UPM_May2013

Urology Practice Management ™

PROCESS IMPROVEMENTS TO ENHANCE PATIENT CARE™

www.UroPracticeManagement.com

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 Biopsy 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

O

By Rosemary Frei, MSc

D

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: 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

E

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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©2013 Engage Healthcare Communications, LLC

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

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

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

Features Exploring Men’s Willingness to Pay for Prostate Cancer Screening to Avoid Unnecessary Biopsy and Treatment.........................1

By Rosemary Frei, MSc

Transitioning to ICD-10.......................................................................................1

By Susanne Talebian, CHBC, RMM, CMOM, CPC-I, CPC, CUA, CCS-P, PCS

Implementing a Patient Portal in Your Urology Practice to Provide Patient-Centered Care .....................................................................1

By Gena Cook

Prostate Health Prostate Cancer Treatment Overview....................................................16

By John Welz

Health Policy The Independent Payment Advisory Board ...........................................21

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 informational storage and retrieval system, without written permission from the publisher. Printed in the United States of America.

The ideas and opinions expressed in Urology Practice Management™ do not necessarily reflect those of the editorial board, the editors, or the publisher. Publication of an advertisement or other product mentioned in Urology Practice Management™ should not be construed as an endorsement of the product or the manufacturer’s claims. Readers are encouraged to contact the manufacturers about any features or limitations of products mentioned. Neither the editors nor the publisher assume any responsibility for any injury and/or damage to persons or property arising out of or related to any use of the material mentioned in this publication.

Postmaster: Correspondence regarding subscriptions or change of address should be directed to CIRCULATION DIRECTOR, Urology Practice Management™, 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.

May 2013

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Prostate Cancer

Exploring Men’s Willingness to Pay for Prostate Cancer Screening…Continued from page 1 particularly those with less education, may overestimate the benefit of prostate cancer screening due to numeracy problems...and that tailored prostate cancer screening programs may result in betterinformed shared decision-making for screening,” wrote Esther W. de Bekker-Grob, PhD, a researcher and health economist at Erasmus Medical Center, Rotterdam, the Netherlands, and her colleagues (de Bekker-Grob EW, et al. Br J Cancer. 2013 Jan 29 [Epub ahead of print]). “Increasing knowledge on over-diagnosis and overtreatment, especially for men with lower educational levels, is warranted to prevent unrealistic expectations from prostate cancer screening.”

The team formulated 2 versions of a questionnaire containing 16 choice sets on prostate cancer screening. These were based on the prostate cancer screening literature and interviews with 8 prostate cancer experts. A total of 459 men (average age, 63.3 years) from southwest Holland responded to the questionnaires. The researchers divided the men into 3 groups:

• Most men in the first group had a lower educational level, did not have anxiety or depression, and were willing to pay for prostate cancer screening • Most men in the second group also had a lower educational level and did not have anxiety or depression, but they were not willing to pay for screening • The third group largely comprised men who had a higher educational level, had anxiety or depression, and were not willing to pay for prostate cancer screening.

The men in all 3 groups indicated that a reduction in the risk of developing prostate cancer, a reduction in the risk of unnecessary treatment and biopsy, and costs are important.

Those in the first group had a preference for annual or biennial screening, those in the second group did not have a preference for shorter or for longer screening intervals, and members of the third group preferred screening every 2 years versus screening every 4 years.

Willingness to Pay When all 3 groups were combined, the men were willing to pay an average of: • €188 (or $245 US) for a 10% reduction in prostate cancer– related death • €33 ($43 US) annually for a 10% reduction in the risk of an unnecessary prostate biopsy • €38 ($50 US) annually for a 10% decrease in the risk of undergoing unnecessary treatment • €87 ($115 US) annually to access a prostate cancer screening program with a 2-year interval rather than a 4-year one.

In addition, the men were willing to exchange 2% of the reduced risk of prostate cancer mortality for a 10% reduction in unnecessary treatment.

They were also willing to trade 1.8% of their reduced mortality risk for a 10% reduction in the probability of an unnecessary biopsy, and a 4.6% reduced risk of prostate cancer–related death for a 2-year screening interval rather than a 4-year screening interval. l

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Urology Practice Management ™

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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

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By Rosemary Frei, MSc

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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

E

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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ICD-10 Update

Transitioning to ICD-10…Continued from page 1 Go Live Preparation, first quarter 2013 through third quarter 2014; and Phase 4: Post Implementation, fourth quarter 2014 through fourth quarter 2015.

process. ANSI v5010 replaced the electronic transaction standards ANSI v4010/v4010A. Once ICD10-CM goes into effect, any trans-

Phase 1: Impact Assessment Your practice should already have completed the impact assessment. If you are behind schedule, you need to work hard now to catch up. The shift from International Classificatin of Diseases, Ninth Revision (ICD-9) involves serious challenges, including transitioning from a system of 13,000 codes to a system of more than 68,000 codes in ICD-10-CM. You may recall that the implementation of a new generation of the 9 electronic standards for the Health Insurance Portability and Accountability Act (HIPAA), known as the American National Standards Institute (ANSI) Version 5010 (v5010), is a part of this

The shift from ICD-9 involves serious challenges, including transitioning from a system of 13,000 codes to a system of more than 68,000 codes in ICD-10-CM. actions that are not compliant with HIPAA (ie, not using ANSI v5010) will be rejected. The new codes will

Table 1. Structural Differences between ICD-9-CM and ICD-10-CM Diagnostic Codes ICD-9-CM

ICD-10-CM

3 to 5 digits

3 to 7 digits

Digit 1, numeric

Digit 1, alpha

Digits 2 to 5, numeric

Digit 2, numeric Digits 3 to 7, alpha or numeric

ICD-9-CM indicates International Classification of Diseases, Ninth Revision, Clinical Modification; ICD-10-CM, International Classification of Diseases, Tenth Revision, Clinical Modification.

Table 2. Structural Differences between ICD-9-CM and ICD-10-CM Procedure codes ICD-9-CM

ICD-10-CM

3 to 4 digits

7 digits

All digits, numeric

Each digit, either alpha or numeric

ICD-9-CM indicates International Classification of Diseases, Ninth Revision, Clinical Modification; ICD-10-CM, International Classification of Diseases, Tenth Revision, Clinical Modification.

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be structurally different from the ICD-9 codes (Table 1 and Table 2). By now, you should have a steering committee in place or have devised a communication schedule involving everyone in your practice who will play a role in implementing the new coding system. If you have not already done so, you should take the following steps as soon as possible: • Begin operational processes • Evaluate workflow (data and staff) • Identify how to improve workflow • Conduct a gap analysis • Modify your software and up­grade your hardware • Educate your staff Phase 2: Preparing for Implementation Now is also the time for the staff to review the practice’s current procedures and improve upon them, making them more efficient and cost-effective. The newly provided codes were designed to ensure that the collected data reflect patients’ conditions more precisely, decrease claims rejections, and improve the benchmarking of data and public health records. Examine the systems, vendor contracts, and costs for both your electronic health records (EHRs) and practice management systems. Use the following questions as a guide through this process.

Are your contracts with payers ready for the move? You may need to review and update these contracts to pave the way for the move to ICD-10.

Will your current practice management system accommodate the change, or will you require a new system? Choose a software package that will accommodate the necessary changes. Review the problems your practice has experienced in the past 2 years and how they affected Continued on page 12

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.

S IMPROV

www.UroP

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 United is adopt the less than 17 Internat Classifi months awa Revision, Clin cation of Disease, ional several phases y, of implement during which Ten ical Modificatio ing System atio n/Procedure th completed. The (IC timeline for n must be than we had D-10-CM/PCS), 1 yea Cod- ing the code sets is divided implementr later Pha Practice Ma initially reported in se into 4 pha 1: Impact Uro nag ses: Assessment The reprieve ement in September logy 2009 through , first quarter seco , although 2012. Pre welcome to paring for Imp nd quarter 2012; Pha se 2: many, 201 2 through seco lementation, first qua rter nd quarter 2014; Phase 3: Cont

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By Gena ion related to Cook or to pay, prostate can in Founder on average and Chief , €188 (in cer, euros—equ Executive of oncolo ivalent to Officer Na gy-specifi $245 in 201 2010 dollars) ann vigating Ca c patient 0 US ually, for a portals ncer, a lea 10% reduce of unnecessar ding provid stablishing d risk y biopsy or er treatment.

“Physician approach is a patient-centered s should be rap idly and becoming aware that requiremen a core for Health Information men, t in US medical tices. Medica Continued on prac- (HI Economic and Cli Technology l hom e page 8 mo able care nical He TECH) req organization dels, accountalth uirements ponent all have com (ACO) mo dels, care s of engaging pat ien . To incorp orate a pat ts in their ient-cente red

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For consideration to become an Editorial Board Member, please complete the form below and fax to: 732-992-1881 or e-mail to editorial@engagehc.com Your Information _______________________________________________________________________________________ First Name

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_______________________________________________________________________________________ Title Company _______________________________________________________________________________________ Address _______________________________________________________________________________________ E-mail Phone

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Credentials

ICD-10 Update

Transitioning to ICD-10…Continued from page 10

12

your practice and cash flow. Ask yourself what responses and issues you faced with your current practice management software vendor/customer support. How difficult was it to resolve any problems? What did it cost you in time, lost productivity, staffing, and overtime to “catch up” from having your system down for maintenance and upgrades?

Will the upgrade to the new system involve a fee? If so, how much will that cost? Will your vendor(s) provide the codes at no cost?

What is your vendor(s’) timeline for implementation, and when will they allow you to test your system?

You will need to know when the upgrade to your existing system will be complete or the entirely new system will be available. When it is complete, you then need to know whether your vendor(s) will provide training for your practice, and if so, what the training will cost.

Have you begun to modify your templates? Remember to update your forms and superbills. The newer forms will, by necessity, be far more comprehensive and complex than the older forms.

Will your vendor(s) load your specialty specifically, or will all of the specialties be included in your system? Will diagnoses be searchable by partial terms, and will they include the coding guidelines, rules, and exceptions to the guidelines that your practice may encounter?

For example, when coding for malignancies, the malignancy will remain the principal diagnosis when the treatment is directed at the malignancy. However, if a patient is admitted for anemia associated with the malignancy and the treatment is exclusively for anemia, the code for the malignancy will be listed as the principal or first-listed diagnosis, followed by the code D63.0, Anemia in neoplastic disease.

Next Steps: • Contract with a consulting service • Redesign and reprint paper forms • Convert your data • Maintain a dual system until all of the problems with the new system have been worked out • Purchase software, seek educational resources, and use mapping tools as needed to help with the transition

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The newly provided codes were designed to ensure that the collected data reflect patients’ conditions more precisely, decrease claims rejections, and improve the benchmarking of data and public health records.

• Anticipate decreased coding accuracy and work to solve those associated issues • Monitor coding from the point of implementation • Develop a communications plan in preparation for going live • Regularly update your senior executives Phase 3: Go Live Preparation Before you “go live,” be sure that any systems that are not working properly are corrected. Again, make sure you know what your vendor(s) will be able to do to help you with the transition. If

May 2013

you do not know for sure, ask your vendor(s) whether a mapping program will be provided. General Equivalence Mappings (GEMs) were developed to help you with the conversion, because ICD-10 is more specific than ICD-9.1 GEMs are basically translation tools for not only payers and providers, but anyone working with coded data. Remember, the diagnostic codes have increased from 14,025 to 68,069. Procedural codes have increased from 3824 to 72,589. The GEMs can be used to convert your data from ICD-9 to ICD-10-CM/ PCS and back again (ie, forward and backward mappings, also known as crosswalks).

The GEMs will allow you to translate data for tracking quality, recording morbidity and mortality, calculating reimbursement, or converting an ICD-9-CM–based application to ICD-10-CM/PCS. They also can be used to help your practice convert payment systems, payment and coverage edits, risk adjustment logic, quality measures, and research applications germane to trend data. In cases where there is no translation between an ICD9-CM code and an ICD-10 code, a flag will indicate “No Map.” One such example is ICD-9-CM Procedure Code 89.8—Autopsy, for which there is no translation in ICD-10-CM/PCS. Next Steps: • Confirm with your vendor(s) that the needed upgrades are in place • Finalize all system changes from January through September 2014 • Complete testing • Conduct claims testing • Make any necessary modifications and reassign testing • Have a contingency plan in place Continued on page 14

Urology Practice Management ™

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PROCESS IMPROVEMENTS TO ENHANCE PATIENT CARE™

Call for submissions

?

Do you have a practice management solution to share

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.

Send us your ideas!

Submit a 1,000- to 2,000-word original article, previously unpublished and submitted exclusively to Urology Practice Management, that your fellow practice managers will want to read.

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

ICD-10 Update

Transitioning to ICD-10…Continued from page 12 Table 3. Examples of ICD-10-CM Urology Codes Enlarged prostate

N40.0

Enlarged prostate with LUTS

N40.1

Additional codes for associated symptoms Incomplete bladder emptying

R39.13

Nocturia

R35.1

Straining on urination

R39.16

Urinary frequency

R35.0

Urinary hesitancy

R30.11

Urinary incontinence

N39.4-

Urinary obstruction

N13.8

Urinary retention

R33.8

Urinary urgency

R39.15

Weak urinary stream

R39.13

ICD-10-CM indicates International Classification of Diseases, Tenth Revision, Clinical Modification; TURP, transurethral resection of the prostate; LUTS, lower urinary tract symptoms.

Phase 4: Postimplementation Reeducate your staff as necessary and continue to monitor all of your systems—cash flow, productivity, revenue, and coding accuracy.

In ICD-10-CM, chapter 14 will provide the codes for diseases of the genitourinary system. These were provided in chapter 10 in ICD-9-CM. Some of the conditions that were moved from the Signs, Symptoms, and Ill-Defined Conditions

chapter in ICD-9-CM also will be found in chapter 14. These include urge incontinence, incontinence without sensory awareness, male stress incontinence, overflow incontinence, and nocturnal enuresis.2 Examples of ICD-10-CM/PCS urology codes are provided in Table 3 and Table 4.

The ICD-10-CM codes for erectile dysfunction provide an example of the higher level of specificity required. The ICD-9 code for erectile dysfunction is 607.84. The new categories for erectile dysfunction include: • N52.0 Vaculogenic erectile dysfunction with subcategories • N52.01 Erectile dysfunction due to arterial insufficiency • N52.02 Corporo-venous occlusive erectile dysfunction • N52.03 Combined arterial in­ sufficiency and corporo-venous occlusive erectile dysfunction • N52.1 Erectile dysfunction due to diseases classified elsewhere (code

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Table 4. Examples of ICD-10-PCS Codes Cystoscopy

OTJB8ZZ

TURP

OVBO8ZZ

Bladder suspension

OTUB8JZ

Foley catheterization

OT9D7OZ

ICD-10-CM indicates International Classification of Diseases, Tenth Revision, Clinical Modification; TURP, transurethral resection of the prostate.

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first underlying disease) • N52.2 Drug-induced erectile dysfunction • N52.3 Postsurgical erectile dysfunction • N52.31 Erectile dysfunction following radical prostatectomy • N52.32 Erectile dysfunction following radical cystectomy • N52.33 Erectile dysfunction following urethral surgery • N52.34 Erectile dysfunction following simple urethral surgery • N52.39 Other postsurgical erec­ tile dysfunction • N52.8 Other male erectile dysfunction • N52.9 Male erectile dysfunction, unspecified To further highlight the differences between ICD-9 and ICD-10CM, there is yet another category for Other Male Sexual Dysfunction (N53), which includes several subcategories: • N53.1 Ejaculatory dysfunction • N53.11 Retarded ejaculation • N53.12 Painful ejaculation • N53.13 Anejaculatory orgasm • N53.14 Retrograde ejaculation • N53.19 Other ejaculatory dysfunction • N53.8 Other male sexual dysfunction • N53.9 Unspecified male sexual dysfunction Exceptions to the Rule As one would expect, there are several exceptions to the rule. One occurs in the etiology/manifestation convention regarding placement of the code, as well as the placement of the notes “use additional code” and “diseases classified elsewhere.” Certain conditions have both an underlying etiology and multiple body system manifestations owing to the underlying etiology. For such conditions, the ICD-9 coding convention requires that the underlying condition be sequenced

ICD-10 Update

first, followed by the systemic manifestation(s). Wherever such a combination exists, there is a “use additional code” note at the etiology code, and a “code first” note at the manifestation code. These instructional notes indicate the proper sequencing order of the codes—etiology followed by manifestation.3 Another exception to the rule occurs with regard to syndromes.

When coding syndromes, it is important to follow the alphabetical index guidance. When there is no index guidance, assign codes for the documented manifestations of the syndrome.3 Looking at the positive side of the ICD-10-CM/PCS transition, once we are prepared, trained, and on our way, the higher level of specificity with which this coding system will allow us to code will paint a very clear picture for the insurance carriers and will clearly identify patients’ medical problems to justify the medical services performed.

All of this assumes, of course, that the provider is well educated on this system and is utilizing it to its fullest potential. The level of detail required should result in decreased requests from insurance carriers for medical records which, in turn, will allow the staff to work on other tasks that are critical to the daily operations of your medical practice.

Next Steps: • Monitor the impact of ICD-10 on reimbursement • Meet with your staff regularly to share information • Monitor the functionality of your practice management and EHRs systems • Monitor coding accuracy and productivity • Train or retrain your staff as required • Monitor your case mix • Resolve payment issues • Communicate with payers

Table 5. Websites to Help with the Transition to ICD-10 AHIMA

www.AHIMA.org/downloads/pdfs/resources/checklist.pdf

AAPC

ICD-9 to ICD-10 Crosswalk for Urology (www.AAPC.com)

CMS

(www.cms.gov/ICD10/) (http://www.himss.org/content/filesICD10FactSheetNon CoveredEntities.pdf.)

Medscape

Transition to ICD-10. Getting Started. (http://www.medscape.org/viewarticle/765754) Urology Practices (http://www.medscape.org/urology/multimedia-cme)

Other

Preparing Your Urology Practice for ICD-10 (www.coding institute.com/preparing-your-urology-practice-for-icd-10) ICD-10 Coding, Billing, Documentation Webinar (www.supercoder.com/coding-education/icd-10) ICD-9 to ICD-10 Mapping for Urology (www.aapcps.com/ resources/icd-10-mapping/icd-10-urology.aspx 2011 ICD-9-CM to ICD-10-CM Diagnostic Code Mapper for Urology (www.codingbooks.com)

AAPC indicates American Association of Professional Coders; AHIMA, American Health Information Management Association; CMS, Centers for Medicare & Medicaid Services; ICD-10, International Classification of Diseases, Tenth Revision.

Conclusion A significant amount of concern and resistance remains in accepting ICD-10-CM/PCS. However, it is coming, and time is ticking away.

It is better to take a look at things now, to take the first step and have the first meeting to see who in your organization knows anything about ICD-10-CM/PCS. Your first step may be to send someone to a seminar or assign someone to spend the time to research the basics online.

Table 5 includes helpful websites that will provide education and training on ICD-10.

To fully participate in this system, it is highly recommended that you fully understand the coding guidelines. Although some of the guidelines have been retained, there are exceptions—particularly with the new combination codes. Diabetes is a good example of a disease that requires combination codes. For example, type 2 diabetes mellitus with

May 2013

related chronic kidney disease requires a combination code (E11.22). The coder will be instructed to use an additional code to identify the stage of chronic kidney disease.

Remember, the ICD-10-CM codes will be used by all medical providers. The ICD-10-PCS codes are only for inpatient hospital procedures and are used only by the hospitals. You must provide a full description of a procedure or diagnosis. It would be a grave error to truncate these codes, as we are attempting to seek the highest level of specificity. If your vendors download only partial codes, the data will not serve its purpose. l References

1. General Equivalence Mappings. www.cms. gov/Medicare/Coding/ICD10/downloads/GEMSCrosswalksBasicFAQ.pdf. Accessed April 17, 2013.

2. Contexo Media. Coding and Billing for Urology/ Nephrology: A Comprehensive and Illustrative Specialty Guide. www.codingbooks.com/Assets/ MEDURO11_Sample.pdf. Accessed April 17, 2013.

3. American Medical Association. CPT® 2013 Professional Edition. 2013; American Medical Association.

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Prostate Health

Prostate Cancer Treatment Overview

By John A. Welz, MPH

B

ecause it is typically a slowgrowing tumor type, patients with prostate cancer tend to be slightly older than patients in other oncology settings. Nearly 66% of prostate cancer cases are diagnosed in men aged 65 years or older; the disease is rare before the age of 40 years.1 Prostate cancer is highly survivable. If it is diagnosed early enough, it has a 99% 5-year survival rate.

However, prostate cancer is also one of the most common cancers, and approximately 1 of 6 men will be diagnosed with the disease during his lifetime.1 Given the large number of patients with prostate cancer, there is a sizable population of patients who develop progressive disease that leads to metastatic disease and

death. Prostate cancer is the second leading cause of cancer mortality in American men, with approximately 30,000 deaths per year in the United States.1 Treatment Options Treatment for prostate cancer is complex and depends on the patient’s age and the stage of the cancer at diagnosis. Prostate cancer has 4 distinct segments, all of which are eligible for pharmacotherapeutic intervention (Table 1).

There are a number of approved prostate cancer therapies. The main classes of prostate cancer drugs are antiandrogens, androgen inhibitors, gonadotropin-releasing hormone (GnRH), immunotherapies, and cytotoxics.

First-line hormone treatments are designed to minimize prostate tumor growth by slowing testosterone production. Usually, a GnRH agonist is used before and during radiation therapy, sometimes with an antiandrogen therapy. While this hormone and radiation therapy are successful for a large proportion of patients, some tumors progress and the cancer metastasizes outside of the prostate, a condition known as metastatic castration-resistant prostate cancer (mCRPC).

Hormonal therapies have long been the mainstay of early prostate cancer treatment. Typically, luteinizing hormone-releasing hormone (LHRH) analogs are used as a firstline therapy to suppress testosterone to castration levels. LHRH is a hor-

Table 1. Stages of Prostate Cancer Stage

Description

Treatment

T1

• Cancer is localized to the prostate only • PSA level is <10 ng/mL • Cancer cannot be felt by digital rectal examination

• Surgical removal of the prostate • Radiation therapy; EBRT and brachytherapy the most frequently used

T2

• More advanced than stage 1, but has not • Surgical removal of the prostate spread outside of the prostate • Radiation therapy; EBRT and brachytherapy the • Stage 2A: PSA level is ≥10 ng/mL but ≤20 ng/ most frequently used mL; cancer is found on 1 lobe of the prostate • Stage 2B: Hormone ablation/GnRH analog as • Stage 2B: PSA can be any level; cancer is monotherapy or used in combination with an found in opposite sides of the prostate antiandrogen

T3

• Cancer has spread beyond the outer layer of the prostate and may have spread to the seminal vesicles • PSA can be any level

IV

• Cancer has spread beyond the seminal vesicles • Radiation to nearby tissues and organs and is near lymph • Hormone ablation nodes and bones • Palliative transurethral surgery • Biopharmaceutical therapy with cytotoxics

• Surgery • Radiation • Hormone ablation

PSA indicates prostate-specific antigen; GnRH, gonadotropin-releasing hormone; EBRT, external beam radiation therapy.

Adapted from National Cancer Institute. Stages of Prostate Cancer; January 2012.

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Prostate Health

mone that is produced by the hypothalamus, which leads to the production of testosterone. LHRH analogs act by blocking the messenger process in the brain, and are generally prescribed during the course of the disease, with further therapies added on while patients continue taking LHRH analogs. The most commonly used LHRH analog is leuprolide acetate (Lupron).

The next main class of hormone therapies is antiandrogens, which are often used as a second-line therapy in combination with LHRH, or as a first-line therapy in combination with LHRH. Antiandrogens work by blocking androgen receptors to prevent the prostate glandâ&#x20AC;&#x2122;s reception of testosterone. The most commonly used antiandrogen is bicalutamide.

Until relatively recently, hormone agents have been the mainstay of treatment, but late-stage therapy has not been as well served. Before 2004, only palliative care for mCRPC was offered, with no disease-modifying therapies available. However, the launch of docetaxel (Taxotere) in May 2004 paved the way for sipuleucel-T (Provenge) in 2010, cabazitaxel (Jevtana) in 2010, abiraterone acetate (Zytiga) in 2011, and, most recently, enzalutamide (Xtandi) in 2012 to garner US Food and Drug Administration (FDA) approval in mCRPC. Table 2 presents the key treatments used in prostate cancer and their approval dates.

The mCRPC population is difficult to treat. These patients still exhibit disease progression despite further hormone manipulation and are, therefore, in stage IV disease.

However, as shown in Table 3, Provenge, Zytiga, and Xtandi have demonstrated improved efficacy compared with older agents in postchemotherapy patient populations.

More recently, research has focused on hormonal manipulation prior to chemotherapy in the treatment

Table 2. Key Treatments Used in Prostate Cancer Drug

Company

FDA approval date

Zytiga (abiraterone acetate)

Johnson & Johnson

April 2011

Xtandi (enzalutamide)

Medivation

August 2012

Casodex (bicalutamide)

AstraZeneca

February 1995

Nilandron (nilutamide)

Sanofi/Astellas

September 1996

Eulexin (flutamide)

Merck & Co./Nippon Kayaku

January 1989

Taxotere (docetaxel)

Sanofi

May 2004

Jevtana (cabazitaxel)

Sanofi

June 2010

Takeda/Abbott

April 1995

Dendreon

April 2010

Androgen inhibitors

Antiandrogrens

Cytotoxics

GnRH agonists Lupron (leuprolide acetate) Immunotherapy Provenge (sipuleucel-T)

FDA indicates US Food and Drug Administration; GnRH, gonadotropin-releasing hormone.

Adapted from National Cancer Institute. Stages of Prostate Cancer; January 2012.

pathway. In December 2012, Zytiga received expanded FDA approval to include use in combination with prednisone for the treatment of mCRPC in men who fail on androgen deprivation therapy but in whom chemotherapy is not yet indicated.

In clinical trials, patients achieved a 35.3-month median increase in overall survival with Zytiga, and there was a 57% decrease in the risk of radiographic progression. In addition, Zytiga delayed the median time to the initiation of chemotherapy by 25.2 months.2 Similar studies have been conducted to evaluate the use of Xtandi in the prechemotherapy setting, and the National Comprehensive Cancer Network guidelines provide a 2A recommendation for the use of Xtandi in this patient population.3

of unmet needs remain. One of the most common reasons why patients do not start treatment is the side effects associated with the current standard-of-care cancer drugs.

Hormone treatment intervention for early-stage disease can lead to fatigue, reduced or absent feelings of sexual desire, impotence, weakness, loss of muscle mass, an overgrowth of breast tissue, hot flashes, and weakening of the bones. The current chemotherapy regimens can be poorly tolerated in some patients, and can cause neutropenia, nausea, vomiting, diarrhea, constipation, fatigue, excessive tearing, infusion-site reactions, and hair loss. Although the newer oral agents are reasonably well tolerated, patients nonetheless may experience fatigue, diarrhea, vomiting, and hypertension. Management of the side effects is often an impor­ tant factor in the successful comple-

Managing Unmet Needs Despite these recent advances in treating prostate cancer, a number

May 2013

Continued on page 18

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Prostate Health

Prostate Cancer Treatment Overview…Continued from page 17 Table 3. Survival Data of Key Drugs for mCRPC Product

Disease

Comparator

HR

P-value

OS improvement

OS difference

Taxotere

mCRPC

Methotrexate + prednisone

0.76

.009

2.4 months (15%)

18.9 vs 16.5

Jevtana

Postchemotherapy mCRPC

Methotrexate + prednisone

0.70

<.0001

2.4 months (19%)

15.1 vs 12.7

Provenge

Postchemotherapy mCRPC

Placebo

0.78

.032

4.1 months (19%)

25.8 vs 21.7

Zytiga

Postchemotherapy mCRPC

Methotrexate+ prednisone

0.74

<.0001

4.6 months (41%)

15.8 vs 11.2

Xtandi

Postchemotherapy mCRPC

Placebo

0.63

<.0001

4.8 months (35%)

18.4 vs 13.6

HR indicates hazard ratio; mCRPC, metastic castration-resistant prostrate cancer; OS, overall survival.

Source: Prescribing information.

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tion of the treatment regimen.

Although many prostate cancer risk factors have been identified, the actual cause of the disease is still unknown. Researchers have identified a number of genetic changes that increase the risk of prostate cancer, which can be used to develop a test for diagnosis and prognosis. A better understanding of the relationship between the genetic and environmental factors of prostate cancer development will aid in drug research and development and decrease the high clinical trial attrition rate that is currently observed in the disease.

In addition, there remains an unmet need for more targeted therapies. One of the major challenges in studying prostate cancer is the inability to identify when patients require therapy and which therapies will work better on individual patients. The potential use of biomarkers as tools to identify how well

therapies will work on patients will help to evaluate the disease-modifying (or -slowing) properties of prostate cancer drugs reliably.

Research continues to address these unmet needs through the development of new drugs, diagnostic tests, and technologies. The late-stage pipeline now spans multiple drug classes, including new hormone therapies, cytotoxic addon therapies, and immunotherapies across the spectrum of early- to latestage metastatic disease. New technologies show promise in the identification and treatment of patients with prostate cancer. Diagnostic manufacturers are developing biomarker-based genomic tests with reasonable specificity and sensitivity, which will help with the diagnosis, treatment, and prognosis of prostate cancer.

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Conclusion In the face of market pressures

May 2013

and constrained reimbursement, urology practices must continue to adapt in order to thrive in today’s challenging business environment.

Clearly, practices must seek to maximize efficiencies and eliminate waste within their current business model.

In addition, the well-planned and executed adoption of new products and technologies also may help practices remain competitive. By offering a broader suite of services, urology practices have the opportunity to better serve their patients, improve outcomes, and retain their patients for longer periods of time. l References

1. American Cancer Society. Learn About Cancer: Prostate Cancer. http://www.cancer.org/cancer/pros tatecancer/detailedguide/prostate-cancer-key-statis tics. Accessed April 22, 2013.

2. FDA expands Zytiga’s use for late-stage prostate cancer [press release]. Washington, DC: US Food and Drug Administration; December 10, 2012. http://www. fda.gov/NewsEvents/Newsroom/PressAnnouncements/ ucm331492.htm. Accessed April 22, 2013.

3. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Prostate Cancer. Version 2. Fort Washington, PA: National Comprehensive Cancer Network; 2013.

Patient Provider Access

Implementing a Patient Portal…Continued from page 1 approach effectively and to meet these requirements, you will be required to institute a patient portal in your practice. More important, you will need to not only implement but also institutionalize new processes and ways to care for your patients using this technology. If done well, it could provide a competitive advantage to your practice, ease some of the administrative burdens on you and your staff, and provide a huge improvement in patient satisfaction and well-being as patients take a more active role in their care.

The following sections discuss the new HITECH and ACO models and their requirements related to a patient-centered care approach.

HITECH The HITECH Act was signed into law in 2009 by President Obama to digitize medicine and to provide incentives to providers to adopt certified electronic health record (EHR) technology. Many practices have started to digitize and are attesting for the stimulus incentives, which peaked in 2012.

To meet meaningful use criteria, practices must provide clinical visit summaries and electronic access to parts of their patient’s health information. It is easier for a practice to attest for Stage 1, with less administrative burden using a patient portal, but a portal will be required for Stage 2 in 2014. One of the primary goals of the HITECH Act is to “engage patients and their families to improve care coordination”; therefore, it is likely that greater patient engagement will be required in Stage 3, which has yet to be finalized. The patient engagement objectives of HITECH include: • Electronic access to health infor­ mation • Patient-specific education, using

certified EHR technology • Online secure messaging.

• Develops and documents selfmanagement plans and goals in collaboration with at least 50% of patients and their families • Provides self-management tools to record self-care results for at least 50% of patients and their families

Medical Home The medical home model concept first evolved in primary care. Some of the patient engagement requirements in the medical home model are similar to those of HITECH; however, the medical home model takes them even further. It is clear that a patient portal will be needed for most of these requirements.

The patient engagement requirements of the patient-centered medical home from the National Committee for Quality Assurance include1: • Electronic access to health in­ formation • Providing continuity of medical record information for care and advice when the office is not open • Providing timely clinical advice using a secure, interactive electronic system when the office is not open • Two-way communication between patients (and their families) and the practice • Requests for appointments, prescription refills, referrals, or test results • Instructions on obtaining care and clinical advice during office hours and when the office is closed • The practice functions most effectively as a medical home if patients and their families provide a complete medical history and information about care obtained outside of the practice • The care team gives the patients and their families access to evidence-based care and self-management support • Uses an EHR to identify and provide patient-specific educational resources or refers at least 50% of patients and their families to educational resources to assist in self-management

May 2013

Accountable Care Organizations ACOs are groups of healthcare providers who provide coordinated care and disease management to improve the quality of care that patients receive. The organization’s payment is tied to achieving healthcare quality goals and outcomes that will result in cost-savings. Although there are no direct patient objectives that must be met, it will be imperative to engage patients to participate in their healthcare to achieve the best outcomes and cost-savings.

Access to Information Many studies have shown that patients want easier access to their health information so that they can be more engaged in their care. A 2012 study revealed that 90% of patients want to self-manage their healthcare online, with access to health information and education to help manage their conditions.2 What patients say they want, and what they actually do, can be 2 different realities; however, we are starting to see that patients are following through on their stated desires. The OpenNotes project was a year-long study that evaluated the effect on doctors and patients of facilitating patient access to visit notes over a patient portal.3 More than 100 doctors and more than 13,500 patients participated across 3 different hospital settings that served urban, rural, and poor communities. The results were overwhelmingly positive, with Continued on page 20

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Patient Provider Access

Implementing a Patient Portal…Continued from page 19 Important Upcoming Meaningful Use Dates 2014: Last year to initiate participation in the Medicare EHR Incentive Program 2015: Medicare payment adjustments begin for eligible providers and eligible hospitals that are not meaningful users of EHR technology 2016: Last year to receive a Medicare EHR incentive payment and last year to participate in Medicaid EHR Incentive Program 2021: Last year to receive Medicaid EHR incentive payment EHR indicates electronic health record.

Source: www.cdc.gov/EHRmeaningfuluse/timeline.html. Accessed April 18, 2013.

the majority of patients viewing at least 1 note. Of those, 77% to 87% of patients across the 3 geographic settings reported that OpenNotes helped them feel more in control of their care, and 60% to 78% of patients taking medications reported increased adherence. Most impressive, nearly 99% of patients wanted OpenNotes to continue, and no doctor elected to stop.3 Implementing a Patient Portal Do Your Research Implementing a new technology in your practice is a big decision. You have likely been through this process previously as you chose your EHR vendor, and you can draw on your experiences through that process.

What did you do well in selecting your vendor? What pitfalls did you discover through that process that you would have done differently?

Patient portal vendors have been around for the past 10 years, so you will have many options to choose from. You will need to decide if you want a general portal application that is transaction-based or something that is specific to urology. Your EHR vendor will likely have a solution to consider. Some EHR vendors have built a modular patient portal into their application that can be used for your practice, and others have partnered with patient portal companies to provide

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an independent solution.

The features and functions of patient portals vary widely, so make sure that you examine several portals before making a decision. Some portals are very robust, and others are basic. Because patient portals are a new requirement, try to understand the vendor’s motivation for providing this service. Is it committed to the patient experience, or did it just create the basic features and functions for HITECH certification? Is the vendor actively continuing to develop the product?

Requirements are constantly changing, and many are not yet finalized, so you need to understand if your vendor will be up to the challenge of meeting all of these new requirements. How quickly does the vendor implement new features?

What kind of customer service does it provide to the staff and to your patients? If possible, talk to the vendor’s current customers as well.

Think About the Experience This is not just another technology for your practice to use; it is also an application that your patients will use and access on a consistent basis.

You need to view the products with that in mind. Choosing a vendor with the best patient experience is crucial.

If you do not, you could not only provide a suboptimal experience for your patients, but you could also cause a sig-

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nificant administrative burden for your staff. Your portal technology should improve your practice and support your patients, not the opposite.

Patient portals will be offered by your competitors, and referring physicians and patients will quickly start to see the differences in products.

Many patients see many doctors, and your choices could either reflect positively or negatively, depending on if you choose a suboptimal product from the patient’s experience.

Questions to Ask Your Vendor How do data flow from my EHR to the patient portal? How is information released to the patient?

1

2

How will patients be notified that they have new health information?

3

What features and functions do you provide for patients? What features and functions are available for staff? What is your product road map for new features?

4

How do I handle a password reset for patients? Who do patients call if they have technical problems?

5

What data do you have that demonstrate this will save my practice time?

6

Do you have patient satisfaction survey information on your product? How about staff satisfaction information?

7

How much does the application cost? Will I need additional software or hardware?

8

What browsers do you support?

If our patients are using a variety of browsers, a portal supporting Microsoft IE 7 is not good enough.

This will cause significant problems

Health Policy

The Independent Payment Advisory Board

By Sydney Abbott, JD, Policy Coordinator, Association of Community Cancer Centers

T

he Patient Protection and Affordable Care Act of 2010 (ACA) created many important reforms in healthcare. Many of the ACA’s provisions are very popular, such as the elimination of insurance denials for preexisting conditions. Other provisions, however, are not as popular.

The Independent Payment Ad­­ visory Board (IPAB), slated to begin in 2013, is one of the controversial provisions. Created by sections 3403 and 10320 of the ACA, the IPAB is tasked with achieving specified savings in Medicare without affecting coverage or quality. Under current law, the Medicare Payment Advisory Council (MedPAC) re­­ views payment policies and makes recommendations to Congress about ways to reduce spending. Congress must then debate and vote on these recommendations in order for them to become law.

What Is the IPAB? The IPAB is a 15-member panel appointed by the president and confirmed by the Senate. The panel will replace the decision-making power of MedPAC, but MedPAC will remain an advisory body for Congress.

Beginning next year, if the chief Medicare actuary determines that the projected 5-year average growth rate spending per Medicare beneficiary is projected to outpace the target growth rate, the IPAB must submit a proposal to Congress to reduce spending on Medicare by a specified amount.

Through 2017, the target growth rate is the 5-year projected average of the Consumer Price Index (CPI) for all consumers and the CPI for medical care. For 2018 and beyond, the target growth rate is the 5-year projected average percentage increase in the per-capita gross domestic product plus 1%. If spending exceeds

these targets, the IPAB must submit a proposal to Congress that reduces spending on Medicare down to the target spending rate per beneficiary.

Congress must then accept the proposal without amendments, or come up with its own plan that achieves at least the same amount of savings.

Congress has a poor track record of compromise and agreement, and it is likely that the identification of more than $3 billion in savings (the expected savings necessary to achieve targets for Medicare in 2015) will be no different. If the IPAB does not submit a proposal, and if Congress is unable to develop a plan, the Secretary of the US Department of Health and Human Services (HHS) must act unilaterally to achieve the target spending rates in Medicare.

The IPAB significantly changes the current Medicare policy development structure. Once appointed, Continued on page 22

Implementing a Patient Portal… for our patients and headaches for me if I am fielding the phone calls.

A Well-Implemented Portal Can Improve Your Practice It is clear that web-based patient portals are already, and will continue to be, a required tool to enable medical practices to communicate with patients and engage them in their care. Most practices have been focused on selecting and implementing an EHR vendor to qualify for the Stage 1 meaningful use incentives, which peaked in 2012. Savvy administrators should now be looking beyond meaningful use criteria to consider patient portal technolo-

gy that will be required for Stages 2 and 3, but will also be necessary to qualify for emerging payer programs (eg, medical homes and ACOs) and new professional standards. All of the options require patient access to their personal health information to enable more patient engagement, which is at the core of a patient-centered approach to care.

Although many practice administrators are concerned that giving patients more information will result in additional work, a well-implemented portal can increase efficiency by reducing data entry and will not add to staff workload as new processes become automated.

May 2013

When evaluating portal options, it is important to keep the big picture in mind—it should address multiple needs, make your practice more efficient, and increase patient satisfaction so you are better able to provide patient-centered care. l References

1. National Committee for Quality Assurance. PatientCentered Medical Home 2011 Standards, Elements and Factors. June 5, 2012. www.ncqa.org/Portals/0/Programs/ Recognition/PCMH_2011_Data_Sources_6.6.12.pdf.

Accessed October 23, 2012.

2. Accenture. Most patients want to self-manage healthcare online, Accenture survey finds. June 20, 2012. http://newsroom.accenture.com/article_display.cfm?arti cle_id=5474. Accessed October 23, 2012.

3. Delbanco T, Walker J, Bell SK, et al. Inviting patients to read their doctors’ notes: a quasi-experimental study and a look ahead. Ann Intern Med. 2012;157:461-470.

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Health Policy PROVENGE® (sipuleucel-T) Suspension for Intravenous Infusion

Rx Only

BRIEF SUMMARY — See full Prescribing Information for complete product information

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.

The Independent Payment Advisory Board…Continued from page 21 the board will be essentially “unchecked,” because there is no oversight by Congress or voters. This means that an unpopular proposal by the IPAB will have no recourse at the polls.

In addition, it is still unknown who will serve on the board, and how well the different fields of medicine will be represented.

Authority of the IPAB These are just a couple of the many questions about the IPAB’s ability to change healthcare.

1. What exactly can the IPAB do? The IPAB’s power is limited to Medicare. Medicaid and other programs are exempt.

2. What kind of changes can the IPAB make to Medicare? The IPAB’s authority is limited to changes in reimbursement only. It is the intent of the ACA that patients not be impacted by the Medicare savings that must be achieved.

Therefore, the IPAB may consider reimbursement rates, payment models, and other mechanisms for achieving these goals; however, patient benefits, such as Medicare rosters and beneficiary composition, cannot be altered. Although the aim of the ACA is to achieve savings without impacting access, those in the provider community understand that you cannot dramatically reduce reimbursement without impacting access to care on some level. Continued squeezing of reimbursement rates—particularly in light of the broken sustainable growth rate formula and sequestration—will only make it increasingly difficult for providers to continue to give the most fitting care at the most appropriate time to all of their patients with Medicare.

The Future of the IPAB Because of the concern that the IPAB will not report directly to the voting public, many in Congress want to repeal the IPAB. In fact, a number of efforts have already been made.

To date, however, there has not been sufficient agreement between both chambers to pass the measure; however, that does not mean legislation will not pass in the future. As elements of the IPAB become more visible, we may see a resurgence of repeal efforts in the House or in the Senate. l

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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.

©2013 Dendreon Corporation.

All rights reserved. January 2013.

Printed in the U.S.A. Dendreon, the Dendreon logo, and PROVENGE are registered trademarks of Dendreon Corporation.

P-A-01.13-002.00

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

STARTS THE FIGHT

AND HELPS HIS IMMUNE SYSTEM SUSTAIN* IT 1

• Targets and attacks prostate cancer cells • Statistically significant overall survival advantage1,2 • Sustained* immune response *A sustained immune response was seen out to 26 weeks in the pivotal study (the last time point measured).1 INDICATION: PROVENGE® (sipuleucel-T) is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.

IMPORTANT SAFETY INFORMATION: PROVENGE is intended solely for autologous use and is not routinely tested for transmissible infectious diseases.

In controlled clinical trials, serious adverse events reported in the PROVENGE group included acute infusion reactions (occurring within 1 day of infusion) and cerebrovascular events. Severe (Grade 3) acute infusion reactions were reported in 3.5% of patients in the PROVENGE group. Reactions included chills, fever, fatigue, asthenia, dyspnea, hypoxia, bronchospasm, dizziness, headache, hypertension, muscle ache, nausea, and vomiting. No Grade 4 or 5 acute infusion reactions were reported in patients in the PROVENGE group.

The most common adverse events (incidence ≥15%) reported in the PROVENGE group were chills, fatigue, fever, back pain, nausea, joint ache, and headache.

For more information on PROVENGE, please see Brief Summary of Prescribing Information on adjacent pages. www.PROVENGEHCP.com