The coronavirus disease 2019 (COVID-19) pandemic has triggered a rapid rise in the use of telemedicine across all specialties, including female pelvic medicine and reconstructive surgery (FPMRS). In an attempt to flatten the curve of transmission, we have made radical changes in the way we provide quality, comprehensive care for our patients.

Telemedicine has classically been useful for providing behavioral therapy, conservative and pharmacological treatment. In these cases, treatment is based on symptom improvement and not physical exam. FPMRS encompasses a spectrum of conditions with varied treatments. An initial challenge exists in identifying the appropriate patients for postoperative telemedicine visits. The nature of the condition, the follow-up questions, and the necessary tests dictate the need for an office-based postoperative visit. For example, subjective questions may assess the response to a midurethral sling. This is not the case, however, for recovery after genitourinary fistula surgery.

The effectiveness of virtual postoperative tension-free vaginal tape visits was first highlighted by Jefferis et al.

 Recently, in an international, prospective, multi-institutional, randomized control trial, the use of telemedicine in the early postoperative follow-up period after midurethral sling was presented at the 2020 American Urological Association Virtual Experience.

 A total of 237 patients were randomized 1:1 to telemedicine or office-based 3-week follow-up. Seventy percent of patients were equally “very satisfied” with their surgical outcomes. Predictors of satisfaction included non-Caucasian ethnicity and no college-level education. Sixteen (13.2%) of the patients requested crossover to office-based visits. Age greater than 65 years was the only predictor of this crossover. The telemedicine group was the most adherent to 3- to 5-month office-based follow-up.

Patients undergoing midurethral sling placement are ideal for postoperative virtual visits. Clinicians may assess success in most cases with subjective questions and quality-of-life questionnaires and, again through appropriate questions, easily identify irregularities. Complications such as an obstructing sling or mesh erosion create symptoms that a patient will easily notice. In such cases, clinicians may ask the patient to come in for a physical exam and testing.

The use of early virtual follow-up provides a balance of patient satisfaction, clinical utilization, and resource conservation. Reimbursement is based on a 90-day global period post sling. With equal satisfaction of both types of visits, a 3- to 5-month office-based visit is beneficial to the patient and clinic. Prior to COVID-19, only 15% of providers reported using telehealth regularly. This was related to obvious barriers that are rapidly being overcome, including lack of training, gaps in technology access and familiarity, apprehension around adoption of the new platform, and reimbursement.

With the foray into telemedicine during the COVID-19 pandemic, we have witnessed rapid growth in our knowledge and patient accessibility. It is clear that virtual visits are a viable option, well liked by patients and physicians alike. Both virtual and office platforms may provide excellent care without compromising quality. The changes in reimbursements are promising. Time will tell how FPMRS further utilizes telemedicine.

® Editorial Council, is a professor of urology at Oakland University William Beaumont School of Medicine, Royal Oak, Michigan.

1. Jefferis H, Muriithi F, White B, et al. Telephone follow-up after day case tension-free vaginal tape insertion. 

2016;27(5):787-790. doi:10.1007/s00192-015-2891-6

2. Derisavifard S, Rueb J, Kocher N, et al. Telemedicine optimizes early post-operative follow up after synthetic mid-urethral sling (MUS): a randomized multi-institutional control trial. Paper presented at: 2020 American Urological Association Virtual Experience; June 27-28, 2020

Articles

"Patients undergoing midurethral sling placement are ideal for postoperative virtual visits," writes Priya Padmanabhan, MD, MPH.

Foray of FPMRS into telemedicine during the coronavirus pandemic

The non–muscle invasive bladder cancer treatment BCG remains in short supply, with Merck currently serving as the sole supplier of the medication in the US. In this interview, 

discusses current recommendations for managing patients during this shortage, what the FDA is doing to resolve the problem, and a SWOG trial testing a new strain of BCG.

Lerner is professor of urology, Beth and Dave Swalm Chair in Urologic Oncology, director of urologic oncology, and director of the multidisciplinary bladder cancer program at Baylor College of Medicine, Houston, Texas. He was interviewed by 

 executive director of the American Board of Urology, Charlottesville, Virginia.

Disclosures: Dr Lerner has conducted clinical trials for Endo, FKD Therapies, JBL Science, Roche/Genentech, UroGen Pharma, Vaxiion Therapeutics, Viventia Bio Inc; is a consultant/advisor for FerGene, Genentech, Merck, Pfizer/EMD Serono, QED Therapeutics, UroGen Pharma, Vaxiion Therapeutics, and Verity Pharmaceuticals; has received honoraria from Grand Rounds Urology and UroToday; and holds a patent for The Cancer Genome Atlas Classifier.

This goes back several years. For a long time, there were 2 manufacturers of BCG in the United States and Canada. In 2012, Sanofi Pasteur in Canada, which manufactured the Connaught strain, went offline because of some inconsistencies in their manufacturing. In 2017, they shut down production completely. Merck, which makes the TICE strain, is the sole supplier of BCG not only in the US and Canada, but for 70 countries worldwide. Over the years, Merck has really stepped up, but they too had brief periods of challenges in the manufacturing process in the last several years. Having solved these, they ramped up production by, according to their numbers, 100% over the course of about 12 to 18 months. That solved a lot of the problem, but demand has essentially outstripped supply. In a recent press release,

 Merck has committed to building a new manufacturing facility for BCG that will take up to 6 years to complete and triple production of Tice BCG.

In February 2019, a group of stakeholders consisting of representatives from the American Urological Association, Society of Urologic Oncology, American Association of Clinical Urologists, the Urology Care Foundation, LUGPA, and the Bladder Cancer Advocacy Network (BCAN) met with representatives from Merck at the GU Cancers Symposium. We crafted a joint statement to try to help urologists manage patients during this shortage. We provided some guidelines to prioritize BCG for the patients who most needed it, such as patients with high-risk, high-grade non-muscle-invasive disease at their first diagnosis. Getting those patients through the induction and the first 3 months of maintenance treatments is critical. For patients who have already had a year or two of maintenance, we recommend curtailing that treatment.

With the statement, we were also trying to help urologists look for alternatives to BCG; namely intravesical chemotherapy for patients with intermediate-risk disease, where there’s less of a distinction about the superiority of BCG over chemotherapy. We’re trying to help urologists understand the AUA guidelines and where we think BCG can be most effective. But despite all of these efforts, the shortage persists, so we have to look for other strategies to help solve the problem.

What are the recommendations for urologists currently?

In high-risk patients for whom clinicians do not have access to BCG, we recommend a combination of chemotherapy drugs that can be delivered intravesically. We’re currently using gemcitabine and docetaxel. This combination was originated by Dr Michael O’Donnell at the University of Iowa, and a number of centers are using it quite successfully for patients for whom we don’t have BCG, or for patients who recur, after induction and one round of maintenance where they don’t necessarily need to go on to a cystectomy.

Another strategy is to extend the use of a vial of BCG by dividing it into 2 or even 3 doses. There’s actually a J code for that, but unfortunately, the payors haven’t given us a way to charge for that appropriately. This remains a challenge for many practices, and efforts are needed to resolve this with CMS and other payors. Another strategy is proper use of perioperative single-dose chemotherapy for low- and intermediate-risk patients to try to reduce the risk of recurrence and the subsequent need for BCG. A recent SWOG trial showed that a single dose of peri-operative intravesical gemcitabine, reduced the risk of recurrence by almost 50% at 4 years in patients with low-grade disease.2 In patients with intermediate-risk disease—patients with multi focal or recurrent Ta low grade cancer—an optimized regimen of mitomycin C first described in 2001 is easy to use and improves the efficacy of mitomycin.

What is the FDA doing to help address the shortage?

The FDA is being very proactive. They fully recognize and appreciate the importance of solving this problem. The group of stakeholders that met at the 2019 GU Cancers Symposium convened again at the 2020 symposium. There were 2 representatives from the FDA at that meeting, and they expressed a very strong interest in working with us and anyone else in the community to try to solve this shortage.

The reality of it is that we need to get new strains of BCG into the US market. They have to go through the standard FDA approval process. In the Southwest Oncology Group, we’re currently conducting a trial led by Dr Robert Svatek (NCT03091660). This is a 3-arm, 969-patient trial for patients who have high-risk, high-grade disease and are BCG naive. In the control arm, patients receive induction and maintenance TICE BCG, which is the current standard of care. We have a contract with Merck to guarantee the supply of Tice BCG for this trial. Patients in the other 2 arms receive the Tokyo-172 strain that was developed in Japan and has been around for decades. There are data suggesting that it is equivalent in efficacy to the Connaught strain and we will compare the efficacy of the Tokyo strain to Tice. We are also evaluating intradermal vaccination to prime the immune system prior to starting BCG treatment in order to improve the response rate. Failure-free survival at 1 year is the primary outcome measure. Two thirds of patients receive intravesical Tokyo-172, and half of those patients get vaccinated with Tokyo-172 BCG.

We’ve had multiple conversations with the FDA regarding the trial. They are very interested in looking at the patients with carcinoma in situ, who make up about one third of the patients in this trial. If the data support the efficacy of the Tokyo-172 strain for these patients, it’s a potential pathway for regulatory approval for this BCG strain.

Companies are looking at bringing other strains into the US market. One company is looking at the Russian strain, which is used mostly in Europe and other parts of the world. They will also have to go through a very strict FDA review and approval process.

Are there data to suggest a protective effect against bladder cancer in patients who have been vaccinated with BCG?

I’m not sure how well that’s been studied. We won’t be able to answer that question in our trial, because previous vaccination is one of the exclusion criteria. The trial design was based upon Dr Matthew Albert’s work from the Institut Pasteur.

 He and his colleagues compared induction BCG in patients who were previously vaccinated and those who were not, and the vaccinated patients seemed to do a lot better but that was with induction only and no maintenance BCG. Conceptually, the idea is that you prime the immune system with vaccination 3 weeks prior to intravesical BCG, so that, where it normally takes between 4-6 intravesical instillations during induction to reach peak cytokine induction, we think that that would happen much earlier, and by virtue of that, yield better outcomes in terms of failure-free survival.

You mentioned a couple of ways to potentially to relieve the stress on urologists who can’t obtain BCG. Is there a role for thiotepa, adriamycin, valrubicin, and some of the other agents that have been used in the past?

I think most urologists should be comfortable using mitomycin and gemcitabine. Here in Houston and the surrounding area, we’ve been very happy to guide clinicians in the use of intravesical chemotherapy drugs that they may not have a lot of experience with, particularly these combinations. I would say that if you don’t have experience, then simply reach out to your nearest academic urology department for guidance. These are really easy to use. We’re available for consultation, guidance, and treatment, if needed. I think most of us are in a situation where we currently have adequate BCG supply, but I’m still getting referrals for patients in my community from physicians who don’t have access to BCG.

You mentioned boosting the immune system. I understand that you are involved with a trial evaluating BCG vaccinations for COVID-19.

Yes, this is something that a number of us have become involved with. Infectious disease experts here in the US, the Netherlands and Australia have done a lot of work in this space, conducting research on BCG vaccination for tuberculosis globally. They observed that, epidemiologically, countries that had programmatic vaccination for tuberculosis from birth had about a ten-fold lower incidence of COVID-19 and about a ten-fold reduction in mortality rate compared with countries that did not have programmatic vaccination from birth.

 There is a fair amount of laboratory and experimental evidence to support why that might be. There are nonspecific immune effects of BCG vaccination that have been shown to reduce the risk of bacterial and viral respiratory infections, particularly yellow fever, which is another virally transmitted disease. The experimental evidence suggests that BCG causes epigenetic modification of immune cells that make them perhaps more alert to other foreign viruses; in this particular case, the novel coronavirus causing COVID-19.

As a result, the infectious disease community has put together randomized clinical trials comparing BCG vaccination to placebo, initially focusing on the highest risk health care workers, first responders and the elderly. The trial that I am involved with is a collaboration with Baylor College of Medicine, MD Anderson Cancer Center (Ashish Kamat, MD, is one of the principal investigators), Texas A&M University, Cedars-Sinai Medical Center, and Harvard University (NCT04348370). This was largely conceived of and led by the infectious disease community, but they logically tapped into the urologic community because we have experience with BCG. The primary outcome measure is incidence of COVID-19, and the secondary outcome measure is disease severity. We do not feel these trials will have a material negative impact on BCG supply as a single vial that is used for 1 treatment of BCG in a patient with bladder cancer can vaccinate up to 500 subjects.

Is there anything else you’d like to add?

I serve on the board of directors for the Bladder Cancer Advocacy Network (BCAN). They have been very active in calling attention to the BCG shortage and trying to develop strategies for patients who face many challenges navigating this complex situation.

As a community, we must always be sensitive to the needs of patients, and work very closely with them. Consider a patient who is out 12 or 18 months and never recurred, receiving their maintenance BCG and surveillance cystoscopies. Then their doctor tells them that, in order to manage this shortage, their treatment is being stopped. That can come as a big shock to patients, and it can create a lot of concern and anxiety. We can reassure them that they have already received most of the benefit and will continue close surveillance. In addition, we need to use BCG only for the highest risk patients. That will go a long way towards helping manage the shortage. Finally, we need to support clinical trials that could lead to getting new strains into the market as well as clinical trials evaluating other drugs that could be used to treat patients with alternative agents if shown to be as effective as BCG.

1. Merck announces plans to construct new facility in the united states to expand manufacturing capacity for TICE BCG. Press release. Merck. October 14, 2020. Accessed October 15, 2020. https://bit.ly/2HBYJhW

2. Messing EM, Tangen CM, Lerner SP, et al. Effect of intravesical instillation of gemcitabine vs saline immediately following resection of suspected low-grade non–muscle-invasive bladder cancer on tumor recurrence SWOG S0337 randomized clinical trial. 

 2018;319(18):1880-1888. doi:10.1001/jama.2018.4657.

3. Au JL, Badalament RA, Wientjes MG, et al. Methods to improve efficacy of intravesical mitomycin C: results of a randomized phase III trial. 

 2001;93(8):597-604. doi:10.1093/jnci/93.8.597

4. Biot C, Rentsch CA, Gsponer JR, et al. Preexisting BCG-specific T cells improve intravesical immunotherapy for bladder cancer. 

 2012;4(137):137ra72. doi:10.1126/scitranslmed.3003586

5. Hegarty PK, Sfakianos JP, Giannarini G, et al. COVID-19 and bacillus Calmette-Guérin: What is the link? 

 2020;3(3):259-261. doi:10.1016/j.euo.2020.04.001

In this interview, Seth P. Lerner, MD, discusses current recommendations for managing patients during the BCG shortage, what the FDA is doing to resolve the problem, and a SWOG trial testing a new strain of BCG.

The BCG shortage: What's being done—and what you can do

Over the past decade, the incidence of metastatic prostate cancer in the United States has been on the rise, according to an analysis published in the Centers for Disease Control and Prevention 

Between 2003 and 2017, the percentage of patients diagnosed with metastatic prostate cancer increased from 4% to 8%. This increase occurred even though the overall age-adjusted incidence of prostate cancer in the United States went down from 155 per 100,000 in 2003, to 105 per 100,000 in 2017.

“Although approximately three-fourths of US men with prostate cancer have localized stage at diagnosis, an increasing number and percentage of men have received diagnoses of distant stage prostate cancer. Survival with distant stage prostate cancer has improved, but fewer than one-third of men survive 5 years after diagnosis,” the investigators wrote.

The CDC analysis examined data from the population-based cancer registries that are used for the official US Cancer Statistics (USCS) composite. Overall, there were 3,087,800 new prostate cancer cases diagnosed in the United States between 2003 and 2017. The incidence was highest among men aged 70-74 years and Black men. The vast majority of these cases were localized (77%), followed by regional (11%), metastatic (5%), and unknown (7%). Compared to all other races/ethnicities, White men had the lowest rates of metastatic (5%) and unknown stage (6%) disease at diagnosis.

Although the rate of patients diagnosed with metastatic disease increased between 2003 and 2017, in that same period, the rate of localized cases decreased from 78% to 70%, respectively. Survival data available for 3,104,380 men across all disease stages showed that between 2001 and 2016, the 5-year relative survival rate was 97.6% and the 10-year relative survival rate was 97.2%. The 10-year relative survival rates for men with localized versus metastatic disease were 100% versus 18.5%, respectively. The 10-year rates were 96.1% for patients with regional disease and 78.1% for patients whose disease status was unknown.

Of note, when comparing 5-year relative survival for the periods of 2001-2005 and 2011-2016, the rate improved from 28.7% to 32.3% in patients with metastatic disease. The authors suggested that the improvement might be attributed to recent advances in the prostate cancer armamentarium, including novel antibody and hormone treatments.

Although the 5-year survival rate was higher for White versus Black or Hispanic men when combining all stages of prostate cancer, the 5-year survival rate for patients with metastatic disease was higher for Black and Hispanic men compared to White men. The 5-year survival rates by race for men diagnosed with metastatic cancer between 2001 and 2016 were 42% for Asian/Pacific Islander; 37.2% for Hispanics; 32.2% for American Indian/Alaska Native; 31.6% for Black men; and 29.1% for White men.

The researchers wrote that one explanation for the recent uptick in the incidence of metastatic disease was the US Preventive Services Task Force (USPSTF) issuing a grade D recommendation in 2012 against the use of PSA screening in the general US population, regardless of age.

“This recommendation likely contributed to a decrease in overall reported prostate cancer incidence and might have contributed to an increase in the percentage and incidence of distant stage prostate cancer,” they wrote.

The current USPSTF PSA screening policy is slightly changed, with a grade C recommendation for men aged 55 to 69 years, meaning in this population, an individual decision on screening should be made based on a physician-clinician discussion of the potential benefits and risks. However, 

many urologists still find this recommendation lacking.

In their concluding remarks, the CDC investigators wrote, “Understanding incidence and long-term survival by stage, race/ethnicity, and age could inform messaging related to the possible benefits and harms of prostate cancer screening and could guide public health planning related to treatment and survivor care. Further research is needed to examine how social determinants of health affect prostate cancer diagnosis and treatment; findings should inform interventions to decrease disparities in outcomes.”

1. Siegel DA, O’Neil ME, Richards TB, Dowling NF, Weir HK. Prostate Cancer Incidence and Survival, by Stage and Race/Ethnicity — United States, 2001–2017. MMWR Morb Mortal Wkly Rep 2020;69:1473-1480. DOI: http://dx.doi.org/10.15585/mmwr.mm6941a1external icon

Although the overall incidence of prostate cancer has declined, the percentage of patients with metastatic disease at diagnosis has increased over the last decade. 

CDC warns incidence of metastatic prostate cancer on the rise

With the new evaluation and management changes for 2021, should I expect to be billing the same levels as before, or do you anticipate any changes due to the new Medical Decision Making section?

This is a great question. Although we have all heard that with the new evaluation and management (E/M) guidelines slated to start on January 1, 2021, overall, urologists will see a bit of a boost in reimbursements due to the increased relative value unit (RVU) of the majority of office E/M codes, and therefore increased payments, that would hold true if year-after-year there were the same E/M services billed (the same number of 99213s, the same number of 99214s, etc).

However, as with any new system, there are likely to be some shifts around, as the Medical Decision Making (MDM) section (which is used to determine the E/M level if time is not chosen to report the service) has changed a bit. The main changes take place in the Complexity of Problem and Amount/Complexity of Data sections. By looking through a number of charts, we do see 

some areas where there will be some shifts. Although not scientifically studied, when reviewing a number of charts and projecting the reported code under the new 2021 guidelines in comparison to current code levels selected, we found that the majority remained unchanged. For those codes that changed, we estimated a level neutral change, meaning the number of codes that went down in level were roughly offset by the number of codes that went up in level. That may not be true for all urologists due to their own individual practices. Here is how we figured that out and how we anticipate some of the shifts to occur.

Number and Complexity of Problems Addressed section of MDM.

 In the 1995/1997 system, points would be added for each condition managed on that date of service, and the sum of the points would determine the level for that section. For example, the provider would get 1 point for each established stable problem, 2 points for an established worsening problem, 3 points for a new problem that does not require further workup, and 4 points for a new problem that requires further workup.

In the 2021 system, this changes. No longer will the problems be summed to reach a final level, but rather the acuity of the illness(es) and the way that the problems affect patient management will determine patient complexity. This change was added to address the few physicians who would stack diagnoses or document in the chart diagnoses/problems that were not medically necessary to address on that day. In the new system, a patient with 1 self-limited or minor problem would still reach a level 2 in 2021, and 2 minor problems would still reach a level 3. In those encounters for which a chronic illness/problem that is worsening is addressed, a level 3 would be reached in the old system; under the 2021 guidelines, it would reach level 4 for this element of MDM. However, one can only reach level 5 if a patient has a severe exacerbation or a threat to bodily function in the 2021 system, regardless of the number of problems addressed.

Amount and/or Complexity of Data to be Reviewed and Analyzed section of MDM. 

Similarly, instead of getting 1 or 2 points for a variety of data types (review and/or order radiology tests/labs/medicine test, obtaining old records, summarizing old records or discussing with another provider, independent visualization of image or specimen), and adding them together, in the new system, again, the way the data is used and how it affect patient management determines the final data level. CPT has added a few clarifying statements as to what counts as data, when it is appropriate to use data as part of MDM and how to consider data as it pertains to each level of code. The clarifications include a specific reference to data included based on each CPT code test for specific data types and the exclusion of data for which you are separately paid for interpretation. It doesn’t necessarily take more or less data to reach certain levels, but what is more important is not the volume of data but the importance of the data, the amount of effort and expertise it takes to interpret the data, and the way that data affects patient care.

The table itself is the section that has changed the least and is in essence the merge of the Diagnostic procedure(s) ordered and Management Options Selected subsections, with Presenting Problem(s) subsection eliminated. Therefore, those who would use the selections on the 2 subsections that remain would find the table unchanged, but those who would use the Presenting Problems subsection would not be able to use that portion on the Table of risk.

So what does this mean? Ultimately, there will be some shifts of patients around between the levels, but it appears on a high level that the overall levels selected would remain unchanged for those who were using the MDM chart correctly. We encourage you to review the changes and seek some additional training. In the long run, these changes are good for the clinician and good for patient care, reducing the amount of clutter in the office note and the work required to add this information.

We would like to add a note to our recent Q&A article with regard to the use of code 99091.

 In our discussion, we wrote, “ ‘Incident to’ services provided by staff and conforming to Medicare guidelines may also be included to assist in the collection and interpretation of data.” We based this information on information included in the proposed rule for the 2021 Medicare Physician Fee Schedule. As we also noted, the description in the CPT coding manual would imply that Physician or a Qualified Healthcare Provider time is required for inclusion in the 30 minutes spent in remote data collection and interpretation. We are going to add a note of caution here as the statement we included was in fact based on a proposed rule interpretation and not a final rule or CPT note. Medicare may not accept the medical assistant or other assistant time in the 30-minute calculation even if the time was spent within “incident to” rules.

1. Rubenstein J, Painter M. What to know about reporting CPT code 99072. 

. October 14, 2020. Accessed October 23, 2020. 

https://www.urologytimes.com/view/what-to-know-about-covid-19-cpt-code-99072-for-your-urology-practice

Send coding and reimbursement questions to Rubenstein and 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.

"The main [Medical Decision Making section] changes take place in the Complexity of Problem and Amount/Complexity of Data sections," write Jonathan Rubenstein, MD, and Mark Painter.

Coding Q&A: How will Medical Decision Making change for urologists in 2021?

Nearly every physician receives requests for prescriptions from coworkers or friends. Granting these requests can take the form of “friendly prescribing,” a situation in which a prescription is provided outside a physician’s normal practice. In an attempt to be helpful, care providers can expose themselves to a risk of being sued, losing insurance coverage, and facing disciplinary investigations. Luckily, there are ways to avoid or minimize these risks while still being a helpful friend.

Imagine the following scenarios: A nurse in your office says, “Doctor, can you call in a prescription for my hypertension medicine? I’m out of refills, and my doctor charges me $100 a visit.” Or a neighbor you know well calls and says, “Doc, I have a cross-country flight coming up and a terrible fear of flying. Can you prescribe me 2 Valium for the trip? I won’t have time to schedule a visit with my doctor before my trip.”

In any variation of these situations, the pressures on the physician are the same. An acquaintance is asking for something that the physician can easily give. Refusing this type of request would surely seem like an insult. How can you say no without the implication being “I could help you, but I won’t because I just don’t care enough about you”?

Unfortunately, even setting aside adverse drug reactions that could stem from informal prescribing, providing a friendly prescription can create a variety of medico-legal risks beyond those associated with a normal patient encounter.

Claims may not be covered by malpractice insurance

If an individual who receives an informal prescription suffers an adverse outcome and a malpractice suit is filed, this claim may not be covered by malpractice insurance. The reason is simple: A friend or acquaintance provided with a prescription may not be a true “patient.”

In one tragic story involving friendly prescribing, an emergency department (ED) physician was asked by a nurse for a prescription for Zoloft for her husband, who had been struggling with depression. The ED physician wrote a prescription for 1 month of medication, just long enough for the husband to make an appointment with a psychiatrist.

Two weeks later, the nurse’s husband took his own life. The widowed nurse sued the ED physician for malpractice on the basis that the physician did not consider that increased risk of suicidal thoughts is a complication for patients starting Zoloft. Ultimately, the ED physician’s malpractice carrier refused to provide coverage for the case because the husband was not one of the physician’s patients.

Even when an informal prescription does not lead to an adverse health outcome, it can still create headaches for practitioners. “Hallway medicine” can run afoul of laws and regulations related to the requirement that an in-person evaluation be performed before a prescription is issued. Moreover, the modified or informal practices associated with writing a friendly prescription can lead to disciplinary actions from a state medical board.

In one recent case, a nurse asked a surgeon for a written prescription for an OTC medication. The nurse needed the prescription to use her health savings account for the purchase. The physician provided a partially completed handwritten prescription, leaving it to the nurse to fill in the specifics. A hospital administrator found the nearly blank prescription on a desk, and both the nurse and the surgeon were investigated by their employer and licensing authorities.

This scenario did not even involve a medication that required a prescription. Yet the physician was still subjected to an investigation by the state medical board for issuing a prescription without keeping proper records.

Best practices for friendly prescriptions

It is possible to handle requests for prescriptions without seeming rude and still protecting against exposure to lawsuits or disciplinary actions. The first step is treating the request as if it comes from a real patient. This means conducting an examination and creating a written record of the encounter. Use of an electronic medical record system can be very helpful in this regard. Creating a record that shows the friend was treated like a normal patient reduces the possibility that an insurer will deny coverage in the event of a lawsuit.

If an acquittance needs a prescription urgently and a physical exam is not possible, physicians should create some contemporaneous record reflecting this fact. Such a record may be very useful in defusing any investigation by a licensing authority. Ultimately, failing to take these simple steps while helping a friend with a request for medication could result in proving the truth of the adage “No good deed goes unpunished.”

 is an attorney in the Columbus, Ohio office of Reminger Co., LPA. He specializes in malpractice defense and insurance litigation. Please contact him at KSteele@reminger.com with any feedback or comments on this column..

Here’s how to guard against lawsuits and disciplinary actions.

Why urologists should beware the perils of friendly prescribing

What are some financial planning tasks I should focus on before year-end?

We are now in the final months of what has been a difficult 2020 for many. Every year, we like to present a number of year-end tasks everyone should cross off their checklist. This time of year presents the perfect opportunity to review and possibly adjust your financial planning strategies. You should update your accounts and see where you stand with many of the goals you set at the beginning of the year.

Check on the status of your emergency fund.

 Did you need to dip into it at all this year? Have your necessary expenses changed? It’s always a good idea to review the balance of the account as well as your budget to see whether additional funds need to be added to bolster the account. The general rule of thumb for emergency funds is to have 3 months of necessary expenses if you are a dual-
income household and 6 months to a year if you are a single-income household.

 You have until the tax filing date next spring to make a 2020 contribution to an individual retirement account (IRA), but 401(k) and 403(b) contributions are deductible only when made in the same calendar year. The 2020 contribution limit is $19,500 for 401(k)s and 403(b)s and $6000 for IRAs. If you are over age 50, catch-up contributions may be available as well.

Use the remaining money in your flexible spending accounts (FSAs). 

If you still have money set aside in an FSA for health care or dependent care expenses, try to use those funds before the end of the year, or you’ll risk forfeiting the money. Some employers offer a grace period into the spring of the following year or a $500 FSA carry-over from one year to the next, but most do not.

Make contributions to your children’s 529 accounts.

 College costs continue to rise, and it is important to start saving early if you hope to reach your college funding goals. Additionally, some states offer a state income tax deduction if you are a resident and contribute to their 529 plan. In some cases, the tax savings can be substantial.

Designate individuals to whom you wish to gift assets. 

The annual gift tax exclusion is $15,000 for 2020 ($30,000 for married couples). You can gift this amount to as many individuals as you would like without having to pay gift tax or have it count against your lifetime gift and estate tax exemption.

Giving to charity can be a very powerful tax-savings tool. Check whether you have any appreciated investment assets that you could gift instead of cash. This way, you will avoid paying capital gains tax on those investments, and you get to claim a deduction for the full value of the donated asset. When the charitable organization sells it, there’s no tax to them. Be aware, however, that under the current tax law, you may need to donate a substantial amount of assets to be eligible to claim a charitable deduction on your tax return.

 The markets have certainly fluctuated a lot this year. If you own stocks and other marketable securities that have lost money in taxable accounts like individual or joint accounts, consider selling those investments to capture the loss. The losses can be used to cancel out taxable gains elsewhere or potentially lower your 2020 tax bill. If your losses exceed your gains, you will have a net capital loss. You can deduct up to $3000 of net capital loss (or $1500 if you are married and file separately) against ordinary income, including your salary, self-employment income, and interest income. Any excess net capital loss is carried forward to future years and puts you in a position for tax savings in 2021 and beyond.

 If you have had a major change in your personal life, such as a recent marriage or divorce, the birth or adoption of a child, or a death in the family, you may need to revise the beneficiaries on your retirement accounts and life insurance policies. You may also need to update your will and power of attorney documents.

These are just a handful of financial issues to consider as you approach year-end. Your financial and legal advisers can run through a more comprehensive checklist of planning options based on your personal circumstances.

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Now is the time to assess your emergency fund and update beneficiaries.

Close out 2020 with these key financial planning tasks

Urology Times® reached out to 3 urologists (selected randomly) and asked them each the following question: Is your urology practice prepared for evaluation/management coding changes in 2021?

"My office manager, who used to be a biller, thinks these changes may simplify billing issues and benefit urology as a specialty overall. I have no experience with how the rules are going to change. I have an electronic medical record [EMR] I trust and that does a fantastic job of generating the right codes for me. We’ve already been alerted to an electronic update coming for the changes.

I don’t know how it will affect surgeries, but from the brief description I have, outpatient visit coding will be maximized. My reimbursement patterns are about 50-50 between surgery and office-based work. So if surgery is affected equally in the negative direction as outpatient is affected in the positive direction, it will probably be a wash for me. Again, it’s just a guess. I rely on my business person and my EMR, which we pay a hefty fee for, to keep these things running well.

We are all naturally skeptical because we are rarely rewarded for an advantage at any time when these changes are made. Urology usually seems to get the short end of the stick. The trend year after year is for a decrease in reimbursement per unit of effort. But this one seems like a potentially reasonable one.”

“I’m an employed physician in a large company. A team does our coding through a systemwide 

EMR, so when codes change, I won’t have access to deleted ones. From that standpoint, there’s not much prep.

I expect it to be ready but don’t know that I’m confident. I’m based on relative value units [RVUs], so whatever the code is, the code is. Am I convinced they’ll be 100% accurate in doing everything? No. But I’m not necessarily worried because I’m RVU based, not cash based.

The higher evaluation/management [E/M] should be helpful for me. I don’t do a lot of big open cases anymore, so I’m not a heavy surgical volume generator of my RVUs. I tend to make more in the office; it shouldn’t be a significant change.

It was different when I operated my own practice because I was responsible for the adjustments. Being employed, that burden falls on somebody else. EMRs have actually made it easier; you can’t put in the wrong codes because they no longer exist.

It’s not like going 10 years without change and suddenly getting one. Come January 1 every year, there’s going to be change somewhere.

With EMRs, as long as coders know a day or 2 ahead of time, they’ll probably be able to make the adjustment because all they have to do at the corporate level is implement an update, which is almost immediate. My understanding is that with the new codes, almost all office visits are going to fall into the same category, so what you have to do to qualify for that code will be more general. It should be a little easier for us.”

“I’m finding that hospital systems are just as clueless as most private practices are. It’s going to 

be a slow process for hospitals to give the proper information to their physicians so that when we’re moving on to the new coding system, we’re not doing extra work.

Fortunately, I’ve been able to educate myself, but I’m finding a lot of my colleagues don’t even know there’s a change coming, and it may be to their benefit, and to their patients’, by reducing the documentation workload. Physicians simply aren’t educated enough on it.

I’m certain it’s not going to be organized by the end of the year, partly because we’re just climbing out of this health crisis and have been focused on surviving that. The E/M changes obviously benefit office-based work, but a lot of doctors, especially those who are procedure heavy, don’t realize that.

Now, I’m director of robotic surgery here, so I’m pretty procedure heavy, but I also have a very busy clinical practice. There will be a drop in my production in terms of surgery and procedures, but I hope my office-based practice will make up for that.

Most hospital-employed physicians probably won’t notice a change for several months, maybe a year. Once administrators realize compensation doesn’t align with the current production, hospital-employed physicians will start feeling it in contract renegotiations. Private practice will need to make adjustments more quickly because they’ll see it on a day-to-day basis. There will definitely be some surprises.

Hospital administrators just don’t know. We’ve had discussions, but nobody realizes this is happening.”

“It’s going to be a slow process for hospitals to give the proper information to their physicians so that when we’re moving on to the new coding system, we’re not doing extra work," says one urologist.

Is your urology practice prepared for evaluation/management coding changes in 2021?

What is the correct coding for a patient who has a stent removed with an externally accessible dangle or if a cystoscopy is performed to remove a dangle within the urethra?

There are a number of CPT codes that can be used to bill the work to remove a stent from a patient depending on the situation, and there are times when no separate CPT code exists and the work for removing a stent is included in the office visit.

Let’s start with the first situation: a “dangle” attached to the stent is used for removal of the stent. There is no CPT code to describe the situation when a patient has a stent removed with an externally accessible component such as a string or dangle. The work of removing a stent in this manner is included in the evaluation and management visit.

In the situation where the dangle is still within the urethra and a cystoscope is used to perform urethroscopy and a grasper is used to grab the dangle for removal, use CPT code 52310 (Cystourethroscopy, with removal of foreign body, calculus, or ureteral stent from urethra or bladder [separate procedure]; simple).

There are some who may be tempted to use CPT code 50386 (Removal [via snare/capture] of internally dwelling ureteral stent via transurethral approach, without use of cystoscopy, including radiological supervision and interpretation) to remove a stent on a dangle that is within the urethra using an instrument to grasp the non-visualized dangle without the use of cystoscopy. However, CPT code 50386 is located in the ureter section of the CPT code book. As the full description implies through its location in the CPT manual and the description, the removal of internally indwelling stent reported with this code would require the use of a snare or capture to directly grasp and remove the stent without the use of a cystoscope. The inclusion statement “including radiological supervision and interpretation” refers to the fact that the procedure would usually require radiologic guidance for the capture or snare to guide the instrument to the stent without the use of the cystoscope. The inclusion would also prevent the separate reporting of a radiological guidance code such as fluoroscopy.

It should also be noted that the relative value units (RVUs) for 50386 were based on the average case reported for the code, which included the use of anesthesia and imaging to place a rigid biopsy forceps into the bladder to remove the stent. Understanding the average case used to develop the RVU provides some additional insight into the intention of the code and can be used by payers to determine appropriate code usage in a chart review.

Despite the fact that anesthesia and radiologic supervision are not required within the description of the code itself, if you are snaring or capturing a dangle in the urethra and remove the stent in this manner, you have not met the definition of code 50386.

Unfortunately, we do not have an accurate code to report a removal of a stent in this manner. Similar to a stent removed via an externally accessible dangle or a catheter, we would recommend including the removal of the stent via a dangle snared in the urethra in an evaluation and management code or reporting the service with an unlisted code.

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

Use CPT code 52310 when a dangle is within the urethra and a grasper is used.

Vol 48 No 11