UPM July 2013 by Value-Based Cancer Care

Urology Practice Management ™

process improvements to enhance patient care™

www.UroPracticeManagement.com

July 2013

Conducting an Operational Assessment By Sandra Paton

“Operations are everything in practice,” noted Jeffery Daigrepont, Senior Vice President of the Coker Group in Alpharetta, Georgia, at the American Urological Association annual practice meeting. He urged managers to have an analytic strat egy—specifically a dashboard—to allow for early intervention and data transfer without becoming what he called “a foren sic accountant.” An operational assess ment is a head-to-toe diagnostic review of your practice. The most difficult thing, he observed, is being objective about your practice. To help achieve objectivity, he recommended having other departments review each other and conduct internal as well as external reviews. Mr Daigrepont identified several areas requiring attention: revenue cycle, work flow, utilization of technology, physician satisfaction, and patient satisfaction. He cautioned practice managers to pay attention to the most important issues, Continued on page 8

Volume 2 • Number 2

Staying Independent—Exploring and Understanding the Options By William Robertson

ome say that being employed by a hospital is inevitable. While this may be true for cardiologists, it does not yet apply to urologists, according to Max Reiboldt, CPA, President of the Coker Group in Alpharetta, Georgia. At the American Urological Association annu al practice management meeting, Mr

Reiboldt led a session to illustrate options for urologists and offer strategies for making practice transitions. While medical care costs are escalating, reimbursements are being cut and greater access to care is being demanded, owing in part to the aging baby boom population. What we are facing, he noted, is all about changing paradigms. Continued on page 10

Billing and Coding Pitfalls for Urology Practice Managers By Sandra E. Cangiano

t the American Urological Asso ciation annual practice manage ment meeting, M. Ray Painter, MD, a practicing urologist with a strong interest in medical economic issues, and Rick Rutherford, MPE, CHA, Director of Practice Management for the American Urology Association, outlined what urol ogy practice managers need to know to prevent succumbing to billing and cod

ing pitfalls. They offered guidance based on Medicare standards for “incident to” services, “shared” services, office super vision requirements, time measurements for evaluation and management (E/M) coding, and red flags for auditing. “Incident to” Services If, after being seen by the physician who has developed a plan of care for Continued on page 8

ct pa 6 a Im .1 st get del.. o ud o pr B M

AN ORAL OPTION FOR YOUR UROLOGY PRACTICE ZYTIGA® is indicated in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC).

FOR PATIENTS WITH mCRPC WHO HAVE PROGRESSED ON ADT* LOCAL

THERAPY†

ADT

‡

ZYTIGA PLUS PREDNISONE

For more information, please visit www.zytigahcp.com.

IMPORTANT SAFETY INFORMATION Contraindications—ZYTIGA® is not indicated for use in women. ZYTIGA® can cause fetal harm (Pregnancy Category X) when administered to a pregnant woman and is contraindicated in women who are or may become pregnant. Hypertension, Hypokalemia, and Fluid Retention Due to Mineralocorticoid Excess—Use with caution in patients with a history of cardiovascular disease or with medical conditions that might be compromised by increases in blood pressure, hypokalemia, or fluid retention. ZYTIGA® may cause hypertension, hypokalemia, and fluid retention as a consequence of increased mineralocorticoid levels resulting from CYP17 inhibition. Safety has not been established in patients with LVEF < 50% or New York Heart Association (NYHA) Class III or IV heart failure (in study 1) or NYHA Class II to IV heart failure (in study 2) because these patients were excluded from these randomized clinical trials. Control hypertension and correct hypokalemia before and during treatment. Monitor blood pressure, serum potassium, and symptoms of fluid retention at least monthly. Adrenocortical Insufficiency (AI)—AI was reported in patients receiving ZYTIGA® in combination with prednisone, after an interruption of daily steroids and/or with concurrent infection or stress. Use caution and monitor for symptoms and signs of AI if prednisone is stopped or withdrawn, if prednisone dose is reduced, or if the patient experiences unusual stress. Symptoms and signs of AI may be masked by adverse reactions associated

with mineralocorticoid excess seen in patients treated with ZYTIGA®. Perform appropriate tests, if indicated, to confirm AI. Increased dosages of corticosteroids may be used before, during, and after stressful situations. Hepatotoxicity—Monitor liver function and modify, withhold, or discontinue ZYTIGA® dosing as recommended (see Prescribing Information for more information). Measure serum transaminases [alanine aminotransferase (ALT) and aspartate aminotransferase (AST)] and bilirubin levels prior to starting treatment with ZYTIGA®, every two weeks for the first three months of treatment, and monthly thereafter. Promptly measure serum total bilirubin, AST, and ALT if clinical symptoms or signs suggestive of hepatotoxicity develop. Elevations of AST, ALT, or bilirubin from the patient’s baseline should prompt more frequent monitoring. If at any time AST or ALT rise above five times the upper limit of normal (ULN) or the bilirubin rises above three times the ULN, interrupt ZYTIGA® treatment and closely monitor liver function. Increased ZYTIGA® Exposures With Food—ZYTIGA® must be taken on an empty stomach. No food should be eaten for at least two hours before the dose of ZYTIGA® is taken and for at least one hour after the dose of ZYTIGA® is taken. Abiraterone Cmax and AUC0-∞ (exposure) were increased up to 17- and 10-fold higher, respectively, when a single dose of abiraterone acetate was administered with a meal compared to a fasted state.

ZYTIGA Next ®

35.3 3 5.3 Months 35.3 months median overall survival vs 30.1 months with placebo plus prednisone§

57% reduction in risk of radiographic progression or death vs placebo plus prednisone (median rPFS not reached vs 8.28 months, respectively)§

Significantly increased median time to chemotherapy vs placebo plus prednisone (25.2 months vs 16.8 months, respectively)||

Significantly increased median time to opiate use for prostate cancer pain vs placebo plus prednisone (not reached vs 23.7 months, respectively)||

Hazard ratio (HR) = 0.792; 95% CI: 0.655, 0.956; P = 0.0151; prespecified value for statistical significance not reached.

HR = 0.425; 95% CI: 0.347, 0.522; P < 0.0001.

HR = 0.580; 95% CI: 0.487, 0.691; P < 0.0001.

HR = 0.686; 95% CI: 0.566, 0.833; P = 0.0001.

*Study Design: ZYTIGA®, in combination with prednisone, was evaluated in a Phase 3, randomized, double-blind, placebo-controlled, multicenter trial in patients with mCRPC who had not received prior chemotherapy (N = 1,088). Patients were using a luteinizing hormone-releasing hormone (LHRH) agonist or were previously treated with orchiectomy. In the ZYTIGA® arm, patients received ZYTIGA® 1,000 mg orally once daily + prednisone 5 mg orally twice daily. In the placebo arm, patients received placebo orally once daily + prednisone 5 mg orally twice daily. In this study, the coprimary efficacy endpoints were overall survival and radiographic progression-free survival. †Local therapy = radiation and/or surgery. ‡For many patients with mCRPC, gonadotropin-releasing hormone (GnRH) agonist therapy typically continues throughout the disease course, and is used concomitantly with other mCRPC treatments, including ZYTIGA®. This illustration is not intended to suggest that ZYTIGA® is the only treatment option following androgen-deprivation therapy (ADT). § Primary endpoint. || Secondary endpoint.

Please see brief summary of full Prescribing Information on adjacent pages. K08Z121176

Adverse Reactions—The most common adverse reactions (≥ 10%) are fatigue, joint swelling or discomfort, edema, hot flush, diarrhea, vomiting, cough, hypertension, dyspnea, urinary tract infection, and contusion. The most common laboratory abnormalities (> 20%) are anemia, elevated alkaline phosphatase, hypertriglyceridemia, lymphopenia, hypercholesterolemia, hyperglycemia, elevated AST, hypophosphatemia, elevated ALT, and hypokalemia. Drug Interactions—ZYTIGA® is an inhibitor of the hepatic drug-metabolizing enzyme CYP2D6. Avoid co-administration with CYP2D6 substrates that have a narrow therapeutic index. If an alternative cannot be used, exercise caution and consider a dose reduction of the CYP2D6 substrate. In vitro, ZYTIGA® inhibits CYP2C8. There are no clinical data on its use with drugs that are substrates of CYP2C8. Patients should be monitored closely for signs of toxicity related to the CYP2C8 substrate if used concomitantly with abiraterone acetate. Based on in vitro data, ZYTIGA® is a substrate of CYP3A4. The effects of strong CYP3A4 inhibitors or inducers on the pharmacokinetics of abiraterone have not been evaluated, in vivo. Strong inhibitors and inducers of CYP3A4 should be avoided or used with caution during treatment with ZYTIGA®. Use in Specific Populations—Do not use ZYTIGA® in patients with baseline severe hepatic impairment (Child-Pugh Class C).

Janssen Biotech, Inc. © Janssen Biotech, Inc. 2013 3/13 K08Z13048

ZYTIGA® (abiraterone acetate) Tablets Brief Summary of Prescribing Information. INDICATIONS AND USAGE ZYTIGA is a CYP17 inhibitor indicated in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer. CONTRAINDICATIONS Pregnancy: ZYTIGA can cause fetal harm when administered to a pregnant woman. ZYTIGA is not indicated for use in women. ZYTIGA is contraindicated in women who are or may become pregnant. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, apprise the patient of the potential hazard to the fetus and the potential risk for pregnancy loss [see Use in Specific Populations]. WARNINGS AND PRECAUTIONS Hypertension, Hypokalemia and Fluid Retention Due to Mineralocorticoid Excess: ZYTIGA may cause hypertension, hypokalemia, and fluid retention as a consequence of increased mineralocorticoid levels resulting from CYP17 inhibition [see Clinical Pharmacology (12.1) in full Prescribing Information]. In the two randomized clinical trials, grade 3 to 4 hypertension occurred in 2% of patients, grade 3 to 4 hypokalemia in 4% of patients, and grade 3 to 4 edema in 1% of patients treated with ZYTIGA [see Adverse Reactions]. Co-administration of a corticosteroid suppresses adrenocorticotropic hormone (ACTH) drive, resulting in a reduction in the incidence and severity of these adverse reactions. Use caution when treating patients whose underlying medical conditions might be compromised by increases in blood pressure, hypokalemia or fluid retention, e.g., those with heart failure, recent myocardial infarction or ventricular arrhythmia. Use ZYTIGA with caution in patients with a history of cardiovascular disease. The safety of ZYTIGA in patients with left ventricular ejection fraction < 50% or New York Heart Association (NYHA) Class III or IV heart failure (in Study 1) or NYHA Class II to IV heart failure (in Study 2) was not established because these patients were excluded from these randomized clinical trials [see Clinical Studies (14) in full Prescribing Information]. Monitor patients for hypertension, hypokalemia, and fluid retention at least once a month. Control hypertension and correct hypokalemia before and during treatment with ZYTIGA. Adrenocortical Insufficiency: Adrenal insufficiency occurred in the two randomized clinical studies in 0.5% of patients taking ZYTIGA and in 0.2% of patients taking placebo. Adrenocortical insufficiency was reported in patients receiving ZYTIGA in combination with prednisone, following interruption of daily steroids and/or with concurrent infection or stress. Use caution and monitor for symptoms and signs of adrenocortical insufficiency, particularly if patients are withdrawn from prednisone, have prednisone dose reductions, or experience unusual stress. Symptoms and signs of adrenocortical insufficiency may be masked by adverse reactions associated with mineralocorticoid excess seen in patients treated with ZYTIGA. If clinically indicated, perform appropriate tests to confirm the diagnosis of adrenocortical insufficiency. Increased dosage of corticosteroids may be indicated before, during and after stressful situations [see Warnings and Precautions]. Hepatotoxicity: In the two randomized clinical trials, grade 3 or 4 ALT or AST increases (at least 5X ULN) were reported in 4% of patients who received ZYTIGA, typically during the first 3 months after starting treatment. Patients whose baseline ALT or AST were elevated were more likely to experience liver test elevation than those beginning with normal values. Treatment discontinuation due to liver enzyme increases occurred in 1% of patients taking ZYTIGA. No deaths clearly related to ZYTIGA were reported due to hepatotoxicity events. Measure serum transaminases (ALT and AST) and bilirubin levels prior to starting treatment with ZYTIGA, every two weeks for the first three months of treatment and monthly thereafter. In patients with baseline moderate hepatic impairment receiving a reduced ZYTIGA dose of 250 mg, measure ALT, AST, and bilirubin prior to the start of treatment, every week for the first month, every two weeks for the following two months of treatment and monthly thereafter. Promptly measure serum total bilirubin, AST, and ALT if clinical symptoms or signs suggestive of hepatotoxicity develop. Elevations of AST, ALT, or bilirubin from the patient’s baseline should prompt more frequent monitoring. If at any time AST or ALT rise above five times the ULN, or the bilirubin rises above three times the ULN, interrupt ZYTIGA treatment and closely monitor liver function. Re-treatment with ZYTIGA at a reduced dose level may take place only after return of liver function tests to the patient’s baseline or to AST and ALT less than or equal to 2.5X ULN and total bilirubin less than or equal to 1.5X ULN [see Dosage and Administration (2.2) in full Prescribing Information]. The safety of ZYTIGA re-treatment of patients who develop AST or ALT greater than or equal to 20X ULN and/or bilirubin greater than or equal to 10X ULN is unknown. Increased ZYTIGA Exposures with Food: ZYTIGA must be taken on an empty stomach. No food should be consumed for at least two hours before the dose of ZYTIGA is taken and for at least one hour after the dose of ZYTIGA is taken. Abiraterone Cmax and AUC0-∞ (exposure) were increased up to 17and 10-fold higher, respectively, when a single dose of abiraterone acetate was administered with a meal compared to a fasted state. The safety of these increased exposures when multiple doses of abiraterone acetate are taken with food has not been assessed [see Dosage and Administration (2.1) and Clinical Pharmacology (12.3) in full Prescribing Information].

ZYTIGA® (abiraterone acetate) Tablets ADVERSE REACTIONS The following are discussed in more detail in other sections of the labeling: • Hypertension, Hypokalemia, and Fluid Retention due to Mineralocorticoid Excess [see Warnings and Precautions]. • Adrenocortical Insufficiency [see Warnings and Precautions]. • Hepatotoxicity [see Warnings and Precautions]. • Increased ZYTIGA Exposures with Food [see Warnings and Precautions]. Clinical Trial Experience: 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 clinical practice. Two randomized placebo-controlled, multicenter clinical trials enrolled patients who had metastatic castration-resistant prostate cancer who were using a gonadotropin-releasing hormone (GnRH) agonist or were previously treated with orchiectomy. In both Study 1 and Study 2 ZYTIGA was administered at a dose of 1,000 mg daily in combination with prednisone 5 mg twice daily in the active treatment arms. Placebo plus prednisone 5 mg twice daily was given to control patients. The most common adverse drug reactions (≥10%) reported in the two randomized clinical trials that occurred more commonly (>2%) in the abiraterone acetate arm were fatigue, joint swelling or discomfort, edema, hot flush, diarrhea, vomiting, cough, hypertension, dyspnea, urinary tract infection and contusion. The most common laboratory abnormalities (>20%) reported in the two randomized clinical trials that occurred more commonly (≥2%) in the abiraterone acetate arm were anemia, elevated alkaline phosphatase, hypertriglyceridemia, lymphopenia, hypercholesterolemia, hyperglycemia, elevated AST, hypophosphatemia, elevated ALT and hypokalemia. Study 1: Metastatic CRPC Following Chemotherapy: Study 1 enrolled 1195 patients with metastatic CRPC who had received prior docetaxel chemotherapy. Patients were not eligible if AST and/or ALT ≥ 2.5X ULN in the absence of liver metastases. Patients with liver metastases were excluded if AST and/or ALT > 5X ULN. Table 1 shows adverse reactions on the ZYTIGA arm in Study 1 that occurred with a ≥2% absolute increase in frequency compared to placebo or were events of special interest. The median duration of treatment with ZYTIGA was 8 months. Table 1: Adverse Reactions due to ZYTIGA in Study 1 ZYTIGA with Placebo with Prednisone (N=791) Prednisone (N=394) System/Organ Class All Grades1 Grade 3-4 All Grades Grade 3-4 Adverse reaction % % % % Musculoskeletal and connective tissue disorders Joint swelling/discomfort2 29.5 4.2 23.4 4.1 Muscle discomfort3 26.2 3.0 23.1 2.3 General disorders Edema4 26.7 1.9 18.3 0.8 Vascular disorders Hot flush 19.0 0.3 16.8 0.3 Hypertension 8.5 1.3 6.9 0.3 Gastrointestinal disorders Diarrhea 17.6 0.6 13.5 1.3 Dyspepsia 6.1 0 3.3 0 Infections and infestations Urinary tract infection 11.5 2.1 7.1 0.5 Upper respiratory tract infection 5.4 0 2.5 0 Respiratory, thoracic and mediastinal disorders Cough 10.6 0 7.6 0 Renal and urinary disorders Urinary frequency 7.2 0.3 5.1 0.3 Nocturia 6.2 0 4.1 0 Injury, poisoning and procedural complications Fractures5 5.9 1.4 2.3 0 Cardiac disorders Arrhythmia6 7.2 1.1 4.6 1.0 Chest pain or chest discomfort7 3.8 0.5 2.8 0 Cardiac failure8 2.3 1.9 1.0 0.3 1 Adverse

events graded according to CTCAE version 3.0 terms Arthritis, Arthralgia, Joint swelling, and Joint stiffness terms Muscle spasms, Musculoskeletal pain, Myalgia, Musculoskeletal discomfort, and Musculoskeletal stiffness

2 Includes 3 Includes

ZYTIGA® (abiraterone acetate) Tablets

4 Includes

1 Adverse

terms Edema, Edema peripheral, Pitting edema, and Generalized edema 5 Includes all fractures with the exception of pathological fracture 6 Includes terms Arrhythmia, Tachycardia, Atrial fibrillation, Supraventricular tachycardia, Atrial tachycardia, Ventricular tachycardia, Atrial flutter, Bradycardia, Atrioventricular block complete, Conduction disorder, and Bradyarrhythmia 7 Includes terms Angina pectoris, Chest pain, and Angina unstable. Myocardial infarction or ischemia occurred more commonly in the placebo arm than in the ZYTIGA arm (1.3% vs. 1.1% respectively). 8 Includes terms Cardiac failure, Cardiac failure congestive, Left ventricular dysfunction, Cardiogenic shock, Cardiomegaly, Cardiomyopathy, and Ejection fraction decreased Table 2 shows laboratory abnormalities of interest from Study 1. Grade 3-4 low serum phosphorus (7%) and low potassium (5%) occurred at a greater than or equal to 5% rate in the ZYTIGA arm. Table 2: Laboratory Abnormalities of Interest in Study 1 Abiraterone (N=791) Placebo (N=394) Laboratory All Grades Grade 3-4 All Grades Grade 3-4 Abnormality (%) (%) (%) (%) Hypertriglyceridemia 62.5 0.4 53.0 0 High AST 30.6 2.1 36.3 1.5 Hypokalemia 28.3 5.3 19.8 1.0 Hypophosphatemia 23.8 7.2 15.7 5.8 High ALT 11.1 1.4 10.4 0.8 High Total Bilirubin 6.6 0.1 4.6 0 Study 2: Metastatic CRPC Prior to Chemotherapy Study 2 enrolled 1088 patients with metastatic CRPC who had not received prior cytotoxic chemotherapy. Patients were ineligible if AST and/or ALT ≥ 2.5X ULN and patients were excluded if they had liver metastases. Table 3 shows adverse reactions on the ZYTIGA arm in Study 2 that occurred with a ≥ 2% absolute increase in frequency compared to placebo. The median duration of treatment with ZYTIGA was 13.8 months. Table 3: Adverse Reactions in ≥5% of Patients on the ZYTIGA Arm in Study 2 ZYTIGA with Placebo with Prednisone (N=542) Prednisone (N=540) 1 System/Organ Class All Grades Grade 3-4 All Grades Grade 3-4 Adverse reaction % % % % General disorders Fatigue 39.1 2.2 34.3 1.7 Edema2 25.1 0.4 20.7 1.1 Pyrexia 8.7 0.6 5.9 0.2 Musculoskeletal and connective tissue disorders Joint swelling/ discomfort3 30.3 2.0 25.2 2.0 Groin pain 6.6 0.4 4.1 0.7 Gastrointestinal disorders Constipation 23.1 0.4 19.1 0.6 Diarrhea 21.6 0.9 17.8 0.9 Dyspepsia 11.1 0.0 5.0 0.2 Vascular disorders Hot flush 22.3 0.2 18.1 0.0 Hypertension 21.6 3.9 13.1 3.0 Respiratory, thoracic and mediastinal disorders Cough 17.3 0.0 13.5 0.2 Dyspnea 11.8 2.4 9.6 0.9 Psychiatric disorders Insomnia 13.5 0.2 11.3 0.0 Injury, poisoning and procedural complications Contusion 13.3 0.0 9.1 0.0 Falls 5.9 0.0 3.3 0.0 Infections and infestations Upper respiratory tract infection 12.7 0.0 8.0 0.0 Nasopharyngitis 10.7 0.0 8.1 0.0 Renal and urinary disorders Hematuria 10.3 1.3 5.6 0.6 Skin and subcutaneous tissue disorders Rash 8.1 0.0 3.7 0.0

2 Includes 3 Includes

events graded according to CTCAE version 3.0 terms Edema peripheral, Pitting edema, and Generalized edema terms Arthritis, Arthralgia, Joint swelling, and Joint stiffness

Table 4 shows laboratory abnormalities that occurred in greater than 15% of patients, and more frequently (>5%) in the ZYTIGA arm compared to placebo in Study 2. Grade 3-4 lymphopenia (9%), hyperglycemia (7%) and high alanine aminotransferase (6%) occurred at a greater than 5% rate in the ZYTIGA arm. Table 4: Laboratory Abnormalities in > 15% of Patients in the ZYTIGA Arm of Study 2 Abiraterone (N = 542) Placebo (N = 540) 1-4 Grade 3-4 Grade 1-4 Grade 3-4 Laboratory Abnormality Grade % % % % Hematology Lymphopenia 38.2 8.7 31.7 7.4 Chemistry 1 Hyperglycemia 56.6 6.5 50.9 5.2 High ALT 41.9 6.1 29.1 0.7 High AST 37.3 3.1 28.7 1.1 Hypernatremia 32.8 0.4 25.0 0.2 Hypokalemia 17.2 2.8 10.2 1.7 1Based on non-fasting blood draws Cardiovascular Adverse Reactions: In the combined data for studies 1 and 2, cardiac failure occurred more commonly in patients treated with ZYTIGA compared to patients on the placebo arm (2.1% versus 0.7%). Grade 3-4 cardiac failure occurred in 1.6% of patients taking ZYTIGA and led to 5 treatment discontinuations and 2 deaths. Grade 3-4 cardiac failure occurred in 0.2% of patients taking placebo. There were no treatment discontinuations and one death due to cardiac failure in the placebo group. In Study 1 and 2, the majority of arrhythmias were grade 1 or 2. There was one death associated with arrhythmia and one patient with sudden death in the ZYTIGA arms and no deaths in the placebo arms. There were 7 (0.5%) deaths due to cardiorespiratory arrest in the ZYTIGA arms and 3 (0.3%) deaths in the placebo arms. Myocardial ischemia or myocardial infarction led to death in 3 patients in the placebo arms and 2 deaths in the ZYTIGA arms. DRUG INTERACTIONS Effects of Abiraterone on Drug Metabolizing Enzymes: ZYTIGA is an inhibitor of the hepatic drug-metabolizing enzyme CYP2D6. In a CYP2D6 drug-drug interaction trial, the Cmax and AUC of dextromethorphan (CYP2D6 substrate) were increased 2.8- and 2.9-fold, respectively, when dextromethorphan was given with abiraterone acetate 1,000 mg daily and prednisone 5 mg twice daily. Avoid co-administration of abiraterone acetate with substrates of CYP2D6 with a narrow therapeutic index (e.g., thioridazine). If alternative treatments cannot be used, exercise caution and consider a dose reduction of the concomitant CYP2D6 substrate drug [see Clinical Pharmacology (12.3) in full Prescribing Information]. In vitro, ZYTIGA inhibits CYP2C8. There are no clinical data on the use of ZYTIGA with drugs that are substrates of CYP2C8. However, patients should be monitored closely for signs of toxicity related to the CYP2C8 substrate if used concomitantly with abiraterone acetate. Drugs that Inhibit or Induce CYP3A4 Enzymes: Based on in vitro data, ZYTIGA is a substrate of CYP3A4. The effects of strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, nefazodone, saquinavir, telithromycin, ritonavir, indinavir, nelfinavir, voriconazole) or inducers (e.g., phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital) on the pharmacokinetics of abiraterone have not been evaluated, in vivo. Avoid or use with caution, strong inhibitors and inducers of CYP3A4 during ZYTIGA treatment [see Clinical Pharmacology (12.3) in full Prescribing Information]. USE IN SPECIFIC POPULATIONS Pregnancy: Pregnancy Category X [see Contraindications].: ZYTIGA can cause fetal harm when administered to a pregnant woman based on its mechanism of action and findings in animals. While there are no adequate and well-controlled studies with ZYTIGA in pregnant women and ZYTIGA is not indicated for use in women, it is important to know that maternal use of a CYP17 inhibitor could affect development of the fetus. Abiraterone acetate caused developmental toxicity in pregnant rats at exposures that were lower than in patients receiving the recommended dose. ZYTIGA is contraindicated in women who are or may become pregnant while receiving the drug. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, apprise the patient of the potential hazard to the fetus and the potential risk for pregnancy loss. Advise females of reproductive potential to avoid becoming pregnant during treatment with ZYTIGA.

ZYTIGA® (abiraterone acetate) Tablets

In an embryo-fetal developmental toxicity study in rats, abiraterone acetate caused developmental toxicity when administered at oral doses of 10, 30 or 100 mg/kg/day throughout the period of organogenesis (gestational days 6-17). Findings included embryo-fetal lethality (increased post implantation loss and resorptions and decreased number of live fetuses), fetal developmental delay (skeletal effects) and urogenital effects (bilateral ureter dilation) at doses ≥10 mg/kg/day, decreased fetal ano-genital distance at ≥30 mg/kg/day, and decreased fetal body weight at 100 mg/kg/ day. Doses ≥10 mg/kg/day caused maternal toxicity. The doses tested in rats resulted in systemic exposures (AUC) approximately 0.03, 0.1 and 0.3 times, respectively, the AUC in patients. Nursing Mothers: ZYTIGA is not indicated for use in women. It is not known if abiraterone acetate is excreted in human milk. Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions in nursing infants from ZYTIGA, a decision should be made to either discontinue nursing, or discontinue the drug taking into account the importance of the drug to the mother. Pediatric Use: Safety and effectiveness of ZYTIGA in pediatric patients have not been established. Geriatric Use: Of the total number of patients receiving ZYTIGA in phase 3 trials, 73% of patients were 65 years and over and 30% were 75 years and over. No overall differences in safety or effectiveness were observed between these elderly patients and younger patients. Other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Patients with Hepatic Impairment: The pharmacokinetics of abiraterone were examined in subjects with baseline mild (n = 8) or moderate (n = 8) hepatic impairment (Child-Pugh Class A and B, respectively) and in 8 healthy control subjects with normal hepatic function. The systemic exposure (AUC) of abiraterone after a single oral 1,000 mg dose of ZYTIGA increased by approximately 1.1-fold and 3.6-fold in subjects with mild and moderate baseline hepatic impairment, respectively compared to subjects with normal hepatic function. No dosage adjustment is necessary for patients with baseline mild hepatic impairment. In patients with baseline moderate hepatic impairment (ChildPugh Class B), reduce the recommended dose of ZYTIGA to 250 mg once daily. If elevations in ALT or AST >5X ULN or total bilirubin >3X ULN occur in patients with baseline moderate hepatic impairment, discontinue ZYTIGA treatment [see Dosage and Administration (2.1) and Clinical Pharmacology (12.3) in full Prescribing Information]. The safety of ZYTIGA in patients with baseline severe hepatic impairment has not been studied. These patients should not receive ZYTIGA. For patients who develop hepatotoxicity during treatment, interruption of treatment and dosage adjustment may be required [see Dosage and Administration (2.2) in full Prescribing Information, Warnings and Precautions, and Clinical Pharmacology (12.3) in full Prescribing Information]. Patients with Renal Impairment: In a dedicated renal impairment trial, the mean PK parameters were comparable between healthy subjects with normal renal function (N=8) and those with end stage renal disease (ESRD) on hemodialysis (N=8) after a single oral 1,000 mg dose of ZYTIGA. No dosage adjustment is necessary for patients with renal impairment [see Dosage and Administration (2.1) and Clinical Pharmacology (12.3) in full Prescribing Information]. OVERDOSAGE There have been no reports of overdose of ZYTIGA during clinical studies. There is no specific antidote. In the event of an overdose, stop ZYTIGA, undertake general supportive measures, including monitoring for arrhythmias and cardiac failure and assess liver function. Storage and Handling: Store at 20oC to 25oC (68oF to 77oF); excursions permitted in the range from 15oC to 30oC (59oF to 86°F) [see USP controlled room temperature]. Based on its mechanism of action, ZYTIGA may harm a developing fetus. Therefore, women who are pregnant or women who may be pregnant should not handle ZYTIGA without protection, e.g., gloves [see Use in Specific Populations].

• Patients receiving GnRH agonists should be informed that they need to maintain this treatment during the course of treatment with ZYTIGA and prednisone. • Patients should be informed that ZYTIGA must not be taken with food and that no food should be consumed for at least two hours before the dose of ZYTIGA is taken and for at least one hour after the dose of ZYTIGA is taken. They should be informed that the tablets should be swallowed whole with water without crushing or chewing. Patients should be informed that taking ZYTIGA with food causes increased exposure and this may result in adverse reactions. • Patients should be informed that ZYTIGA is taken once daily and prednisone is taken twice daily according to their physician’s instructions. • Patients should be informed that in the event of a missed daily dose of ZYTIGA or prednisone, they should take their normal dose the following day. If more than one daily dose is skipped, patients should be told to inform their physician. • Patients should be apprised of the common side effects associated with ZYTIGA, including peripheral edema, hypokalemia, hypertension, elevated liver function tests, and urinary tract infection. Direct the patient to a complete list of adverse drug reactions in PATIENT INFORMATION. • Patients should be advised that their liver function will be monitored using blood tests. • Patients should be informed that ZYTIGA may harm a developing fetus; thus, women who are pregnant or women who may be pregnant should not handle ZYTIGA without protection, e.g., gloves. Patients should also be informed that it is not known whether abiraterone or its metabolites are present in semen and they should use a condom if having sex with a pregnant woman. The patient should use a condom and another effective method of birth control if he is having sex with a woman of child-bearing potential. These measures are required during and for one week after treatment with ZYTIGA.

PATIENT COUNSELING INFORMATION See FDA-approved patient labeling (Patient Information) • Patients should be informed that ZYTIGA and prednisone are used together and that they should not interrupt or stop either of these medications without consulting their physician.

Manufactured by: Patheon Inc. Mississauga, Canada Manufactured for: Janssen Biotech, Inc. Horsham, PA 19044 © Janssen Biotech, Inc. 2012 Revised: December 2012 2000005445 K08Z121174A

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 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 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

AUA Practice Management Meeting Highlights Conducting an Operational Assessment..................................................1 By Sandra Paton

Staying Independent—Exploring the Options..............................................1 By William Robertson

Billing and Coding Pitfalls ................................................................................1 By Sandra E. Cangiano

Benchmarking and Practice Data Analysis................................................10 By Sandra Paton

Preparing for Bundled Payment Reimbursement.....................................12 By G. Amrit Khalsa

Ask the Expert Maximizing Efficiencies in the Urology Office..........................................14 An Interview with Cheris L. Craig, MBA, FACMPE

Prostate Cancer AUA Revises Guidelines for PSA Screening..............................................15 By Charles Bankhead

Budget Impact Model .............................................................................16 By Wade Aubry, MD, et al

Editorial Advisory Board 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 2 times a year by Engage Healthcare Communications, LLC, 241 Forsgate Drive, Suite 205A, Monroe Township, NJ 08831. 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 informa tional 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™, 241 Forsgate Drive, Suite 205A, Monroe Township, NJ 08831. Fax: 732-992-1881. Yearly subscription rates: 1 year: $99.00 USD; 2 years: $149.00 USD; 3 years: $199.00 USD.

July 2013

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American Urology Association Practice Management Meeting

Conducting an Operational Assessment…Continued from page 1 examine potential solutions, devel op an action plan, share the action plan, and report on the action plan. When conducting a physical on your practice, he observed, “You need to identify the reason for the assess ment, such as changes in cash flow, high employee turnover, increased patient complaints, fewer referrals or new patients, unhappy physicians, or external audits.” Give the front desk workers their due. These people are vital to your practice. When there are errors, have the back office and the front office work together. And if you must cut expenses, staffing should be the last cut a practice makes. A modern practice management with electronic medical records (EMRs) is vital to productivity. Your ability to survive will require having modern practice manage ment systems, well-trained users, and responsive vendors to satisfy

reporting needs. The market trend in the industry is to use fully inte grated single vendor solutions. Patient flow is another important issue. Avoid patient bottlenecks in the office; be sure you are HIPAA compliant; ensure that the building and parking are convenient for staff and physicians; and set up EMRs. Keep your examination room stocked with sufficient supplies and keep equipment current, maintained, and monitored. Schedule follow-ups. Check on patient satisfaction using patient surveys. Collect copays before the visit, not afterward. Embezzlement is increas ing in this economy. Balance receipts daily. Keep good checks and balances in check-in and checkout areas. Hiring a certified coder is nec essary, particularly with the advent of the International Classification of Diseases, Tenth Revision (ICD-10). Mr Daigrepont cautioned that health care fraud is a high priority of the

Department of Justice, second only to terrorism and violent crimes. The Department of Health and Human Services estimates a $17 return on every $1 it invests. Avoid practice flags, such as waiving copays, pro fessional courtesy in the write-off system, bell curve outliers, billing Medicare for phone calls, overcoding, and EMR issues. Use a vendor with a clearinghouse (electronic data exchanges, such as McKesson and Gateway) and enhanced scrubbing tools to be sure your claim goes out correctly the first time. In renegotiating contracts, he suggests having the vendor put their source code into an escrow account in case they discontinue a product. If a vendor goes out of business, having an escrow account will help you reverse engineer the data. Be proactive and prepare your practice to meet the challenges and demands of the future. l

Billing and Coding Pitfalls…Continued from page 1 the patient, a patient presents with a problem, the nurse practitioner (NP) or physician assistant (PA) can see the patient under the plan of care. If the treating physician is out of the office when services are provided to the patient, the care can be listed as “incident to.”

Medicare Shared Services and Office Supervision Requirements For Medicare services that are not related to “incident to,” the physician must be in the office and face-to-face with the patient and involved in all or part of history taking, examination, or the medical decision. If a physician orders a pro cedure, but the physician on duty does the procedure, the physician on duty gets paid for the procedure. If the physician who performed the

initial service has been actively involved in the patient’s treatment and provided supervision to the NP or PA, Medicare will pay 100% of the fee on the physician’s fee schedule. If the NP or PA provides the E/M service to a new patient or without direct personal supervision from the physician, Medicare will pay only 85% of the fee listed on the fee schedule. Dr Painter and Mr Rutherford also outlined the hottest auditing issues: • Modifier 25 (“Physicians in the same group practice who are in the same specialty must bill and be paid as though they were a single physician.”): Commercial payers are profiling providers to scare physicians into accepting net pay for services. If you receive a profiling report, be wary of it.

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July 2013

• Electronic health record (EHR) document cloning: Long-term follow-up care is especially vul nerable. Be sure to document fresh review of history and systems, including vital signs, height, weight, blood pressure, and history of present illness. Be sure to avoid making it look as though you are cutting and past ing from previous visits. • Cloning: As of April 2013, there is a 2% Medicare sequester budget fee. You will be able to write off the 2% loss. • PQRS #48, assessment of urinary incontinence (UIC) in a medical female older than age 65 years: Many urologists select the measure and file it. No diagnosis is required. Even if a patient does not have UIC, you must write “Yes.” • PQRS #24 EHR has been retired. l

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MDxHealth is regulated under the Clinical Laboratory Improvement Amendments (CLIA) and the College of American Pathologists as an accredited laboratory to perform high complexity clinical testing. The ConfirmMDx for Prostate Cancer test was developed and its performance characteristics determined by MDxHealth. This test is intended for use as an aid to clinicians for patient management decisions for the need to perform repeat biopsy on patients with a previous histopathologically negative biopsy result (benign or HGPIN, but excluding ASAP) within the past twenty-four months and high-risk clinical factors for occult prostate cancer. Use outside of this indication has not been validated by MDxHealth. The test results should be interpreted in conjunction with other laboratory and clinical data available to the clinician and relevant guidelines in the decision for repeat biopsy. References: 1.Resnick MJ et al: Repeat prostate biopsy and the incremental risk of clinically insignificant prostate cancer. Urology. 2011 Mar;77(3):548-52. doi: 10.1016/j.urology.2010.08.063. 2. Stewart G et al.: Clinical Utility of an Epigenetic Assay to Detect Occult Prostate Cancer in Histopathologically Negative Biopsies: Results of the MATLOC Study. J Urol (2013), 189, 1110-1116. 3. Henrique R et al.: Epigenetic Heterogeneity of High-Grade Prostatic Intraepithelial Neoplasia: Clues for Clonal Progression in Prostate Carcinogenesis, Mol Cancer Res 2006;4:1-8.

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American Urology Association Practice Management Meeting

Benchmarking and Practice Data Analysis By Sandra Paton

enchmarking—whether in ternal, competitive, function al, or generic—will help prac tices know in real time where your data are compared with the stan dard. If revenues are down, bench marking can help you to understand why. Part of this process involves tracking and trending patient visits to determine how many patients might be required to help make up a revenue loss. At the American Urology Association annual prac tice management meeting, Mark Eldredge, Director of Southern Urology in Lafayette, Louisiana, noted that practices should know what to benchmark or collect, how

to collect the data, and how to analyze it to make it meaningful for your practice. Part of this process requires knowing and learning how to use external tools, such as dashboards, to collect data. Dashboards come in a variety of packages and can be used as quality indicators by hospi tals, surgical care facilities, health care providers, pharmaceutical companies, medical device com panies, and emergency services. Dashboards such as Allscripts and Eurochart provide Physician Quality Reporting System data. They can collect a variety of data in real time, including admissions

data, patient waiting times, quar terly income, number of patients, patient satisfaction, total num ber of patients, number of new patients, number of patients lost, average length of patient hospital stay, and even laboratory turn around time. The data collected from a dashboard can be used to manage existing policies and make improvements where necessary. Resource-based relative value scale (RBRVS) assigns a relative value unit (RVU) to determine how much money medical providers should be paid. Any procedure performed by a physician or other medical provider Continued on page 12

Staying Independent—Exploring…Continued from page 1

A 2012 survey of 100,000 phy sicians predicted a decline in inde pendent practices by 33% in 2013. Reasons for moving to a hospital or group practice included financial stability, infrastructure support, ease of recruiting and retaining staff, and not having to deal with a practice “cash-out.” He further noted that strength in numbers does not mean loss of employment or autonomy, or degradation of income. Mr Reiboldt described several possible routes for practices: lim ited integration, as in a managed care network; moderate integration, such as a service line management within a hospital, joint ventures or comanagement with ties to a hospi tal, other physicians, and business es; or full integration to minimize the economic risk. These settings include a physician enterprise model or a professional services agreement (PSA), accountable care organiza tion (ACO), clinically integrated network (CIN), and quality care

(QC) organization. A comanagement agreement with hospitals would reward urologists for administrative time (nonclinical aspect) and for metrics achieved in performance and patient satis faction. In a provider-to-provider alignment, urologists can merge with other urologists in a single-specialty practice or a multispecialty practice. This setup might be done in stages: merger assessment, practice forma tion, legal formation, and preopera tional development. A PSA can be arranged in one of several configurations: (1) tradition al, whereby the hospital contracts with the physician for services (the physician remains in private prac tice, but the staff is employed by the hospital); (2) global, whereby both the physician and staff con tract with the health system, but the practice retains the responsibility for managing everyday functions; (3) practice management arrangement, whereby physicians are employed by

urology Practice Management

July 2013

the hospital, but practice manage ment remains separate; and (4) the hybrid model, whereby the hospital employs the physician and the prac tice is jointly owned. An integrated delivery system would include the physician, the hos pital, and ancillary services. The CIN works on the same principle as the ACO, but the focus remains on the private side, whereas the focus of an ACO is on the government side (as in Medicare). In a CIN, physicians are contracted and employed within hospital health systems, which provide a key source of capital. Choosing an ACO/CIN/QC concept could help to reduce or control the per capita costs of care by stopping unnecessary procedures. Mr Reiboldt observed that practic es should have an alignment strategy in mind and be poised to consider the range of alternatives. The Affordable Care Act is going to bring unprece dented changes. Deny them or deal with them accordingly. l

Urology Practice Management ™

PROCESS IMPROVEMENTS TO ENHANCE PATIENT CARE™®

YOUR COMPLIMENTARY SUBSCRIPTION IS ONLY A CLICK AWAY Urology Practice Management ™

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MAY 2013

VOLUME 2 • NUMBER 1

Transitioning to ICD-10 Exploring Men’s By Susanne Talebian, CHBC, RMM, CMOM, CPC-I, CPC, CUA, CCS-P, PCS Willingness to Pay Certified Healthcare Business Consultant, American Health Information for Prostate Cancer Management Association—AHIMA Certified ICD-10-CM/PCS Trainer n October 1, 2014, the United is less than 17 months away, during which Screening to Avoid States will adopt the International several phases of implementation must be Classification of Disease, Tenth completed. The timeline for implementUnnecessary Biopsys Revision, Clinical Modification/Procedure Cod- ing the code sets is divided into 4 phases: and Treatment ing System (ICD-10-CM/PCS), 1 year later Phase 1: Impact Assessment, first quarter

By Rosemary Frei, MSc

utch researchers have peered into the minds and wallets of a group of men aged 55 to 75 years to determine what they are willing to trade for a reduced risk of prostate cancer–related death or to avoid unnecessary procedures and treatment. Men with more education had a lower probability of opting for prostate cancer screening. Furthermore, the men were willing to lose 2% of risk reduction in mortality related to prostate cancer, or to pay, on average, €188 (in 2010 euros—equivalent to $245 in 2010 US dollars) annually, for a 10% reduced risk of unnecessary biopsy or treatment. “Physicians should be aware that men, Continued on page 8

than we had initially reported in Urology Practice Management in September 2012. The reprieve, although welcome to many,

2009 through second quarter 2012; Phase 2: Preparing for Implementation, ﬁrst quarter 2012 through second quarter 2014; Phase 3:

Receive timely information on the latest developments in urology practice management to assist you in your daily roles and responsibilities. Sign up now for Urology Practice Management.

Continued on page 10

Implementing a Patient Portal in Your Urology Practice to Provide Patient-Centered Care By Gena Cook Founder and Chief Executive Ofﬁcer Navigating Cancer, a leading provider of oncology-speciﬁc patient portals

stablishing a patient-centered approach is rapidly becoming a core requirement in US medical practices. Medical home models, accountable care organization (ACO) models,

and Health Information Technology for Economic and Clinical Health (HITECH) requirements all have components of engaging patients in their care. To incorporate a patient-centered Continued on page 19

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Benchmarking and Practice…Continued from page 10 is assigned a relative value (adjusted by region), which is then multiplied by a conversion factor. This deter mines the value of the procedure. The RBRVS hinges on 3 factors: physician work, practice expenses, and malpractice fees. Knowing the RVUs of a practice, however, can be particularly useful for directing or correcting productivity and to determine the share of ownership for physicians seeking to retire from a practice. Mr Eldredge recommended using a billing system, such as Med-Evolve, an electronic health records (EHRs) management program. The program includes a patient tree, integrated patient document management sys

tem, case management, patient sched uling, tracking and calculating surgi cal days, referring physician reports, online transcription management, and collection information for patient balances and insurance reimburse ment. Med-Evolve has an auto-dialer system to remind patients of appoint ments and to help with reschedul ing. It expedites patient enrollment, verifying patient insurance coverage, eligibility, documents, and billing history, and recording demographic information. Furthermore, it facil itates collections and copayment processing and promise-to-pay agree ments. The process will improve reimbursements or trends in your rev enue stream.

eclinicalWorks, another EHR solution for quality improvment and performance measures, improves workflow at the front desk through billing. It streamlines documenta tion, and is customizable to 40 spe cialties and subspecialties. athenaClinicals provides a webbased EHR that offers support and coaching to help practices achieve meaningful use measures and guar antees payment for meaningful use. It tracks new rules and incentive programs. athenaClinicals moni tors government requirements, adds those requirements to the quality management engine, and analyzes all providers’ performance in real time. l

Preparing for the Eventuality of Bundled Payment Reimbursement By G. Amrit Khalsa

s there life after fee-for-service? Kenneth T. Hertz, principal con sultant of the MGMA Health Care Consulting Group in Englewood, Colorado, believes there is and that it depends on physicians’ ability to adapt to the future. We have, he noted, the best healthcare system in the world, but the cost per person is very high, accounting for $3 trillion per year on healthcare expenditures (18% of the gross domestic product). “Eighty-nine percent of healthcare payments do nothing but encourage high expenditures, high services, and ancillary services, and redundancy,” said Mr Hertz. The goal for 2020 is to go from having 11% of payments based on quality standards (where we are now) to having 20% of payments based on quality indicators (val ue-based pricing). He warned that

“there is no direct path from here to there, and it will be strewn with a lot of bodies.”

urology Practice Management

Physicians need to understand every piece that goes into 1 episode of care, including the… staff involved, the devices used, the drugs prescribed.

The future will involve bundled payments. Any visit to the hospital results in dozens of bills. Patients would prefer to get all of these bills

July 2013

bundled into 1 bill instead. Just as there are currently many types of payment models, so will there be different types of bundled payments. To learn the costs of care, Mr Hertz cautioned that physicians need to understand every piece that goes into 1 episode of care, including the physicians and non-physician staff involved, the devices used, the drugs prescribed, and facility usage. If you fail to know how many patient revisits you have for 1 episode of care, the payments made by each payer, how much you charge per payer, by patient, by provider—your contracts will fail. If you do not know every piece in the matrix, you cannot agree upon and accept a bundled payment amount. We must now know how to nego tiate with payers and become allies Continued on page 21

Invitation to Join the UPM Editorial Board The publishers of Urology Practice Management™ (UPM) are inviting qualified urology practice owners and administrators to participate as members of the UPM Editorial Board. As an editorial board member, you will play an active role in helping to shape the content of this exciting new publication. Urology Practice Management is a novel publication focused on process solutions for urology practices. UPM is designed to provide the urology care team – medical, practice administrators, coders, and billers – with the knowledge and skills required to keep abreast of today’s fast-changing business environment, allowing practice professionals more time to concentrate on high-quality patient care. Each issue of UPM will focus on various areas of urology practice, featuring current topics such as:

Urology P ractice Managem ent

• Healthcare technology • Models of care • Staffing • Reimbursement and coding

PROCES

MAY 201 3

Take advantage of this unique opportunity to help your peers and enhance your professional reputation by becoming the newest member of the UPM Editorial Board.

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Exploring Men’s Willingness to Pay for Prosta te Cance r Screening to Avoid Unnecess ary Biopsy s and Treat ment By Rosem

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ed Hea RMM, CM OM, CP Managem lthcare Business Co nsultant, Am C-I, CPC, CUA, CC ent Associ S-P, ation—AH IMA Certifi erican Health Informa PCS ed ICD-10CM/PCS Trai tion n October ner 1, 2014, the States will Un ited is less ado than 17 mon Classification pt the International ths away, several of Revision, Clin ical Modificatio Disease, Tenth com phases of implement during which ing System atio pleted. The n/Procedure (IC timeline for n must be than we had D-10-CM/PCS), 1 yea Cod- ing the code implement sets r later Pha Practice Ma initially reported in se 1: Impact is divided into 4 pha Urology nagement in ses: Ass essment 2009 The reprieve September , although 2012. Pre through second quarter , first quarter welcome to pari many, 201 ng for Implementatio 2012; Phase 2: 2 through seco n, first qua rter nd quarter 2014; Phase 3: Cont

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Ask the Expert

Maximizing Efficiencies in the Urology Office An Interview with Cheris L. Craig, MBA, FACMPE

rology offices can realize sub stantial benefits by taking steps to improve office effi ciencies, which can be accomplished by maximizing the use of existing technologies and software programs. Urology Practice Management (UPM) asked Cheris Craig, the Chief Administrative Officer at Urology of Greater Atlanta, LLC, to share her favorite time- and money-saving tips for managing her office. UPM: Once fully implemented, technologies such as electronic medical records (EMR) and e-prescribing systems can help the office function more efficiently. But there are also a number of more modest enhancements that can save the office time and money, correct? CC: Yes, there are a number of pro grams that we use every day. For example, Microsoft Outlook has quite a bit of functionality that is useful. Take the calendar-sharing fea ture. We have centralized the hos pital call schedules for our urologists on one shared calendar, which phy sicians and staff can quickly look up—from their offices or their smart phones. We’ve done the same with our contacts. Shared contacts provide a single place for commonly used information on insurance companies, referring physicians, and pharmaceu tical representatives. It has allowed us to eliminate posting multiple lists in the office (which quickly become outdated). Some offices use Microsoft SharePoint, an intranet-based con tent management system, to perform the same functions.

CC: We use Interpage, a closed text-paging system that can be cus tomized to page certain individuals as a group. It’s a great way to com municate within the office and it has a range of 2 miles, allowing us to communicate with nearby satel lite offices as well. And, because it operates on a closed network, it’s fully HIPAA-compliant. Likewise, Microsoft Outlook also can be set up as a closed e-mail system, allow ing staff to communicate and share patient-related information in a con venient, HIPAA-compliant man ner. Anything that can be done to ensure patient privacy is important to us. UPM: Although today’s medical practices are increasingly paperless, there is a large volume of documents that must be completed, submitted, processed, and stored. Have you found any tools to help with document flow and storage? CC: Yes, there are a few things. Servers can be set up to receive inbound faxes in shared folders. If you use a cloud-based provider, you can consolidate multiple fax num bers to receive all inbound commu nications into one centralized num ber. These communications are all electronic, and inbound documents are automatically saved as .pdf files and are easily downloadable into our EMR. Of course, these commu nications also can be set up to be HIPAA-secure. UPM: Are there other tools to facilitate document flow into your EMR?

UPM: What about office communications?

CC: Yes, there is a program called PDF995, which installs on office computers like a printer. Rather

urology Practice Management

July 2013

than printing, however, it creates a .pdf file for any document. We’ve found it to be especially useful because .pdf documents are easily imported into our EMR. For exam ple, we use PDF995 for lab-based ordering. We print a hard copy of the order to travel with the spec imen to the lab. But we also print the same order to PDF995, and then import it directly into the EMR for handy reference. We use the same approach for patient intake forms, appeal letters, radiology orders, and referral forms. UPM: Speaking of labs, we’ve heard that some of the larger labs— such as Quest and LabCorp— allow electronic order entry. CC: That’s correct. Some of the lab providers offer a password-protected web-based environment for order entry. If you interface with the office practice management system, it automatically populates many of the required fields. Over the course of a week, that can save a lot of time. UPM: Are there any other ideas that you think would be valuable to share with our readers? CC: Yes, there is one more. We have eliminated our expensive postage meters and now use SmartPostage, an online desktop-based postage and shipping system. We no longer need to have postage meters in each of our 7 satellite offices, which saves us a considerable amount of money. It’s more efficient too—we can now easily track postage expenses for each satellite office. So, overall, it’s been a win–win in terms of saving time and money. l

Prostate Cancer

AUA Revises Its Guidelines for PSA Screening By Charles Bankhead

an Diego, CA—Prostate cancer S screening with prostate-specific antigen (PSA) tests should focus on men aged 55 to 69 years, the group that is the most likely to ben efit from screening, according to a new clinical guideline issued by the American Urological Association (AUA) at its 2013 annual meeting. This represents a significant shift from the previous position held by the AUA for strong support of PSA screening for men of all age-groups. The new AUA position now does not recommend routine PSA screening tests for average-risk men aged 40 to 54 years. The organi zation recommends against PSA screening for men aged <40 years. Screening for men aged ≥70 years “is not recommended,” nor is screening for men of any age who have a life expectancy of less than 10 to 15 years. The AUA acknowl edges that some older men aged ≥70 years and in excellent health may benefit from screening and should be evaluated on an individual basis. Regardless of age or recommen dation, the AUA emphasizes that screening should proceed only after a careful discussion with the patient about potential benefits and risks of screening. The deci sion to screen should be a shared one between physician and patient. “It’s time to reflect on how we screen men for prostate cancer and take a more selective approach in order to maximize benefit and min imize harms,” said the guideline panel chair H. Ballentine Carter, MD, Professor of Urology at Johns Hopkins University in Baltimore. “Our focus was to help urologists identify those individuals who are most likely to benefit from being

tested,” Dr Carter said. “The con clusion we came to, based on the evidence, was that the group more likely to benefit would be men ages 55 to 69, which is where we should be focusing our efforts.”

AUA Best Practice Statement that was issued in 2009. The practice statement supported screening of average-risk men in the 40- to 54-year-old age-group. However, the statement also addressed risk stratification and prostate cancer management. The guideline has a sole focus on the use of PSA screen ing tests. Moreover, the practice statement relied heavily on expert and consensus opinions. The guide line was derived from a review of published evidence through 2012. In addition to the age-related rec ommendations, the guideline offers physicians the option to screen less frequently than annually in appro priately selected men. The decision to screen every other year, or even less frequently, should be preceded by a careful discussion with the patient, and should be guided by the patient’s baseline PSA value. The US Preventive Services Task Force recommendation against rou tine screening for men of any age was targeted to primary care physi cians, and was strongly objected to by urologists. By contrast, the AUA guideline emphasizes that the rec ommendations apply to urologists. The AUA “is not dismissing the PSA test as the task force has done,” said guideline committee member Philip W. Kantoff, MD, Director, Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute, and Professor of Medicine, Harvard Medical School, Boston. “There should be a more reasonable approach to the use of PSA.” In keeping with AUA policy, the guidelines will be updated as appro priate in response to new informa tion about prostate cancer screen ing, said Dr Carter. l

The new AUA position now does not recommend routine PSA screening tests for average-risk men aged 40 to 54 years. The recommendation pertaining to men aged 40 to 54 years is likely to be the most controversial aspect of the guideline, Dr Carter added in a video interview released by the AUA. Patients in that age range have a low risk of prostate cancer and a very long lead time with respect to testing. If they are test ed and are found to have prostate cancer, the disease is likely to be in a very early stage, including what many urologists and oncologists have termed “clinically insignifi cant” or “inconsequential” cancers. If men in the 40- to 54-year-old age- group are treated, they will “live with the harms of treatment for a very long time,” he empha sized. “For all of those reasons, we concluded that these men, while some may benefit [from screening], there is probably more harm than benefit as compared with begin ning screening at age 55,” said Dr Carter. The new guideline replaces an

July 2013

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Prostate Cancer

Budget Impact Model: Epigenetic Assay Can Help Avoid Unnecessary Repeated Prostate Biopsies, Reduce Spending By Wade Aubry, MD; Robert Lieberthal, PhD; Arnold Willis, MD; Grant Bagley, MD, JD; Simon M. Willis III, MS; Andrew Layton, BA

This is an abbreviated version of the original article that was recently published in American Health & Drug Benefits. 2013;6(1):15-24. Used with permission. The full version of this article is available at www.AHDBonline.com.

rostate cancer is the most fre quently detected cancer in men: 1 of 6 men will be diag nosed with prostate cancer during their lifetime based on Medicare enrollment data.1 In the United States, approximately 19 million men annually are screened by pros tate-specific antigen (PSA) test ing,2 resulting in approximately 4.7 million abnormal PSA test results (≥4.0 ng/mL)3 and approximately 1.3 million biopsy procedures.4 According to the National Cancer Institute, 241,740 men are diagnosed with prostate cancer annually, and 28,170 prostate can cer–related deaths were reported in 2012.5 Although some forms of prostate cancer are deadly, many forms are low grade and can be managed by active surveillance. Aggressive variants of prostate cancer can be one of the deadliest cancers in men, and accurate diag nosis and follow-up remain a chal lenge and come at a considerable cost to the US healthcare system.

The Burden of PSA Screening Despite the recent contro versy that was raised by the US Preventive Services Task Force findings on PSA testing, leading to their recommendations to stop routine PSA-based screening,6 the American Urological Association (AUA) continues to recommend the PSA blood test, along with dig ital rectal examination (DRE), for screening men at risk for prostate

cancer. (The AUA has just revised its screening recommendations. See article on page 15.) Screening has led to detection of earlier-stage disease, resulting in an increased likelihood for curative treatment. If screening is eliminat ed, urologists fear an increased inci dence of advanced cancers and an increase in healthcare costs to effec tively treat these patients.7 Today, urologists typically perform a biopsy for high-risk patients with a rising PSA level and for patients with a PSA level ≥4.0 ng/mL, obtaining approximately 10 to 12 needle-core tissue samples according to the cur rent standard of care.8,9 An abnormal PSA result can often be caused by factors other than cancer, including infection, inflam mation, or other benign conditions, such as benign prostatic hyperpla sia. This leads to the inclusion of many men with no cancer among those who are being subjected to prostate biopsies (ie, false-positive PSA screening). The rate of cancer detection in men undergoing pros tate biopsies is approximately 30%, and approximately 75% of men undergoing biopsies have negative prostate biopsy results.2,3 An elevated PSA and/or abnor mal DRE identify men at high risk for prostate cancer, and, as a result, many of these men will under go a biopsy procedure. However, because of the nature of random and limited sampling of the pros tate, many cancers are undetected

urology Practice Management

July 2013

by histopathologic review. Studies by urology and pathology opinion leaders report that initial prostate biopsy histopathology has a 20% to 30% false-negative rate.8,10,11 Given these false-negative rates for histol ogy, many patients with persistently elevated PSA values are at risk for occult cancer. This uncertainty poses a diagnostic dilemma, result ing in many men receiving 2, 3, and sometimes 4 repeated biopsy procedures.12-14 Repeated biopsies expose patients to the discomfort and risk of com plications associated with this inva sive procedure1; they also generate high medical costs. Approximately $1.86 billion is spent annually on PSA tests alone.2,15 More than $4 billion is spent annually on ther apies for prostate cancer, and this amount is expected to increase to $8.7 billion by 2019.16 Molecular Testing With such high costs to the US healthcare system, as well as nega tive quality-of-life implications to patients, the AUA has called for new biomarkers for the improved diagnosis and treatment of prostate cancer.17 With the growing move ment toward personalized medicine, the application of molecular testing to improve cancer detection and the management of patients rep resents an evolution in oncology.2,18 Epigenetic assays, in particular, have been reported to improve on Continued on page 18

Urology Practice Management ™

PROCESS IMPROVEMENTS TO ENHANCE PATIENT CARE™

Call for submissions

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In your background as a urology practice manager, it’s likely there’s one business experience—and maybe more—that practice managers across the nation would want to read about.

High-interest topics include: the solution you found to a practice management challenge, reimbursement, your experience with EMR, Medicare audits, a memorable encounter that shaped the way you now run your business and/or practice medicine, or how you successfully integrated ancillary products and services into your practice as a revenue-generator.

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Submit to: Editorial Department Fax to: 732-992-1881 or e-mail to editorial@engagehc.com UPM_42513

Prostate Cancer

Budget Impact Model: Epigenetic Assay…Continued from page 16 the accuracy of prostate biopsies and histopathologic review.2,8 In a recent multicenter, blinded study, the epigenetic assay ConfirmMDx for Prostate Cancer was used to detect occult cancer in histopatho logically negative prostate biopsies.8 The assay used multiplex meth ylation-specific polymerase chain reaction to assess the DNA meth ylation status of the GSTP1, APC, and RASSF1 genes associated with the presence of cancer in residu al negative prostate biopsy tissue samples.3,8,10 Using this advanced molecular diagnostic test allows for a higher degree of accuracy that was previously unattainable through prostate biopsy procedures alone. The results of this new epigenetic assay can guide urologists in deci sions regarding the need to repeat a biopsy in patients with a pre

viously negative biopsy who are still considered at risk for prostate cancer. The test is designed such that its high (90%) negative predic tive value accurately distinguishes the patients with negative prostate biopsies from patients who may have occult cancer.8

plans, while providing guidance for patient management that leads to less invasive and less costly care. The assumed membership of the hypothetical health plan is 1 mil lion members, half of whom are males, aged 40 to 64 years (similar to those in a commercial health plan; younger and older men were excluded from the analysis). For men at risk of undergoing a repeat ed biopsy, the model allows for the simulation of the current (reference scenario) and a counterfactual real ity (new scenario). In the reference scenario, the model uses current clinical patterns of care to simu late the treatment of men at risk of prostate cancer in the reference scenario; a molecular assay was not utilized for prostate cancer detec tion. In the new scenario, men at risk for repeated biopsy are evalu

A Budget Impact Analysis A budget impact model was developed to assess whether the epigenetic assay can also produce financial benefits, beyond the reported clinical and health ben efits. The model was designed to quantify the impact on the costs associated with repeated biopsies used for the screening and diagno sis of prostate cancer, and to test the hypothesis that the epigenetic assay produces a beneficial reduc tion in costs to commercial health

Table 1. Men at Risk for a Repeated Prostate Cancer Biopsy

Reference scenario (standard of care)

New scenario (epigenetic assay)

2101

Men referred for repeated biopsy or methylation test, %

Men referred for repeat biopsy or methylation test, N

903

N/A

99.9

Evaluable cases, N

N/A

875

Cases with positive methylation markers, N

N/A

365

Cases with negative methylation markers, N

N/A

510

903

365

Variable Men at risk of repeated biopsy, N

Men with ASAP, % Cases with sufficient tissue for methylation test, % Risk stratification based on methylation markers

Total men referred for repeated biopsy, N

ASAP indicates atypical small acinar proliferation; N/A, not applicable.

urology Practice Management

July 2013

Prostate Cancer

Table 2. Per-Patient Costs Associated with Biopsy Complications

Infectious complications

DRG payment, $

Kidney infection

5594

Urinary tract infection

5594

Prostatitis

6220

Cystitis

5594

Incidence (SEER-Medicare)

Per-patient cost, $

Sepsis/bacteremia

16,662

Endocarditis

10,943

Hypotension

5801

Average payment for infectious complications

8058

0.04

322

Noninfectious complications

DRG payment, $

Incidence (SEER-Medicare)

Per-patient cost, $

Gastrointestinal hemorrhage

6559

Hematuria

5366

Acute posthemorrhagic anemia

5660

Urinary symptoms/retention

5594

Average payment for noninfectious complications Average cost

5795

0.012

70 392

DRG indicates diagnosis-related group; SEER, Surveillance, Epidemiology and End Results. ated with the epigenetic assay, and those with negative DNA methyla tion test results are spared a repeat of the biopsy, thereby reducing the number of unnecessary procedures. In the budget impact model, under the reference scenario, 43% (903) of men at risk for repeat biopsy were referred for repeat biop sy. In the new scenario, testing the high-risk patients with the epi genetic assay significantly reduced the number of repeated biopsies by confirming the histopathologically negative biopsy results for 510 men. The epigenetic assay identified 365 men with positive DNA methyla tion results who would be referred for repeated biopsy (Table 1). The average cost of a prostate

biopsy procedure is $1946, which is a conservative estimate, based on decreased interim 2013 Medicare Physician Fee Schedule rates; this does not take into account pro phylactic antibiotic, pain, or other concomitant medication costs. The total expected complication costs per patient for an initial or repeated biopsy were calculated using Surveillance, Epidemiology and End Results (SEER)-Medicare cancer registries’ reported incidence of infectious and noninfectious complications and the associated mean payment for the Medicare Severity-Diagnosis Related Groups (MS-DRGs) from the 2012 Centers for Medicare & Medicaid MS-DRG payment schedule. Table 2 shows

July 2013

the calculations for the average cost ($392) of complications per patient undergoing repeated prostate can cer biopsy. The total weighted cost of a fully burdened biopsy is $1946—the sum of the procedural cost and the cost of complications weighted by incidence. The retail price for the epigenetic assay is $206 per individual core, or $2060 for a 10-core biopsy. The model assesses the health plan’s costs com pared with billed charges; therefore, the cost of this assay is discounted by 10%, to conservatively reflect payer costs, at $1855.02 per test. Results The total cost of repeated biop Continued on page 20

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Prostate Cancer

Budget Impact Model: Epigenetic Assay…Continued from page 19 Table 3. Total Annual Costs and Budget Impact: Reference Scenario versus New Scenario

Reference scenario (standard of care)

New scenario (epigenetic assay)

Total annual cost, $

PMPM cost, $

Total annual cost, $

PMPM cost, $

Total cost of epigenetic assay

1,623,143

0.14

Total cost of repeated biopsies

2,864,142

0.33

710,198

0.06

2,152,276

0.18

2,864,142

0.24

2,333,341

0.19

3172

0.24

2584

0.19

Cost

Total cost of repeated biopsies avoided Total diagnostic cost to health plan Total diagnostic cost per patient Total budget impact to plan

–530,801

Total budget impact to plan PMPM

–0.0442

PMPM indicates per member per month.

sies avoided is $2,152,276 (1106 biopsies avoided × $1946 per biop sy). The total cost to the health plan in 1 year was calculated to be $2,864,142 in the reference scenar io versus $2,333,341 with the epi genetic assay in the new scenario. To calculate the total diagnostic cost per patient in the reference scenario, the cost of a prostate biop sy ($1946) was applied and weight ed to repeated biopsy distribution rates for the percentage of men who receive first, second, and third repeated biopsies of 43%, 44%, and 43%, respectively.13 For the new scenario, the total diagnostic cost per patient includes the cost of the assay plus the weight ed biopsy cost, applied and weight ed to 43% of men who have positive results based on the epigenetic assay (based on the sensitivity, speci ficity, and negative and positive

predictive values).8 The total diag nostic cost per patient was $3172 in the reference scenario compared with $2584 in the new scenario, resulting in a savings of $588 per patient managed. This results in a total savings of $530,801 annually to the health plan, or –$0.0442 per member per month (Table 3). This analysis demonstrates that the net cost to a commercial plan is lower if patients undergoing prostate cancer biopsies are man aged using the assay. Although this involves an additional cost for the acquisition of the assay, using the assay results in a reduction of 1106 unnecessary biopsies in a health plan with 1 million members.

urology Practice Management

Implications This analysis demonstrates that a commercial health plan would real ize cost-savings with the coverage

July 2013

of the epigenetic assay. The upfront cost of the assay will be recovered based on the savings associated with avoided biopsies and the associated complications. The inclusion of the epigenetic assay in the management of men who are screened for prostate cancer would result in a net cost-sav ings of –$530,801 in the first year after the assay became available in the United States in a health plan with 1 million members. The epigenetic assay provides clear and actionable results that aid the urologist in treatment deci sion-making, improving patient care, and yielding significant healthcare savings. A key assumption is that a health plan inclusion of the epi genetic assay in medical policy and coverage decisions will motivate a change in the behavior of urologists, resulting in a reduction of repeated biopsies. Policy tools that promote

Prostate Cancer

appropriate patient management according to evidence-based guide lines, such as value-based payment (eg, financial incentives for choos ing evidence-based interventions) or coverage restrictions for repeated biopsies, may further enhance such outcomes. l References

1. Loeb S, Carter HB, Berndt SI, et al. Complications after prostate biopsy: data from SEER-Medicare. J Urol. 2011;186:1830-1834. Epub 2011 Sep 23. 2. Ekwueme DU, Stroud LA, Chen Y. Cost analysis of screening for, diagnosing, and staging prostate cancer based on a systematic review of published studies. Prev Chronic Dis. 2007;4:A100. 3. Van Neste L, Herman JG, Otto G, et al. The epi genetic promise for prostate cancer diagnosis. Prostate. 2012;72:1248-1261. 4. Mosquera J-M, Mehra R, Regan MM, et al. Prevalence of TMPRSS2-ERG fusion prostate cancer among men undergoing prostate biopsy in the United States. Clin Cancer Res. 2009;15:4706-4711. 5. National Cancer Institute. Surveillance, Epidemiology and End Results. 2012. http://seer. cancer.gov/csr/1975_2009_pops09/results_single/ sect_01_table.01.pdf. Accessed November 1, 2012. 6. US Preventive Services Task Force. Screening for Prostate Cancer. May 2012. www.uspreventiveser vicestaskforce.org/prostatecancerscreening/prostatefi nalrs.htm. Accessed September 20, 2012. 7. Crawford D, Grubb R, Pinsky P, Black A. Factors influencing initial treatment decisions in PLCO: comparison of screening and control arms. Abstract LBA4. Proceedings of the AUA Annual Meeting; May 21, 2012; Atlanta, GA. 8. Stewart G, Van Neste L, Delvenne P, et al.

17. Thompson I, Thrasher JB, Aus G, et al. Guideline for the management of clinically localized prostate cancer: 2007 update. J Urol. 2007;177:2106-2131. 18. Stricker S. The era of personalized medicine in oncology: novel biomarkers ushering in new approaches to cancer therapy. Am Health Drug Benefits. 2011;4(6):387-388.

Clinical utility of a multiplexed epigenetic gene assay to detect cancer in histopathologically negative pros tate biopsies: results of the multicenter MATLOC study. J Urol. 2012. doi: 10.1016/j.juro.2012.08.219. 9. Kehinde EO, Al-Maghrebi M, Sheikh M, Anim JT. Combined ciprofloxacin and amikacin prophy laxis in the prevention of septicemia after transrectal ultrasound-guided biopsy of the prostate. J Urol. September 23, 2012. pii: S0022-5347(12)04945-2. doi: 10.1016/j.juro.2012.08.237. 10. Trock B, Brotzman MJ, Mangold LA, et al. Evaluation of GSTP1 and APC methylation as indicators for repeat biopsy in a high-risk cohort of men with negative initial prostate biopsies. BJU Int. 2012;110:56-62. 11. Rabets JC, Jones JS, Patel A, Zippe CD. Prostate cancer detection with office based saturation biopsy in a repeat biopsy population. J Urol. 2004;172:94-97. 12. Laurila M, van der Kwast T, Bubendorf L, et al. Detection rates of cancer, high grade PIN and atypical lesions suspicious for cancer in the European Randomized Study of Screening for Prostate Cancer. Eur J Cancer. 2010;46:3068-3072. 13. Pinsky PF, Crawford ED, Kramer BS, et al. Repeat prostate biopsy in the prostate, lung, colorectal and ovarian cancer screening trial. BJU Int. 2007;4:775-779. 14. Resnick MJ, Lee DJ, Magerfleisch L, et al. Repeat prostate biopsy and the incremental risk of clinically insignificant prostate cancer. Urology. 2011;77:548-552. 15. National Cancer Institute Trends Progress Report-2009/2010 Updated. www.cancer.gov/news center/newsfromnci/2010/ProgressReport2010. Accessed November 1, 2012. 16. Merril J. Prostate cancer market snapshot: more than provenge. The Pink Sheet. November 22, 2010. Elsevier Business Intelligence Publications and Products. www.elsevierbi.com/Publications/The-PinkSheet/72/47/Prostate-Cancer-Market-Snapshot-MoreThen-Provenge?result=2&total=2&searchquery=%25 3fq%253dProstate%252520Cancer%252520Market% 252520Snapshot%2526date%253don%25253a11%25 252f22%25252f2010. Accessed January 29, 2013.

About the Authors Dr Aubry is Associate Clinical Professor of Medicine, Philip R. Lee Institute for Health Policy Studies, University of California, San Francisco, and Senior Medical Director, Quorum Consulting, San Francisco, CA; Dr Lieberthal is Assistant Professor, Jefferson School of Population Health, Thomas Jefferson University, Philadelphia, PA; Dr A. Willis is Associate Dean of Clinical Sciences and Professor of Urology, Aureus University School of Medicine, Oranjestad, Aruba; Dr Bagley is Senior Advisor, HillCo HEALTH, Washington, DC; Mr S.M. Willis is a third-year medical student, Aureus University School of Medicine, Oranjestad, Aruba; and Mr Layton is Director, Information Technology, Quorum Consulting, San Francisco, CA.

American Urology Association Practice Management Meeting

Preparing for the Eventuality of…Continued from page 12 with them. Value-based payments have already begun, even if they have not yet hit individual practic es. “It’s all about transferring risk to the provider,” he noted. Physicians need to understand the revenue stream, cost structures, and every aspect of a care plan. To plan for the future, he recommended sell ing, joining, or leading. All of this should be dictated by the distance of the physician in a practice to

retirement, the market, and the principal’s ability to manage risk (data information and episodes of care and cost). Practices must be able to quantify what care is. The key to bundled care is having a standardized plan. If the owner of the practice does not understand accounts receivable and the drivers and behaviors of fixed, variable, direct, and indirect costs, cost con trol will be impossible and negotiat

July 2013

ing fees and contracts will be impos sible. Before you plan your budget, you must know the total expenses of your practice, the expenses per day, the cost per patient per year, the number of patients you see in 1 period, and the total number of visits needed to break even (ie, fixed and variable costs). “Change is happening,” he observed, “deal with it. This is all about taking your analytic skills to a new level.” l

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GBC_2013Conf_vertical_62512_Layout 1 7/11/12 11:38

PROVENGE® (sipuleucel-T) Suspension for Intravenous Infusion

SECOND ANNUAL CONFERENCE

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BRIEF SUMMARY — See full Prescribing Information for complete product information

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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.

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.

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