Urology Practice Management July 2012 Volume 1 No2

UROLOGY PRACTICE MANAGEMENT ™

PROCESS IMPROVEMENTS TO ENHANCE PATIENT CARE™

www.UroPracticeManagement.com

Procedure Payment Reductions for Imaging Services: Implications for Urology Practice Administrators Sean M. Weiss, CCP-P, CCA-P, ACS-EM, CPC, CPC-P Vice President & Chief Compliance Officer DecisionHealth/Professional Services

S

ince 2001, physicians in solo and small group practices have seen a 7% annual reduction in reimbursement. Although the downward trend in reimbursement continues, costs continue to escalate. The change from the International Classification of Diseases, Ninth Revision (ICD-9) to the ICD-10 looms, bringing with it the financial burden associated with increased training and implementation. Individuals will be required to undergo 16 hours of coding Continued on page 8

VOLUME 1 • NUMBER 1

Letter to Our Readers Dear Colleague,

W

hat are the trends in Medicare Part D, and how can you guide your patients through them to an understanding of which plan is right for them based on its formulary and benefit design? How does specialty pharmacy impact your practice from a financial perspective? How can you assist your patients in accessing extra financial help if they

need it? How can you gain a working awareness of information technology (IT), and how can it improve your practice’s efficiency, productivity, and profitability?

With these questions we welcome you to the inaugural issue of Urology Practice Management, which is designed to deliver practical process and business solutions.

Urology Practice Management will acquaint Continued on page 7

Medicare Part D: Considerations for Urology Practices

By Kip Piper, MA, FACHE President, Health Results Group, LLC, Washington, DC

T

he Medicare Part D drug benefit has important implications for urology practices. As Part D continues to evolve, so do its challenges and opportunities. This article outlines some of the basic details of Medicare Part D, some of the challenges it poses, and some of the trends associated with it.

Today, the Medicare program provides $591 billion in healthcare services to 48

million beneficiaries. In 2012, Medicare benefits include $130.7 billion worth of physician services and $69.4 billion in prescription drugs.

To understand Medicare Part D—the Medicare prescription drug benefit—it is important to understand all 4 parts of Medicare, and how care is delivered through either fee-for-service (FFS) or plans. Medicare Part A proContinued on page 11

Pr is emi su er e

JULY 2012

©2012 Engage Healthcare Communications, LLC

ADRENALS

PROSTATE TUMOR TISSUE

TESTES

Important Safety Information Contraindications—ZYTIGA® may cause fetal harm (Pregnancy Category X) 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 hypertension, hypokalemia, and 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 because these patients were excluded from the randomized clinical trial. 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 has been reported in clinical trials 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—Increases in liver enzymes have led to drug interruption, dose modification, and/or discontinuation. 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.

Food Effect—ZYTIGA® must be taken on an empty stomach.

Exposure of abiraterone increases up to 10-fold when abiraterone acetate is taken with meals. 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 C max and AUC 0-∞ (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.

From the Editor

Mechanism of action ZYTIGA® is converted in vivo to abiraterone, an androgen biosynthesis inhibitor (ABI) that directly affects the androgen biosynthesis pathway by inhibiting CYP17 (17␣-hydroxylase/C17,20-lyase) — Consequently, androgen biosynthesis is inhibited at 3 sources of testosterone production: the testes, adrenal glands, and prostate tumor tissue Androgen biosynthesis inhibition with ZYTIGA® results in decreased levels of serum testosterone and other androgens

Proven survival benefit Results of the interim analysis of the pivotal phase 3 study*† showed a statistically significant improvement in overall survival (OS) in patients treated with ZYTIGA® plus prednisone compared with patients who received placebo plus prednisone (median OS: 14.8 months vs 10.9 months [hazard ratio (HR) = 0.646; 95% confidence interval (CI): 0.543, 0.768; P < 0.0001]) — This represents a 3.9-month difference/improvement in median OS In an updated analysis,‡ results were consistent with the interim analysis, with a 4.6-month difference/improvement in median OS with ZYTIGA® plus prednisone compared with placebo plus prednisone (median OS: 15.8 months vs 11.2 months [HR = 0.74; 95% CI: 0.638, 0.859])

ZYTIGA® (abiraterone acetate) in combination with prednisone is indicated for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) who have received prior chemotherapy containing docetaxel.

*Study Design: ZYTIGA®, in combination with prednisone, was evaluated in a phase 3, randomized, double-blind, placebo-controlled, multicenter

Janssen Biotech, Inc. © Janssen Biotech, Inc. 2012 3/12 08Z12069

THERAPY

study in patients with metastatic castration-resistant prostate cancer (mCRPC) who had received prior chemotherapy containing docetaxel (N = 1,195). Patients were randomized 2:1 to receive ZYTIGA® 1,000 mg orally once daily + prednisone 5 mg orally twice daily (n = 797) or placebo orally once daily + prednisone 5 mg orally twice daily (n = 398).

Patients were using a gonadotropin-releasing hormone (GnRH) agonist or were previously treated with orchiectomy and were at castration levels of testosterone (serum testosterone ≤ 50 ng/dL).1 The primary efficacy endpoint was overall survival. †552 events. ‡775 events.

08Z11121R3

Adverse Reactions—The most common adverse reactions (≥ 5%) are joint swelling or discomfort, hypokalemia, edema, muscle discomfort, hot flush, diarrhea, urinary tract infection, cough, hypertension, arrhythmia, urinary frequency, nocturia, dyspepsia, fractures and upper respiratory tract infection.

Drug Interactions—ZYTIGA® is an inhibitor of the hepatic drug-metabolizing enzyme CYP2D6. Avoid coadministration 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. Additionally, abiraterone is a substrate of CYP3A4 in vitro. Strong inhibitors and inducers of CYP3A4 should be avoided or used with caution.

Use in Specific Populations—The safety of ZYTIGA® in patients with baseline severe hepatic impairment has not been studied.

These patients should not receive ZYTIGA®.

ORAL

Reference: 1. de Bono JS, Logothetis CJ, Molina A, et al. Abiraterone and increased survival in metastatic prostate cancer. N Engl J Med. 2011;364(21):1995-2005.

Please see adjacent pages for brief summary of full Prescribing Information.

www.zytiga.com

ZYTIGA® (abiraterone acetate) Tablets Brief Summary of Prescribing Information.

INDICATIONS AND USAGE ZYTIGA in combination with prednisone is indicated for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC) who have received prior chemotherapy containing docetaxel.

CONTRAINDICATIONS Pregnancy: ZYTIGA may cause fetal harm when administered to a pregnant woman. 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, the patient should be apprised of the potential hazard to the fetus.

WARNINGS AND PRECAUTIONS Hypertension, Hypokalemia and Fluid Retention Due to Mineralocorticoid Excess: Use ZYTIGA with caution in patients with a history of cardiovascular disease. ZYTIGA may cause hypertension, hypokalemia, and fluid retention as a consequence of increased mineralocorticoid levels resulting from CYP17 inhibition [see Adverse Reactions and Clinical Pharmacology (12.1) in full Prescribing Information]. 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. The safety of ZYTIGA in patients with left ventricular ejection fraction <50% or NYHA Class III or IV heart failure has not been established because these patients were excluded from the randomized clinical trial. 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: Adrenocortical insufficiency has been reported in clinical trials 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: Marked increases in liver enzymes leading to drug discontinuation or dosage modification have occurred [see Adverse Reactions]. 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.

Food Effect: 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 17- and 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].

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].

Food effect [see Warnings and Precautions].

ZYTIGA® (abiraterone acetate) Tablets 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.

In a placebo-controlled, multicenter phase 3 clinical trial of patients with metastatic castration-resistant prostate cancer who were using a gonadotropin-releasing hormone (GnRH) agonist or were previously treated with orchiectomy, ZYTIGA was administered at a dose of 1,000 mg daily in combination with prednisone 5 mg twice daily in the active treatment arm (N = 791). Placebo plus prednisone 5 mg twice daily was given to control patients (N = 394). The median duration of treatment with ZYTIGA was 8 months.

The most common adverse drug reactions (≥5%) reported in clinical studies were joint swelling or discomfort, hypokalemia, edema, muscle discomfort, hot flush, diarrhea, urinary tract infection, cough, hypertension, arrhythmia, urinary frequency, nocturia, dyspepsia, fractures and upper respiratory tract infection.

The most common adverse drug reactions that resulted in drug discontinuation were aspartate aminotransferase increased, alanine aminotransferase increased, urosepsis and cardiac failure (each in <1% of patients taking ZYTIGA).

Adverse reactions and laboratory abnormalities related to mineralocorticoid effects were reported more commonly in patients treated with ZYTIGA than in patients treated with placebo: hypokalemia 28% versus 20%, hypertension 9% versus 7% and fluid retention (edema) 27% versus 18%, respectively (see Table 1). In patients treated with ZYTIGA, grades 3 to 4 hypokalemia occurred in 5% of patients and grades 3 to 4 hypertension was reported in 1% of patients [see Warnings and Precautions].

Table 1 shows adverse reactions due to ZYTIGA that occurred with either a ≥ 2% absolute increase in frequency compared to placebo, or were events of special interest (mineralocorticoid excess, cardiac adverse reactions, and liver toxicities).

Table 1: Adverse Reactions due to ZYTIGA in a Placebo-Controlled Phase 3 Trial ZYTIGA with Placebo with Prednisone Prednisone (N=791) (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 6 Arrhythmia 7.2 1.1 4.6 1.0 Chest pain or 7 chest discomfort 3.8 0.5 2.8 0 Cardiac failure8 2.3 1.9 1.0 0.3 1 2 3 4

Adverse events graded according to CTCAE version 3.0 Includes terms Arthritis, Arthralgia, Joint swelling, and Joint stiffness Includes terms Muscle spasms, Musculoskeletal pain, Myalgia, Musculoskeletal discomfort, and Musculoskeletal stiffness Includes terms Edema, Edema peripheral, Pitting edema, and Generalized edema

ZYTIGA® (abiraterone acetate) Tablets

ZYTIGA® (abiraterone acetate) Tablets

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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].

Includes all fractures with the exception of pathological fracture 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 Cardiovascular Adverse Reactions: Cardiovascular adverse reactions in the phase 3 trial are shown in Table 1. The majority of arrhythmias were grade 1 or 2. Grade 3-4 arrhythmias occurred at similar rates in the two arms. There was one death associated with arrhythmia and one patient with sudden death in the ZYTIGA arm. No patients had sudden death or arrhythmia associated with death in the placebo arm. Cardiac ischemia or myocardial infarction led to death in 2 patients in the placebo arm and 1 death in the ZYTIGA arm.

Cardiac failure resulting in death occurred in 1 patient on both arms.

Hepatotoxicity: Drug-associated hepatotoxicity with elevated ALT, AST, and total bilirubin has been reported in patients treated with ZYTIGA. Across all clinical trials, liver function test elevations (ALT or AST increases of > 5X ULN) were reported in 2.3% of patients who received ZYTIGA, typically during the first 3 months after starting treatment. In the phase 3 trial, patients whose baseline ALT or AST were elevated were more likely to experience liver function test elevations than those beginning with normal values.

When elevations of either ALT or AST > 5X ULN, or elevations in bilirubin > 3X ULN were observed, ZYTIGA was withheld or discontinued. In two instances marked increases in liver function tests occurred [see Warnings and Precautions]. These two patients with normal baseline hepatic function, experienced ALT or AST elevations 15 to 40X ULN and bilirubin elevations 2 to 6 X ULN. Upon discontinuation of ZYTIGA, both patients had normalization of their liver function tests and one patient was re-treated with ZYTIGA without recurrence of the elevations.

In clinical trials, the following patients were excluded: patients with active hepatitis, patients with baseline ALT and/or AST ≥ 2.5X ULN in the absence of liver metastases, and patients with ALT and/or AST > 5X ULN in the presence of liver metastases. Abnormal liver function tests developing in patients participating in clinical trials were managed by treatment interruption, dose modification and/or discontinuation [see Dosage and Administration (2.2) in full Prescribing Information and Warnings and Precautions]. Patients with elevations of ALT or AST > 20X ULN were not re-treated.

Other Adverse Reactions: Adrenal insufficiency occurred in two patients on the abiraterone arm of the phase 3 clinical trial (< 1%).

Laboratory Abnormalities of Interest: Table 2 shows laboratory values of interest from the phase 3 placebo-controlled clinical trial. Grade 3-4 low serum phosphate (7.2%) and potassium (5.3%) occurred more frequently in the ZYTIGA arm.

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Table 2: Laboratory Abnormalities of Interest in a Phase 3 Placebo-Controlled Clinical Trial Abiraterone (N=791) Placebo (N=394) All Grades Grade 3-4 All Grades Grade 3-4 Laboratory Abnormality (%) (%) (%) (%) High Triglyceride 62.5 0.4 53.0 0 High AST 30.6 2.1 36.3 1.5 Low Potassium 28.3 5.3 19.8 1.0 Low Phosphorus 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 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 was shown to inhibit the hepatic drug-metabolizing enzyme CYP2C8. There are no clinical data on the use of ZYTIGA with drugs that are substrates of CYP2C8.

USE IN SPECIFIC POPULATIONS Pregnancy: Pregnancy Category X [see Contraindications]. 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, the patient should be apprised of the potential hazard to the fetus and the potential risk for pregnancy loss. Women of childbearing potential should be advised to avoid becoming pregnant during treatment with ZYTIGA. 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: ZYTIGA is not indicated in children.

Geriatric Use: Of the total number of patients in a phase 3 trial of ZYTIGA, 71% of patients were 65 years and over and 28% were 75 years and over. No overall differences in safety or effectiveness were observed between these elderly patients and younger patients.

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 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F 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].

Manufactured by: Patheon Inc. Mississauga, Canada Manufactured for: Janssen Biotech, Inc. Horsham, PA 19044 Issued: May 2012

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In This Issue

PUBLISHING STAFF Publisher Cristopher Pires cris@engagehc.com 732-992-1896 Editorial Director Dalia Buffery dalia@engagehc.com 732-992-1889 Senior Vice President Nicholas Englezos nick@engagehc.com 732-992-1884

Letter to Our Readers ............................................................1 Sean M. Weiss, CCP-P, CCA-P, ACS-EM, CPC, CPC-P

Procedure Payment Reductions for Imaging Services: Implications for Urology Practice Administrators .........................................................1 Sean M. Weiss, CCP-P, CCA-P, ACS-EM, CPC, CPC-P

Medicare Part D: Considerations for Urology Practices....................................................................1

Associate Publisher American Health & Drug Benefits Maurice Nogueira maurice@engagehc.com 732-992-1895

Kip Piper, MA, FACHE

Project Manager John A. Welz john@engagehc.com 732-992-1525

Understanding Medicare Incentives and Payment Adjustments for e-Prescribing, PQRS, and Meaningful Use ............................................................17

Associate Editor Lara J. Lorton Editorial Assistant Jennifer Brandt jennifer@generaladminllc.com 732-992-1536 Production Manager Marie R. S. Borelli

AUA ANNUAL MEETING

By Sandra Paton

Improving Patient Throughput through Shared Services ....................................................................18 Managing the Transition to ICD-10 ....................................19 Implementing a Compliance Plan ....................................20

Quality Control Director Barbara Marino Business Manager Blanche Marchitto 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 Sean M. Weiss, CCP-P, CCA-P, ACS-EM, CPC, CPC-P Vice President & Chief Compliance Officer DecisionHealth/Professional Services

UPM0112-1

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

Urology Practice Management™, ISSN (requested), is published 2 times a year by Engage Healthcare Communications, LLC, 241 Forsgate Drive, Suite 205A, Monroe Township, NJ 08831. Copyright © 2012

by Engage Healthcare Communications, LLC. All rights reserved. Urology Practice Management™ is a registered trademark of Engage Healthcare Communications, LLC. No part of this publication may be reproduced or transmitted in any form or by any means now or hereafter known, electronic or mechanical, including photocopy, recording, or any informational storage and retrieval system, without written permission from the publisher. Printed in the United States of America.

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

Postmaster: Correspondence regarding subscriptions or change of address should be directed to CIRCULATION DIRECTOR, Urology Practice Management™, 241 Forsgate Drive, Suite 205A, Monroe Township, NJ 08831. Fax: 732-992-1881. Yearly subscription rates: 1 year: $99.00 USD; 2 years: $149.00 USD; 3 years: $199.00 USD.

UROLOGY PRACTICE MANAGEMENT

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Introduction Letter

Letter to Our Readers…Continued from page 1 you with engaging articles addressing the core vision of urology practice management and its execution—the systems, practices, forces, and “must-dos” required to meet the clinical, business, and policy criteria for success. The stakes are high. Urology practices are entering a space that was previously the exclusive province of oncologists, and they must understand the healthcare system as thoroughly as the pathophysiology and pharmacotherapy involved in treating patients. What’s more, you must be conversant in these matters to share them with your patients.

The articles in this journal will help you manage nuances of federal incentives and payment adjustments: e-prescribing, the Patient Quality Reporting System, electronic health records, and meaningful use. These articles will guide you in making the transition to the International Statistical Classification of Diseases and Related Health Problems, Tenth Revision (ICD-10) coding system, and we will help you understand its impact on measuring healthcare services, conducting public health surveillance, facilitating comparison of mortality and morbidity data, processing claims, identifying fraud and abuse, and conducting research.

This publication will show you a 4-phase plan to secure the financial well-being of your practice, one that will involve everyone in the practice—from senior executives to the medical staff, IT personnel, data users, clinical managers, and business associates. You will find here expert advice on setting aside a budget for consulting services, redesign, reprinting forms, data conversion, maintenance of dual systems, and the purchase of additional software, educational resources, and mapping tools to assist with the transition to the ICD-10. This journal will help you unlock the potential of IT to improve patient throughput, and help you keep abreast of Medicare rules and regulations for coding, fees, privacy, and fraud and abuse issues.

In short, Urology Practice Management is your guide to practice efficiency and clinical acumen through awareness of how to incorporate practice skills throughout your entire staff to keep your practice in compliance with clinical best practices and regulatory demands. Thank you for your interest in Urology Practice Management. We look forward to being there as your practice grows over the coming years.

Sincerely,

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

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Reimbursement 2.0

Procedure Payment Reductions…Continued from page 1

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training as required by the American Health Information Management Association. Practices that have withstood continued reimbursement decreases for more than a decade must now invest thousands of dollars in training to bring their employees up to speed on biomedical sciences, anatomy, physiology, pharmacology, and medical terminology to comply with the new coding system.

Adding further insult to injury, the Centers for Medicare & Medicaid Services (CMS) has expanded the Multiple Procedure Payment Reduction (MPPR) for 2012. The MPPR was initially designed to lower Medicare costs and improve efficiency by modifying payments for overlapping consecutive services. Medicare sought to reduce payment for subsequent procedures furnished to the “same patient by the same physician on the same day.”

Since 2006, Medicare has cut reimbursement on the technical component when multiple imaging services were conducted in the same session. The primary service was reimbursed 100%, and each subsequent service was reimbursed 50% of the allowable amount. This was primarily based on “expected efficiencies”: providing multiple imaging services in the same session and duplicating physician work in the pre- and postservice periods (ie, before the implementation of a service and after the same service).

As of January 1, 2012, Medicare applied a 25% MPPR on the professional component of advanced imaging services (ie, magnetic resonance imaging, computed tomography [CT] scans, positron-emission tomography, and ultrasound).

For multiple imaging services, practices are paid 100% of the first professional component of the service, and then 75% of the second and each successive professional service

provided. CMS was originally going to impose a 50% rate reduction, but it settled on a 25% reduction to the professional component. These services, which are already affected by the technical component, are now subject to a double reduction (on the professional component) for those who own their own equipment.

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physicians are engaged in rendering services, the MPPR will not be in effect. The professional component will not be reduced by 25%. As noted, however, if the same physician sees the same patient on the same day and does a multiple study related to the same condition, the MPPR will come into play, except when medical necessity applies.

Using Modifier -59 It is equally important A direct tie-in to the MPPR is profor urology practice cedure code modifier -59. CMS states, “In cases where the physician administrators to demonstrates medical necessity of furunderstand the financial nishing interpretations in separate and legal implications of sessions, use of the -59 modifier would be appropriate.” But here is the catch: their practice. it may not always be easy to deter-

CMS Rationale for the Reduction CMS identified a level of duplication in the professional component for second and subsequent advanced imaging services. After adjusting for preservice, postservice, and intraservice work, the total relative value unit reduction ranges from 27.3% to 43.1% for second and subsequent procedures.

Exceptions to the Rule One exception to the 25% professional service reduction should be of particular interest to urology practices. When a second and subsequent imaging service is furnished by the same physician in the same session, the MPPR is no longer applicable when a single code is billed for a combined CT of the pelvis and abdomen.

For operational considerations, CMS also does not apply the imaging MPPR to group practices when different physicians in a group see the same patient on the same day.

Thus, if you are a physician in a group practice in which multiple

mine whether a service was furnished in the “same” session, particularly in the case of the professional component. Thus, practices should be conservative in using the -59 modifier.

There will be opportunities to use the -59 modifier to bypass Medicare edits; however, CMS cautions, “The physician will need to exercise judgment to determine when it is appropriate to use the -59 modifier indicating separate sessions. We do not expect the use of the modifier to be a frequent occurrence.”

Of course, if you are audited, you can appeal. If you receive a letter from a recovery audit contractor, make sure you were actually paid for the service in question before you refund any money. Also make certain that the policy the recovery audit contractor is referring to was actually in effect when the service was rendered, because policies change. A local coverage determination provides insight into the carrier’s thought process and furnishes the approved ICD-9 code. Local coverage determinations will tell you what diagnoses will be covered by an insurance carrier. To use a diagnostic

Reimbursement 2.0

code, you must have a patient with that specific condition.

Medicare contractors will append the -51 modifier (used to denote >1 medical/surgical procedure being performed by the same physician on the same day at the same operative session) to take into account certain rules and to identify any reduction to the professional component and reduce global services as they do for technical services. They will append Claim Adjustment Reason Code 59 based on multiple or concurrent procedure rules (eg, multiple surgeries and concurrent anesthesia).

What Urology Practice Managers Should Know In addition to keeping abreast of medical developments, it is equally important for urology practice administrators to understand the financial and legal implications of their practice. When reimbursement is cut, the practice administrators must understand the charges for the services they render in their practice zip code. Merely using the insurance company fee schedule is inadequate.

Know how the fees are derived, what kind of usual and customary data these fees are based on, how many practices in the local market submit claims, and how many were calculated to determine the usual, customary, and reasonable data.

If practice administrators do not understand how fees are generated, they may not have the knowledge required to optimize contracts with payers to the practice’s best advantage. Certainly some payers will negotiate, and some will not. A caveat to all urology practice managers: be mindful of your contracts.

Be engaged in your practice. Avoid doing “business as usual.” Understand the carve-outs afforded to practices for services that are usually bundled, and become familiar with participation agreements.

Every penny counts these days.

Reimbursement 2.0 How to maximize available reimbursement • Understand the prevailing charges in the practice’s zip code • Understand how many claims were calculated in figuring the usual, customary, and reasonable data • Know the carve-out information • Know participation agreements How Medicare determines what to pay you The Medicare fee structure is based on the resource-based relative value scale.

Resources used for all services are divided into the following 3 components: • Physicians’ work (52% of total relative value) • Practice expenses (44%) • Professional liability insurance (4%) CMS arrives at a fee using geographically adjusted relative value units and a monetary conversion factor.

Collect copays and/or deductibles at the point of service. If a patient comes for an appointment with no money, have that person return with the money before services are rendered.

Generating statements can cost hundreds of thousands of dollars annually.

Every insurance company has national coverage determinations and local coverage determinations.

Understanding the local coverage determination is a “must” for coders or practice managers when appealing a claims decision. The local coverage determination provides a view of what is required to substantiate a level of service—what constitutes medical necessity, whether additional services are automatically bundled, and what modifiers come into play. Physicians can use local coverage determinations to argue against a rejection from an insurance company and to substantiate their eligibility for payment.

The American Medical Association (AMA) formed the Specialty Society Relative Value Scale Update Committee (RUC), an expert panel staffed by the AMA and specialty societies. The RUC panel speaks for physicians in a variety of specialties to help shape Medicare relative values and other items related to reimbursement involving CMS. The

July 2012

RUC is an independent group comprising 29 members who petition the federal government. The AMA described the RUC as “an expert panel of individuals exercising their judgment…not advocates for their specialty.” Urology practice administrators should know their RUC representative and keep abreast of updates from the committee. l

Resources Medical Group Management Association. Practice Management Solutions. www.mgma.com/practicemanagement-solutions.

American Urological Association.

Practice Management. www.auanet. org/content/health-policy/practicemanagement.cfm.

A complete list of codes subject to the MPPR on diagnostic imaging and examples of how payments are calculated in CR7442 (the official instruction issued to your carrier or A/B MAC on this issue): www.cms. gov/Regulations-and-Guidance/ Guidance/Transmittals/downloads/ R99 OTN.pdf.

For questions, contact your carrier or A/B MAC at their toll-free number, or go to www.cms.gov/Outrea ch-and-Education/Medicare-Learn ing-Network-MLN/MLNProducts/ index.html?redirect=/MLNProducts/.

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Prostate Cancer Prevention

Nonpharmacologic Strategies Have Mixed Results in Prostate Cancer Prevention

By Phoebe Starr

San Francisco, CA—Nonpharmacologic strategies for prevention of cancer are potentially attractive and costeffective, but success stories are few.

According to 2 separate studies presented at the recent Genitourinary Cancers Symposium, vigorous exercise prevented recurrence of prostate cancer and reduced mortality, whereas long-term vitamin E supplementation at commonly used doses actually increased the risk of prostate cancer in otherwise healthy men.

Value of Vigorous Exercise Men who exercised vigorously at least 3 hours per week had favorable changes in gene expression patterns in normal prostate tissue, according to June M. Chan, MD, University of California at San Francisco, and colleagues. This study builds on a previous study showing that vigorous exercise slowed the progression of prostate cancer and reduced the number of prostate cancer deaths.

“The favorable effects on gene expression may explain the protective effects of vigorous exercise,” Dr Chan said.

Vigorous exercise was defined as jogging, playing singles tennis, brisk walking, or any sustained exercise that accelerates the heart rate.

The study included 70 men diagnosed with low-risk prostate cancer who were treated with watchful waiting. Prostate biopsies were obtained at baseline. Men who reported vigorous exercise at least 3 times per week (N = 23) showed different expression in 184 genes in normal prostate tissue compared with men who did not do vigorous exercise (N = 47).

Upregulated genes included the known tumor-suppressor genes

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BRCA1 and BRCA2. Gene-set analysis demonstrated that cell cycle and DNA repair pathways related to cancer were positively modulated in the men who reported vigorous exercise at least 3 times per week versus those who exercised less. These favorable effects on genes and path-

Vigorous exercise slowed the progression of prostate cancer and reduced the number of prostate cancer deaths. “The favorable effects on gene expression may explain the protective effects of vigorous exercise.”

— June M. Chan, MD

ways were not found in men who reported engaging in any type of physical activity—but not vigorous exercise—3 times per week, or those who did not exercise.

The findings suggest that a certain threshold of intensity or duration of exercise may be important in reducing the risk of prostate recurrence.

Larger studies are needed to replicate its findings.

Long-Term Vitamin E Use May Increase the Risk for Prostate Cancer The large, National Cancer Institute–sponsored Selenium and Vitamin E Cancer Prevention Trial

I July 2012

(SELECT) suggests that healthy people should exercise caution in taking supplements without firm evidence.

Long-term follow-up of the SELECT trial showed that vitamin E 400 IU/day was associated with a 17% increased risk of developing prostate cancer when taken for 5.5 years by healthy men. The study also looked at the effect of selenium 200 mg/day alone or in combination with vitamin E, and found no increased risk of prostate cancer, as well as no benefit.

SELECT enrolled 35,434 men aged ≥55 years (aged >50 years if they were black) at more than 400 study sites across the United States, Puerto Rico, and Canada. At an interim analysis in 2008, selenium 200 mg/day and vitamin E 400 IU/day alone or in combination had no effect on preventing prostate cancer in otherwise healthy men. The trial was halted early, and subjects stopped taking both supplements, but follow-up continued to determine long-term effects.

Longer-term follow-up showed that for every 1000 men who took placebo, 65 cases of prostate cancer developed over 7 years. For every 1000 men who took vitamin E, 76 cases of prostate cancer developed.

Updated results were presented by Eric J. Klein, MD, of the Cleveland Clinic Foundation, OH. Dr Klein said that the supplement industry accounts for approximately $23 billion annually; approximately 50% of men aged >60 years take vitamin E, and approximately 23% take selenium for putative prevention of prostate cancer. SELECT suggests that taking vitamin E is in fact harmful, whereas taking selenium has no positive effect. l

Medicare Part D

Medicare Part D: Considerations…Continued from page 1 vides inpatient hospital and postacute services. Medicare Part B covers physician services, other outpatient services, and physician-administered drugs and biologics. Part B is optional, but approximately 95% of beneficiaries elect to participate. Medicare beneficiaries have the choice of receiving their Part A and Part B services through a FFS basis or through Part C. Part C is more frequently known as Medicare Advantage. Medicare Advantage plans are like HMOs and PPOs that cover all Part A and Part B services.

In 2012, approximately 27% of Medicare beneficiaries receive Part A and Part B benefits through Medicare Advantage plans.

The Medicare prescription drug benefit (ie, Medicare Part D) was established in 2006 to provide access to outpatient prescription drug coverage for all Medicare beneficiaries. Like Part B, participation in Part D is voluntary. However, the Part D benefit is delivered through plans only. Unlike Part A and Part B, there is no FFS option for Part D drug coverage. Medicare beneficiaries must select a drug plan through which they receive Part D coverage.

Urologists and urology practice administrators should remain particularly aware of the availability of drugs frequently taken by patients in the practice, because each Part D plan can have different coverage and costsharing requirements.

Medicare Drug Plans There are 2 Medicare prescription drug plans. If Medicare patients elect to receive Part D drug coverage and wish to receive Part A and Part B benefits through the traditional government-run FFS system, they may choose from numerous stand-alone prescription drug plans. Prescription drug plans are at risk only for Medicare-covered outpatient drugs.

The average Medicare beneficiary has approximately 30 different drug plans and benefit designs to choose from.

If Medicare beneficiaries enroll in the Part D benefit but wish to receive their other Medicare benefits—Part A and Part B—through a

Most Medicare Part D enrollees pay a monthly premium and are subject to an annual deductible, copayments, and a coverage gap (described below). However, approximately 11 million low-income Medicare beneficiaries receive subsidies to cover most or virtually all Medicare Part D costs. Of these individuals, approximately 7 million are also enrolled in their state’s Medicaid program and thus may also receive all Medicaidcovered services. The other 3 million or so beneficiaries are enrolled in subsidy programs designed to substantially reduce costs for low-

Medicare Advantage health plan, they may sign up for the Medicare Advantage prescription drug plan of their HMO or PPO. In 2012, approximately 32.7 Americans are enrolled in Medicare Part D. Approximately 66% of them are enrolled in stand-alone prescription drug plans, and 33% receive Part D benefits through a Medicare Advantage drug plan.

July 2012

income beneficiaries who do not qualify for full Medicaid benefits.

Rules Regarding Drugs Often Used in Urology Practices Medicare Part D is available to everyone who is eligible to Kip Piper, MA, FACHE enroll in Medicare— individuals aged ≥65 years, those with permanent disabilities, and those with end-stage renal disease.

This also includes all individuals who already are enrolled in Medicare Part A or Part B. Urologists and urology practice administrators should remain particularly aware of the availability of drugs frequently taken by patients in the practice, because each Part D plan can have different coverage and cost-sharing requirements.

Part D formularies are devised with an eye toward the appropriate use of pharmacologic agents and cost. Stand-alone Part D plans may be particularly sensitive to drug cost, because they are at risk for pharmacy expenses alone. Unlike stand-alone Part D plans, Medicare Advantage plans also provide medical benefits, and therefore are potentially able to realize hospital-related and other net medical savings from improved medication therapy.

Urologists and urology practice administrators can provide additional value to their patients by keeping abreast of approved drugs on health plan formularies in their coverage area. Drugs such as oxybutynin or tamsulosin, for example, are likely to be covered in most plans, because they are inexpensive and available in generic formulations; however, there may be more effective agents available. If solifenacin, a branded agent, Continued on page 12

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Medicare Part D

Medicare Part D: Considerations…Continued from page 11 Table 1. Enrollment Considerations for Urology Patients

Patients should be instructed to: • Make a list of all prescription medications they are taking, including chemotherapy agents • Examine the plan options carefully, because the plan premiums, drug coverage, and patient cost-sharing can vary substantially • Check the Medicare plan finder for health, prescription drug, and Medigap plans (www.medicare.gov/find-a-plan/) to see which of the patient’s prescription drugs are on the formulary of the plan of their choice. If patients do not have access to a computer, conducting the search for them will facilitate their being able to afford a necessary drug later and will help ensure compliance • Speak with their urology practice administrator, especially if they are unsure whether a drug they are taking is covered by a specific plan • Obtain the prescribed drug from a pharmacy that participates in the network of the patient’s Medicare Part D plan. Often, Part D enrollees may also use a mail-order pharmacy service offered by their drug plan

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is available under a patient’s Part D plan, it may require prior authorization or step therapy, because of a higher unit cost. In addition, quantity limitations might apply, based on how much can be dispensed to patients during a specific amount of time (eg, 30 days). Thus, it is important to be aware of the availability on health plan formularies of drugs commonly prescribed by your practice and of limitations imposed on drugs by specific plans, such as prior authorization, step therapy, and quantity limitations.

Before your patients enroll in a Medicare prescription drug plan, encourage them to first determine whether they are eligible for the plan and whether the plan is suitable for their needs (Table 1). Urge them to secure a list of prescription drugs covered by the plan and to determine the cost of the prescription drugs that they take in the plan.

Patients receiving medication for a chronic condition should be urged to find a plan that will offer them continued use of a necessary drug at a reasonable cost and without undue restrictions on quantity. If monthly quantity limitations become an issue (usually with mail-order pharmacies), it may be necessary to prescribe smaller quantities of a drug that could be filled at a local retail pharmacy. To ensure adherence to therapy, practice managers should have a system in place to provide timely prescriptions when necessary to prevent patients from going without their medications.

Medicare prescription drug coverage is also available to patients who have joined or remain in a Medicare Advantage plan that provides all Medicare benefits, including outpatient drug coverage.

Be aware that if a patient is enrolled in a Medicare plan that pro-

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vides prescription drug coverage and then enrolls in a stand-alone (ie, drug only) prescription drug plan, the patient will be disenrolled from their Medicare Advantage plan and returned to Medicare FFS for Part A and Part B services. This may have consequences for the patient, because many Medicare Advantage plans offer lower premiums or other cost-sharing features—sometimes with added benefits—than traditional FFS Medicare.

Medicare prescription drug plan enrollees must choose a specific benefit option (offered by private insurers) to help pay for their prescription drugs. The annual open enrollment period occurs between November 15 and December 31. Joining or changing a current plan can be done only during the open enrollment period.

The plan a patient chooses will become effective on January 1. For further information on Medicare enrollment periods, urology practice administrators should direct patients to www.medicare.org/medicare-basics/ 23-medicare-basics/287-medicareenrollment-periods.html.

Encourage your patients to read their plan coverage carefully on annual renewal or to bring questions about drug coverage to your attention, because changes can occur that may affect their coverage or choice of drugs, such as formulary changes or changes related to plan premiums, deductibles, copayments, and member pharmacies where prescriptions can be filled. All of these issues can affect your patients’ ability to pay for medications, and, ultimately, their adherence to the treatment plan.

Educate Patients on How Medicare Part D Works Some of your patients may have questions about the Medicare prescription drug benefit. By answering patient questions and serving as a

Medicare Part D

knowledgeable source of information, you have an opportunity to improve patient satisfaction and retention.

A potential customer should first review the prescription drug formulary that lists which drugs a plan covers to be sure his/her current drugs are on that insurer’s formulary.

Educate patients about what to look for in a plan, such as: • The formulary (the list of prescription drugs covered by the insurer) • The premium (monthly fee for the plan) • The deductible (amount you must pay before your plan begins to pay for drugs); no plan may have a deductible higher than $320 (in 2012); some plans have no deductible • The copay (amount you must pay toward the cost of each prescription you fill) • The member pharmacies that can fill the patient’s prescriptions • The coverage gap, the amount of extra coverage provided during the “doughnut hole.”

Explain How a Formulary Works The formulary lists drugs that are covered by a Part D plan. Plans are often flexible with regard to benefits with cost-sharing. Levels of costsharing tend to vary for generic, preferred drugs, and nonpreferred drugs.

Each Medicare drug plan— whether a stand-alone or a Medicare Advantage plan—is required to cover at least 2 outpatient drugs in every therapeutic class. In addition, these plans are required to cover all drugs in the following 6 drug classes when they are prescribed according to their approved indication: 1. Anticonvulsants 2. Antidepressants 3. Antineoplastics 4. Antipsychotics 5. Antiretrovirals

Table 2. Drugs Not Covered by Medicare Part D

• OTC drugs (however, some Medicare Advantage plans offer limited OTC coverage) • Prescription vitamins and minerals • Certain antiseizure and antianxiety drugs (barbiturates and benzo-diazepines will be covered in 2014) • Fertility drugs • Erectile dysfunction drugs (when used to treat sexual or erectile dysfunction) • Drugs for weight loss, weight gain, or anorexia • Cosmetic and hair growth drugs • Cough and cold medications • Drugs covered under Medicare Part A or Part B OTC indicates over the counter.

6. Immunosuppressants for the treatment of transplant rejection.

Patients should be alerted to check not only the formulary but also the formulary tiers of each plan they are considering, because this affects the cost of each drug. Remind patients that drugs in a lower tier will cost less than drugs in a higher tier. However, if the urologist prescribes a drug in a higher tier, your patient may be able to ask the drug plan for an exception or arrange for a lower copayment.

A formulary finder (available at www.medicare.gov) can help patients determine whether the drugs they need are on a plan’s formulary.

The Epocrates website (www.epo crates.com) provides current tier and step therapy information.

Alert patients when they are already taking drugs that are not covered by Part D (Table 2). Some of these drugs may be covered for individuals with Medicaid. For Medicaid and Medicare/Medicaid dual-eligibles, direct patients to their state Medicaid program to see which drugs are covered. Again, be sure patients have checked online for drugs covered specifically in their

July 2012

state (www.medicare.gov).

Patients or prescribers must contact the drug plan before certain prescriptions can be filled. All drugs must be medically necessary, and quantity limits on how much medication can be purchased at one time will apply. Quantity limits usually apply for self-administered drugs.

Part D covers all commercially available vaccines and all drugs deemed necessary to prevent illness; however, each plan varies regarding which drugs are considered preventive.

Chemotherapeutic Agents Chemotherapeutic agents require special attention from a coverage perspective. Infused agents are typically covered under Medicare Part B, not Part D. Medicare Part B covers 80% of the cost, and patients pay 20% for the duration of infused chemotherapy. If the Medicare patient is also enrolled in Medicaid, the state Medicaid program will cover the 20% copay. As noted, other low-income Medicare beneficiaries may apply through their Social Security office for special programs, under which Medicaid pays Continued on page 14

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Medicare Part D

Medicare Part D: Considerations…Continued from page 13 for some or all of Medicare Part A and Part B cost-sharing on a sliding scale, based on income.

However, Medicare Part D, not Part B, typically covers oral chemotherapies that have no infusion equivalent. There may be substantial patient cost-sharing associated with oral agents, which may quickly bring patients to the coverage gap, when the patient must pay 100% of the drug cost, as discussed below.

What Is the Coverage Gap? Under Medicare law, Part D plans have a temporary limit on coverage for prescription drugs. This limit is called a “coverage gap,” also known as the “doughnut hole.” The coverage gap begins after a plan has spent a certain amount of money for drugs covered in the plan on a beneficiary.

Because each Part D plan varies, urology practice administrators

Accessing Dedicated Help Physicians Physicians can access dedicated help for Medicare drug benefit questions at PRIT@ cms.hhs.gov. A regular conference call has been established at 2 PM (ET) on Tuesdays at 1-800-619-2457. Use the pass-code RBDML. Patients Call 1-800-MEDICARE or visit www. medicare.gov/find-a-plan/questions/ home.aspx to access the plan finder.

Physicians can get information about local organizations and personally direct their patients by visiting www.eldercare.gov.

Low-Income Patients or Patients with No Computer Access Patients requiring financial help should be directed to call the Social Security Administration at 1-800-772-1213 or to visit www.socialsecurity.gov/prescription help to fill out an application.

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should instruct their patients to call their plan to get information about the coverage gap.

In general, when the patient and the insurer pay a combined total of $2930 in 2012 drug spend, the coverage gap comes into play. After spending an additional $4700 out of pocket (OOP), or $6658 in total drug costs under the standard benefit, the plan once again pays a share of the drug cost. These amounts are updated annually.

Closing the Coverage Gap Under the Affordable Care Act, the Part D coverage gap will be gradually reduced until total beneficiary cost-sharing for brand-name and generic drugs purchased during the coverage gap reaches 25% by 2020.

This is funded through a combination of a new, mandatory 50% discount provided by branded drug manufacturers and increased federal government subsidies for both branded and generic drugs.

For beneficiaries in the coverage gap, branded drugs are discounted by 50% in 2012. Starting in 2013, the federal government will begin to further subsidize the cost of brandname drugs. Specifically, Medicare will provide an additional 2.5% discount in 2013 and 2014. This added discount—in addition to the 50% discount provided by drugmakers— will increase until it reaches 25% in 2020 and after.

By 2020, the combined discounts from manufacturers and the government will amount to 75%. Medicare Part D beneficiaries will be responsible for the remaining 25%, which is the same amount of cost-sharing as in the initial coverage phase. As with brand-name drugs, the beneficiary will be responsible for the remaining 25% of the cost of a generic drug plus the dispensing fee.

Although the patient in the cov-

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erage gap pays only 50% of the cost of a branded drug in 2012, the entire pharmacy price of the drug will count as an OOP expense. This helps to remove patients from the coverage gap faster. However, patients must continue to pay any applicable pharmacy dispensing fee.

While in the coverage gap, Medicare Part D patients receive a 14% discount on the cost of generic drugs in 2012. Medicare will cover an additional 7% in subsidies annually until, in 2020 and thereafter, the subsidy reaches 75% of the cost of generic drugs in the coverage gap.

When requirements and cost thresholds of the coverage gap are met, “catastrophic coverage” begins, meaning that patients will pay only a small coinsurance or copayment for covered drugs for the remainder of the year (5% or $2.60 for generic or preferred multisource drugs and the greater of 5% or $6.50 for all other drugs in 2012).

Medicare Part D enrollees who are also enrolled in Medicaid (ie, dualeligible) are exempt from Part D premiums, deductibles, and the coverage gap, and they have lower copayments. They are also exempt from all other Medicare cost-sharing, including Part B premiums and the deductible, and the 20% copayments for physician services and physician-administered drugs.

How Your Patients Can Save Money during the Coverage Gap Patients have several options to help them manage prescription drug costs during the coverage gap:

1 2

Switching to generic or lowercost drugs where possible Using a mail-order pharmacy

Medicare Part D

3

Applying for Medicaid—Medicare Part D enrollees who are also enrolled in Medicaid are exempt from Part D premiums, deductibles, and the coverage gap, and they have lower copayments

4

Checking out pharmaceutical assistance programs: many leading drug manufacturers offer such programs for people enrolled in Medicare Plan D; to determine whether this program is offered by the manufacturers of the drugs your patients take, suggest that they visit www.medicare.gov/pharmaceuticalassistance-program/index.aspx

5

Seeking assistance from a possible state pharmaceutical assistance program (www.medicare.gov/pharma ceutical-assistance-program/stateprograms.aspx)

erage/PrescriptionDrugCovGenIn/ bridgingthegap.html, or call 1-800MEDICARE.)

800-772-1213. The National Patient Advocate Foundation (www.npaf. org) or the National Organization for Rare Disorders (www.raredis eases.org) might also help patients in need of assistance with drug costs.

Are Your Patients Qualified for Extra Help?

Patients who are unable to continue taking necessary medications because of cost may qualify for a government-sponsored Extra Help pro-

Specialty Tier for High-Cost Drugs Some higher-cost drugs are included in what is called a “specialty tier.” Although enrollees can request an exception when a plan designates a drug as nonpreferred, exceptions cannot be made for drugs in the specialty tier. Cost-sharing for drugs listed in the specialty tier typically is approximately 25% coinsurance but may be as high as 50%.

As of 2007, all drugs that cost >$500 per month were eligible for the specialty tier. Today, some drugs on the specialty tier cost >$1000 per month. The objective of the specialty tier is to limit the liability of plans to pay for expensive drugs, because these drugs are not eligible for exceptions requests from enrollees.

Although the use of the specialty tier has increased annually, there are concerns that the specialty tier may limit patient access to prescription drugs. As a result, in 2010, New York became the first state to prohibit the use of specialty drug tiers. Several states are in the process of following suit. Specialty drugs are used by 2% of Americans, but these drugs are expected to account for 40% of total drug spending by 2014.

Your patients are likely to have significant OOP costs for their medications. Using medication therapy management programs can help control drug costs.

6

Continuing to use the Medicare drug plan each time they fill a prescription to ensure they are getting the correct coverage and manufacturer discounts; this will count toward OOP costs

7

Exploring national and community-based charitable programs that might offer financial help with drug costs (www.benefitscheckup.org)

8

Contacting Social Security about qualifying for the Extra Help program to help pay for prescription drugs.

OOP costs that contribute to the maximum threshold and therefore help patients move out of the coverage gap include: • The annual deductible • Costs of drugs • Coinsurance or copayments • Manufacturers’ discounts • Any fees paid during the coverage gap.

(For more information, see “Bridg ing the Coverage Gap,” www.cms.gov/ Medicare/Prescription-Drug-Cov

gram. Individuals earning less than $16,335 (single) or less than $22,065 (married, with no other dependents) in 2012 may qualify for the prescription drug low-income subsidy. Rules vary from state to state, and there also may be restrictions based on a person’s cash resources in savings or checking accounts.

Individuals who are already enrolled in state Medicaid programs or Supplemental Security Income benefits will automatically qualify for the Extra Help program and need not apply for the benefit.

Extra Help will subsidize the individual’s Part D premium as well as his/her copayments, coinsurance, and deductibles and will be required to pay anywhere from $1 to $6 for each drug. Patients who qualify for Extra Help will not experience a coverage gap.

Individuals can apply for the Extra Help program online (www.ssa.gov/ prescriptionhelp/) or by calling 1-

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Controlling Drug Costs: Medication Therapy Management Strategies Your patients are likely to have significant OOP costs for their medications. Fortunately, using medication therapy management (MTM) programs can help control drug costs. MTM services can improve patients’ quality of life and ensure cost-effectiveness and appropriate Continued on page 16

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Medicare Part D

Medicare Part D: Considerations…Continued from page 15 utilization of drugs by enrollees.

In early 2007, the Agency for Healthcare Research and Quality published the results of a survey of 70 health insurance plans, covering 12.1 million Medicare enrollees. The survey findings show that among the most frequently offered plan services are patient education programs (75%); patient adherence (70%); and medication review (60%) by a pharmacist or by a physician.

Where tiered benefits apply, some services may only apply to a subgroup of enrollees. These services include information provided by mail (used by 75% of plans surveyed), telephone (used by 90.4% of plans with in-house telephone services), or face-to-face interactions with clinicians (used by 19% of plans). The last method proved the most effective. The MTM can be provided by a pharmacist—as they are in 95% of the cases—in cooperation with physicians and directed to beneficiaries; however, 47.6% of programs employ nurses, and 14.3% use physicians.

Patients taking several prescription medications for >1 chronic condition should contact their drug plan to see if they are eligible for an MTM. Part D requires that healthcare providers or pharmacists provide counseling to enrollees with chronic conditions who must use multiple medications. Part of this initiative works to ensure that your patients choose plans that will provide them with continued access to necessary prescription drugs and help them take their medications properly to reduce adverse events.

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ers and a federal effort to simplify beneficiary choices by narrowing the number of complex benefit designs offered by each insurer. Nonetheless, Medicare beneficiaries have an average of 31 stand-alone prescription

The marketplace for Medicare health plans and drug plans is highly competitive. To increase enrollment, Part D plans have changed their benefit structures and premium design. Most drug plans now offer a no-deductible option and have replaced coinsurance with a tiered copayment for covered drugs.

Trends in Medicare Part D In 2012, there are fewer standalone prescription drug plans than there were in 2006, because of merg-

drug plans to choose from, in addition to multiple Medicare Advantage plans that offer all Medicare services, including Part D coverage.

The marketplace for Medicare health plans and drug plans is highly competitive. To increase enrollment, Part D plans have changed their benefit structures and premium design. Most drug plans now offer a no-deductible option and have replaced coinsurance with a tiered copayment for covered drugs. By 2020, the “doughnut hole” will be substantially reduced.

Although it is a generous drug

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benefit, Medicare Part D remains extraordinarily complex for all of those concerned—patients, physicians, pharmacies, plans, and manufacturers. Patients will require continued guidance through the Part D maze. In addition, like the rest of Medicare, Part D will likely see frequent legislative and regulatory changes in the future.

Urology practice administrators can play an important and valuable role in the Medicare Part D process by helping patients navigate the system and identify plans that will cover necessary drugs, prioritizing the drugs on their patients’ regimens, and being proactive during the appeals process. l Acknowledgment

Sandra Paton contributed to the development of this article.

Patient Resources Epocrates. www.epocrates.com.

Medicare.gov. Understanding Medicare enrollment periods. www.medicare.gov/publications/ Pubs/pdf/11219.pdf.

Medicare Part D prescription drug plan and Medicare Advantage plan finder tutorial. www.q1 medicare.com/PartD-Medicare_ PartDPlanFinderTutorial.php.

Medicare Prescription Drug Coverage (Part D). www.medicare. gov/navigation/medicare-basics/ medicare-benefits/part-d.aspx# CoverageGap. My Medicare Matters. www.my medicarematters.org/.

Social Security. Extra help with prescription drug plan costs. www.socialsecurity.gov/prescrip tionhelp.

AUA Annual Meeting

Understanding Medicare Incentives and Payment Adjustments for e-Prescribing, PQRS, and Meaningful Use

By Sandra Paton

Atlanta, GA—The American healthcare system continues to transform as payers seek to contain costs and increase quality, all while adapting to the significant changes mandated under the Affordable Care Act. Many initiatives supported by the Centers for Medicare & Medicaid Services (CMS), including electronic prescribing (e-prescribing), the Physician Quality Reporting System (PQRS), and electronic health record (EHR) meaningful use guidelines, have been instituted in an effort to place the healthcare delivery system on the pathway to higher quality, fewer medical errors, and cost-efficiency. As we move toward 2013, a shift is taking place in these voluntary programs, with waning incentive amounts and increasing penalties for organizations that do not meet minimum thresholds for performance.

At the 2012 American Urological Association (AUA) annual meeting, Rosemarie Nelson, MS, Principal at MGMA Healthcare Consulting Group, and Rick Rutherford, Director of Practice Management at the AUA, delineated procedures and explained how incentive payments and penalties apply for each of these programs.

e-Prescribing Practices are now obligated to use e-prescribing for their Medicare patients. The penalty for not doing this will gradually increase from 1% in 2012 to 1.5% in 2013 and to 2% in 2014. Penalties are assessed the year after the reporting year; for example, a practice not meeting the minimum threshold of reporting 10 times during

the first 6 months of 2012 will incur a 1.5% penalty in 2013.

Many practices use e-prescribing through their EHR (as opposed to a stand-alone e-prescribing system).

For e-prescribing through the EHR, the submission of the G-code (G8553) on the Medicare claim form is required. Practices cannot earn both e-prescribing incentives and meaningful use incentives in the

G-code, (2) to a qualified Physician Quality Reporting registry, (3) to CMS via a qualified EHR product, or (4) to a qualified PQRS vendor.

To be eligible for an incentive payment, practices must report on a minimum of 3 applicable measures if reporting individual measures, or select at least 1 measures group for reporting. Registration is not required for practices to begin reporting e-prescribing and PQRS data. For the PQRS, there is a group practice reporting option for practices with ≥25 providers. Larger practices electing this option are required to report a minimum of 29 quality measures and to submit this information through a web-based interface (available at www.cms.gov).

Mr Rutherford observed that “About half the people who report on Medicare Part B claims [receive] an incentive. And about 80% of those who report to a registry receive an incentive. The AUA has recently negotiated a contract with CE City, where we have created a urology registry. As members of the AUA, you are entitled to use it for a discounted fee. It’s a tool you should consider for PQRS.”

“As members of the AUA, you are entitled to use it for a discounted fee. It’s a tool you should consider for PQRS.” —Rick Rutherford

same year. In addition, earning a meaningful use incentive does not preclude being penalized for e-prescribing deficiencies. Ms Nelson estimated that the penalty to an average urology practice for such deficiencies would be approximately $4500 in 2013 (for the 2012 reporting date).

Meaningful Use The PQRS will shift away from an incentive-based program beginning in the 2013 reporting year, with practices not meeting the minimum standards in 2013 receiving a 1.5% penalty on their Medicare reimbursement in 2015. Penalties can be mitigated to some degree by participation in the Maintenance of Certification program—practices that do so can earn an incentive of 0.5%. l

The PQRS The PQRS remains a voluntary Medicare program for reporting on certain aspects of patient care, including prevention, chronic and acute care, procedure-related care, resource utilization, and care coordination.

When reporting, quality data codes can be submitted in several ways: (1) on Medicare Part B claims using the

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AUA Annual Meeting

Improving Patient Throughput through Shared Services

By Sandra Paton

Atlanta, GA—All practices seek to increase productivity and patient satisfaction. Sean M. Weiss, CCP-P, CCA-P, ACS-EM, CPC, CPC-P, Vice President and Chief Compliance Officer, DecisionHealth Professional Services, offered a route to further increasing operational efficiency, productivity, and reimbursement through what are called “shared services,” all of which are associated with a common controlling factor: time.

At the 2012 American Urological Association annual meeting, Mr Weiss reviewed the operational efficiencies that could help urology practice administrators maximize their reimbursements. Shared services will bring providers to a new level of productivity, improve patient satisfaction with the visit, and ensure that the education patients receive is comprehensive.

There are 2 types of shared or group setting services—shared medical appointments (SMAs) and drop-in group medical appointments (DIGMAs). The ultimate purpose of the SMA or DIGMA is to free physicians’ time for more individual visits and for being on the hospital floor.

When providers have more time to educate their patients, it ensures that the patients will become more proactive in their own health and will increase their compliance with treatment modalities.

An SMA usually accommodates 8 to 12 patients with similar conditions, such as incontinence or benign prostate hyperplasia. Such groups typically run for an average of 90 minutes, allowing clinicians sufficient time to educate patients in

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a single group setting, perhaps twice daily, instead of in 8 to 12 individual appointments.

The DIGMA is used for acute patient encounters or an unannounced emergency. Scheduling SMAs and DIGMAs should reflect the time actually needed for the type of encounter. A patient care team, typically consisting of nurses and

“Every single E/M service is stored in your practice management system, and at any time in the year, this gives you an opportunity to see how many of each service you are running out. Figure out your numbers. Then, implement a program like the SMAs.” —Sean M. Weiss, CCP-P, CCA-P, ACS-EM, CPC, CPC-P

administrative personnel, should obtain and/or verify patients’ insurance information, record vital signs, and register participants to officially record that the encounter took place. During the meetings, only the physician and the nurse should remain in the room, to comply

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with HIPAA (Health Insurance Portability and Accountability Act) regulations.

The process permits patients and their families to network with other patients who share a common issue and to form an additional support network. In addition, SMAs free up valuable spots for scheduling other patients and result in higher productivity and reimbursement. Holding these group meetings over a minimum 6-month period allows patients to bond with each other and the staff.

Documentation must be accurate and specific. Practices must identify the total number of patients present, the date of the visit, and the total amount of time for the visit (in minutes), as well as provide a complete description of the topics that are covered. Billing for prolonged evaluation and management (E/M) services is done by using an add-on code (ie, a code added to regular E/M services that is based on unit or floor time).

Each level of service a practice bills must be coded accurately. Practice managers are encouraged to have audits conducted to ensure that service encounters are billed correctly.

Mr Weiss encouraged the audience to “run one of your productivity reports. Every single E/M service is stored in your practice management system, and at any time in the year, this gives you an opportunity to see how many of each service you are running out. Figure out your numbers. Then, implement a program like the SMAs. I guarantee you, [the difference] will be night and day.”

He emphasized that “these programs are intended to bring operational efficiencies into practices.” l

AUA Annual Meeting

Managing the Transition to ICD-10

By Sandra Paton

Atlanta, GA—The International Classification of Diseases, Ninth Revision (ICD-9) is slated to be replaced by ICD-10, the tenth revision of this coding system, which was first adopted 17 years ago by the United Kingdom and has since been adopted by France, Australia, Germany, and Canada. The change to ICD-10 is conservatively estimated to cost between $425 million and $1.15 billion, unless there are further delays in the implementation. The ICD-10 will replace the ICD-9-CM (Clinical Modification) volumes 1 and 2, whereas the ICD-10-PCS (Procedural Coding System) replaces the ICD-9-CM volume 3, but only for billing hospital inpatient procedures.

At the 2012 American Urological Association annual meeting, Susanne Talebian, CHBC, RMM, CMOM, CUA, CPC, PCS, CCS-P, a certified healthcare business consultant with Healthcare Business Solutions, Ltd, described some of the reasons for the change and some of the challenges it poses.

The new coding system is expected to improve the government’s ability to measure healthcare services, to conduct public health surveillance, and to facilitate comparison of morbidity and mortality data, processing claims, and the identification of fraud and abuse. ICD-10 will also help to ensure the integrity of our clinical data for use in regulatory issues, reimbursement, research, and outcomes management.

ICD-10 will allow practices to create combination codes (eg, connect diabetes with neuropathy and con-

nect an injury code with the cause of the injury). One of the challenges associated with the new system is the tremendous increase in the number of codes. Whereas the ICD-9 has 13,000 codes, ICD-10 will have more than 68,000 codes. Ms Talebian observed that “more than

claims, and identifying fraud and abuse.”

Because everyone—from front desk to clinical providers and senior executives—will be affected by this change, it is important to encourage universal “buy in” and prepare early for the transition, Ms Talebian advised. Urology practice administrators are encouraged to begin talking now with insurance companies to see what changes will occur, and how those changes will affect their practices. Initially, “there will be no immediate changes in reimbursement, but local coverage rules will need to change.”

Having systems in place correctly and in a timely manner may help avoid an audit by a recovery audit contractor (RAC). Urology practice administrators should ensure that the numbers on their computers are correct, and that they are solidly supported by accurate medical documentation. Because RACs can data mine computers electronically, practices should conduct internal audits and spot checks before the need for an audit is signaled.

Practices should also set aside a budget for consultation services, redesign, reprinting of forms, data conversion, maintenance of dual systems, and the purchase of additional software, educational resources, and mapping tools that are necessary for the transition. In short, proceed with haste in preparing for the transition by analyzing your needs, implementing a plan, setting up a budget, and training staff. The current compliance date is October 1, 2013. l

“More than 25,000 codes will now tell us between left and right.

This provides us with better data for making clinical decisions, measuring care to patients, tracking public health, conducting research, processing claims, and identifying fraud and abuse.”

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

25,000 codes will now tell us between left and right. This provides us with better data for making clinical decisions, measuring care to patients, tracking public health, conducting research, processing

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Implementing a Compliance Plan

By Sandra Paton

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Atlanta, GA—L. Michael Fleischman, FAAHC, a principal with Atlanta-based Gates, Moore, and Company, urged practice managers to identify key areas of compliance and seek authoritative guidance when implementing a compliance plan for their practices at the 2012 annual meeting of the American Urological Association.

The federal government is serious about fraud and abuse, recovering $4.1 billion in fines related to Medicare and Medicaid alone in 2011. The government is seeking to recoup even more money through the Healthcare Enforcement Action Team, which is funded under the Affordable Care Act, Mr Fleischman said. These actions are jointly sponsored by the US Department of Justice and the US Department of Health and Human Services (HHS).

The largest areas of concern for medical practices involve fraud and abuse of Medicare/Medicaid and noncompliance to rules promulgated by the Health Insurance Portability and Accountability Act (HIPAA), the Occupational Safety and Health Administration (OSHA), and the National Labor Relations Board.

To be compliant, it is imperative to identify goals for establishing approved uniform standards of conduct for physicians and support staff, to implement internal controls that encourage practice adherence to federal and state laws, and to ensure the accuracy of all patient documentation. Conducting a baseline audit shortly after a compliance plan is established and performing “spot checks” should be done routinely.

“The goal of compliance plans is to

make sure everybody understands the issues. Internal controls must be in place that adhere to all the local, state, and federal guidelines,” Mr Fleischman stressed. “Communication is critical. All staff [must] be on board and not be afraid to speak up when they see things that are wrong.

Routine training is also critical.”

Any audit results should be disclosed to physicians, business partners or owners, and legal counsel, especially if corrective action is necessary. Practice administrators should ensure that all personnel are credentialed for the services they perform and that all patient inquiries or complaints are handled sensitively and in a timely manner.

Billing compliance is essential. Bill only for services rendered. Employ a certified coder to avoid fines associated with incorrect coding. Adhering to financial policies as outlined in the compliance manual is essential.

Physicians should be sure that billing strictly describes services rendered, documentation is adequate and legible, and that Medicare payments are properly assigned or reassigned.

Be aware of HIPAA changes, because HIPAA has expanded to include business associates, who are required to notify individuals and the HHS Secretary of unsecured protected health information breaches (ie, “unauthorized acquisition, access, use, or disclosure of protected health information which compromises the security and privacy of such information”). In many cases, HIPAA violations result from the loss of a laptop computer that contained unencrypted patient data. If a violation involves more than 500 people, it must

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be reported to the media.

The impact of OSHA is increasingly felt. More than 100 compliance safety officers have been hired recently, and they are conducting random inspections. The scope has been expanded beyond the workplace, and fines have increased. According to David Michaels, Assistant Secretary of OSHA, the tactic is “regulation by shaming” through “hard-hitting press releases.” The number of press releases has increased from 161 in 2008 to 588 in 2011.

Compliance with federal and state regulations is an element of performance evaluation. When issues arise, be proactive: • Notify the compliance officer, the compliance committee, and your legal counsel • Conduct an internal investigation by talking with all relevant personnel, and document everything—but not necessarily on paper • Any paper documentation will become admissible evidence • Analyze your position with regard to laws, regulations, and requirements • Above all, avoid destroying critical documents • When necessary, fix the problem and refund money, document everything, and begin disciplinary action • Report the problem to federal and/or state authorities before they approach you • To avoid penalties and disciplinary action against your practice, keep abreast of the rules and regulations for Medicare, coding, fees, and fraud and abuse issues. l

INDICATION and IMPORTANT SAFETY INFORMATION about ZYTIGA® (abiraterone acetate) INDICATION ZYTIGA® (abiraterone acetate) in combination with prednisone is indicated for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) who have received prior chemotherapy containing docetaxel.

IMPORTANT SAFETY INFORMATION

Please see brief summary of Prescribing Information on adjacent pages.

© Janssen Biotech, Inc. 2012

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Contraindications ZYTIGA® (abiraterone acetate) may cause fetal harm (Pregnancy Category X) 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 hypertension, hypokalemia, and 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 because these patients were excluded from the randomized clinical trial. 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 has been reported in clinical trials 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 Increases in liver enzymes have led to drug interruption, dose modification, and/or discontinuation. 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.

Food Effect ZYTIGA® must be taken on an empty stomach. Exposure of abiraterone increases up to 10-fold when abiraterone acetate is taken with meals. 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.

Adverse Reactions The most common adverse reactions (≥5%) are joint swelling or discomfort, hypokalemia, edema, muscle discomfort, hot flush, diarrhea, urinary tract infection, cough, hypertension, arrhythmia, urinary frequency, nocturia, dyspepsia, fractures and upper respiratory tract infection.

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. Additionally, abiraterone is a substrate of CYP3A4 in vitro. Strong inhibitors and inducers of CYP3A4 should be avoided or used with caution.

Use in Specific Populations The safety of ZYTIGA® in patients with baseline severe hepatic impairment has not been studied. These patients should not receive ZYTIGA®.

Our goal is to make access to ZYTIGA®(abiraterone acetate) simple, convenient, and easy.

Support for you:

Support for your patients:

Benefit Investigation

Care Coordination

• Rapid assessment of patient eligibility/coverage • Prior authorization support • Concise benefit summary • Identification of specialty pharmacy provider

• Access to the ZytigaOne™ Instant Savings Program • Referral to a patient assistance program • Coordination with SPP for processing/delivery of medication • Educational materials and prescription reminders

Take advantage of ZytigaOne™ Support today.

1-855-ZYTIGA-1 (998-4421) Monday–Friday, 8:00 AM–8:00 PM ET Single-Source Support for Access to ZYTIGA® Also available online at janssenaccessone.com

Please see Indication, Important Safety Information, and Brief Summary of Prescribing Information on adjacent pages.

Patient insurance benefit investigation is provided as a service by TheraCom, LLC and The Lash Group, Inc., under contract for Janssen Biotech, Inc. In this regard, TheraCom, LLC, and The Lash Group, Inc., assist healthcare professionals in the determination of whether treatment could be covered by the applicable third-party payer based on coverage guidelines provided by the payer and patient information provided by the healthcare provider under appropriate authorization following the provider’s exclusive determination of medical necessity.

Importantly, insurance verification is the ultimate responsibility of the provider. Third-party reimbursement is affected by many factors. Therefore, TheraCom, LLC, The Lash Group, Inc., and Janssen Biotech make no representation or guarantee that full or partial insurance reimbursement or any other payment will be available. This information is provided as an information service only. While TheraCom, LLC, and The Lash Group, Inc., try to provide correct information, they and Janssen Biotech make no representations or warranties, expressed or implied, as to the accuracy of the information. In no event shall TheraCom, LLC, The Lash Group, Inc., or Janssen Biotech or its employees or agents be liable for any damages resulting from or relating to the services. All providers and other users of this information agree that they accept responsibility for the use of this service.

Janssen Biotech assumes no responsibility for, and does not guarantee the quality, scope, or availability of the services including but not limited to reimbursement support services, patient education, and other support services. Each provider, not Janssen Biotech, is responsible for the services they provide. These support services have no independent value to providers apart from the product and are included within the cost of the product. © Janssen Biotech, Inc. 2012

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