In 2003, urologist Richard Augspurger, MD, and healthcare administrator Bob Asinof developed a plan to create a singlesite, full-service urology practice. So they began pitching their vision to individual practices in the Denver area.

“Bob and I saw where medicine was headed, and we knew that large-group practices were the future,” said Augspurger, TUCC’s medical director. “We wanted to be big enough that we could capitalize projects, because it’s very difficult to do that in a small group. We also wanted to offer the highest-quality care to our patients, and one of the best ways to do that was in a single location. Finally, we wanted to offer integrated ancillary services to our patients and capture the revenue [technical fees] that we were previously sending out.”

“We wanted to create a center of excellence where all outpatient urologic care could be provided in one facility,” explained Asinof, Chief Executive Officer of TUCC. “We knew we had to find land to build the center. We did that at the start. If the groups and individuals put money in the real estate early on, there would be no turning back.”

Two Colorado-area practices, Colorado Urology Associates and Western Urologic Associates, merged to form TUCC, and in 2006, the center opened the doors of its 60,000-square foot facility, offering Colorado urology patients what Asinof called a “one-stop healthcare experience.”

 spoke with Asinof and Augspurger about the practice’s history and how such a large group manages to stay at the top of its game. In addition, Eric Gross, MD, TUCC’s radiation oncologist, offered his perspective on the advances his field has made in treating urologic cancer.

TUCC includes radiology, laboratory, and pathology services; a urologic cancer treatment program including robotic surgery and radiation therapy; a clinical research department led by Lawrence Karsh, MD; and an ambulatory surgical center. The practice has 16 physicians and four allied health professionals, plus over 100 employees and support staff.

The practice has also established the TUCC Foundation to support its community outreach programs such as “The Blue Shoe Run for Prostate Cancer,” an annual 5K run/walk fundraiser for prostate cancer research and community screenings.

How does a major organization like this run smoothly? Constant communication facilitated by having everyone in the same place.

“We have a lot of interaction between our physicians, which make us very culturally strong as a practice,” Augspurger said. “It’s not just a collective of physicians, working out of multiple locations, practicing medicine without any input for their colleagues. We really work collaboratively.”

Those united efforts include an executive board that meets monthly to develop the practice’s game plan. There are also several subcommittees that manage TUCC’s clinical programs, operations, and marketing.

		Patient undergoing image-guided radiation therapy with a linear accelerator.

It’s in urologic cancer that TUCC has refined its group-effort strategy. First, they have an in-house tumor board that includes urologists, pathologists, and radiologists, as well as medical and radiation oncologists. “A medical oncologist from one of the largest cancer treatment centers in the state holds office hours at our facility twice a month,” Augspurger said.

TUCC also formed a committee focused on castration-resistant prostate cancer and consisting of the research director, urologists, the medical oncologist, and a reimbursement specialist. “Our physicians are able to present their prostate cancer cases to this panel, which helps figure out the next step: Is this patient a candidate for a trial? Is he a candidate for a treatment like Provenge? Then, we make recommendations based not only on what’s best for patients clinically, but also what’s most cost effective,” Augspurger said.

“Starting in April, we’ll invite patients’ primary care physicians (PCPs) to attend the committee meetings to get their input,” he added.

This approach allows TUCC to find balance between meeting the expectations of their patients—who may want access to any and all treatments, regardless of the cost&mdash;and a healthcare system that demands more and more accountability.

	Radiotherapy: Expanding Its Role in Urologic Treatment

“On the whole, patients are responsive to our recommendations, especially after we tell them that we presented their case to our review committee for their input and expertise,” Augspurger said. “And it helps us ensure that we are offering the highest quality care that still meets the goal of containing costs.”

Gross came to TUCC in 2008 after completing elective rotations at the MD Anderson Cancer Center in Houston and Memorial Sloan-Kettering Cancer Center in New York City. As a radiation oncologist, he’s seen the tremendous advances the field has made in cancer care.

“With radiation therapy, we’ve been able to transition away from having to perform major, potentially disfiguring surgery,” he said. “We saw that shift most dramatically in breast cancer, and we’re now seeing it happen in urologic cancers.”

He cited image-guided radiation therapy (IGRT) and brachytherapy as two modalities that have altered the treatment of prostate cancer, and he anticipates that radiotherapy will soon become more common in the treatment of bladder cancer.

“With bladder cancer, [radiation therapy] has a role in bladder sparing, although it’s more commonly used overseas,” he said. “The standard of care in the United States is radical cystectomy, but the data show that you can use chemotherapy and radiotherapy just as effectively.”

But when asked what he considered to be one of the most striking advances in urologic cancer care, Gross did not cite a specific treatment. “What I think has been very groundbreaking has been our shift away from intervention toward more surveillance,” he said. “The role of surveillance has become more prominent in early-stage prostate and testicular cancer.”

Given the scrutiny that medicine now faces from government agencies and payers, the “less is more” approach is one way that practices can avoid accusations of overutilization. Another is to keep a keen eye on outcomes, Gross said.

“Our approach is to manage and present our outcomes data. I think that’s key for any practice that is going to survive in this volatile healthcare market,” he said. “If a practice is able to produce data and show that it has consistently practiced responsible medicine using evidence-based guidelines, it has a much better chance of surviving.”

With the passage of the Patient Protection and Affordable Care Act (ACA), TUCC is potentially looking at a much larger patient population. Rather than waiting to see how the ACA plays out, the practice has gone on the offensive.

Asinof explained that the group has reached out to the two largest PCP practices in Denver to discuss how TUCC can better meet the needs of their patients.

“It’s no longer just about treating an individual patient; we now have to look at treating populations of patients,” he said. “In the Denver area, we have over 2 million people. The PCPs control most of our patient flow, especially for urologic cancer care. At the same time, cancer care has become very expensive and we have to find ways to cut costs. We’re talking about strategies we can use to work together more efficiently and effectively.”

Cancer survivorship is another issue that TUCC has embraced, especially for its younger patients with testicular cancer who are looking at a long life after a highly curable disease. “There are a lot of considerations with this population,” Gross said. “Are they candidates for surveillance? What’s their socioeconomic status? Are they likely to change jobs? How will that impact their healthcare benefits? Do they want to have a family? Given the life expectancy of these patients, we want to help them focus on their overall health: cardiovascular disease, obesity, smoking cessation, and nutrition.”

		Stephen Ruyle, MD, meets with a patient in one of TUCC’s exam rooms.

TUCC is also looking to bring more physicians to the practice, including specialists in female urology. While they’re aware that recruitment will not be easy given the current shortage of urologists and the trend for physicians to bypass private practice for “safer” jobs such as hospital or healthcare system employees, the TUCC team is primed to go the distance.

“We have to make ourselves attractive to someone who is finishing residency and may be saddled with medical school debt, so he or she doesn’t feel overburdened by what it would take to join the group,” Augspurger said. “We are in the process of pursuing avenues to meet that challenge.”

Articles

"If you build it, they will come," became a catchphrase thanks to the 1989 movie "Field of Dreams." For the founders of The Urology Center of Colorado (TUCC), it was more than just a saying.

The Urology Center of Colorado: Raising the Bar for Collaborative Urologic Care

Frank G. Opelka, MD, is the executive vice president of Health Care and Medical Education Redesign for the Louisiana State University (LSU) System. He also serves as vice chancellor for Clinical Affairs and is a professor of Surgery at the LSU Health Sciences Center in New Orleans. With expertise in healthcare patient safety, quality improvement, and healthcare finance, and as a recognized national leader in patient-centric healthcare, Opelka has been involved at the national level in the design and implementation of the Affordable Care Act.

Opelka delivered the Ambrose-Reed Lecture at the 77th Annual Southeastern Section of the American Urological Association (SESAUA) meeting held in Williamsburg, Virginia. The Ambrose-Reed Lecture honors two pioneers in the field of health policy: Samuel S. Ambrose, MD, and Josiah F. Reed, Jr, MD, both of whom held leadership offices in the AUA.

 conducted an interview with Opelka to explore some of the health policy initiatives that will impact how physicians will be compensated in the future.

: Dr Opelka, you stated that, in the general framework of the Affordable Care Act, performance measurement and performance improvement are linked “by design.” Can you comment on this as a goal of the Centers for Medicare & Medicaid Services (CMS)?

: CMS is not just measuring for its own sake, but [is using performance measurements] in order to improve the quality, safety, and patient experience of care. CMS is challenging the profession to come up with performance measures that are actionable by physicians, hospitals, patients, and purchasers.

Physicians feel that performance measurement is important if the measures are important to patients, meaningful, actionable, relevant, feasible, clinical, and within practice workflows.

In your lecture title, you use the term “value-based purchasing.” Can you explain what that means?

The federal government or private corporations that purchase the healthcare or health insurance want to know that what they are purchasing has value—that they are getting a product that improves the quality of life of the patient and of overall healthcare. Or, if there is no way to improve it, that it at least provides the patient with all the relief he or she can potentially get in their care system.

How does the concept of “resource appropriateness” apply to the purchase of healthcare or to physicians who are involved in the delivery of healthcare?

Of all areas of performance measurement, resource use, or appropriateness, is one of the most complex and difficult. It is really quite easy to say that you have a structural measure that says you’re licensed and board-certified—a “check the box” measure. With “appropriateness” such as in prostate cancer, the clinician may be looking at four different diagnostic tests, of which perhaps three are absolutely appropriate, but the fourth one is questionable; it is a waste of resources to administer the fourth one. With surgeons, we have found that appropriateness lives on a scale; it is not black and white. But there are times when we order diagnostics or other tests that are of limited overall value. Today, we cannot afford that.

What do you mean when you say that the Measures Application Partnership is not driven by measuring physicians, but instead by measuring an outcome for a patient?

The Partnership is part of the Affordable Care Act, and the goal or function of the Partnership is to look at the National Quality Strategy (NQS), which is patient-centric, and to try to provide measures that optimize NQS. Using cancer care as an example, instead of just measuring one moment in care, such as one office visit, the Partnership is more interested in the overall outcome of cancer care for that patient over a continuum of, say, three months, six months, or one year, regardless of providers.

What does the patient expect at the end of a given time period? Instead of talking about whether the patient got antibiotics in a timely fashion around the time of surgery, we want to ensure the patient had a surgery that resulted in the lowest possible level of complications and the best and most optimal quality of life subsequent to the surgery.

In light of the new “value-based” payment approaches, would you say that fee-for-service is dead?

Some people have made public statements regarding the death of fee-for-service. It is not so much the death of fee-for-service as it is that purchasing based on volume will significantly diminish. But even now there are many instances where physicians are not compensated by fee-for-service by their employer, but they don’t know it. The employer may have global cap in an HMO contract or some alternative payment system. Yet, administratively, the physician’s contributions to the overall practice are still measured by some scale of relative value similar to a fee-for-service environment. They measure the clinician volume of services, whether it is done by dollars and cents or by relative value units, and then align these results with their alternative means of financing, such as paying for a global cap, or being salaried in an HMO, or packaging services into a bundle of care.

A new array of considerations is emerging about how physicians are compensated using alternative payments. Physicians will hear about the death of fee-for-service, or the diminishing of aspects of fee-for-service. But actually, we will always need to measure the volume of physician contribution as part of an overall value proposition.

Fee-for-service isn’t dead, but how we track performance will go away and how we use that to compensate physicians will now change.

How might shared savings affect certain physicians’ bottom line under the new business model?

Whether it is in an alternative payment system such as an Accountable Care Organization or bundled payment or even in a fee-forservice world, the payers are adding various incentives, such as related to diving down readmissions, or driving down emergency room use, or moving away from the less appropriate testing.

If outcomes remain the same or improve, and the other complications that are driving up the cost of care are reduced, the payer can create a shared savings model which would incentivize physicians to reach certain goals. If the physician is on the upside of that, he/she will win not only in the shared savings model, but will probably gain market share. Those who are on the downside will lose market share and dollars. So, physicians will want to make sure that they are moving toward or performing above the mean.

How will the National Surgery Quality Improvement Program impact the lives and practices of clinicians in this new healthcare environment?

The National Surgery Quality Improvement Program (NSQIP) began in the mid-1980s, and it was brought into the College of Surgeons, where it was promoted. It is now in almost 500 hospitals across the country. NSQIP is a risk-adjusted outcomes database that tracks the care of a population that receives care and undergoes procedures within the involved hospitals.

With the NSQIP database, multiple data points can be entered, including the expected [patient] outcome to be on a risk-adjusted basis. So, it is possible to identify high-risk patients who are more likely to have more complications and low-risk patients who should be expected to have fewer complications. Along with that you get the observed outcome. So once you have the expected outcome and compare that to the observed outcome, you create a ratio of performance that is risk-adjusted. This exists in multiple specialties, including urology, and it allows hospitals to drive improvement.

There are multiple examples of how NSQIP has generated enormous improvements in quality of care. The overall outcomes have included fewer complications and the delivery of better overall care. This is all invaluable to patients. It has also created a team-based approach to care.

How could this play out in, for example, an association such as the American Urological Association (AUA)? The AUA could look at this and further enhance it or enrich it, or make it a part of their membership. Ultimately, the goal would be to consider NSQIP for its use in a value-based payment system.

The “putting the patient in the middle” concept is part of the new business model, you said, and prostate cancer is an example of how things might develop in other medical specialties in terms of patient-reported outcomes. Can you explain this?

We are learning about the ability to use patient-reported outcomes as a way of establishing the overall success of care. As clinicians, we are accustomed to thinking in terms of the basic sciences, research sciences, and clinical sciences. Patient-centric outcomes are not so similar, but when you put them together you have a valuable tool for assessing care. It is more than the patient experience of care—more directed to their expected outcomes&mdash; and whether or not those outcomes were achieved. If I were asking a patient who had major prostate surgery about his postoperative experience with incontinence, this patient-reported outcome is probably going to be more accurate than a providerreported outcome of the patient experience. That kind of patientreported outcome work remains to be defined, however.

How will these patient outcomes and physician performance data be used to ultimately improve patient care?

Measuring physician performance using a billing and collection system is of limited usefulness. By bringing the range of clinical metrics into registries, we can get to more meaningful and actionable performance measures. There are other registries in addition to NSQIP, and the more and sooner medical associations get involved in establishing registries, the sooner they will be appreciated by the performance measurement world. CMS has recently put out an inquiry about registries, and multiple professions have submitted comments.

Registries feed off clinical data that have been entered into EHRs (electronic health records), but if EHRs are used only to record the delivery of care, the data they contain will not have been leveraged in such a way that it can fully drive improvement.

This national concept of how to capture and use big data is sweeping industries of all ilk. This is where all of this change in healthcare is going, and registries are a part of it.

What are the important take-home messages for urologists?

I think the most important message is that getting reasonable, actionable, and important performance measures that drive real improvement and a better patient experience of care comes jointly from the patients and the profession. We as clinicians have got to do our part and also make it easier for [the patients] to do their part, so that we can get to better, more affordable care.

We have been fighting, resisting this change. But I am starting to see the profession step up and put forth efforts into defining the best elements that can drive improvement. This whole new area of science—performance measurement, patient-reported outcomes, improvement sciences&mdash;is not going away.

Some thoughts about surgical measurement and innovation… There is a group in Massachusetts that got “tiered out” and wanted to get back in. So, they changed their cost structure and quality and went back to the payer and said, “We will give you a condition-specific risk calculator, and we will put the risk of our patients into it. We’ll give you an appropriateness score for the procedure(s) we’re doing and we’ll give you an outcomes target.” For the payer this was a game changer. The payer sees this as the innovation that could improve care and change the status of a provider’s tiering in the network.

Physicians are on a journey and there is no going back. The only real solution is in our hands. We are the only ones who have the skill set and training. By jumping on board, we are saying that these rules for improvement are reasonable, actionable, relevant, “in my work flow,” and “I can use these.” And by the way, most surgeons just want to operate and are eager to get to that point with a business model that is sustainable and rewarding.

We are going to be looking at system-based care, and we, as surgeons, are going to lead teams within that system. We look at risk, outcomes, and appropriateness. We are the source of the evidence: we generate it, we test it, we validate it and re-validate. We drive the data. We know the experience in care and will have to work that experience in care in a new way.

An interview with Frank G. Opelka, MD, exploring some of the health policy initiatives that will impact how physicians will be compensated in the future.

Value-Based Purchasing: How Physicians Will Be Compensated in the Future

Attendees at the 6th Annual Interdisciplinary Prostate Cancer Congress gathered in New York City on March 16 to review the latest strategies and therapeutic agents available for patients with the disease, and to build consensus about their application. In the wake of the approval of several novel treatments for prostate cancer—including anti-androgens enzalutamide and abiraterone and immunotherapy sipuleucel-T &mdash; a special focus this year was “Integrating New Therapies into the Prostate Cancer Continuum.”

Panel and audience members considered several case studies and discussed the treatment options they thought were best. The cases were presented by event co-chair Leonard G. Gomella, MD, and discussed by a panel that included co-chair Daniel P. Petrylak, MD; Robert Dreicer, MD, MS; E. David Crawford, MD; and Susan F. Slovin, MD.

The patient is a 55-year-old white male. His father died of prostate cancer at 65 years of age, and no other family members have any history of prostate cancer. The patient is worried and wants to be checked, although he’s done some reading and is doubtful about the value of the prostate-specific antigen (PSA) test. What do you tell him?

The patient is at risk since he had a first-degree relative who was impacted. Screening is reasonable for him.

I’d tell him that PSA has its implications. If it’s elevated, he’ll need a biopsy, and then he’ll have to choose either local therapy or observation. I would do it if I were him. But he needs to know what the studies say.

I would explain the pros and cons and then leave it up to him, although I probably would give him the strong arm because his risk is at least two-fold higher than John Doe’s next door as a result of his family history. I’d also make sure he’s had a screening colonoscopy.

One family member probably doesn’t increase your risk a lot. You’ve got to have two or three to be at a higher risk.

The patient has his PSA tested and it’s deemed normal at 1.1 His digital rectal exam is normal. Can you tell him he doesn’t have prostate cancer?

No. Based on the results of the Prostate Cancer Prevention Trial [in which 15% of men with PSAs of <4 ng/mL were found to have prostate cancer],

 he still faces a risk. I’d do a prostate cancer gene 3 (PCA3) test on him.

Even though he hasn’t had a biopsy yet, you would jump the fence on the PCA3 and use it sort of off-label? The labeled indication is to see if a second biopsy is needed.

What I tell my residents—and my patients&mdash;is that we’re finding our way with PCA3, but that we have a lot of questions. Still, I’d rather have a PCA3 in the bank in case some breakthrough comes up over the next couple of years.

Which of the following treatment options would you recommend in this setting?

So, you can’t tell the patient he doesn’t have prostate cancer. What would you do next?

I would ask him to repeat a PSA in a short period of time to get a sense of how rapidly it’s going up.

Let’s assume he had a biopsy a year ago that was completely normal. Now he comes in and his PSA has gone up to 5. He still has a normal digital rectal exam. What would you do next?

 He needs a repeat biopsy. I would do a saturation biopsy.

How about PCA3, if he didn’t have it before?

It probably would be appropriate, but I still think he’s going to need a biopsy.

What about free-to-total PSA? Is anyone using that anymore? We asked this question two years ago and just about everybody put their hands up, and now, as I look around, there seems to be a lot of cooled enthusiasm.

I agree, although it does scare me a little bit that his PSA has had such a rapid rise.

The PCA3 would make me feel better about doing another biopsy.

The patient comes back three years later and his PSA is up to 8. He’s had at least three sets of 12-core biopsies, and they’ve all been negative. Now where are we?

This is a guy that I would get the MRI on, and the mapping biopsies. I’d also consider the fact that, every time you have one negative biopsy, your risk goes down. If the guy is tired of biopsies or his insurance company won’t pay for more, I’d also think about putting him on dutasteride to see what his PSA does, because I’ve seen people like this go from 8 to 1 again, or at least cut their PSA in half.

Dave, what about transurethral (TUR) biopsy? We used to do that in the ’90s when we ran into this situation. It was sort of an anterior biopsy. Is this a dead issue now because of MRIs?

A lawyer told me the other day that he’s defending a urologist for that very thinking. The patient was just like this one: negative biopsy, negative biopsy, negative biopsy, PSA not even up this high, and so he didn’t do anything. A couple of years later he’s got metastatic disease, and they’re saying he should have had a TUR biopsy. But to me, what takes the place of the TUR biopsy are the staging and mapping biopsies. We’ve actually shown that if you take those biopsies and you correlate them to whole mount radical prostatectomy specimens, they’re just as accurate, if not more accurate, at predicting what’s there.

I have a question about PSA leaks in people who’ve had multiple biopsies. I’ve certainly done three or four biopsies on people, but I worry that I have created the [elevated] PSA with all the [needle] sticks.

Dave, with all those needle sticks in the prostate, are you making a leaky prostate, making neovascular channels when it heals and sending more PSA out to the bloodstream?

There’s some data out there now saying that the more biopsies you have, the more difficult it may be to spare nerves when you get treated definitively with a radical prostatectomy. What do you think about that, Dave?

Well, I’ve had a lot of experience in going in after mapping. Since the mapping is done transperineally, it’s not much more difficult to do. In the people that have had a couple of what you described as saturation biopsies, which are transrectal, that has been difficult.

So, what can a patient like this do to prevent prostate cancer, and what should you recommend?

There is data that there is some benefit to changing the diet, limiting the amount of red meat. And while I recommend that for some patients who are on the heavier side, I don’t know that it’s something we would do for everybody. The question is, do I put him on dutasteride or finasteride? I’d be a little worried, but you can make an argument that if the prostate shrinks down a little bit more it’s going to be easier to find a Gleason 8 or 9 cancer sitting there waiting for us.

It’s kind of disappointing that we don’t have this as an approved prevention strategy, since we have two large clinical trials that show a 20% to 25% relative risk reduction with 5 alpha-reductase inhibitors, and data from trials such as CombAT

 demonstrating no increased risk of high-grade cancer. Dr Dreicer, you’ve been involved in some drug discussions at the FDA level. Do you think there’s any chance that this thing could get resurrected?

Less than none. We’ve been through so many things on the prevention of prostate cancer: vitamin E, and selenium, and saw palmetto, and the 5-alpha reductase inhibitors, and Vioxx. I think the benefit of 5-alpha reductase inhibitors is real, but we also need to document the risk of high-grade cancer, which is probably volume-related. In my opinion, chemoprevention trials in prostate cancer are dead because it’s too risky.

You may also be familiar with the data that came out a few years ago that patients with advanced prostate cancer who went on hyper-vitamin therapy actually had a worse outcome. They progressed more rapidly. So, we have to convince our patients that more is not necessarily better.

That was demonstrated in the SELECT trial

 too. The trial took all comers, and you wonder what giving these vitamins at high dosages to somebody who has a normal level is going to do to their prostate tissue. A lot of these agents are “yin-yang”: In low doses they may be inhibitory, in high doses they may be stimulatory. So when designing these studies in the future, you’re going to have to look at levels and see whether you’re supplementing something that doesn’t need to be supplemented.

And despite these data, we still find all our patients taking vitamin E and selenium to prevent prostate cancer, which is really sad.

The patient is a 62-year-old who develops urinary frequency. His primary care doctor detects a nodule on rectal exam and a PSA of 82. A urologist does a biopsy and finds Gleason 7 cancer. A bone scan shows four lesions in the lumbar sacral spine, and a CT scan of the abdomen shows retroperitoneal lymphadenopathy. The patient undergoes combined androgen blockade. His PSA bottoms out at less than 0.1 seven months after the blockade is started, and he remains on continuous androgen blockade for about three years. His PSA then begins to slowly rise from 0.2 to 0.8 to 1.0 over a six-month period. On bone scan, progression is noted with two more spots in the ribs. A CT scan of the abdomen and pelvis shows resolution of retroperitoneal adenopathy, and the patient feels pretty good. He’s not in any pain, and he has a good appetite and a good performance status.

			Discontinue bicalutamide and monitor for antiandrogen withdrawal syndrome

			Start second-line hormonal therapy with ketoconazole and hydrocortisone

The only times I’ve used ketoconazole in a patient who’s castrate resistant is when the patient has nonmetastatic disease. Except in that situation, abiraterone has superseded ketoconazole in this clinical state.

I’ve gone back to ketoconazole because abiraterone is not always covered by insurance. Ketoconazole is not as effective, and it has more toxicity, but if you’re in a dither it’s the best one to use. On this particular patient, though, I could make the argument that if he went into a complete biochemical radiographic remission, I would have radiated his prostate for local control and maybe used adjuvant hormones for an extra year, and then gotten him off everything. He’s a young guy, and the law does not say one should stay on hormones for ever and ever.

Clearly we’re going to stop his bicalutamide—that’s a no brainer&mdash;and if you’re going to think about immunomodulatory therapy, this might be a very good patient to use it in. Even if he has an antiandrogen withdrawal response, you could argue that that’s okay, and may make him even a better candidate.

The patient’s testosterone is 55 and he’s been getting leuprolide. What would you do at that point?

One option would be to put him on abiraterone, which would reduce his testosterone even further. A second would be to put him on degarelix, which could also lower his testosterone. Of course, the final option is simply to do an orchiectomy.

An important point, and one that Dr Crawford has been out in the lead on, is that our LHRH analog therapies are one-size-fits-all. If you have a 98-pound gentleman and a 300-pound gentleman, they get the same dose of the LHRH analog, and there are some issues now to suggest that the mode of administration and obesity can actually affect absorption and utility. So, at our shop, we’ve flipped people from goserelin to triptorelin, or triptorelin to leuprolide, and I have to say that we’ve always gotten their testosterone to come down.

In a study, we looked at patients with testosterone less than 50 who went on sipuleucel-T, and then [investigational] GTx-758 and a couple of other agents, and watched testosterone levels. Twenty-one percent of participants had testosterone levels above about 20. Orchiectomy gets you to 14 to 17. And so, theoretically, these patients aren’t castrate. And maybe the reason 20% to 30% of people respond to secondary androgen ablation is because they weren’t totally suppressed to begin with.

While we’re getting serum testosterone levels down, we still are never 100% sure of intratumoral testosterone levels. That’s always sitting in the background.

And the testosterone assays most of us use in the hospitals are not very sensitive, especially at the low level.

You’ve got to also measure the free testosterone level.

 The patient gets sipuleucel-T and, at one month post-therapy, his PSA continues to rise to 20 and then to 30. His bone scan is stable with no new lesions. He has no complaints and feels well. Six months later, his bone scan stays stable and his PSA goes up to 50. What would you tell him now about the sipuleucel-T?

I would tell him that we don’t know how long it takes to see a propitious antitumor response, and as long as his cancer is stable, it’s fine.

In this case, the patient was put on abiraterone and prednisone. Do you think he needed to be there, Rob?

I would have been concerned that, in a relatively short period of time, he was going to become symptomatic, and I’d want to obviate that, so I think it’s eminently reasonable to have treated him.

So the patient is put on the abiraterone/prednisone regimen, and his PSA goes down. Eight months after treatment, it’s down to 3. However, it then goes up to 5 and then, four weeks later, to 9. He has new or recurring retroperitoneal adenopathy. His bone scan shows more lesions, and he has lumbosacral spine pain. He’s failed hormonal therapy, sipuleucel-T, and abiraterone.

It looks like the clear winner here is standard docetaxel and prednisone. Dan, any comments about using it in the setting of having pain?

The right situation to use it is when the patient is symptomatic. As far as your alternatives, there’s no data for using cabazitaxel in the frontline setting. With enzalutamide, we don’t know what the response rate is after abiraterone. Also, at this point, it’s not approved for that indication.

The patient is 69 years old and has Gleason 4+3 prostate cancer. His PSA is 9, and his rectal exam shows a T2a nodule. He is staged negative on bone scan and CAT scan, has good GU function, and is sexually active without PDE-5 inhibitors. He has had no previous pelvic radiation or irritable bowel disease, and his prostate size is about 40 ccs on transrectal ultrasound.

Several case studies highlighting the latest strategies and therapeutic agents available for patients with prostate cancer. 

Integrating New Therapies Into the Prostate Cancer Continuum

	I am the third urologist in my family, having the good fortune to have both a father and older brother in the same field, albeit in different parts of the country (thankfully for them, they did not have to tolerate my idiosyncrasies on a daily basis). I recall being in medical school during the early 1980’s and my father getting involved with a partnership that involved joint ownership of a “stone machine” with other urologists in the central Ohio area. Unlike some of his other investment ventures, which were questionable at best and not an uncommon scenario for many physicians then and now, the lithotripsy partnership was an absolute home run and provided many years of financial stability to our family. Because the regulatory environment and the amount one could put away for retirement were much more restrictive than they are today, he was able to earn some extra income as a result, and retire a little earlier.

	Our specialty has always been able to adapt and adopt new technology and ideas: Lithotripsy is one example from the past, and today that adaptability is evidenced by the evolution of large group practices, which are now becoming more commonplace. I believe much of this has to do with the personality types that enter into this great field, as well as the fact that many urologists across the country had positive experiences with forming successful business ventures with their colleagues, just like my dad, despite being in competitive groups in the same market or region.

	For the most part, as classically trained surgeons, we are all uÌˆber intense and strive to be the alpha presence in the room. As the old joke goes, if you ask a surgeon to name the three greatest surgeons in his field or area, he has no difficulty naming himself, but it is the other two he has problems identifying! Yet, because urologists recognized the need for a business model that allowed for state-of-the-art patient care and also provided financial return, lithotripsy partnerships were (and still are) successful. In forming lithotripsy partnerships, physicians had to relinquish some control to the management team and go against some of their natural tendency to always be the leader.

	This holds true today as the urology community continues to adapt: As we evolve toward large group practices, not everyone can be the leader or president. But for the organization to be ultimately successful, which requires a mix of optimal patient management, integrated care, and financial stability, we are oftentimes forced to check our egos at the door and not micromanage and control every facet. This is very difficult for a surgeon to do, and thus not all urologists are suited to work well in a large group model.

	But the ever-growing number of independent, large integrated practices in urology highlights the fact that for the most part, we as a specialty are very collegial and open to change. In fact, to my knowledge, no other specialty has a national network that equals what exists among large urology practices. Urologists realize that the biggest threats to our survival are not our urologic colleagues, but hospitals and insurance companies (and I would include the government in this latter category).

	Times are changing rapidly in the healthcare environment. The days of walking into the operating theater, no H and P on the chart, telling the occasional off-color joke, uttering the occasional expletive, and having available to you whatever new instrument or latest greatest stent that just hit the market are long gone. They have long been replaced by not being able to even take the patient back to the operating room until the site-appropriate side has been marked, x-rays are available, and an accurate time out has been verbalized with all in agreement. This is all implemented for better, safer patient care, which is at the core of what we do.

	In that same vein, we need to begin to migrate toward a system that embraces evidence-based medicine, and begin the development of protocols and the measurement of quality metrics. No longer can we continue to practice by “gestalt” or “feel,” without care for costs to the system or whether or not there is literature to support therapeutic and diagnostic plans. No longer can we say we practice better urology without outcomes data to back our claims. Payers are going to want to pay for quality and physicians who provide better care for the monies spent.

	It is up to us as physicians, and not a bureaucrat or insurance executive, to define what those outcome metrics might look like. To that end, all of us, whether we practice in an academic setting, large group, or small solo practice, must work together as a specialty to help define and answer “What is good?” This solution requires working together as colleagues, just as we have done in the past. To borrow a song title from Dire Straits, we need to be “Brothers in Arms” to ensure survival of our chosen profession.

We need to begin to migrate toward a system that embraces evidence-based medicine, and begin the development of protocols and the measurement of quality metrics.

"Brothers in Arms"

Urologic Specialists of Oklahoma, Inc (USO) prides itself on innovations in urologic care as well as its commitment to constantly improving patient satisfaction. At the same time, however, rising costs and declining insurance reimbursement levels challenge physicians and medical groups to explore new revenue opportunities. To help meet these challenges while maintaining high-quality care and patient satisfaction, USO researched, tested, and fully implemented an office-based prescription medication dispensing solution. This was certainly not a concept or program we entered into lightly, however. Many of our physicians and staff were quite skeptical about the viability, legality, and successful implementation of a medication-dispensing solution for our practice.

	Advantages of Office-Based Prescription Dispensing

	Explore Options and Perform Due Diligence

Nationally, studies suggest that three out of four Americans would prefer to fill their medication prescriptions in their doctor’s office instead of having to go to a pharmacy. Unfortunately, only a very low percentage (approximately 10%) of physicians and clinics across the country currently offer this option to patients. At the same time, pharmacies report that as many as 20% to 30% of prescriptions written annually go unfilled, which contributes to therapy noncompliance for patients.

Patients appreciate the convenience of being able to purchase their medications or supplements at the physician’s office. Office-based dispensing can save patients time and a trip to a local pharmacy. In addition, dispensing the medication prescribed by the physician in the office ensures that the prescription has been filled, thus increasing therapy compliance. Patients appreciate the confidentiality of discussing their course of treatment within the privacy of a physician’s office. Finally, office-based dispensing creates a new revenue and profit center for practices.

Compliance and patient safety are paramount. Practices need to understand the laws and guidelines governing medication dispensing in their states, and also must select a top-notch strategic dispensing partner to help manage and implement the optimal platform for their offices. USO’s strategic partner, ProMentum Health (www.ProMentumHealth.com), emphasized three critical points up front: First, USO would not be a full-service pharmacy, but rather focus on dispensing the most commonly prescribed medications (mostly generic). USO had to resist the urge to overstock our inventory, and instead follow ProMentum Health’s recommendations to initiate dispensing with only 15 to 20 high-volume medications.

Second, physician and staff “buy-in” are critical in launching a successful medication-dispensing solution. Patients are not the only audience that may benefit from this efficient medication delivery model: The clinical staff will also benefit by actually saving hours each week from taking pharmacy calls about prescription orders and substitutions, and from handling prior authorization requests that are occurring more frequently in urology.

	How Does the Office-Based Prescription- Dispensing Process Work?

Third, if possible, visit an existing dispensing site or two that mirrors your clinic size, patient volume, and technological capabilities. With over 20 providers and 275 patient visits per day, USO needed to validate that the dispensing platform and model we were considering was already working successfully in other large practices. Visiting other sites gave our medical leadership the opportunity to speak directly with peers about the pros and cons of operating an office-based prescription-dispensing program, including getting candid feedback from participating clinical staff. Ultimately, taking the time to visit other large dispensing sites validated our decision to move forward with a program that would increase our patient satisfaction scores, increase therapy compliance with our patients, and also provide a new revenue stream for our practice.

The Web-based, easily customizable system scans, labels, and dispenses safety-sealed, FDA-approved, prepackaged prescriptions in about a minute. Additionally, the platform tracks medication inventory levels in real time, as well as directly reports the dispensing of Schedule II to V controlled substances to our state’s reporting agency, if applicable. The ability to ePrescribe medications is crucial in our practice, so the dispensing software has the distinct advantage of having a direct link to SureScripts so that our providers can ePrescribe from our electronic medical records (EMR) software (UROchart).

Basically, the appropriate prescription therapy is selected during the patient encounter, immediately sent and recognized by the dispensing software from our EMR, then received, scanned, verified, and filled by our clinical staff. We have customized our dispensing platform with appropriate staff access and security levels, and streamlined the checkout process for our patients. They leave our office with an itemized invoice of their medication purchase, along with the system-provided patient instructions for their medication (also available in Spanish) reviewed during their visit. The work-and patient-flow process occurs without the need to hire any additional staff.

The profit potential for office-based dispensing can be significant. On average, we generate between $7 to $12 per prescription, and on a few medications the margin is slightly higher, all while maintaining prices that are similar to patient copay levels, and often less than local area pharmacies. We’ve recently noticed an increase in the number of refills from patients taking medication for chronic urologic conditions.

Additionally, with the implementation of our urodynamics protocols, we expect to see an increase in the number of patients purchasing medications from our clinic simply due to convenience. With the platform’s ability to dispense nonprescription products (nutraceuticals, specialty urology products, etc), we’re now evaluating requests from patients to carry those items in our formulary, which will further improve patient satisfaction and potentially double the net revenue of the program.

As we continue to see shifts in reimbursement methodology, we must continue to evaluate programs and technology that will not only enhance the comprehensive care of our patients, but also optimize revenue for our practices. With those goals in mind, the adoption and implementation of an office-based prescription medication-dispensing initiative should be strongly considered as a new and emerging opportunity for urologists.

Steve Dobbs, the CEO of Urologic Specialists of Oklahoma, Inc, discusses the viability, legality, and successful implementation of an office-based medication-dispensing solution.

The Value of Office-Based Prescription Dispensing

A cost analysis presented at the 2013 Genitourinary Cancers Symposium found that para-aortic radiotherapy (PA-RT), dogleg radiotherapy (DL-RT), and 1 cycle of carboplatin are cost-effective strategies for the management of stage I testicular seminoma post-orchiectomy compared with surveillance, when reimbursement costs for salvage bleomycin, etoposide, platinum (BEP) chemotherapy are factored in after potential relapse.

An estimated 8000 new cases of testicular germ cell tumors will be diagnosed each year in the United States, and about 50% will be stage I seminoma treated with radical orchiectomy. Approximately 80% to 85% of patients can be managed by surveillance, since the relapse rate is about 18%. Tumor size does not exclude patients from surveillance.

Salvage radiotherapy with either technique and cisplatin-based chemotherapy are highly effective for patients at relapse, explained presenting author John A. Cox, MD, University of Texas Medical Branch, Galveston.

The impetus for the cost analysis was a change in the National Comprehensive Cancer Network (NCCN) guidelines from 2011 to 2012, scaling back the use of imaging and lab tests after orchiectomy, driven in part by results of randomized trials, as well as a desire to reduce exposure to frequent CT scans.

The goal of the cost analysis was to compare costs associated with each management strategy (ie, surveillance, PA-RT, DL-T, and carboplatin) in 2011 and 2012, as well as costs associated with the required 10-year follow-up for each strategy.

To construct this analysis, the investigators assumed that the 5-year failure rate was 18% for surveillance, 4% for each radiotherapy technique, and 5% for carboplatin. Medicare reimbursement rates were used to determine the actual reimbursement for each treatment course over a 10-year period.

Factoring in the costs of salvage therapy, the total Medicare reimbursement was $10,643 for surveillance, $11,648 for PA-RT, $9662 for DL-RT, and $7870 for carboplatin under the 2012 NCCN guidelines. In 2011, reimbursement for the four strategies was $20,986, $11,517, $9394, and $20,365, respectively.

Without factoring in the cost of salvage therapy with BEP, based on 2012 reimbursement rates and the 5-year relapse-free survival rates, surveillance was less costly than adjuvant radiation and no incremental benefit was seen for surveillance compared with carboplatin, since the cost of surveillance was much higher. However, when salvage BEP therapy was factored in, surveillance alone was more costly and less effective compared with the other three strategies.

Cox acknowledged that the study had several limitations. These men have a long life expectancy and the analysis did not account for quality of life, nor did it include quality-adjusted data.

	Cox JA, Gajjar SR, Lanni TB, Swanson TA. Cost analysis of adjuvant management strategies in early-stage testicular seminoma. 

A cost analysis found that para-aortic radiotherapy, dogleg radiotherapy, and 1 cycle of carboplatin are cost-effective strategies for the management of stage I testicular seminoma post-orchiectomy compared with surveillance.

Surveillance Following Orchiectomy Most Costly Option for Stage I Testicular Seminoma

Studies that continue to shed light on the optimal use of sipuleucel- T in men with prostate cancer were presented at the 2013 Genitourinary Cancers Symposium.

Sipuleucel-T, the first-approved vaccine for the treatment of prostate cancer; is an autologous cellular immunotherapy designed to stimulate an immune response to prostate cancer. Studies have shown that it takes approximately 6 months for the treatment effect to become evident.

Results of trials presented at this year’s GU Cancers Symposium evaluated the effect on cancer-related pain, as measured by time to first opioid administration (TFOA), in patients on sipuleucel- T; effect of the vaccine in different age groups and in patients with and without prior docetaxel; and the optimal sequencing of sipuleucel-T and androgen-deprivation therapy (ADT) in men with biochemically recurrent prostate cancer.

IMPACT was the pivotal trial leading to the FDA approval of sipuleucel-T in patients with asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer (mCRPC). An exploratory analysis of the IMPACT trial suggests that sipuleucel-T has a clinical impact in this patient population that goes beyond its known effect on improving overall survival, according to Eric J. Small, MD, deputy director of Clinical Sciences at the UCSF Helen Diller Family Comprehensive Cancer Center in San Francisco, California, and coauthors [Abstract 74].

IMPACT randomized 512 men with asymptomatic or minimally symptomatic mCRPC to a 2:1 ratio to treatment with sipuleucel-T versus placebo. Sipuleucel-T was associated with a significant improvement in overall survival (OS) compared with controls (

 = .03, absolute difference of 4.1 months favoring the vaccine).

The analysis Small presented found that TFOA for cancer-related pain was significantly delayed in patients on the vaccine versus placebo (

 <.041). Median TFOA was 11.9 months for sipuleucel-T versus 8.3 months for placebo.

At 12 months, 48.7% of the sipuleucel-T group and 39.7% of the placebo group were opioid-free, and the difference between the two groups was evident at 6 months, which may reflect the delayed treatment effect, Small commented.

Shorter TFOA was significantly associated with higher PSA and alkaline phosphatase levels, younger age, an ECOG performance status of 1, a Gleason score of 8 or higher, increased weight, previous primary radiotherapy, and a higher number of bone metastasis.

Two separate analyses of the PROCEED trial showed that patients aged 80 years or older derive the same benefit from sipuleucel-T as younger patients, and that patients previously exposed to docetaxel derived a similar benefit from the vaccine as those who were docetaxel-naïve.

PROCEED is an ongoing, multicenter, phase IV registry enrolling patients who are receiving sipuleucel- T in the real-world setting.

The first analysis presented by lead author Chadi Nabhan, MD, director, Division of Hematology/Oncology at Advocate Lutheran General Hospital in Park Ridge, Illinois, compared product parameters in 111 patients who were aged 80 years or older (20%) versus 449 patients younger than age 80 [Abstract 131]. All 560 patients had completed sipuleucel-T treatment as of September 2012.

A lower proportion of PROCEED patients were 80 years or older. Among this group, fewer patients had ECOG performance status of 0, Gleason scores of 8 or higher, and 10 or more bone metastases compared with those in the younger cohort. Both age groups had comparable total nucleated count (TNC) and antigen presenting cell (APC) activation, showing that the older patients exhibited similar immune activation compared with younger patients, with evidence of immunologic prime-boosting.

The second analysis of the same patient population compared the immunologic effects of the vaccine in patients previously exposed to docetaxel versus those who were docetaxel-naïve upon entry to the registry [Abstract 30]. These data were presented by Oliver Sartor, MD, professor of Medicine and Urology at Tulane University School of Medicine, New Orleans, Louisianna.

Sartor noted that in the IMPACT trial, the use of docetaxel was prohibited within 3 months prior to registration, but there was no restriction on docetaxel use in the real-world PROCEED registry.

Of the 560 patients enrolled in the study, 82 (15%) previously had received docetaxel and 474 (85%) had received no docetaxel; the docetaxel stop date was not available for 4 patients. Of the patients who had received docetaxel, 14 patients received docetaxel for 90 days or less before initiation of sipuleucel-T, and 68 patients received docetaxel more than 90 days before initiation of the vaccine.

Baseline demographics and disease characteristics were different in patients with and without prior docetaxel exposure. Product parameters of sipuleucel-T, including APC and TNC counts and APC activation, were comparable in both groups independent of prior docetaxel use.

“Sipuleucel-T stimulated a robust immune response that is consistent with immune prime-boost independent of prior docetaxel exposure,” the authors wrote, but said that only a small number of patients received docetaxel less than 90 days before sipuleucel-T, so further evaluation is warranted in this group of patients.

The optimal sequencing of sipuleucel-T and androgen ablation is still under study. A randomized phase II trial of 68 patients with biochemically recurrent prostate cancer provides preliminary evidence that ADT should be administered first to improve antitumor immune response [Abstract 34]. The lead author on the study was Emmanuel Antonarakis, MB BCh, assistant professor of Oncology at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore, Maryland.

Dr. Emmanuel Antonarakis on Sequencing ADT and Sipuleucel-T

The combination of sipuleucel-T and ADT was well tolerated in patients with biochemically recurrent prostate cancer in this analysis. Immune activation of the vaccine was independent of the timing of ADT. Measurement of serum cytokines, including IFN-gamma, suggested that ADT may enhance T cell activity when administered before sipuleucel-T.

Further study is needed to establish with certainty optimal sequencing of these two modalities in men with biochemically recurrent prostate cancer.

Small EJ, Higano CS, Kantoff PW, Whitmore JB, Frohlich MW, Petrylak DP. Relationship of sipuleucel-T with time to first use of opioid analgesics in patients with asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer on the IMPACT trial. 

Nabhan C, Sartor AO, Cooperberg MR. Real-world experience with sipuleucel-T in patients ≥80 years old with metastatic castration-resistant prostate cancer: Data from PROCEED. 

Sartor AO, Cooperberg MR, Vogelzang NJ. Real-world experience with sipuleucel-T in patients with metastatic castration-resistant prostate cancer who received prior docetaxel: Data from PROCEED. 

Antonarakis ES, Kibel A, Tyler RC. Randomized phase II trial evaluating the optimal sequencing of sipuleucel-T and androgen-deprivation therapy in patients with biochemically recurrent prostate cancer.

Studies that continue to shed light on the optimal use of sipuleucel-T in men with prostate cancer were presented at the 2013 Genitourinary Cancers Symposium.