As many of us are keenly aware, the coming 12 months present some very challenging times in the medical community. Having just returned from the 4th Annual Meeting of the Large Urology Group Practice Association (LUGPA), the issues that confront our specialty, and society, were made painfully clear to all who were in attendance.

Economically, we are moving quickly toward the fiscal cliff that Federal Reserve System Chairman Ben S. Bernanke warned of earlier this year. Due to pending legislative events expected to hit in January, there will be a projected 50% reduction in the 2013 budget deficit (from $1.2 trillion to $560 billion) and potential flattening of the debt curve for the next decade. Many economists predict that this may result in a short-term recession, slowing of economic recovery, and more than likely an increased tax burden for all Americans.

Even more sobering is our current national debt–running around $17 trillion as I type and increasing with every key stroke. The first keynote speaker at the LUGPA meeting, Robert Laszewski, president of Health Policy and Strategy Associates, Inc, in Alexandria, Virginia, noted that although entitlement spending is the major driver of our runaway deficit, the Medicare program has the pole position. If Medicare continues to go unchecked without significant payment reform, it will for all intents and purposes consume our resources and bankrupt the country in the years to come. As a result, alternative methodologies to pay providers will be developed, and the likely intent of those methodologies will be to pay all of us less. Not redistribute, not keep things even–less.

My good friend and colleague, Neil D. Shore, MD, of Carolina Urologic Research Center in Myrtle Beach, South Carolina, moderated a program at the LUGPA meeting on advances in the management of patients with castration-resistant prostate cancer (CRPC). The session provided a comprehensive overview of the advances and complexities that currently confront the practicing urologist. The good news for our patients is that there are many new therapies already available, and more on the horizon, that provide hope and the potential for long-term survival. However, there are no existing data on sequencing or combinatorial therapy.

One of the problems with obtaining these data is that in most trials, the FDA still requires a primary endpoint of overall survival. This hampers our ability to gather data quickly, since such trials take years to complete.

Another difficulty that we all face is the rising cost of oncologic care. While the drug component is the fastest-rising element within that sector, it does not actually represent the largest cost to the healthcare system. With all of our medical advances, we now simply have more cancer patients to manage. And with every patient comes the associated costs of therapy, including monitoring (lab, advanced imaging, etc), procedures, office visits, and hospitalizations. The challenge, given the economic landscape, is how to pay for these new therapies that clearly have a survival advantage and better side-effect profile, but individually carry a high price tag. Patients and their doctors face a difficult conundrum, given the economic downturn and loss of personal and corporate income versus trying to obtain/deliver quality care.

As physicians, we take the Hippocratic Oath on completion of our medical school training to always try to do what is best for our patients and do no harm. It is a lifetime plan that we try to formulate for those who come to us for help and medical expertise. Given the many obstacles in the way of providing quality care for cancer patients, it is disappointing to me that many of our leaders in government–in either party–seem to only have a two-, four-, or six-year commitment and will do whatever it takes to get them to the next election. They may win elections, but their constituents, patients, and our country end up losing by this short-sighted strategy.

Articles

As many of us are keenly aware, the coming 12 months present some very challenging times in the medical community.

The Challenges That Lie Ahead

	ï»¿I have always found the summer to be an interesting time, especially as I walk through the doors of the hospital to make my rounds. It conjures up memories of my first few months as a general surgical intern at Vanderbilt Hospital in 1984, wondering why I was driving with the traffic lights still blinking in Nashville to start rounds at 4:30 in the morning, knowing that I would not return to the comforts of my apartment until sometime the following night. Many of you probably remember putting on the standard hospital-issue attire—white pants and short lab coat, looking as if we had just finished working a shift at the ice cream shop. (And we wonder why many of our colleagues possess peculiar sartorial tastes.)

	The routine was the same, irrespective of your location or what teaching hospital you were affiliated with: Make rounds, meet with senior residents to be assigned cases (for which you would then be the primary object of verbal abuse), round again and make sure everything was checked off your scut list, hopefully grab a meal in the bowels of the hospital cafeteria (not a food court with multiple options!), and then start the evening grind of preparing patients for surgery the following day. There was no such entity as early-morning admissions or 23-hour stays. I checked pre-op labs and x-rays, made sure that operative permits were signed (whoever heard of informed consent?), and still managed the 20 or so patients on my service, without the benefit of a nutritional support team, IV therapy, or in-house hospitalist. I believe back then they were called your “friends” on other services. This pattern would repeat itself every other day for the next two years. Who would believe that I voluntarily asked for this schedule?

	Many of you would agree, however, that despite this grueling and insane way of life, the learning curve was exponential, and our ability to take care of and manage the acutely ill patient served us well as we became attendings. More important, the friendships forged as a result of those shared efforts will last forever. I personally look back on those times and would not trade the experience for anything.

	Times have certainly changed for residents and house officers (can we still call them that?). The Libby Zion law has limited the number of hours that they can spend in patient care on a continued basis. The support at most hospitals is far superior compared with what was previously available. Technology has driven the market to a more minimally invasive/robotics-assisted world. I have had the distinct pleasure, despite being in “private practice,” to work daily with the Vanderbilt Urology residents as a part of their training for the past 22 years. I am not saying that the residency system is better or worse. It is simply different.

	Now we are certainly entering into a changing system in the healthcare environment. It is, and certainly will be in the future, different. As you know, the Patient Protection and Affordable Care Act (ACA) has been upheld by the United States Supreme Court. Dr Deepak Kapoor, current president of the Large Urology Group Practice Association (LUGPA), has written a very thoughtful piece in this edition of 

, discussing the potential effects of this legislative action on urology groups in the United States. (

The Affordable Care Act: An Analysis of Its Impact on Urology Practices

	Many out there do not want to accept the fact that traditional fee-for-service is going away. As with most industries where outcome metrics are crucial for continued success, the government is wanting physicians to deliver care that is outcome- and evidence-based, which will hopefully result in lower costs. Payment will be based on the ability to implement such a system. This will be a very daunting process, to say the least, but one that is clearly critical to long-term success and viability.

	The management of the urologic cancer patient may well be a great starting point. As many of you are keenly aware, we are often on point for the early management of these patients. Now, with new therapies being introduced and fast-tracked for approval, we need to begin to develop integrated models within our existing practices that will allow us to continue to direct patient care well past the immediate postoperative period. We need to venture outside of our traditional surgical toolbox in order to survive in this changing environment. Generally, we physicians are resistant to change and prefer the status quo. It won’t be easy for most of us, but it will be worth it. (A bit like trying to change your golf swing: If it seems simple, you probably haven’t really changed anything.)

	Because we are in the middle of an election year, and depending on the November result, the battle over the ACA likely will not commence until 2014. Now is the time for us to look forward and be proactive in our efforts to effect change. As my good friend, Sandy Siegel, MD, (of Chesapeake Urology Associates, Baltimore, MD) says, doctors usually do not know they are drowning until the water is up to their chins. The waters are rising rapidly. Let’s put on the life vests now before it’s too late.

As with most industries where outcome metrics are crucial for continued success, the government is wanting physicians to deliver care that is outcome- and evidence-based.

Are Physicians Drowning?

Raoul S. Concepcion, MD, editor-in-chief, Urologists in Cancer Care, Director of Clinical Research, Urologic Surgeon, Urology Associates, PC, Nashville, TN, explains that over the past few years multiple new therapies have become available that are well suited for a urologist to deliver for the treatment of cancers. 

Concepcion believes that the number of new therapies becoming available that urologists are able to administer will only continue to increase. Additionally, many of these new therapies have fewer side effects and may not require changes in the way that practices are set up, since many are oral therapies. The most recent explosion in new therapies has taken place in advanced prostate cancer, but Concepcion believes this paradigm will remain true for both kidney and bladder cancer. 

Many urologists are well adapted to providing the management and treatment needed for many advanced urologic cancers, Concepcion stresses. However, the idea of urologists treating cancer represents a change in how treatment has traditionally been delivered and may still need to be embraced by some as a potentially beneficial opportunity.

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Dr. Raoul Concepcion, from Urology Associates, PC, Discusses Urologists Treating Cancer.


Dr. Concepcion Discusses Urologists Treating Cancer

Raoul S. Concepcion, MD, editor-in-chief, Urologists in Cancer Care, Director of Clinical Research, Urologic Surgeon, Urology Associates, PC, Nashville, TN, discusses the costs and novel treatments on the horizon for patients with bladder cancer.

Concepcion believes that bladder cancer comes in two forms: non—muscle invasive and invasive. He adds that non-invasive bladder cancer is one of the most expensive forms of cancer because of the costs associated with the extensive monitoring and follow-up that is needed to detect recurrence or invasion into the muscle.

In order to help ease costs and to ensure better outcomes, companies are currently investigating biological markers for non-invasive bladder cancer that could help predict the tumors that are at high-risk of progressing or recurring.

Additionally, for invasive bladder cancer the company Dendreon is examining the HER2/neu targeted immunotherapy DN24-02. This therapy is currently in a phase II adjuvant trial for patients with HER2-positive urothelial carcinoma following surgical resection.

Dr. Raoul Concepcion, from the Urology Associates, PC, Nashville, TN, on Bladder Cancer Treatment and Costs.

Dr. Concepcion on Bladder Cancer Treatment and Costs

Raoul Concepcion, MD, editor-in-chief, Urologists in Cancer Care, Director of Clinical Research, Urologic Surgeon, Urology Associates, PC, Nashville, TN, discusses the multiple new therapies that have been approved in recent years for advanced prostate cancer.

The first agent Concepcion mentions is cabazitaxel (Jevtana), which was approved June 17, 2010, in combination with prednisone, for metastatic castration-resistant prostate cancer (CRPC). This agent is a cytotoxic semi-synthetic taxane and is approved to be administered following the failure of docetaxel.

The oral agent abiraterone acetate (Zytiga) was approved April 28, 2011, in combination with prednisone, for metastatic CRPC patients who have received prior docetaxel. This agent inhibits the dual-enzyme complex CYP17, which prevents androgen biosynthesis.

Concepcion feels that the most exciting new agent available is the autologous cellular immunotherapy sipuleucel-T (Provenge), which was approved April 29, 2010, for asymptomatic or minimally symptomatic metastatic CRPC. He explains this agent has a proven survival benefit with very few side effects. Additionally, following leukapheresis the administration process is fairly simple to complete in an urologist's office.

Dr. Raoul Concepcion, from Urology Associates, PC, Nashville, TN, Discusses New Prostate Cancer Therapies.

Raoul S. Concepcion, MD

Articles

The Challenges That Lie Ahead

Are Physicians Drowning?

Dr. Concepcion Discusses Urologists Treating Cancer

Dr. Concepcion on Bladder Cancer Treatment and Costs

Dr. Concepcion Discusses Prostate Cancer Therapies