With fears about the coronavirus (COVID-19) causing the markets to fluctuate significantly, should I make any adjustments to my investment strategy?

The markets have certainly been a roller coaster lately. At the end of February, the Dow experienced its “first” largest single-day drop, down 1,191 points, then posted its largest single-day gain, at 1,293 points, a couple of days later. On March 10, the Dow beat its single-day loss record again by posting a jaw-dropping 2,021-point loss only to follow this up with a larger 2,997-point drop on March 16.

This volatility isn’t unexpected when you have a stock market that was consistently setting new record highs come face to face with a potential global health threat. With a global pandemic causing countries to limit trade and social distancing limiting people’s ability to purchase goods, it is likely that a highly volatile environment will remain for the short term.

As investors, it is critical not to overreact. You need to block out the surrounding noise and follow your investment strategy in the face of volatile markets. Actions based on emotion and fear can cause you to make mistakes that can negatively affect your long-term investment performance. In 2018, we wrote an article during another period of high volatility and provided some insights for investing in these environments. We would like to share those with you again.

I made an excess contribution to my Roth IRA; how do I fix it?

Fight the impulse to sell your holdings if the markets are dropping.

 Selling after drops can make temporary losses permanent and difficult to recover. Sticking to your investment strategy, although it can be difficult emotionally, may be healthier for your portfolio. It is important to continue monitoring your investments but remember the long-term reasons the investment is in your portfolio. What role is it playing? If it is still a good fit, holding the investment may be the better long-term strategy.

Remember that you are investing for the long term.

 Markets have always fluctuated up and down, and during your lifetime, you’re likely to experience several significant declines. Investors should ignore the noise and stay disciplined to the investment strategy they designed. The strategy was created specifically to avoid falling into these pitfalls.

 Risk you took on years ago may no longer make sense given your current circumstances and stage of life.

Make sure your portfolio is well diversified

Make sure your portfolio is well diversified.

 Volatile markets have a way of exposing improperly diversified portfolios.

 Market volatility can skew your allocation from its original target. Certain assets will be more affected by market swings and will move outside their target allocations. Rebalance your portfolio by selling positions that have become overweight in relation to the rest of your portfolio and move the proceeds to positions that have become underweight.

If you must trade during volatile markets, there are defensive steps you can take to protect your positions. Stop orders and stop-limit orders can help shield unrealized gains or limit potential losses on an existing position.

Self-employed? Here’s how you can save for retirement

Consider adding defensive assets such as cash and cash equivalents, Treasury securities, and other U.S. government bonds. These can help stabilize a portfolio when stocks are slipping.

If I want to take advantage of the down market, is there a preferred way to invest?

First, evaluate if you are in a financial position to invest more and proceed with caution. If you determine you are able to invest during a volatile environment, the best approach is to do so over a period of time. It is impossible to tell when the markets have hit their bottom. Don’t try to guess and invest everything in one lump sum. If markets continue to decline, you could potentially lose a significant amount.

It is better to break up the investment into smaller increments. If you are wrong, you are not wrong with all the money you planned to invest. This strategy is called dollar-cost averaging. With a dollar-cost averaging strategy, it is best to select 1 day a week or 1 day a month to invest a smaller percentage of the total amount you planned to invest. By selecting a day and sticking to it, it will allow you to ignore the outside noise. If markets continue to decline, you are incrementally buying on the downslope and will be in a good position when markets recover.

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

Articles

Avoid making decisions motivated by emotion and fear, advises Jeff Witz, CFP.

COVID-19 and market fluctuation: What you should do

Dr. Gadzinski is a senior fellow and acting instructor of urologic oncology, University of Washington, Seattle; Dr. Ellimoottil is assistant professor of urology, University of Michigan, Ann Arbor; Dr. Odisho is assistant professor of urology, University of California, San Francisco; Dr. Watts is assistant professor of urology, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY; and Dr. Gore is professor of urology, University of Washington, Seattle. 

 Dr. Odisho had a prior consulting relationship with Vsee from January 2019 to January 2020.

In response to the COVID-19 pandemic, multiple emergency measures have dramatically changed the policies and requirements for telemedicine in the United States. On March 13, 2020, Secretary of Health and Human Services (HHS) Alex Azar authorized waivers and modifications under Section 1135 of the Social Security Act, retroactive to March 1, 2020, to lift telemedicine restrictions. Medicare Part B beneficiaries are now eligible to participate in video visits from any location, including their home, 

We aim to briefly summarize these changes, provide resources for urologists (from 

), and give practical guidance for quickly launching or scaling a telemedicine program. We primarily focus on video visits, which are live simultaneous audio and visual interactions with patients via a videoconferencing platform. (Also see a summary of updated Medicare Part B policy on video visits in the table below.)

Given that most urologic outpatient visits are non-urgent, almost all in-person visits should be eliminated out of appropriate concern for COVID-19. Continuing urologic care now will mitigate the later surge of patients needing care once this crisis is over. Video visits may also provide some financial stability to urology practices during this time when surgical reimbursements will be greatly reduced. Finally, with uncertainty surrounding the duration of the current State of Emergency and the enacted telemedicine changes beyond this emergency period, investing in telemedicine now will likely benefit urologists in the long term.

Several platforms can be used to perform video visits. Most insurance companies require that the visit has an audio and visual component for real-time communication. A desktop, laptop, smartphone, or tablet can all be used as long as they have a webcam and microphone. The visit should be performed through a reliable and secure platform, which can be integrated into the electronic medical record or be a stand-alone product. Many platforms, such as Skype for Business, Updox, VSee, Zoom for Healthcare, Google G Suite Hangouts Meet, and Doxy.me meet HIPAA compliance requirements.

During the COVID-19 pandemic, the HHS Office for Civil Rights announced that providers can use non-HIPAA-compliant tools to deliver medical care. Because this federal rule may not impact individual state's laws, providers should prioritize a HIPAA-complaint platform. This will allow for sustainability of new telemedicine programs post-pandemic.

Billing and documentation for video visits

Physicians should follow standard guidelines for documenting and billing video visits, with three key differences. First, the physical exam for video visits will be limited. Although established patient billing criteria does not require a physical exam, the absence of a physical exam limits the ability to achieve Level 4 and 5 billing for established and new patients. Therefore, it is generally recommended that time-based billing be used and documented. Second, the claim should include a Place of Service = 02 or a modifier code (GT/95) to indicate the service was performed using telemedicine. While Medicare does not require a modifier code, several private payers require this code. Lastly, provider documentation should include that the visit was conducted via a live face-to-face video conference, the location of the patient (originating site), and the provider’s location (distant site).

Insurance reimbursement for video visits varies among payers. Most will reimburse for video visits, but coverage is limited to select locations. Historically, payers required patients to be physically located in a rural medical facility or a designated Healthcare Professional Shortage Area during the video visit. This requirement has been relaxed by many private payers, and coverage from any location (including the patient’s home) is common. In 29 states, Medicaid does not require patients to be in a specific location for the visit.

More states are permitting visits from home during the COVID-19 emergency (

see this page from the Center for Connected Health Policy

). Medicare has historically been the most restrictive on this requirement. However, during the COVID-19 pandemic, 

 and allows patients to connect from home.

Most states have specific policies regarding telemedicine use. These include documenting informed consent for telemedicine visits in the visit note, limiting some medication prescriptions (mainly narcotics), and requiring a medical license in the patient’s state of residence. The Center for Connected Health Policy 

 lists each individual state’s laws and policies alongside emergency laws during the COVID-19 crisis. Providers should understand their state’s policies prior to performing telemedicine visits. Although 

 that providers with an active non-restricted medical license can provide interstate care without a license in that state, 

some states require providers to submit an emergency application

 prior to practicing telemedicine in their state.

Providers should familiarize themselves with their video conferencing platform. We recommend conducting a mock visit to practice initiating and ending a visit and to test screen sharing to display radiology images or diagrams. Patients will invariably have some technical difficulties, and knowing how to troubleshoot with patients is crucial (eg, helping patients turn on video or unmute their microphone). Providers should conduct the visits from a secure location to ensure privacy. Headphones or earbuds may be needed.

Logistical workflow also requires thoughtful implementation to prevent frustration for patients and providers. We have our office staff contact the patient when scheduling the appointment to ensure that the patient understands how to download needed software and log in for the video visit. There are several 

 to walk patients through telemedicine setup. Many platforms allow for multiple users to join a visit, which can be used to involve family members or a professional language interpreter.

In some circumstances-the patient may not have the capability to perform a video visit, a scheduled video visit may fail, or a health system may not have invested in video visit infrastructure-a phone call may be used in lieu of a video visit. Due to the imperative to keep non-urgent patients at home during the COVID-19 pandemic, many providers are opting for telephone calls. Phone calls can be billed CPT 99441-3 and must include a time attestation. Typically, Medicaid does not reimburse telephone calls, though 

some states have made emergency exceptions

. For Medicare, G2012 is the appropriate code for telephone services 5-10 minutes long; there is no higher level for longer conversations.

The State of Emergency for the COVID-19 pandemic has created an environment where urologists can continue to safely provide care through telemedicine. We hope this article helps urologists successfully implement telemedicine and video visits. This will maintain safety both for our patients and for the health care workers in our offices.

Share your comments on this article by sending an email to 

"Given that most urologic outpatient visits are non-urgent, almost all in-person visits should be eliminated out of appropriate concern for COVID-19," advise Drs. Gadzinski, Ellimoottil, Odisho, Watts, and Gore.

Telemedicine in urology: A crash course during the COVID-19 pandemic

Urology Times reached out to three urologists (selected randomly) and asked them each the following question: 

Is MRI fusion Bx the new gold standard for diagnosing PCa?

“It hasn’t become the gold standard yet. There are still a lot of inter-reader reliability issues. The same MRI scans, read by different radiologists, may be read differently. That’s going to limit its broad application across the country as a whole and is a major issue.

Anecdotally, within our own practice we’ve seen that when a scan done in one facility needs to be translated for the fusion biopsy machine we utilize, we’ll get a different reading from the radiologist here than from the original radiologist. There’s a discrepancy between what the two radiologists see on the scan. That issue definitely needs to be worked out.

I expect some interesting data on that in the future. The PI-RADS system tries to standardize the readings, but there are still discrepancies between the different readers.

Working out the readability issue will make a difference. There will be patients who have a false-negative MRI but still have significant prostate cancer present. The data isn’t there yet that MRI fusion biopsy can be used as a rule-out test for someone with a very high suspicion of prostate cancer. It’s another data point as to whether someone needs a biopsy.

The gold standard is still a positive traditional biopsy, but that could evolve over the next few years.

The other issue is whether it gets broad acceptance from insurance companies. Some insurers approve it in the initial biopsy setting, but many do not. So that’s going to be the next point for broad applicability.

Still, I would say we’re definitely seeing an increased utilization of MRI for additional diagnosis of prostate cancer within our practice as a whole.”

"I don’t think they’re necessary for everybody"

“We don’t have MRI fusion biopsy available in our community, in our hospital, or in our office, so for an initial biopsy, we still do standard transrectal ultrasound biopsy in the office with ultrasound guidance. We may refer patients who need a second biopsy to a university center for MRI fusion for a second biopsy if they have persisting elevated PSA or other factors that are suspicious. It’s just not feasible for everybody to do MRI fusion yet. For the majority of urologists, it’s still not even commercially available.

Even if it were available, I’m not sure it would be our first choice yet. The yield is a little bit better, but our percentage yield of positive biopsies is pretty close to MRI fusion biopsies, at least in our practice. Our results differ by just 5% to 10%-not much.

I don’t think they’re necessary for everybody. As I said, we use them when we’re puzzled, when men have already had two or three biopsies, and we see them for consultations. In those situations, MRI fusion is a good next step.”

"I am still skeptical about MRI fusion because MRI quality varies so much nationwide"

“That’s a great question. At our center, probably 80% of biopsies are done the traditional way with a transrectal ultrasound-guided approach.

Practice patterns in our area and insurance coverage usually dictate that the patient with an elevated PSA who needs a first-time biopsy is not able to get an MRI covered by insurance. That may change over the next couple years, but now most initial biopsies are done the standard way.

I am still skeptical about MRI fusion because MRI quality varies so much nationwide.

A regular biopsy certainly is more efficient, less expensive, and takes less time in the urologist’s office. Fusion biopsy generally takes about twice as long as a standard biopsy. Fusion biopsies could easily create issues of having enough providers, nurses, and rooms to do all biopsies in a fusion manner on every patient with an elevated PSA. It’s resource intensive and expensive.

We initiated an important program with our primary care doctors to do a better job identifying younger men with elevated PSA, high-risk men, such as African-American men, and men with a family history of prostate cancer. That’s increased the number of men who need biopsies at our center.

I’d rather focus on reaching underserved men and not be totally swept away by the MRI craze, especially since some recent data shows that results from initial MRI fusion biopsies can vary greatly, even in clearly high-grade cases.

The other thing is, no one just does fusion biopsy. Every single fusion biopsy is associated with a regular biopsy. Why do all the doctors advocating fusion biopsy do fusion plus regular biopsy in everybody?”

“It hasn’t become the gold standard yet. There are still a lot of inter-reader reliability issues. The same MRI scans, read by different radiologists, may be read differently," says one urologist.

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

Active surveillance (AS) for low-risk prostate cancer is recommended as a viable or preferred option by most professional organizations, and it has gradually gained acceptance by most physicians who manage this condition. Several reports over the last two decades demonstrated the safety of AS for men with very low- or low-risk prostate cancer. An AS approach, unlike watchful waiting, still retains the option to treat, with an intention to cure, if treatment becomes necessary. The natural history of PSA-detected, early-stage prostate cancer is quite long, so long-term safety and efficacy of AS is of particular interest.

Tosoian et al report that AS in men with very low- or low-risk, Grade Group 1 prostate cancer appears to be quite safe, with risk of metastasis or prostate cancer-specific mortality (PCSM) of <1% 

Jan. 6, 2020 [Epub ahead of print]). In their large, prospective AS program, 1,818 men were enrolled after the initial prostate biopsy revealed very low-risk (1,293, 71%) or low-risk (525, 29%) prostate cancer.

After enrollment, the initial monitoring protocol included repeat prostate biopsy every year. Multiparametric MRI and mpMRI/ultrasound-fusion targeted biopsy were used since 2013 and 2014, respectively. Five hundred thirty-seven men (30%) underwent pre-enrollment mpMRI, with nearly half (47%) with a positive MRI requiring image-fusion targeted biopsy.

The study enrolled 1,818 patients from January 1995 through June 2018, with 920 men followed for ≥5 years and 305 men for ≥10 years. The median interval between biopsies was 13 months. The cumulative incidence of loss to follow-up at 3, 5, and 10 years was quite low at 3%, 4%, and 6%, respectively. Definitive treatment was offered to all patients with grade reclassification (Grade Group ≥2) on any subsequent prostate biopsy. Treatment or continued AS was offered to men whose repeat biopsy showed increase in volume of cancer (more than two positive cores and/or >50% involvement of a core).

Of the entire cohort, 92 men (5%) died at a median age of 80 years, and of those, 88 were due to non-prostate cancer causes. The cumulative incidence of all-cause mortality was 6.8% at 10 years and 28% at 15 years. Death due to prostate cancer was quite rare, with only four men (0.2%) dying of prostate cancer during the study period. The cumulative incidence of PCSM or metastasis was 0.1% at both 10 and 15 years.

Seven hundred twenty-seven men (40%) underwent biopsy grade reclassification, with the 5-, 10-, and 15-year incidence of grade reclassification of 21%, 30%, and 32%, respectively. The incidence of reclassification to Grade Group ≥3 was 7%, 10%, and 11%, respectively. Of the 693 men who underwent treatment, 78% were due to biopsy reclassification while 22% were due to change in preference. The 5-, 10-, and 15-year incidence of receiving definitive treatment was 36%, 48%, and 52%, respectively.

On multivariable analysis, pre-enrollment mpMRI was associated with a reduced risk of grade reclassification 

=.03). Factors associated with grade reclassification included older age, later year of diagnosis, African-American race, and increased PSAD, number of positive cores, and core involvement. Although the data showed that older age, African-American race, and measures of cancer volume, as well as use of pre-enrollment mpMRI were associated with an increased risk of grade reclassification, these variables did not appear to negatively impact any of the survival outcomes. There does not appear to be any strong rationale to limit African-American patients from enrolling in an AS protocol.

Because the mortality rate (overall and cancer specific) and metastases were so infrequent, the Grade Group reclassification was the most frequent outcome reported. Clearly, grade reclassification should not be viewed as an ominous event since these patients were captured through AS and treated, without negatively affecting their overall survival. Nearly 38% of patients underwent treatment, including those who had a change of heart about AS. No data are provided about the type of definitive treatment received by these patients. It would be instructive to know their pathologic outcomes, recurrence rates, or the need for secondary therapies.

Pre-enrollment mpMRI was associated with a decreased risk of biopsy grade reclassification during follow-up, especially if the mpMRI was negative. It’s not clear from this study whether the mpMRI was used “during” AS and how often. It will be interesting to learn whether these patients with pre-enrollment and/or surveillance mpMRI benefitted in terms of fewer subsequent biopsy sessions or fewer cores taken.

The monitoring protocol reported by the authors is quite stringent, with frequent (annual) repeat biopsies. As active surveillance protocols for low-risk prostate cancer become more widely accepted, there are justifiable concerns about the AS-related morbidity of intensive monitoring. It’s likely that a less invasive surveillance protocol, incorporating better imaging (eg, mpMRI) or genomic testing and fewer biopsies, will not adversely impact the excellent survival outcomes while making AS a more readily acceptable option for low-risk prostate cancer.

"Death due to prostate cancer was quite rare, with only four men (0.2%) dying of prostate cancer during the study period," writes Badar M. Mian, MD.

Surveillance safe for patients with Grade Group 1 prostate Ca

Some 15% of men with metastatic castrate-resistant prostate cancer have a clearly identified germline genetic inherited component to their disease, and these patients may soon benefit from new treatment options. In this interview, Leonard G. Gomella, MD, discusses the increasingly important role genetic testing plays in prostate cancer, current obstacles to testing, and when and how it will be carried out.

Dr. Gomella is professor and chair of urology at Thomas Jefferson University and senior director for clinical affairs at the Sidney Kimmel Cancer Center, Philadelphia. He was interviewed by Richard R. Kerr, content channel director of 

Currently about what percentage of patients with prostate cancer have an identifiable inherited component to their disease?

While the majority of prostate cancers are sporadic, approximately 30% of prostate cancers can be identified as being inherited or familial in nature. Prostate cancer is connected genetically to mutated genes that also increase the risk of melanoma, pancreatic, breast, and ovarian cancer not only in the individual but within the family as well.

When you get down to specific clinical situations in prostate cancer, about 15% of patients with metastatic castrate-resistant prostate cancer have an identified germline genetic inherited component. In localized prostate cancer, about 5% of patients have an identifiable genetic component. These numbers in localized disease may not seem big, but these are the patients who are likely to progress to life-threatening prostate cancer and this group is now receiving increased research attention.

There are new therapeutics being developed for advanced prostate cancer that are based on genetic testing. One such example is the poly (ADP-ribose) polymerase (PARP) inhibitors. PARP inhibitors stop the PARP from repairing cancer cells and cause the cells in the presence of a mutated DNA repair gene to die. When the PARP inhibitors get approved for the treatment of advanced prostate cancer they will require a companion diagnostic test that will have to show that the patient with metastatic castrate-resistant prostate cancer has a specific germline mutation to be eligible for treatment.

What have been the major developments in prostate cancer genomics and germline testing in particular over the last year or two?

What we’re seeing is that patients with advanced and aggressive prostate cancer are increasingly undergoing germline genetic testing for inherited prostate cancer risk, not only in the individual but also in their family members. Testing other family members for an inherited cancer risk is known as “cascade testing.” More medical organizations are advocating that men who have 

, and related abnormalities should be aggressively screened for prostate cancer. This is a big take-home message over the last few years.

Our colleagues in Europe, particularly in England, who have done extensive population studies, are promoting this. They’ve shown that if a man has one of these inherited abnormalities in the DNA repair pathway-

 are the highlights right now but there are others-he should undergo more focused screening for prostate cancer than a man who does not have such abnormalities.

Today, how does a man without a diagnosis of prostate cancer come to be identified with one of these mutated genes? Most likely he has a relative who has had aggressive prostate cancer and has undergone genetic testing or he’s had a female first-degree relative-mother or sister-who had hereditary breast or ovarian cancer, and it’s been recommended based on a family pedigree that he undergo germline genetic testing.

Discussing the second International Prostate Cancer Consensus Conference

The second International Prostate Cancer Consensus Conference was held in Philadelphia in October 2019. The meeting emphasized implementation of genetic testing for inherited prostate cancer. What have been the major developments in how genetic testing is implemented?

The second International Prostate Cancer Consensus Conference focused on the practical aspects of testing for these genetic alterations in men with prostate cancer. The consensus sought to optimize testing strategies integrating evolving genetic data and growth of panel options, recommend consistency in testing indications and genetically based management, and identify alternate evaluation models addressing a shortage of genetic services.

How should men with prostate cancer be evaluated for the need to undergo genetic testing? Ideally, a provider identifies a patient as having a potential genetically inherited mutation that predisposes to prostate cancer or the patient has an advanced or aggressive cancer. A prostate cancer genetic panel can be ordered, or the patient can be referred to a genetic counselor.

The reality is that not all men with prostate cancer need to undergo genetic testing. In the ideal setting, a genetic counselor would go over the characteristics of the individual’s tumor, the family pedigree, and what other cancers may be in the family and come up with a reasonable approach to testing. There would be a recommendation for the individual to undergo genetic testing or for genetic testing in family members.

How should we handle genetic testing when there is currently limited access to genetic counselors in the United States who have expertise in prostate cancer? The fact is that we have a nationwide shortage of genetic counselors. What alternative evaluation models are needed was a central theme of our second consensus conference. Many genetic testing reference labs have helped to deal with this limitation by providing basic initial genetic consultation by phone.

What are some of the current best practices in the use of these tests?

Right now, the best practices are genetic testing in men with advanced metastatic castrate-resistant prostate cancer, metastatic prostate cancer, and newly diagnosed prostate cancer with adverse features. Organizations supporting genetic testing for this group of high-risk men include the National Comprehensive Cancer Network (NCCN). As noted, the PARP inhibitors, which are already available and FDA approved for ovarian and breast cancer, are a significant driver of this. We’re now looking for PARP inhibitors to be approved, probably sometime in the first half of 2020, for metastatic castrate-resistant prostate cancer.

The PARP inhibitors are found to be most effective in cases where the patient has an inherited mutated gene in the 

and other DNA repair pathway. The approval for the PARP inhibitors will include pharmacogenomic testing to e determine eligibility for these drugs. From a best practice standpoint, using genetic testing in men with advanced castrate-resistant prostate cancer is a good approach because it will give men with difficult-to-manage prostate cancer more options, including participation in clinical trials.

Does genomic testing have a role beyond metastatic disease?

We’re really just beginning to explore that. If a patient has high-risk prostate cancer-a very high Gleason score, high PSA, advanced clinical stage, adverse features, or intraductal carcinoma-while his cancer might not yet be metastatic or castrate resistant, NCCN guidelines indicate he should undergo genetic testing. What’s happening, as with everything in medicine, is that you start with the most advanced clinical scenarios and then begin to investigate earlier stages of a disease.

I believe one of the most exciting areas for genomic testing is the area of active surveillance. One paper in particular by Dr. Ballentine Carter from Johns Hopkins looked at doing genetic profiling on men who are in active surveillance 

 It showed that if you have an altered inherited DNA repair pathway gene like 

, you are more likely to fall off the active surveillance pathway because of grade progression on subsequent biopsy.

Did the consensus conference address gaps in prostate cancer guidelines?

We identified a series of priority genes that should be used to direct precision treatment of prostate cancer such as 

, and other mismatch repair (MMR) genes. In non-metastatic PCA, consensus testing recommendations emerged encompassing personal, pathologic, and family history criteria. Priority genes for active surveillance discussions primarily focused on 

. Our 2019 consensus paper is currently in press in the 

 and we are hopeful that the recommendations of our interdisciplinary group will help address issues in prostate cancer guidelines. The NCCN has been very good at rapidly responding to new developments and updating their recommendations in this area over the last 2 years.

What other issues were discussed at the consensus conference?

There was a great deal of discussion about the best way to share the information from genetic testing with the patient and the best way to counsel them. The federal GINA (Genetic Information Nondiscrimination Act of 2008) laws protect individuals from health insurance and employment discrimination who have undergone genetic testing. Providers who are ordering genetic testing should be aware that these laws may not apply to patients who are interested in long-term health care, disability insurance, and related issues.

An area of group discussion centered on whether genetic testing should be done reflexively. Or should you actually have informed consent before the test is ordered? A focus of this discussion was the fact that we have such a significant shortage of genetic counselors in the United States, and we need to look at genetic testing alternatives until we build up an adequate pool of genetic counselors.

How are practicing urologists being educated about genetic testing for prostate cancer?

I recommend keeping up with the latest NCCN guidelines. I don’t think urologists are as engaged in this area as other medical specialists because genetic testing came into our clinical practices very quickly. The department of urology at the Sidney Kimmel Cancer Center conducted the first international consensus on genetic testing for inherited prostate cancer risk in 2017 because we realized that scientific information was coming at a very rapid rate, but it was not being acted upon in general urology practice. I believe we need to improve training of our residents, in particular, in this area.

Providers who are trained in medical oncology tend to have more background in this area, simply because breast and ovarian cancer are so far ahead of prostate cancer in the genetic testing world. Most fellows who are completing medical oncology training have had some formal genetic counseling and testing experience because of the well-established world of breast cancer genetic testing.

We are very interested in having urologists get up to speed and include genetic testing in our training programs. The Society of Urologic Oncology and the AUA have partnered in educational programs in advanced prostate cancer for residents, fellows, advanced practice providers, and practicing urologists. We have incorporated educational modules that address genetic testing and what are the best practices today. We need to do more to have urologists engaged considering the PARP inhibitors are oral agents that many urologists who treat advanced prostate cancer will begin to prescribe.

Who should be conducting genetic testing for prostate cancer?

Most urologists outside of major medical centers don’t have easy access to prostate cancer-trained genetic counselors and can easily order genetic panel testing from a variety of commercial labs. Urologists are used to asking male patients if their father or grandfather or brothers had prostate cancer. We can’t just ask those family history questions anymore. We’ve got to expand our questioning and ask about pancreatic, breast, and ovarian cancer, melanoma, as well as Lynch syndrome and colorectal cancer. The urologist needs to start asking these questions and identify that a patient may have a familial hereditary or potentially inherited form of prostate cancer. (Also see, 

“Hereditary vs. inherited prostate cancer")

Do we know yet precisely which genetic mutations to look for in prostate cancer, or is that a work in progress?

There are a lot of candidate genes; the list includes at least 20 or 30 genes. We have what I would call the “top” mutated genes, most of which are DNA repair pathway abnormalities: 

We certainly don’t have all the genes identified yet. If you look at the commercial prostate cancer panels, most will have a core of those 10 to 12 most common genes, but many of the genetic testing companies test for many more genes than that. Unfortunately, we still don’t know how to interpret a lot of those other genes, specifically when it comes to prostate cancer. (See table on page 20 that summarizes some of the most common mutated genes that increase prostate cancer risk.)

Are there genetic tests for prostate cancer that are in development and might become commercially available?

There is considerable work being done with single nucleotide polymorphism (SNP or “snip”) tests. These tests look not necessarily at identified genes that are mutated but at identified variable DNA sequences-SNPs associated with prostate cancer. Some researchers feel that looking at a few short sequences of DNA as opposed to a whole known gene may be more useful in some patients. Those tests are just becoming available.

Is there anything else you would like to add?

This is an area that is exploding in urology, and urologists need to keep abreast of what’s happening. We are working on alternatives to identify ways to address a shortage of genetic services. At the Sidney Kimmel Cancer Center, our team members are involved in graduate training programs and are developing an app to help medical oncologists and urologists potentially screen patients for appropriate prostate cancer genetic testing.

It’s important to draw a distinction between hereditary and inherited prostate cancer, according to Leonard G. Gomella, MD.

“Hereditary prostate cancer is a much broader umbrella that suggests there may be genetic alterations that are passed down from generation to generation that may increase the risk of developing an aggressive prostate cancer or other cancers known to cluster in families,” Dr. Gomella said. “Inherited prostate cancer, by comparison, involves genes such as the 

gene, a gene in family members where multiple younger men develop aggressive prostate cancer. Most of the mutated genes we’re talking about in prostate cancer are DNA damage response genes-

, and others. They can result in increased heredity prostate cancer risk or may simply suggest that there may be something going on in the family that increases the risk of other associated cancers in multiple family members.

“It’s also important to point out that these mutated genes do not cause prostate cancer,” he pointed out. “This is a common misconception. They don’t cause the cancer, but it turns out if you have one or more of these of these mutated genes, it does something to make prostate cancer a more aggressive, more lethal form.”

In this interview, Leonard G. Gomella, MD, discusses the increasingly important role genetic testing plays in prostate cancer, current obstacles to testing, and when and how it will be carried out.

Genetic testing’s role centers on advanced prostate cancer

Unhealthy eating, like that associated with the Western diet, is associated with notably worse semen quality and less favorable testicular function than healthier eating patterns, according to a study of nearly 3,000 young Danish men published in 

Researchers at Harvard T.H. Chan School of Public Health, Boston performed a cross-sectional study of men in Denmark (median age, 19 to 20 years) who didn’t know their fertility status and had filled out a validated food frequency questionnaire. The authors assessed semen quality and concentrations of total and free testosterone, estradiol, inhibin B, follicle-stimulating hormone, luteinizing hormone, and sex hormone-binding globulin. They also studied testicular volume.

“This study is the largest study to date to examine diet pattern with men’s testicular function,” said study co-author Feiby Nassan, ScD, MBBCH, MSc, a research associate at the Harvard T.H. Chan School of Public Health who worked on the study with Niels JÃ¸rgensen, MD, PhD, and colleagues.

Decline of semen quality is a growing concern in men around the world. Total sperm count among men in Western countries fell by 50% to 60% from 1973 to 2011, according to a meta-analysis of 185 studies published in 

Why this is happening is a topic of debate. And while authors are looking at environmental exposures, such as pollution, and behavioral factors, such as smoking and alcohol consumption, they say few have looked at diet quality as a possible cause.

Dr. Nassan and colleagues identified four popular dietary patterns: the largely unhealthy Western diet, with staples such as pizza, processed and red meats, refined grains, and sweets; the generally healthy prudent diet, emphasizing fish, chicken, vegetables, fruit, and water; the traditional Danish open-sandwich pattern, featuring consumption of cold, processed meats, whole grains, mayonnaise, cold fish, condiments, and dairy; and a vegetarian-like pattern, which avoids red meat and chicken and emphasizes vegetables, soy milk, and eggs.

They found that men consuming a Western diet had the lowest total median sperm count at 122 million. Men consuming foods associated with the prudent pattern had the highest median total sperm count at 167. Median sperm counts were 151 million for the vegetarian-like and 146 for the open-sandwich patterns.

Average sperm counts varied within the categories. For example, men in the highest quintile of Western diet consumers had an average 26 million sperm count lower than men in the lowest quintile of Western diet eaters. And those that adhered most to the prudent pattern, the highest quintile, had an average 43 million more sperm than prudent eaters in the lowest quintile.

Men who highly adhered to the open-sandwich pattern had higher counts of motile spermatozoa, while those who consumed a vegetarian-like pattern were more likely to have more morphologically normal spermatozoa compared to men in other dietary categories. Further, men in the highest quintile of Western diet consumers had lower serum inhibin B concentrations and ratios of inhibin B to follicle-stimulating hormone than men in the lowest quintile of Western diet eaters.

Hormone results ‘difficult to explain’

“The hormone results are difficult to explain. Men who had the highest adherence to the Western pattern had higher testosterone concentrations, compared with men with less adherence. But they also had the highest estradiol concentration with unchanged luteinizing hormone levels,” Dr. Nassan said. “This could be due to increased aromatization of testosterone to estradiol and could have resulted in increased negative feedback at the hypothalamic level. If this is correct, this might also explain why follicle-stimulating hormone was not sufficiently higher as a compensation for the lower inhibin B concentration.”

The authors speculated that adherence to the Western diet pattern, at least in part, could lead to reduced hypothalamic activity, which could explain the observed reduction in spermatogenesis, according to Dr. Nassan.

“In addition to this possible explanation, the lower ratio of inhibin B to follicle-stimulating hormone, itself, could also explain a direct adverse effect on the testicles,” she said.

A take-home for urologists, according to Dr. Nassan, is that it may be useful for men’s fertility to follow a generally healthy diet with higher intake of fish, chicken, vegetables, fruit, and water, while cutting back on pizza, French fries, processed and red meats, snacks, refined grains, high-energy drinks, and sweets.

“Patients usually come to your clinics asking those questions about what they should eat and what they should avoid to boost their fertility. Peer-reviewed evidence is limited to answer these questions. This study provides some evidence of the benefits of the generally healthy diet patterns that you could advise your patients to follow-especially the ones whose fertility may need a nudge and may benefit from such diets,” she said.

A limitation of the study is its cross-sectional design, as the authors cannot imply causation from the work.

“However, this does not mean that this association is not important. Many scientific groups, including ours, are working to further study the role of diet and environment on fertility. However, I do not think we have to wait until the perfect controlled blinded clinical trial to happen until we change behavior. In addition, many other studies have suggested consistent results with other health outcomes, so we really have little or nothing to lose if we follow a generally healthy diet,” Dr. Nassan said.

Unhealthy eating, like that associated with the Western diet, is associated with notably worse semen quality and less favorable testicular function than healthier eating patterns, according to a study of nearly 3,000 young Danish men published in JAMA Network Open (2020; 3:e1921610).

Unhealthy diet associated with poor semen quality

The shift from fee for service to value-based care and reimbursement may be happening faster than some physicians like and slower than most payers would like. While urologic care is estimated to comprise only 2% of the “health care spend” in the U.S., it may not logically follow that urologists will delay or escape the consequences of oversight, scrutiny, and policies of government and commercial payers.

The increased burden of preauthorization faced by many physician practices is but one sign that payers are watching the dollars closely. Another trend is the availability of your practice and physician data in the public domain. In this article, I will review the concept of “utilization review” in the modern context and describe how you can gain insights into how payers and other stakeholders view your own practice.

Utilization review in health care dates to the 1970s and was defined by Merriam-Webster then as “a critical evaluation of health care services provided to patients that is made especially for the purpose of controlling costs and monitoring quality of care.” The term evokes an image of a nurse, or an entire department, in a hospital poring over individual charts in the pursuit of reducing the cost of care in the hospital. Others may think of utilization review as a mechanism used by payers to systematically delay or deny care.

In the modern context, utilization review is more likely to be conducted by examining large data sets looking for service patterns, outliers, or comparisons to a benchmark that can help lead to better “value.”

One example familiar to many urologists is the American Board of Urology’s collection of practice logs from diplomates during the maintenance of certification process. According to the ABU’s website 

 “the practice logs allow the trustees to be certain that the Diplomate has a sufficient case load to maintain their skills. Most importantly we have the opportunity to provide feedback to the Diplomate.”

Another example is the publication of utilization and payment data by physician in the Medicare program 

 Medicare also publishes Part D prescriber data for individual physicians 

 and drug utilization and cost data. Commercial private payers have their own physician utilization data, though they do not usually publish it. Other companies collect pharmacy dispensing data, claims submission and remittance data, pharmaceutical sales data, and more-at the physician level. Many companies understand your utilization, payment, and prescribing data much more thoroughly than you might think.

How can you begin to understand your practice-as it is reflected in how much you “cost” those paying for the care-as well as these outside entities? The process begins with access to your claims data-something that almost all practice management systems allow in the application, with an inexpensive reporting module, by employing a third party with very basic database skills, or by using a commercial platform.

The next step that can be very helpful and save time is determining what question you would like to answer. For example, the data extracted for a review of procedures for stone surgery might be completely different than that needed for a comparison of physician in-office administration of injectable medications. By thinking through the purpose of your review and how you would act upon the results of that review, you can streamline the analysis, find your answers faster, and put that knowledge to work.

A common challenge in understanding utilization of health care services is comparing apples to apples. Building on the example of utilization of stone surgery, raw claims data are likely to show some physicians perform more surgery than others-perhaps by an order of magnitude (10 times) in a large practice. This information by itself is of limited use and needs to be calibrated to some reference common to the physicians being compared.

For example, the rate of stone surgery per unique patient with a diagnosis of a ureteral or renal stone might provide the necessary indexing to make a better comparison. The Quality Payment Program levels its comparisons of episode costs using risk adjustment. Commercial payers often index their utilization metrics simply to number of beneficiaries, and you can do the same.

Another challenge in using utilization data is finding a definition of average, normal range, or outlier for comparison-a benchmark. Benchmarking in health care can be internal to an organization (such as comparing physicians in one practice) or external to an organization (such as comparing your urology practice to hundreds of others across the country). Statistical methods used in benchmarking include comparisons to mean, median (the midpoint of data or 50th percentile), rank, or decile. Medicare’s Quality Payment Program uses deciles in the Quality, Cost, and Promoting Interoperability categories to determine relative performance.

The median or 50th percentile is often a better point of comparison than the mean in health care data, which may not always follow a “normal” distribution. Available sources for external benchmarking of claims data include Medical Group Management Association survey data 

 Medicare public use files mentioned earlier, the Quality Payment Program (limited at this point), and commercial platforms.

Perhaps the biggest challenge is once you understand your utilization data, you will need to decide what to do about it. Some decisions may be easy; if you have a large practice and a single outlier, your data and internal benchmarking may convince the outlier physician to examine and change their practice. Other decisions may be more difficult and require an external credible benchmark to support a crucial conversation. The larger that benchmark, the more closely you can understand the perspective of a large payer. The underlying premise for understanding and acting on your utilization data is the knowledge that this information is available, and being used, by the sources of revenue for your practice.

Bottom line: Your utilization data are widely available and understood by the federal government, commercial payers, and commercial data aggregators. Improving your literacy with your own data will position your practice to better face the challenges of value-based care and reimbursement.

"Many companies understand your utilization, payment, and prescribing data much more thoroughly than you might think," writes Robert A. Dowling, MD.