Atezolizumab (Tecentriq) appears to have similar activity and safety in upper tract urothelial carcinoma as in the more common bladder urothelial cancer, according to exploratory analyses of the single-arm, multicenter SAUL study (NCT02928406).

The finding provides reassurance considering the expected worse outcomes in patients with upper urinary tract versus bladder urothelial carcinoma, said Cora N. Sternberg, MD, who presented the data at the 2020 Genitourinary Cancers Symposium in San Francisco.

Median overall survival (OS) was 8.3 months in patients with upper tract urothelial carcinoma compared with 8.8 months in those with bladder carcinoma, and the 1-year OS rates were 42% and 41%, respectively. At a data cutoff of September 16, 2018, 56% of the group with upper tract urothelial carcinoma and 55% with bladder carcinoma had died.

The percentages with progression-free survival (PFS) events were 78% in the group with upper tract urothelial carcinoma and 79% in patients with bladder carcinoma. Median PFS was 2.2 months in both groups.

“It is thought that patients with upper tract tumors respond less well than those with bladder carcinoma, when, in fact, we found that the median OS for patients with upper tract cancer, many of whom had poor renal function or were ineligible for enrollment into registration trials, was exactly the same as that for patients with bladder tumors,” said Sternberg, professor of medicine, Division of Hematology and Medical Oncology, Weill Cornell Medicine, New York. “We can say from this large single-arm study that it’s safe to treat both upper tract, renal pelvis and ureter, as well as bladder carcinoma with atezolizumab.”

Upper tract urothelial carcinoma tends to respond poorly to standard chemotherapy. Further, an analysis of 220 patients treated with atezolizumab, for whom biomarkers were evaluable, suggested worse outcomes in upper versus lower tract urothelial carcinoma, prompting the analysis presented at the symposium.

SAUL enrolled a broader population of patients with urinary tract carcinoma who were more representative of real-world practice compared with those typically enrolled in randomized phase 3 trials of immunotherapy.

Patients in SAUL had locally advanced/metastatic urothelial or nonurothelial carcinoma of the urinary tract. Patients enrolled could have poor clinical characteristics and/or immune-mediated conditions.

“The primary end point of the study was safety. We allowed patients in who are not normally allowed in the registration studies. We allowed in patients with immunologic disease or poor creatinine clearance, renal transplant patients, patients on steroids, and patients with brain metastases, for example,” Sternberg told 

Participants were treated with atezolizumab, 1200 mg intravenously every 3 weeks, until loss of efficacy, patient or investigator decision to withdraw from treatment, or death. The group with upper tract carcinoma consisted of 226 patients, 99 with ureteral carcinoma and 127 with renal pelvis carcinoma. They were followed for a median of 13.2 months. The bladder carcinoma subgroup had 749 patients, who were followed for a median of 12.2 months.

Baseline characteristics in the subgroups were generally similar. However, a numerically smaller proportion of the group with upper tract urothelial cancer had no prior lines of therapy for metastatic disease compared with the bladder cancer subgroup (30% vs 41%) and a numerically smaller proportion reported being current or former smokers (59% vs 70%, respectively).

Treatment was ongoing at data cutoff in 21% of patients with upper tract urothelial carcinoma (26% with ureteral carcinoma, 17% with renal pelvis carcinoma) and in 22% with bladder carcinoma. The median duration of treatment was 2.1 months in patients with upper tract urothelial carcinoma versus 2.9 months in patients with bladder carcinoma.

The incidence of grade 3 or higher adverse effects (AEs) was 42% in the upper tract urothelial carcinoma group and 46% in the bladder carcinoma group. Urinary tract infection was more common in the bladder carcinoma group compared with the upper tract urothelial carcinoma group (17% vs 11%, respectively). Arthralgia was more common in patients with ureteral versus renal pelvis carcinoma (12% vs 6%, respectively).

Rates of grade 3 or higher treatment-related AEs were 14% in the group with upper tract urothelial carcinoma versus 13% in those with bladder carcinoma. AEs leading to treatment discontinuation occurred in 6% of both groups.

Disclosures: F. Hoffmann-La Roche & Co. provided funding for the study. Sternberg has received honoraria from Astellas Pharma, AstraZeneca, Ipsen, Janssen, Pfizer, and Sanofi. She is a consultant/adviser for Astellas Pharma, AstraZeneca, Bayer, Bristol Myers Squibb, Clovis Oncology, Eisai, Incyte, Ipsen, Medscape, Merck, MSD, Novartis, Pfizer, Roche, Sanofi, and UroToday. For full disclosures, go to bit.ly/sauldisclosures.

Articles

Median overall survival is the same for both malignancies, study results show.

Atezolizumab shows similar efficacy in upper tract urothelial carcinoma and standard bladder cancer

Unfortunately, the coronavirus disease 2019 (COVID-19) wasn’t just a bad dream. Now it’s time to think about its aftermath. Urologists are emerging from the pandemic’s economic rubble with a different perspective on how they’ll run their practices in the months and potentially years to come.

Stephen Wills, CMPE, administrator at University Urology in Tennessee, said his practice’s 

staff of about 45, including 5 urologists, stayed intact through April and into May, while clinic visits and operating room cases took a deep dive.

“We’re down about 65% in clinic visits and 75% in the OR,” Wills said in late April.

COVID-19 caused a huge revenue drop for urology practices nationwide, according to LUGPA President Richard G. Harris, MD, a urologist at UroPartners in the greater Chicago, Illinois, area.

“What I’m hearing is most people are functioning with about 30% to 40% capability,” Harris said.

In hard-hit New York, Wayne Waltzer, MD, professor and chairman of the Department of Urology at SUNY Stony Brook University, said his practice has seen about a 75% decline in 

office visits and procedures and a decline in surgery of nearly 90%.

“Every practice is like a business, with a certain amount of overhead that has to be met every month. Most practices with a contraction of 60% to 70% will have difficulty meeting that overhead,” Waltzer said.

In general, 97% of physician practices have experienced a negative financial impact from COVID-19, according to a Medical Group Management Association survey conducted April 7-8. US practices reported a 60% average decrease in patient volume and a 55% average decrease in revenue since the pandemic started, according to the Medical Group Management Association.

Researchers at Harvard University and the health care technology company Phreesia analyzed nationwide data on changes in visit volume for more than 50,000 providers and found the number of visits to ambulatory practices fell nearly 60% in mid-March and remained low through mid-April.

 They reported dramatic declines in visits in all US regions, with the greatest declines in New England and the Mid-Atlantic states.

Surgical and procedural specialties like urology were harder hit. Urology ranked tied for fifth among specialties in terms of greatest decline in visits during the pandemic, with a 63% drop from early March to early April, the Harvard/Phreesia study found. Ophthalmology and otolaryngology experienced the biggest declines, with visits dropping an average 79% and 75%, respectively.

Many practices initially reacted to the pandemic thinking they’d have to lay off staff. The Federal Government prevented some of those layoffs, or furloughs, with grant and loan 

programs that are helping to buoy practices until the crisis subsides, according to Owen Dahl, a health care business consultant.

The Coronavirus Aid, Relief, and Economic Security Act Paycheck Protection Program (PPP) has helped many practices retain staff. It requires that employers pay 75% of their employees at 75% or more of payroll, according to Dahl.

Technically, the PPP is a loan but could be forgiven if practices meet the government’s criteria. The government has also helped to keep practices afloat with grants or stimulus money. The Families First Coronavirus Response Act requires employers to provide their employees with paid sick leave or expanded family and medical leave for COVID-19–related reasons, and the Economic Injury Disaster Loan option is available through the Small Business Administration.

University Urology, which has not cut anybody’s pay or furloughed staff, applied for and received a PPP loan.

“Without that, we would have to use much more drastic measures than we have. I think that’s going to get us by for at least a couple of months. We also did get a little stimulus from Health and Human Services,” Wills said. “If it continues well into the summer and into the winter, we’re definitely going to have to reevaluate.”

Although the infusion of money has been a big help for some practices, not all have received a PPP loan or other funds. The other problem is government grants and loans only will go so far—until about the beginning of June to mid-June, according to Dahl.

Medicine’s revenue cycle tends to lag about 2 months after practices bill for services. Urologists might not have realized the full impact of the COVID-19 monetary crisis until May or into June, according to Harris.

Still, if COVID-19 abates sooner than expected, physicians and hospitals might fare well due to excess demand for services deemed essential, according to the authors of a recent Viewpoint article in 

 “If the COVID-19 shutdown lasts for months or the normal business of health care does not resume until the fall, the implications for physicians and hospitals would be much more severe,” the authors wrote. “The bank accounts of many practices are not large enough to absorb a long-term shutdown.”

The recovery for procedurally oriented specialists, including urologists, will resemble a U-shape rather than a V-shape, according to Travis Singleton, executive vice president Merritt Hawkins, a health care search and consulting firm.

“It will take some time for employment to rebound and for patients to reestablish both the health care coverage and the confidence they need to move forward with procedures that 

can otherwise be postponed,” Singleton said. “While primary care physicians can pivot to telehealth and be paid for many of the services they provide, urologists can’t perform cystoscopies and other procedures virtually.

“However, the underlining dynamics that are driving demand for urologists and other specialists, particularly population aging, remain in place. Demand will return, and with it the need to recruit urologists and other needed health care professionals and support staff.”

Experts say telehealth is a lifeline. Waltzer said ramping up his practice’s telehealth services has helped to keep his staff on the job.

“Telemedicine has really essentially risen up and become a very dominant piece of urology practice,” he said. “We have staff calling patients, scheduling appointments, and converting some [of these appointments] to telemedicine. This is very time consuming. But telehealth visits are helping our practice and others increase billing.”

Wills said that University Urology doctors were each seeing about 10 patients daily in the office in late April and were conducting about another 25 telehealth visits each day.

“We’re just starting to get payments in for things that we have been billing the last few weeks and, for the most part, insurance companies are paying as if the patients were in the office. Telehealth will probably be one of the redeeming factors that will get us through all of this,” Wills said.

Telemedicine is slowly ramping up at UroPartners and should help pay the bills as the practice resumes in-person appointments and elective procedures, according to Harris.

“In a normal month, we have between 16,000 and 18,000 evaluation and management code submissions. Right now, the telehealth code submissions are in the 3,000 to 4,000 range. That’s double what it was a month ago,” Harris said in late April.

If laws remain relaxed for telehealth use, the trend for increasing utilization will continue in urology. LUGPA is lobbying for the government to keep telehealth regulations as they have been during the pandemic, according to Harris.

The biggest concern for practices after the pandemic is whether they have the staff needed to go forward, according to Dahl.

“If they were able to retain the employees and maintain good communication and relationships with the staff, that makes life a whole lot easier when they reopen,” he said.

Communicating with patients is the other piece of a successful reboot.

“What we’re finding is that a lot of patients who had urgent or what could be urgent medical needs didn’t seek care,” Dahl said. “What I think is critical is how the practice communicates with those patients. Have they adequately communicated up to now and can they reestablish relationships with those patients? We need to make sure that they know we’re open for business. And that would include things like posting on the website, things like emails, texts, different ways to reach out to those patients.”

Relationship building will help practices move forward. That includes relationships with the staff and addressing the issues they might have related to the pandemic. Practice administrators or managers need to listen and meet staff members’ needs where possible.

A seamless transition to a new normal includes providing staff with adequate training in new practice areas, such as telemedicine, according to Dahl.

Doctors will have to look at and revise scheduling models to better respond to patients’ needs, Dahl said. That includes attending to patients’ safety and improving workflow so they don’t have to wait for their appointments when they do come to the office.

Wills anticipates that patient foot traffic will double or triple through the summer and hopes the practice will be running according to a new normal in 6 months, assuming there’s no second wave.

University Urology plans to continue taking safety precautions for patients and staff for the long term. Like many practices, University Urology will likely shrink daily templates for office visits and focus on making operations and staffing leaner and more efficient even when the pandemic is a memory.

“We won’t look at staffing as the luxury that we have in the past because of the fear that anything could happen again and all of a sudden,” Wills said. “I think we’ll be more cognizant of who we hire and when we hire. If people move on to other places, we might not replace them. I’d say we’ll get a little more lean and mean in general.”

Waltzer said a lesson he learned during the pandemic is the value of communication. Clear, consistent communication will continue to help practices act on future uncertainty.

“We’ve really learned about the value of using both Microsoft Teams and Zoom for meetings. Those 2 things really help us to get people together, sometimes literally on a daily basis to discuss issues,” Waltzer said. “It really makes the planning much easier because you can get large groups of people together at 1 time instead of trying to have sequential meetings. For our own urology department, we have a daily briefing with our practice managers, office managers, and advanced practitioners to make sure we’re doing what we have to do to serve our patients.”

Waltzer said that despite being in the country’s epicenter of COVID-19 cases, he believes urology practices can and will recover.

“The time frame is of course uncertain because everyone is worried about the second surge, particularly in very dense urban areas. But I think going forward, there are some good lessons that are coming out of this as far as managing patients with telemedicine, particularly older patients for whom it may be difficult to travel,” said Waltzer, who noted his practice hasn’t changed plans to welcome 2 new urologists at summer’s end.

Just don’t expect business as usual. That’s not going to happen, Dahl said.

“The way we’ve always done it is gone and should be gone,” he said.

 COVID-19 financial impact on medical practices. Medical Group Management Association. Accessed May 18, 2020. 

https://www.mgma.com/getattachment/9b8be0c2-0744-41bf-864f-04007d6adbd2/2004-G09621D-COVID-Financial-Impact-One-Pager-8-5x11-MW-2.pdf.aspx?lang=en-US&ext=.pdf

https://www.commonwealthfund.org/publications/2020/apr/impact-covid-19-outpatient-visits

Mehrotra A, Chernew M, Linetsky D, Hatch H, Cutler D. What impact has COVID-19 had on outpatient visits? The Commonwealth Fund. April 23, 2020. Accessed May 18, 2020. 

Cutler DM, Nikpay S, Huckman RS. The business of medicine in the era of COVID-19. May 1, 2020. Accessed May 18, 2020. doi:10.1001/jama.2020.7242 

https://jamanetwork.com/journals/jama/fullarticle/2765668?guestAccessKey=85145fdc-9111-4f32-b0f0-cdc65e0d0bed&utm_source=For_The_Media&utm_medium=referral&utm_campaign=ftm_links&utm_content=tfl&utm_term=050120

 Mehrotra A, Chernew M, Linetsky D, Hatch H, Cutler D. What impact has COVID-19 had on outpatient visits? The Commonwealth Fund. April 23, 2020. Accessed May 18, 2020. 

As practices reboot, urologists consider leaner staffs and operations.

Pandemic exacts economic toll on urology practices

Growth in drug costs and spending for Medicare beneficiaries continues to be an area of concern for patients, policy makers, and regulators. In an article last year,1 I reported that for 7 of 16 drugs commonly administered in the office by urologists, spending increased faster than Part B drug spending overall. There have been no significant regulatory changes that have directly affected Medicare Part B drug policy in 2019. In this article, I update the spending and costs for Medicare Part B drugs commonly used by urologists in the office setting.

The Centers for Medicare & Medicaid Services recently released detailed drug spending data for the years 2014-2018 (Medicare Part B Drug Spending Dashboard. Centers for Medicare & Medicaid Services. December 17, 2019. Accessed May 11, 2020. https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/Information-on-Prescription-Drugs/MedicarePartB.html). “Spending” in this context includes the estimated total costs including deductible, coinsurance, and Medicare spending. Total spending in 2018 for the Part B program was $33.3 billion, up 9.3% from 2017. Spending on any single drug may increase because of increased utilization, increased price, or both. Let’s take a closer look at some individual drugs that urologists typically use in their practice (it is not possible using these data to determine what fraction of spending is “ordered” by urologists, or the indication for any individual drug).

Of 17 common drugs used in the urology office for Medicare beneficiaries 

 the drug with the largest 2018 total spent was denosumab ($1.42 billion). In 2018, utilization for denosumab increased 12.4%, spending per dose increased 1.79%, and total spending increased 14.39% compared with 2017. Denosumab spending has increased 4.53% per year over the past 5 years and continues to be the target of automated medical review in some areas of the country.

The drug with the largest annual growth in spending per dose unit among this selected group is mitomycin (54.18% annual growth over the past 5 years); spending per dose on mitomycin increased 13.4% in 2018 alone. Although overall usage of mitomycin and gemcitabine (Gemzar) declined in 2018 compared with 2017, the impact of the recent bacillus Calmette-Guérin shortage will probably result in greater utilization of mitomycin and gemcitabine in 2019 reports.

Among the same set of drugs, spending on onabotA was $348 million, up 7.1% over 2017 and due primarily to increased utilization. The annualized growth in spending/dose (a surrogate for price) for onabotA has been just 1.7% over the past 5 years.

, leuprolide acetate was still the most common drug with spending in 2018 of $272 million (1.7% higher than 2017). Over the last 5 years, growth in spending per dose has decreased 1.3% annually. Spending on triptorelin pamoate decreased sharply (26%) in 2018, whereas the price of goserelin (Zoladex) rose almost 16%, increasing spending on that drug by 3.8% over 2017.

In general, among these 17 drugs, those with 1 or 2 manufacturers have seen higher annual growth in spending per dose (a surrogate for price) and those with 3 or more manufacturers have seen lower or negative annual growth. Mitomycin is the notable exception to this rule as mentioned earlier.

The bottom line: of 17 Part B drugs commonly used by urologists, only 3 drugs increased in spending faster than Part B spending overall in 2018. The drug with the largest total spending is denosumab, and the drug with the largest annual growth in spending per dose over the last 5 years is mitomycin (54.2%). Urologists should be familiar with the average sales price and trends of the common Medicare Part B drugs administered to their patients.

1. Dowling, Robert A. CMS data reveal trends in Part B drug spending. 

Mitomycin sees the largest annual growth in spending per dose over the past 5 years, Robert A. Dowling, MD, reports.

Denosumab tops spending for common urology Part B drugs

Perineal biopsy has been performed since the early 1980s and has recently seen a resurgence. How should one code for performing a perineal biopsy?

The typical code to use will be CPT 55700, which describes prostate biopsy by any approach. Imaging can be added if appropriately performed and documented.

There are 3 CPT codes that describe the sampling of prostate tissue by biopsy: CPT codes 55700, 55705, and 55706. Each is described below.

55700: Biopsy, prostate; needle or punch, single or multiple, any approach.

 CPT code 55700 is used for prostate biopsy by any technique, whether transrectal, perineal, or endoscopic. CPT code 55700 can be billed with or without imaging guidance, such as ultrasound, so imaging guidance can be billed separately if performed. This code should be reported once per session no matter how many cores are obtained, and there is no upper limit to the number of cores taken to bill 55700 once. The procedure may be performed in the nonfacility (office) or facility (ambulatory surgery center, hospital) setting. This procedure is a 0-global day procedure.

Note: Imaging for this procedure is often provided with transrectal ultrasound. We remind you that although in the past, Medicare allowed for reporting of both the diagnostic ultrasound (76872 ultrasound, transrectal) and ultrasound guidance (76942 ultrasonic guidance for needle placement [eg, biopsy, aspiration, injection, localization device], imaging supervision and interpretation), this is no longer appropriate, as they are now bundled. Many private payers are following Medicare’s lead and are also bundling the 2 codes. Therefore, when using ultrasound in conjunction with the biopsy code 55700, you will need to select the appropriate imaging code supported by the documentation and medical necessity.

55705: Biopsy, prostate; incisional, any approach.

 CPT code 55705 is the code to use for an “open” prostate biopsy, by surgical exposure of the prostate, with cores taken by direct visualization of the prostate. The work of this code includes obtaining tissue from the prostate by direct incisional sampling and specifically describes the need to make a surgical incision and tissue dissection to expose the prostate. The procedure may be performed in the facility (ambulatory surgery center, outpatient, or inpatient hospital) setting and is a 10-day global procedure.

55706: Biopsies, prostate, needle, transperineal, stereotactic template-guided saturation sampling, including imaging guidance.

 CPT code 55706 is used for the performance of a “saturation” biopsy. A true saturation biopsy is a unique procedure that is performed in specific indications and following the steps as defined by the American Medical Association (the owner of the CPT copyright):

• The patient has a prior suspicious biopsy, or a prior negative biopsy [result] with rising PSA [prostate-specific antigen].

• The procedure is performed in an operating room under general or spinal anesthesia.

• A template grid to map the (entire) prostate gland is used. This grid enables the physician to remove cores at 5-mm intervals using a stereotactic approach.

• Cores are taken at 5-mm intervals, and each specimen is labeled to correspond with the location of each core chosen. In deeper planes, both a proximal and distal biopsy may be obtained.

• Each biopsy sample is marked for its coordinates, and all are mapped in 3D to determine the extent and exact position of malignant cells.

• Typically, 35 to 60 biopsies are taken, based on the size of the gland.

CPT code 55706 should not be performed in the office setting, as there are no practice expense inputs to reimburse for supplies, clinical staff, or equipment. This is a 10-day global procedure, and imaging guidance is included so imaging cannot be billed separately.

Why is CPT code 55700 typically the correct code for performing a perineal biopsy?

Perineal biopsy is correctly reported using CPT code 55700 prostate biopsy, any technique. As stated in the descriptor, CPT code 55700 should be used for any technique of prostate biopsy, including perineal biopsy, no matter how many cores are taken and even if using a stepper or grid. This code was valued with consideration of the typical time, skill, and resource use for the performance of the procedure by any route, including both capital and disposable costs. As perineal biopsy was being performed when this code was valued, the time skill and resources needed for the performance of biopsy by any technique were included in the value.

It would not be proper to bill CPT code 55706 for a typical perineal biopsy. CPT code 55706 is to be used only for a saturation biopsy and only if the indications and steps outlined by CPT are followed. Although saturation biopsy is performed by the perineal approach, one should not confuse the definitions and choose CPT 55706 unless a true saturation biopsy is being performed, even if the perineal biopsy is extensive and performed in an operating room.

Send coding and reimbursement questions to Jonathan Rubenstein, MD, and Mark Painter c/o 

Questions of general interest will be chosen for publication. 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.

Three codes are available for prostate biopsy, but only one is typically used for perineal biopsy, according to Jonathan Rubenstein, MD, and Mark Painter.

Vol 48 No 6

Atezolizumab shows similar efficacy in upper tract urothelial carcinoma and standard bladder cancer

Pandemic exacts economic toll on urology practices

Denosumab tops spending for common urology Part B drugs

How to code for a perineal prostate biopsy