Urology Practice Management - VOLUME 1 • NUMBER 2

UROLOGY PRACTICE MANAGEMENT ™

PROCESS IMPROVEMENTS TO ENHANCE PATIENT CARE®

www.UroPracticeManagement.com

SEPTEMBER 2012

VOLUME 1 • NUMBER 2

The Role of Specialty Test Your Knowledge of Group Pharmacy in Urology Purchasing Organizations: Fact

By Atheer A. Kaddis, PharmD Senior Vice President, Sales and Marketing, Diplomat Specialty Pharmacy, Flint, MI

U

rology encompasses many subspecialties, such as pediatric urology, male infertility, and renal transplantation, among others; however, it is the subspecialty of urologic oncology that is having a profound impact on the future of urology as a specialty.

Urologic oncology focuses primarily on malignancies such as prostate cancer, kidney cancer, bladder cancer, and testicular cancer, all of which specialty pharmaceuticals have a place in their therapy.

There is also a rich drug development pipeline that will offer additional specialty pharmaceutical treatment options in the future. The impact of specialty pharmaceuticals on urology is expected to continue to grow.

Continued on page 7

or Fiction?

Interview with Cheris Craig, MBA, CMPE Chief Administrative Officer, Urology of Greater Atlanta, LLC

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avvy urology practices can effectively leverage the buying power of group purchasing organizations (GPOs). An experienced practice administrator who knows the ins and outs of GPOs can save the practice money and

contribute to employee satisfaction.

Urology Practice Management (UPM) recently asked Cheris Craig, Chief Administrative Officer at Urology of Greater Atlanta, LLC, to discuss her experience and insights regarding GPOs. Continued on page 12

Transitioning to ICD-10 — Implications for Urology Practices

By Susanne Talebian, CUA, CPC, CUC, CCS-P, CMOM, PCS, RMM Certified Healthcare Business Consultant, American Health Information Management Association–Certified ICD-10-CM/PCS Trainer

O

n October 1, 2013, the International Classification of Diseases, Ninth Revision (ICD-9) medical classification code sets used to report diagnoses are scheduled to be replaced by the International Classification of Diseases,

Tenth Revision, Clinical Modification/Procedural Coding System (ICD-10-CM/PCS).

The World Health Organization (WHO) first endorsed the ICD-10 in 1990 and released the full version in 1994. The WHO owns and publishes the classification, and has sanctioned its use and adaptation by the US government; therefore, all modifications of the ICD-10 must conform to WHO conventions. The current version incorporates new concepts, representing the ICD-9-CM modifications from 2003 to 2011 and the ICD-10 modifications from 2002 to 2010.1 The ICD-10-CM has been used to code and classify mortality data from death cerContinued on page 14

©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 Senior Vice President Nicholas Englezos nick@engagehc.com 732-992-1884 Associate Publisher Cristopher Pires cris@engagehc.com 732-992-1896 Editorial Director Dalia Buffery dalia@engagehc.com 732-992-1889 Associate Publisher American Health & Drug Benefits Maurice Nogueira maurice@engagehc.com 732-992-1895 Project Manager John A. Welz john@engagehc.com 732-992-1525 Associate Editor Lara J. Lorton Editorial Assistant Jennifer Brandt jbrandt@the-lynx-group.com 732-992-1536 Production Manager Marie R. S. Borelli Quality Control Director Barbara Marino Business Manager Blanche Marchitto

FEATURES The Role of Specialty Pharmacy in Urology........................1

By Atheer A. Kaddis, PharmD

Test Your Knowledge of Group Purchasing Organizations: Fact or Fiction? ..............................................1 Interview with Cheris Craig, MBA, CMPE

Transitioning to ICD-10 — Implications for Urology Practices....................................................................1

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

Renewing Your Practice’s Insurance Coverage: Tips for the Practice Administrator ....................................18

By Rick Janss, MBA, CMPE

DRUG CODING

Medications Used for the Treatment of Prostate Cancer....................................................................21 Navigating the Medicare Part D Exception Process ................................................................24

By Sandra Paton

Timely and Accurate Billing..............................................26 Interview with John McMann, MS

AUA ANNUAL MEETING

By Sandra Paton

AUA Practice Management Highlights ..............................30

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.

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Urology Practice Management™, ISSN (requested), is published 2 times a year by Engage Healthcare Communications, LLC, 1249 South River Road, Suite 202A, Cranbury, NJ 08512. 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™, 1249 South River Road, Suite 202A, Cranbury, NJ 08512. Fax: 732-992-1881. Yearly subscription rates: 1 year: $99.00 USD; 2 years: $149.00 USD; 3 years: $199.00 USD.

UROLOGY PRACTICE MANAGEMENT

I September 2012

Specialty Pharmacy

The Role of Specialty Pharmacy inâ&#x20AC;ŚContinued from page 1 This article will provide an overview of specialty pharmaceuticals that are currently prescribed in urology practices, specialty pharmaceuticals that may have a place in therapy within urology and are currently in drug development, and of the support that specialty pharmacies may provide urologists.

kidney cancer. In fact, combination chemotherapy has been shown to cure testicular cancer in most cases.

Although chemotherapy agents are also considered specialty pharmaceuticals, there has been no greater impact of specialty pharmaceuticals on urology than the introduction of leuprolide acetate (Lupron Depot) in 1985 for the palliative treatment of patients with advanced prostate cancer. Leuprolide acetate was the first hormonal treatment for advanced prostate cancer approved by the US Food and Drug Administration in more than 40 years, and it quickly became the most frequently used injectable hormone therapy for prostate cancer in the United States.

Since the introduction of leuprolide acetate, we have experienced the introduction of additional specialty pharmaceuticals for the treatment of

preparation or distribution site, and restricted locations for medication administration. In regard to complex treatment maintenance, these pharmaceuticals require personalized dosing, dosage adjustments, and treatment protocols, as well as clinical management, to closely monitor for serious side effects and adherence issues.

Specialty pharmaceuticals typically cost more than $600 per patient per month.1 Specialty pharmaceuticals exceeded $100 billion in spending in the United States as of 2010, and it is expected that the growth in spending on specialty pharmaceuticals is expected to trend at more than 25% annually.2

What Are Specialty Pharmaceuticals?

Although there is no consensus on the definition of a specialty pharmaceutical, there is general consensus on the characteristics that describe specialty pharmaceuticals, which include difficult medication delivery, complex treatment maintenance, and high cost.1 In regard to the characteristic of difficult medication delivery, these pharmaceuticals typically require special handling, including strict temperature control, restricted medication

The Impact of Specialty Pharmaceuticals on Urology Chemotherapy has been used for more than 4 decades to treat conditions such as testicular cancer and

Continued on page 8

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

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

James A. Sylora, MD Urologist AUSâ&#x20AC;&#x201C;Midwest Urology Evergreen Park, IL

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

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

Rick Janss, MBA, CMPE Practice Administrator Clinical Urology Associates Gadsden, AL

September 2012

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Specialty Pharmacy

The Role of Specialty Pharmacy inâ&#x20AC;ŚContinued from page 7 Table 1. Specialty Pharmaceuticals Available for the Treatment of Prostate and Kidney Cancers

Cancer type Prostate

Drug

I

Approved use

Dose

Docetaxel (Taxotere)

Intravenous

Hormone-refractory metastatic prostate cancer

75 mg/m2 with oral prednisone 5 mg twice daily

Abiraterone (Zytiga)

Oral

Metastatic castrationresistant prostate cancer in patients who have previously received docetaxel

1000 mg once daily with prednisone 5 mg twice daily

Cabazitaxel (Jevtana)

Intravenous

Hormone-refractory metastatic prostate cancer in patients previously treated with docetaxel

25 mg/m2 intravenously every 3 wks with prednisone 10 mg daily

Sipuleucel-T (Provenge)

Intravenous

Asymptomatic or minimally symptomatic hormone-refractory metastatic prostate cancer

Minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF in 250 mL of lactated ringers in patient-specific bag Use 3 doses at approximately 2-wk intervals

Enzalutamide (Xtandi)

Oral

160 mg once daily

Leuprolide acetate (Lupron Depot) Triptorelin (Trelstar)

Intramuscular injection

Metastatic castrationresistant prostate cancer in patients who have previously received docetaxel Palliative treatment of advanced prostate cancer

Goserelin (Zoladex)

8

Administration route

Intramuscular injection Implant

UROLOGY PRACTICE MANAGEMENT

Palliative treatment of advanced prostate cancer Stage B2-C prostate cancer and palliative treatment of advanced prostate cancer

I September 2012

7.5 mg every mo, 22.5 mg every 3 mo, 30 mg every 4 mo, or 45 mg every 6 mo 3.75 mg every 4 wks, 11.25 mg every 12 wks, or 22.5 mg every 24 wks 3.6 mg administered subcutaneously every 28 days For stage B2-C prostate cancer, administer with flutamide

Specialty Pharmacy

Table 1. Specialty Pharmaceuticals Available for the Treatment of Prostate and Kidney Cancers (Continued)

Cancer type Kidney

Drug

Administration route

Approved use

Dose

Everolimus (Afinitor)

Oral

Adults with renal-cell carcinoma after treatment with sunitinib or sorafenib; renal angiomyolipoma with tuberous sclerosis complex

10 mg once daily

Sorafenib (Nexavar)

Oral

Advanced renal-cell carcinoma

400 mg twice daily

Sunitinib (Sutent)

Oral

Advanced renal-cell carcinoma

50 mg once daily for 4 wks on treatment followed by 2 wks off

Temsirolimus (Torisel)

Intravenous

Advanced renal-cell carcinoma

25 mg once weekly

Pazopanib (Votrient)

Oral

Advanced renal-cell carcinoma

800 mg once daily

Axitinib (Inlyta)

Oral

Advanced renal-cell 5 mg twice daily carcinoma after failure of 1 prior systemic therapy

Bevacizumab (Avastin)

Intravenous

Metastatic renal-cell carcinoma

10 mg/kg every 2 wks with interferon alfa

Aldesleukin (Proleukin)

Intravenous

Metastatic renal-cell carcinoma

600,000 IU/kg every 8 hrs for a maximum of 14 doses After 9 days of rest, another 14 doses are administered, for a maximum of 28 doses per course, as tolerated

PAP-GM-CSF indicates prostatic acid phosphatase granulocyte/macrophage colony-stimulating factor. prostate cancer, with significant escalation of new treatment options within the past 5 years. In addition to other hormonal agents that have been approved, there have been introductions of newer therapies that are primarily used for the treatment of metastatic castration-resistant prostate cancer, such as docetaxel (Taxotere), abiraterone (Zytiga), cabazitaxel (Jevtana), sipuleucel-T

including everolimus (Afinitor), sorafenib (Nexavar), sunitinib (Sutent), temsirolimus (Torisel), pazopanib (Votrient), and axitinib (Inlyta). In addition, 2 injectable chemotherapy agents, bevacizumab (Avastin) and aldesleukin (Proleukin) are also approved for the treatment of kidney cancer.

Table 1 lists the therapies for

(Provenge), and the most recently approved enzalutamide (Xtandi).3 In addition to advances in the treatment of prostate cancer, there have been significant advances made with the introduction of specialty pharmaceuticals for the treatment of kidney cancer over the past 10 years.

There are currently 6 oral specialty pharmaceuticals that are approved for the treatment of kidney cancer

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Specialty Pharmacy

The Role of Specialty Pharmacy inâ&#x20AC;ŚContinued from page 9 Table 2. Baseline Services Compared with High-Touch Services Offered by Specialty Pharmacies

Baseline services

High-touch specialty

Minimal patient training regarding use and proper handling other than traditional counseling Injection training support provided by phone

High level of patient training regarding use and proper handling Injection training provided by phone or with in-home training

Generally, one-time patient counseling session on first fill followed by availability to answer questions as needed

High-level and continued patient interaction beyond initial dispensing process Motivational interviewing and goal setting with disease-specific surveying with baseline and quarterly evaluations to set goals and monitor patient Quality of life, depression screening, and disease progression are examples of assessments

Monthly patient contact proactively addressing refills and availability to answer questions as needed

Targeted intervention by drug or disease state, additional contact points to review therapy, adverse events, or monitoring Monthly patient contacts Collection of laboratory results or monitoring levels incorporated into care plan

Basic level of communication with other healthcare professionals

Coordinate care with prescribers and other healthcare professionals, including case management team of payer

Patient compliance education is generally limited to counseling and labeling of product

Rigorous patient education often provided by nurse or pharmacist staff with monitoring to assure optimal outcomes

Adapted with permission from Foundation for Managed Care Pharmacy. Specialty pharmacy initiative: phase I discovery and US environmental scan. October 2009. prostate cancer and kidney cancer. In addition, there are a multitude of treatment options available for testicular cancer and bladder cancer, the majority of which are chemotherapy agents. Current treatment options for bladder and testicular cancers can be found on the National Comprehensive Cancer Networkâ&#x20AC;&#x2122;s website.4,5

10

The Future of Specialty Pharmaceuticals in Urology In addition to the currently available specialty pharmaceuticals for the treatment of patients with urologic conditions, the drug development pipeline holds significant

promise for the introduction of several new therapies that are currently in phase 2 or phase 3 clinical trials. There are currently 71 investigational therapies in phase 2 or phase 3 clinical trials for prostate cancer, 29 therapies in clinical trials for kidney cancer, and 9 therapies in clinical trials for bladder cancer.6 Many of the therapies currently being investigated may have applications beyond urologic conditions. We also expect expansion in the use of existing therapies to urologic conditions, as well as the potential use of certain agents earlier in disease stages.

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The Role of Specialty Pharmacies in Urology Practice Management As with specialty pharmaceuticals, there is no consensus about the definition of a specialty pharmacy, despite the significant growth in the number and size of specialty pharmacies in the United States over the past decade. Specialty pharmacies are companies that are focused on a high-touch comprehensive care system of pharmacologic care, wherein patients receive expert therapy management and support tailored to their individual needs.7 Table 2 describes the level of serv-

Specialty Pharmacy

ice that high-touch specialty pharmacies provide, based on research conducted by the Foundation for Managed Care Pharmacy.8 When providing high-touch services as described in Table 2, specialty pharmacies can provide urology practices with important assistance to ensure that patients receive high-quality, cost-effective care.

At the core, specialty pharmacies provide urology practices with an efficient and reliable method of drug distribution, either to the patient or to the physician office for office administration. As increasing numbers of specialty pharmaceuticals are coming to market and are being offered through limited distribution networks—which is usually limited to fewer than 15 pharmacies—specialty pharmacies become the only source for distribution of many of these newer therapies.

One of the critical roles of specialty pharmacies involves the services provided for insurance benefits verification, prior authorization facilitation, medication side effect and refill management, and patient copayment assistance. In addition, specialty pharmacies can provide the operational and clinical assistance to prescribers who dispense oral and injectable medications from their practices. This service can be provided even when the specialty pharmacy is not dispensing the medication.

It is clear that specialty pharmacies can assist urology practices and their patients in improving patient adherence to prescribed drug therapy. One of the most important services that specialty pharmacies provide is that of medication adherence, because there are many factors that lead to patient nonadherence when it comes to specialty pharmaceuticals.7 Table 3 lists some of the causes of nonadherence related to specialty pharmaceuticals.7 Additional factors that may impact patient adherence include drug pref-

Table 3. Factors Leading to Patient Nonadherence of Specialty Pharmaceuticals

Complex, large-molecule, and biologic drugs • Difficult to manufacture and shorter shelf life • Generally limited inventory • All routes of administration including orals, self-injectables, etc • High cost per unit Requires special handling and services • A high level of patient support—more education and monitoring than traditional pharmaceuticals • Often requires periodic laboratory results, diagnostic tests, or REMS reporting Target small-population rare and chronic diseases • High medical cost for the patient • Patients require education on disease, drug regimen, and administration High cost results in reimbursement challenges • Copay programs and patient-assistance programs • Covered by prescription and/or medical benefit REMS indicates risk evaluation and mitigation strategies.

Source: URAC. The patient-centered outgrowth of specialty pharmacy. Specialty pharmacy white paper. www.urac.org/Whitepaper/ PQM-Specialty_Pharmacy.pdf. ty pharmaceuticals currently approved for urologic conditions, and more than 100 additional therapies in the drug development pipeline, it is time for urology practices to begin partnering with payers, with specialty pharmacies, and with specialty pharmaceutical manufacturers to better understand this industry and the impact it is going to have on urology practice management.

The role of urologists in the treatment of patients with prostate cancer is expected to expand as drugs such as abiraterone and others are added to the recommendations for first-line therapy of metastatic castrationresistant prostate cancer in the future. Currently, specialty pharmaceuticals such as abiraterone, cabazi-

erencing strategies, especially as the number of medications used to treat a specific condition grows; partial-fill programs that have been adopted by payers that limit prescription quantities to a 15-day supply most times; and payer delays in reviews of new medications that come to market, which result in noncoverage or in high patient out-of-pocket costs for a specified period of time. High out-ofpocket costs can cause nonadherence,9 and copay cards from pharmaceutical manufacturers, as well as assistance from nonprofit charitable organizations, can help cover some of the costs of medication therapy.

What You Can Do about Specialty Pharmacy With more than a dozen special-

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Group Purchasing Organizations

Test Your Knowledge of Group Purchasing…Continued from page 1 UPM: Can you briefly tell us about your practice?

Ms Craig: Sure. We have 7 urologists, 7 offices, and a full-time pathologist. We also have 1 surgery center. Our GPO contract is set up through the surgery center, which is a separate entity from the practice but with some of the same owners.

That is important, because a surgery center gets better pricing than a urology practice. So, when you are looking at contracting with a GPO, you should evaluate the structure from a business perspective.

If I had set up the GPO contract with the practice as the main parent company, I would not have gotten the same access to pricing as I did with the surgery center as the parent site. We joined as a surgery center with practice sites, instead of practice sites with a surgery center.

UPM: There seem to be some misconceptions about GPOs, and

we would like to ask you a few questions about your experiences. We are going to use a “fact or fiction”

Our GPO contract is set up through the surgery center, which is a separate entity from the practice but with some of the same owners. That is important, because a surgery center gets better pricing than a urology practice. approach, by making a statement regarding GPOs, and you will tell us whether it is fact or fiction.

Ms Craig: Go ahead.

UPM: GPO discounts are limited to medical and office supplies— fact or fiction?

Ms Craig: Fiction. I have used the same GPO for many years, and it offers discounts on just about everything you can think of. We are expanding into new office space, and the GPO was able to offer us discounts on construction supplies— paint, flooring, you name it. GPOs offer employee discounts on cell phone service. By going through our GPO, we were able to realize significant cost-savings on copier equipment, service, and supplies. And, of course, GPOs offer discounts on medical equipment—I just bought vital sign monitors through my GPO. UPM: So your GPO offers discounts on services, as well as products?

Ms Craig: Yes. For example, cell phone companies offer discounted rate plans and discounted phones Continued on page 13

The Role of Specialty Pharmacy in…Continued from page 11

12

taxel, enzalutamide, and sipuleucel-T are primarily being prescribed by oncologists, because the use of docetaxel is recommended before these drugs can be used to treat patients with this type of cancer.

All stakeholders, especially patients, play a critical role in the effectiveness of these new therapies and in the ability to effectively treat conditions such as prostate cancer, kidney cancer, and other urologic conditions. Specialty pharmacies can be important resources for urology practices in helping to navigate insurance benefits, prior authorization requirements, and copay assistance among other areas that are

important in improving patient adherence to therapy.

Now is the time for you to gain a better understanding of the role of specialty pharmacy, and how specialty pharmacies can assist urology practices to provide high-quality patient care. The futures of specialty pharmacy and urology practice management are intertwined. l

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References 1. Blaser DA, Lewtas AJ, Ousterhout MM, et al. How to define specialty pharmaceuticals—a systematic review. Am J Pharm Benefits. 2010;2:371-380.

2. Express Scripts. Drug Trend Report 2010. April 2011. www.express-scripts.com/research/research/dtr/archive/ 2010/dtrFinal.pdf. Accessed September 1, 2012.

3. National Comprehensive Care Network. NCCN Clinical Practice Guidelines in Oncology—Prostate Cancer. Version 3.2012. www.nccn.org/professionals/physician_

gls/pdf/prostate.pdf. Accessed September 1, 2012.

4. National Comprehensive Care Network. NCCN Clinical Practice Guidelines in Oncology—Bladder Cancer. Version 2.2012. www.nccn.org/professioals/physician_ gls/pdf/bladder.pdf. Accessed September 3, 2012.

5. National Comprehensive Care Network. NCCN Clinical Practice Guidelines in Oncology—Testicular Cancer.

Version 1.2012. www.nccn.org/professioals/physician_ gls/pdf/testicular.pdf. Accessed September 3, 2012.

6. Pharmaceutical Research and Manufacturers of America. Medicines in development—cancer. 2012. www. phrma.org/sites/default/files/1000/phrmamedicinesin developmentcancer2012.pdf. Accessed September 3, 2012.

7. URAC. The patient-centered outgrowth of specialty pharmacy. Specialty pharmacy white paper. www.urac.org/Whitepaper/PQM-Specialty_Pharmacy. pdf. Accessed September 3, 2012.

8. Foundation for Managed Care Pharmacy. Specialty pharmacy initiative: phase I discovery and US environmental scan. October 2009. www.amcp.org/Work Area/DownloadAsset.aspx?id=14305. Accessed September 3, 2012.

9. Gleason PP, Starner CI, Gunderson BW, et al.

Association of prescription abandonment with cost share for high-cost specialty medications. J Manag Care Pharm. 2009;15:648-658.

Group Purchasing Organizations

Test Your Knowledge of Group Purchasing…Continued from page 12 and tablets for the organization and for the employees of a member organization. It is something to boost employee satisfaction in our practice.

UPM: GPOs charge membership fees—fact or fiction?

Ms Craig: For most of them, it is fiction. For the most part, GPOs have eliminated per-physician membership fees in the past few years. Now membership is free for a practice or a surgery center.

UPM: Working through a GPO simplifies the buying process—fact or fiction?

Ms Craig: Fact. Let’s say I am shopping for vital sign monitors.

With the GPO, all I have to do is go to their member website, look up vital sign monitors, and the website will tell me who has a monitor on contract. At that point, I hone in on the 2 or 3 monitors that are on contract, and I immediately exclude from my consideration any monitors that are not. I do not need to go to several different vendors to compare prices.

UPM: When purchasing through a GPO, items are always provided through a distributor—fact or fiction?

Ms Craig: That is fiction, because you need to look at the contract to see if you can go through a GPOauthorized distributor. In the majority of cases you can buy from the distributor, but in some cases you have to buy directly from the manufacturer.

In such a case, you have to contact your manufacturer’s representative.

The advantage, of course, is that you

are able to buy the item at the price that the GPO has negotiated.

up front. There is the paperwork required to sign up. Then you have to choose an authorized distributor. You need to look closely at the contract to see which discounts are dependent on purchase volume. In such a case, you have to be careful, because if you do not meet the volume threshold, you may be subject to a penalty.

You have to complete a contract with every single manufacturer. The contract has to be submitted, it has to be approved, the price has to be loaded, and then, finally, you access the price. After all that, you begin the process of evaluating your purchases and transitioning from noncontracted items to contract items.

It is much easier once everything is set up, but it can be time-consuming in the beginning. However, the costsavings are substantial, and in my opinion, it is well worth the effort.

UPM: GPOs monitor distributor pricing—fact or fiction?

Ms Craig: Fact. GPOs know what contracts you are signed up for, who your distributor is, and your cost plus mark-up with that distributor; they monitor your purchases for items such as pharmaceuticals. As a result,

Choosing a GPO should not be something that you do lightly. That is one of the big stumbling blocks for practices, because getting the maximum benefit from a GPO requires a lot of work up front.

UPM: Larger GPOs offer educational programs for their members—fact or fiction?

Ms Craig: Fact. My GPO has an annual user’s conference. It is very helpful, with sessions on topics such as inventory control, streamlining, and leadership. GPOs also conduct webinars. For example, my GPO is currently sponsoring a webinar on some of the drug shortages that are affecting practices, offering some alternative solutions. GPOs also provide newsletters and an interactive website. The information can be very useful. For example, beginning not too long ago, we had to start including National Drug Code numbers on pharmaceutical claims to get reimbursed. The GPO has been a great resource for us. l

GPOs have the ability to notify you if you were overcharged by your distributor. If you are overcharged, the GPO will go back to the distributor and get the price fixed.

UPM: It is easy to switch if you are not satisfied with your current GPO—fact or fiction?

Ms Craig: Fiction. Choosing a GPO should not be something that you do lightly. That is one of the big stumbling blocks for practices, because getting the maximum benefit from a GPO requires a lot of work

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ICD-10 Implementation

Transitioning to ICD-10…Continued from page 1 tificates. Consequently, the National Center for Health Statistics developed a clinical modification to classify morbidity data. Iterations of the ICD-10-CM for this purpose are currently in use in Australia, Belgium, Canada, Denmark, Finland, France, Germany, Iceland, Norway, Sweden, and the United Kingdom. The new system will replace the ICD-9-CM volumes 1 and 2, whereas the ICD10-PCS will replace ICD-9-CM volume 3, which will be used exclusively for billing hospital inpatient procedures.

Clinical modifications of the ICD-10 from the ICD-9 are significant and include1:

1

The addition of information relevant to ambulatory and managed care encounters

2 3

Expanded injury codes

The creation of combination diagnosis/symptom codes to reduce the number of codes required to adequately describe a condition (eg, connecting retinopathy with diabetes)

The built-in ability to expand.

The new coding system will allow the government to more accurately measure healthcare use and to facilitate comparison of mortality and morbidity data, claims processing, identification of fraud and abuse, and the addition of value to clinical data captured by the ICD-10-CM/PCS for regulatory issues, reimbursement, research, and outcomes management.

This shift brings some serious challenges, not the least of which is moving from 13,000 codes in the ICD-9 to more than 68,000 codes in the ICD-10-CM.

Increased specificity in code assignment; procedure codes will go from 13,000 under the ICD-9 to approximately 68,000 under the ICD-10-CM

Making the Switch Under the US Department of Health and Human Services’ (HHS) final rule, the transition to the ICD10 will be implemented on October 1, 2013. This shift brings some serious challenges, not the least of which is moving from 13,000 codes in the ICD-9 to more than 68,000 codes in the ICD-10-CM. Adopting the ICD-10-CM required implementation of a new generation of the 9 Health Insurance Portability and Accountability Act (HIPAA) electronic transaction standards, known as the American National Standards Institute (ANSI) 5010. The designation of “5010” refers to the revised set of HIPAA electronic transaction standards adopted to replace the current version 4010/4010A standards.

Every standard has been updated,

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4

The addition of sixth and seventh alphanumeric characters (3-7 characters total, with an alpha character first, a numeric digit second, and an alpha character or a numeric digit third through seventh)

5 6 7

The incorporation of fourth- and fifth-character subclassifications

The enhanced ability to designate laterality

14

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UROLOGY PRACTICE MANAGEMENT

from claims to eligibility to referral authorizations. As of January 1, 2012, all HIPAA-covered entities were required to be compliant with version 5010. Any electronic transaction for which a standard has been adopted must be submitted using version 5010. Electronic transactions that do not use version 5010 are not compliant with HIPAA and will be rejected.

The HHS authorized an enforcement discretion period through June 30, 2012. During this time, the Centers for Medicare & Medicaid Services (CMS) did not initiate enforcement action against any covered entity that was not compliant with the updated version 5010/D.0 standards.

The ANSI 5010 is governed by HIPAA. The transition to ANSI 5010 must take place before the ICD-10 is implemented, because the ICD-10 code set cannot operate with the current HIPAA transaction standards (ie, 4010).2 As a result, the adoption of ANSI 5010 literally paved the way to allow for a seventh digit to be added to the ICD-10 codes and to accommodate procedural codes for all covered HIPAA entities, including providers, payers, hospitals, vendors, some noncovered HIPAA entities, businesses (workers’ compensation), and information technology (IT) platforms.

The shift to the ICD-10-CM/PCS will require software modifications for insurance coverage and for billing. Training will also be required for office staff—up to 40 hours per person, possibly more, for certified coding staff; at least 8 hours for administrative staff; and a minimum of 12 hours for providers.

For medical practices, the transition to the ICD-10-CM/PCS consists of 4 phases: Phase 1 involves “impact assessment,” during which practices should

ICD-10 Implementation

create a steering committee comprising providers, medical staff, a practice manager, a financial manager, and the IT team, and should devise a communication schedule and timeline for everyone in the practice who will be involved with the ICD-10CM/PCS implementation.

Phase 2 involves “preparation for implementation,” requiring a readiness assessment of the medical practice management system; interfaces with laboratories, ancillary services, hospitals, and radiology; health information exchanges; and shared systems. During this phase, practices should review and update contract renewals with vendors to ensure compliance with the ICD-10-CM/ PCS, update software and hardware with payers as warranted, and should assess coverage of medical and urologic supplies and chemotherapy medications.

Because the diagnosis coding system and local coverage determinations for CMS are changing, practices must ensure that the service they intend to provide will be considered medically necessary before they submit a claim.

These preparations will help medical and IT staff to be organized. By this time, staff should have undergone training for the transition, or, at the very least, plans should be in place for staff education.

Phase 3 is the “going live” phase, during which practices should re-

business process analysis of contract coverage issues, increased documentation, modifications to super bills and office forms, IT and software updates, and cash flow disruption and loss of income resulting from seeing fewer patients initially, until the system is fully in place.3 Implementing the ICD-10-CM/PCS is expected to affect practices in a similar manner to electronic health record (EHR) implementation.

engineer any processes that are not working properly and should review timelines and budgets. This phase requires a firm understanding of the general equivalency mapping system that was created to facilitate the transition from the ICD-9 to the ICD-10. Each code in the ICD-9 will have at least 1 code, and possibly several codes in the ICD-10-CM/PCS. Phase 2 plans should include followup on business associate readiness, checking to see if billing services are ready and whether contracts with vendors, clearinghouses, and software providers are in place.

During this phase, practices should continue working on payer coverage issues. Because the diagnosis coding system and local coverage determinations for CMS are changing, practices must ensure that the service they intend to provide will be considered medically necessary before they submit a claim. The earlier this is done, the better. Staff should receive comprehensive education and training on the ICD-10-CM codes to completely understand the rules and regulations.

Phase 4 is the “postimplementation” phase, and it ranges from the fourth quarter in 2013 through the end of 2014. During this period, practices will monitor cash flow, productivity, revenue, coding, and case mix. All appeal claims will be done immediately, and work with insurance companies will be continual.

Any problems or discrepancies will require re-educating staff and providers. Data analysis will be ongoing throughout this phase.

Nachimson Advisors, LLC, estimated that it will cost practices as much as $83,290 for a small practice and as much as $2.7 million for a 100-physician practice to implement the ICD-10-CM/PCS coding.

In 2004, the RAND Corporation examined the cost of implementing the ICD-10-CM/PCS and compared it with cost reduction benefits over time.4 It predicted a one-time cost to the industry of $425 million to $1.15 billion for training and system changes for all providers, hospitals, health plans, and vendors, plus an estimated $5 million to $40 million annually for up to 10 years in lost productivity. The productivity loss was based almost exclusively on coders and physicians. Any delay in implementation would significantly affect this prediction. If upgrades are not required for EHR software or practice management, costs might be less, because the focus would remain on processes and staff education and training.

Cost to Practices In a report to the ICD-10 Coalition, Nachimson Advisors, LLC, estimated that it will cost practices as much as $83,290 for a small practice and as much as $2.7 million for a 100-physician practice to implement the ICD-10-CM/PCS coding.3 Costs include staff education and training,

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ICD-10 Implementation

Transitioning to ICD-10…Continued from page 15 Benefits to Practices The more specific the coding for new procedures is, the more accurate the payments will be. The greater efficiencies of the new coding system should minimize confusion over new or unlisted procedures, resulting in

The combination codes in the ICD-10-CM/PCS will render EHRs more specific, resulting in improvements in clinical measurements, modeling and performance, and managing patient care.

16

• Fewer miscoded, rejected, and improper reimbursement claims • Better understanding of the value of new procedures • Improved disease management • Better understanding of health outcomes.

Although the estimates for implementing the new system may seem daunting, RAND estimates that the cost of implementing the ICD-10CM/PCS will be offset by up to $8 billion in savings over a 10-year period for both the clinical modification and the procedural coding systems.

fewer rejected claims and fewer improper payments. The revenue and billing cycle will become more efficient, bringing money back into the practice more quickly and reducing overhead in working claims that would have been rejected or denied with the old system.

The combination codes in the ICD-10-CM/PCS will render EHRs more specific, resulting in improvements in clinical measurements, modeling and performance, and managing patient care. The clinical picture will be more strictly defined and described, ultimately leading to improved quality of care.

Medical records documentation will become very specific, beginning with scheduling appointments and gathering information on the intake form. This is a job for the front desk, and it will facilitate the physician’s task. RAND predicted that benefits will accrue from4: • More accurate payments for new procedures

Late-Breaking Legislative Update The Office of Management and Budget (OMB) is currently reviewing the proposed rule, “Administrative simplification: standard unique identifier for health plans and ICD-10 compliance date delay.” The OMB’s review is the final step before the release of the rule; however, the review can take up to 60 days. The HHS originally proposed a 1-year delay (from October 1, 2013, to October 1, 2014) for the ICD-10 implementation.5 The HHS received a large number of comments on the proposed delay, possibly explaining why it has taken so long for the rule to make its way to the OMB. Although the final compliance date has not been determined, we are getting closer to knowing what that date will be.

At the moment, all practices can do is proceed as planned, prepare, and continue to educate staff. The conversion to the ANSI 5010 standards was the first step in the process; we have recently passed the extension period (June 30, 2012) to enforce ANSI 5010 compliance. The American Health Information Management Association (AHIMA) is not in favor of a further delay and is continuing full speed ahead to edu-

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cate providers, coders, and billers.

Further delays will result in additional costs to providers for implementing ANSI 5010 and EHRs and the consequent disruption in practice. Any further delay would only delay the inevitable; however, CMS has placed a partial freeze on code diagnoses that might complicate the transition.

This October, codes for the ICD10-CM/PCS that reflect new technologies or new diseases and disorders will receive updates. These updates are expected to minimize the need for manufacturers and other stakeholders to request unlisted codes after the ICD-10-CM/PCS is rolled out.

ICD-11 The ICD-11 is now being developed through a collaborative process with more than 177 countries. This version is not expected to roll out until 2015, and it will be translated into 43 languages. Practices will be able to download the ICD-11 free of charge on the internet. It will be

Medical records documentation will become very specific, beginning with scheduling appointments and gathering information on the intake form.

even more specific than the ICD-10CM/PCS; however, unless practices understand how to use the ICD-10, they will be unable to implement the ICD-11, because the ICD-10-CM/ PCS is the foundation on which the ICD-11 will be built.

ICD-10 Implementation

Resources for Urology Practices There are several platforms for education and training on the ICD10-CM/PCS, including internet programs and webinars, seminars, classes at local colleges and medical societies, and coding seminars. AHIMA has contracted with CMS to provide training for the new coding system.

The American Association of Professional Coders and CMS also provide resource material and courses, some specifically for urology practices. The Table provides a short list of resources available to urology practices.

Practices should prepare for the ICD-10-CM/PCS the same as they did for the year 2000. In the end, the transition was not a serious problem, because everyone was ready for it.

Practices must adopt the same philosophy with the ICD-10-CM/PCS. l

Table. Resources for Urology Practices

AHIMA

ICD-10-CM/PCS transition: planning and preparation checklist www.AHIMA.org/downloads/pdfs/resources/ checklist.pdf

AAPC

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

CMS

ICD-10 www.cms.gov/ICD10/ The ICD-10 transition: focus on non-covered entities www.himss.org/content/files/ICD10FactSheetNon CoveredEntities.pdf

Medscape

Transition to ICD-10: getting started www.medscape.org/viewarticle/765754 Medscape Education: Urology www.medscape.org/urology/multimedia-cme

Other

Preparing your urology practice for ICD-10 www.codinginstitute.com/preparing-your-urologypractice-for-icd-10.html

References 1. Centers for Disease Control and Prevention. International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM). www.cdc.gov/nchs/icd/icd10 cm.htm. Accessed September 10, 2012.

2. Law L, Porucznik MA. Switching to ICD-10: the impact on physicians. AAOS Now. February 2009. www.aaos.org/news/aaosnow/feb09/reimbursement1. asp. Accessed September 10, 2012.

3. Nachimson Advisors, LLC. The impact of implementing ICD-10 on physician practices and clinical laboratories. A report to the ICD-10 Coalition.

October 8, 2008. http://nachimsonadvisors.com/ Documents/ICD-10%20Impacts%20on%20Providers. pdf. Accessed September 10, 2012.

4. Stewart SM. ICD-10 will lead to better patient outcomes and reduced costs. Really. April 4, 2012. www. hhnmag.com/hhnmag/HHNDaily/HHNDailyDisplay. dhtml?id=1900006047. Accessed September 10, 2012.

5. Office of the Secretary, US Department of Health and Human Services. Administrative simplification: adoption of a standard for a unique health plan identifier; addition to the National Provider Identifier requirements; and a change to the compliance date for the International Classification of Diseases, 10th Edition (ICD10-CM and ICD-10-PCS) medical data code sets. Final rule. Fed Regist. 2012;77:54663-54720.

ICD-10 audio conferences www.supercoder.com/coding-education/icd-10 Top 50 codes for urology: fast forward to ICD-10 www.aapcps.com/resources/icd-10-mapping/icd-10urology.aspx 2012 ICD-9-CM to ICD-10-CM Diagnostic Code Mapper for Urology www.codingbooks.com/books/icd-10-cm/2012-ICD9-CM-to-ICD-10-CM-Diagnostic-Code-Mapperfor-Urology-Download_786.html AAPC indicates American Association of Professional Coders; AHIMA, American Health Information Management Association; CMS, Centers for Medicare & Medicaid Services.

September 2012

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Insurance Coverage

Renewing Your Practice’s Insurance Coverage: Tips for the Practice Administrator

By Rick Janss, MBA, CMPE Practice Manager, Clinical Urology Associates, Gadsden, AL

P

ractice administrators working in an average urology office often face an imposing array of business-related responsibilities.

Many of these tasks, such as billing, involve day-to-day, hands-on attention, whereas others may necessitate less frequent effort. In small to midsize practices, practice administrators are often charged with the responsibility to research and recommend insurance options for the partners.

Some practices may retain a benefits consultant to provide recommendations, but those recommendations are still often reviewed by the practice administrator before they are put in front of the partners.

Insurance renewals—health, life, and disability—typically require attention once annually. However, this does not diminish the vital importance of this responsibility. In general, practice administrators would be well advised to review all insurance policies on an annual basis.

A good practice administrator will conduct the necessary background research to allow the partners of the practice to make well-informed, knowledgeable decisions about the practice’s insurance options.

18

managers can do is reduce non–patient care costs. Practice managers’ primary objective is to allow clinicians—physicians, nurses, and midlevel providers—to focus on their jobs, so these clinicians have to do as little as possible, except generate revenue.

Creative employee cost-sharing options may be available that allow the practice to have increased flexibility in choosing health insurance options.

Health Insurance According to the Medical Group Management Association’s 2011 Physician Compensation and Production Survey, urologist compensation declined by 4.6% between 2009 and 2010, underscoring the need for practice administrators to “hold the line” on overhead expenses. One of the most important things practice

Health insurance is typically one of the most expensive types of insurance coverage, for employees in terms of their cost-sharing, and for the practice in terms of overhead cost. Because health insurance is typically renewed on an annual basis, practices should consider “shopping around” for a few months before their policies are set to expire for the year. By doing so, the practices may be able to find an option that better suits their needs.

For example, in a practice with a group of younger physicians and ancillary staff, the practice may want to consider benefit designs with higher deductibles, whereas with more senior groups, or with women of

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UROLOGY PRACTICE MANAGEMENT

childbearing age, the deductible may not be a consideration. When looking at health insurance options for the upcoming year, practices should consider their cost of coverage, as well as the employee cost-sharing.

Creative employee cost-sharing options may be available that allow the practice to have increased flexibility in choosing health insurance options. For example, some practices may pay the lion’s share of the employee’s coverage but make the employee responsible for most or all of the spouse or the family coverage.

Benefit designs can be structured in numerous ways. Different types of health coverage—medical, dental, and vision—are often provided by different carriers. However, some companies offer more than one type of coverage, and these companies may offer discounts to practices that purchase multiple types of insurance.

Life Insurance In terms of life insurance, a wide range of options is available. Some practices buy whole life, also known as “permanent” insurance policies, for their physicians. Although these policies have a cash value, they are also significantly more expensive than term insurance policies, which do not accrue a cash value. One option is to purchase a term policy in which the premium stays level for 5, 10, 15, or even for 30 years. In this case, the practice could purchase a longer term policy and only cover its employees for most of their working lives, at a reasonable premium.

Continued on page 20

YOUR COMPLIMENTARY SUBSCRIPTION IS ONLY A CLICK AWAY UROLOGY PRACTICE MANAGEMENT ™

PROCESS IMPROVEMENTS TO ENHANCE PATIENT CARE™

www.UroPracticeManagement.com

JULY 2012

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 pro-

Continued on page 11

©2012 Engage Healthcare Communications, LLC

To sign up, visit www.UroPracticeManagement.com

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

Insurance Coverage

Renewing Your Practice’s Insurance…Continued from page 18 Regardless of the term insurance option selected, long-term policies are typically less expensive than permanent, cash value–bearing policies.

Another life insurance option that group practices may want to consider is often described as “key man” coverage, which is used to buy out a partner in the event of his or her untimely demise. Regardless of the coverage selected, a good practice administrator will carefully evaluate the cost of the coverage versus the benefits (and drawbacks).

Regardless of the option chosen, never cancel your existing insurance before your new coverage takes effect. It is impossible to know when an accident or medical event may take place, making the practice partner or employee uninsurable.

Life insurance carriers may require a medical examination for certain types of coverage, and you never know what that examination may uncover. Medical examination necessity is often based on the amount of coverage, age, and previous health conditions of the proposed insured individual.

Another important life insurance consideration is to determine the policy owner versus the policy beneficiary. One option that makes sense for many practices is to designate the medical practice as the owner of the policy, the physician as the insured party, and the physician’s spouse or partner as the beneficiary. Remember that a life insurance payout is typically a tax-free event.

20

disabled because of an accident or illness is far greater than the risk of premature death for most individuals, and it may make sense to consider disability coverage for the practice partners and other key employees.

This is a great way to provide value for no extra cost to the employee. It is important for employees to fully understand their benefits in advance, so that they are not blindsided by unanticipated out-of-pocket expenses.

When looking at disability coverage, be sure that this coverage pertains to the own-occupation, specific roles of the partners or other employees. This is especially true for physicians who perform surgery, to ensure that they are covered in the event that they lose the ability to perform surgical tasks.

Disability Insurance Disability insurance is another issue to consider. The chance of becoming

Your Role in Adding Value For each of your different employee benefit options—insurance, retirement, and so on—you, the practice administrator, may want to set aside a certain month of the year. For example, you may want to designate November as “employee insurance month” and allow agents and bro-

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UROLOGY PRACTICE MANAGEMENT

kers to visit the office, present their benefit options, and answer any questions that the employees may have. I do this on Fridays, and I will have one person come in and present the health insurance options one Friday, followed by presentations on disability and life insurance on another Friday.

This is a great way to provide value for no extra cost to the employee. It is important for employees to fully understand their benefits in advance, so that they are not blindsided by unanticipated out-of-pocket expenses when they have an unexpected hospitalization or an outpatient procedure. For example, if an employee requires a computed tomography scan or an emergency department visit, I want that person to know in advance what the required copayment will be.

When you begin the fact-finding process, work closely with the practice partners to ensure that you are shopping for the appropriate benefit designs that they intend to offer their employees, and shop around for each type. After you shop around, bring a couple of alternatives to the physicians, and allow them to make the ultimate decision.

Remember, careful consideration of insurance options is a way for the practice administrator to help the practice to contain overhead costs and enhance the value this person brings to the organization. l Note: This article is not intended to provide financial, legal, or insurance advice. Please consult with your legal or insurance professional for specific information pertaining to your practice.

Drug Coding: Prostate Cancer Supplied by RJ Health Systems

Medications Used for the Treatment of Prostate Cancer The following sections will assist healthcare professionals and payers by providing appropriate coding and billing information associated with the management of prostate cancer.

The following sections include: • Associated ICD-9-CM codes used for the classification of prostate cancer • Drugs that have been FDA-approved in the treatment of prostate cancer • Drugs that are Compendia listed for offlabel use for prostate cancer based on clinical studies that suggest beneficial use in some cases.

Please note: if a check mark appears in the FDA column it will NOT appear in the Compendia off-label use column • Corresponding HCPCS/CPT® codes and code descriptions

Associated ICD-9-CM codes for prostate cancer: 185

Malignant neoplasm of prostate Excludes: seminal vesicles (187.8)

FDA-approved for prostate cancer

Compendia listed off-label use for prostate cancer

CPT ® administration codes

Generic (brand) name

HCPCS code: code description

abiraterone acetate (Zytiga)

J8999*: Prescription drug, oral, chemotherapeutic Not otherwise specified

✓

N/A

abiraterone acetate (Zytiga)

C9399*: Unclassified drugs or biologics (Hospital outpatient use only)

✓

N/A

bacillus Calmette-Guerin 90585: Bacillus Calmette-Guerin vaccine (Tice BCG) (BCG) for tuberculosis, live, for percutaneous use

✓

90471

bacillus Calmette-Guerin 90586: Bacillus Calmette-Guerin vaccine (Tice BCG, TheraCys) (BCG) for bladder cancer, live, for intravesical use

✓

51720

bacillus Calmette-Guerin J9031: BCG (intravesical), per installation (Tice BCG, TheraCys)

✓

51720

bevacizumab (Avastin)

J9035: Injection, bevacizumab, 10 mg

✓

96413, 96415

bicalutamide (Casodex)

J8999*: Prescription drug, oral, chemotherapeutic Not otherwise specified

✓

N/A

cabazitaxel (Jevtana)

J9043: Injection, cabazitaxel, 1 mg

✓

96413

cisplatin (Platinol AQ)

J9060: Injection, cisplatin, powder or solution, per 10 mg

✓

96409, 96413, 96415

cyclophosphamide (Cytoxan)

J8530: Cyclophosphamide, oral, 25 mg

✓

N/A

cyclophosphamide (Cytoxan)

J9070: Cyclophosphamide, 100 mg

✓

96409, 96413, 96415

degarelix (Firmagon)

J9155: Injection, degarelix, 1 mg

96402

✓

Continued on page 22 September 2012

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21

Drug Coding: Prostate Cancer Supplied by RJ Health Systems

Generic (brand) name

HCPCS code: code description

FDA-approved for prostate cancer

dexamethasone (Decadron) docetaxel (Taxotere, Docefrez) doxorubicin (Adriamycin) epirubicin (Ellence) estradiol valerate (Delestrogen) estramustine (Emcyt)

J8540: Dexamethasone, oral, 0.25 mg J9171: Injection, docetaxel, 1 mg

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✓

UROLOGY PRACTICE MANAGEMENT

I September 2012

CPT ® administration codes N/A 96413

✓

J9000: Injection, doxorubicin hydrochloride, 10 mg J9178: Injection, epirubicin HCl, 2 mg

J1380: Injection, estradiol valerate, up to 10 mg J8999*: Prescription drug, oral, chemotherapeutic Not otherwise specified estrogens (eg, estradiol, J8499*: Prescription drug, oral, conjugated estrogen, nonchemotherapeutic esterified estrogen) Not otherwise specified fluorouracil J9190: Injection, fluorouracil, 500 mg (Adrucil) flutamide J8999*: Prescription drug, oral, (Eulexin) chemotherapeutic Not otherwise specified flutamide S0175: Flutamide, oral, 125 mg (Eulexin) goserelin acetate J9202: Goserelin acetate implant, (Zoladex) per 3.6 mg histrelin J9225: Histrelin implant, 50 mg (Vantas) hydrocortisone J1720: Injection, hydrocortisone sodium (Solu-Cortef) succinate, up to 100 mg ixabepilone J9207: Injection, ixabepilone, 1 mg (Ixempra) ketoconazole J8499*: Prescription drug, oral, (Nizoral) nonchemotherapeutic Not otherwise specified leuprolide acetate J9217: Leuprolide acetate (Eligard, Lupron Depot) (for depot suspension), 7.5 mg leuprolide acetate J9218: Leuprolide acetate, per 1 mg (Lupron) medroxyprogesterone J1051: Injection, medroxyprogesterone (Depo-Provera) acetate, 50 mg megestrol J8499*: Prescription drug, oral, (Megace) nonchemotherapeutic Not otherwise specified megestrol S0179: Megestrol acetate, oral 20 mg (Megace) melphalan J8600: Melphalan, oral, 2 mg (Alkeran) melphalan J9245: Injection, melphalan hydrochloride, (Alkeran) 50 mg

Compendia listed off-label use for prostate cancer

✓

96409

✓

96409, 96413

✓

96372

✓

N/A

✓

N/A

✓

96409

✓

N/A

✓

N/A

✓

96372, 96402

✓

✓

11981, 11982, 11983 96365, 96366, 96372, 96374 96413, 96415

✓

N/A

✓

✓

96402

✓

96402 ✓

96402

✓

N/A

✓

N/A

✓

N/A

✓

96409, 96413

Drug Coding: Prostate Cancer Supplied by RJ Health Systems

FDA-approved for prostate cancer

Compendia listed off-label use for prostate cancer

CPT ® administration codes

Generic (brand) name

HCPCS code: code description

methylprednisolone (Medrol)

J7509: Methylprednisolone, oral, per 4 mg

✓

N/A

methylprednisolone (Depo-Medrol)

J1020: Injection, methylprednisolone acetate, 20 mg

✓

11900, 11901, 20600, 20605, 20610, 96372

methylprednisolone (Depo-Medrol)

J1030: Injection, methylprednisolone acetate, 40 mg

✓

11900, 11901, 20600, 20605, 20610, 96372

methylprednisolone (Depo-Medrol)

J1040: Injection, methylprednisolone acetate, 80 mg

✓

11900, 11901, 20600, 20605, 20610, 96372

methylprednisolone (Solu-Medrol)

J2920: Injection, methylprednisolone sodium succinate, up to 40 mg

✓

96365, 96366, 96372, 96374

methylprednisolone (Solu-Medrol)

J2930: Injection, methylprednisolone sodium succinate, up to 125 mg

✓

96365, 96366, 96372, 96374

mitoxantrone (Novantrone)

J9293: Injection, mitoxantrone hydrochloride, per 5 mg

✓

96409, 96413

nilutamide (Nilandron)

J8999*: Prescription drug, oral, chemotherapeutic Not otherwise specified

✓

N/A

paclitaxel (Taxol)

J9265: Injection, paclitaxel, 30 mg

✓

96413, 96415

prednisone (Deltasone)

J7506: Prednisone, oral, per 5 mg

✓

N/A

✓

N/A

prednisolone J7510: Prednisolone, oral, per 5 mg (eg, Orapred, Millipred) sipuleucel-T (Provenge)

Q2043: Sipuleucel-T, minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF, including leukapheresis and all other preparatory procedures, per infusion (Code price is per 250 mL)

96413, 96415

topotecan (Hycamtin)

J9351: Injection, topotecan, 0.1 mg

✓

96413

trastuzumab (Herceptin)

J9355: Injection, trastuzumab, 10 mg

✓

96413, 96415

triptorelin (Trelstar Depot, Trelstar LA)

J3315: Injection, triptorelin pamoate, 3.75 mg

vinBLAStine (Velban)

J9360: Injection, vinblastine sulfate, 1 mg

✓

96372, 96402

✓

✓

96409

*When billing a nonclassified medication using a CMS 1500 claim form, you must include both the HCPCS code in Column 24D and the drug name, strength, and NDC (National Drug Code) in Box 19 or Column 24A to ensure appropriate reimbursement. Please note: Check with payer regarding correct placement of medication information.

References • HCPCS Level II Expert 2012 • Current Procedural Terminology (CPT®), 2011 (CPT® copyright 2011. American Medical Association. All rights reserved. CPT® is a registered trademark of the American Medical Association) • ICD-9-CM for Professionals Vol 1, 2, 2012 • FDA-approved indication (from product prescribing information) • Compendia references available upon request • www.ReimbursementCodes.com powered by RJ Health Systems International, LLC., Rocky Hill, Connecticut • CMS (Centers for Medicare & Medicaid Services).

BCG indicates Bacillus Calmette-Guerin; CPT®, Current Procedural Terminology; HCPCS, Healthcare Common Procedure Coding System; PAP-GM-CSF, prostatic acid phosphatase granulocyte-macrophage colony-stimulating factor.

September 2012

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Medicare Part D

Navigating the Medicare Part D Exception Process

By Sandra Paton

N

avigating Medicare Part D drug coverage can be challenging if a medication is denied. Formularies change, and each plan may have a different approach to utilization management (Table). However, under section 3312 of the Patient Protection and Affordable Care Act of 2010, each Medicare drug plan sponsor is required to provide a uniform exception and appeal process. The process is less complicated than you may think, and it only requires completion of a single formâ&#x20AC;&#x201D;the Medicare Part D Coverage Determination Request Form.

The Exception Process Medicare Part D plans that manage prescription drug utilization by means of a formulary must have an exception process in place. The process provides an avenue for plan enrollees to request coverage for nonformulary medications or for requesting that a formulary drug be provided at a lower tier, thus reducing the copayment. The exception process may also be used to request that cer-

tain utilization management measures, such as quantity limits or step therapy requirements, are bypassed.

An exception request for a formulary exception or a tiering exception may be initiated by either the enrollee or the prescriber. The pre-

Once an exception has been requested, the plan must render a decision within 72 hours of the receipt of the request. scriber must demonstrate that the patient cannot be treated effectively with any of the formulary drugs on any tier, that substitutions would be harmful, or both. In the past, the exception requests were required in writing; however, as of January 1, 2012, the plans are required to accept verbal statements from the

Table. Health Plan Drug Management Cost-Savings Measures

24

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Measure

What it means

Prior authorization

Permission must be obtained from the health plan before the drug will be covered

Step therapy

Patients are required to try a less expensive drug before a more expensive agent will be covered

Quantity limits

The amount of a drug that will be covered by the plan is limited

Formulary tiers

Covered medications are divided into several tiers, with less expensive or generic drugs placed on the lower tiers

UROLOGY PRACTICE MANAGEMENT

I September 2012

prescriber, although the plan may also request a written statement. If a prescribed drug is covered but has one of the restrictions noted in the table, the prescriber can ask to override the restriction.

Once an exception has been requested, the plan must render a decision within 72 hours of the receipt of the request. If, in the opinion of the prescriber, this delay could seriously harm the patient, an expedited exception can be requested, and the decision must be rendered within 24 hours. If a nonformulary exception request is granted, the patient receives access to the drug with the same copayment or coinsurance that would be paid for a comparable formulary drug.

New patients should know that the Centers for Medicare & Medicaid Services requires every participating Medicare drug plan to have a transition policy. This means that if a patient has been receiving a nonformulary drug from another plan, the new plan must provide a 30-day supply of the same drug without any restrictions, such as prior authorizations or step therapy. This policy is in place for the new enrolleeâ&#x20AC;&#x2122;s first 90 days in the new plan. It is worth noting that pharmacists may have to ask the plan to override its code to be compliant with the regulation. In this case, it is essential for the prescriber to initiate an exception request, if needed, so that the medication will continue to be covered after the transition period.

Appeals Process If the exception request is not approved, the patient has the right to engage in a structured appeals process. The first appeal level is

Medicare Part D

called a Redetermination and may be filed by the enrollee or prescriber within 60 days of a denial of an exception. The standard time limit by which the plan must make the determination is 7 days, but an expedited time limit of 72 hours is available in cases where a patient may suffer harm if the medication is not provided. Standard appeals must be made in writing, but expedited appeals may be initiated verbally.1 The next level of appeal, which must be filed within 60 days of the first-level appeal determination, is a Reconsideration by an Independent Review Entity. This appeal again is subject to a 7-day standard time limit or a 72-hour expedited time limit. If this appeal does not result in an exception, the next appeal also must be filed within 60 days of the prior determination. If the case is not resolved at this juncture, it will then be sent to the Office of Medicare Hearings and Appeals to

ed decision. If the issue still is not resolved, it may go to the Medicare Appeals Council within 60 days of the prior denial. The last level of appeal is in Federal District Court, where the amount in contention must exceed $1350.1 Although this appeals process may seem cumbersome, higher-level appeals are relatively uncommon and most cases are resolved early in the process. Although each planâ&#x20AC;&#x2122;s formulary and restrictions may vary, the appeals algorithm is standardized. To save time, the office staff should have a copy of the formulary and restrictions for each plan.

Offices should consider asking new patients to check their planâ&#x20AC;&#x2122;s website and print out the formulary and the restrictions for their records. l

There is a standard 90-day time limit for this decision to be rendered or a 10-day time limit for an expedited decision.

If the issue still is not resolved, it may go to the Medicare Appeals Council within 60 days of the prior denial.

be decided by an administrative law judge. At this level, the amount in contention must exceed $130 (2012 calendar year).1 There is a standard 90-day time limit for this decision to be rendered or a 10-day time limit for an expedit-

September 2012

Reference 1. Center for Medicare Advocacy. Medicare Coverage & Appeals. www.medicareadvocacy.org/medicareinfo/medicare-coverage-appeals/#articles. Accessed September 10, 2012.

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25

Billing Management

Timely and Accurate Billing Interview with John McMann, MS Practice Administrator, Advanced Urology Associates, LLC, Oxford, FL

W

hen it comes to the business side of urology, maintaining consistent cash flow is critical to the operation of the practice, and delays can be problematic and costly. To find out how urology practices can maximize billing efficiencies, Urology Practice Management (UPM) asked John McMann, an experienced practice administrator at Advanced Urology Associates, LLC, in Oxford, FL, to describe how he and his team deal with the billing processes and procedures, and what may be some of the issues to consider for urology practices.

UPM: Please tell us a little about your urology practice.

Mr McMann: We have several offices that are located in Central Florida, and we have 18 board-certified physicians, including 16 urologists, 1 pathologist, and 1 radiation oncologist. We also have 1 physician assistant.

UPM: How does your practice bill for the services you provide? Do you use a billing service?

Mr McMann: No. The charges are entered daily at each individual location, because the office staff knows what procedures have been performed. The next morning, the lead biller updates all the closed batches and prepares them for transmission to our clearinghouse, or for mailing. We believe that it is important to bill every day. That is the best way to ensure your cash flow, because we know that in 14 days we will receive Medicare reimbursement on a clean claim.

UPM: What processes do you have in place to ensure billing ac-

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curacy, to make sure that you get it right the first time?

Mr McMann: Before transmitting a bill, we do some data scrubbing to make sure that everything is accurate. We especially keep a close eye on things such as the 5010 edits. All the offices have been educated to record the patient’s name exactly as it appears on their Medicare or on their insurance card. That includes the “juniors,” the “seniors,” the “thirds,” and so on. Somebody may go by the name of Bill Smith, but if his Medicare card is William F. Smith, Jr, that is how it has to go into our system. So you cannot use nicknames for billing. It has to be the legal name that is on the card.

All bills must go through 2 rounds of edits before they are submitted. First, the bills must clear our system, and then they go through a clearinghouse edit. This ensures that errors are fixed before we submit the claim.

That is very important, because if you do not input the data correctly, then the claim gets kicked back.

When it gets kicked back, it takes you longer to collect your money.

UPM: Approximately how much longer?

Mr McMann: It depends on the insurance carrier. Here in Central Florida the majority of our patients are Medicare beneficiaries. When Medicare kicks back a claim, it can take 2 weeks or more to get it resolved. And of course we do not want that, because we have to rebill the claim in such a case, and that is an added administrative expense, as well as delaying payment.

UPM: What about coding? How

I September 2012

do you make sure the procedure codes are accurate?

Mr McMann: Each individual office staff is responsible to enter their procedure codes, and we rely on them to be accurate. We stress coding the claim correctly the first time, because it reduces delay of payment.

From time to time, we hire an outside audit firm to come in and review the charts. You want that independent audit, because if you ever get a Medicare audit, this will ensure that you have the documentation to show that quality control processes are in place to ensure that the coding staff is doing their job correctly.

UPM: Have you had any issues with claims being denied because of coding issues?

Mr McMann: Sometimes a claim is denied, but it is usually because the insurer wants more information or a medical necessity letter from the doctor. It happens from time to time, but it is rarely caused by a coding error.

UPM: Are there differences in submitting claims to Medicare and to commercial payers?

Mr McMann: With Medicare, if you have a claim, you are going to get your money in 14 days. Health insurance companies usually take longer, sometimes 30 days or more.

With commercial payers, the turnaround is often slow.

UPM: Can you elaborate on why daily billing is so important for your practice, and how does that work?

Mr McMann: We have to have the cash to pay our bills, and to pay our staff. If we do not bill every day, especially in a larger practice such as ours, we could have a tremendous

Billing Management

amount of cash that is not at our disposal. We would have to borrow against our line of credit and incur interest expense.

One thing I have instituted is that every day I get a quick report of the status of all outstanding claims. The entire practice bills under 1 tax ID number, which allows us to generate a single report for all the offices. So at a glance I can review the daily report, which tells me how many claims were submitted, the dollar amount we submitted, how many claims are pending, and the dollar amount that is pending.

I started this daily report, because about 5 or 6 years ago we were encountering lengthy delays in getting money from Medicare. We did not know what was going on. It happened to be a Medicare system issue.

But, I said, “There’s got to be a better way to monitor this.” So, I set up this report to allow us to be proactive.

Now, if the dollar amount of pending claims keeps building, then we know there may be a problem. We do not have to wait until we get a letter from Medicare, we can look and say, “Hey, we’re waiting on an awful lot of money here. What’s going on?” In such a case we will call Medicare and inquire as to why we are experiencing a delay of payments.

The daily report has truly helped us to monitor our claims. In the past, it could be 2 weeks before we realized that payment of claims was being delayed. I would rather know within 3 or 4 days of potential payment delays, so we can address the issue immediately.

UPM: When you look at the amount of money tied up in pending claims, is there a certain threshold that you exceed that raises a red flag for you that something’s not right?

Mr McMann: Yes. We know the standard amount (of money) that’s tied up in claims, especially for

Medicare. If we see that number creeping up substantially higher than where it should be, then we begin to suspect that we may have a problem somewhere.

reimbursed the contracted amount for each carrier. If you have a contract with Blue Cross and Blue Shield, for example, they are supposed to pay you $100 for a certain procedure. Our practice staff is checking that to make sure that they are getting paid $100, not $95. Obviously we do not have time to check every claim, but we randomly spot check to ensure that we are being reimbursed for the contracted amount.

UPM: Have you had challenges in getting reimbursement for emerging therapies? How do you handle those situations?

Mr McMann: Initially, we work with the drug representatives to make sure that we know the J codes.

We need to make sure we are going to get paid.

UPM: Finally, do you have any other business advice for urology practices?

Mr McMann: I would advise practices to make sure that they are billing everything. If your physician goes to the hospital, you should have a system in place to track all the patients the physician saw, and all the procedures she or he performed.

Make sure that you bill for everything. In radiation and oncology, we do chart reviews on every patient.

In addition, to maximize your profits and cash flow, get your copays up front. When the patient comes in, collect the copay. If you do not, you have to send them a bill, which costs money to generate, plus you need postage. I recommend keeping a list of all the patients that come in each day, and their copayment amount. Then the office manager can compare that list to what has actually been collected.

Then there are the self-pay patients. We have arranged monthly payment plans for many of these patients. Of course, you have to make sure that they are making their monthly payments. Therefore, someone in the office needs to be reviewing the self-pay patients to make sure that they are paying as they agreed to pay. There are automated systems that will send out a notice if a payment is late. The system checks to see when the payments are due, and if payments are late, it automatically generates a bill. l

The daily report has truly helped us to monitor our claims. In the past, it could be 2 weeks before we realized that payment of claims was being delayed. I would rather know within 3 or 4 days of potential payment delays.

For a new procedure, many insurance companies require a preauthorization. We need to make sure that we understand the process and the information that needs to be provided. If it is an emergency down at the hospital, that is obviously a different game. But many office procedures require preauthorization. We have to be very careful. We are fortunate, however, that it has not been a big issue for us.

UPM: What about making sure that you are paid the contracted fee for a procedure?

Mr McMann: Yes, practices need to check and make sure that they are

September 2012

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Invitation to Join the UPM Editorial Board The publishers of Urology Practice Management (UPM) are inviting qualified urology practice owners and administrators to participate as members of the UPM Editorial Board.

As an editorial board member, you will play an active role in helping to shape the content of this exciting new publication.

Urology Practice Management is a novel publication focused on process solutions for urology practices. UPM is designed to provide the urology care team – medical, practice administrators, coders, and billers – with the knowledge and skills required to keep abreast of today’s fast-changing business environment, allowing practice professionals more time to concentrate on high-quality patient care. Each issue of UPM will focus on one area of urology practice, featuring current topics such as:

UROLOGY P MANAGEMREACTICE

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

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Procedur e Reductions Payment Imaging Se for rvices: Implicatio

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

ns fo Practice Ad r Urology ministrator s

Sean M. We iss, CCP-P ACS-EM, , CCA-P, CPC, Vice Preside CPC-P Complian nt & Chief ce Office r DecisionH ealth/Pro fessional Services

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Continued on page 11

©2012 Eng age Communicat Healthcare ions, LLC

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AUA Annual Meeting

AUA Practice Management Highlights

By Sandra Paton

Atlanta, GA—At the 2012 Annual Meeting of the American Urological Association (AUA), Sandie J. Preiss, MPA, Director of Government Relations and Public Policy at Abbott Laboratories, outlined the challenges facing urology practice managers regarding the sustainable growth rate (SGR) formula, the system by which physicians are reimbursed. She urged listeners to become politically active, to contact their elected officials, and to inform them about what it takes to keep a practice going. Part of Ms Preiss’s mission on the regulatory front is to “inspire physicians to talk with their elected officials.”

Reductions to the Medicare Physician Fee Schedule A 27.4% reduction to the Medicare physician fee schedule was slated to begin on January 1, 2012; however, Congress responded by approving a 2-month freeze on Medicare physician payments the month before. The money to repeal the SGR was sought from the Overseas Contingency Operations.

An appeal was made to Congress, but was opposed. A 10-month freeze for the remainder of 2012 was put into effect until alternatives were examined. “If the SGR is not repealed, there will be a 30% decline in reimbursement. Approximately $300 billion is needed to fund the SGR repeal, and with no consensus in place, the outlook is bleak,” noted Ms Preiss.

Ms Preiss pointed out that the Medicare Payment Advisory Commission also weighs in on the SGR. “The common strategy in Washington is to treat primary care physicians different from specialists,” she said. A 5.9% reduction was proposed for 3 years, followed by a 7-year freeze

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for specialists, but a freeze on rates was proposed for primary care physicians (PCPs). “In October, the SGR recommendation was passed and transmitted to Congress. Several groups have been meeting to determine what to do next,” Ms Preiss said.

The Independent Payment Advisory Board (IPAB) was created as part of the healthcare reform bill to reduce excess growth in the Medicare program. Unfortunately,

“If the SGR is not repealed, there will be a 30% decline in reimbursement.”

—Sandie J. Preiss, MPA

“The IPAB is unelected and unaccountable, and has no physician experience,” Ms Preiss observed.

Repealing the IPAB, however, would require a $2.4-billion offset according to a Congressional Budget Office estimate. According to Ms Preiss, “In Congress now, you cannot pass something that costs money, unless you can find the money to pay for it.

We did find 224 cosponsors for the repeal, but it is not likely that this effort will pass the Senate or even [encourage] them to have additional conversations about it.”

Preventive Services Undermined Under the Affordable Care Act, the US Preventive Services Task Force (USPSTF) has been given the authority to make recommendations on preventive services. It is this board that recommended that

I September 2012

prostate-specific antigen (PSA) testing receive a D rating based on flawed studies and without consultation with urologists. The state legislatures of New Jersey and Pennsylvania have enacted resolutions for Congress to reject the recommendation on PSA testing. “The AUA is working to draft federal legislation to limit the powers of the USPSTF and should encourage you to contact your elected officials.”

Maintaining Access to Specialists Legislation has been introduced on private contracting, namely, the Medicare Patient Empowerment Act (H.R. 1700/S. 1042). The bill would permit Medicare beneficiaries and providers to privately contract for Medicare-covered services without penalty. The AUA has endorsed both bills through The Alliance of Specialty Medicine. In collaboration with other specialty medicine societies, the AUA has advocated for private contracting as a viable option for maintaining access to specialists.

More attention must be focused on prostate-related issues. The Prostate Research, Outreach, Screening, Testing, Access, and Treatment Effectiveness (PROSTATE) Act of 2011 (H.R. 2159/S. 1190) requires the Veterans Administration and the US Department of Defense to coordinate and intensify prostate cancer research. PROSTATE supports the development of a national education campaign on prostate screening. “To date, 45 House sponsors and 9 Senate sponsors have signed on to support this bill. The bills will be reintroduced next year, and again [take] the opportunity to talk with your state representatives,” emphasized Ms Preiss.

AUA Annual Meeting

Medicare Overpayments There is a 10-year look back regarding overpayments from Medicare. One issue that still has to be decided is when overpayments are identified. Ms Preiss reported, “We are arguing aggressively to change this and to provide a real definition of [what constitutes having identified] an overpayment, and are also looking at more realistic penalties and at developing a uniform reporting form. The AUA has submitted comments expressing concern that these requirements underestimate the burden to providers.”

PQRS Bonuses—Get Involved Now The Physician Quality Reporting System (PQRS) bonus is going to affect reimbursement down the road.

The Centers for Medicare & Medicaid Services (CMS) will provide comparative performance information on cost and quality to providers through the value-based physician modifier (VBPM) and the physician feedback programs. Ms Preiss stressed, CMS is “saying the information they provide will be meaningful and actionable by individual providers, [and will] be based on cost and quality information from the PQRS data. So I urge you to get involved in PQRS.” Payments will be adjusted in 2015, and all physicians will be subject to the VBPM. Participation Is Essential “Participate in UROPAC [the political action committee for the AUA],” urged Ms Preiss. “But also come to the joint advocacy conference,” which will be held in March 2013, in Washington, DC. “Become acquainted and become politically active. This will benefit everyone.

Invite your elected officials to come see your practice.” (For more information, contact govaffairs@aua net.org.)

“The outlook is bleak,” said Ms

Preiss. “There is no real understanding of what you do every day. Nor is there an understanding of what it takes to keep a practice going.”

Again she urged listeners to talk with their elected officials or to call to arrange for her department to meet with their elected officials.

through electronically connected systems with dedicated care extenders who assist primary care and who are available for chronic and after-hours urgent care. Payment is based on performance and is between stakeholders (ie, payers and providers).

The demographics tell why this transition is necessary. There are 10,000 new Medicare patients per day. “Forty percent of them are obese; they are sicker and living longer,” said Dr Spitz. “If this scenario continues, Medicare and Medicaid together are expected to consume 20% of the GDP [gross domestic product] in 20 years. The cost of healthcare would be unsustainable.”

The amount spent in the United States far exceeds what is spent in other countries, and it increases 8% to 10% annually. “Study after study shows that there is not a tight correlation between outcomes and costs.

So, we really need to take a look at what we are doing,” said Dr Spitz.

“Much of this has to do with coordinating care [and] duplication of tests….But patients have to participate as well. Chronic conditions are driving up the costs. [Patients] have to become accountable for their own health, including having a financial stake in their own healthcare.”

Payers and employers must participate by emphasizing prevention and compliance. Their view of value is short-sighted, because they only have to look at 1 year. A system that will reward value over the long-term is needed. “The government should ensure transparency so that we can all work together effectively. The government must also continue to protect citizens who cannot pay, and continue to support research and education and support training of residents.”

ACOs are a work in progress, but they all share 3 fundamental properties: (1) they must be able to provide or manage a continuum of care as a

One Urology Practice’s Experience in Exploring the World of ACOs Aaron Spitz, MD, is a practicing physician with Orange County Urology Associates, Laguna Hills, CA, where nearly half of the patients are capitated and partici-

“There is no real understanding of what you do every day. Nor is there an understanding of what it takes to keep a practice going.”

—Sandie J. Preiss, MPA

pate in one of the pioneer accountable care organizations (ACOs) through Medicare. At the AUA annual meeting, he recounted his experience in the accountable care environment, giving an overview of the ACO arena, how we got to this point, and how to capitalize on the situation. “We are now in a new world order when it comes to healthcare.…We are moving away from fee for service, whether we like it or not,” observed Dr Spitz.

The current fee-for-service (FFS) system is a specialist-based delivery system that provides, at best, fragmented care. Providers are paid for their services and not to manage care.

The ACO models are centered on primary care. All care is provided

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Continued on page 32

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AUA Annual Meeting

AUA Practice Management…Continued from page 31 real or virtually integrated delivery system, (2) they must be large enough to support comprehensive performance measures, and (3) they must be capable of distributing shared-savings payments internally.

Patients are attributed or assigned to Medicare ACOs based on their history of visits to providers and their episodes of care. A PCP must provide at least 80% of a patient’s care. Patients are automatically attributed to a provider without choice. The provider can attempt to keep the patient within that narrow network of services, but they cannot coerce patients to stay there. Patients can choose to go where they want, but they are still counted economically to the PCP to whom they are attributed. If the PCP cannot control the consumption of resources, that PCP must work to convince the patient that he or she will get the best quality care possible.

PCPs must choose 1 ACO, but specialists can be part of several ACOs. ACOs have several requirements.

Practices must: • Have a track record of a strong financial performance and adequate financial reserves, plus the ability to take risk and distribute shared savings and profit • Meet all legal and regulatory requirements • Be invested in information technology systems with a data warehouse and wide connectivity • Have demonstrated the ability to manage hospital and payer relationships • Be capable of providing valueadded care coordination for patients.

Furthermore, practices must manage their patient populations and employ care navigators to reduce the cost of hospital readmissions or relapses. They must also provide disease management and prevention.

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There are 2 types of ACOs. The first type includes hospital-based organizations (eg, University of Michigan), independent practice associations (eg, Monarch), physician-led and hospital-based practices (eg, Sharp in San Diego, CA), and hybrids (eg, Healthcare Partners).

“The amount we get paid is benchmarked by what Medicare and what commercial FFS is paying. We do not pay ourselves for things that cost us money.”

—Aaron Spitz, MD

From among 80 applicants, 32 ACOs have already been selected. They must have a minimum of 15,000 patient lives. In the first year, 50% of PCPs must be on the same electronic health record (EHR). Outliers will be excluded. Benchmarks are derived from participants’ historic performance. “As ACOs prove their worth, the benchmarks will get tighter and tighter,” observed Dr Spitz.

The second type includes medical shared-savings programs, in which only 5000 patient lives are needed to participate. Payment is based on FFS. This program is good for entrylevel ACOs. Some ACOs will fail, but patients can align themselves with other ACOs. There is a “retail spillover concept,” explained Dr Spitz, whereby referring physicians eventually use the same laboratories for commercial patients as well as contracted patients. “If the laboratory performs well, the physician eventually

I September 2012

sends all of his patients to the one proven laboratory. As we enter into new contracts, we get almost as many assigned patients as unassigned patients,” he noted. This is an opportunity for growth for urologists and urology referrals. “We can expect almost equal numbers of commercial referrals as we do contracted referrals as our competency shines through. But even if an ACO model fails, the new referring physician relationship can endure.”

Dr Spitz simplified the picture for his audience: “The amount we get paid is benchmarked by what Medicare and what commercial FFS is paying. We do not pay ourselves for things that cost us money. We don’t credit urologists in the group for items or procedures that cost the group money (for example, cultures, bladder scans, trays). Traditional ways of picking up extra revenue no longer pertain. If you don’t do that, people will drive up utilization. You need to look at your internal utilization. Establish a pool of money from the capitated payment that is set aside. You will have money to redistribute, provided you are not gaming the system.”

The Narrow Network This is a subdivision of the preferred provider. It is a small or select network of physicians within a larger network. Participants are selected based on “efficiency of care” (costs plus quality of outcomes). In exchange for a narrow choice of providers (ie, hospitals, physicians, ambulatory surgery centers, imaging centers), employers and patients are offered lower costs for premiums and copays and higher quality.

Large employers are feeling the strain of continually increasing premiums. They are becoming more open to restricted access. Businesses Continued on page 34

Call for submissions

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

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

AUA Annual Meeting

AUA Practice Management…Continued from page 32 are demanding that insurers create networks that include some hospitals and physicians and leave others out.

They are willing to forego choices for costs. Employers are now willing to limit choices to create a better cost advantage.

Dr Spitz explained that narrow networks appear to be the solution to the dilemma that is facing employers—a way to make sure workers stay healthy, get high-quality care, and help businesses save money. Employees, too, are looking for this. Employees have had enough with cost shifts. Cigna has increased enrollment in ACOs 10-fold in the past few years.

Large urology groups are uniquely positioned to participate in narrow networks. This gives them the bandwidth to look at their data and to show that they do quality work.

These large groups have subspecialty expertise that obviates outsourcing.

They have internal and external benchmarking of utilization and outcomes (eg, positive biopsy rate), and they have comprehensive cost containment. They leverage ancillary ownership. Incorporating ancillary services saves money over hospital use. Anything a group provides will be cheaper than what a hospital provides. Dr Spitz observed that seemingly disparate entities are buying entities that used to work against each other but are now working with each other. Reform is driving diversification.

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tion],” said Dr Spitz. He urged listeners to try to understand the risks and not fear them. “Eliminate fee for service as the Holy Grail….Consolidation will continue to occur at all levels, and very few independent private practices will survive.

Most medical doctors will be employed and salaried by someone.

Most marketplaces will have no more than 3 integrated systems, and many will have fewer. Insurance

“If you start in Medicare and realize you could qualify in Medicaid, you can switch once [from Medicare to Medicaid and vice versa] at any time during the 5-year period.”

—Rosemary Nelson, MS

companies will continue to reinvent themselves to remain relevant as large employers do direct contracting and insurance exchanges evolve for individual and small groups.”

Fundamental Changes Are Required Trends in healthcare expenditures mandate fundamental changes in delivery systems. Pioneer ACOs will show which models work and which do not. “FFS, as we know it, is likely to go away and be replaced by population management or bundled episodes [another name for capita-

The Basics of Meaningful Use: Registration, Measuring, and Attestation Certification by an authorized testing and certification body indicates to professionals and hospitals that an EHR technology can support their efforts to meet the goals and objectives of meaningful use.

Rosemary Nelson, MS, a principal consultant at the MGMA Healthcare Consulting Group, reviewed the basics involved with qualifying

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for meaningful use incentives at the AUA annual meeting.

Ms Nelson warned her audience to take nothing for granted, relating an example where a physician on staff was still enrolled as a fellow at another practice. Consequently, the practice he was currently working for did not get reimbursed for his work.

“Even if you think you’ve done everything, you should make sure that everything is set up correctly,” Ms Nelson cautioned.

Medicaid incentive payments can be made to physicians and nurse practitioners who have a Medicaid patient volume of at least 30%.

Pediatricians require a Medicaid patient volume of only 20%. Payments can be made to physicians, dentists, certified nurse midwives, and nurse practitioners. Ms Nelson noted that physicians cannot collect incentive payments from both Medicare and Medicaid. “If you start in Medicare and realize you could qualify in Medicaid, you can switch once [from Medicare to Medicaid and vice versa] at any time during the 5-year period.”

Ms Nelson urged eligible professionals to have everything lined up before they start the registration process for the EHR incentive program (at www.cms.gov/EHRIncen tivePrograms/), including:

1

Being enrolled in medical FFS/ Medicare Advantage or Medicaid (FFS or managed care)

2 3

Having a national provider identifier (NPI) standard

Being enrolled in the Medicare Provider Enrollment, Chain, and Ownership System (PECOS)

4

Having a National Plan & Provider Enumeration System (NPPES) user name and password

AUA Annual Meeting

(https://nppes.cms.hhs.gov/NPPES/ CreateLoginForExistNPIPage.do).

Medicaid money is managed by each state, and every state has its own nuances. Ms Nelson urged physicians to check out how their state manages it. Incentive payments are based on 75% of Medicareallowed charges. Physicians who have practices in a designated health professional shortage area will receive a 10% increase in incentives.

“Medicare allows a total incentive payment of $44,000, but the later you get into it, the less money you will receive within the 5-year period,” advised Ms Nelson.

She noted that certification will only be offered for complete EHR modules that meet 1 or more of the criteria. To get on track, urology practice managers must first register, determine their percentage of Medicaid patients, verify that the EHR version is certified by the Office of the National Coordinator for Health Information Technology Authorized Testing and Certification Body (at http://oncchpl. force.com/ehrcert), identify selection for the menu set, and monitor the CMS website for changes. Ms Nelson noted, “Everybody’s versions will eventually need updating. So check your software version number on your application and upgrade to a certified version, if necessary. If you don’t have a certified version, you will need to get in a queue to upgrade with a vendor. This could change your forms, particularly if you use a custom template. And even though the download is free, you might need to spend some money to [complete the process].”

Ms Nelson urged physicians to audit themselves on the core objectives and how to meet them, including:

1

Use the computer provider order entry for all medication orders.

“In Stage 2, orders for laboratories and radiology, as well as medications, will eventually have to be input. So you need to be comfortable with Stage 1 first”

getting your Medicare numbers high enough”

7

Maintain an active medication allergy list. “Again, at least 80% of all patients should have at least 1 recorded entry to indicate they have no known medication allergies”

2

Implement drug-drug and drugallergy interaction checks. This is done automatically for the entire EHR reporting period. “This is already set up in the software. Just enable this function”

8

Record and chart changes in vital signs (eg, height, weight, blood pressure, body mass index, growth charts for children aged 2-20 years) for at least 50% of patients aged 2 to 20 years

“Medicare allows a total incentive payment of $44,000, but the later you get into it, the less money you will receive within the 5-year period.”

9

Record smoking status for patients aged ≥13 years for at least 50% of all patients aged ≥13 years. “We can track smoking and make a recommendation for patients to go through a hospital smoking cessation program. This will afford you a quality indicator and will help you meet a core objective”

—Rosemary Nelson, MS

10

Implement a clinical decision support rule relevant to your specialty, and track compliance to that rule

3

Generate and transmit permissible prescriptions electronically.

More than 40% of all permissible prescriptions must be transmitted electronically using certified EHR technology

11

Report ambulatory clinical quality measures to CMS and the state

12

Provide patients, who request it, an electronic copy of their health information, including test results, problems list, medication list, and medication allergies; at least 50% of patients should receive electronic copies of their health records within 3 days of requesting them

4

Record patient demographics, including preferred language, sex, race, ethnicity, and date of birth; this is a job for the front desk

5

Maintain a list of current and active diagnoses; this should be part of an established practice management issue

13

Provide clinical summaries to patients for each office visit.

Clinical summaries should be provided to 50% of all patients who ask for it within 3 business days. Ms Nelson recommends giving it to patients on the day of service to avoid having to mail anything to them

6

Maintain an active medication list. At least 80% of all patients must have at least 1 entry recorded as structured data, an indication that the patient is not currently prescribed any medication. “The key is

September 2012

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AUA Annual Meeting

AUA Practice Management…Continued from page 35

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Exchange key clinical information among providers and patients

15

Protect electronic health information created or maintained by certified EHR technology by implementing appropriate technical capabilities. Conduct or review a security risk analysis, implement security updates as necessary, and correct identified security deficiencies as part of the risk management process. “Not conducting a test is likely to result in an audit,” said Ms Nelson

16

Implement drug formulary checks. Enable functionality and access to at least 1 internal or external formulary for the entire EHR reporting period

17

Incorporate clinical laboratory test results into certified EHRs as structured data. More than 40% of all clinical laboratory tests must be ordered during the EHR reporting period when results are in a positive/negative or numerical format.

“This means you should have an interface with a laboratory. If you have an EHR, you don’t want the bulk of laboratories coming in via fax”

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Generate lists of patients by specific conditions to use for quality improvement, reduction of disparities, research, or outreach.

“You must have at least 1 report that lists patients with a specific condition. This is a great way to enhance revenue”

19

Send reminders to patients for preventive follow-up care.

You will need to do this for >20% of all patients aged ≥65 years or aged ≤5 years during the reporting period

20

Provide at least 10% of patients with timely electronic access to their health information

21

Use certified EHR technology to identify patient-specific education resources and provide these to at least 10% of patients, where appropriate

22

Perform medication reconciliation for patients from another care setting or provider of care.

“You need to document that you do it for more than 50% of transitions of care”

23

Provide a summary of care record for >50% of patients referred to or transitioned to another

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provider of care or setting of care

24

Submit electronic data to immunization registries or immunization information systems

25

Staff should record 3 core quality measures—blood pressure, weight, and tobacco use assessment—for all patients

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Finally, preview and test attestation. Ms Nelson urged practices to conduct internal audits on core objectives. Practices should access a meaningful use attestation calculator (one is available at www.cms.gov/apps/ehr/) and conduct a pretest before the 90-day report is due, and be sure to have the following provider data ready: an NPI, a registration identification, 90-day reports with volume breakdowns, a CMS EHR certification identification, and meaningful use reports from EHRs. “Practice generating these reports. Look at which reports you can generate automatically and which you will have to piece together. Check to see if you are storing data redundantly, especially demographic details,” she said.

The message was clear: get ready now. Don’t delay. l

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IMPORTANT SAFETY INFORMATION

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08Z11121R3

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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