Congress has been urged to reject a proposal by the Medicare Payment Advisory Commission to ditch the fledgling Merit-based Incentive Payment System (MIPS) quality program that was established in 2015 as part of a plan to replace an outdated physician payment system that annually threatened deep cuts in provider payments.

In testimony before the House Energy and Commerce Committee’s Health Subcommittee July 26, ophthalmologist Parag Parekh, MD, representing the Alliance of Specialty Medicine, said the MIPS program “provides the only mechanism for many specialists and subspecialists to engage in federally-sponsored quality improvement and demonstrate their commitment to deliver high-value care.”

The hearing on MIPS came just a week after 11 members of the AUA met with members of Congress as part of an Alliance “fly-in” to advocate on key federal issues, including the need to retain and strengthen MIPS.

AACU, UROPAC continue to gain momentum on the Hill

The AUA delegation met with 18 Senate and 35 House of Representatives offices and represented urologists from Arizona, California, Louisiana, Maryland, Minnesota, New York, North Carolina, Pennsylvania, and Tennessee. In addition to stressing the need for maintaining a viable fee-for-service option for MIPS, they also expressed support for the Local Coverage Determination Clarification Act, Prior Authorization/Step Therapy reform, the U.S. Preventive Services Task Force Transparency and Accountability Act, the Resident Physician Shortage Education Act, and medical liability reform.

“No other clinician, provider, or health care professional can replace the value offered by specialty physicians,” Dr. Parekh told subcommittee members during the hearing. “To that end, MIPS must be implemented successfully and set up for long-term viability since it will be the only option for many of these specialists to engage in pay-for-performance given they will have no other option than to remain in fee-for-service.”

MIPS is one of two reimbursement tracks established by Congress under the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). In the second track, physicians can participate in Advanced Alternative Payment Models (APMs) and potentially earn incentives and increased reimbursement. Although some specialty organizations, including LUGPA, are working to establish APMs for specific services, reimbursement for most services by most urologists will fall under MIPS.

Dr. Parekh noted that several Alliance member organizations working on developing APMs have been told by officials at the Center for Medicare & Medicaid Innovation that models centered on primary care were the agency’s priority.

“It is frustrating to be viewed as a costly part of the Medicare program,” said Dr. Parekh, “while simultaneously being turned away when we present proactive, innovative solutions and proposals.”

Despite that frustration, Dr. Parekh said MIPS allows specialists without suitable Advanced APM opportunities “a fair opportunity to remain in fee-for-service while continuing to measure, report, and improve performance on key areas of clinical quality improvement initiatives, and more importantly, continue to deliver high-quality care to America’s senior and disabled population.”

Starting in 2019, the quality incentive programs that existed prior to MACRA, including the Physician Quality Reporting System, Meaningful Use, and the Value-based Payment Modifier, will be combined and streamlined into a single new value-based payment system.

Utilizing tools like electronic health record technology and qualified clinical data registries, eligible professionals will transition to MIPS as the sole quality reporting system. As part of this adjustment, the penalties associated with the old incentive programs expired. Under MIPS, eligible professionals’ reimbursement will be adjusted based on four categories: Quality, Cost, Advancing Care Information, and Improvement Activities.

Each eligible clinician reporting to MIPS will be given a composite score based on performance in these categories, based on a scale of 0-100. Each year, the Department of Health and Human Services will establish a performance threshold in the form of a mean or median composite score. The score for 2018 was set at 15, rising to 30 for 2019 under the Centers for Medicare & Medicaid Services' proposed rule for revisions to the Medicare Physician Fee Schedule for calendar year 2019.

Dr. Parekh said in his testimony to the subcommittee the Alliance supports technical corrections approved by Congress for the MIPS program in the Bipartisan Budget Act of 2018. They include:

providing CMS 3 additional years of flexibility to determine the appropriate weight of the MIPS cost category based on the availability of relevant measures. “A significant amount of work remains to be done to ensure that new episode-based cost measures are developed and integrated in a way that accurately reflects the complexities of cost measurement and does not inadvertently discourage clinicians from caring for high-risk and medically complex patients,” he said.

provisions allowing CMS to more gradually increase the MIPS performance threshold year-over-year to give physicians the opportunity to implement necessary practice changes as they gain experience and to be certain that practices with fewer resources are not negatively impacted

elimination of Medicare Part B drugs and other items and services outside the physician fee schedule from the MIPS payment adjustments and determination of MIPS eligibility.

Nevertheless, Dr. Parekh said, additional refinements to MIPS are still needed to reduce the administrative burden and costs that must be borne by physicians.

Antitrust case may impact physician referrals

“A more simplistic and applicable approach will ensure not just greater clinician engagement, but more purposeful engagement,” he said, adding that the Alliance supports “practical solutions that would lessen the complexity of MIPS scoring.”

He said the Alliance supports a proposal by CMS to reduce the number of objectives and measures that physicians would report to be meaningful users of certified electronic health record technology, eliminate the “convoluted scoring construct,” and focus exclusively on a clinician’s performance on a more limited set of measures.

“If finalized,” he said, “these modifications will make a meaningful difference in the ability of many specialists to engage in the MIPS promoting interoperability performance category.”

The hearing was the committee’s fourth oversight session since passage of MACRA in 2015. Additional hearings will be held as CMS continues to implement the program.

Articles

"[The MIPS program] provides the only mechanism for many specialists and subspecialists to engage in federally-sponsored quality improvement and demonstrate their commitment to deliver high-value care," says Parag Parekh, MD, of the Alliance of Specialty Medicine.

Specialties to Congress: Don’t ditch MIPS

One of my colleagues tells me that he is billing a urethral suspension at the same time he does his laparoscopic radical prostatectomy and is getting paid by Medicare. That seemed too good to be true since a suspension could be performed on every patient. Is it OK to bill a suspension with a radical prostatectomy?

Good question. Unfortunately, it deserves several answers. According to the National Correct Coding Initiative (NCCI), Medicare’s bundling edits, the two codes (55866 - Laparoscopy, surgical prostatectomy, retropubic radical, including nerve sparing, includes robotic assistance, when performed) and 51990 (Laparoscopy, surgical; urethral suspension for stress incontinence) are not bundled and can be charged together without a modifier.

However, we have several concerns about billing for the urethral suspension at the same time you perform a radical prostatectomy in a patient who did not have a preoperative incontinence problem necessitating the suspension. First and foremost, by law, Medicare cannot pay for preventive services unless specifically enacted by Congress. That means Medicare could ask for their money at a future date if a record review resulted in the determination that the service was not medically necessary at the time the service was performed.

The AUA has also reviewed this issue and indicated in a Policy and Advocacy Brief published May 3, 2017 that reporting the suspension with a prostatectomy should be reserved for those patients with an existing diagnosis of incontinence.

Medicare proposed rule outlines significant changes

Considering both the current policy interpretation risk and the AUA position, we feel it’s important to highlight the concern for future bundling edits. If a high percentage of the radicals are billed with urethral suspension, then it is likely to be bundled in the future and it is possible that it will be tagged with an indicator that will not allow unbundling, closing the door on appropriate billing for those patients with existing incontinence.

Consider this similar situation: Initially, 51800 (Cystoplasty or cystourethroplasty, plastic operation on bladder and/or vesical neck [anterior Y-plasty, vesical fundus resection], any procedure, with or without wedge resection of posterior vesical neck) was not bundled with 55845 (Prostatectomy, retropubic radical, with or without nerve sparing; with bilateral pelvic lymphadenectomy, including external iliac, hypogastric, and obturator nodes), and many physicians were billing the two together. Currently, they are bundled and cannot be unbundled.

In summary, yes, the two procedures can be billed and should be paid. However, we recommend you do not bill, unless the patient has incontinence and the need for the suspension prior to surgery.

My question is about the use of the −59 modifier. I was taught that if two procedures were performed and the bundling edits stated they could be billed with the modifier, you should add the modifier in order to get paid. My understanding from a friend who attended your seminar is that just because the bundling edits indicated you could unbundle with the modifier does not mean that you always should unbundle with a modifier. What is correct?

Codes that are included in the NCCI bundling edits with an indicator “1” allow for unbundling if circumstances support that the service is distinct. The computer recognizes that there is special circumstance only if the modifier is appended to the code.

The NCCI is developed using Medicare data with review by a contracted entity. In order to add a modifier to any procedure, the documentation should clearly indicate that the procedure meets the definition of the modifier. Private payers may use modified versions of the NCCI data with additional restrictions or allowances.

NP, PA incident-to billing: What is (and isn’t) allowed

The −59 modifier CPT definition is as follows:

Distinct Procedural Service: Under certain circumstances, it may be necessary to indicate that a procedure or service was distinct or independent from other non-E/M services performed on the same day. Modifier −59 is used to identify procedures/services, other than E/M services, that are not normally reported together, but are appropriate under the circumstances. Documentation must support a different session, different procedure or surgery, different site or organ system, separate incision/excision, separate lesion, or separate injury (or area of injury in extensive injuries) not ordinarily encountered or performed on the same day by the same individual.

Breaking down the definition, there are five separate circumstances in which modifier −59 should be used: different session on the same day, different site or organ system, separate lesion or injury, separate incision/excision, or different procedure or surgery.

Medicare does not pay for a different procedure or surgery-this is one of the reasons, therefore, that we recommend that you use the −X (E, S, P, or U) modifiers for Medicare:

As with most coding discussions, it all starts with documentation supporting the services billed. If the operative note does not clearly support one of the definitions above, any denial will be difficult to appeal and once a payer determines that the practice is not appropriately using the modifiers reported, more denials will follow.

Therefore, in our seminars we teach that documentation and circumstances noted must drive correct coding. If the second procedure is a component of the first procedure, is performed to facilitate the first procedure, or the documentation does not support one of the five definitions of the circumstances by which it should be used, then you should not charge for the second procedure with a modifier even if it is allowed by the NCCI.

Send coding and reimbursement questions to Ray Painter, MD, and Mark Painter c/o Urology Times, at 

 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.

"If a high percentage of the radicals are billed with urethral suspension, then it is likely to be bundled in the future and it is possible that it will be tagged with an indicator that will not allow unbundling," write Ray Painter, MD, and Mark Painter.

Can you bill a urethral suspension with radical prostatectomy?

Should I still hold bonds in my portfolio while there continues to be talk of the Fed raising interest rates?

In June the Federal Reserve, commonly referred to as the Fed, raised interest rates for the second time in 2018. During the announcement, the Fed also indicated rates may rise another two times before the year is over. While generally a signal that the economy is strengthening, it also means that rates on credit cards, home equity loans, and other types of borrowing will increase. Another common side effect of rising interest rates is that the price of existing bonds and bond funds generally fall. Many investors own bond positions as part of their diversification strategy; therefore, it is important to understand how rising interest rates may affect investment portfolios.

Individual bonds, bond mutual funds, and exchange-traded funds react differently to rising interest rates. Individual bonds pay a stated interest rate until they mature so, when held to maturity, investors are spared the impact of price fluctuations caused by rising interest rates. However, if investors want to sell a bond before its maturity, they may have to do so at a discount. Why? Now that interest rates have increased, potential buyers can purchase that same face-value bond on the open market and receive a higher interest rate. To entice buyers to purchase your (now) less valuable bond, you must offer it at a discount with still no guarantee you can sell it.

Donor-advised funds offer several advantages for charitable giving

 rates don’t affect all bonds equally either. Generally speaking, the longer the 

, the more it’s affected by changing interest rates. For example, a bond that matures in 20 years will usually lose more of its value if rates go up than another bond that matures in 5 years. Also, the lower a bond’s “

 is to changes in interest rates. For example, a bond with a coupon rate of 3% will experience more price fluctuation than a bond with a coupon rate of 5%.

The lower the coupon rate, with all other things being equal, the less valuable the bond is and the bigger the discount that needs to be applied if the intention is to sell the bond.

Bond mutual funds and exchange-traded funds react a little differently to rising interest rates than individual bonds. Since a 

 date, often the fund’s total return will go down. Total return encompasses both change in prices and 

 rate payments. If interest rates rise, the values of bonds held by the fund fall, negatively affecting total return. However, the fund continues to receive interest payments from the bonds it holds and will pass those along to investors regularly, maintaining 

Even in a rising-rate environment, owning bond funds may make more sense to some investors. For example, bond funds tend to offer greater ability to sell at a given price, if you need to, on any given day, and more diversification relative to individual bonds.

"Whether you own individual bonds or bond funds, rising interest rates could create some short-term difficulties"

Whether you own individual bonds or bond funds, rising interest rates could create some short-term difficulties. If an individual bond needs to be sold to increase cash flow or provide retirement income, it may need to be sold at a discount to attract a timely buyer. If you have bond funds, the short-term total return may be reduced. If you rely on payouts from these funds to supply your retirement income, you may need to replace the lost income from other sources.

Take advantage of compounding interest when saving for retirement

Overall, bonds and bond funds remain an important investment asset and an integral part of a well-diversified portfolio. However, now may be a good time to speak with your financial adviser to discuss the role bonds play in your portfolio and if any changes should be made.

How often should I be speaking with my financial adviser?

Many advisers like to speak with their clients every financial quarter. This is a good time to discuss changes that may have occurred over the last 3 months in your personal life, stay up to date on the performance of your accounts, and discuss planning needs that you foresee in the near future. At a minimum, it is important to speak with your financial adviser once a year. They need to remain updated on changes in your life so they can evaluate whether your current wealth management strategy is still appropriate for your circumstances. They are there to be a resource for you. Take advantage of their expertise.

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

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

Selling a bond prior to maturity may require offering a discount, according to Jeff Witz, CFP.

How can rising interest rates affect your bond portfolio?

In this Urology Times Q&A, Jessica Nelson, MPAS, PA-C, past president of the Urological Association of Physician Assistants (UAPA), offers a physician assistant’s perspective on PAs performing urologic procedures, PA training, and more. Nelson works in the department of urology at UT Southwestern Medical Center in Dallas. She was interviewed by Urology Times Correspondent Lisette Hilton.

What is UAPA’s position on the use of PAs performing urologic procedures? 

Currently the board has not taken a stand or published a formal statement regarding PAs performing urologic procedures. PAs legally function under the delegatory authority of physicians. Therefore, PAs can perform procedures within their training and scope of practice if delegated by a physician.

UAPA members are known to perform cystoscopy (diagnostic, therapeutic, catheter placement, and stent removal); hormone pellet insertions; intracavernosal injections and irrigations; transrectal ultrasound, with or without prostate biopsy; posterior tibial nerve stimulation; bladder Botox injections; circumcision; vasectomy; and first assisting in surgery. UAPA would encourage PA-physician teams to practice in accordance with state law and for the physician to delegate activities that are in their scope of practice and can be safely delegated as determined by the skill of the PA.

Is there interest among urology PAs in practicing independently from urologists?

PAs have never described the goal of the profession to “practice independently” of a physician. In May 2017, the American Academy of Physician Assistants published a policy change describing Optimal Team Practice 

 and the policy emphasizes the PA’s commitment to team practice. UAPA supports the call for physicians and PAs to make practice-level decisions to improve patient access to care and to optimize patient outcomes in light of the challenges facing the specialty regarding adequate work force.

Looking at the data from National Commission on Certification of Physician Assistants, from the standpoint of all practicing PAs, the most popular specialties for PAs are family medicine/general practice (19.9%) followed by surgical subspecialties, which include orthopedic surgery, cardiothoracic surgery, and neurosurgery (18.5%).

I feel that the lack of exposure to urology as a specialty while in training likely contributes somewhat to the overall lack of large presence of PAs in urology. In addition, the UAPA is actively working towards physician education to integrate PA team members into their clinical practice to extend patient care beyond “routine follow-up cases.”

For example, I personally enjoy (as do my PA colleagues here at UT Southwestern) my ability to function in the outpatient, inpatient, and OR setting with the ability to perform numerous urologic procedures. Lastly, education training is evolving with the development of PA Urologic Fellowships to expand PA breadth of knowledge in urologic care.

"PA education is rigorous and the average program length is 28 months"

What do you think urologists might not know about PA training?

PA education is rigorous and the average program length is 28 months. All programs (currently 236) are accredited by the Accreditation Review Commission on Education for the Physician Assistant. Our education is modeled on the medical school curriculum with both pre-clinical instruction and clinical rotations. There are seven required rotations in family practice, internal medicine, women’s health, mental health, pediatrics, general surgery, and emergency medicine, with medicine and surgery elective rotations offered. The mean number of clinical contact hours is 1,993 hours spaced over an average of 51.2 weeks, according to the last Physician Assistant Education Association curriculum survey.

All graduate PAs must sit and pass the Physician Assistant National Certification Exam in order to become licensed in any of the 50 states. Lastly, multiple studies have shown that PAs add value to health care teams, provide excellent patient care, and are accepted by the patients they serve. 

What is one tip that you think would help urologists better utilize advanced practice providers?

The PA profession does not use the term advanced practice provider to describe the profession and my comments are directed to how urologists can best utilize PAs on the health care team. There is no prescribed standard for which PAs gain urology-specific training. There are some postgraduate programs, which provide vast knowledge and experience, but there are not enough to meet the need and fellowship training is not for everyone. With that said, I would recommend investing the first several weeks, even months of a new PA’s onboarding in urology to be spent side by side with the physician, so they learn not only about urology but also certain practice preferences and standards of patient care. Teach them how to perform procedures, encourage them to read/attend journal clubs or grand rounds if that is an option.

And finally, mentoring is an important component of long-term physician-PA partnership. Of course, encourage their attendance at our annual UAPA conference, which is specifically geared toward PAs and advanced practice nurses in urology, providing both didactic lectures and hands on skills.

To conclude, there are numerous benefits of using PAs to their full scope of practice. They include: increased appointment availability with more timely access to care for patients, increasing work flow efficiency and coordination of care, management of non-surgical patient and those with chronic urologic diseases, care coordination for postoperative patients (for instance post-prostatectomy patients regarding incontinence and sexual function rehabilitation), follow-up care and cancer survivorship programs for oncology patients, and participation in clinical trial research.

In this Urology Times Q&A, Jessica Nelson, MPAS, PA-C, past president of the Urological Association of Physician Assistants, offers a physician assistant’s perspective on PAs performing urologic procedures, PA training, and more.

The PA perspective on performing procedures and more

Focal therapy has emerged as a treatment strategy for low-risk prostate cancer that bridges the gap between definitive whole-gland treatments and active surveillance, although long-term data are limited. In this interview, 

 discusses the advantages and limitations of focal therapy, the ideal candidate, and what current guidelines say about its use. Dr. Davis is professor of urology at the University of Texas MD Anderson Cancer Center, Houston. He was interviewed by 

 professor of urology at the University of Kansas Medical Center, Kansas City.

Please define focal therapy for prostate cancer in its current format.

I think it’s important look at two different, related concepts. The first, which I think is the most critical, is agreeing on what is focal and what is not. Three strategies have been tested in various forms. One is true lesion-directed therapy, which assumes the patient has a positive MRI and an ablation source will be directed at it, plus or minus a defined margin, and that’s probably going to be surgeon dependent. The other two-hemiablation and “hockey-stick” ablation-are not necessarily historically image guided. There is published experienced with both approaches in patients with a low-volume, unilateral biopsy.

Dr. John Ward of MD Anderson worked on the hockey-stick approach over 10 years ago. He found that by studying radical prostatectomy specimens, if you had a patient with unilateral cancer and wanted to address the dominant and most of the secondary tumors, it was necessary to treat the affected side completely and the anterior contralateral side. You might say that shouldn’t be called focal therapy because it’s subtotal therapy, and that’s a fair criticism. Although I haven’t seen data on it, I would imagine it would affect how much residual PSA you will be measuring when you’re treating 25% versus 75% of a gland.

The second concept where there is less controversy involves seven ablation sources: cryotherapy, high-intensity focused ultrasound (HIFU), laser ablation (which assumes real-time MR monitoring), photodynamic therapy, irreversible electroporation, brachytherapy, and radiofrequency ablation.

When you mention laser ablation, what type of laser are you talking about?

They are not identical to holmium or GreenLight type applications for benign disease. These are termed “laser interstitial thermotherapy” that are either continuous wave or pulsed. The mechanisms are the same-thermal coagulation, vascular damage, and finally, cellular damage.

What are the perceived advantages of focal therapy?

The one that is the least controversial is quality of life. Compared to standard, full-gland treatment with surgery or radiotherapy, patients will have less reduction in sexual function and possibly fewer irritative side effects. That probably applies to the range of focal and subtotal approaches I mentioned. There’s plenty of literature on cryotherapy with hockey stick showing that if you leave one entire posterolateral zone alone, patients will have fairly reasonable maintenance of sexual function.

Obviously patients need to be well-selected candidates in terms of prostate size, lower urinary tract symptoms, and pelvic anatomy. In other words, the selection is similar to that used for brachytherapy.

What are the limitations? One that comes to mind that I’ve always been concerned about is men with a large gland, whom I’m hesitant to treat with radiation therapy or brachytherapy. Do we see the same limitation with focal therapy?

Regarding men with large glands, that may be a little more technique based. In cryotherapy and brachytherapy where templates are used, there will probably still be an upper limit of prostate size; ie, my comment regarding brachytherapy selection. In the laser and some of the other procedures that are perhaps more in-bore, MRI-based, you probably can be a little more creative about what you can access. The techniques are evolving and in some cases premature; ie, some patients may have an Artemis robot-driven biopsy, and yet their actual treatment is somewhat freehand the way it’s commonly applied.

Are there other limitations? For instance, what about bleeding and incontinence?

Those events are going to be favorable and similar to what is seen with active surveillance. Keep in mind, though, that even an active surveillance cohort will show very subtle declines in sexual function over time, but that is very minimal and probably just related to aging.

One criticism may come from high-volume surgeons who live in a world of constantly seeing image results and pathology results in the circle of planning therapy. Specifically, MRI is an estimation of what’s going on in the prostate. It does not have the precision yet that people want it to have. One particular paper in the 

 used a modeling system of what a full radical prostatectomy specimen looks like, similar to 3-D printing. This was used to carve out what the MRI was showing. In their method, the authors found almost 80% of the tumor volume was outside of the line you would have drawn around the tumor based on the MRI.

 and that’s not for us to referee, necessarily. But high-volume surgeons know very well that MRIs can be off. That’s where the templates may make a difference. If the future is really lesion-driven therapy, we’re going to have to image better to not make a mistake. Otherwise we’re going to have to treat a lot of unaffected areas.

Whom do you consider the ideal candidate for focal therapy today?

The same question applies to whether or not we should be using biomarkers in prostate cancer, such as Prolaris or Oncotype. If you apply those to low-volume, Gleason 6 tumors, there aren’t many events already so it’s difficult for the biomarker to affect long-term endpoints. The same dynamic exists with focal therapy. If you apply it to a Gleason 6 tumor, you’ll have a hard time finding an oncologic benefit. You may be able to simplify patients’ monitoring compared to active surveillance, but you’re not going to be able to affect prostate cancer mortality.

There’s some potential for selecting Gleason 7 patients, especially those with favorable-risk, intermediate disease. These are mostly patients with Gleason 3+4 disease that can be reasonably defined in imaging and can be treated with the idea of converting their disease to a low-volume Gleason 6 tumor. If you do truly lesion-directed therapy, some satellite non-significant tumors will probably be ignored. You will have detectable PSA to interpret and you’ll probably still have to do some biopsy- and image-related follow-up testing.

The weakness of active surveillance for some patients is that they feel like they’re just waiting around for something bad to happen as opposed to proactively changing it. For focal therapy, I think most experts in the field-and some Delphi consensus panels have been published on this 

-have defined the intermediate, especially favorable intermediate-risk patient, as the ideal patient. I don’t think the choice of focal therapy has to be age dependent, but older age and comorbidity might make more sense.

Are we really treating these patients emotionally, or do we have good outcome data suggesting we’re making a difference with focal therapy in patients with Gleason 3+4 low-volume cancer?

The data will take time. I would lean on the surveillance outcome data from Dr. Laurence Klotz because, even in his series, the Gleason 3+4s typically have a slow pathway but when they hit that 10-year mark and beyond, there tends to be an uptick on conversion to therapy. The mortality statistics are still very low, but to the extent that frequency of biopsies could be reduced and quality of life maintained, that’s where you could probably carve out a benefit. Would biomarkers help in that space? Maybe. There is potential there as well.

What do the AUA/ASTRO/SUO guidelines say on the topic?

The guidelines on localized prostate cancer were announced and discussed at the 2017 AUA annual meeting and were published this year in two parts in the 

 The guidelines basically recommend that focal therapies are not standard and really should be done on a trial. It would be fair to say a trial can be somewhat loosely defined. One definition is a direct comparative trial, which would be the best, and the lack of comparative evidence was what the AUA panel was concerned about.

A trial could also include a registry. A recent Journal of Urology paper discusses the creation of a national online registry by a group of experts 

 At this time, there are no data in the publication, but it shows the defined and agreed-upon endpoints of focal therapy that practitioners should be recording. From that, clinicians can start crafting questions. 

Because the guidelines state that focal therapy is actually not one of the standard treatments yet and we don’t have Level 1 evidence, what would you tell practicing urologists about counseling their patients and referring them to an academic center?

The AUA Office of Education, under Dr. Victor Nitti’s direction, has wrestled with this for a couple of years. Dr. Nitti’s question to the Laparoscopic, Robotic and New Surgical Technologies Committee, of which I am a member, is, should we be teaching focal therapy and how? We’re trying not to promote a head-in-the-sand mentality and ignore it, but we’re trying to be reasonable. We’re promoting the idea that urologists should be very aware of the science, the modalities, and how to integrate focal therapy in the discussion with standard therapies.

We’re not to the point of doing a giant live-demonstration how-to course and explaining how to roll it out in your practice. Without a doubt, patients will go online to read about this and have questions, so you should be expert on this topic. I work at a big tertiary cancer center and when I tell patients what the standards are and where we are on alternative therapies, most of them choose the standard therapy-surgery, one of multiple radiation delivery methods, or active surveillance if they’re a candidate.

If you have patients who really want to pursue focal therapy, I would determine who in your community is doing this on a registry or a trial and develop a partnership in that direction.

Is knowing this information also a benefit because we have potential competing interests in this space, including interventional radiologists and possibly medical oncologists? Since urologists have been known as the experts and the champions of this space, is it important to refer within the specialty?

As someone who was part of the early wave of robotic surgery that clearly rolled out without high-level evidence, you could draw a parallel argument. Are we holding focal therapy to a higher standard than the other treatments? It’s a question that’s somewhat fair.

But part of the reason why we need to be strict about rolling out focal therapy is that the endpoints we’ve used in prostate cancer are very long term. If you do a robotic prostatectomy, you get a pathology report and perioperative outcomes, for example. If clinicians start applying focal therapy to aggressive disease, we don’t know what that means biologically; I’ve clearly seen people come back with metastatic relapse within 2 years. Perhaps that would have happened anyway, but if that is being done with no trial or comparative registry, there is potential for harm.

What happens if focal therapy fails, and what PSA criteria are you using for recurrence?

Regarding PSA recurrence, I don’t think there is agreement on it. I don’t think you can apply the Phoenix definition because that was developed out of full-gland radiation dosage. Most of it comes out of repeat biopsy and repeat imaging. In almost all the men I’ve treated for salvage, it’s been biopsy generated. The PSA may set the stage for how concerned we are, but all patients should probably undergo a 1-year biopsy, and these are the types of parameters the registries are working on.

The salvage HIFU and cryotherapy literature would suggest that, with experts doing the salvage therapy, urinary control is probably going to be OK. I do think sexual function will take a hit. With the less and less intensive, true lesion-directed focal therapies, we don’t know yet about adverse events with salvage therapy. Hypothetically their salvage surgery might be better. Then there’s the option, as in some of the older patients who have failed, to radiate. And some of these focal therapies can be repeated.

When we talked about measurement for recurrence, you said biopsy will be critical. We have a difficult time obtaining a Gleason sum in patients after radiation. Can we still use a Gleason grading system when we re-biopsy after using the focal therapies you mention?

Yes and no. Obviously some of those recurrences are going to be out of field and valid for that reason. With some of the infield recurrences, pathologists will hedge a little bit; they’ll give you a Gleason score but say there’s treatment effect there. We do have data from salvage radiation that, even if they can’t obtain a Gleason score on radiated patients, if they see residual tumor, it is usually real, not just dead cells.

I hear there are 5 Tesla and 6 Tesla MRI scanners out there now. Will imaging change this in the future?

I think imaging will have to improve if we’re going to move to a lesion-directed philosophy. We’re going to have to see a little better. These tumors are not perfectly round circles like they appear on an MRI. The real growths tend to be very scattered, so the better you can draw out a template, the better. As surgeons, we always struggle with the fact that when we see pathology results, the dominant tumor is not always the aggressive one. It can be the second or third largest tumor foci.

Do you have any take-home messages for practicing urologists about focal therapy? Where do you see it fitting into practice?

I think the AUA guidelines will help you to define standards versus alternatives, and I recommend being well versed in that. Have a plan for how you would refer patients or perhaps your group will have a designated expert. There will be how-to courses and trial workshops. The AUA currently is sticking to more of the educational plan. I think that’s what is sufficient for now. I think this is going to be a small but growing field.

In this interview, John W. Davis, MD, discusses the advantages and limitations of focal therapy, the ideal candidate, and what current guidelines say about its use.

Focal therapy for prostate Ca: Ready for prime time?

According to U.S. Census data, there are at least 25 million people in the United States over the age of 5 years who are considered to be Limited English Proficient, or LEP. This population increased by over 80% between the years of 1990 and 2013 

 This simultaneously represents a significant increase in the number of patients presenting for medical care who may not speak or understand English sufficiently. 

Cases highlight need for adequate translation

Failure to provide adequate medical interpreter and translation services for patients who are LEP is not only mandated by The Joint Commission and the Affordable Care Act, but it is a clear and present risk for malpractice litigation. A number of cases have been highly publicized in recent years and underscore the importance of using a certified medical interpreter for every patient who needs it.

In 2010, a Spanish-speaking California patient was to undergo a nephrectomy. The patient signed an informed consent that was in English, and was not provided with a copy in Spanish. He did not have access to a Spanish interpreter. The wrong kidney was removed. When the mistake was caught, the diseased kidney was also removed, leaving the patient with no kidneys 

In the mid-2000s in Germany, a translation error on the package label of a knee prosthesis required 47 people to undergo repeat knee replacement.

In 2015, a Macedonian patient was able to use her friend, rather than a certified medical interpreter, at a consultation for a vestibular nerve tumor. She left with the impression that the tumor was malignant, which was not correct. During surgery, the surgeon severed the patient’s facial nerve, resulting in unilateral palsy. Only after that did she learn that her tumor was not malignant to begin with.

Perhaps the most famous, and costly of all, was the $71 million settlement for an 18-year-old male who presented to an emergency room in a coma. The use of the Spanish word “intoxicado,” which means you ingested something that made you ill, was interpreted as “intoxicated” in English. The patient was treated for drug overdose when he really was suffering a brain hemorrhage. He became a quadriplegic 

One study analyzing 35 claims across just four states found that one liability insurer paid $2.3 million in damages or settlements, and $2.8 million in legal fees for situations where a provider failed to provide a professional interpreter 

There is no question that providing high-quality interpreting and translation services comes at a financial cost; a survey by the American Medical Association found that interpreter services might cost $150 or more per visit, an amount that might exceed a physician’s payment for the visit. However, failure to provide these services potentiates clinical and legal risk, as is apparent from the above cases. Regulatory risks loom as well; under the Affordable Care Act a $70,000 fine, per encounter, may be imposed for failing to provide a medical interpreter 

Hospital 30-day readmission rates are higher for LEP patients, which may then lead to reduced federal reimbursement 

 Finally, the Office of Civil Rights has stated that when an LEP patient is denied or delayed care due to language barriers, it represents a form of discrimination. The Office of Civil Rights also mandates that any recipient of Medicare or Medicaid provide adequate language assistance to LEP patients 

Social media: Mitigate your risk of litigation

Translation and interpreter services provided by Certified Medical Interpreters is the gold standard. Studies have shown that the rate of error is far lower when a professional interpreter with more than 100 hours of training is used 

 These individuals are credentialed through one of two boards and are familiar with medical terminology. Just because someone is bilingual does not mean they can be a medical interpreter. In fact, just like physicians, certified interpreters are required to obtain continuing education every year 

Additionally, the use of family and friends as interpreters is fraught with risk. A certified medical interpreter has a unique skill set that organizations should seek out and celebrate. High-risk situations such as emergency room visits, surgical procedures, informed consent, and medication reconciliation are all areas where use of a certified medical interpreter can be hugely beneficial to all in the moment, and in the future, should a lawsuit arise.

With the use of a certified medical interpreter, a urologist can be much more confident that a urethra is not confused with a ureter, that the bladder vesicle is not mixed up with the seminal vesicle, or that a nephrectomy is not misinterpreted as a nephrostomy.

Failure to provide an interpreter incurs legal and regulatory risk.

Adequate translation services crucial; here’s why

Opportunistic salpingectomy (OS), the removal of fallopian tubes at the time of hysterectomy for non-cancer indications, has emerged over the past 2 decades as a promising procedure for reducing the risk of ovarian cancer. While definitive evidence of the benefit of OS in ovarian cancer prevention remains to be had, the current supporting literature is compelling and this practice is being evaluated for other types of surgery. (Also see, 

“Ovarian cancer risk and OS: Current evidence.")

In 2018, a survey of female pelvic medicine and reconstructive surgeons found that 82% of respondents discuss and/or perform OS at the time of pelvic organ prolapse repair 

April 14, 2018 [Epub ahead of print]). However, the sample size was small and did not include urologic surgeons. Given that over 200,000 prolapse procedures are performed annually, many of which are performed by urologists, there is an opportunity for including salpingectomy at the time of these procedures.

This article discusses surgical approaches to OS for urologists, risks of surgery, and cost.

The current recommendation for OS is that the entire tube be removed. However, in cases when this is not feasible, such as adhesive disease or vaginal repair, removing the distal one-third of the fallopian tube, which includes the fimbria, is thought to be sufficient.

Salpingectomy may be performed before or after pelvic reconstruction. The laparoscopic approach is as follows:

The fimbriated end of the fallopian tube (figure 1) is grasped with an atraumatic grasper such as an Allys clamp. The fallopian tube is then separated from the mesosalpinx (figure 1) using a vessel-sealing device such as a LigaSure. Care should be taken to perform the mesosalpingeal dissection close to the fallopian tube to avoid injuring the infidibulopelvic ligament, which contains the ovarian artery and disrupting ovarian anastomotic vessels within the broad ligament (figure 1, yellow arrow).

The vessel-sealing device is then used to dissect the fallopian tube off the mesosalpinx, moving proximally toward the uterine cornua (figure 2). It is then transected, after cauterization, approximately 1 cm to 2 cm from the cornua (figure 3). The tubal segment can be removed through a 5-mm or larger diameter port in most circumstances. The same procedure may be performed starting at the corunal end of the fallopian tube, 1 cm to 2 cm from the cornua itself, and dissecting the tube off of the mesosalpinx distally toward the fimbria.

The procedure may also be performed via laparotomy in a similar fashion, but dissection of the tube from the mesosalpinx can be accomplished using monopolar cautery and the tube is ligated with a 0 or 2-0 vicryl suture near the cornua. Both the abdominal and laparoscopic approaches may be performed in a similar fashion during non-gynecologic surgeries.

Challenging case: A young woman presenting with rapid weight gain

The vaginal approach for salpingectomy may be more challenging and can usually be performed after vaginal hysterectomy. A right-angle retractor is used to retract the ipsilateral side-wall, and a sponge stick is used to retract the bowel away from the fallopian tube. The fimbria is grasped with a Babcock clamp and cross clamped with either a Haney or Kelly clamp. It is not usually feasible to remove the full length of the tube via the vaginal approach, and studies have shown removal of the 

of the fallopian tube is sufficient for OS.

The gynecologic and urogynecologic literature has shown that vaginal salpingectomy does not appreciably increase operative times or bleeding if an experienced surgeon is performing the procedure. At this time, there is not sufficient evidence to justify altering the surgical approach to hysterectomy or pelvic reconstructive procedures solely for the purpose of completing the salpingectomy.

While OS has been rapidly adopted by the gynecologic community over a relatively short time period due to the promise of preventing a cancer that is difficult to diagnose and treat, at this time there is no evidence that OS has led or will lead to a reduction in the incidence of ovarian cancer, and this data is likely still at least a decade away. Furthermore, some surgeons have concerns about long-term consequences of salpingectomy with ovarian conservation.

Figure 4 shows the blood supply of the uterus, ovaries, and fallopian tubes. It is clear from the schematic that there is significant potential for the disruption of ovarian blood supply with salpingectomy. There has been concern that salpingectomy in premenopausal women could lead to earlier onset of menopause and resulting consequences of vasomotor symptoms, increased cardiovascular disease risk, and osteoporosis. However, studies evaluating anti-MÃ¼llerian hormone levels (a proxy of ovarian function), postoperative ovarian blood flow, and onset of menopausal symptoms have not shown a difference in women who did and did not have salpingectomy.

Increasing health care costs have also been cited as a possible result of salpingectomy, particularly in the absence of tangible risk reduction. Presently, studies have shown that at the time of hysterectomy, salpingectomy does not increase the cost of the procedure, but salpingectomy for sterilization has been shown to be less cost-effective than tubal ligation. Studies evaluating cost of salpingectomy at the time of pelvic floor reconstruction and non-gynecologic procedures are lacking.

Opportunistic salpingectomy has rapidly emerged as a promising procedure for the reduction of ovarian cancer. While definitive evidence of risk reduction is currently lacking, large-scale studies of tubal sterilization patients and salpingectomy for non-risk-reducing indications have strongly indicated the removal of the fallopian tube will lead to a reduction in the incidence of ovarian cancer.

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While more study must be done before there is universal adoption of this procedure, there is evidence to suggest that incorporation of salpingectomy into female pelvic reconstructive surgery is safe and will not lead to an appreciable increase in health care costs.

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There are 20,000 new cases of epithelial ovarian cancer diagnosed annually in the United States. While ovarian cancer accounts for fewer than 3% of cancers in women, it is the fifth most common cause of death in women from any cancer and the most common cause of death from gynecologic cancer. Survival, which is between 19% and 48% at 5 years depending on stage at diagnosis, has not changed appreciably in the past 3 decades.

One major reason for this is that ovarian cancer is most often diagnosed in advanced stages because it is often asymptomatic in early stages and effective screening strategies are lacking. Epithelial ovarian cancer has multiple subtypes, with the serous subtype being the most common (70% of all cases). Over the past 2 decades, histologic evidence has suggested that serous epithelial ovarian cancer arises from precursor lesions within the fallopian tubes, termed serous tubal intraepithelial carcinomas (STIC), rather than from the ovary itself. The exact percentage of epithelial ovarian cancers arising from STIC lesions is not entirely clear but is currently estimated at 50%.

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Over this same time period, multiple population-based studies demonstrated that female sterilization procedures-which include removal of a mid-tubal segment and occlusion with various devices including silicone rings and titanium clips or total removal of the fallopian tube-are associated with significant reductions in epithelial ovarian cancer incidence. Based on these findings, in 2010 the British Columbia Ovarian Cancer Research team developed and distributed an educational video to promote the practice of removing fallopian tubes at the time of hysterectomy for non-cancer indications, a practice termed opportunistic salpingectomy (OS). Since that time, this practice has gained widespread acceptance among gynecologic surgeons who perform hysterectomies and, in some cases, sterilization procedures.

OS refers to the removal of fallopian tubes in women who have a general population lifetime risk of developing ovarian cancer, which is around 1.5%. The American College of Obstetricians and Gynecologists (ACOG) currently does not make specific recommendations regarding OS, stating only that the risks and benefits should be discussed with patients and that surgical planning should not change based on whether or not a salpingectomy will be performed. However, a 2017 ACOG survey showed that 75% of gynecologists perform OS at the time of hysterectomy.

 is a female pelvic medicine and reconstructive surgery fellow at Case Western Reserve University, and 

 is associate professor of urology, vice chairman of academics and research, and director of the University Hospitals Female Pelvic Medicine and Surgery Center at Urology Institute of University Hospitals Cleveland Medical Center, Cleveland.

Section Editor Christopher M. Gonzalez, MD, MBA,

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

Evidence suggests fallopian tube removal will lead to reduced ovarian cancer ­incidence.