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Urology Practice Management ™

process improvements to enhance patient care™

Special issue

September 2013

Volume 2 • Number 3

Proceedings of the Prostate Cancer Steering Committee Meeting

Evolving Paradigm of Metastatic Prostate Cancer Management: Timely Identification and Intervention

June 8, 2013, Dallas, Texas

By Lisa A. Raedler, PhD, RPh, John A. Welz, MPH, and Gary M. Kirsh, MD

The healthcare delivery landscape in the United States continues to shift as reforms mandated in 2010 by the Patient Protection and Affordable Care Act become manifest. The Center for Medicare & Medicaid Innovation, accountable care organizations, and the health insurance marketplace (or exchange), slated to begin in January 2014, will continue to impact the practice of medicine. Today’s physicians are tasked with learning about and complying with new data collection requirements, clinical practice pathways, and healthcare delivery models.

For urologists who manage prostate cancer, these sweeping healthcare policy changes coincide with remarkable technological and therapeutic innovations. Continual enhancements in prostate surgery, radiation delivery techniques, diagnostic imaging, and pharmaceuticals have significantly improved outcomes for Continued on page 3

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 or men in the United States, prostate cancer is the most commonly diagnosed solid tumor malignancy. It is one of the highest cancer-specific causes of death, second only to lung cancer.1 At the time of diagnosis with prostate cancer, most men have early-stage, asymptomatic disease. Prostate cancer is typically identified through prostate-specific antigen (PSA) testing and a digital rectal examination, and confirmed with a needle biopsy. When biopsy results are positive, the affected tissue is assessed microscopically and a Gleason score is calculated. In conjunction with other disease features and diagnostic test results, this score helps urologists determine the disease stage and prognosis, and facilitates the selection of initial therapy.2 Active surveillance, external radiation therapy, brachytherapy, radical prostatectomy, and androgen deprivation therapy (ADT) are relevant treatment options for men in the early stages of

prostate cancer. Treatment selection is influenced by the risk of disease recurrence, the patient’s life expectancy, and quality-of-life considerations.3 Even with treatment, prostate cancer often progresses. Among patients with biochemical recurrence of localized disease, more than one third (33%) of men who are treated with surgery or radiation are not cured. In men who are treated with ADT, nearly all will go on to develop castration-resistant prostate cancer (CRPC). CRPC is characterized by a rising PSA level despite a castrate testosterone level of <50 ng/dL.3-6 More than 80% of patients with CRPC will advance and develop metastases.5 Progression to metastatic disease (mCRPC) is frequently rapid, with 46% of men with CRPC developing metastases within 2 years. Even patients with a low PSA level or longer PSA doubling time are at significant risk for metastatic disease.6 In addition to the men who progress to mCRPC, approximately 5% of men with prostate cancer are newly diagnosed with metastatic disease.7 Because the 5-year relative survival rate at diagnosis is only 28% for these men, mCRPC treatment tends to be relatively aggressive and generally involves ADT. Various agents are characterized as ADT, including luteinizing hormone-releasing hormone agonists Continued on page 3

©2013 Engage Healthcare Communications, LLC


In This Issue

PUBLISHING STAFF Senior Vice President/Group Publisher Nicholas Englezos nick@engagehc.com Vice President, Director of Sales & Marketing Joe Chanley joe@greenhillhc.com Publisher Cristopher Pires cris@engagehc.com Editorial Director Dalia Buffery dalia@engagehc.com Managing Editor Lisa Neuman Associate Editor Lara J. Lorton Editorial Assistants Jennifer Brandt Cara Guglielmon Production Manager Marie RS Borrelli

Proceedings

of the

Prostate Cancer Steering Committee Meeting

Evolving Paradigm of Metastatic Prostate Cancer Management: Timely Identification and Intervention.................................................... 1 By Lisa A. Raedler, PhD, RPh, John A. Welz, MPH, and Gary M. Kirsh, MD

Panel Discussion

Testing for Metastatic Castration-Resistant Prostate Cancer.............. 6 Business Challenges and Opportunities for Today’s Urology Practices......................................................................................................................7 By Lisa A. Raedler, PhD, RPh, John A. Welz, MPH, and Joel Young

Panel Discussion

What Keeps Urology CEOs and Practice Administrators Up at Night?............................................................................................... 9

Editorial Advisory Board The Lynx Group President/CEO Brian Tyburski Chief Operating Officer Pam Rattanonont Ferris Vice President of Finance Andrea Kelly Associate Editorial Director, Projects Division Terri Moore Director, Quality Control Barbara Marino Quality Control Assistant Theresa Salerno Director, Production & Manufacturing Alaina Pede Director, Creative & Design Robyn Jacobs Creative & Design Assistant Lora LaRocca Director, Digital Media Anthony Romano Web Content Managers David Maldonado Anthony Travean Digital Programmer Michael Amundsen Senior Project Manager Andrea Boylston Project Coordinators Deanna Martinez Jackie Luma Business Manager Blanche Marchitto Executive Administrator Rachael Baranoski Office Coordinator Robert Sorensen Engage Healthcare Communications 1249 South River Road - Ste 202A Cranbury, NJ 08512 phone: 732-992-1880 fax: 732-992-1881

Neil Baum, MD Practicing Urologist New Orleans, LA Cheris Craig, MBA, CMPE Chief Administrative Officer Urology of Greater Atlanta, LLC Atlanta, GA Rick Janss, MBA, CMPE Practice Administrator Clinical Urology Associates Gadsden, AL

John McMann, MS Administrator Advanced Urology Specialists, LLC Oxford, FL

James A. Sylora, MD Urologist AUS–Midwest Urology Evergreen Park, IL

Jonathan Oppenheimer, MD, FCAP Medical Director, Chief Pathologist Oppenheimer Urologic Reference Laboratory Nashville, TN

Sean M. Weiss, CCP-P, CCA-P, ACS-EM, CPC, CPC-P Vice President & Chief Compliance Officer DecisionHealth/ Professional Services Gaithersburg, MD

Mission Statement Urology healthcare requires providers to focus attention on financial concerns and strategic decisions that affect the bottom line. To continue to provide the high-quality care urology patients deserve, providers must master the ever-changing business of urology. Urology Practice Management will offer process solutions for members of the urology care team—medical, surgical, and radiation urologists, as well as executives, administrators, and coders/billers—to assist them in reimbursement, staffing, electronic health records, REMS, and compliance with state and federal regulations.

Urology Practice Management™, ISSN (requested), is published 4 times a year by Engage Healthcare Communications, LLC, 1249 South River Road, Cranbury, NJ 08512. Copyright © 2013 by Engage Healthcare Communications, LLC. All rights reserved. Urology Practice Management™ is a registered trademark of Engage Healthcare Communications, LLC. No part of this publication may be reproduced or transmitted in any form or by any means now or hereafter known, electronic or mechanical, including photocopy, recording, or any informational storage and retrieval system, without written permission from the publisher. Printed in the United States of America. The ideas and opinions expressed in Urology Practice Management™ do not necessarily reflect those of the editorial board, the editors, or the publisher. Publication of an advertisement or other product mentioned in Urology Practice Management™ should not be construed as an endorsement of the product or the manufacturer’s claims. Readers are encouraged to contact the manufacturers about any features or limitations of products mentioned. Neither the editors nor the publisher assume any responsibility for any injury and/or damage to persons or property arising out of or related to any use of the material mentioned in this publication. Postmaster: Correspondence regarding subscriptions or change of address should be directed to CIRCULATION DIRECTOR, Urology Practice Management™, 1249 South River Road, Cranbury, NJ 08512. Fax: 732-992-1881. Yearly subscription rates: 1 year: $99.00 USD; 2 years: $149.00 USD; 3 years: $199.00 USD.

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Proceedings of the Prostate Cancer Steering Committee Meeting

Proceedings of the Prostate Cancer…Continued from page 1 men with prostate cancer. Together, however, the combination of comprehensive healthcare reforms and fast-paced clinical advances has resulted in a challenging environment for urologists. To continue to provide state-of-the-art, quality-driven, and cost-effective care for their patients with prostate cancer, these

specialists must reconsider both clinical and economic aspects of their practices. In June 2013, the Prostate Cancer Steering Committee met in Dallas, Texas, to explore ways in which urology practices are addressing today’s business and healthcare environment challenges, including the viability of

implementing integrated and comprehensive cancer care services. The Steering Committee also deliberated on various trends in the clinical management of men with prostate cancer, focusing primarily on the diagnosis of metastatic prostate cancer and the incorporation of newer therapies to treat these patients. l

Evolving Paradigm of Metastatic Prostate…Continued from page 1 such as Lupron (leuprolide acetate) and antiandrogen agents, such as Nilandron (nilutamide), Casodex (bicalutamide), and Eulexin (fluta­ mide). While ADT is a mainstay of prostate cancer treatment, these agents are associated with various side effects, including hot flashes and flushing; bone demineralization, which can lead to osteoporosis; and central weight gain and insulin resistance, which can contribute to the onset of diabetes and cardiovascular disease.3 Urologists monitor patients who use ADT for these toxicities, and frequently offer nutritional and cardiovascular care to mitigate longterm complications. In the past, most men with mCRPC

autologous cellular immunotherapeutic agent that is typically administered in 3 doses at approximately 2-week intervals for 4 weeks. In the prechemotherapy setting, sipuleucel-T is the only anticancer agent that has demonstrated statistically significant improvement in overall survival (OS). In a clinical study, sipuleucel-T extended OS in patients with mCRPC by 25.8 months (vs 21.7 months for controls), conferring an OS advantage of 4.1 months.8 Data suggest that an optimal treatment window may exist for sipuleucel-T. In a subgroup analysis of clinical trial data, sipuleucel-T was shown to work better in men with lower PSA scores, extending OS up to 41.3 months (Table 2).9

received cytotoxic chemotherapy. However, the treatment landscape has changed in recent years with the approval of several novel therapies (Table 1).3

In men who are treated with ADT, nearly all will go on to develop CRPC. Provenge (sipuleucel-T) was approved by the US Food and Drug Administration (FDA) in 2010 for asymptomatic or minimally symptomatic mCRPC. Sipuleucel-T is an

Table 1. New Agents Among Treatment Recommendations for Metastatic CRPC3,a

Asymptomatic disease • Sipuleucel-Tb (category 1)c • Abiraterone acetate (category 1)c • Enzalutamide

Symptomatic disease after treatment with docetaxel

Symptomatic disease • Abiraterone acetated • Enzalutamide • Radium 223e (category 1)c

• Abiraterone acetate (category 1)c • Enzalutamide (category 1)c • Radium 223e (category 1)c

Unless specified, all recommendations are category 2A, which means that, based on lower-level evidence, there is uniform NCCN consensus that the intervention is appropriate. b Appropriate for asymptomatic or minimally symptomatic patients. c Based on high-level evidence, there is uniform NCCN consensus that the intervention is appropriate. d For patients who are not candidates for docetaxel-based regimens. e For symptomatic bone metastases. CRPC indicates castration-resistant prostate cancer; NCCN, National Comprehensive Cancer Network.

a

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Proceedings of the Prostate Cancer Steering Committee Meeting

Evolving Paradigm of Metastatic Prostate…Continued from page 3 Table 2. Sipuleucel-T OS by PSA Range

OS, months PSA range, ng/mL

≤22.1

Sipuleucel-T

41.3

27.1

20.4

18.4

Controls

28.3

20.1

15.0

15.6

–22.1 to 50.1 –50.1 to 134.1

>134.1

OS indicates overall survival; PSA, prostate-specific antigen. Source: Reference 9.

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The most common adverse events (AEs) reported in trials of sipuleucel-T were chills, fatigue, fever, back pain, nausea, joint ache, and headache. Serious AEs included acute infusion reactions, cerebrovascular events, and single case reports of eosinophilia, rhabdomyolysis, myasthenia gravis, myositis, and tumor flare.8 Zytiga (abiraterone acetate), an oral agent given once daily with prednisone, was initially approved by the FDA in 2011 for patients with mCRPC after cytotoxic chemotherapy. In the postchemotherapy setting, the phase 3 trial demonstrated that abiraterone improved OS by a median of 3.9 months in the primary survival analysis, and 4.6 months in an updated OS analysis. Zytiga has also been studied in the prechemotherapy setting. Researchers selected 2 primary end points, radiographic progression-free survival (rPFS) and OS. At the prespecified analysis of rPFS, 72% of patients had neither experienced radiographic progression nor died while receiving abiraterone versus 54% receiving placebo. The median time to initiation of cytotoxic chemotherapy was 25.2 months with abiraterone versus 16.8 months with placebo. This difference between the treatment groups was statistically significant. The findings were less compelling in terms of OS. Although OS was longer with Zytiga than with placebo (hazard ratio = 0.792), the P value

was .015, which did not meet the prespecified value for statistical significance. Abiraterone received approval for patients with mCRPC prior to chemotherapy in December 2012.10 Side effects of abiraterone can include fluid retention, which can cause an increase in blood pressure, and, occasionally, lowering of potassium levels and elevation of liver functions. Liver function tests are recommended for patients receiving abiraterone.10

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Progression to mCRPC is frequently rapid, with 46% of men with CRPC developing metastases within 2 years. Another oral agent, Xtandi (enza­ lutamide), was approved in August 2012 as monotherapy for patients with mCRPC who have previously received docetaxel. Enzalutamide is given once daily, and in a phase 3, placebo-controlled, randomized clinical trial of patients with mCRPC who previously received docetaxel, OS was extended by 18.4 months versus 13.6 months in patients receiving placebo, for an OS advantage of 4.8 months. Common side effects September 2013

include fatigue, diarrhea, hot flushes, and headache. In a pivotal phase 3 clinical trial, 7 patients receiving enzalutamide reported seizures versus no patients in the placebo group.11 In May 2013, the FDA approved Xofigo (radium Ra 223 dichloride), the first alpha particle-emitting radioactive therapeutic agent for the treatment of patients with CRPC, symptomatic bone metastases, and no known visceral metastatic disease. In these patients, radium 223 combined with best standard of care demonstrated a significant 3.6-month improvement in median OS compared with placebo plus best standard of care. This OS improvement was supported by a delay in time to the first symptomatic skeletal-related event favoring the radium 223 arm. Radium 223 is not approved for use in combination with docetaxel or any other chemotherapy agent.3,12 Sequential or concurrent treatment of patients with mCRPC with newer agents is being explored in clinical trials. In a randomized, phase 2 open-­ label study, researchers are evaluating concurrent or sequential abir­aterone acetate plus prednisone to determine whether increased suppression of the androgen axis with abir­aterone acetate could provide synergy when combined with sipuleucel-T. In an interim analysis reported during the 2013 Genitourinary Cancers Symposium in Orlando, Florida, concurrent administration of the immunostimulatory agents sipuleucel-T and abir­ aterone acetate plus prednisone results in si­ puleucel-T potency and prime boost similar to that of sipuleucel-T alone in men with mCRPC.13 Although some physicians prescribe secondary hormonal therapies after progression using ADT, such as ketoconazole, steroids, and estrogens, these drugs have significant side effects. Furthermore, none of these drugs have phase 3 clinical trial evidence demonstrating a sig-


Proceedings of the Prostate Cancer Steering Committee Meeting

nificant improvement in OS. With the approval of 4 new therapeutic agents since 2010, many urologists now view the use of secondary hormonal maneuvers as a tactic that may adversely affect patient access to therapies with demonstrable survival benefits. For men with prostate cancer to qualify for newer therapies, they must have documented mCRPC. However, the panelists consistently described challenges in the recognition and treatment of patients with mCRPC by urologists. First, urologists must understand that patients with mCRPC do not always have symptoms or even a rising PSA.3 A recent study demonstrated that 32% of men who were thought to have nonmetastatic CRPC had evidence of metastases upon imaging.14 Second, urology practices must proactively identify patients with CRPC who might have metastatic disease and order appropriate imaging to evaluate them. Primary detection techniques include bone scan, 18F sodium fluoride (NaF) positron emission tomography (PET) scan, and computed tomography scan (for nodal metastases). The panelists indicated that NaF PET scanning is far more sensitive in detecting metastases than traditional bone scanning. Routine scanning of “at-risk” patients receiving ADT is not occurring for multiple reasons: the lack of national guidelines regarding the frequency and type of scans; concern that payers will not reimburse scan costs, particularly for NaF PET scans; and uncertainty regarding pa­ tient selection and timing of scans. Of note, NaF PET scanning is reimbursed by Medicare, but only under the auspices of the National Oncologic PET Registry.15 Third, upon detection of metastatic disease, it is imperative for urologists and their patients to discuss treatment options, including sipuleucel-T and other appropriate agents. Treatment recommendations should

always be made in accordance with product labeling. The panelists outlined several steps that their and others’ urology practices have taken to address issues related to early detection of mCRPC. For example, the practices represented by the panelists typically designate 1 person—a nurse, patient navigator, or mid-level provider—to review patients’ charts and identify the signals of emerging metastatic disease. These professionals then notify urologists to order scans and evaluate treatment alternatives for identified patients. Some urology practices have established their own protocols for routine bone scanning (eg, every 6-12 months for patients receiving ADT). Others are consulting proactively with local and regional payers to clarify payers’ positions regarding precertification and medical necessity requirements for PET scans and other diagnostic tests for suspected patients with mCRPC. Progressive urology practices have developed bone health clinics for patients with prostate cancer who require Xgeva (denosumab) or Zo­ meta (zolendronic acid). At Regional Urology (Shreveport, Louisiana) and The Urology Group (Cincinnati, Ohio), clinics have evolved into full-service CRPC clinics. Patients with CRPC are referred to these clinics within the practice after CRPC develops, with or without metastases. Urologists who have a special interest in prostate cancer management then direct the treatment of these patients. In the discussion, participating urologists identified sipuleucel-T as a preferred treatment option for patients with newly diagnosed mCRPC. In addition to the clinical data supporting its use prior to chemotherapy (which urologists typically do not administer), panelists cited a number of advantages in treating appropriate patients with sipuleucel-T, including ease of administration and favorable September 2013

safety profile. Treatment with sipuleucel-T also allows urologists to retain their patients longer, thereby extending the continuity of care in treating their disease. l About the Authors Dr Raedler and Mr Welz are medical writers with Engage Healthcare Communications, and Dr Kirsh is President, The Urology Group, Cincinnati, Ohio Author Disclosure Statement Dr Raedler and Mr Welz have nothing to disclose. Dr Kirsch is a speaker and a consultant for Dendreon Corporation, and a speaker for Amgen and Bayer.

References

1. US Cancer Statistics Working Group. United States Cancer Statistics: 1999–2009 Incidence and Mortality Web-based Report. Atlanta, GA: Centers for Disease Control and Prevention, and National Cancer Institute, US Department of Health and Human Services; 2012. http://apps.nccd.cdc.gov/uscs/topten cancers.aspx. Accessed September 2, 2013. 2. Urology Care Foundation: Official Foundation of the American Urological Association. Prostate Cancer. http:// www.urologyhealth.org/urology/index.cfm?article=146. Updated March 2013. Accessed August 14, 2013. 3. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology (NCCN Guideline®): Prostate Cancer. Version 4.2013. http:// www.nccn.org/professionals/physician_gls/pdf/prostate. pdf. Accessed August 14, 2013. 4. Abdulla A, Kapoor A. Emerging novel therapies in the treatment of castration-resistant prostate cancer. Can Urol Assoc J. 2011;5:120-133. 5. Kirby M, Hirst C, Crawford ED. Characterising the castration-resistant prostate cancer population: a systematic review. Int J Clin Pract. 2011;65:1180-1192. 6. Smith MR, Cook R, Lee KA, Nelson JB. Disease and host characteristics as predictors of time to first bone metastasis and death in men with progressive castration-resistant nonmetastatic prostate cancer. Cancer. 2011;117:2077-2085. 7. Siegel R, Naishadham D, Jemal A. Cancer statistics, 2013. CA Cancer J Clin. 2013;63:11-30. 8. Provenge [package insert]. Seattle, WA: Dendreon Corporation; 2011. 9. Schellhammer PF, Chodak G, Whitmore JB, et al. Lower baseline prostate-specific antigen is associated with a greater overall survival benefit from sipuleucel-T in the Immunotherapy for Prostate Adenocarcinoma Treatment (IMPACT) trial. Urology. 2013;81:1297-1302. 10. Zytiga [package insert]. Horsham, PA: Janssen Biotech, Inc; 2012. 11. Xtandi [package insert]. San Francisco, CA: Astellas Pharma US, Inc; 2012. 12. Xofigo [package insert]. Wayne NJ: Bayer HealthCare Pharmaceuticals, Inc; 2013. 13. Small EJ, Lance R, Gardner TA, et al. A randomized phase II, open-label study of sipuleucel-T with concurrent or sequential abiraterone acetate (AA) in metastatic castrate-resistant prostate cancer (mCRPC). Presented at: 2013 Genitourinary Cancers Symposium; February 14-16, 2013; Orlando, FL. Abstract 114. 14. Yu EY, Miller K, Nelson J, et al. Detection of previously unidentified metastatic disease as a leading cause of screening failure in a phase III trial of zibotentan versus placebo in patients with nonmetastatic, castration resistant prostate cancer. J Urol. 2012;188:103-109. 15. National Oncologic PET Registry. What is the NOPR? http://www.cancerpetregistry.org/what.htm. Accessed September 4, 2013.

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Proceedings of the Prostate Cancer Steering Committee Meeting

Panel Discussion Richard G. Harris, MD President and CEO UroPartners Melrose Park, Illinois

Jonathan Henderson, MD Urologist Regional Urology, LLC Shreveport, Louisiana

Gary M. Kirsh, MD President The Urology Group Cincinnati, Ohio

Sharon Rouleau Practice Manager Urology Specialists, PC Middlebury, Connecticut

Testing for Metastatic Castration-Resistant Prostate Cancer A number of physicians on the panel highlighted the challenges that are associated with early testing to identify castration-resistant prostate cancer (CRPC) that has metastasized (mCRPC). The following exchange among several panelists illustrates some of the issues that affect urologistsâ&#x20AC;&#x2122; ability to proactively evaluate patients who are receiving androgen deprivation therapy (ADT). Gary Kirsh (Moderator): There is a tendency on the part of many urologists to think that if the patient is on Lupron and their prostate-specific antigen (PSA) level is rising slightly (ie, 2.0 ng/mL-4.0 ng/mL) that they are doing all right. But the fact is that many of them have metastases and we do not know that. We need to know that. Once we establish that they have mCRPC, we have a variety of therapeutic options that will actually extend their lives.

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watch their PSA levels go up and do nothing. One of the dilemmas is that there are no national testing guidelines right now. Everybody is going it alone. Urologists who specialize in prostate cancer have their own ideas about testing, but there are no guidelines. That is difficult for us.

It is a long process to get some urology groups to realize that times have changed. Jonathan Henderson: We need to think about all of our patients with prostate cancer who are taking ADT, and who are becoming patients with CRPC. They metastasize before the PSA reflects that. In our practice, we routinely perform bone scans for patients who are receiving ADT to find the patients with CRPC before they are detected using PSA.

Richard Harris: It can be a hard message to get across. It is a long process to get some urology groups to realize that times have changed. They have to start looking at these patients. Now that we have good therapeutic options, we must not

Dr Kirsh: The classic approach when you suspect metastatic disease is to order bone and computed tomography scans. Increasingly, we are using

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September 2013

18F sodium fluoride (NaF) positron emission tomography (PET) scanning, which is a better way of identifying bony metastases. Sharon Rouleau: We had several patients with negative bone scans, but positive NaF PET scans. It started a controversy in our area. Radiologists went back to the bone scans and thought they had missed something; they could not understand how bone scans were negative and NaF PET scans were positive. Dr Kirsh: The problem is that NaF PET is not covered by many commercial payers. It is covered by Medicare through a registry arrangement. We complete additional paperwork for each patient. I do not know why the test has not received widespread support from commercial payers, but clearly we need to go in that direction. It is probably more expensive than a technetium bone scan, but the results are significantly more reliable and accurate. Dr Harris: We believe that the NaF PET scan is another tool that can be used to help confirm that the patient has metastases. Obviously, the presence of metastatic disease will affect the patientâ&#x20AC;&#x2122;s treatment plan. l


Proceedings of the Prostate Cancer Steering Committee Meeting

Business Challenges and Opportunities for Today’s Urology Practices By Lisa A. Raedler, PhD, RPh, John A. Welz, MPH, and Joel Young

O

wnership of any type of business means balancing income and expenses to ensure profitability and stability. External factors that influence business success include market dynamics (ie, competition, pricing, consumer needs and pref­ erences), product and service inno­ vations, and industry regulations. Changes in all of these external influences are culminating in both opportunities and challenges for urologists and their practice managers. Declining payer reimbursement, higher business expenses, increasing involvement in patient care by government and private payers, more aggressive competition, novel treatments and surgical techniques, and patient preferences for comprehensive yet cost-effective medical care are just a few market trends that are currently shaping urologists’ and practice managers’ strategic decisions. In order to thrive, progressive urology practices have been forced to take action. Some of the tactics that have been implemented to mitigate risk and improve financial health for urology practices include: • Increasing patient volume (workload): more patients per day, more surgeries per week, the addition of evening hours • The addition of urology staff or the consolidation of private practices to broaden the catchment area • Partnership with local or regional hospital networks •  Service-line expansion (ie, drug infusion services, pathology, diagnostic imaging, radiation, surgery, clinical research) • Development of in-house specialty clinics (ie, prostate cancer, bone health) Panelists described concrete steps that their practices have taken, as

well as the success associated with implementation. One practice documented a 15% year-to-date increase in office visits, primarily due to care provided to current patients rather than new patients. Other urology practices have effectively expanded their service geography to attract new patients, added clinics, and opened new appointment times to enhance patient access to care. To preclude high rates of missed patient appointments (“no shows”), which affect office productivity and revenue, some practices contact patients well in advance of their appointments. This proactive step reduces no-show and last-minute cancellation rates, as well as facilitates payments from financially risky patients. One urology practice has developed a “virtual” schedule that is designed to accommodate chronic no-show patients, fitting them in without affecting the “standard” schedule. Panelists also discussed the merits of charging patients for missed appointments, but this practice is not commonplace at this time. Both government and private payers require urologists and other physicians to document and improve the quality of patient care. Panelists highlighted their participation in Medicare quality initiatives, including the Physician Quality Reporting System, as well as their experience with commercial payers’ increasing documentation and comparison of urology practices’ “cost to cure” statistics. One panelist recalled a commercial payer that requires urology practices to develop their own quality care (or “pay for performance”) metrics prior to engaging in contract negotiations. Although evaluations of the quality of patient care are perceived to be important, their administration costs

remain uncompensated. For urology practices, the expenses associated with collecting and reporting these data are included in the overhead. To address this, some panelists referred to the Large Urology Group Practice Association working group, which is designed to support member practices by developing and disseminating measurable and relevant quality-care metrics.

Declining payer reimbursement, higher business expenses, increasing involvement in patient care by government and private payers...and patient preferences for comprehensive yet cost-effective medical care are just a few market trends that are currently shaping urologists’ and practice managers’ strategic decisions. In response to the Affordable Care Act, many markets are seeing the growth of accountable care organization (ACO)-like arrangements. Some panelists expressed concerns that, particularly in markets that are dominated by primary care practitioners (PCPs), ACO-like arrangements will result in the appropriation by PCPs of patient services that are best provided by urology specialists. In Continued on page 8

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Proceedings of the Prostate Cancer Steering Committee Meeting

Business Challenges and Opportunities…Continued from page 7

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such settings, urologists need to be prepared to “defend” their position as experts in the care of patients with prostate cancer. To maintain practice profitability, various reimbursement arrangements, including at-risk or capitated arrangements, are becoming more commonplace among physician groups. One panelist’s practice is involved in capitated arrangements with 2 different payers. Ancillary services (imaging, radiation), biologics, and other specialty medications (denosumab, sipuleucel-T, and radium 223) are not included in these contracts. Although these arrangements have been profitable, the practice is currently renegotiating the administration of specialty medications. Panelists in other re­ gions of the country have chosen to expand their geographic coverage (and urology staff) to grow patient volume, as well as to enhance their market-specific leverage with payers. One urology group has also considered hiring a medical oncologist to support their expanding prostate cancer care clinic. Despite past communication challenges with payers (typically regarding contracting, prior authorization requirements, and step-edit restrictions), private urology practices now recognize that their financial objectives are increasingly aligned with those of payers. At the same time, payers now appreciate that supporting independent physician practices (relative to hospital-based care settings) has meaningful consequences in terms of both the quality and cost of patient care. Panelists noted positive consequences of including payers’ medical directors, whom one dubbed “the voice of [clinical] reason,” in contract negotiation meetings. In addition to more “fair” contracts, such meetings lay the groundwork for constructive future collaborations with the payer. Panelists believe that

quantitative data regarding differences in patient satisfaction, as well as the cost of care, between officeand hospital-based sites of care will enhance the likelihood that these productive payer–practitioner relationships will continue.

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Despite past communication challenges with payers...private urology practices now recognize that their financial objectives are increasingly aligned with those of payers. The unreimbursed time associated with obtaining prior authorizations for branded medications for patients with prostate cancer can be highly problematic for urology practices. Many practices rely on manufacturers’ support programs to ease the burden for both staff members and patients. In the ongoing effort to improve practice efficiency and reduce costs, panelists extolled the value of patient support and reimbursement programs for high-cost medications, particularly those provided by the manufacturers of denosumab and sipuleucel-T. Both of these programs were cited as practice-friendly and easy to use. With the help of these programs, practices represented by the panelists have had very few issues in obtaining reimbursement for denosumab and sipuleucel-T. Use of specialty pharmacy services is relatively low among urology practices. However, panelists acknowledged the importance of these services—including reimbursement support, patient counseling, Risk September 2013

Evaluation and Mitigation Strategy program management, and patient compliance programs—that many pharmacy-benefit management firms provide. Some urology practices employ nurse navigators and/or financial counselors to provide similar patient assistance services, but their time to perform these tasks is generally unreimbursed. Based on their state’s regulations, other urologists are ex­ploring the addition of pharmacy (dispensing) services to their practices to capture service-related revenue. Throughout the Prostate Cancer Steering Committee meeting, it was clear that the practice of urology is complicated by multiple and often intertwined influences: financial, logistical, political, and legislative. Despite this, however, the desire to optimize care for patients, particularly men with prostate cancer, remains strong among participating urologists and practice managers. They summarized their recommendations by emphasizing the need to educate patients and families, as well as payers, about the unique expertise that urologists offer men with prostate cancer. It is clear from their example that urologists who gain professional satisfaction from managing early-­ stage and metastatic prostate cancer can also benefit financially. While barriers to change may initially appear daunting, panelists consistently and enthusiastically emphasized the personal and financial rewards associated with urology practice models that offer continuous, comprehensive care for patients with prostate cancer. l About the Authors Dr Raedler and Mr Welz are medical writers with Engage Healthcare Communications, and Mr Young is Chief Executive Officer, Regional Urology, Shreveport, Louisiana. Author Disclosure Statement Dr Raedler, Mr Welz, and Mr Young have nothing to disclose.


Proceedings of the Prostate Cancer Steering Committee Meeting

Panel Discussion Steve Bass Executive Vice President and Chief Financial Officer Chesapeake Urology Associates, PA Baltimore, Maryland

John B. Forrest, MD Urologist Urologic Specialists of Oklahoma, Inc. Tulsa, Oklahoma Gary M. Kirsh, MD President The Urology Group Cincinnati, Ohio

Sharon Rouleau Practice Manager Urology Specialists, PC Middlebury, Connecticut

Joel Young Chief Executive Officer Regional Urology, LLC Shreveport, Louisiana

Daniel A. Schonwald, CMPE Practice Administrator Comprehensive Urologic Care, SC Chicago, Illinois

What Keeps Urology CEOs and Practice Administrators Up at Night? Management of a urology office— large or small—is fraught with challenges, particularly as regulatory and fiscal environments evolve. Increasing costs and decreasing reimbursements have compelled practices to offer new products and services to maximize business efficiencies, and to consider strategic alliances. The following interactive discussion highlights the challenges and outlines potential solutions for the issues faced by today’s urology practices, especially in adopting new treatment options for patients with metastatic castrate-resistant prostate cancer. Joel Young (Moderator): We are in a perfect storm of declining reimbursements, increasing overhead, and more camels’ noses in our tents, if you will. Government and regulatory agencies have a never-ending desire to garner more information and restrict our payments, which leads to increased competition and consolidation. We talked about recent consolidations in order to control overhead numbers and, of course, the expansion of hospital-based practices. In our practice, we must be smarter with our money than we were last year. We are pushing fewer people to do much more work. My question for you is what are you doing to address financial challenges? John Forrest: To increase cash

flow, we are making everybody see more patients, including me. We have had a 15% year-to-date increase in office visits.

Daniel Schonwald: In our market, Medicare and Blue Cross make up 78% of reimbursement. The biggest reimbursement problems that I have are with Medicare, especially with the sequester issue. We are grappling with how to address this issue.

Steve Bass: We think one of the ways to protect ourselves in the future is to aggressively expand into markets where the service line or the availability of services is extremely poor.

Mr Bass: My biggest fear right now is not about reimbursement, it is the pervasiveness of high-deductible insurance plans. People in the new insurance exchanges as well as employed individuals with high-deductible plans will have insurance, but they will basically be the walking uninsured because few will be able to pay their deductibles. Em­­ ployers are not able to continue to subsidize employee health insurance, and will end up pushing more of the financial burden to the employee/patient. We are rapidly moving to a system where patients who are scheduled for a procedure must pay for their portion upfront. In addition, patients who require services in the office but do not satisfy their outstanding balances will not be seen. We have already had a couple of cases in front of our medical board regarding patient abandonment, which we won. It might sound heartless, but at the end of the day, we cannot survive unless we are paid. We are not a charity.

People in the new insurance exchanges as well as employed individuals with highdeductible plans will have insurance, but they will basically be the walking uninsured because few will be able to pay their deductibles. Dr Forrest: Practices are venturing out into other ancillary services, such as pathology, diagnostic services, radiation, surgery, and clinical research to replace some of the revenue that is being carved out, and to keep their practices financially whole.

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Proceedings of the Prostate Cancer Steering Committee Meeting

PROVENGE® (sipuleucel-T) Suspension for Intravenous Infusion

Rx Only

BRIEF SUMMARY — See full Prescribing Information for complete product information

What Keeps Urology... Continued from page 9

Sharon Rouleau: Patients who have high deductibles for things like computed tomography (CT) scans are coming in screaming, “The doctor should have told me that I was going to have to pay for this out-of-pocket!” We then try to explain that any charges are based on their insurance policy and that they need to know about their deductibles and other out-of-pocket expenses. The typical response is, “No, the doctor should have known that.” So the doctors are now rethinking whether the patient really needs another CT scan. Who is supposed to know the provisions of each policy? It can become quite a morass. Gary Kirsh: You cannot win this game by reducing costs. It is not feasible to do that. You cannot win. Back to products like Provenge, we cannot afford to give these products up to the oncology people. Dr Forrest: If a practice says that there are financial or logistical reasons to avoid using new products, such as Provenge, they either do not understand enough or they are making excuses. They need to move away from “cruise control” and take some risks to make it in this new world. Mr Bass: Doctors never talked about costs before. Now we talk about it. I want each patient to know immediately that there is a financial aspect to their healthcare and that they need to deal with it. The quicker that message gets delivered, the better off all parties will be. At the end of the day, what we are going to see is that patients who cannot pay will just not show up at all. I think accountable care will result in unintended consequences. People will not come to the office seeking care until they are really sick. At that point, it is much more expensive to treat them. They can go to the hospital, but then hospital costs will skyrocket. It is going to be very messy out there over the next 12 to 18 months. l

INDICATIONS AND USAGE: PROVENGE® (sipuleucel-T) is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer. DOSAGE AND ADMINISTRATION • For Autologous Use Only. • The recommended course of therapy for PROVENGE is 3 complete doses, given at approximately 2-week intervals. • Premedicate patients with oral acetaminophen and an antihistamine such as diphenhydramine. • Before infusion, confirm that the patient’s identity matches the patient identifiers on the infusion bag. • Do Not Initiate Infusion of Expired Product. • Infuse PROVENGE intravenously over a period of approximately 60 minutes. Do Not Use a Cell Filter. • Interrupt or slow infusion as necessary for acute infusion reactions, depending on the severity of the reaction. (See Dosage and Administration [2] of full Prescribing Information.) CONTRAINDICATIONS: None. WARNINGS AND PRECAUTIONS • PROVENGE is intended solely for autologous use. • Acute infusion reactions (reported within 1 day of infusion) included, but were not limited to, fever, chills, respiratory events (dyspnea, hypoxia, and bronchospasm), nausea, vomiting, fatigue, hypertension, and tachycardia. In controlled clinical trials, 71.2% of patients in the PROVENGE group developed an acute infusion reaction. I n controlled clinical trials, severe (Grade 3) acute infusion reactions were reported in 3.5% of patients in the PROVENGE group. Reactions included chills, fever, fatigue, asthenia, dyspnea, hypoxia, bronchospasm, dizziness, headache, hypertension, muscle ache, nausea, and vomiting. The incidence of severe events was greater following the second infusion (2.1% vs 0.8% following the first infusion), and decreased to 1.3% following the third infusion. Some (1.2%) patients in the PROVENGE group were hospitalized within 1 day of infusion for management of acute infusion reactions. No Grade 4 or 5 acute infusion reactions were reported in patients in the PROVENGE group. Closely monitor patients with cardiac or pulmonary conditions. In the event of an acute infusion reaction, the infusion rate may be decreased, or the infusion stopped, depending on the severity of the reaction. Appropriate medical therapy should be administered as needed. • Handling Precautions for Control of Infectious Disease. PROVENGE is not routinely tested for transmissible infectious diseases. Therefore, patient leukapheresis material and PROVENGE may carry the risk of transmitting infectious diseases to health care professionals handling the product. Universal precautions should be followed. • Concomitant Chemotherapy or Immunosuppressive Therapy. Use of either chemotherapy or immunosuppressive agents (such as systemic corticosteroids) given concurrently with the leukapheresis procedure or PROVENGE has not been studied. PROVENGE is designed to stimulate the immune system, and concurrent use of immunosuppressive agents may alter the efficacy and/or safety of PROVENGE. Therefore, patients should be carefully evaluated to determine whether it is medically appropriate to reduce or discontinue immunosuppressive agents prior to treatment with PROVENGE. • Product Safety Testing. PROVENGE is released for infusion based on the microbial and sterility results from several tests: microbial contamination determination by Gram stain, endotoxin content, and in-process sterility with a 2-day incubation to determine absence of microbial growth. The final (7-day incubation) sterility test results are not available at the time of infusion. If the sterility results become positive for microbial contamination after PROVENGE has been approved for infusion, Dendreon will notify the treating physician. Dendreon will attempt to identify the microorganism, perform antibiotic sensitivity testing on recovered microorganisms, and communicate the results to the treating physician. Dendreon may request additional information from the physician in order to determine the source of contamination. (See Warnings and Precautions [5] of full Prescribing Information.) ADVERSE REACTIONS Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

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Table 1 Incidence of Adverse Events Occurring in ≥5% of Patients The safety evaluation of PROVENGE is based on 601 prostate cancer patients in the PROVENGE group who underwent at least 1 leukapheresis procedure in four randomized, Randomized to PROVENGE controlled clinical trials. The control was non-activated autologous peripheral blood PROVENGE (N = 601) Control* (N = 303) mononuclear cells. The most common adverse events, reported in patients in the PROVENGE group at a rate ≥15%, were chills, fatigue, fever, back pain, nausea, joint ache, and headache. Severe (Grade 3) and life-threatening (Grade 4) adverse events were reported in 23.6% and 4.0% of patients in the PROVENGE group compared with 25.1% and 3.3% of patients in the control group. Fatal (Grade 5) adverse events were reported in 3.3% of patients in the PROVENGE group compared with 3.6% of patients in the control group. Serious adverse events were reported in 24.0% of patients in the PROVENGE group and 25.1% of patients in the control group. Serious adverse events in the PROVENGE group included acute infusion reactions (see Warnings and Precautions), cerebrovascular events, and single case reports of eosinophilia, rhabdomyolysis, myasthenia gravis, myositis, and tumor flare. PROVENGE was discontinued in 1.5% of patients in Study 1 (PROVENGE group n=341; Control group n=171) due to adverse events. Some patients who required central venous catheters for treatment with PROVENGE developed infections, including sepsis. A small number of these patients discontinued treatment as a result. Monitoring for infectious sequelae in patients with central venous catheters is recommended. Each dose of PROVENGE requires a standard leukapheresis procedure approximately 3 days prior to the infusion. Adverse events that were reported ≤1 day following a leukapheresis procedure in ≥5% of patients in controlled clinical trials included citrate toxicity (14.2%), oral paresthesia (12.6%), paresthesia (11.4%), and fatigue (8.3%). Table 1 provides the frequency and severity of adverse events reported in ≥5% of patients in the PROVENGE group of randomized, controlled trials of men with prostate cancer. The population included 485 patients with metastatic castrate resistant prostate cancer and 116 patients with non-metastatic androgen dependent prostate cancer who were scheduled to receive 3 infusions of PROVENGE at approximately 2-week intervals. The population was age 40 to 91 years (median 70 years), and 90.6% of patients were Caucasian.

Table 1 Incidence of Adverse Events Occurring in ≥5% of Patients Randomized to PROVENGE PROVENGE (N = 601)

Any Adverse Event Chills Fatigue Fever Back pain Nausea Joint ache Headache Citrate toxicity Paresthesia Vomiting Anemia Constipation Pain Paresthesia oral Pain in extremity Dizziness Muscle ache Asthenia Diarrhea Influenza-like illness Musculoskeletal pain Dyspnea Edema peripheral Hot flush Hematuria Muscle spasms

Control* (N = 303)

All Grades n (%)

Grade 3-5 n (%)

All Grades n (%)

591 (98.3) 319 (53.1) 247 (41.1) 188 (31.3) 178 (29.6) 129 (21.5) 118 (19.6) 109 (18.1) 89 (14.8) 85 (14.1) 80 (13.3) 75 (12.5) 74 (12.3) 74 (12.3) 74 (12.3) 73 (12.1) 71 (11.8) 71 (11.8) 65 (10.8) 60 (10.0) 58 (9.7) 54 (9.0) 52 (8.7) 50 (8.3) 49 (8.2) 46 (7.7) 46 (7.7)

186 (30.9) 13 (2.2) 6 (1.0) 6 (1.0) 18 (3.0) 3 (0.5) 11 (1.8) 4 (0.7) 0 (0.0) 1 (0.2) 2 (0.3) 11 (1.8) 1 (0.2) 7 (1.2) 0 (0.0) 5 (0.8) 2 (0.3) 3 (0.5) 6 (1.0) 1 (0.2) 0 (0.0) 3 (0.5) 11 (1.8) 1 (0.2) 2 (0.3) 6 (1.0) 2 (0.3)

291 (96.0) 33 (10.9) 105 (34.7) 29 (9.6) 87 (28.7) 45 (14.9) 62 (20.5) 20 (6.6) 43 (14.2) 43 (14.2) 23 (7.6) 34 (11.2) 40 (13.2) 20 (6.6) 43 (14.2) 40 (13.2) 34 (11.2) 17 (5.6) 20 (6.6) 34 (11.2) 11 (3.6) 31 (10.2) 14 (4.6) 31 (10.2) 29 (9.6) 18 (5.9) 17 (5.6)

Grade 3-5 n (%) 97 (32.0) 0 (0.0) 4 (1.3) 3 (1.0) 9 (3.0) 0 (0.0) 5 (1.7) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 7 (2.3) 3 (1.0) 3 (1.0) 0 (0.0) 1 (0.3) 0 (0.0) 0 (0.0) 2 (0.7) 3 (1.0) 0 (0.0) 3 (1.0) 3 (1.0) 1 (0.3) 1 (0.3) 3 (1.0) 0 (0.0)

Hypertension Anorexia Bone pain Upper respiratory tract infection Insomnia Musculoskeletal chest pain Cough Neck pain Weight decreased Urinary tract infection Rash Sweating Tremor

All Grades n (%)

Grade 3-5 n (%)

All Grades n (%)

Grade 3-5 n (%)

45 (7.5) 39 (6.5) 38 (6.3) 38 (6.3)

3 (0.5) 1 (0.2) 4 (0.7) 0 (0.0)

14 (4.6) 33 (10.9) 22 (7.3) 18 (5.9)

0 (0.0) 3 (1.0) 3 (1.0) 0 (0.0)

37 (6.2) 36 (6.0)

0 (0.0) 2 (0.3)

22 (7.3) 23 (7.6)

1 (0.3) 2 (0.7)

35 (5.8) 34 (5.7) 34 (5.7) 33 (5.5) 31 (5.2) 30 (5.0) 30 (5.0)

0 (0.0) 3 (0.5) 2 (0.3) 1 (0.2) 0 (0.0) 1 (0.2) 0 (0.0)

17 (5.6) 14 (4.6) 24 (7.9) 18 (5.9) 10 (3.3) 3 (1.0) 9 (3.0)

0 (0.0) 2 (0.7) 1 (0.3) 2 (0.7) 0 (0.0) 0 (0.0) 0 (0.0)

*Control was non-activated autologous peripheral blood mononuclear cells.

Cerebrovascular Events. In controlled clinical trials, cerebrovascular events, including hemorrhagic and ischemic strokes, were reported in 3.5% of patients in the PROVENGE group compared with 2.6% of patients in the control group. (See Adverse Reactions [6] of full Prescribing Information.) To report SUSPECTED ADVERSE REACTIONS, contact Dendreon Corporation at 1-877-336-3736 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Dendreon Corporation Seattle, Washington 98101

REFERENCES: 1. PROVENGE [package insert]. Dendreon Corporation; June 2011. 2. Kantoff PW, Higano CS, Shore ND, et al; for the IMPACT Study Investigators. Sipuleucel-T immunotherapy for castration-resistant prostate cancer. N Engl J Med. 2010;363:411-422.

©2013 Dendreon Corporation. All rights reserved. January 2013. Printed in the U.S.A. Dendreon, the Dendreon logo, and PROVENGE are registered trademarks of Dendreon Corporation. P-A-01.13-002.00


In the newly metastatic CRPC patient who is asymptomatic or minimally symptomatic

STARTS THE FIGHT

AND HELPS HIS IMMUNE SYSTEM SUSTAIN* IT 1

• Targets and attacks prostate cancer cells • Statistically significant overall survival advantage1,2 • Sustained* immune response *A sustained immune response was seen out to 26 weeks in the pivotal study (the last time point measured).1 INDICATION: PROVENGE® (sipuleucel-T) is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer. IMPORTANT SAFETY INFORMATION: PROVENGE is intended solely for autologous use and is not routinely tested for transmissible infectious diseases. In controlled clinical trials, serious adverse events reported in the PROVENGE group included acute infusion reactions (occurring within 1 day of infusion) and cerebrovascular events. Severe (Grade 3) acute infusion reactions were reported in 3.5% of patients in the PROVENGE group. Reactions included chills, fever, fatigue, asthenia, dyspnea, hypoxia, bronchospasm, dizziness, headache, hypertension, muscle ache, nausea, and vomiting. No Grade 4 or 5 acute infusion reactions were reported in patients in the PROVENGE group. The most common adverse events (incidence ≥15%) reported in the PROVENGE group were chills, fatigue, fever, back pain, nausea, joint ache, and headache. For more information on PROVENGE, please see Brief Summary of Prescribing Information on adjacent pages. www.PROVENGEHCP.com

UPM September 2013 Vol 2, No 3 Special Issue  

Urology Practice Management September 2013 Vol 2, No 3 Special Issue