UPM December 2013

Urology Practice Management ™

PROCESS IMPROVEMENTS TO ENHANCE PATIENT CARE™

DECEMBER 2013

www.UroPracticeManagement.com

Are You Ready to Test Your ICD-10 Proficiency with CMS?

By Susanne Talebian, CHBC, RMM, CMOM, CPC-I, CPC, CCS-P, PCS, CUA Senior Urology Consultant, Healthcare Business Solutions, Ltd

I

f you haven’t al­ ready, take the time now to prepare for the International Classification of Diseases, Tenth Re­ vision (ICD-10) transition. This will not be easy, and it will require changes to your medical record documentation as well as time and money.

This testing, which will be conducted by the Centers for Medicare & Medicaid Services (CMS), is a mere 3 months away, and much preparation is necessary to test claims by then. Begin by meeting with providers and management, Continued on page 8

VOLUME 2 • NUMBER 4

What to Expect in the “Affordable Care” Era

By Aimee Greeter, MPH Senior Manager, Coker Group

T

he Affordable Care Act and economic pressures have ushered in a new era in healthcare delivery based on quality improvements and cost control, formally known as the “accountable care era.” With change becoming an operative word in virtually every realm of the healthcare industry,

providers in all specialties have been forced to make radical adjustments for the sake of survival. Very few specialties, including urology, have been left unscathed by the government’s (specifically by the Centers for Medicare & Medicaid Services [CMS]) cuts to physician reimbursements and changes Continued on page 12

Your Practice Management Software Is Only as Good as Your Practice Management

By Mary Pat Whaley, FACMPE, CPC Patient Advocate and Consultant, Manage My Practice

A

colleague of mine has been part of a well-known practice management/electronic medical record (EMR) company’s software support team for 10 years. She often tries to steer people to me when she cannot solve a client’s

problems with a software solution. Even though she was once a practice administrator herself, she is a software support person now and the problems she sends to me cannot be solved with software. “Mary Pat,” she asks me, “Why do they think I Continued on page 19

N IT O RA T IS u IN g Yo 0 DM pin ...2 A Kee ight

©2013 Engage Healthcare Communications, LLC

E s N IT C hat’ At C W Up A PR

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 nenglezos@the-lynx-group.com Vice President, Director of Sales & Marketing Joe Chanley jchanley@the-lynx-group.com Publisher Cristopher Pires cpires@the-lynx-group.com Editorial Director Dalia Buffery dbuffery@the-lynx-group.com Managing Editor Lisa Neuman lneuman@the-lynx-group.com 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 Rattananont Ferris Vice President of Finance Andrea Kelly Director, Human Resources Blanche Marchitto Associate Director, Content Strategy & Development John Welz Associate Editorial Director, Projects Division Terri Moore Director, Quality Control Barbara Marino Quality Control Assistant Theresa Salerno Director, Production & Manufacturing Alaina Pede Director, Creative & Design Robyn Jacobs Creative & Design Assistant Lora LaRocca Director, Digital Media Anthony Romano Web Content Managers David Maldonado Anthony Trevean Digital Programmer Michael Amundsen Meeting & Events Planner Linda Sangenito Senior Project Managers Andrea Boylston Jini Gopalaswamy Project Coordinators Jackie Luma Deanna Martinez IT Specialist Carlton Hurdle 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 Are You Ready to Test Your ICD-10 Proficiency with CMS?…...........1

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

What to Expect in the “Affordable Care” Era.......................................1

By Aimee Greeter, MPH

Your Practice Management Software Is Only as Good as Your Practice Management...............................................................1

By Mary Pat Whaley, FACMPE, CPC

Keeping Up with IT Solutions..............................................................15

By Sandra Paton

What’s Keeping You Up at Night?…................................................20

By Robertson Payton

To submit articles, contact Lisa Neuman at lneuman@the-lynx-group.com

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

Urology Practice Management™, ISSN (requested), is published 2 times a year by Engage Healthcare Communications, LLC, 1249 South River Road, Cranbury, NJ 08512. Copyright ©2013 by Engage Healthcare Communications, LLC. All rights reserved. Urology Practice Management™ is a registered trademark of Engage Healthcare Communications, LLC. No part of this publication may be reproduced or transmitted in any form or by any means now or hereafter known, electronic or mechanical, including photocopy, recording, or any informational storage and retrieval system, without written permission from the publisher. Printed in the United States of America.

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

Postmaster: Correspondence regarding subscriptions or change of address should be directed to CIRCULATION DIRECTOR, Urology Practice Management™, 1249 South River Road, Cranbury, NJ 08512. Fax: 732-992-1881.

Yearly subscription rates: 1 year: $99.00 USD; 2 years: $149.00 USD; 3 years: $199.00 USD.

December 2013

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ICD-10 Transition

Are You Ready to Test Your ICD-10…Continued from page 1 then perform your impact assessment, educate the providers and billing staff, then start dual coding your claims. Practice is the best teacher and, with practice, the time required to code in ICD-10 will decrease as you go along.

CMS has stated that testing with Recovery Audit Contractors (RACs) will suffice for ICD-10 testing. However, this testing period is scheduled for March 3-7, 2014.

You should test claims that reflect the majority of your services and the most commonly used diagnosis codes, as this may be your only chance at testing with CMS. According to a CMS statement, this is what practice managers should expect: • The testing week will be March 3-7, 2014.

• Your RAC will announce and promote the testing week via listserv messages and will post the testing week announcement on their website.

• Your RAC will host a registration site or provide an e-mail address for the trading partners to provide registration information.

The registration site or e-mail address will be available and publicized to trading partners at least 4 weeks prior to the testing week.

• During the testing week, electronic data interchange helpdesk support will be available, at a minimum, from 9:00 am to 4:00 pm local contractor time, with enough support to handle any increased call volume.

• Participating providers and suppliers will receive electronic acknowledgment confirming that the submitted test claims were accepted or rejected.

On or before March 18, 2014, your RAC will report the following to CMS: • The number of trading partners

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conducting testing during the testing week • The percentage of trading partners that conducted testing (vs the number of trading partners supported by contract) • The percentage of test claims accepted and rejected • A report of any significant issues found during testing.

You should test claims that reflect the majority of your services and the most commonly used diagnosis codes, as this may be your only chance at testing with CMS. Conversations with your critical trade partners and vendors are necessary as well. Questions regarding schedules, testing and preparedness, a copy of their test plan, and the number of tests that can be submitted should be discussed so you can put this in your time line.

Percentage of Providers in Transition Currently, 55% of physicians have not yet begun ICD-10 transition.

Holt Anderson, executive director of the North Carolina Healthcare Information & Communications Alliance, shared his experience at the Medical Group Management Association 2013 Annual Con­ ference, in San Diego, CA, and he reported that the initial results of transitioning were not favorable. Coding in ICD-10 reduced productivity by 50%, increased time for chart audits, and peer-reviewed scenarios only

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matched 55% the first time around and 66% the second time around. The lesson learned is to focus on ICD-10, by training, educating, and practicing assigning ICD-10 codes.

Some of the basics are necessary to review, such as: the difference between O and 0, I and 1, Not Elsewhere Classified (NEC), Not Otherwise Stated (NOS), and other specified and not specified codes.

Because time is an obstacle in our training efforts, breaking down the training for our physicians and providers may be a better way to handle their training. Explaining that your efforts to make this transition as easy as possible, and as least disruptive to productivity, can be appreciated as you make accommodations in their schedules.

Specialty training will increase your efforts in dealing with time issues for providers—train on their codes first, then general codes and guidelines. To reduce the need for memorization of new codes, provide guide sheets for your providers, but always keep the current version of code books on hand for reference. Your efforts in training the providers and staff is to reduce the number of queries when you go live, which, in turn, reduces delays in sending out claims, then reduces denied claims, and finally decreases cash flow disruption.

The best way to accomplish this goal is to have well-educated providers and staff and practice, practice, practice before going live and being prepared to test in March with CMS.

Tips for Dealing with the Potential Financial Impact Measure your financial performance now by evaluating your accounts receivable. Look for concerns such as large balances over 45 days, secondary claim balances still showing as not paid, and a large percentage Continued on page 10

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 niche 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. an affiliate of

S IMPROV

www.UroP

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

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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 lneuman@the-lynx-group.com _______________________________________________________________________________________ First Name

Last Name

Credentials

_________________________________________________________________________________________________________ Title Company _________________________________________________________________________________________________________ Address _________________________________________________________________________________________________________ E-Mail Phone

Urology Practice Management™ 1249 South River Road, Suite 202A, Cranbury, NJ 08512

ICD-10 Transition

Are You Ready to Test Your ICD-10…Continued from page 8 of patient balances as well as aging patient balances. Your practice will need money collected in the timeliest fashion. Your financial policy will need to be reviewed, as will your policies on patient collection, such as patients paying their copayments when they check in, being advised of outstanding balances, and being handed a current statement at that time—before seeing the provider. The best time to collect is when the patient is right in front of you.

Whatever issues, reasons, or problems you are having now that delay your payments, they need to be resolved before October 1, 2014, as we will have to devote all of our time and effort to tracking and ensuring proper payment with the new ICD10 codes. Measure your cash flow performance now so you can tell if it is abnormal after October 1, 2014.

How will you know if there is a slowdown if you do not know what your normal days to collection are?

The Tasks of your Project Leader Making Time Available As providers are dealing with e-prescribing, electronic health record (EHR) implementation, and meeting meaningful use, ICD-10 is being pushed to the back burner. This 1-year delay has given many providers and administrators a false sense of relief.

See where you compare with the timeline recommendation of the CMS.

10

your EHR company about the costs and timing of their upgrades as well.

Working Together with Your Vendors You will need to modify your templates to reflect the higher level of specificity in ICD-10 and this translates into time and money for your staff and your resources. After all, someone has to modify these templates and you may need to add staff or reallocate duties to allow someone to make these modifications.

Training and Education Your staff will have different needs and require different levels of training—basic training for front desk, moderate training for the clinical support team, and comprehensive training for administration, the billing department, and providers.

Some staff members may not want to attend training outside of regular business hours, and you will need to modify schedules to handle that.

Perhaps smaller offices or solo providers will need to attend training at the same time to minimize the office being closed or minimize productivity losses. Keeping the money flow steady is a huge concern. Immediate action and the understanding of urgency as well as comprehensive training can help mitigate this negative effect on your practice.

Biggest Budget Concerns We are 10 months from implementation. ICD-10 must be in your budget for next year as well as a contingency plan for a cash slowdown the last quarter of 2014. Check with your software vendors and ask if there is a fee for the ICD-10 upgrade, when they will upgrade, and when you can send claims for testing. Ask

Crosswalks and GEMs When using computer-assisted coding (CAC), it may be helpful to choose a code, but it does have its limits. There are certain guidelines on using other specified and unspecified codes and it is fine to use them when appropriate. However, CAC may try to direct you to a more specific code when one is not available.

CMS has directly stated that they are not requiring or asking providers to

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December 2013

run medically unnecessary tests just to get a more specific diagnosis code.

General equivalency mappings (GEMs) are used to translate a large set of codes from ICD-9 to ICD-10 and ICD-10 to ICD-9. Of course, because there is a higher level of specificity, there are many ICD-10 codes that do not have an ICD-9 companion code, so there is not a 1-to-1 relationship. Some ICD-9 codes translate too many codes— keep in mind that mapping is not the same as coding. The GEMs are free of charge and available to any provider who wishes to use them.

CMS warns that the GEMs do not allow for the selection of the most accurate and applicable ICD-10 codes. To code appropriately, you will need to refer to the electronic or hard copy of the ICD-10 code book and follow these guidelines and conventions: • Remember to keep the communication lines open with payers.

• Work with a dedicated contact person at the insurance company.

• Ask when external testing will be available and if they can accept dual processing.

• You also need to know what their contingency plan is if things do not go as planned.

• You will want to know how they will process claims and how you can get your reimbursement for services rendered in a timely fashion.

Conclusion Take a look at where you are in the implementation of ICD-10. Set up a time line, a budget, and training. We were prepared for Y2K and it went off without a hitch. Approach ICD-10 with the same certainty, preparation, and knowledge. We can do this together and are offering many ICD-10 “boot camps” across the country to help you prepare. l

Urology Practice Management ™

PROCESS IMPROVEMENTS TO ENHANCE PATIENT CARE™

MAY 2013

www.UroPracticeManagement.com

VOLUME 2 • NUMBER 1

Call for submissions

Transitioning to ICD-10 Exploring Men’s

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

By Rosemary Frei, MSc

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DoO you have a practice management solution to share 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:

utch researchers have peered Continued on page 10 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

By Gena Cook willing to lose 2% of risk reduction in Founder and Chief Executive Officer Navigating Cancer, a leading provider mortality related to prostate cancer, of oncology-specific patient portals or to pay, on average, €188 (in 2010 In your background a urology practice it’s likely there’s one stablishing a as patient-centered and Health manager, Information Technology euros—equivalent to $245 in 2010 US approach is rapidly becoming a core for Economic and Clinical dollars) annually, for a 10% reduced risk business experience—and maybe more—that practiceHealth managers across requirement in US medical prac- (HITECH) requirements all have comof unnecessary biopsy or treatment. the nation would want to read about. tices. Medical home models, account- ponents of engaging patients in their “Physicians should be aware that men, able care organization (ACO) models, care. To incorporate a patient-centered Continued on page 8

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

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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 H business and/or practice medicine, or how you successfully integrated LT A r E ancillary products and services into your practice asH a revenue generator. e c TE

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Send us your ideas!

Submit a 1000- to 2000-word original article, previously unpublished and submitted exclusively to Urology Practice Management, that your fellow practice managers will want to read.

Submit to: Lisa Neuman, Managing Editor E-Mail: lneuman@the-lynx-group.com UPM_73113

The Affordable Care Act

What to Expect in the “Affordable Care”…Continued from page 1 Figure. Traditional Alignment Strategies Models that fall short of employment • Managed care networks • Medical directorships • Joint ventures • Clinical comanagement agreements

• Service line management • Professional services agreements • Quality collaboratives • Accountable care organizations/ clinically integrated networks

Independent Alignment model options Employment Increasing integration Employment is not the only viable option

to payment systems and regulations. Based on the 2013 CMS fee schedules, urologists are facing a 2% reduction in reimbursement from Medicare. Federal pay cuts to radiology and pathology have amplified the threat to urologists by impacting revenues from patient care and from in-house ancillaries.

Although quality of care is generally not an issue for most physicians, the lack of adequate resources and infrastructure for tracking and demonstrating quality, as federally regulated, have proved to be challenging for most. Furthermore, shifts in focus among payers from volume to efficiency and outcomes have translated into greater financial and administrative burdens for private physicians. Urologists have realized such burdens when submitting urodynamics charges, in that Medicare will only reimburse for the professional components of some of these codes if there are written reports accompanying them. The sum of all these factors has painted a grim picture for most urologists, specifically those in private practice.

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Alignment Strategies Under the current climate, independent urologists can benefit from alignment strategies that drive providers to partner and collaborate

Shifts in focus among payers from volume to efficiency and outcomes have translated into greater financial and administrative burdens for private physicians. with other providers, thereby allowing for the pooling of resources and the eventual strengthening of their infrastructure, competitiveness, and financial health. Urologists in private practice can maintain their autonomy using several alignment strategies that fall short of employment. In addition, as the country

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ages, the need for urologic services will increase, indicating that demand will be sustained over the long-term.

However, workforce shortages and an aging physician population will make it more difficult for urologists to meet the demand. Alignment can offer urologists a resolution for taking full advantage of these opportunities and for leveraging with potential partners.

Although the idea of “strength in numbers” through consolidation and collaboration is continuing to grow in popularity and prevalence, some specialists may be caught short among these new alliances without careful planning and strategy development. Thus, it is pivotal for independent urologists to plan their overall strategy in the context of accountable care, in which alignment is used to meet the immediate organizational needs while building the foundation for the ultimate goal of clinical integration.

Alignment encompasses various structural constructs that bind the participating parties together on mutually agreed-upon goals and objectives. It represents the contracts and terms outlining the design of the relationship. These include the agreed-upon terms for governance, compensation, and legal structures that will make up the affiliation between the parties. These agreements ultimately build the foundation for integration. Fortunately for independent urologists, alignment can occur in multiple ways (Figure), and among various parties, not just physicians and hospitals. The strategies are flexible and diverse enough to meet the short-term goals of most providers while setting them up for achieving their long-term objectives, including the retention of their autonomy.

In provider-to-provider alignment, independent urologists may

The Affordable Care Act

decide to align with their peers.

Although recruitment may serve as the best solution for some smaller practices, other practices may want to grow into a large multispecialty clinic with extensive ancillary service offerings. Growing an existing practice is 1 form of alignment that is accessible to all practices, regardless of size, and it is practical for smaller practices because it requires little upfront capital; however, these strategies are seldom “one size fits all” and must be customized to the specific needs of the practice and its partner.

In a single-specialty practice, the strategy can include either a handful of providers in the same office or a large group of providers spanning multiple facilities. This expansion can begin through a gradual increase of providers within an existing practice or through a merger with 1 or more practices of the same specialty. The new group will share practice profits and at least some of the costs related to facilities, equipment, and employees. Similarly, for a multispecialty practice strategy, the development can occur through growth or through mergers; however, it is imperative for the new practice to have a strong primary care base, because these physicians will be the main vehicle for providing a continual stream of referrals to specialists within the practice.

Merging practices is a significant undertaking, requiring considerable planning and due diligence. The overall merger process is often divided into stages, with each stage having its own set of requirements and considerations. To ensure successful mergers, it is of the utmost importance to involve managers and physicians in the decision-making process and to formally educate all parties both before and after the transaction.

There are differences between a legal merger and a full operational merger. A legal merger is the devel-

Table 1. Potential Professional Service Agreement Arrangements Global payment professional services agreement The hospital contracts with the practice for services in exchange for a global payment rate, which includes all physician compensation and benefits as well as all practice overhead expenses. The practice retains all management responsibilities.

Practice management arrangement A hospital employs physicians; the practice entity is retained and contracts with the hospital for management services. The administrative management staff is not employed by the hospital because the practice provides these services via a management contract (ie, another agreement) and receives a corresponding fee.

Traditional professional services agreement A hospital contracts with physicians or their practice entity for professional services; the hospital employs staff and “owns” administrative structure.

Hybrid arrangements Various scenarios involving the mixing and matching of services (both professional and administrative).

opment of a new legal entity either through the actual establishment of a new organization or through practice A merging into practice B or vice versa. Conversely, an operational merger means that the operations of the merging parties are consolidated and the new entity is fully functional. A full merger can entail an initial legal merger phase followed by an operational merger that occurs over time.

Outside the realm of mergers, provider-to-provider alignment strategies can include managed care networks, medical directorships, and call coverage stipends. These models represent loosely formed alliances that are primarily for contracting purposes. They are all limited in ability, unless they become clinically integrated. In fact, managed care networks, which include independent practice associations and physician-owned hospitals, can be used as a platform for the development of accountable care organizations (ACOs), quality collaboratives, and clinically integrated networks/organizations. They can also help private practices grow

December 2013

(via alignment with other private practices) as either a single-specialty practice or into a multispecialty practice.

Physician-hospital alignment strategies are gaining momentum in the industry. For independent urologists, several of these alignment models can serve as viable options without compromising physician autonomy.

One such model worth considering is the clinical comanagement agreement (CCMA). These agreements are prevalent among specialty service lines, and they offer private physicians added revenue from professional and management services. When a CCMA occurs between a hospital and a practice, it offers a way for the hospital to strengthen its specialty service lines while partnering with a local practice.

Under a hospital-practice CCMA, the hospital contracts with a private practice for management services and clinical oversight for a specific service line. These physicians then receive hourly remuneration for their administrative time, with the opportunity to receive performance Continued on page 14

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The Affordable Care Act

What to Expect in the “Affordable Care”…Continued from page 13 Table 2. Accountable Care Era Strategies Strategy

Structure

Patient-centered medical homes

A primary care–based model in which a team of providers delivers patient-centric care across the continuum; part of an accountable care organization/clinically integrated network model

Quality collaboratives

Consortium of providers focused on furthering the quality outcomes for a defined population; accountable care organization–like qualities, but not limited to a specific payer

Clinically integrated networks and organizations

Interdependent healthcare facilities for a network with providers that collaboratively develop and sustain the Institute for Healthcare Improvement Triple Aim

Accountable care organizations

Participating hospitals, providers, and other healthcare professionals collaborating to deliver quality and cost-effective care to (predominantly) Medicare patient populations

incentives for reaching or surpassing several established criteria regarding care quality, efficiency, or patient satisfaction. A CCMA is a viable strategy for developing a strong hospital–physician relationship without engaging in any high-level affiliation agreements. In addition, this arrangement can position a practice and its partner to easily transition to a fully integrated alignment model, such as employment or a professional services agreement.

One of the greatest myths in the medical community has been that alignment is synonymous with employment. Most independent physicians were leery of aligning with hospitals because they feared that they would lose all of their autonomy to a hospital or healthcare system. However, the professional services agreement, also known as “employment lite,” allows physicians to achieve a high level of integration without having to become a “W-2” employee of a hospital.

The professional services agreement model is undeniably one of the most frequently used and recommended nonemployment alignment strategies. The professional services agreement has quickly come

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to the forefront because it exemplifies an affiliation between hospitals and physicians that falls short of employment but that provides enough of the aspects and benefits of the employment model. The beauty of this model is in its flexibility of design. There are 4 basic scenarios (Table 1, page 13) under which the professional services agreement falls, but there are endless variations for how it can be structured. Once either 1 or both of the parties decide on a professional services agreement model, the terms and conditions are memorialized by a professional services agreement document.

The global payment and traditional professional services agreements have the most applicability to private practices; however, the availability of all 4 models offers physicians boundless opportunities to customize the arrangement as they desire. Some physicians only want to be responsible for the clinical aspects of medicine. Engaging in a traditional professional services agreement with a hospital transfers the business aspect of the practice over to the hospital, which then manages the practice’s overhead and employs its support staff. Thus,

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these physicians, who continue to see their own patients as well as the hospital’s patients, now focus solely on productivity and performance without engaging in employment with the hospital.

Moreover, urology practices that provide services at multiple hospitals or healthcare systems can benefit most from the global payment professional services agreement by either contracting for professional services with each facility or by affiliating with just 1 but maintaining the ability to render services (and to bill) at all of them. A global payment professional services agreement is usually effectuated after a hospital engages a practice that then continues to employ physicians to provide comprehensive services through a professional services agreement. The practice is compensated on a global basis, and its independent practice structure is maintained. Essentially, the practice acts as an independent contractor to the hospital(s), and the physicians are still employed by their practice. A global payment professional services agreement serves as a comprehensive alignment strategy that does not encourage any fractioning of the practice. As

The Affordable Care Act

compensation, the practice invoices the hospital(s) for actual services rendered and is usually paid on a work relative value unit basis.

The overall alignment strategy can be a combination of various alignment options. Providers may engage in a professional services agreement model with a CCMA component and perhaps even potential “wraparounds” (ie, add-ons), such as medical directorships. These strategic formations are optimal for independent urologists who are seeking to stay independent and competitive. However, as noted earlier, alignment is just the first step of an organization’s accountable care strategy, and it should not be an organization’s terminal goal. The second step in the process is to develop an accountable care era strategy, which entails planning for a long-term response model that fits within an integrated delivery sys-

tem. Today, several of these “progressive” models exist and payers in both the federal and commercial arenas are piloting and/or encouraging their development through financial incentives or penalties.

Recently, the most notable integrated model is the ACO. However, other models are quickly gaining momentum both in the media and in the healthcare community. These collaborative alternatives include patient-centered medical homes, quality collaboratives, and clinically integrated networks/ clinically integrated organizations.

Table 2 (page 14) outlines the basic structures for each model. Although they have slight differences in structure, all of these organizations are patient-centric and focus on enhancing the patient experience of care, improving the health of the population, and reducing (or controlling) the cost of care. Private

practices and specialists are pivotal components within each of these structures. Through contractual agreements, independent urologists can choose to participate in only 1 or in multiple integrated delivery system structures. This route can serve as a potential response for independent urologists over the long-term.

Although risks and challenges exist for all models and strategies, doing nothing will have detrimental ramifications for independent physicians, especially as the traditional care delivery system proves to be ever more costly and unsustainable over time. Survival during these trying times will entail independent providers developing a strategic plan that responds to accountable care.

Consolidation and partnerships offer viable solutions to a number of challenges without compromising physician autonomy. l Health Information Technology

Keeping Up with IT Solutions

By Sandra Paton

A

ll practices are facing serious changes brought about by government and healthcare reform, some of which have not been fleshed out clearly enough.

In the midst of this flux, practice managers must assess their practice’s performance and needs and make decisions that will affect the continued health and financial success of their business operations.

Calling in a practice management consultant to help your practice wade through the mountains of healthcare reform regulatory requirements—as well as to help keep your practice abreast of normal industry changes,

identify opportunities for growth, and prevent potential disasters—is more of a necessity than a luxury these days.

But where do you go for guidance when it comes to determining the best electronic medical records (EMRs) or electronic health records (EHRs) for your practice? Even if you are already satisfied with your system(s), this is no time to relax. Constant surveillance of the ever-changing technological world should now be a part of your routine, particularly where reimbursement is concerned.

You might recall the old saying, “You are what you eat.” The adage for your practice today might be

December 2013

better expressed by saying, “You are what your data say.” If you have accurate charge and payment data, you are halfway there. When it comes to medical information technology (IT), how fast you can supply medical records, how accurate those records are, and how good your technical support is when problems arise all play a part in this picture.

To this end, we have listed and described a few EMR software systems that you can use in your practice. Bear in mind that change is occurring rapidly. So even if you are satisfied with your current system, Continued on page 16

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Health Information Technology

Keeping Up with IT Solutions…Continued from page 15 consider reviewing some of the other systems that may solve problems for your practice down the line. If IT demands are dogging your practice, keep this caveat in mind: “Keep up.”

The following “bytes” were adapted from a variety of reviews.

ADP AdvancedMD ADP AdvancedMD (www. advancedmd.com) offers a blog to help improve clinical documentation and facilitate coding for International Classification of Diseases, Tenth Revision, Clinical Modification.

The company recently released a whitepaper entitled, “A Case for EHR: 5 Status Quo Myths that Hold You Back and Reduce Your Bottom Line.” The idea was to urge practices to adopt change and overcome the myths that reduce their bottom line.

The 5 EHR myths outlined in the paper include: • Maintaining the existing paper chart system makes sense financially.

• Paper charge slips are the quickest and easiest way to enter visit charges.

• Lost charts, orders, and notes are an unavoidable part of a busy private practice.

• Electronic records are not as secure as paper patient files.

• Portability of patient records is a luxury reserved for large practices.

Allscripts Allscripts (http://clientconnect. allscripts.com) provides EHRs for private practices, hospitals, and other healthcare providers. Their services include electronic prescribing, care management, and revenue cycle management software. Their products are currently used by more than 180,000 physicians, 1500 hospitals, and 10,000 postacute care organizations.

Their website offers online client discussions (through “ClientConnect”),

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online learning modules, online issue or enhancement requests through their support team, web referrals, and a provider search through an extended-care database.

Benchmark Systems Benchmark Systems (www.bench mark-systems.com) offers cloud-based software featuring scheduling, EHR, practice management, and billing and collection services. Their templates are customizable and can be set up to function as your practice requires.

They also provide a patient portal

Even if you are already satisfied with your system(s), this is no time to relax. through which patients can access their own medical records, billing statements, and appointments. Their systems automatically receive and scrub coding information for billing and offer comprehensive revenue-cycle management services. Benchmark operates its own claims clearinghouse, complete with statement processing and electronic remittance management. A variety of administrative processes—such as billing and collection, scheduling appointments, and core accounting functions—can be outsourced to Benchmark’s “Virtual Practice Management Services.”

eClinicalWorks This software is designed for ambulatory care environments.

The system has been touted as usable and efficient, featuring single-click patient accessibility, mobile support, and a patient portal that allows patients to access their billing and scheduling. eClinical-

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Works (www.eclinicalworks.com) can be integrated into community or state-wide health record networks.

Their cloud-based EHR can be accessed by computer, smartphone, and tablets such as the iPad. They developed the “Care Coordination Medical Record” (CCMR), a platform that supports the components of accountable care. The CCMR provides population health data and health alerts; cost utilization dashboards; clinical quality measures specific to patient-centered medical home and accountable care organization measures; patient engagement via apps on smartphones and patient responses at the point of care; and a patient referral and consultation network.

Epic Systems This company (www.epic.com) offers a “one patient, one record” approach to simplifying administrative duties. Their “Single Billing Office”—a single bill and payment plan—simplifies accounting, administration, patient follow-up, and can streamline back-office staffing, not to mention that it offers convenience for patients. Patients can access their records via “MyChart,” where they can schedule appointments and access their test results.

An interoperable health diary can be connected to or disconnected from MyChart as required or desired. A “Call Management” feature stores patient information and service issues in a central location, allowing users to resolve inquiries from patients and analyzing your practice’s overall customer service effectiveness.

GE Healthcare Centricity EMR and Centricity Group Management Both products from GE Healthcare (www3.gehealthcare.

Continued on page 18

COE_vertical_fish_62212_Layout 1 7/9/12 12:47 PM Pa

FRee Continuing Education

Pushing Your Limits Scan Here to Register.

RegisteR today at www.coexm.com CALL FOR SUBMISSIONS! Do you have a practice management solution to share?

An answer to a problem with reimbursement, EMR implementation, medicare audits, or navigating the rules of the ACA?

SEND US YOUR SOLUTION! Submit a 1,000-2,000 word original, previously unpublished article to Lisa Neuman, Managing Editor, at lneuman@the-lynx-group.com

Health Information Technology

Keeping Up with IT Solutions…Continued from page 16 com) work together to coordinate practice management, while offering a single vendor for service and support. This system provides both clinical and financial management, from practice administration to EMRs, in large practices. It can integrate with medical devices, medical imaging, and other GE Healthcare products. The EMR is designed for community hospitals, academic medical centers, and integrated delivery networks. It features clinical, financial, and administrative software to help manage patient billing, revenue cycles, and closed-loop medication. The system is certified by the Certification Commission for Healthcare In­ formation Technology (CCHIT), an independent 501(c)(3) nonprofit organization whose mission is to encourage the adoption of interoperable health information technology. CCHIT certification ensures that an EHR has been thoroughly inspected for functionality, interoperability, and security of patients’ personal health information.

Greenway Medical Technologies PrimeSUITE PrimeSUITE (www.greenway medical.com/solutions/primesuite) was designed for easy adaptability to the existing workflow of any office.

It is based on a single database that supports all EHR and practice management requirements, ensuring the seamless flow of clinical, administrative, and financial data from one to the other (ie, from registration, scheduling, revenue cycle management, and reporting). Templates are customizable. There are currently 3500 clinical templates available.

Users have access to a “Clinical Content Library,” where they can share clinical information with their peers. Efficiencies have been recorded in coding improvements,

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elimination of transcription and chart expenses, and improved collections.

Constant surveillance of the ever-changing technological world should now be a part of your routine, particularly where reimbursement is concerned.

Kareo The Kareo EHR (www.kareo. com), designed by a practicing physician for use on the iPad and the web, can keep the physician connected to a patient during an examination while taking and building patient notes. The program is integrated with third parties for prescription and lab orders. It is certified by the Office of the National Coordinator–Authorized Testing and Certification Body (ONCATCB). The system permits transition between the mobile and web versions without restrictions. It was designed on a knowledge base by Epocrates to help physicians readily access clinical information.

MediTouch This EHR can be accessed as a web-based system and a touchscreen interface. It provides management for charting, medication, electronic prescribing, allergy checks, clinical orders, lab tests, and documents.

Forms are customizable. The system can be used as a stand-alone system or with HealthFusion’s practice management system. It is certified by the ONC-ATCB. The system is entirely

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hosted by HealthFusion (www.healthfusion.com), obviating installation or maintenance of software. It is accessed through a web browser, is usable on iPads, and is being touted as the fastest iPad EHR. It is provided via a monthly subscription, which includes all customer support and training.

meridianEMR and UroChartEHR Both systems were developed by HealthTronics (http://www.health tronics.com/physicians/it-solu tions/information-technology-solu tions-urologists) and offer technology solutions and research data solely for urologists. The meridianEMR system was designed by practicing urologists. It focuses on ease of use and total mobility, and it offers a library of customizable urology templates and content, including practice-level data analytics.

The UroChartEHR was built for speed and to withstand practical daily use. Preprogrammed data and terms were specifically developed for pelvic health practices to afford accurate notes and urology coding linked to office management systems. Economics analyses are built in. Data are backed by relationships with government, pharmaceuticals, clinical trial companies, and payers.

The system affords remote access for iPhone, iPad, and the web. It also offers integrated meaningful use tracking tools and support.

Conclusion Note there are many more options in the market and many specific to urology. Most companies offer resource and support centers.

Check with companies directly before making a decision about your practice’s needs. Do your homework in person and online and check with practices that are using the systems for real-world advice. l

Practice Management

Your Practice Management Software…Continued from page 1 can solve their practice management issues? All I am empowered to do is to help them use the software.”

Earlier in my career (before EMR), I heard someone call “practice management” software “billing” software and I remember being offended for some reason. I thought “billing” was such a narrow description of what practice management software did—but they were right.

That software is meant to deal with everything billing. It all comes down to billing—whether it is the actual billing/claims management itself, running reports to diagnose billing problems, or capturing recalls so patients are reminded to come in for a service and...get billed. Let me be clear that I am not saying that healthcare is all about billing. I am only saying that practice management software was developed to handle the financial side of the house.

Practice management software cannot “do” practice management.

It cannot figure out your workflow so you capture data in the most efficient way, and it cannot analyze your reports and tell you what to change to increase efficiency or decrease overhead. It certainly cannot tell you the best way to schedule, or how much to charge your self-pay patients. It is only a billing tool.

I have worked in healthcare long enough to have helped practices go from manual billing (you typed or hand-wrote claim information on a 1500 form and mailed it in) to their first practice management system. I did a lot of practice management consulting even though that’s not what I was there to do. I had to get them in shape on paper

so they could handle the software.

I had to get their workflow optimized so the software would make things better—not worse.

process so patients can register and check-in online, or at a kiosk in the practice.

But your practice management software cannot: Train staff to greet patients and make them feel welcome in the practice.

Practice management software cannot “do” practice management.

It cannot figure out your workflow so you capture data in the most efficient way, and it cannot analyze your reports and tell you what to change to increase efficiency or decrease overhead.

Mary Pat Whaley, FACMPE, CPC

Your practice management software can: Check the patient’s eligibility for active insurance coverage.

But your practice management software cannot: Automatically choose the correct insurance company/payer to attach to each patient account (one of the biggest problems I hear about in the field!).

Your practice management software can: Calculate the days since the patient’s last physical, the days left in a global period, or visits left in annual cap.

But your practice management software cannot: Help the patient understand their benefit plans and understand their financial responsibility.

What Your Practice Management Software Can and Cannot Do An implementation of practice management software is not intended to do anything but set up the system and train you to use it. Sometimes that perfectly rosy future the salesperson paints is nothing like the painful first steps (and cash-flow jam) of a new system. An implementation will not fix the issues that are existing in your practice that have nothing to do with the functionality of your billing system.

Conclusion Good practice management has a lot to do with attracting, training, coaching, and retaining the right staff, as well as providing them with the tools to do the job you hired them to do. Getting the software right is a must, but don’t expect your software trainers to be able to solve any of your staffing, communication, workflow, or cultural problems. That’s up to you, the practice manager. l

Your practice management software can: Automate your registration

To submit articles, contact Lisa Neuman at lneuman@the-lynx-group.com

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What’s Keeping You Up at Night?

By Robertson Payton

A

s if implementing the imperfect Affordable Care Act (ACA) and its demands on private and group practices (eg, training the front desk, collecting copays, determining deductibles, and identifying exchange patients) was not enough, many urologists—especially those not considering early retirement or leaving medicine altogether—are also examining the possibility of consolidating their practices via mergers or acquisitions. Faced with training staff for the transition to the International Statistical Classification of Diseases and Related Health Problems, Tenth Revision and avoiding heavy penalties for errors to partially fund the ACA, practices have to study and choose from an array of electronic medical records (EMRs) offerings and determine which is best for their respective practices.

As if this were still not enough, payer issues, designing and implementing inventory systems, benchmarking and identifying benchmarking sources, forming surgical specialty networks, and dealing with accountable care organization (ACO) penetration into the market are sure to steal some nights’ sleep from any conscientious practitioner. Who knew that practicing medicine would one day have required facility in accounting, office management, marketing, and insurance issues? Some of these topics were discussed at the 2013 Medical Group Management Association (MGMA) annual conference in San Diego, CA.

To Align or Not to Align Some practices might be in the process of examining the possibility of aligning with another medical group and setting up a practice “without walls,” where physicians from one practice would be free to join

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physicians in another practice across town, while remaining in the same system; retaining fee schedules; sharing a common EMR program; and integrating finances, markets, and payer mixes. Practices without walls are becoming a healthcare delivery system preferred by a growing number of physicians. The model builds on the best features of a traditional group practice, retaining each physician’s autonomy and practice identity, while offering legal and financial protection for the professional staff.

Problems might arise, however, if members do not share the same values and the same company culture.

Practices without walls are becoming a healthcare delivery system preferred by a growing number of physicians.

A practice in Montana attempted to partner with a hospital while retaining some autonomy (ie, remaining independent, but being owned by the hospital system). The hospital eventually bought many of the surrounding practices. The fear was that all of this practice’s patients would ultimately be a part of the hospital system, giving the hospital the upper hand and obliterating further attempts for the practice to remain independent.

After their primary care cohort formed a large independent practice association, urologists and other specialistsin several practices in Nashville, TN, were cast off to the side. The specialists joined forces and formed Health Innovation

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Specialists. The new partnership will collect and manage clinical data for practices ranging from orthopedic surgery and urology to obstetrics and neurosurgery. The group is investigating ways to move from a fee-forservice system to a value-based reimbursement system that will reward physicians who deliver high-quality care.

In the Dallas/Fort Worth, TX, metroplex, large systems are buying up independent physician practices at a prodigious rate. One of the most difficult aspects of this practice had been to keep employee turnover low.

When buyouts first began over the past few years, the annual turnover was approximately 25% (AU: When?

In 2012? 2013?), but increased communication with employees has decreased the turnover rate to 12%.

Many integrated practices that are being subsidized by hospitals, however, are already showing a loss in profits. In addition to trying to retain some degree of independence from the hospital, practices must also compete with other physician groups that are merging and attempting to control referrals in their market.

Through all of this, patient choice still plays a role in driving which practice will provide the healthcare.

Although physicians in a group might refer patients to urologists in the same group, a patient who has had a bad experience with a particular practitioner can seek care from another practice. Aligning with a hospital can help if reimbursements have diminished and Medicare continues to cut into costs. Physicians might initially negotiate elevated relative value units during discussions and negotiations with hospitals, but their leverage will ultimately come from hospitals banking on having surgical procedures being performed at their

Practice Administration

facilities. As the patient population grows and costs increase, however, reimbursements will decrease.

Having the data, sharing the data, and showing the data can help determine who comes out on top.

Collecting data is crucial to survival.

If you are not collecting data now, as one participant at the MGMA meeting noted, you won’t have to bother, because in 5 years, you will probably not be in business.

One urologic surgical specialist practice chose which ACOs to align with. The choice was determined by benchmarking based on internal quality measures. There are few census figures on prostate laboratories or vasectomy complications. Thus, it is important to capture data and use the data to show patients what you are doing and how well you are doing. Of course, doing this requires creating a system for collecting data. For example, it is important to create a database to illustrate the percentage of positive results of prostate biopsies. Instead of relying on numbers (eg, having 4-5 positive biopsies in a small practice or 20-30 in a larger practice), use percentages because that provides patients with a better picture of their results.

Another attendee at the MGMA meeting seconded the need for benchmarking: “Unless you can measure it, you cannot fix it.” He recommended using Trellis Healthcare’s InfoDive, a web-based intelligence solution that allows a medical practice to analyze its internal data and compare them with those of other practices.

Communicating with Primary Care Specialists fear that they are taking a back seat. This may be true, particularly because they are going full risk with patients through Medicare Advantage programs. Primary care physicians will seek specialists with whom they have good relationships and who provide high-quality care for their patients. This will ensure

continued referrals. The key to this is to control costs and to communicate with primary care physicians about what is happening with their patients. The primary care physician wants assurance that a patient who comes in on a Friday afternoon with a kidney stone will not be put in the hospital with morphine and be left there until Monday. The ideal is to keep the patient out of the hospital, to keep costs low, and to continue keeping the patient on the road to recovery whenever possible.

90-day window. Some therapies and treatments for radical postoperative surgeries are provided over a 90-day period. Numerous challenges abound at the moment, and many questions will remain unanswered.

The ACA requires plans to notify providers when members enter the grace period, but the ACA does not identify how plans must do this. If a healthcare plan provides electronic notifications or sends a postcard, it is not clear if either of these will qualify as a notification. Most plans will be high-deductible plans, so practices should attempt to collect what they can upfront for financial protection.

During the first 30 days of the grace period, plans will continue to pay claims and can seek recoupment for any claims they have paid. They will also be obligated to pay the federal government back for any subsidies they have received for a member during this period; however, if a patient does not pay his or her premium, providers cannot pay the bill during the grace period. After the grace period, patients become self-pay.

As one speaker at the MGMA meeting noted, there is nothing to prevent a patient from obtaining a plan and paying a premium for 1 month, living off the system for the next 3 months, losing that plan, moving to another plan, and playing the same game all over again. Conceivably, there is noth­ing to prevent a patient from paying 4 months of premiums for insurance in an entire year; consequently, this makes it all the more important to collect payments upfront.

Having the data, sharing the data, and showing the data can help determine who comes out on top.

Insurance Exchanges and Impact of the ACA An insurance representative at the MGMA conference claimed that dealing with exchange patients is straightforward: “It’s just another contract.” The decision to stay in or out of the exchange is up to the urology practice managers. The first step might be to determine who in your region will bear the weight of the insurance exchanges. The larger companies are most likely to lose. The key is to start training employees now about collecting upfront. Members might be noted as “active” over the 90-day grace period, even though their premiums have not been paid. Certain patients might require ongoing treatment and recurring visits either for surgical interventions or therapy. Costs associated with these are often quite high.

Determining whether to treat patients during this period is going to be problematic, and it opens a large concern for practices, particularly if treatment has already been provided within the

December 2013

Speak Now or Forever…

If practices have not had discussions with their groups about sending employees to the exchange, it is now getting late. Some employers may postpone making this decision for another year, but medical practices must make the decisions as soon as possible. Some urology practices are Continued on page 22

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PROVENGE® (sipuleucel-T) Suspension for Intravenous Infusion

Rx Only

BRIEF SUMMARY — See full Prescribing Information for complete product information

What’s Keeping You Up…Continued from page 21 seeking to set up health savings accounts (HSAs) and are allowing their employees to pick and choose what they want. Whichever route a practice chooses, it should be aware that premiums will continue to increase by 20%, 25%, or 30% annually. One practitioner at the meeting noted that her staff would be eligible to participate in buying insurance on the exchange. The practice then required its staff to go to the ACA website and determine their rates based on their income. The staff learned what the out-of-pocket (OOP) costs were for each plan (bronze, silver, and gold), the cost for premiums, and the allowable subsidy. Employees then compared these benefits with their current group plan, specific to their family members, their children, and their costs. In all cases, the OOP costs for a catastrophic event with the exchange were roughly double the amount the group plan would have required.

Unfortunately, as reimbursement declines, expenses increase, and pressure from the government continues, current plans might not prove sustainable in another year. Employees often take benefits for granted. They do not understand the value and can absolutely benefit from such teachable moments.

Seeking Solutions One practice joined a trust called the Multiple Employer Welfare Association to help control costs and premium increases. The practice noted a decrease in premiums associated with being part of the trust. Another group of urologists and radiation oncologists switched to a partially self-funded exclusive provider organization plan for benefits. The plan will offer a high deductible with an HSA component, where employees can make contributions.

Several participants urged piggybacking events onto large conferences. The American Urology Association encourages collaboration with smaller groups, such as the MGMA, the Financial Management Conference, and the Large Urology Group Practice Association, which is currently considering including small group practices.

Collaboration at this time is essential to starting the grassroots movement rolling. Urology-specific education on how to get things done and on why getting them done is important is sorely needed.

Collecting data and benchmarking must begin now if your practice will have a future. l

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INDICATIONS AND USAGE: PROVENGE® (sipuleucel-T) is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.

DOSAGE AND ADMINISTRATION • For Autologous Use Only.

• The recommended course of therapy for PROVENGE is 3 complete doses, given at approximately 2-week intervals.

• Premedicate patients with oral acetaminophen and an antihistamine such as diphenhydramine.

• Before infusion, confirm that the patient’s identity matches the patient identifiers on the infusion bag.

• Do Not Initiate Infusion of Expired Product.

• Infuse PROVENGE intravenously over a period of approximately 60 minutes.

Do Not Use a Cell Filter.

• Interrupt or slow infusion as necessary for acute infusion reactions, depending on the severity of the reaction.

(See Dosage and Administration [2] of full Prescribing Information.)

CONTRAINDICATIONS: None.

WARNINGS AND PRECAUTIONS • PROVENGE is intended solely for autologous use.

• Acute infusion reactions (reported within 1 day of infusion) included, but were not limited to, fever, chills, respiratory events (dyspnea, hypoxia, and bronchospasm), nausea, vomiting, fatigue, hypertension, and tachycardia. In controlled clinical trials, 71.2% of patients in the PROVENGE group developed an acute infusion reaction.

I n controlled clinical trials, severe (Grade 3) acute infusion reactions were reported in 3.5% of patients in the PROVENGE group. Reactions included chills, fever, fatigue, asthenia, dyspnea, hypoxia, bronchospasm, dizziness, headache, hypertension, muscle ache, nausea, and vomiting. The incidence of severe events was greater following the second infusion (2.1% vs 0.8% following the first infusion), and decreased to 1.3% following the third infusion. Some (1.2%) patients in the PROVENGE group were hospitalized within 1 day of infusion for management of acute infusion reactions.

No Grade 4 or 5 acute infusion reactions were reported in patients in the PROVENGE group.

Closely monitor patients with cardiac or pulmonary conditions. In the event of an acute infusion reaction, the infusion rate may be decreased, or the infusion stopped, depending on the severity of the reaction. Appropriate medical therapy should be administered as needed.

• Handling Precautions for Control of Infectious Disease. PROVENGE is not routinely tested for transmissible infectious diseases. Therefore, patient leukapheresis material and PROVENGE may carry the risk of transmitting infectious diseases to health care professionals handling the product. Universal precautions should be followed.

• Concomitant Chemotherapy or Immunosuppressive Therapy. Use of either chemotherapy or immunosuppressive agents (such as systemic corticosteroids) given concurrently with the leukapheresis procedure or PROVENGE has not been studied. PROVENGE is designed to stimulate the immune system, and concurrent use of immunosuppressive agents may alter the efficacy and/or safety of PROVENGE. Therefore, patients should be carefully evaluated to determine whether it is medically appropriate to reduce or discontinue immunosuppressive agents prior to treatment with PROVENGE. • Product Safety Testing. PROVENGE is released for infusion based on the microbial and sterility results from several tests: microbial contamination determination by Gram stain, endotoxin content, and in-process sterility with a 2-day incubation to determine absence of microbial growth. The final (7-day incubation) sterility test results are not available at the time of infusion. If the sterility results become positive for microbial contamination after PROVENGE has been approved for infusion, Dendreon will notify the treating physician. Dendreon will attempt to identify the microorganism, perform antibiotic sensitivity testing on recovered microorganisms, and communicate the results to the treating physician. Dendreon may request additional information from the physician in order to determine the source of contamination.

(See Warnings and Precautions [5] of full Prescribing Information.)

ADVERSE REACTIONS Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

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Table 1 Incidence of Adverse Events Occurring in ≥5% of Patients The safety evaluation of PROVENGE is based on 601 prostate cancer patients in the PROVENGE group who underwent at least 1 leukapheresis procedure in four randomized, Randomized to PROVENGE controlled clinical trials. The control was non-activated autologous peripheral blood PROVENGE (N = 601) Control* (N = 303) mononuclear cells.

The most common adverse events, reported in patients in the PROVENGE group at a rate ≥15%, were chills, fatigue, fever, back pain, nausea, joint ache, and headache. Severe (Grade 3) and life-threatening (Grade 4) adverse events were reported in 23.6% and 4.0% of patients in the PROVENGE group compared with 25.1% and 3.3% of patients in the control group. Fatal (Grade 5) adverse events were reported in 3.3% of patients in the PROVENGE group compared with 3.6% of patients in the control group.

Serious adverse events were reported in 24.0% of patients in the PROVENGE group and 25.1% of patients in the control group. Serious adverse events in the PROVENGE group included acute infusion reactions (see Warnings and Precautions), cerebrovascular events, and single case reports of eosinophilia, rhabdomyolysis, myasthenia gravis, myositis, and tumor flare.

PROVENGE was discontinued in 1.5% of patients in Study 1 (PROVENGE group n=341; Control group n=171) due to adverse events. Some patients who required central venous catheters for treatment with PROVENGE developed infections, including sepsis. A small number of these patients discontinued treatment as a result. Monitoring for infectious sequelae in patients with central venous catheters is recommended.

Each dose of PROVENGE requires a standard leukapheresis procedure approximately 3 days prior to the infusion. Adverse events that were reported ≤1 day following a leukapheresis procedure in ≥5% of patients in controlled clinical trials included citrate toxicity (14.2%), oral paresthesia (12.6%), paresthesia (11.4%), and fatigue (8.3%).

Table 1 provides the frequency and severity of adverse events reported in ≥5% of patients in the PROVENGE group of randomized, controlled trials of men with prostate cancer.

The population included 485 patients with metastatic castrate resistant prostate cancer and 116 patients with non-metastatic androgen dependent prostate cancer who were scheduled to receive 3 infusions of PROVENGE at approximately 2-week intervals. The population was age 40 to 91 years (median 70 years), and 90.6% of patients were Caucasian.

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

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

Control* (N = 303)

All Grades n (%)

Grade 3-5 n (%)

All Grades n (%)

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

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

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

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

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

All Grades n (%)

Grade 3-5 n (%)

All Grades n (%)

Grade 3-5 n (%)

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

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

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

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

37 (6.2) 36 (6.0)

0 (0.0) 2 (0.3)

22 (7.3) 23 (7.6)

1 (0.3) 2 (0.7)

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

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

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

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

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

Cerebrovascular Events. In controlled clinical trials, cerebrovascular events, including hemorrhagic and ischemic strokes, were reported in 3.5% of patients in the PROVENGE group compared with 2.6% of patients in the control group.

(See Adverse Reactions [6] of full Prescribing Information.)

To report SUSPECTED ADVERSE REACTIONS, contact Dendreon Corporation at 1-877-336-3736 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Dendreon Corporation Seattle, Washington 98101

REFERENCES: 1. PROVENGE [package insert]. Dendreon Corporation; June 2011.

2. Kantoff PW, Higano CS, Shore ND, et al; for the IMPACT Study Investigators. Sipuleucel-T immunotherapy for castration-resistant prostate cancer. N Engl J Med. 2010;363:411-422.

©2013 Dendreon Corporation.

All rights reserved. January 2013.

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

P-A-01.13-002.00

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IMMUNITY FROM

HASSLE Prescribe PROVENGE®(sipuleucel-T).

Dendreon ON Call will do the rest— • One-stop enrollment • Dedicated case managers coordinate treatment logistics • Benefit verification and patient assistance eligibility within 48 hours* • Coding, billing and reimbursement assistance

Phone: 1-877-336-3736 I Fax: 1-877-556-3737 Monday through Friday I 8:00 am to 9:00 pm ET www.PROVENGEreimbursement.com *Missing information may delay the 48-hour turnaround.

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.

©2013 Dendreon Corporation. All rights reserved.

October 2013. P-A-10.13-230.00

www.provengeHCp.com