussion today.

The current incidence of bladder cancer diagnoses and most common symptoms that newly diagnosed patients present with.

Incidence and Typical Characteristics of Newly Diagnosed Bladder Cancer

Translocation renal cell carcinoma (tRCC) is a rare and aggressive form of kidney cancer that has not historically received the same research attention as more common forms of RCC. Available treatment options consist mainly of therapies that have succeeded in other forms of RCC; however, these treatments are often unsuccessful in tRCC patients.

Now, Ziad Bakouny, MD, MSc , an internal medicine resident at Brigham and Women's Hospital, says ongoing research is focusing specifically on gaining an understanding of the biology and genomic drivers of tRCC.

“If we do not understand the biology [of the disease], we are not going to be able to target it correctly,” Bakouny said. “Currently, extrapolating treatments from clear cell RCC has not yielded optimal outcomes. Because of this, we want to understand the biology more to be able to target the disease better, treat patients better, and ultimately get them better clinical outcomes.”

, Bakouny, discussed ongoing research into the genomic drivers and biology of tRCC that could lead to improved outcomes for patients.

Could you provide some background on the treatment of tRCC?

: tRCC is a very rare disease that affects primarily young patients, and interestingly, females more than males. It is thought to account for 1% to 5% of all RCCs in adults, and in children, it accounts for 20% to 50% of kidney cancers. The disease is aggressive, and what we know about is actually that we do not know that much. There have been large studies on more frequent forms of kidney cancer, including clear cell RCC and papillary RCC, and because of these efforts, there is quite a bit understood about the genomic drivers of this disease.

However, rarer forms, like tRCC, have not been studied as extensively, and we do not know much about them. This contributes to the fact that we do not have many therapies that work for them. All the therapies currently used for tRCC are extrapolated from clear cell RCC, as well as from other forms of kidney cancer.

The reason it is important to understand the biology of tRCC is because it is aggressive, and patients, unfortunately, often have poor outcomes, Additionally, it disproportionately affects young patients, and there is a significant burden of disease for these young patients, particularly young women.

What were the key takeaways from this research? Did investigators identify any clinical molecular features of the disease?

Because of how rare this disease is, we realized that we could not do this on our own, in the sense that no one center anywhere across the world would have been able to get enough samples to study the molecular characteristics of the disease, in addition to the clinical characteristics. What we did was pull data from approximately 10 different data sets that were publicly available, including some of our own. We put it all together and we analyzed it, using some unorthodox methods, to be able to ask the questions about what the molecular characteristics of these tumors are, what is driving these tumors, and what therapies might work for them.

To do this, we pulled the data together and included genomic data such as DNA level analyses and mutations. We also looked at fusions because these tumors are known to be driven by a characteristic fusion involving the 

 family of genes. Then we looked at was transcriptomic data, as well, and wanted to know what the transcriptomic characteristics of these tumors are. Finally, we looked at clinical responses to therapies.

In the DNA-level analyses of data, we found that these tumors have a silent genome—they do not have a lot of mutations, they do not have a lot of copy number alterations. Despite that, they do seem to have some recurrent alterations that we have identified, primarily 9p21.3 deletion, which is the 

 locus that seems to be deleted in up to 20% of these tumors, as well as a few mutations that we detected in DNA damage response genes and 

 genes. That was the mutational bucket, in fusion bucket, it is known that these tumors evolve 

 genes. What we noticed is that the pattern of how these fusions form, what they conserve as part of these genes, differs between fusions. These genes seem to conserve the C-terminal domain, the DNA binding domain, of these proteins well, but depending on the actual gene itself, there are different parts of the protein domains that are conserved in the fusion product between them, so we that was characterized.

On the transcriptomic side of things, what we found is that these tumors seem to have a distinct transcriptional signature that is different from all other forms of RCC. This is characterized by genes that are known to be targets of 

. We then used cell lines to transfect the fusion into this alliance [and were then able to] deduct that the transcriptional program of these tumors appears to be induced by the fusion itself. We then asked, what is this transcriptional program and what is it characterized by? What we found is that it is characterized by activation of the NRF2 transcriptional program, and that is a program that has been known to be activated across several malignancies.

Now that we know what the genomic characteristics are, we know what the fusion looks like, and we know what the transcriptomics look like for these tumors, we are left with the clinical response. What we found is that, as expected, these NRF2-expressing tumors do not seem to respond well to targeted therapies, which explains the usually poor outcomes seen in this patient population. We used to treat clear cell RCC with targeted therapies like mTOR inhibitors and VEGF inhibitors, and because of the NRF2 activation, we see poor responses to those with tRCC. However, they [do seem to] respond well to immune checkpoint inhibitors. We used our own data, as well as data from tRCCs that were identified post hoc in the phase 3 IMmotion151 trial (NCT02420821) to show that these tumors respond well to immune checkpoint inhibitors. This is still preliminary data, but given how rare this disease is, we believe they are convincing data that patients with these tumors may do well on immune checkpoint inhibitors or immune checkpoint inhibitor-based combinations.

What are some next steps for this research?

I am excited that through our study, and from multiple other studies that have been done in this space, we now have a firmer grasp on what the genomics of these tumors are and what the drivers are. What remains to be understood is how these interplay with each other. For instance, what is the fusion doing with the 

 loss? How are they cooperating to drive the pathogenesis of these tumors?

The next step that I am excited about is figuring out the underlying biology and following up on some of the signals that we have seen on how [these factors] interact with each other to drive tumor pathogenesis. The hope is that with a more granular understanding of these tumors, we will be able to develop specific therapies that target the pathogenic processes and be able to improve the outcomes of these patients, which is still a huge unmet clinical need.

Are there any recent therapeutic developments in tRCC, that should be highlighted that you want to discuss?

Unfortunately, the main therapeutic developments are the ones I previously mentioned as part of our study and others. These therapeutic developments are using the treatments we already have for RCC and seeing how they do in tRCC. This alludes to some of our own work that was just mentioned about how immune checkpoint inhibitors might do well in these tumors. There is corroborating data from other studies that have shown similar things, and right now, that is the most exciting space, in terms something that is clinically actionable. That said, the next steps are targeting the underlying biology of disease. That is what may drive improvement in the outcomes of patients with these tumors.

Ziad Bakouny, MD, MSc, highlights efforts to gain an understanding of the biology and genomic drivers of the rare and aggressive form of kidney cancer. 

Dr. Bakouny details ongoing research in translocation renal cell carcinoma

Dr. Dowling is president of Dowling Medical Director Services, a private health care consulting firm specializing in quality improvement, clinical informatics, and health care policy affecting specialty care. He is the former medical director of a large, 

The new year is a time to reflect on the past and prepare for the future. Looking back at topics covered in 2021, I am going to suggest some resolutions for your practice in 2022.

®, I looked at the most recent data (2019) on Medicare Part B drug spending, which revealed increased usage of denosumab and mitomycin.

 I concluded that urology practices continue to derive substantial revenue from administering “buy and bill” drugs. Leading the list were denosumab (Xgeva), onabotulinumtoxinA (Botox), leuprolide acetate, and sipuleucel-T (Provenge). Of the 17 Part B drugs most commonly used by urologists, total spending in 2019 increased for 10 drugs and decreased for 7 drugs over the previous year. Price was the factor driving the change in spending in 7 drugs, whereas it was utilization in 10 drugs. 

: Understand the fraction of your revenue from Part B drugs, your net profit by drug, your purchasing power (vendor options), and how policy changes in this area could affect your practice—before they happen.

Then in April, I noted that Tamsulosin tops the list of Part D drugs prescribed by urologists,

 the most recent data (2018) showing that drug costs to the Medicare Part D program also continue to increase each year. However, urology accounts for less than 1% of the spending in this program. Expensive oral drugs are under close scrutiny—especially if there are generic equivalents—and urologists prescribe and, in some cases, dispense some of these drugs. 

 Be sure you are prescribing and dispensing the most clinically and cost-effective alternatives for your patients, and check that your information systems (electronic health records) are configured to display formulary information as you prescribe.

The opioid epidemic continued to be a hot news topic in 2021 in the United States, with landmark court cases holding large manufacturers and distributors accountable. Many states require continuing medical education on controlled substances as part of the license renewal process. In May, I reviewed prescribing habits in the specialty as reflected in Medicare Part D data (2018) and learned that urologists collectively prescribe opioids in numbers and rates lower than the national average of all specialties and unevenly across the US.

 Hydrocodone/acetaminophen was the most common opioid prescribed by urologists, and very few urologists were linked to claims for long-acting opioids. 

Follow clinical guidelines and best practices (auanet.org//guidelines/guidelines/opioid-use) for prescribing opioids, including only prescribing opioids when nonopioid alternatives are inappropriate.

Payments from industry to physicians continue to receive scrutiny, as I outlined in April.

 General payments from manufacturers to urologists in 2020 reported to and by Centers for Medicare & Medicaid Services (CMS) under the Sunshine Act are sharply down from the previous year, represent a small fraction of general payments to all physicians, and average $211 per urologist. Most of these payments are from device manufacturers, and payments are concentrated in just a handful of individual companies, drugs, devices, physician recipients, and disease states. 

Log on to the Open Payments site (openpaymentsdata.cms.gov/) and review your data.

As year 5 of the Quality Payment Program (QPP) draws to a close, and its impact was again muted by last-minute changes and flexibilities invoked by extreme and unusual circumstances (COVID-19 pandemic), urologists may be lulled into a sense of complacency. I reviewed the most recent data for the Merit-based Incentive Payments System (MIPS) in August.

 In general, urologists participating in QPP group reporting used the same generic quality category measures as clinicians in most other specialties. But with a few exceptions, they scored worse on average. In the “Promoting Interoperability” category, urologists outperformed their peers on e-prescribing and providing patients electronic access to their health information. They underperformed relative to peers on supporting electronic referral loops. The data begin to form specialty-specific benchmarks not readily available from other sources, which could guide improvement efforts. For example, in 2019, a performance rate of 95% on the measure “Prostate Cancer: Combination Androgen Deprivation Therapy for High Risk or Very High-Risk Prostate Cancer” was significantly above average for all clinicians, but significantly below the mean score for urologists. One of the most valuable benchmarks—cost category measures—was not reported by CMS in 2019. 

 Focus on 1 improvement area where your score is below the urology average.

My September column looked at the QPP data used as a source of information about the specialty itself.

 The Medicare data suggest that approximately 35% of urologists are in organizations they dominate (what might have once been called single-specialty groups). This compares favorably with general surgery (17%), cardiology (28%), and orthopedic surgery (31%). Many providers are probably familiar with factors that have caused specialists to consolidate, and these data help quantify that consolidation—at least among Medicare providers. Urology-dominated groups appear to have a foothold, which is good news for those who prefer this model of practice.

In December, I reviewed the overlap and impact of 2 important rules governing patient access to their health information—the HIPAA Privacy Rule and the Information Blocking Rule.

 These rules empower patient access to their health information and impose significant penalties for violations. Compliance with these rules is straightforward but requires a shift from the traditional concept of medical record ownership and a physician audience to the contemporary concept of shared access with the patient and others they designate. I provide some specific scenarios and recommendations for compliance. 

 Review your patient access policies for compliance with these 2 rules.

Finally, I wrote about my experience on the patient side of care.

 My turn as a patient reminded me that providers may not always treat patients the way they would want to be treated. There are many opportunities for positive change that require no significant investment of money or time—only for the provider to walk in the patient’s shoes. As 2022 kicks off, take a fresh look at how you communicate, maintain a safe environment, and ensure optimum quality in your practice—you could be the next patient.

1. Dowling RA. Part B data reveal increased usage of denosumab and mitomycin. 

March 25, 2021. Accessed January 13, 2022. https://www.urologytimes.com/view/part-b-data-reveal-increased-usage-of-denosumab-and-mitomycin

2. Dowling RA. Tamsulosin tops list of Part D drugs prescribed by urologists. 

April 13, 2021. Accessed January 13, 2022. 

https://www.urologytimes.com/view/tamsulosin-tops-list-of-part-d-drugs-prescribed-by-urologists

3. Dowling RA. The urologist’s role as a responsible opioid prescriber. 

May 31, 2021. Accessed January 13, 2022. 

https://www.urologytimes.com/view/the-urologist-s-role-as-a-responsible-opioid-prescriber

4. Dowling RA. Industry payments to urologists see sharp decline in 2020. 

August 6, 2021. Accessed January 13, 2022. 

https://www.urologytimes.com/view/industry-payments-to-urologists-see-sharp-decline-in-2020

5. Dowling RA. How does urology’s 2019 MIPS performance stack up? 

August 26, 2021. Accessed January 13, 2022. 

https://www.urologytimes.com/view/how-does-urology-s-2019-mips-performance-stack-up-

6. Dowling RA. What CMS data reveal about urology practice composition. 

September 22, 2021. Accessed January 13, 2022. 

https://www.urologytimes.com/view/what-cms-data-reveal-about-urology-practice-composition

7. Dowling RA. Is your practice compliant with patient record access rules? 

December 8, 2021. Accessed January 13, 2022. 

https://www.urologytimes.com/view/is-your-practice-compliant-with-patient-record-access-rules-

8. Dowling RA. A urologist's experience on the patient side of care. 

October 12, 2021. Accessed January 13, 2022. https://www.urologytimes.com/view/a-urologist-s-experience-on-the-patient-side-of-care

"Be sure you are prescribing and dispensing the most clinically and cost-effective alternatives for your patients, and check that your information systems (electronic health records) are configured to display formulary information as you prescribe," advises Robert A. Dowling, MD.

Safety, communication, quality: Resolve to improve your practice in 2022

® Assistant Editor Janelle Hart spoke with 

 She discusses how and why urologists are succumbing to burnout and depression and suggests ways in which they can improve their mental health in their everyday practice. Londoño is a urologic oncology surgeon and assistant clinical professor in the department of surgery at the City of Hope National Medical Center in Duarte, California.

Podcasts

“We cannot give if our cup is empty,” says Diana Londoño, MD.

Consequences of burnout and depression in urology

, clinical assistant professor, University of Michigan Health, medical oncologist, Brighton Center for Specialty Care, Rogel Cancer Center, Michigan Medicine, explains what sequencing research and novel treatment development is needed in metastatic renal cell carcinoma.

Sarah Elizabeth Yentz, MD, discusses what sequencing research and novel treatment development is needed to advance the metastatic renal cell carcinoma paradigm. 

Safety, communication, quality: Resolve to improve your practice in 2022

Consequences of burnout and depression in urology

Next steps to advancing metastatic kidney cancer care