VOLUME 4 • NUMBER 1
Oncology Practice Management ™
FOR ONCOLOGISTS, PRACTICE MANAGERS, FINANCIAL COUNSELORS, AND REIMBURSEMENT SPECIALISTS™
One of the Many Faces of Oncology Care Management By Sheryl A. Riley, RN, OCN, CMCN Director of Clinical Services SAI Systems, Shelton, CT
s oncology care managers, we are in a constant struggle to prove our value to our employers. The industry generally admires and values the role we play as part of the patient care model, yet employers are startled when we request worthwhile compensation. Employers seem to be in a constant quandary over our value and do not immediately see the return-oninvestment we inherently possess.
Finances Influencing Oncology Care Much of this confusion is driven by
From the Editor
Weathering the Storm Ahead By Dawn Holcombe, MBA, FACMPE, ACHE President, DGH Consulting, South Windsor, CT; Editor-in-Chief, Oncology Practice Management
s I write this, trav eling into Philadelphia on the train from Connecticut, snow is lightly falling and air travel is already disrupted on the East Coast. Yet elsewhere the sun is shining and flights are on time. Eventually, flight delays will affect travel even in the sunny areas, and we will all feel the pain as a nation of travelers.
Ripples from even a small change magnify and create waves. We have seen an ever-growing pattern of ripples affecting the stream of cancer care delivery in 2013 and prior years. Sometimes, in an effort to educate and anticipate, we project the downstream impact of what are initially considContinued on page 13
Controlling Your Practice’s Destiny By Sandra Paton
San Diego, CA—Do you know where your practice is heading? If so, you are in control of your practice’s destiny. Dennis Wipperling, FACMPE, practice administrator with Surgical Specialists of Minnesota, Minneapolis, spoke at the Medical Group Management
Association’s annual conference, where he noted that planning today is not what it used to be. Whereas organizations once had 5-year plans, these plans are much shorter now, necessitated by the many changes coming from Washington, DC. Continued on page 14
Continued on page 10 From the publishers of
INTEGRATING ONCOLOGISTS, PAYERS, AND THE ENTIRE CANCER CARE TEAM
of n it o s D ia er VI ssoc ent ilar O A rC m PR y the nce Biosi a 9 D N ou bity C g at …2 A o y un kin ion T N ght t mm Loo ulat E TI u o s g A Bro C ate Re
©2014 Engage Healthcare Communications, LLC
Kyprolis速 (carfilzomib) for Injection Now Has a Permanent J Code: J9047 For the treatment of patients with multiple myeloma who have received at least 2 prior therapies including bortezomib and an immunomodulatory agent and have demonstrated disease progression on or within 60 days of completion of last therapy. Approval is based on response rate. Clinical benefit, such as improvement in survival or symptoms, has not been verified.
THE POWER OF SECOND-GENERATION PROTEASOME INHIBITION TAKES FLIGHT
Important Safety Information CONTRAINDICATIONS None.
WARNINGS AND PRECAUTIONS The safety of KYPROLIS was evaluated in clinical studies of 526 patients with relapsed and/or refractory multiple myeloma. Cardiac Arrest, Congestive Heart Failure, Myocardial Ischemia: Death due to cardiac arrest has occurred within a day of KYPROLIS administration. New onset or worsening of pre-existing congestive heart failure with decreased left ventricular function or myocardial ischemia have occurred following administration of KYPROLIS. Cardiac failure events (e.g., cardiac failure congestive, pulmonary edema, ejection fraction decreased) were reported in 7% of patients. Monitor for cardiac complications and manage promptly. Withhold KYPROLIS for Grade 3 or 4 cardiac events until recovery and consider whether to restart KYPROLIS based on a benefit/risk assessment. Patients with New York Heart Association Class III and IV heart failure, myocardial infarction in the preceding 6 months, and conduction abnormalities uncontrolled by medications may be at greater risk for cardiac complications. Pulmonary Hypertension: Pulmonary arterial hypertension (PAH) was reported in 2% of patients treated with KYPROLIS and was Grade 3 or greater in less than 1% of patients.
Evaluate with cardiac imaging and/or other tests as indicated. Withhold KYPROLIS for pulmonary hypertension until resolved or returned to baseline and consider whether to restart KYPROLIS based on a benefit/risk assessment. Pulmonary Complications: Dyspnea was reported in 35% of patients enrolled in clinical trials. Grade 3 dyspnea occurred in 5%; no Grade 4 events, and 1 death (Grade 5) was reported. Monitor and manage dyspnea immediately; interrupt KYPROLIS until symptoms have resolved or returned to baseline. Infusion Reactions: Infusion reactions were characterized by a spectrum of systemic symptoms including fever, chills, arthralgia, myalgia, facial flushing, facial edema, vomiting, weakness, shortness of breath, hypotension, syncope, chest tightness, or angina. These reactions can occur immediately following infusion or up to 24 hours after administration of KYPROLIS. Administer dexamethasone prior to KYPROLIS to reduce the incidence and severity of reactions. Inform patients of the risk and symptoms, and to contact physician if symptoms of an infusion reaction occur. Tumor Lysis Syndrome: Tumor lysis syndrome (TLS) occurred following KYPROLIS administration in < 1% of patients. Patients with multiple myeloma and a high tumor burden should be considered to be at greater risk for TLS. Prior to receiving KYPROLIS, ensure that patients are well hydrated. Monitor for evidence of TLS during treatment, and manage promptly. Interrupt KYPROLIS until TLS is resolved.
KYPROLIS is engineered for selective inhibition1 • Single-agent KYPROLIS phase 2 study results2,* - Overall response rate (ORR) of 22.9% in PX-171-003 study (95% CI: 18.0, 28.5) - Median duration of response of 7.8 months (95% CI: 5.6, 9.2) • Most patients across all phase 2 studies (85%) did not need to discontinue therapy due to an adverse event - Adverse reactions leading to discontinuation included congestive heart failure (2%), cardiac arrest, dyspnea, increased blood creatinine, and acute renal failure (1% each) ADVERSE REACTIONS The safety of KYPROLIS was evaluated in clinical trials of 526 patients with relapsed and/or refractory multiple myeloma. • Serious adverse reactions were reported in 45% of patients. The most common were pneumonia (10%), acute renal failure (4%), pyrexia (3%), and congestive heart failure (3%) • The most common adverse reactions (incidence ≥ 30%) were fatigue (56%), anemia (47%), nausea (45%), thrombocytopenia (36%), dyspnea (35%), diarrhea (33%), and pyrexia (30%) *Study PX-171-003 was a single-arm, multicenter clinical trial of KYPROLIS in 266 patients with relapsed multiple myeloma and whose disease had a ≤ 25% response to the most recent therapy or had disease progression during or within 60 days of the most recent therapy. At the time of study entry, patients had received a median of 5 prior lines of therapy. The primary endpoint was ORR. Response was determined by Independent Review Committee assessment using International Myeloma Working Group criteria. References: 1. Demo SD, Kirk CJ, Aujay MA, et al. Antitumor activity of PR-171, a novel irreversible inhibitor of the proteasome. Cancer Res. 2007;67(13):6383-6391. 2. KYPROLIS [prescribing information]. South San Francisco, CA: Onyx Pharmaceuticals, Inc.; 2012.
Thrombocytopenia: KYPROLIS causes thrombocytopenia with platelet nadirs occurring around Day 8 of each 28-day cycle and recovery to baseline by the start of the next 28-day cycle. In patients with multiple myeloma, 36% of patients experienced thrombocytopenia, including Grade 4 in 10%. Thrombocytopenia following KYPROLIS administration resulted in a dose reduction in 1% of patients and discontinuation of treatment with KYPROLIS in < 1% of patients. Monitor platelet counts frequently during treatment with KYPROLIS. Reduce or interrupt dose as clinically indicated. Hepatic Toxicity and Hepatic Failure: Cases of hepatic failure, including fatal cases, have been reported (< 1%). KYPROLIS can cause elevations of serum transaminases and bilirubin. Withhold KYPROLIS in patients experiencing Grade 3 or greater elevations of transaminases, bilirubin, or other liver enzyme abnormalities until resolved or returned to baseline. After resolution, consider if restarting KYPROLIS is appropriate. Monitor liver enzymes frequently. Embryo-fetal Toxicity: KYPROLIS can cause fetal harm when administered to a pregnant woman based on its mechanism of action and findings in animals. There are no adequate and well-controlled studies in pregnant women using KYPROLIS. Carfilzomib caused embryo-fetal toxicity in pregnant rabbits at doses that were lower than in patients receiving the recommended dose. Females of reproductive potential should be advised to avoid becoming pregnant while being treated with KYPROLIS.
ADVERSE REACTIONS Serious adverse reactions were reported in 45% of patients. The most common serious adverse reactions were pneumonia (10%), acute renal failure (4%), pyrexia (3%), and congestive heart failure (3%). Adverse reactions leading to discontinuation of KYPROLIS occurred in 15% of patients and included congestive heart failure (2%), cardiac arrest, dyspnea, increased blood creatinine, and acute renal failure (1% each). The most common adverse reactions (incidence ≥ 30%) were fatigue (56%), anemia (47%), nausea (45%), thrombocytopenia (36%), dyspnea (35%), diarrhea (33%), and pyrexia (30%).
USE IN SPECIFIC POPULATIONS Since dialysis clearance of KYPROLIS concentrations has not been studied, the drug should be administered after the dialysis procedure.
Please see Brief Summary of the full Prescribing Information on adjacent pages.
Onyx, Onyx Pharmaceuticals, Onyx Pharmaceuticals logo, Kyprolis and Kyprolis logo are all trademarks of Onyx Pharmaceuticals, Inc. ©2013 Onyx Pharmaceuticals, Inc., South San Francisco, CA 0512-CARF-243R1 December 2013
KYPROLIS™ (carfilzomib) for Injection Brief Summary of Prescribing Information. Please see the KYPROLIS package insert for full prescribing information. INDICATIONS AND USAGE: KYPROLIS is indicated for the treatment of patients with multiple myeloma who have received at least two prior therapies including bortezomib and an immunomodulatory agent and have demonstrated disease progression on or within 60 days of completion of the last therapy. Approval is based on response rate [see Clinical Studies section of full PI]. Clinical benefit, such as improvement in survival or symptoms, has not been verified. DOSAGE AND ADMINISTRATION: Dosing Guidelines. KYPROLIS is administered intravenously over 2 to 10 minutes, on two consecutive days, each week for three weeks (Days 1, 2, 8, 9, 15, and 16), followed by a 12‑day rest period (Days 17 to 28). Each 28‑day period is considered one treatment cycle (Table 1). In Cycle 1, KYPROLIS is administered at a dose of 20 mg/m2. If tolerated in Cycle 1, the dose should be escalated to 27 mg/m2 beginning in Cycle 2 and continued at 27 mg/m2 in subsequent cycles. Treatment may be continued until disease progression or until unacceptable toxicity occurs [see Dosage and Administration]. The dose is calculated using the patient’s actual body surface area at baseline. Patients with a body surface area greater than 2.2 m2 should receive a dose based upon a body surface area of 2.2 m2. Dose adjustments do not need to be made for weight changes of less than or equal to 20%. Table 1: KYPROLIS Dosage Regimen for Patients with Multiple Myeloma Cycle 1 Week 1 Week 2 Week 3 Week 4 Day Day Days Day Day Days Day Day Days Days 2 3–7 8 9 10–14 15 16 17–21 22–28 1 KYPROLIS No 20 20 20 No 20 20 No No 20 (20 mg/m2): Dosing Dosing Dosing Dosing a Cycles 2 and Beyond Week 1 Week 2 Week 3 Week 4 Day Day Days Day Day Days Day Day Days Days 2 3–7 8 9 10–14 15 16 17–21 22–28 1 KYPROLIS 27 No 27 27 No 27 27 No No 27 2 Dosing Dosing Dosing Dosing (27 mg/m ): a If
previous cycle dosage is tolerated.
Hydration and Fluid Monitoring. Hydrate patients to reduce the risk of renal toxicity and of tumor lysis syndrome (TLS) with KYPROLIS treatment [see Warnings and Precautions]. Maintain adequate fluid volume status throughout treatment and monitor blood chemistries closely. Prior to each dose in Cycle 1, give 250 mL to 500 mL of intravenous normal saline or other appropriate intravenous fluid. Give an additional 250 mL to 500 mL of intravenous fluids as needed following KYPROLIS administration. Continue intravenous hydration, as needed, in subsequent cycles. Also monitor patients during this period for fluid overload [see Warnings and Precautions]. Dexamethasone Premedication. Pre‑medicate with dexamethasone 4 mg orally or intravenously prior to all doses of KYPROLIS during Cycle 1 and prior to all KYPROLIS doses during the first cycle of dose escalation to 27 mg/m2 to reduce the incidence and severity of infusion reactions [see Warnings and Precautions]. Reinstate dexamethasone premedication (4 mg orally or intravenously) if these symptoms develop or reappear during subsequent cycles. Dose Modifications based on Toxicities. Recommended actions and dose modifications are presented in Table 2. Table 2: Dose Modifications for Toxicitya during KYPROLIS Treatment Hematologic Toxicity • Grade 3a or 4 Neutropenia • Grade 4 Thrombocytopenia [see Warnings and Precautions]
Recommended Action • Withhold dose. • If fully recovered before next scheduled dose, continue at same dose level. • If recovered to Grade 2 neutropenia or Grade 3 thrombocytopenia, reduce dose by one dose level (from 27 mg/m2 to 20 mg/m2, OR from 20 mg/m2 to 15 mg/m2). • If tolerated, the reduced dose may be escalated to the previous dose at the discretion of the physician. Non-Hematologic Toxicity Recommended Action • Withhold until resolved or returned to baseline. Cardiac Toxicity Grade 3 or 4, new onset or worsening of: • After resolution, consider if restarting KYPROLIS at a reduced dose is appropriate (from 27 mg/m2 to • congestive heart failure; 20 mg/m2, OR from 20 mg/m2 to 15 mg/m2). • decreased left ventricular • If tolerated, the reduced dose may be escalated to the function; previous dose at the discretion of the physician. • or myocardial ischemia [see Warnings and Precautions] Pulmonary Hypertension • Withhold until resolved or returned to baseline. • Restart at the dose used prior to the event or reduced [see Warnings and Precautions] dose (from 27 mg/m2 to 20 mg/m2, OR from 20 mg/m2 to 15 mg/m2), at the discretion of the physician. • If tolerated, the reduced dose may be escalated to the previous dose at the discretion of the physician. • Withhold until resolved or returned to baseline. Pulmonary Complications • Consider restarting at the next scheduled treatment • Grade 3 or 4 with one dose level reduction (from 27 mg/m2 to [see Warnings and Precautions] 20 mg/m2, OR from 20 mg/m2 to 15 mg/m2). • If tolerated, the reduced dose may be escalated to the previous dose at the discretion of the physician. • Withhold until resolved or returned to baseline. Hepatic Toxicity • After resolution, consider if restarting KYPROLIS is • Grade 3 or 4 elevation of appropriate; may be reinitiated at a reduced dose (from transaminases, bilirubin or other 27 mg/m2 to 20 mg/m2, OR from 20 mg/m2 to 15 mg/m2) liver abnormalities with frequent monitoring of liver function. [see Warnings and Precautions)] • If tolerated, the reduced dose may be escalated to the previous dose at the discretion of the physician. (continued)
Table 2: Dose Modifications for Toxicitya during KYPROLIS Treatment (continued) • Withhold until renal function has recovered to Grade 1 Renal Toxicity or to baseline and monitor renal function. • Serum creatinine equal to or • If attributable to KYPROLIS, restart at the next scheduled greater than 2 × baseline treatment at a reduced dose (from 27 mg/m2 to [see Adverse Reactions] 20 mg/m2, OR from 20 mg/m2 to 15 mg/m2). • If not attributable to KYPROLIS, restart at the dose used prior to the event. • If tolerated, the reduced dose may be escalated to the previous dose at the discretion of the physician. • Withhold until resolved or returned to baseline. Peripheral Neuropathy • Restart at the dose used prior to the event or reduced • Grade 3 or 4 dose (from 27 mg/m2 to 20 mg/m2, OR from 20 mg/m2 [see Adverse Reactions] to 15 mg/m2), at the discretion of the physician. • If tolerated, the reduced dose may be escalated to the previous dose at the discretion of the physician. • Withhold until resolved or returned to baseline. Other • Grade 3 or 4 non-hematological • Consider restarting at the next scheduled treatment with one dose level reduction (from 27 mg/m2 to toxicities 20 mg/m2, OR from 20 mg/m2 to 15 mg/m2). • If tolerated, the reduced dose may be escalated to the previous dose at the discretion of the physician. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0.
Administration Precautions. The quantity of KYPROLIS contained in one single‑use vial (60 mg carfilzomib) may exceed the required dose. Caution should be used in calculating the quantity delivered to prevent overdosing. Do not mix KYPROLIS with or administer as an infusion with other medicinal products. The intravenous administration line should be flushed with normal saline or 5% Dextrose Injection, USP immediately before and after KYPROLIS administration. KYPROLIS should not be administered as a bolus. KYPROLIS should be administered over 2 to 10 minutes. Reconstitution and Preparation for Intravenous Administration. KYPROLIS vials contain no antimicrobial preservatives and are intended only for single use. Unopened vials of KYPROLIS are stable until the date indicated on the package when stored in the original package at 2°C to 8°C (36°F to 46°F). The reconstituted solution contains carfilzomib at a concentration of 2 mg/mL. Read the complete preparation instructions prior to reconstitution. Reconstitution/Preparation Steps: 1. Remove vial from refrigerator just prior to use. 2. Aseptically reconstitute each vial by slowly injecting 29 mL Sterile Water for Injection, USP, directing the solution onto the INSIDE WALL OF THE VIAL to minimize foaming. 3. Gently swirl and/or invert the vial slowly for about 1 minute, or until complete dissolution of any cake or powder occurs. DO NOT SHAKE to avoid foam generation. If foaming occurs, allow solution to rest in vial for about 2 to 5 minutes, until foaming subsides. 4. After reconstitution, KYPROLIS is ready for intravenous administration. The reconstituted product should be a clear, colorless solution. If any discoloration or particulate matter is observed, do not use the reconstituted product. 5. When administering in an intravenous bag, withdraw the calculated dose [see Dosage and Administration] from the vial and dilute into 50 mL 5% Dextrose Injection, USP intravenous bag. 6. Immediately discard the vial containing the unused portion. The stabilities of reconstituted KYPROLIS under various temperature and container conditions are shown in Table 3. Table 3: Stability of Reconstituted KYPROLIS Storage Conditions of Reconstituted KYPROLIS
Stabilitya per Container Vial
IV Bag (D5Wb)
Refrigerated (2°C to 8°C; 36°F to 46°F)
Room Temperature (15°C to 30°C; 59°F to 86°F)
Total time from reconstitution to administration should not exceed 24 hours. b 5% Dextrose Injection, USP.
WARNINGS AND PRECAUTIONS: Cardiac Arrest, Congestive Heart Failure, Myocardial Ischemia. Death due to cardiac arrest has occurred within a day of KYPROLIS administration. New onset or worsening of pre‑existing congestive heart failure with decreased left ventricular function or myocardial ischemia have occurred following administration of KYPROLIS. Cardiac failure events (e.g., cardiac failure congestive, pulmonary edema, ejection fraction decreased) were reported in 7% of patients. Monitor for cardiac complications and manage promptly. Withhold KYPROLIS for Grade 3 or 4 cardiac events until recovery and consider whether to restart KYPROLIS based on a benefit/risk assessment [see Dosage and Administration]. Patients with New York Heart Association Class III and IV heart failure, myocardial infarction in the preceding 6 months, and conduction abnormalities uncontrolled by medications were not eligible for the clinical trials. These patients may be at greater risk for cardiac complications. Pulmonary Hypertension. Pulmonary arterial hypertension (PAH) was reported in 2% of patients treated with KYPROLIS and was Grade 3 or greater in less than 1% of patients. Evaluate with cardiac imaging and/or other tests as indicated. Withhold KYPROLIS for pulmonary hypertension until resolved or returned to baseline and consider whether to restart KYPROLIS based on a benefit/risk assessment [see Dosage and Administration]. Pulmonary Complications. Dyspnea was reported in 35% of patients enrolled in clinical trials. Grade 3 dyspnea occurred in 5%; no Grade 4 events, and 1 death (Grade 5) was reported. Monitor and manage dyspnea immediately; interrupt KYPROLIS until symptoms have resolved or returned to baseline [see Dosage and Administration and Adverse Reactions]. Infusion Reactions. Infusion reactions were characterized by a spectrum of systemic symptoms including fever, chills, arthralgia, myalgia, facial flushing, facial edema, vomiting, weakness, shortness of breath, hypotension, syncope, chest tightness, or angina. These reactions can occur immediately following or up to 24 hours after administration of KYPROLIS. Administer dexamethasone prior to KYPROLIS to reduce the incidence and severity of reactions [see Dosage and Administration]. Inform patients of the risk and symptoms and to contact physician if symptoms of an infusion reaction occur [see Patient Counseling Information]. Tumor Lysis Syndrome. Tumor lysis syndrome (TLS) occurred following KYPROLIS administration in < 1% of patients. Patients with multiple myeloma and a high tumor burden should be considered to be at greater risk for TLS. Prior to receiving KYPROLIS, ensure that patients are well hydrated [see Dosage and Administration]. Monitor for evidence of TLS during treatment, and manage promptly. Interrupt KYPROLIS until TLS is resolved [see Dosage and Administration].Thrombocytopenia. KYPROLIS causes thrombocytopenia with platelet nadirs occurring around Day 8 of each 28‑day cycle and recovery to baseline by the start of the next 28-day cycle. In patients with multiple myeloma, 36% of patients experienced thrombocytopenia, including Grade 4 in 10%. Thrombocytopenia following KYPROLIS administration resulted in a dose reduction in 1% of patients and discontinuation of treatment with KYPROLIS in < 1% of patients. Monitor platelet counts frequently during treatment with KYPROLIS. Reduce or interrupt dose as clinically indicated [see Dosage and Administration]. Hepatic Toxicity and Hepatic Failure. Cases of hepatic failure, including fatal cases, have been
reported (< 1%). KYPROLIS can cause elevations of serum transaminases and bilirubin. Withhold KYPROLIS in patients experiencing Grade 3 or greater elevations of transaminases, bilirubin, or other liver abnormalities until resolved or returned to baseline. After resolution, consider if restarting KYPROLIS is appropriate. Monitor liver enzymes frequently [see Dosage and Administration and Adverse Reactions]. Embryo-fetal Toxicity. KYPROLIS can cause fetal harm when administered to a pregnant woman based on its mechanism of action and findings in animals. There are no adequate and well‑controlled studies in pregnant women using KYPROLIS. Carfilzomib caused embryo‑fetal toxicity in pregnant rabbits at doses that were lower than in patients receiving the recommended dose. Females of reproductive potential should be advised to avoid becoming pregnant while being treated with KYPROLIS. 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 [see Use in Specific Populations]. ADVERSE REACTIONS: The following adverse reactions are discussed in greater detail in other sections of the labeling: • Cardiac Arrest, Congestive Heart Failure, Myocardial Ischemia [see Warnings and Precautions] • Pulmonary Hypertension [see Warnings and Precautions] • Pulmonary Complications [see Warnings and Precautions] • Infusion Reactions [see Warnings and Precautions] • Tumor Lysis Syndrome [see Warnings and Precautions] • Thrombocytopenia [see Warnings and Precautions] • Hepatic Toxicity and Hepatic Failure [see Warnings and Precautions] The most common adverse reactions (incidence of 30% or greater) to KYPROLIS observed in clinical trials of patients with multiple myeloma were fatigue, anemia, nausea, thrombocytopenia, dyspnea, diarrhea, and pyrexia. Clinical Trials Safety 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 with rates in the clinical trials of another drug, and may not reflect the rates observed in medical practice. A total of 526 patients with relapsed and/or refractory multiple myeloma received KYPROLIS as monotherapy or with pre‑dose dexamethasone. Patients received a median of four treatment cycles with a median cumulative KYPROLIS dose of 993.4 mg. Deaths due to all causes within 30 days of the last dose of KYPROLIS occurred in 37/526 (7%) of patients. Deaths not attributed to disease progression were cardiac in 5 patients (acute coronary syndrome, cardiac arrest, cardiac disorder), end‑organ failure in 4 patients (multi‑organ failure, hepatic failure, renal failure), infection in 4 patients (sepsis, pneumonia, respiratory tract bacterial infection), dyspnea and intracranial hemorrhage in 1 patient each, and 1 patient found dead of unknown causes. Serious adverse reactions were reported in 45% patients. The most common serious adverse reactions were pneumonia (10%), acute renal failure (4%), pyrexia (3%), and congestive heart failure (3%). Adverse reactions leading to discontinuation of KYPROLIS occurred in 15% of patients and included congestive heart failure (2%), cardiac arrest, dyspnea, increased blood creatinine, and acute renal failure (1% each). Adverse reactions occurring at a rate of 10% or greater are presented in Table 4. Table 4: Incidence of Adverse Reactions Occurring in ≥ 10% of Multiple Myeloma Patients Treated with KYPROLIS
Event Fatigue Anemia Nausea Thrombocytopenia Dyspnea Diarrhea Pyrexia Upper respiratory tract infection Headache Cough Blood creatinine increased Lymphopenia Edema peripheral Vomiting Constipation Neutropenia Back pain Insomnia Chills Arthralgia Muscle spasms Hypertension Asthenia Hypokalemia Hypomagnesemia Leukopenia Pain in extremity Pneumonia Aspartate aminotransferase increased Dizziness Hypoesthesia Anorexia Pain Hyperglycemia Chest wall pain Hypercalcemia Hypophosphatemia Hyponatremia
All Gradesa 292 (55.5) 246 (46.8) 236 (44.9) 191 (36.3) 182 (34.6) 172 (32.7) 160 (30.4) 149 (28.3) 145 (27.6) 137 (26.0) 127 (24.1) 126 (24.0) 126 (24.0) 117 (22.2) 110 (20.9) 109 (20.7) 106 (20.2) 94 (17.9) 84 (16.0) 83 (15.8) 76 (14.4) 75 (14.3) 73 (13.9) 72 (13.7) 71 (13.5) 71 (13.5) 70 (13.3) 67 (12.7) 66 (12.5) 66 (12.5) 64 (12.2) 63 (12.0) 63 (12.0) 62 (11.8) 60 (11.4) 58 (11.0) 55 (10.5) 54 (10.3)
Patients (N = 526) [n (%)] Grade 3 Events 38 (7.2) 111 (21.1) 7 (1.3) 69 (13.1) 25 (4.8) 4 (0.8) 7 (1.3) 17 (3.2) 7 (1.3) 1 (0.2) 13 (2.5) 84 (16.0) 3 (0.6) 5 (1.0) 1 (0.2) 50 (9.5) 15 (2.9) 0 1 (0.2) 7 (1.3) 2 (0.4) 15 (2.9) 12 (2.3) 14 (2.7) 2 (0.4) 27 (5.1) 7 (1.3) 52 (9.9) 15 (2.9) 5 (1.0) 3 (0.6) 1 (0.2) 12 (2.3) 16 (3.0) 3 (0.6) 13 (2.5) 24 (4.6) 31 (5.9)
Grade 4 Events 2 (0.4) 7 (1.3) 0 54 (10.3) 1 (0.2)b 1 (0.2) 2 (0.4) 0 0 0 1 (0.2) 11 (2.1) 0 0 0 4 (0.8) 0 0 0 0 0 2 (0.4) 1 (0.2) 3 (0.6) 0 1 (0.2) 0 3 (0.6)b 1 (0.2) 1 (0.2) 0 0 0 3 (0.6) 0 8 (1.5) 3 (0.6) 3 (0.6)
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0. One event was Grade 5 severity.
Description of Selected Adverse Drug Reactions. Renal Events: The most common renal adverse reactions were increase in blood creatinine (24%) and renal failure (9%), which were mostly Grade 1 or Grade 2 in severity. Grade 3 renal adverse reactions occurred in 6% of patients and Grade 4 events occurred in 1%. Discontinuations due to increased blood creatinine and acute renal failure were 1% each. In one patient, death occurred with concurrent sepsis and worsening renal function [see Dosage and Administration]. Peripheral Neuropathy: Peripheral neuropathy (including all events of peripheral sensory neuropathy and peripheral motor neuropathy) occurred in 14% of patients enrolled in clinical trials. Grade 3 peripheral neuropathy occurred in 1% of patients. Serious peripheral neuropathy events occurred in < 1% of patients, which resulted in dose reduction in < 1% and treatment discontinuation in < 1%. Withhold or discontinue treatment as recommended [see Dosage and Administration]. Herpes Virus Infection: Herpes zoster reactivation was reported in 2% of patients. Consider antiviral prophylaxis for patients who have a history of herpes zoster infection. DRUG INTERACTIONS: Carfilzomib is primarily metabolized via peptidase and epoxide hydrolase activities, and as a result, the pharmacokinetic profile of carfilzomib is unlikely to be affected by concomitant administration of cytochrome P450 inhibitors and inducers. Carfilzomib is not expected to influence exposure of other drugs [see Clinical Pharmacology section of full PI]. USE IN SPECIFIC POPULATIONS: Pregnancy. Pregnancy Category D [see Warnings and Precautions]. Females of reproductive potential should be advised to avoid becoming pregnant while being treated with KYPROLIS. Based on its mechanism of action and findings in animals, KYPROLIS can cause fetal harm when administered to a pregnant woman. Carfilzomib caused embryo‑fetal toxicity in pregnant rabbits at doses that were lower than in patients receiving the recommended dose. If KYPROLIS 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. Carfilzomib was administered intravenously to pregnant rats and rabbits during the period of organogenesis at doses of 0.5, 1, and 2 mg/kg/day in rats and 0.2, 0.4, and 0.8 mg/kg/day in rabbits. Carfilzomib was not teratogenic at any dose tested. In rabbits, there was an increase in pre‑implantation loss at ≥ 0.4 mg/kg/day and an increase in early resorptions and post‑implantation loss and a decrease in fetal weight at the maternally toxic dose of 0.8 mg/kg/day. The doses of 0.4 and 0.8 mg/kg/day in rabbits are approximately 20% and 40%, respectively, of the recommended dose in humans of 27 mg/m2 based on body surface area. Nursing Mothers. It is not known whether KYPROLIS is excreted in human milk. Since many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from KYPROLIS, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Pediatric Use. The safety and effectiveness of KYPROLIS in pediatric patients have not been established. Geriatric Use. In studies of KYPROLIS there were no clinically significant differences observed in safety and efficacy between patients less than 65 years of age and patients 65 years of age and older. Renal Impairment. The pharmacokinetics and safety of KYPROLIS were evaluated in a Phase 2 trial in patients with normal renal function and those with mild, moderate, and severe renal impairment and patients on chronic dialysis. On average, patients were treated for 5.5 cycles using KYPROLIS doses of 15 mg/m2 on Cycle 1, 20 mg/m2 on Cycle 2, and 27 mg/m2 on Cycles 3 and beyond. The pharmacokinetics and safety of KYPROLIS were not influenced by the degree of baseline renal impairment, including the patients on dialysis. Since dialysis clearance of KYPROLIS concentrations has not been studied, the drug should be administered after the dialysis procedure [see Clinical Pharmacology section of full PI]. Hepatic Impairment. The safety, efficacy and pharmacokinetics of KYPROLIS have not been evaluated in patients with baseline hepatic impairment. Patients with the following laboratory values were excluded from the KYPROLIS clinical trials: ALT/AST ≥ 3 × upper limit of normal (ULN) and bilirubin ≥ 2 × ULN [see Clinical Pharmacology section of full PI]. Cardiac Impairment. Patients with New York Heart Association Class III and IV heart failure were not eligible for the clinical trials. Safety in this population has not been evaluated. OVERDOSAGE: There is no known specific antidote for KYPROLIS overdosage. In the event of an overdosage, monitor the patient and provide appropriate supportive care. NONCLINICAL TOXICOLOGY: Carcinogenesis, Mutagenesis, and Impairment of Fertility. Carcinogenicity studies have not been conducted with carfilzomib. Carfilzomib was clastogenic in the in vitro chromosomal aberration test in peripheral blood lymphocytes. Carfilzomib was not mutagenic in the in vitro bacterial reverse mutation (Ames) test and was not clastogenic in the in vivo mouse bone marrow micronucleus assay. Fertility studies with carfilzomib have not been conducted. No effects on reproductive tissues were noted during 28‑day repeat‑dose rat and monkey toxicity studies or in 6‑month rat and 9‑month monkey chronic toxicity studies. Animal Toxicology and/ or Pharmacology. Monkeys administered a single bolus intravenous dose of carfilzomib at 3 mg/kg (approximately 1.3 times recommended dose in humans of 27 mg/m2 based on body surface area) experienced hypotension, increased heart rate, and increased serum levels of troponin‑T. The repeated bolus intravenous administration of carfilzomib at ≥ 2 mg/kg/dose in rats and 2 mg/kg/dose in monkeys using dosing schedules similar to those used clinically resulted in mortalities that were due to toxicities occurring in the cardiovascular (cardiac failure, cardiac fibrosis, pericardial fluid accumulation, cardiac hemorrhage/degeneration), gastrointestinal (necrosis/hemorrhage), renal (glomerulonephropathy, tubular necrosis, dysfunction), and pulmonary (hemorrhage/inflammation) systems. The dose of 2 mg/kg/dose in rats is approximately half the recommended dose in humans of 27 mg/m2 based on body surface area. The dose of 2 mg/kg/dose in monkeys is approximately equivalent to the recommended dose in humans based on body surface area. PATIENT COUNSELING INFORMATION: Discuss the following with patients prior to treatment with KYPROLIS: Instruct patients to contact their physician if they develop any of the following symptoms: fever, chills, rigors, chest pain, cough, or swelling of the feet or legs. Advise patients that KYPROLIS may cause fatigue, dizziness, fainting, and/or drop in blood pressure. Advise patients not to drive or operate machinery if they experience any of these symptoms. Advise patients that they may experience shortness of breath (dyspnea) during treatment with KYPROLIS. This most commonly occurs within a day of dosing. Advise patients to contact their physicians if they experience shortness of breath. Counsel patients to avoid dehydration, since patients receiving KYPROLIS therapy may experience vomiting and/or diarrhea. Instruct patients to seek medical advice if they experience symptoms of dizziness, lightheadedness, or fainting spells. Counsel females of reproductive potential to use effective contraceptive measures to prevent pregnancy during treatment with KYPROLIS. Advise the patient that if she becomes pregnant during treatment, to contact her physician immediately. Advise patients not to take KYPROLIS treatment while pregnant or breastfeeding. If a patient wishes to restart breastfeeding after treatment, advise her to discuss the appropriate timing with her physician. Advise patients to discuss with their physician any medication they are currently taking prior to starting treatment with KYPROLIS, or prior to starting any new medication(s) during treatment with KYPROLIS.
Manufactured for: Onyx Pharmaceuticals, Inc., 249 East Grand Avenue, South San Francisco, CA 94080 U.S. Patent Numbers: 7,232,818; 7,417,042; 7,491,704; 7,737,112 05-1088-00 ©2012 Onyx Pharmaceuticals, Inc. 1012-CARF-409 September 2012
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February 2014 • Volume 4 • Number 1
Oncology Practice Management ™
FOR ONCOLOGISTS, PRACTICE MANAGERS, FINANCIAL COUNSELORS, AND REIMBURSEMENT SPECIALISTS™
FROM THE EDITOR Weathering the Storm Ahead...........................................................................1
By Dawn Holcombe, MBA, FACMPE, ACHE
FEATURES Best Practices One of the Many Faces of Oncology Care Management............................1 By Sheryl A. Riley, RN, OCN, CMCN
Medical Group Management Association Conference Controlling Your Practice’s Destiny.........................................................................1 By Sandra Paton
Maximizing Your Practice Scores…..................................................................18 By Sandra Paton
Cancer Center Business Summit Data Drive Change: Identifying Trends and Shifts in Oncology.........................................................................................................26 By Frederique H. Evans, MBS
DEPARTMENTS Clinical Trial Tracker New Clinical Trials Under Way…......................................................................23 Continued on page 8
MISSION STATEMENT Oncology 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 that patients with cancer deserve, providers must master the ever-changing business of oncology. Oncology Practice Management offers process solutions for members of the cancer care team—medical, surgical, and radiation oncologists, as well as executives, administrators, and coders/billers—to assist them in reimbursment, staffing, electronic health records, REMS, and compliance with state and federal regulations. POSTMASTER: Correspondence regarding subscriptions or change of address should be directed to CIRCULATION DIRECTOR, Oncology 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. BPA Worldwide membership applied for September 2013.
ONCOLOGY PRACTICE MANAGEMENT
I February 2014
Now enrolling Investigating ABT-199 (GDC-0199) in Chronic Lymphocytic Leukemia Phase II Open-Label Study of the Efficacy and Safety of ABT-199 in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia Harboring the 17p Deletion N=100
ABT-199 is an investigational agent that has not been approved by regulatory agencies for the use under investigation in this trial. Primary Endpoint
• Overall response rate
• • • • • • • •
Complete remission rate Partial remission rate Duration of response Progression-free survival Time to progression Overall survival Percentage of patients who move on to stem-cell transplant Safety and tolerability of ABT-199
Key Inclusion Criteria • Adult patients ≥18 years of age • Diagnosis of CLL that meets 2008 IWCLL NCI-WG criteria (relapsed/refractory after receiving ≥1 prior line of therapy and 17p deletion) • ECOG performance score of ≤2 • Adequate bone marrow function • Adequate coagulation, renal, and hepatic function, per laboratory reference range
NCT#01889186 Reference: ClinicalTrials.gov.
@ 2013 Genentech USA, Inc. All rights reserved. BIO0001961500 Printed in USA.
To learn more about this study, please visit www.ClinicalTrials.gov.
Table of Contents
February 2014 • Volume 4 • Number 1
Oncology Practice Management™, ISSN 2164-4403 (print), is published 8 times a year by Engage Healthcare Communications, LLC, 1249 South River Road, Suite 202A, Cranbury, NJ 08512. Copyright ©2014 by Engage Healthcare Communications, LLC. All rights reserved. Oncology 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 Oncology 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 Oncology 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.
Oncology Practice Management ™
FOR ONCOLOGISTS, PRACTICE MANAGERS, FINANCIAL COUNSELORS, AND REIMBURSEMENT SPECIALISTS™
Continued from page 6
DEPARTMENTS Patient and Provider Access States Looking at Biosimilar Regulation...........................................................29 By Sydney Abbott, JD
Drug Coding FDA-Approved Medications Used for Supportive Care in Cancer Treatment........................................................................................30 Wealth Management Eight Resolutions to Improve Your Finances in the New Year...............................................................................................36 By Andrew D. Schwartz, CPA; and Lawrence B. Keller, CFP®, CLU®, ChFC®, RHU®, LUTCF
EDITORIAL ADVISORY BOARD Editor-in-Chief Dawn Holcombe, MBA, FACMPE, ACHE President DGH Consulting South Windsor, CT Peggy Barton, RN Practice Manager Toledo, OH Risë Marie Cleland President Oplinc, Inc Portland, OR Craig K. Deligdish, MD Hematologist/Oncologist Oncology Resource Networks Orlando, FL
Patrick A. Grusenmeyer, ScD, FACHE President Christiana Care Health Initiatives Newark, DE Teri U. Guidi, MBA, FAAMA President and CEO Oncology Management Consulting Group Pipersville, PA Marianna Lamb, MS Exceutive Director Medical Oncology Association of Southern California Upland, CA
ONCOLOGY PRACTICE MANAGEMENT
Ruth Linné Lander, FACMPE Practice Administrator Columbus Oncology & Hematology Associates, Inc Columbus, OH
Robert D. Orzechowski, MBA, SPHR CEO Lancaster Cancer Center Ltd. Lancaster, PA
Bonnie J. Miller, RN, BSN, OCN, FAAMA Administrative Director Women’s Cancer Center Fox Chase Cancer Center Philadelphia, PA
Mary Pat Whaley, FACMPE, CPC Physician Advocate and Consultant www.managemypractice.com Durham, NC
Karna W. Morrow, CPC, RCC, CCS-P, PCS Senior Consultant CSI Coding Strategies, Inc Powder Springs, GA
Carla C. Wood Balch, CPC, MS President Altos Solutions, Inc Los Altos, CA
I February 2014
exhaust all possibilities.
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• Prescription status • Celgene free medication program • Celgene products and restricted distribution programs 4 out of 5 patients who requested assistance from Celgene Patient Support ® received their medication.
Celgene Patient Support® is a registered trademark of Celgene Corporation. © 2013 Celgene Corporation 09/13 US-CELG110059(1)
One of the Many Faces of Oncology…Continued from the cover the current compensation models in the medical profession. In the past 10 years, I have seen the value of physician practices, hospital and managed care plans, as well as the vendors that serve them, being squeezed financially by governmental regulation and price cuts for services rendered. This type of environment is not patient-friendly or patient-focused as regulators would lead you to believe. Regulators want the public to believe that these changes and new rules are for the consumers’ benefit, so they do not get overcharged; however, these changes force practices to make a choice between staying profitable and remaining open, or providing patients with the most effective and appropriate care for their condition(s). They further force care-giving institutions and physician practices to make decisions for their patients driven solely by the cost and not by quality. This is not a direction that is beneficial for providers or for patients. Unfortunately, these new policies create a type of disincentive that, in turn, leads to poor quality of care and limited access to care for our oncology patients and their families. One thing that has remained universal over the years in healthcare is, “good care follows the dollar, not the other way around.” The start of accountable care organizations and the patient-centered medical home (PCMH) in the mid-2000s was the beginning of a new era in patient care, and one that we, as oncology care managers, applauded and embraced. These models place patient care back into the hands of physicians who ultimately have the proper training to direct patient care. Although these models were ideal for placing physicians back in charge of patients’ care rather than third-party payers, it required that their practices make significant changes to daily operations.
Because current governmental regulations and these care models are at odds with one another, it makes it all that more difficult for nurses to show physicians their need for appropriate compensation. Physicians will need to obtain the highest Centers for Medicare & Medicaid Services
STAR rating and reimbursement level possible to support well-qualified and highly trained oncology nurses, as well as the supporting staff required to run and manage a PCMH. The demands are high and the budgets tight. These practice-related decisions demand that physicians exercise excellent technology and are operational and business savvy. Oncology nurses who are knowledgeable in electronic care management software, electronic medical records (EMRs), and managed care will greatly assist in this process. They will need to become center stage if the practice or organizations are to succeed.
patients and families, but also create and develop the key components needed for a successful practice. Those components include: • EMR and care-coordination software will be key to the quality and financial success of each organization • Identifying patients in the practice or institution that can benefit most from the PCMH; those patients are the sickest and have the highest risk of failure in the community • Big data: the collection of as much patient data as possible to identify, engage, and retain patients in the program • Operational efficiency: utilizing innovative information technology (IT) systems and support to assist the practice and organization in moving from paper to electronic records. Finding ways to improve patient touches and patient self-management, and decrease failure rate and readmissions • Actionable data: reporting that helps the physician and oncology care manager improve treatment and manage patients, adverse effects to improve care • Highly educated and trained subset of oncology care managers with IT and managed care expertise • Key support staff, such as social workers and intake office staff, to engage and manage resources and services • Quality metrics for achieving a STAR rating of 5. Physicians and care-giving institutions need to stop contemplating and get started: you can do this by hiring well-qualified oncology care managers and watch your practice take flight. l
Successful Practices Knowledgeable oncology care managers can not only coordinate and assist in the management of
Acknowledgment I would like to thank Cortney C. Riley, PT, DPT, CSCS, for her assistance in editing this article.
Knowledgeable oncology care managers can not only coordinate and assist in the management of patients and families, but also create and develop the key components needed for a successful practice.
ONCOLOGY PRACTICE MANAGEMENT
I February 2014
Take a bite out of G-CSF acquisition costs* GRANIX is another option in short-acting G-CSF therapy TM
GRANIX™ is an option for hospitals and payers to consider when determining health system budgets » FDA approved through the rigorous BLA† process » Teva’s short-acting G-CSF was first introduced in Europe in 2008 and is available in 42 countries‡1 » GRANIX J Code: J 1446-Injection, tbo-filgrastim, 5 micrograms, effective January 1, 2014 †Biologics License Application. ‡As of February 2014. *Based on wholesale acquisition cost (WAC) of all short-acting G-CSF products as of November 11, 2013. WAC represents published catalogue or list prices and may not represent actual transactional prices. Please contact your supplier for actual prices.
» GRANIX is a leukocyte growth factor indicated for reduction in the duration of severe neutropenia in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia.
Important Safety Information » Splenic rupture: Splenic rupture, including fatal cases, can occur following the administration of human granulocyte colonystimulating factors (hG-CSFs). Discontinue GRANIX and evaluate for an enlarged spleen or splenic rupture in patients who report upper abdominal or shoulder pain after receiving GRANIX. » Acute respiratory distress syndrome (ARDS): ARDS can occur in patients receiving hG-CSFs. Evaluate patients who develop fever and lung infiltrates or respiratory distress after receiving GRANIX, for ARDS. Discontinue GRANIX in patients with ARDS. » Allergic reactions: Serious allergic reactions, including anaphylaxis, can occur in patients receiving hG-CSFs. Reactions can occur on initial exposure. Permanently discontinue GRANIX in patients with serious allergic reactions. Do not administer GRANIX to patients with a history of serious allergic reactions to filgrastim or pegfilgrastim. » Use in patients with sickle cell disease: Severe and sometimes fatal sickle cell crises can occur in patients with sickle cell disease receiving hG-CSFs. Consider the potential risks and benefits prior to the administration of GRANIX in patients with sickle cell disease. Discontinue GRANIX in patients undergoing a sickle cell crisis. » Potential for tumor growth stimulatory effects on malignant cells: The granulocyte colony-stimulating factor (G-CSF) receptor, through which GRANIX acts, has been found on tumor cell lines. The possibility that GRANIX acts as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia, diseases for which GRANIX is not approved, cannot be excluded. » Most common treatment-emergent adverse reaction: The most common treatment-emergent adverse reaction that occurred in patients treated with GRANIX at the recommended dose with an incidence of at least 1% or greater and two times more frequent than in the placebo group was bone pain. Please see brief summary of Full Prescribing Information on adjacent page. For more information, visit GRANIXhcp.com. Reference: 1. Data on file. Teva Pharmaceuticals: Filgrastim MA Approvals Worldwide. February 2014.
©2014 Cephalon, Inc., a wholly-owned subsidiary of Teva Pharmaceutical Industries Ltd. GRANIX is a trademark of Teva Pharmaceutical Industries Ltd. All rights reserved. GRX-40134 February 2014.
BRIEF SUMMARY OF PRESCRIBING INFORMATION FOR GRANIX™ (tbo-filgrastim) Injection, for subcutaneous use SEE PACKAGE INSERT FOR FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE GRANIX is indicated to reduce the duration of severe neutropenia in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. 4 CONTRAINDICATIONS None. 5 WARNINGS AND PRECAUTIONS 5.1 Splenic Rupture Splenic rupture, including fatal cases, can occur following administration of human granulocyte colony-stimulating factors. In patients who report upper abdominal or shoulder pain after receiving GRANIX, discontinue GRANIX and evaluate for an enlarged spleen or splenic rupture. 5.2 Acute Respiratory Distress Syndrome (ARDS) Acute respiratory distress syndrome (ARDS) can occur in patients receiving human granulocyte colony-stimulating factors. Evaluate patients who develop fever and lung infiltrates or respiratory distress after receiving GRANIX, for ARDS. Discontinue GRANIX in patients with ARDS. 5.3 Allergic Reactions Serious allergic reactions including anaphylaxis can occur in patients receiving human granulocyte colony-stimulating factors. Reactions can occur on initial exposure. The administration of antihistamines‚ steroids‚ bronchodilators‚ and/or epinephrine may reduce the severity of the reactions. Permanently discontinue GRANIX in patients with serious allergic reactions. Do not administer GRANIX to patients with a history of serious allergic reactions to filgrastim or pegfilgrastim. 5.4 Use in Patients with Sickle Cell Disease Severe and sometimes fatal sickle cell crises can occur in patients with sickle cell disease receiving human granulocyte colony-stimulating factors. Consider the potential risks and benefits prior to the administration of human granulocyte colony-stimulating factors in patients with sickle cell disease. Discontinue GRANIX in patients undergoing a sickle cell crisis. 5.5 Potential for Tumor Growth Stimulatory Effects on Malignant Cells The granulocyte colony-stimulating factor (G-CSF) receptor through which GRANIX acts has been found on tumor cell lines. The possibility that GRANIX acts as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia, diseases for which GRANIX is not approved, cannot be excluded. 6 ADVERSE REACTIONS The following potential serious adverse reactions are discussed in greater detail in other sections of the labeling: • Splenic Rupture [see Warnings and Precautions (5.1)] • Acute Respiratory Distress Syndrome [see Warnings and Precautions (5.2)] • Serious Allergic Reactions [see Warnings and Precautions (5.3)] • Use in Patients with Sickle Cell Disease [see Warnings and Precautions (5.4)] • Potential for Tumor Growth Stimulatory Effects on Malignant Cells [see Warnings and Precautions (5.5)] The most common treatment-emergent adverse reaction that occurred at an incidence of at least 1% or greater in patients treated with GRANIX at the recommended dose and was numerically two times more frequent than in the placebo group was bone pain. 6.1 Clinical Trials 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. GRANIX clinical trials safety data are based upon the results of three randomized clinical trials in patients receiving myeloablative chemotherapy for breast cancer (N=348), lung cancer (N=240) and non-Hodgkin’s lymphoma (N=92). In the breast cancer study, 99% of patients were female, the median age was 50 years, and 86% of patients were Caucasian. In the lung cancer study, 80% of patients were male, the median age was 58 years, and 95% of patients were Caucasian. In the non-Hodgkin’s lymphoma study, 52% of patients were male, the median age was 55 years, and 88% of patients were Caucasian. In all three studies a placebo (Cycle 1 of the breast cancer study only) or a non-US-approved filgrastim product were used as controls. Both GRANIX and the non-US-approved filgrastim product were administered at 5 mcg/kg subcutaneously once daily beginning one day after chemotherapy for at least five days and continued to a maximum of 14 days or until an ANC of ≥10,000 x 106/L after nadir was reached.
Bone pain was the most frequent treatment-emergent adverse reaction that occurred in at least 1% or greater in patients treated with GRANIX at the recommended dose and was numerically two times more frequent than in the placebo group. The overall incidence of bone pain in Cycle 1 of treatment was 3.4% (3.4% GRANIX, 1.4% placebo, 7.5% non-US-approved filgrastim product). Leukocytosis In clinical studies, leukocytosis (WBC counts > 100,000 x 106/L) was observed in less than 1% patients with non-myeloid malignancies receiving GRANIX. No complications attributable to leukocytosis were reported in clinical studies. 6.2 Immunogenicity As with all therapeutic proteins, there is a potential for immunogenicity. The incidence of antibody development in patients receiving GRANIX has not been adequately determined. 7 DRUG INTERACTIONS No formal drug interaction studies between GRANIX and other drugs have been performed. Drugs which may potentiate the release of neutrophils‚ such as lithium‚ should be used with caution. Increased hematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone imaging changes. This should be considered when interpreting bone-imaging results. 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Pregnancy Category C There are no adequate and well-controlled studies of GRANIX in pregnant women. In an embryofetal developmental study, treatment of pregnant rabbits with tbo-filgrastim resulted in adverse embryofetal findings, including increased spontaneous abortion and fetal malformations at a maternally toxic dose. GRANIX should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. In the embryofetal developmental study, pregnant rabbits were administered subcutaneous doses of tbo-filgrastim during the period of organogenesis at 1, 10 and 100 mcg/kg/day. Increased abortions were evident in rabbits treated with tbo-filgrastim at 100 mcg/kg/day. This dose was maternally toxic as demonstrated by reduced body weight. Other embryofetal findings at this dose level consisted of post-implantation loss‚ decrease in mean live litter size and fetal weight, and fetal malformations such as malformed hindlimbs and cleft palate. The dose of 100 mcg/kg/day corresponds to a systemic exposure (AUC0-24) of approximately 50-90 times the exposures observed in patients treated with the clinical tbo-filgrastim dose of 5 mcg/kg/day. 8.3 Nursing Mothers It is not known whether tbo-filgrastim is secreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when GRANIX is administered to a nursing woman. Other recombinant G-CSF products are poorly secreted in breast milk and G-CSF is not orally absorbed by neonates. 8.4 Pediatric Use The safety and effectiveness of GRANIX in pediatric patients have not been established. 8.5 Geriatric Use Among 677 cancer patients enrolled in clinical trials of GRANIX, a total of 111 patients were 65 years of age and older. No overall differences in safety or effectiveness were observed between patients age 65 and older and younger patients. 8.6 Renal Impairment The safety and efficacy of GRANIX have not been studied in patients with moderate or severe renal impairment. No dose adjustment is recommended for patients with mild renal impairment. 8.7 Hepatic Impairment The safety and efficacy of GRANIX have not been studied in patients with hepatic impairment. 10 OVERDOSAGE No case of overdose has been reported. ©2013 Cephalon, Inc., a wholly owned subsidiary of Teva Pharmaceutical Industries Ltd. All rights reserved. GRANIX is a trademark of Teva Pharmaceutical Industries Ltd. Manufactured by: Distributed by: Sicor Biotech UAB Teva Pharmaceuticals USA, Inc. Vilnius, Lithuania North Wales, PA 19454 U.S. License No. 1803 Product of Israel GRX-40189 January 2014 This brief summary is based on TBO-003 GRANIX full Prescribing Information.
From the Editor
Weathering the Storm Ahead…Continued from the cover ered to be small changes and get slammed for crying doom before it happens. How often have you called a representative or senator in your state or in Congress to alert them to pending issues? We know oncology, and understand our patients and the day-to-day issues they face. It is our obligation to look at all change and consider whether the intended changes will actually take place. We have no choice but to look forward and anticipate, but now the field we need to survey is expanding. The weight of many small changes can create a long-lasting impact. Oncology is not a stand-alone specialty, and our connection with other services and patient medical conditions means that we are also affected by changes in other areas of the healthcare delivery system as well as to the nation’s economy. Those ripples, beginning outside of our normal focus of attention, are likely to hit with more force than the regular nuisances that we worry about daily. These storms swirling outside of our normal field of influence encompass control of healthcare dollars on a global basis. We rely on referrals from primary care, surgeons, pathologists, and others. Cancer must be suspected and detected before we can consider treatment. We rely on imaging, diagnostics, complementary surgery, and radiation therapy as part of the cancer care process. We focus on care details, developing oncology medical homes, quality programs, care guidelines and pathways, and other elements that are—for the large part—under our control. While we build solutions from the oncology community outward, we need to also engage with the issues growing outside of our normal field of influence. Where are the biggest storms coming from the outside?
Accountability. Many emerging accountable care organizations will be flashes in the pan and dissolve as the complexity of the task they have undertaken overwhelms them. However, many more organizations are taking the role of accountability very seriously and starting significant changes that will affect the oncology community and care process. Treatment choices, costs, and care patterns of patients diagnosed with cancer will be affected as integrated systems or primary care groups work with private health plans to develop performance measures or even risk models that encompass total costs of care for an insured individual or population. Knowing who is entering this market, how they are defining accountability, and what choices they are making for controlling referrals, imaging, diagnostics, and preferred provider networks will be essential in 2014 for oncology groups.
Patient financial pressures. Patients are facing higher deductibles, copays, coinsurance, and other health-benefit restrictions. In some cases, formulary restrictions may not include the particular treatment that the physician or patient may desire. How will those financial or benefit-design pressures affect patient choice for treatment? The days are over when a physician could say with confidence, “I have the best reputation in the area, no matter what, so patients will overcome any hurdles to come to me.” We are starting to see patients acquiescing to benefit limitations on referral options, as well as making hard choices when faced with high costs and limited financial resources. It is unfortunate, but reality.
Oncology Practice Managers As we face 2014, challenges not just from arenas we habitually address, but new expanded challenges are coming at us from unfamiliar directions. We now have to keep our eyes on subtle ripples growing elsewhere in our markets; partnerships and institutional affiliations will become ever more important for both community and institutional cancer groups. Oncology practice managers will continue to be crucial to oncology, for their business and strategic acumen and focus, as well as financial and operational skill sets. Eventually, these changes will shift the course of oncology practice. That is inevitable. How we ride the waves and adapt will be determined by the strength of our vision and tenacity. Patients will continue to battle cancer. Physicians and nurses will continue to treat them. How, and in what structure, may change. Strong leadership will always be needed, even in the new order. We look forward to traversing this course together with you. l
Provider networks. Are you in or out? Are major insurers setting a course in 2014 to restrict networks and just have not yet had that conversation with you? Right and left, practices and physicians— even full academic hospital physician networks—received letters in 2012 and 2013 that they were being dropped from a provider network for no cause other than a change in business direction. This will become even more of an issue as those insurers, struggling to make the dollars work on health exchange insurance programs, balance their costs and provider options, or as institutions accepting risk and financial accountability for care, review their provider pools for how much control they hold in costly specialties. Look at your alignments, assess your opportunities and vulnerability.
Medical Group Management Association Conference
Controlling Your Practice’s Destiny…Continued from the cover Strategic Planning and Implementation Mr Wipperling cautioned that although strategic planning is one thing, it is equally impor tant to develop a way to achieve the goals your organization has identified. “Strategic planning is the process, but then you need to talk about implementation,” he said. Mr Wipperling referred to an old adage to emphasize his point: “Organizations don’t plan to fail. They fail to plan.” He illustrated this by describing the machinations of one organization that developed a 5-year strategic plan, 7 years ago. At the time, the organization had identified 5 priorities, but had managed to accomplish only 3 of them in 7 years. When he joined the group, it had begun the planning process, but shortened its vision from 5 years to 3 years. Eventually, he predicted, it would shorten the range to only 6 months. Why Have a Strategic Plan? A strategic plan is a process that begins with a vision that leads to an outcome. In other words, where does your practice want to be in 2 or 3 years? This process begins with gathering information, and necessitates defining goals along the way. The planning process must also be dynamic, one in which change is inherent, especially in today’s quickly evolving healthcare world. All organizations must begin with a vision. Mr Wipperling illustrated this need with 3 case studies. In the first, a pulmonary specialist group that he helped transition to close to St. Paul, MN, once had a vision to be the predominant pulmonary critical care group and sleep medicine provider in the eastern part of the Minneapolis–St. Paul metrop-
olis. Indeed, they once dominated the market there, covering all of the intensive care units and all of the large health systems in St. Paul. But then, things began to change. The hospital began to make changes and decisions that made the pulmonary group’s vision obsolete. Payers began to drive the changes. And with Obamacare in the works, the entire healthcare system changed rapidly. Soon enough, the group found itself with a failed vision and faced the prospect of having to close its doors. Thus, “now more than ever, strategic planning is a must,” Mr Wipperling observed. In the second case, a physician wanted to start her own practice. Her ideas were not well conceived and she jumped from one idea to the next before the practice even had a sufficient infrastructure to build upon. Practice administrators spent most of their time doing damage control and putting out fires rather than helping the organization realize its vision. Within a 5-year period, the practice lost 13 providers. Although the practice is still in business today, they have lost a considerable amount of time and money in the process because of a lack of discipline, focus, and planning. A third case illustrated how a comfortably established and predominant specialty group, in business for more than 20 years, finally faced competition in the form of the hospital system for which it had been the primary provider. The hospital system became the entity introducing the competition. The practice had not felt that it needed a strategic plan, because they had operated without one for many years. As the competition from the hospital increased, the practice diminished greatly and is even now continually losing revenue.
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How to Form a Strategic Plan To form a strategic plan, it is necessary to first define your practice’s capabilities and determine how it can accomplish its vision. Referring back to the pulmonary practice, Mr Wipperling noted that its initial vision was to be the predominant player in its market. And indeed, for a time, it was. It provided value to the community. But for the first time, and because of a set of rapid changes, this successful practice had to completely regroup and reassess the position it was in. It was forced into a reactive position because of its lack of anticipation in a quickly changing marketplace. What had worked for the practice in the past no longer applied. This is especially true of any medical practice today. What was important even 2 years ago—electronic health records, access to care, and reimbursement—has been replaced with new issues, including pending retirements, hospital coverage, compensation and productivity, and staffing shortages. What things still apply are a practice’s core competencies. Practices must know what they do well. In view of the current environment and even more impending changes, practices must know their priorities, have a strategic plan for coping with the changes, and be able to make sense of it all. “One thing that should not change is your mission,” Mr Wipperling observed. “You are here to take care of a population and provide healthcare. Bear in mind that what is not working is just as important as what is working. Prepare to adjust your vision to make a course correction.” The pulContinued on page 16
NEW FOR 2014
Oncology Practice Management, Advocacy, and Navigation An educational session for practice managers and other care providers focusing on cancer care and innovative delivery techniques. CO-CHAIRS
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Linda Bosserman, MD, FACP President Wilshire Oncology Medical Group
Vicki Kennedy, LCSW
Vice President, Program Development and Delivery Cancer Support Community
AGENDA 8:30am – 8:45am
Introductions and Opening Remarks Linda Bosserman, MD, FACP; Vicki Kennedy, LCSW
8:45am – 9:15am
Session 1: Cancer Care in Crisis: An Imperative for Change Douglas Blayney, MD, Ann & John Doerr Medical Director, Cancer Center, Stanford University Medical Center; Professor of Medicine, Stanford University School of Medicine
9:15am – 10:30am
Session 2: Innovation in Practice Management and Care Delivery: A Progress Report on Value-Based Innovation Linda Bosserman, MD, FACP, President, Wilshire Oncology Medical Group John Fox, MD, Associate Vice President of Medical Affairs, Priority Health John Sprandio, MD, Chief of Medical Oncology and Hematology, Oncology Management Services
10:30am – 10:45am
10:45am – 11:45am
Session 3: Uniting the Patient, Provider, and Community Voice in Value-Based Cancer Care Terry Langbaum, Chief Administrative Officer, Kimmel Center, Johns Hopkins School of Medicine Lillie Shockney, RN, BS, MAS, Administrative Director, The Johns Hopkins Breast Center Kim Thiboldeaux, President & CEO, Cancer Support Community
11:45am – 1:00pm
Lunch/Meet the Experts Roundtables John Fox, MD, Associate Vice President of Medical Affairs, Priority Health Lillie Shockney, RN, BS, MAS, Administrative Director, The Johns Hopkins Breast Center John Sprandio, MD, Chief of Medical Oncology and Hematology, Oncology Management Services
1:00pm – 1:45pm
Keynote Address Michael A. Kolodziej, MD, National Medical Director, Oncology Solutions, Aetna
1:45pm – 2:00pm
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Medical Group Management Association Conference
Controlling Your Practice’s Destiny…Continued from page 14 monary practice in St. Paul did not particularly like the change that occurred, but it had no choice. He recommended conducting a SWOT (strengths, weaknesses, opportunities, and threats) analysis to help gather the information necessary for them to switch gears: • Strengths: Know your core competencies • Weaknesses: Determine where your organization is most vulnerable • Opportunities: Determine what your organization should be doing that it is not doing now and identify unmet needs • Threats: Identify problems that might pose a threat to your longterm success. The pulmonary associates were unaware—and, therefore, unprepared—that their strongest business partner (the hospital) would eventually wind up becoming their fiercest competitor.
Surveys, Plans, and Priorities Surveys can be very useful in helping to map out the planning process and identifying potential problems. Mr Wipperling shared that a survey for one practice revealed that the physicians worked well together (an attribute that ranked high on the survey), but lacked a unified vision (an attribute that ranked low on the survey). This dichotomy showed the lack of a common vision and illustrated the need for a course correction. He urged practices to align their priorities over the next 2 years especially. Determine which priorities are most important and attach a time line to each. But most impor tant, limit the priorities. Having a 7-year plan might sound impressive, but in today’s environment, it makes little sense. Limit your
priorities to what will have the greatest impact on your practice, and be realistic. Develop an action plan for each priority, which should include identifying the specific steps to take, establishing the time frames for accomplishing each step,
processes would be aligned with the practice’s priorities, including same-day appointments for new patients, ensuring excellent experiences for new patients, and following up with new patients and referring physicians.
“One thing that should not change is your mission. You are here to take care of a population and provide healthcare. Bear in mind that what is not working is just as important as what is working.” —Dennis Wipperling, FACMPE
assigning who will be responsible for achieving each step, and creating a review process to determine how successfully each priority has been achieved. Mr Wipperling strongly suggested reviewing each measure regularly. He recalled how one practice had identified access for new appointments as one of its greatest challenges. The practice’s staff members determined how many new patients they wanted to see each month, and set this number as their goal. Then they developed measures and a responsible plan that required frequent reporting. They also planned out what they would do if their vision failed: They would visit their referring physicians and identify practices that had not yet referred patients. Everyone in the practice was to play a role in the process, including the scheduler. All systems and
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All plans require a debriefing process during which practices should determine whether their priorities are being addressed and whether they are sufficiently following through on them. When things go well, celebration and reward should be a part of the process. When things fail, it is time to drill and engage all staff, including the receptionist and whoever else has contact with patients. Mr Wipperling noted, “It’s about having measures and being diligent and tracking this information. It’s about transparency, feedback, rewards, and celebrations.” Above all, he observed, “It’s important to ask if we are accomplishing our goals and, if not, what or who is keeping us from doing so?” During this time of unprecedented healthcare changes, practices do not have the luxury of lying down and waiting for something to happen. l
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VELCADE and Millennium are registered trademarks of Millennium Pharmaceuticals, Inc. Other trademarks are property of their respective owners. Millennium Pharmaceuticals, Inc., Cambridge, MA 02139 Copyright ÂŠ 2010, Millennium Pharmaceuticals, Inc. All rights reserved. Printed in USA
Medical Group Management Association Conference
Maximizing Your Practice Scores By Sandra Paton
San Diego, CA—Do survey rankings have you worried? Do you need to improve your own service performance as well as the performance of your staff members? Meryl D. Luallin, owner and partner of SullivanLuallin Group, San Diego, CA, developed a patient satisfaction survey system for physicians and administrators who were dissatisfied with their low patient satisfaction scores. Ms Luallin works with physicians and administrators, sometimes as a “shadow coach,” to identify their limitations and to help improve their survey rankings.
Coming to a Practice Near You Pay-for-performance will be coming to a practice near you within the next 3 to 4 years. This news should not come as a surprise to anyone in healthcare, but many are not clear about the implications. At the 2013 Medical Group Management Association annual conference, Ms Luallin translated: “It’s [measuring] patient engagement, patient satisfaction, care coordination, and health outcomes.” In 2017, which may seem a long way off, pay-for-performance will apply to all payments made to individual providers. Knowing that your pay will be based on what patients have to
To “Knock” or Not to “Knock” Approximately 30% of practitioners do not knock on the door before entering an examination room. One physician said he never knocked. When she asked him why not, he replied, “because they don’t answer.” Another physician said that he knocks and then waits a beat or 2 before entering.
say about you can be daunting. Ms Luallin recommended transitioning as soon as possible from whatever survey a practice might be currently using to the Consumer Assessment of Healthcare Providers and Systems Clinician & Group Surveys (CG-CAHPS), a standardized tool that will measure how patients perceive the care they receive from physicians in an office setting.
“Start now to insert questions into your current survey that would be appropriate for the CG-CAHPS.” —Meryl D. Luallin
A value-based modifier pilot program will be tested in some states. Ms Luallin strongly urged practices to modify their current surveys using, as an example, the SullivanLuallin Group’s survey. “Start now to insert questions into your current survey that would be appropriate for the CG-CAHPS. Over a period of years, you will have adopted the entire required list of questions,” she urged. Ms Luallin also recommended putting
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the survey questions in order, starting with the most positive choice in the beginning to the most negative choice at the end. Ms Luallin further recommended running a linear regression analysis, or finding someone who can do this for you, to identify which survey questions promise the highest likelihood of improving your scores. “To know where to go, you first need to know where you are,” she noted. “Doing so will help you focus your priorities and help identify which items, if they are improved, would increase your survey score.” The 4 areas where practices are most likely trying to improve include: • Patient satisfaction with patient experience • Overall satisfaction with the practice • The likelihood of recommending the provider to others • Overall rating of care from your provider. Although waiting times are important, she noted that this is not a driver that can boost survey scores. “Problems with long waits will arise, but it is important to make the wait palatable,” she noted. Ms Luallin recommends that doctors arrive 15 minutes before their first appointment to avoid getting started late. To avoid the patient who says, “By the way, there is something else…” just as the physician is leaving the examination room, consider asking patients for the 2 most important issues that have brought them in to meet with the doctor. She further noted that physicians can raise their scores by being CLEAR: • Connect. Establish a rapport with a patient. Connect with patients throughout an encounter. Come
Medical Group Management Association Conference
across as though you care about the person. Allow the patient to speak. Show compassion. Be sympathetic. Shaking hands is a nice touch, if it is appropriate. Otherwise, pat a patient on the shoulder. “But never shake hands with a patient while wearing rubber gloves,” Ms Luallin warned. • Listen actively to patients and caregivers. The practitioner must show they are listening and do so while sitting, if possible. Studies show that patients perceive that their practitioner has spent more time with them if the practitioner was seated during the session. • Explain the diagnoses, directions, and instructions clearly. It is often necessary to explain why you recommend a certain procedure or avenue or diagnosis or whatever course of treatment you are proposing. Never ask a patient if he or she understands. They might be too embarrassed to tell you that they do not. • Ask key questions at key times. The practitioner must ask the patient specific questions to get all of the necessary information. Instead of asking “Do you have any questions?” ask, “What questions do you have for me?” • Reconnect with the patient before ending each part of the visit. And, importantly, caution your team not to say, “Have a nice day.” Ms Luallin observed, “If a man in his mid-50s comes in and learns that his PSA [prostate-specific antigen] is inordinately high, indicating a very aggressive form of prostate cancer requiring radiation therapy plus hormonal therapy amount-
ing to chemical castration, he is not going to have a nice day.”
Priorities • Modify your survey to reflect the CG-CAHPS list of questions over time • Identify evidence-based improvement initiatives that will have the highest impact on your overall score • Practice being CLEAR • Develop an action plan that engages every member of your team. Service performance is as important as clinical performance • Convey a sense of courtesy and caring to patients and caregivers.
Making the Wait Palatable Always go out of your way to make your patients feel comfortable. Ms Luallin related an experience she had in a reception area at an urgent care center. The receptionist asked her if she would like a cup of coffee and alerted her that there might be “a little bit of a wait.” Ms Luallin declined, and was then offered tea, which she also declined.
you,” she offered hot chocolate, to which everyone responded, “Yes.” Without further ado, the receptionist went to the kitchenette and brought all of the patients hot chocolate, to their great joy. During the same visit, Ms Luallin, who was scheduled for an x-ray, anticipated a cold and dim imaging room, but she was in for another surprise. True to form, the imaging room was indeed cold and dim. She furthermore expected the examination table to be cold and hard, but the table in this imaging department had a 1-inch foam pad. She noted out loud how comfortable it was, and the x-ray technician said, “I know. We like to make our patients comfortable.” When Ms Luallin asked the technician if she was scripted to say that, the technician smiled and repeated, “We like to make our patients comfortable.” Before your contented patients leave, be sure to ask them to fill out a survey of their experience while they are still at your office or clinic. Remember, a happy patient is less likely than a disgruntled patient to go out of his or her way to fill out a survey. l
“If a man in his mid50s comes in and learns that his PSA is inordinately high, indicating a very aggressive form of prostate cancer requiring radiation therapy plus hormonal therapy amounting to chemical castration, he is not going to have a nice day.” —Meryl D. Luallin
When the receptionist finished registering another patient, she asked all of the patients in the waiting room again, “Can I get anyone a cup of tea?” When everyone responded, “No, thank
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Brief Summary: Consult package insert for complete Prescribing Information INDICATIONS AND USAGE: Bone Metastasis from Solid Tumors. Xgeva is indicated for the prevention of skeletal-related events in patients with bone metastases from solid tumors. Important Limitation of Use. Xgeva is not indicated for the prevention of skeletal-related events in patients with multiple myeloma (see Clinical Trials in full Prescribing Information). DOSAGE AND ADMINISTRATION: Recommended Dosage. The recommended dose of Xgeva is 120 mg administered as a subcutaneous injection every 4 weeks in the upper arm, upper thigh, or abdomen. Administer calcium and vitamin D as necessary to treat or prevent hypocalcemia (see Warnings and Precautions). Preparation and Administration. Visually inspect Xgeva for particulate matter and discoloration prior to administration. Xgeva is a clear, colorless to pale yellow solution that may contain trace amounts of translucent to white proteinaceous particles. Do not use if the solution is discolored or cloudy or if the solution contains many particles or foreign particulate matter. Prior to administration, Xgeva may be removed from the refrigerator and brought to room temperature (up to 25°C/77°F) by standing in the original container. This generally takes 15 to 30 minutes. Do not warm Xgeva in any other way (see How Supplied/Storage and Handling). Use a 27-gauge needle to withdraw and inject the entire contents of the vial. Do not re-enter the vial. Discard vial after single-use or entry. CONTRAINDICATIONS: Hypocalcemia. Pre-existing hypocalcemia must be corrected prior to initiating therapy with Xgeva (see Warnings and Precautions). Hypersensitivity. Xgeva is contraindicated in patients with known clinically significant hypersensitivity to Xgeva (see Warnings and Precautions and Adverse Reactions). WARNINGS AND PRECAUTIONS: Drug Products with Same Active Ingredient. Xgeva includes the same active ingredient (denosumab) found in Prolia. Patients receiving Xgeva should not take Prolia. Hypersensitivity. Clinically significant hypersensitivity including anaphylaxis has been reported with use of Xgeva. Reactions may include hypotension, dyspnea, upper airway edema, lip swelling, rash, pruritus, and urticaria. If an anaphylactic or other clinically significant allergic reaction occurs, initiate appropriate therapy and discontinue Xgeva therapy permanently (see Contraindications and Adverse Reactions). Hypocalcemia. Xgeva can cause severe symptomatic hypocalcemia, and fatal cases have been reported. Correct pre-existing hypocalcemia prior to Xgeva treatment. Monitor calcium levels and administer calcium, magnesium, and vitamin D as necessary. Monitor levels more frequently when Xgeva is administered with other drugs that can also lower calcium levels. In the postmarketing setting, severe symptomatic hypocalcemia has been reported (see Adverse Reactions). Advise patients to contact a healthcare professional for symptoms of hypocalcemia (see Contraindications, Adverse Reactions, and Patient Counseling Information in full Prescribing Information). Based on clinical trials using a lower dose of denosumab, patients with a creatinine clearance less than 30 mL/min or receiving dialysis are at greater risk of severe hypocalcemia compared to patients with normal renal function. In a trial of 55 patients, without cancer and with varying degrees of renal impairment, who received a single dose of 60 mg denosumab, 8 of 17 patients with a creatinine clearance less than 30 mL/min or receiving dialysis experienced corrected serum calcium levels less than 8.0 mg/dL as compared to 0 of 12 patients with normal renal function. The risk of hypocalcemia at the recommended dosing schedule of 120 mg every 4 weeks has not been evaluated in patients with a creatinine clearance less than 30 mL/min or receiving dialysis. Osteonecrosis of the Jaw (ONJ). Osteonecrosis of the jaw (ONJ) can occur in patients receiving Xgeva, manifesting as jaw pain, osteomyelitis, osteitis, bone erosion, tooth or periodontal infection, toothache, gingival ulceration, or gingival erosion. Persistent pain or slow healing of the mouth or jaw after dental surgery may also be manifestations of ONJ. In clinical trials, in patients with osseous metastasis, the incidence of ONJ was higher with longer duration of exposure (see Adverse Reactions). Seventy-nine percent of patients with ONJ had a history of tooth extraction, poor oral hygiene, or use of a dental appliance as a predisposing factor. Perform an oral examination and appropriate preventive dentistry prior to the initiation of Xgeva and periodically during Xgeva therapy. Advise patients regarding oral hygiene practices. Avoid invasive dental procedures during treatment with Xgeva. Patients who are suspected of having or who develop ONJ while on Xgeva should receive care by a dentist or an oral surgeon. In these patients, extensive dental surgery to treat ONJ may exacerbate the condition. Atypical Subtrochanteric and Diaphyseal Femoral Fracture. Atypical femoral fracture has been reported with Xgeva (see Adverse Reactions). These fractures can occur anywhere in the femoral shaft from just below the lesser trochanter to above the supracondylar flare and are transverse or short oblique in orientation without evidence of comminution. Atypical femoral fractures most commonly occur with minimal or no trauma to the affected area. They may be bilateral and many patients report prodromal pain in the affected area, usually presenting as dull, aching thigh pain, weeks to months before a complete fracture occurs. A number of reports note that patients were also receiving treatment with glucocorticoids (e.g. prednisone) at the time of fracture. During Xgeva treatment, patients should be advised to report new or unusual thigh, hip, or groin pain. Any patient who presents with thigh or groin pain should be suspected of having an atypical fracture and should be evaluated to rule out an incomplete femur fracture. Patient presenting with an atypical femur fracture should also be assessed for symptoms and signs of fracture in the contralateral limb. Interruption of Xgeva therapy should be considered, pending a risk/benefit assessment, on an individual basis. EMBRyO-FETAL TOxICITy: Xgeva can cause fetal harm when administered to a pregnant woman. Based on findings in animals, Xgeva is expected to result in adverse reproductive effects. In utero denosumab exposure in cynomolgus monkeys resulted in increased fetal loss, stillbirths, and postnatal mortality, along with evidence of absent peripheral lymph nodes, abnormal bone growth, and decreased neonatal growth (see Use in Specific Populations). Advise females of reproductive potential to use highly effective contraception during therapy, and for at least 5 months after with the last dose of Xgeva. Apprise the patient of the potential hazard to a fetus if Xgeva is used during pregnancy or if the patient becomes pregnant while patients are exposed to Xgeva. Advise patients to contact their healthcare provider if they become pregnant or a pregnancy is suspected during this time (see Use in Specific Populations). ADVERSE REACTIONS: The following adverse reactions are discussed below and elsewhere in the labeling: • Hypocalcemia (see Warnings and Precautions) • Osteonecrosis of the Jaw (see Warnings and Precautions) The most common adverse reactions in patients receiving Xgeva (per-patient incidence greater than or equal to 25%) were fatigue/asthenia, hypophosphatemia, and nausea (see Table 1). The most common serious adverse reaction in patients receiving Xgeva was dyspnea. The most common adverse reactions resulting in discontinuation of Xgeva were osteonecrosis and hypocalcemia. Clinical Trials 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 other clinical trials and may not reflect the rates observed in practice. The safety of Xgeva was evaluated in three randomized, double-blind, double-dummy trials (see Clinical Trials in full Prescribing Information) in which a total of 2841 patients with bone metastasis from prostate cancer, breast cancer, or other solid tumors, or lytic bony lesions from multiple myeloma received at least one dose of Xgeva. In Trials 1, 2, and 3, patients were randomized to receive either 120 mg of Xgeva every 4 weeks as a subcutaneous injection or
4 mg (dose adjusted for reduced renal function) of zoledronic acid every 4 weeks by intravenous (IV) infusion. Entry criteria included serum calcium (corrected) from 8 to 11.5 mg/dL (2 to 2.9 mmol/L) and creatinine clearance 30 mL/min or greater. Patients who had received IV bisphosphonates were excluded, as were patients with prior history of ONJ or osteomyelitis of the jaw, an active dental or jaw condition requiring oral surgery, non-healed dental/oral surgery, or any planned invasive dental procedure. During the study, serum chemistries including calcium and phosphorus were monitored every 4 weeks. Calcium and vitamin D supplementation was recommended but not required. The median duration of exposure to Xgeva was 12 months (range: 0.1 – 41) and median duration on-study was 13 months (range: 0.1 – 41). Of patients who received Xgeva, 46% were female. Eighty-five percent were White, 5% Hispanic/Latino, 6% Asian, and 3% Black. The median age was 63 years (range: 18 – 93). Seventy-five percent of patients who received Xgeva received concomitant chemotherapy. Table 1. Per-patient Incidence of Selecteda Adverse Reactions of Any Severity (Trials 1, 2, and 3) xgeva n = 2841 %
Zoledronic Acid n = 2836 %
GASTROINTESTINAL Nausea Diarrhea
GENERAL Fatigue/ Asthenia
INVESTIGATIONS Hypocalcemiab Hypophosphatemiab
RESPIRATORy Dyspnea Cough
Adverse reactions reported in at least 10% of patients receiving Xgeva in Trials 1, 2, and 3, and meeting one of the following criteria: • At least 1% greater incidence in Xgeva-treated patients, or • Between-group difference (either direction) of less than 1% and more than 5% greater incidence in patients treated with zoledronic acid compared to placebo (US Prescribing Information for zoledronic acid) b Laboratory-derived and below the central laboratory lower limit of normal [8.3 – 8.5 mg/dL (2.075 – 2.125 mmol/L) for calcium and 2.2 – 2.8 mg/dL (0.71 – 0.9 mmol/L) for phosphorus] Severe Mineral/Electrolyte Abnormalities • Severe hypocalcemia (corrected serum calcium less than 7 mg/dL or less than 1.75 mmol/L) occurred in 3.1% of patients treated with Xgeva and 1.3% of patients treated with zoledronic acid. Of patients who experienced severe hypocalcemia, 33% experienced 2 or more episodes of severe hypocalcemia and 16% experienced 3 or more episodes (see Warnings and Precautions and Use in Specific Populations). • Severe hypophosphatemia (serum phosphorus less than 2 mg/dL or less than 0.6 mmol/L) occurred in 15.4% of patients treated with Xgeva and 7.4% of patients treated with zoledronic acid. Osteonecrosis of the Jaw In the primary treatment phases of Trials 1, 2, and 3, ONJ was confirmed in 1.8% of patients in the Xgeva group (median exposure of 12.0 months; range 0.1 – 40.5) and 1.3% of patients in the zoledronic acid group. The trials in patients with breast (Trial 1) or prostate (Trial 3) cancer included an Xgeva open label extension treatment phase where patients were offered Xgeva 120 mg once every 4 weeks (median overall exposure of 14.9 months; range 0.1 – 67.2). The patient-year adjusted incidence of confirmed ONJ was 1.1% during the first year of treatment and 4.1% thereafter. The median time to ONJ was 20.6 months (range: 4 – 53) (See Warnings and Precautions). Atypical Subtrochanteric and Diaphyseal Fracture Atypical femoral fracture has been reported with Xgeva (see Warnings and Precautions). Postmarketing Experience. Because postmarketing reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following adverse reactions have been identified during post approval use of Xgeva: • Hypocalcemia: Severe symptomatic hypocalcemia, including fatal cases. • Hypersensitivity, including anaphylactic reactions. Immunogenicity. As with all therapeutic proteins, there is potential for immunogenicity. Using an electrochemiluminescent bridging immunoassay, less than 1% (7/2758) of patients with osseous metastases treated with denosumab doses ranging from 30 – 180 mg every 4 weeks or every 12 weeks for up to 3 years tested positive for binding antibodies. No patient with positive binding antibodies tested positive for neutralizing antibodies as assessed using a chemiluminescent cell-based in vitro biological assay. There was no evidence of altered pharmacokinetic profile, toxicity profile, or clinical response associated with binding antibody development. The incidence of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of a positive antibody (including neutralizing antibody) test result may be influenced by several factors, including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of antibodies to denosumab with the incidence of antibodies to other products may be misleading. DRUG INTERACTIONS: No formal drug-drug interaction trials have been conducted with Xgeva. In clinical trials in patients with breast cancer metastatic to bone, Xgeva was administered in combination with standard anticancer treatment. Serum denosumab concentrations at 1 and 3 months and reductions in the bone turnover marker uNTx/Cr (urinary N-terminal telopeptide corrected for creatinine) at 3 months were similar in patients with and without prior intravenous bisphosphonate therapy. There was no evidence that various anticancer treatments affected denosumab systemic exposure and pharmacodynamic effect. Serum denosumab concentrations at 1 and 3 months were not altered by concomitant chemotherapy and/or hormone therapy. The median reduction in uNTx/Cr from baseline to month 3 was similar between patients receiving concomitant chemotherapy and/or hormone therapy (see Clinical Pharmacology in full Prescribing Information). USE IN SPECIFIC POPULATIONS: Pregnancy: Category D [see Warnings and Precautions]. Risk Summary: Xgeva can cause fetal harm when administered to a pregnant woman based on findings in animals. In utero denosumab exposure in cynomolgus monkeys resulted in increased fetal loss, stillbirths, and postnatal mortality, along with evidence of absent lymph nodes, abnormal bone growth and decreased neonatal growth. There are no adequate and well-controlled studies with Xgeva in pregnant women. Women should be advised not to become pregnant when taking Xgeva. 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. Women who become pregnant during Xgeva treatment are encouraged to enroll in Amgen’s Pregnancy Surveillance Program. Patients or their physicians should call 1-800-77-AMGEN (1-800-772-6436) to enroll. a
Clinical Considerations: The effects of Xgeva are likely to be greater during the second and third trimesters of pregnancy. Monoclonal antibodies are transported across the placenta in a linear fashion as pregnancy progresses, with the largest amount transferred during the third trimester. If the patient becomes pregnant during Xgeva therapy, consider the risks and benefits in continuing or discontinuing treatment with Xgeva. Animal Data: The effects of denosumab on prenatal development have been studied in both cynomolgus monkeys and genetically engineered mice in which RANK ligand (RANKL) expression was turned off by gene removal (a “knockout mouse”). In cynomolgus monkeys dosed subcutaneously with denosumab throughout pregnancy at a pharmacologically active dose, there was increased fetal loss during gestation, stillbirths, and postnatal mortality. Other findings in offspring included absence of axillary, inguinal, mandibular, and mesenteric lymph nodes; abnormal bone growth, reduced bone strength, reduced hematopoiesis, dental dysplasia and tooth malalignment; and decreased neonatal growth. At birth out to one month of age, infants had measurable blood levels of denosumab (22-621% of maternal levels). Following a recovery period from birth out to 6 months of age, the effects on bone quality and strength returned to normal; there were no adverse effects on tooth eruption, though dental dysplasia was still apparent; axillary and inguinal lymph nodes remained absent, while mandibular and mesenteric lymph nodes were present, though small; and minimal to moderate mineralization in multiple tissues was seen in one recovery animal. There was no evidence of maternal harm prior to labor; adverse maternal effects occurred infrequently during labor. Maternal mammary gland development was normal. There was no fetal NOAEL (no observable adverse effect level) established for this study because only one dose of 50 mg/kg was evaluated. In RANKL knockout mice, absence of RANKL (the target of denosumab) also caused fetal lymph node agenesis and led to postnatal impairment of dentition and bone growth. Pregnant RANKL knockout mice showed altered maturation of the maternal mammary gland, leading to impaired lactation (see Use in Nursing Mothers and Nonclinical Toxicology in full Prescribing Information). Nursing Mothers. It is not known whether Xgeva is excreted into human milk. Measurable concentrations of denosumab were present in the maternal milk of cynomolgus monkeys up to 1 month after the last dose of denosumab (≤ 0.5% milk:serum ratio). Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Xgeva, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother. Maternal exposure to Xgeva during pregnancy may impair mammary gland development and lactation based on animal studies in pregnant mice lacking the RANK/RANKL signaling pathway that have shown altered maturation of the maternal mammary gland, leading to impaired lactation postpartum. However, in cynomolgus monkeys treated with denosumab throughout pregnancy, maternal mammary gland development was normal, with no impaired lactation. Mammary gland histopathology at 6 months of age was normal in female offspring exposed to denosumab in utero; however, development and lactation have not been fully evaluated (see Nonclinical Toxicology in full Prescribing Information). Pediatric Use. Xgeva is not recommended in pediatric patients. The safety and effectiveness of Xgeva in pediatric patients have not been established. Treatment with Xgeva may impair bone growth in children with open growth plates and may inhibit eruption of dentition. In neonatal rats, inhibition of RANKL (the target of Xgeva therapy) with a construct of osteoprotegerin bound to Fc (OPG-Fc) at doses ≤ 10 mg/kg was associated with inhibition of bone growth and tooth eruption. Adolescent primates treated with denosumab at doses 5 and 25 times (10 and 50 mg/kg dose) higher than the recommended human dose of 120 mg administered once every 4 weeks, based on body weight (mg/kg), had abnormal growth plates, considered to be consistent with the pharmacological activity of denosumab. Cynomolgus monkeys exposed in utero to denosumab exhibited bone abnormalities, reduced hematopoiesis, tooth malalignment, decreased neonatal growth, and an absence of axillary, inguinal, mandibular, and mesenteric lymph nodes. Some bone abnormalities recovered once exposure was ceased following birth; however, axillary and inguinal lymph nodes remained absent 6 months post-birth (see Use in Specific Populations). Geriatric Use. Of patients who received Xgeva in Trials 1, 2, and 3, 1260 (44%) were 65 years of age or older. No overall differences in safety or efficacy were observed between these patients and younger patients. Renal Impairment. In a trial of 55 patients without cancer and with varying degrees of renal function who received a single dose of 60 mg denosumab, patients with a creatinine clearance of less than 30 mL/min or receiving dialysis were at greater risk of severe hypocalcemia with denosumab compared to patients with normal renal function. The risk of hypocalcemia at the recommended dosing schedule of 120 mg every 4 weeks has not been evaluated in patients with a creatinine clearance of less than 30 mL/min or receiving dialysis (see Warnings and Precautions, Adverse Reactions, and Clinical Pharmacology in full Prescribing Information). Females and Males of Reproductive Potential. Contraception Females: Counsel patients on pregnancy planning and prevention. Advise females of reproductive potential to use highly effective contraception during therapy, and for at least 5 months after the last dose of Xgeva. Advise patients to contact their healthcare provider if they become pregnant, or a pregnancy is suspected, during treatment or within 5 months after the last dose of Xgeva [see Use in Specific Populations and Patient Counseling Information]. Males: The extent to which denosumab is present in seminal fluid is unknown. There is potential for fetal exposure to denosumab when a male treated with Xgeva has unprotected sexual intercourse with a pregnant partner. Advise males of this potential risk. OVERDOSAGE: There is no experience with overdosage of Xgeva. HOW SUPPLIED/STORAGE AND HANDLING: Xgeva is supplied in a single-use vial. Store Xgeva in a refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton. Do not freeze. Once removed from the refrigerator, Xgeva must not be exposed to temperatures above 25°C/77°F or direct light and must be used within 14 days. Discard Xgeva if not used within the 14 days. Do not use Xgeva after the expiry date printed on the label. Protect Xgeva from direct light and heat. Avoid vigorous shaking of Xgeva. PATIENT COUNSELING INFORMATION: Advise patients to contact a healthcare professional for any of the following: • Symptoms of a hypersensitivity reaction, including rash, urticaria, pruritus, lip swelling, shortness of breath, hypotension and respiratory tract edema (see Contraindications, Warnings and Precautions, and Adverse Reactions) • Symptoms of hypocalcemia, including paresthesias or muscle stiffness, twitching, spasms, or cramps (see Contraindications, Warnings and Precautions, and Adverse Reactions) • Symptoms of ONJ, including pain, numbness, swelling of or drainage from the jaw, mouth, or teeth (see Warnings and Precautions and Adverse Reactions) • Persistent pain or slow healing of the mouth or jaw after dental surgery (see Warnings and Precautions) • Symptoms of atypical femoral fracture, including new or unusual thigh, hip, or groin pain (see Warnings and Precautions) • Pregnancy or nursing (see Warnings and Precautions and Use in Specific Populations) Advise patients of the need for: • Avoiding therapy with Xgeva if a serious allergic reaction occurred with prior Xgeva or Prolia therapy (see Contraindications and Warnings and Precautions) • Proper oral hygiene and routine dental care • Informing their dentist that they are receiving Xgeva • Avoiding invasive dental procedures during treatment with Xgeva • The use of highly effective contraception during and for at least 5 months after treatment with Xgeva for females of reproductive potential Advise patients that denosumab is also marketed as Prolia®. Patients should inform their healthcare provider if they are taking Prolia. Amgen Manufacturing Limited, a subsidiary of Amgen Inc. One Amgen Center Drive Thousand Oaks, California 91320-1799 ©2010-2013 Amgen Inc. All rights reserved. Printed in USA. 68257-R4-V2
Clinical Trial Tracker
New Clinical Trials Under Way
he following clinical trials are currently recruiting patients with various types of cancer for inclusion in several investigations. Each trial description includes the NLM Identifier to use as reference with clinicaltrials.gov.
Genomic Testing for Primary Breast Cancer This research study will help researchers to determine if genetic testing done on tumor samples will be able to predict whether the tumor responds to treatments for breast cancer. Researchers will test tumor samples to see if certain genes are activated, with the hope that such activation may predict if the tumor will be sensitive or resistant to routine chemotherapy or hormonal treatments for breast cancer. To be eligible for inclusion, female patients with cancer must be aged 18 years or older. The study will enroll 500 patients, and will be conducted at The University of Texas M.D. Anderson Cancer Center in Houston, TX. For more information, contact Stacy Moulder, MD, at 713792-2817. The NLM Identifier is NCT01334021.
Spray Cryotherapy for Esoph ageal Cancer (ICE-CANCER) This study will evaluate the safety and efficacy of endoscopic spray cryotherapy in patients with previously untreated early-stage esophageal cancer using the truFreeze System (CSA Medical, Inc). The patients in this study will not be eligible for or have refused conventional therapy, including surgery, chemotherapy, radiation therapy, or endoscopic resection. The study will be conducted at
the University of Maryland Medical Center, Baltimore. For more information, contact Bruce D. Greenwald, MD, principal investigator, at 410328-8731 or bgreenwa@medicine. umaryland.edu. The NLM Identifier is NCT01868139.
patients with small-cell lung cancer who have received this combination therapy. Patients aged 18 years or older with a histologically or cytologically confirmed diagnosis of progressive or recurrent malignancy may be eligible for inclusion if several other criteria are met. For a full list of inclusion criteria, contact Susanne M. Arnold, MD, at 859-323-8043 or smarno0@ uky.edu. The University of Kentucky Markey Cancer Center Lexington, is currently recruiting patients. The NLM Identifier is NCT01941316.
Specimen and Data Study for Early Detection and Prevention of Ovarian Cancer The objectives for this study are to identify and develop highly sensitive and specific tumor markers that can detect and help to manage ovarian cancer and other gynecologic cancers, identify new approaches to prevention and therapy, and identify measures to improve the quality of life for women who have been diagnosed with ovarian cancer, as well as women at increased risk for the disease. Women aged 18 to 80 years who are at high risk for ovarian cancer due to family or personal medical history, or because of a gynecologic abnormality, are eligible for inclusion in this study. The study will be conducted at the Robert H. Lurie Comprehensive Cancer Center at Northwestern University, Chicago IL. Lee Shulman, Chief, Division of Clinical Genetics, Northwestern University, is the study chair, and can be reached at 312-695-1301 or firstname.lastname@example.org. The NLM Identifier is NCT00005095.
Comprehensive Gene Sequenc ing in Guiding Treatment Rec ommendations for Patients with Metastatic or Recurrent Solid Tumors This pilot clinical trial is studying comprehensive gene sequencing in patients with metastatic or recurrent solid tumors. Studying samples of blood and tissue from patients with cancer in the laboratory may improve the ability to plan their treatment. The primary objectives of the study are to assess the feasibility and logistics that are associated with a clinical trial using the Foundation Medicine, Inc (FMI) test in an academic therapeutic setting, and to determine the proportion of patients who will receive a cancer-related therapy based on the results of the FMI test. Patients must be aged 18 years or older to participate in this study. Patients must have been diagnosed with a recurrent or metastatic solid tumor cancer. The first patients to be enrolled will have a diagnosis of breast cancer (Cohort 1) or colorectal cancer (Cohort 2). Furthermore, at the time of inclusion, patients are within 10 weeks of starting their current line of therapy and are enrolled before
Study of Carfilzomib with Irinotecan in IrinotecanSensitive Malignancies and Patients with Lung Cancer This study aims to determine a well-tolerated dose of carfilzomib in combination with irinotecan in patients with relapsed small-cell and non–small-cell lung cancer or with other irinotecan-sensitive cancers. It will also assess the 6-month survival rate of relapsed disease in
Continued on page 24
Clinical Trial Tracker
New Clinical Trials Under Way…Continued from page 23 their first computed tomography scan. The study is being conducted at the Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center in Columbus. For more information and a full list of inclusion criteria, contact Erin M. Olson, principal investigator, at 614-366-8541 or Erin.Olson@ osumc.edu. The NLM Identifier is NCT01987726.
Trametinib, Fluorouracil, and Radiation Therapy Before Surgery in Patients with Stage II or Stage III Rectal Cancer This phase 1 trial investigates the side effects and best dose of trametinib when given together with fluorouracil and radiation therapy before surgery for the treatment of patients with stage II or stage III rectal cancer. Giving trametinib together with fluorouracil and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. For a full list of inclusion criteria, contact Evan J. Wuthrick, MD, principal investigator, at 614-2933422 or email@example.com. The study will be conducted at the Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center, Columbus. The NLM Identifier is NCT01740648.
Low-Dose Naltrexone for Metastatic Melanoma, CastrateResistant Prostate Cancer, and Renal Cancer This phase 2 clinical trial will evaluate whether low-dose naltrexone has activity in refractory solid tumors. Melanoma, castrate-resistant prostate cancer, and kidney cancer will be studied. Patients who are aged 18 years or older who meet
all of the inclusion criteria will be considered for participation in the study. Inclusion criteria include histologically or pathologically confirmed melanoma, renal cancer, or prostate cancer; patients with melanoma or renal cancer must have metastatic disease and radiographically measurable advanced disease. Patients with prostate cancer must be castrate refractory and must have radiographically assessable metastatic disease or must have rising prostate-specific antigen on 2 sequential measurements. For a full list of inclusion criteria, contact Maureen Jean at 401-7934283 or firstname.lastname@example.org. The study will be conducted at Miriam Hospital, Providence, RI. The NLM Identifier is NCT01650350.
2B3-101 Open-Label Study for Patients with Solid Tumors and Brain Metastases The safety, tolerability, and pharmacokinetics of 2B3-101 as a single agent and in combination with trastuzumab will be evaluated in this phase 1/2a dose-escalating, open-label study. Patients with solid tumors and brain metastases or recurrent malignant glioma, as well as patients with various forms of breast cancer with and in combination with trastuzumab in patients with HER2-positive breast cancer and brain metastases are also eligible for inclusion. Other criteria include age 18 years or older, measurable intracranial disease by magnetic resonance imaging, and estimated life expectancy of at least 8 weeks. For more information, contact Rachel Phipps, RN, at 919966-4432 or rachel_phipps@med. unc.edu. The study will be conducted at the UNC Lineberger Comprehensive Cancer Center, Chapel Hill, NC. The NLM Identifier is NCT01386580.
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New Delivery System for Mar qibo Drug to Be Put to the Test This study aims to evaluate the safety, activity, and pharmacokinetics of Marqibo, a new anticancer drug that combines vincristine sulfate, a widely used anticancer drug, packaged in a liposome to improve the drug’s ability to destroy cancer cells and reduce treatment-related adverse events. Children and adolescents between ages 2 years and 21 years diagnosed with solid tumors, primary brain tumors, leukemias, or lymphomas, who did not respond to standard treatment, are eligible for inclusion. The principal investigator of this study, Alan S. Wayne, MD, can be contacted at 301-496-426 or email@example.com. The study will be conducted at the National Institutes of Health Clinical Center, Bethesda, MD. The NLM Identifier is NCT01222780.
Safety and Efficacy of Cediranib Maleate with or without Lenalidomide in Patients with Thyroid Cancer A randomized phase 1/2 study will evaluate the safety and efficacy of cediranib maleate with or without lenalidomide in patients with thyroid cancer. Adverse events and best dose of cediranib will be evaluated. To be elegible for inclusion, patients should be aged 18 years or older, have radiographically measurable disease, evidence of disease progression, and a life expectancy of more than 12 weeks. For the full list of inclusion criteria, contact Jonas De Souza, principal investigator, at 773-834-1736 or firstname.lastname@example.org. The study will be conducted in multiple states, including California, Colorado, Florida, and Illinois. The NLM Identifier is NCT01208051.
Clinical Trial Tracker
Genetic Epidemiology Stud ies to Evaluate Genetic Causes of Cancer This observational study will evaluate the genetic causes of cancer and the inherited tendency to develop cancer by collecting blood specimens and/or saliva samples and/or tumor and normal tissue blocks from patients and families of patients with cancer. Eligibility criteria include patients with a referral to the Cancer Family Clinic of the Department of Medicine at Memorial SloanKettering Cancer Center, as well as a history of cancer including breast, ovary, and colon, in first-degree relative or successive generations in a suspected cancer family syndrome. Contact Kenneth Offit, MD, principal investigator, at 646-888-4050, for a full list of inclusion criteria and/or more information. The study will be conducted at the Memorial Sloan-Kettering Cancer Center, New York, NY. The NLM Identifier is NCT00579163.
Sirolimus, Cisplastin, and Gemcitabine Hydrochloride in Patients with Bladder
Cancer This phase 1/2 clinical trial will be evaluating the adverse events, optimal dosage, and efficacy of sirolimus in combination with cisplatin and gemcitabine hydrochloride in patients with blader cancer. Patients aged 18 years or older, with a signed informed consent form, histologically or cytologically confirmed carcinoma of the bladder of all histologies, except neuroendocrine differentiation or squamous-cell histology, will be included in the study. For a full list of inclusion criteria, contact Robert B. Montgomery, principal investigator, at 206-6168289. This study will be conducted at Fred Hutchinson Cancer Research
Center/Universty of Washington Cancer Consortiun, Seattle. The NLM Identifier is NCT01938573.
reported any amount of smoking in the past 7 days; and be scheduled to receive or are currently undergoing surgery, radiation, or chemotherapy, or have undergone surgery, last radiation treatment, and/or last chemotherapy treatment in the past 6 months. Participants must also be willing to consider smoking and able to understand/sign an informed consent and have a Karnofsky performance status of 70 to 100. To receive a full list of inclusion criteria, contact Robin Rosdhal, RN, at 336-713-6519 or rosdhal@ wakehealth.edu. W F Baptist Health Winston-Salem, NC, is currently recruiting patients, The NLM Identifier is NCT01434342.
Collecting Data for EarlyOnset and Familial Gastric Cancer Registry This gastric cancer registry is recruiting patients to learn more about the genetic causes of gastric cancer and develop methods for early diagnosis, prevention, and treatment. Study participants will be asked to join a registry of families who are affected by various forms of gastric cancer. Participants have to be aged 18 years or older. To be eligible for the study, participants must have (1) a diagnosis of gastric or gastroesophageal junction (GEJ) adenocarcinoma, or (2) have/had a first-degree relative with early-onset gastric cancer or with familial gastric cancer, and/ or (3) has a personal familial history of a genetic mutation associated with gastric or GEJ adenocarcinoma. For more information, contact David Kelsen, MD, principal investigator, at 646-888-4179. This study will be conducted in multiple locations by the Memorial SloanKettering Cancer Center. The NLM Identifier is NCT00582257.
Pilot Study to Evaluate Renal Lesions via Accuracy Contrast-Enhanced Ultra sound in Patients with and at Risk for Renal Malignancy To evaluate the accuracy of cont rast-enhanced ultrasound in patients with renal tumors or patients at risk for renal malignancy (ie, if a screening ultrasound indicates the possibility of a malignant renal mass), this study is recruiting approximately 48 patients. The criteria for inclusion are age 18 years or older, ability to provide written informed consent, willingness to comply with protocol requirements, eligibility to receive radical or partial nephrectomy or ablative therapy (Cohort 1) or be at high risk and have at least 1 kidney lesion identified by incompletely characterized at screening (Cohort 2). For more information, contact Gayle Grigson, RN, at 919-9664432 or email@example.com. edu. This study will be conducted at the Linenberg Comprehensive Cancer Center, Chapel Hill, NC. The NLM Identifier is NCT01751529. l
Testing a New Delivery System for Smoking Ces sation in Patients with Lung Cancer This trial is seeking to evaluate the feasibility of delivering a Quitline-based smoking-cessation intervention in patients with lung cancer who are receiving treatment in the outpatient setting. To be included in this randomized, parallel, open-label study, patients must be aged 18 years or older, and must have American Joint Committee on Cancer stage 0, I, II, or III lung, breast, colorectal, bladder, head and neck, or cervical cancer; have
Cancer Center Business Summit
Data Drive Change: Identifying Trends and Shifts in Oncology By Frederique H. Evans, MBS
Chicago, IL—Information is king in this day and age, and while collecting it is difficult, possessing it could lead to change. In oncology, collecting data on trends and pressures may influence policymakers, suggested Allen S. Lichter, MD, FASCO, Chief Executive Officer, American Society of Clinical Oncology (ASCO) and Conquer Cancer Foundation in opening remarks at the 2013 Cancer Center Business Summit.
Physician Compare Data Analysis Dr Lichter began his discussion with preliminary findings of an analysis of data from Physician Compare (www.medicare.gov/phy siciancompare/), a website provided by the Centers for Medicare & Medicaid Services (CMS) that allows consumers to find and choose physicians and other healthcare professionals enrolled in Medicare. The website includes information on clinical practices, such as specialty, location, and will eventually include performance information. Data from Physician Compare were used to determine the number of practicing oncologists in the United States. According to the database, there are 11,343 physicians with the primary specialty of oncology or hematology; 2584 practices have ≥1 oncologists and more than 7600 billing addresses. The data include some inaccuracies: a practice whose billing address may be spelled out, but is abbreviated in another location, would be counted twice. A practice with 2 entrances would be counted twice as well. Not surprising, when taking a
closer look at the number of oncologists by state, data from Physician Compare indicate that highly populated states, such as New York, California, Texas, and Florida, also have the most oncologists. Similarly, the presence of an oncologist in a practice coincides with the number of oncologists and population in that state.
According to the database, there are 11,343 physicians with the primary specialty of oncology or hematology; 2584 practices have ≥1 oncologists and more than 7600 billing addresses. However, some of the most populous states, such as California, have a per capita number of oncologists that actually tends to be low compared with states such as North Dakota that have a per capita number of oncologists that tends to be high.
The Iowa Project Using data from Physician Compare, the state of Iowa was selected to further assess the extent of the differences in the data. Iowa was considered a good candidate, because it has a very well-developed physician registry through the Iowa Medical Society, Dr Lichter explained. Four data sets were triangulat-
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ed and a detailed analysis of each physician record was performed. According to the Iowa Physician Information System (IPIS), 88 oncologists live in the state. However, based on 3 other databases—the National Provider Index, the American Medical Association (AMA) and the ASCO membership database—the actual number is between 88 and 90 oncologists. Arguably, if the aim was to find the approximate number of oncologists in the state, these data would be it, Dr Lichter noted. However, more information is needed to better understand the trends and shifts in oncology. Looking back to Physician Com pare, 105 oncologists are listed in Iowa, but this difference with IPIS data could be explained by several factors. First, Physician Compare data include information from oncologists whose primary practice is outside of Iowa. For instance, if the practice is located on a road that crosses state borders, it may be counted twice. Second, the data from IPIS date back to 2011, whereas Physician Compare is updated every 6 months (2013). Finally, the listing of primary and secondary specialty could also account for the differences in the number of oncologists. Patient access was also evaluated as part of the analysis. If a patient lives in Des Moines, Dr Lichter explained, where there are 15 oncologists, and 1 of the practices close, then patients are able to go to another oncologist in the area. However, if the area only has 1 oncologist, and that practice closes, then that area is not covered. “The general surgeons have done a great job of understanding these Continued on page 28
4TH ANNUAL CONFERENCE
MAY 6-9, 2014 LOEWS HOLLYWOOD HOTEL â€˘ LOS ANGELES, CA Government and Employers Co-Chairs Jayson Slotnik, JD, MPH
F. Randy Vogenberg, PhD, RPh
Vice President of Reimbursement Strategy & Innovation United BioSource Corporation
Principal Institute for Integrated Healthcare
Personalized Medicine and Payers Co-Chairs Michael A. Kolodziej, MD National Medical Director Oncology Solutions Aetna
Grant Lawless, RPh, MD, FACP Program Director Associate Professor University of Southern California
Oncology Practice Management, Advocacy, and Navigation Co-Chairs Linda Bosserman, MD, FACP
President Wilshire Oncology Medical Group
Vicki Kennedy, LCSW
Vice President, Program Development and Delivery Cancer Support Community
AVBCC Leadership Burt Zweigenhaft, BS President and CEO OncoMed
Gary M. Owens, MD
President Gary Owens Associates
Craig K. Deligdish, MD Hematologist/ Oncologist Oncology Resource Networks
HELD IN PARTNERSHIP WITH
NEW FOR 2014! Principles in Value and Market Access Educational sessions for Product Managers, Reimbursement Specialists, Account Managers, and Marketers focusing on access, reimbursement, proving product value, and international markets.
Cancer Center Business Summit
Data Drive Change: Identifying…Continued from page 26 data in their specialty, and have coined the expression ‘surgical islands,’ big swaths of geographic data where there is no access to a general surgeon,” Dr Lichter added. “Having that information has helped inform policymakers, and has helped lead to decisions that are impacting general surgery in a positive way.” Collecting these data is difficult, because practices have satellite locations that cover areas beyond the primary practice.
Results of the Community Oncology Census To start collecting the data themselves, ASCO undertook a census of oncology practices. In 2012 the first census included 632 practices and 5018 physicians; in 2013, it included 530 practices and 8011 physicians. The census is open from May 30 to August 30 and is promoted through many ASCO channels. The results are reported at the annual meeting of the Association of Community Cancer Centers. “Not only are we trying to count everybody, and where they are, what they are affiliated with,” Dr Lichter
KEY POINTS • Physician Compare allows patients to find and choose physicians enrolled in Medicare • The Iowa Project highlights variations in the number of practicing oncologists listed in the state, compared with other databases • The oncology workforce is getting older, according to the latest community oncology survey • Physician payment reform must include means to test the modified feefor-service approach
stated. “We are trying to understand the pressures on the field.” Overall, data from the 2012 and the 2013 census indicate that the pressures to close and sell oncology practices are stable, although there are efforts to merge with or purchase
thought when it comes to formulating payment reform: one is focused on the current fee-for-service (FFS) approach, but has payment modifiers based on quality and value metrics. The other breaks from the FFS system to offer new ways of
“We are trying to understand the pressures on the field.… Policymakers are influenced by data. They nod when you have an opinion. They are influenced to do things when you have data.” —Allen S. Lichter, MD, FASCO
another practice. Consolidation is another area of flux. Furthermore, many oncology practices are likely to affiliate with another practice, community hospital, or academic medical center. In terms of the workforce, the number of oncologists who are older than 64 years surpassed the number of those younger than 40 years in 2008. In addition, the number of oncology trainees who are international medical graduates is also trending up (44%-45%). Whether these trainees stay in the United States or return to their home countries is also being tracked. Furthermore, the data indicate that African American oncologists are underrepresented compared with other internal medicine subspecialties. Physician Payment Reform in Oncology There are currently 2 schools of
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reimbursement based entirely on quality and value metrics. The proposal being set forth by ASCO’s volunteer committees involves a new style of reimbursement based on monthly fees for patient evaluation, treatment management, transitions and care, and follow-up. More important, this proposal includes a plan to test a modified FFS system and to test alternatives. Other projects being developed by ASCO include precision medicine in oncology, defining value in oncology, Risk Evaluation and Mitigation Strategies and drug safety, a better understanding of the 340B drug pricing program, and oncology patient-centered medical homes. “Policymakers are influenced by data,” Dr Lichter concluded. “They nod when you have an opinion. They are influenced to do things when you have data.” l
Patient and Provider Access
States Looking at Biosimilar Regulation By Sydney Abbott, JD Manager, Provider Economics and Public Policy, Association of Community Cancer Centers
ll oncology practices are facing serious changes brought about by government and healthcare reform, some of which have not been fleshed out clearly enough. In the midst of this flux, practice managers must assess their practice’s performance and needs and make decisions that will affect the continued health and financial success of their business operations. Calling in a practice management consultant to help your practice wade through the mountains of healthcare reform regulatory requirements—as well as to help keep your practice abreast of normal industry changes, identify opportunities for growth, and prevent potential disasters—is more of a necessity than a luxury these days. But where do you go for guidance when it comes to determining the best electronic medical records (EMRs) or electronic health records (EHRs) for your practice? Even if you are already satisfied with your system, this is no time to relax. Constant surveillance of the ever-changing technological world should now be a part of your routine, particularly where reimbursement is concerned. You may recall the old saying, “You are what you eat.” The adage for your practice today may be better expressed by saying, “You are what your data say.” If you have accurate charge and payment data, you are halfway there. When it comes to medical information technology (IT), how fast you can supply medical records, how accurate those records are, and how good your technical support is when problems arise all play a part in this picture. To this end, we have listed and described a few EMR software systems that you can use in your prac-
tice. Bear in mind that change is occurring rapidly. So even if you are satisfied with your current system, consider reviewing some of the other systems that may solve problems for your practice down the line. If IT demands are dogging your practice, keep this caveat in
est and easiest way to enter visit charges • Lost charts, orders, and notes are an unavoidable part of a busy private practice • E l e c t r o n i c records are not as secure as paper patient files • Portability of patient records is a luxury reserved for large practices.
A number of states have taken up legislation to address this issue and create a framework for automatic biosimilar substitution at the pharmacy.
Allscripts Allscripts (http://clientconnect. allscripts.com) provides EHRs for private practices, hospitals, and other healthcare providers. Their services include electronic prescribing, care management, and revenue cycle management software. Their products are currently used by more than 180,000 physicians, 1500 hospitals, and 10,000 post–acute care organizations. Their website offers online client discussions (through “ClientConnect”), online learning modules, online issue or enhancement requests through their support team, web referrals, and a provider search through an extended-care database.
mind: “Keep up.” The following “bytes” were adapted from a variety of reviews.
ADP AdvancedMD ADP AdvancedMD (www. advancedmd.com) offers a blog to help improve clinical documentation and facilitate coding for International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM). The company recently released a white paper entitled, “A Case for EHR: 5 Status Quo Myths that Hold You Back and Reduce Your Bottom Line.” The idea was to urge practices to adopt change and overcome the myths that reduce their bottom line. The 5 EHR myths outlined in the paper include: • Maintaining the existing paper chart system makes sense financially • Paper charge slips are the quick-
Benchmark Systems Benchmark Systems (www. benchmark-systems.com) offers cloud-based software featuring scheduling, EHR, practice management, and billing and collection services. Their templates are customizable and can be set up to function as your practice requires. They also provide a patient portal through which patients can access their own medical records, billing statements, and appointments. Their systems automatically receive and scrub
Drug Coding Supplied by RJ Health Systems
FDA-Approved Medications Used for Supportive Care in Cancer Treatment The following sections will assist healthcare professionals and payers by providing appropriate coding and billing information associated supportive care in cancer treatment. The following sections include: • Associated ICD-9-CM codes used for the classification of supportive care in cancer treatment • Drugs that have been FDA approved in the treatment of supportive care in cancer treatment • Corresponding HCPCS/CPT® codes and code descriptions • Please note: The following list does not include drugs that maybe listed in the Compendia for off-label uses for supportive care in cancer treatment.
Associated ICD-9-CM codes for supportive care in cancer treatment 787.0 Nausea and vomiting Emesis Excludes:hematemesis NOS (578.0) vomiting: bilious, following gastrointestinal surgery (564.3) cyclical (536.2) >associated with migraine (346.2)< psychogenic (306.4) excessive, in pregnancy (643.0–643.9) habit (536.2) of newborn (779.3) psychogenic NOS (307.54) 787.01 Nausea and vomiting 787.02 Nausea alone 787.03 Vomiting alone 280 Iron-deficiency anemias Includes: anemia: asiderotic hypochromic-microcytic sideropenic Excludes: familial microcytic anemia (282.49) 280.0 Secondary to blood loss (chronic) Normocytic anemia due to blood loss Excludes: acute posthemorrhagic anemia (285.1) 284.89 Other specified aplastic anemias Aplastic anemia (due to): chronic systemic disease drugs infection
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radiation toxic (paralytic) Use additional E code to identify cause 285 Other and unspecified anemias 285.1 Acute posthemorrhagic anemia Anemia due to acute blood loss Excludes: anemia due to chronic blood loss (280.0) blood loss anemia NOS (280.0) 285.21 Anemia in chronic kidney disease Anemia in end-stage renal disease Erythropoietin-resistant anemia 285.3 Antineoplastic chemotherapy-induced anemia Anemia due to antineoplastic chemotherapy Excludes: anemia due to drug NECâ€”code to type of anemia anemia in neoplastic disease (285.22) aplastic anemia due to antineoplastic chemotherapy (284.89) 288.0 Neutropenia Decreased absolute neutrophil count Use additional code for any associated: fever >(780.61)< mucositis (478.11, 528.00-528.09, 538, 616.81) Excludes: neutropenic splenomegaly (289.53) transitory neonatal neutropenia (776.7) 288.00 Neutropenia, unspecified 288.01 Cogenital neutropenia Congenital agranulocytosis Infantile genetic agranulocytosis Kostmannâ€™s syndrome 288.02 Cyclic neutropenia Cyclic hematopoiesis Periodic neutropenia 288.03 Drug-induced neutropenia Use additional E code to identify drug 288.04 Neutropenia due to infection 288.09 Other neutropenia Agranulocytosis Neutropenia: immune toxic 288.5 Decreased white blood cell count Excludes: neutropenia (288.01-288.09) 288.50 Leukocytopenia, unspecified Decreased leukocytes, unspecified Decreased white blood cell count, unspecified Leukopenia NOS 288.59 Other decreased white blood cell count Basophilic leukopenia Eosinophilic leukcopenia Monocytopenia Plasmacytopenia
E930.7 Antineoplastic antibiotics Actinomycins, such as: Bleomycin Cactinomycin Dactinomycin Daunorubicin Mitomycin Excludes: other antineoplastic drugs (E933.1) E933.1 Antineoplastic and immunosuppressive drugs Azathioprine Busulfan Chlorambucil Cyclophosphamide Cytarabine Fluorouracil Mechlorethamine hydrochloride Mercaptopurine Triethylenethiophosphamide Excludes: antineoplastic antibiotics (E930.7)
Generic (brand) Name
HCPCS code: code description
Possible CPT 速 administration codes
J8501: Aprepitant, oral, 5 mg
Q0161: Chlorpromazine hydrochloride, 5 mg oral, FDA-approved prescription antiemetic, for use as a complete therapeutic substitute for an IV antiemetic at time of chemotherapy treatment, not to exceed a 48-hour dosage regimen
darbepoetin alfa (Aranesp)
J0881: Injection, darbepoetin alfa, 1 mcg (non-ESRD use)
darbepoetin alfa (Aranesp)
J0882: Injection, darbepoetin alfa, 1 mcg (for ESRD on dialysis)
Q0163: Diphenhydramine hydrochloride, 50 mg oral, FDA-approved prescription antiemetic, for use as a complete therapeutic substitute for an IV antiemetic at time of chemotherapy treatment, not to exceed a 48-hour dosage regimen
dolasetron mesylate (Anzemet)
Q0180: Dolasetron mesylate, 100 mg, oral, FDA-approved prescription antiemetic, for use as a complete therapeutic substitute for an IV antiemetic at time of chemotherapy treatment, not to exceed a 24-hour dosage regimen
Q0167: Dronabinol, 2.5 mg oral, FDA-approved prescription antiemetic, for use as a complete therapeutic substitute for an IV antiemetic at time of chemotherapy treatment, not to exceed a 48-hour dosage regimen
epoetin alfa (Procrit, Epogen)
J0885: Injection, epoetin alfa (for non-ESRD use), 1000 units
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Generic (brand) Name
HCPCS code: code description
epoetin alfa (Procrit, Epogen)
J0886: Injection, epoetin alfa, 1000 units (for ESRD on dialysis) (renal dialysis facilities and hospitals must use code Q4081 effective 1/1/07)
epoetin alfa (Procrit, Epogen)
Q4081: Injection, epoetin alfa, 100 units (for ESRD on dialysis) (for renal dialysis facilities and hospital use)
J1440: Injection, filgrastim (G-CSF), 300 mcg
96365, 96366, 96369, 96370, 96372, 96374
J1441: Injection, filgrastim (G-CSF), 480 mcg
96365, 96366, 96369, 96370, 96372, 96374
J1453: Injection, fosaprepitant, 1 mg
J1626: Injection, granisetron hydrochloride, 100 mcg
Q0166: Granisetron hydrochloride, 1 mg oral, FDA-approved prescription antiemetic, for use as a complete therapeutic substitute for an IV antiemetic at time of chemotherapy treatment, not to exceed a 24-hour dosage regimen
S0091: Granisetron hydrochloride, 1 mg (for circumstances falling under the Medicare statute, use Q0166)
J2765: Injection, metoclopramide hydrochloride, up to 10 mg
J8650: Nabilone, oral, 1 mg
J2405: Injection, ondansetron hydrochloride, per 1 mg
Q0162: Ondansetron 1 mg, oral, FDA-approved prescription antiemetic, for use as a complete therapeutic substitute for an IV antiemetic at time of chemotherapy treatment, not to exceed a 48-hour dosage regimen; see also S0119
S0119: Ondansetron, oral, 4 mg (for circumstances falling under the Medicare statute, use HCPCS code Q0162)
J2469: Injection, palonosetron hydrochloride, 25 mcg
J2505: Injection, pegfilgrastim, 6 mg
Q0175: Perphenazine, 4 mg, oral, FDA-approved prescription antiemetic, for use as a complete therapeutic substitute for an IV antiemetic at time of chemotherapy treatment, not to exceed a 48-hour dosage regimen
prochlorperazine maleate (Compazine)
Q0164: Prochlorperazine maleate, 5 mg oral, FDA-approved prescription antiemetic, for use as a complete therapeutic substitute for an IV antiemetic at time of chemotherapy treatment, not to exceed a 48-hour dosage regimen
Q0169: Promethazine hydrochloride, 12.5 mg oral, FDA-approved prescription antiemetic, for use as a complete therapeutic substitute for an IV antiemetic at time of chemotherapy treatment, not to exceed a 48-hour dosage regimen
Possible CPT 速 administration codes
Generic (brand) Name
HCPCS code: code description
Possible CPT ® administration codes
J2820: Injection, sargramostim (GM-CSF), 50 mcg
96365, 96366, 96372
J1446: Injection, tbo-filgrastim, 5 mcg
*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 to ensure appropriate reimbursement. Please note: Check with payer regarding correct placement of medication information. References HCPCS Level II Expert 2014 • Current Procedural Terminology (CPT®) 2014 (copyright 2014 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association) • ICD-9-CM for Professionals Volumes 1, 2, 2014 • 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) CPT ® indicates Current Procedural Terminology; ESRD, end-stage renal disease; G-CSF, granulocyte colony-stimulating factor; GM-CSF, granulocyte-macrophage colony-stimulating factor; HCPCS, Healthcare Common Procedure Coding System; IV, intravenous; NEC, not elsewhere classified; NOS, not otherwise specified.
This information was supplied by:
30 Cold Spring Road, Rocky Hill, CT 06067 T: (860) 563-1223 • F: (860) 563-1650 • www.RJHealthSystems.com
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RJ Health Systems The Creators of ReimbursementCodes.com
RJ Health Systems â€” the pharmaceutical specialists that healthcare professionals have turned to since 1983 for their drug information. We work with over 170 Payor organizations that touch approximately 110 million lives. RJ Health Systems has established and continuously maintains a Library of Drug Intelligence that provides the most comprehensive, trusted, and up-to-date coding and reimbursement information in the industry. ReimbursementCodes.com incorporates the CMS HCPCS and AMA CPT Drug codes into a system that crosswalks each drug code with the drugâ€™s NDC and brand/generic name. Please visit www.rjhealthsystems.com to learn more about our products and services listed below:
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Wealth Management With Lawrence B. Keller
Eight Resolutions to Improve Your Finances in the New Year By Andrew D. Schwartz, CPA; and Lawrence B. Keller, CFP® , CLU®, ChFC®, RHU®, LUTCF
inancial planning is a process that can help you reach your goals by evaluating the whole financial picture, then outlining strategies that are tailored to your individual needs and available resources.
maximize their retirement plans by depositing a fixed dollar amount each month or a percentage of their salary. Instruct your employer to withhold enough each month for your 401(k) or 403(b) plan to ensure reaching the maximum contribution of $17,500 in 2014. Are you self-employed? If so, you can
Why Is Financial Planning Important? The term financial planning can be used to illustrate many things. It can be a comprehensive plan, focusing on several needs or goals simultaneously, or limited to specific areas such Andrew D. Schwartz as establishing a budget, saving for a home, a child’s education, or retirement. A comprehensive financial plan serves as a framework for organizing your financial life. One of the main benefits of a financial plan is that it can help you balance competing financial priorities by clearly showing you how your financial goals are related, and how decisions made in one area subsequently affect the others.
The New Year is a good time to review your financial goals and make sure that your plan is up to date. It is also possible that you will need to modify your plan due to changes in your personal circumstances or the economy.
Lawrence B. Keller
What Does 2014 Have in Store for You? Who knows how financially friendly this year will be? For that reason, here are some prudent steps you can take to keep personal finances heading in the right direction:
Reset your retirement savings. Most people find it easier to
contribute up to $52,000 annually into a Simplified Employee Pension (SEP), Keogh, or Solo 401(k) plan for 2014. In addition, if you are aged 50 years or older by December 31, the maximum contribution increases to $23,000 for 401(k) and 403(b) salary deferrals, and $57,500 for Solo 401(k)s.
Refinance your home. There are still a variety of low-rate mortgages currently available for physicians looking to purchase a new home or refinance an existing mortgage. As you are probably aware, physicians, especially
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early in their careers, have rapidly expanding income levels and need specialized home loan products that allow for principal reduction and reamortization of their mortgage payments. Fortunately, in most cases, there are several programs that allow physicians to make big principal reductions, which trigger both lower mortgage interest rates and lower minimum monthly payments without refinancing. A good resource is Josh Mettle, a top- producing mortgage lender specializing in financing physicians, dentists, and other medical professionals in Salt Lake City, UT ( www. utahphysicianhome loans.com).
Reduce your personal debt. Over time, some physicians seem to forget that any money borrowed needs to be repaid. Remember, leverage equals risk. It is best to pay your credit card balances in full each month to avoid paying any interest charges. However, if you must carry a balance, make sure your card has the lowest interest rate possible or apply for a lowrate credit card that allows you to transfer your current balance to it. If you own a home, consider using a home equity loan or home equity line of credit (HELOC) to pay some of your outstanding debt. The interest rate you pay on a home equity loan or line of credit will likely be lower than the rate you pay on credit cards and other unsecured consumer debt. In addition, the interest on home equity financing is generally income tax deductible (up to $100,000). Make 2014 a year to pay down some of your personal debt. Continued on page 38
Eight Resolutions to Improve Your…Continued from page 36
Revise your savings and debt reduction goals. Take a few minutes to set new savings goals. Ideally, physicians should also save 20% of their income toward retirement starting the day they graduate from residency or fellowship. While it is true that if you start early you can save less, saving 20% provides flexibility for years where you might not be able to save as much, to allow for poor investment returns, or for a personal or financial catastrophe such as divorce or disability. If all goes well and none of these scenarios materialize, then you will be left with a wonderful choice: retire earlier or retire wealthier.
Rebalance your investment portfolio. Warren Buffett said it best by stating, “A simple rule dictates my buying: Be fearful when others are greedy, and be greedy when others are fearful.” During 2013, the stock market posted substantial gains. By rebalancing your portfolio to its original or updated asset allocation, you lock in gains from the sectors that performed the best and move money into sectors that underperformed and soon enough should be poised to catch up.
Recalculate how much your retirement savings will be worth when you retire. With the Dow at all-time highs, now is a great time to take a look at how much buying power you can expect to have at retirement. Be sure to download the online retirement calculator (www. mdtaxes.com) to find out what your savings will really be worth when you retire.
Revisit your disability and life insurance needs. Throughout your career and life, disability and life insurance needs change. Give some thought to how much of these insur-
ances you need versus how much you currently receive through your employer, and how much individual coverage you have already purchased. As a physician, the ability to earn an income is your most valuable asset. Because any company will only insure you for $15,000 to $17,000 per month, by combining at least 2 companies you can potentially reach a total monthly benefit of $20,000 to $30,000, depending on earned income, state of residence, and other disability insurance in force. Look for a policy with a multilife or association discount. Although this can provide male physicians with savings of 10% to 15% off of their policies, female physicians can save as much as 60% off of the normal female rates if a gender neutral or unisex rate is available. Term life insurance is for the most part a commodity, so the pricing is very competitive and comparison shopping is easy. Websites such as www.term4sale.com can compare the premium rates of several insurance companies and various death benefit amounts and guarantee periods. You should employ the services of an experienced insurance agent who represents several companies to help you get the best rates, especially if your health is less than perfect. The agent will know which carriers are likely to provide a better underwriting classification based on your height and weight, immediate family history, and/or other medical issues to allow you to secure a lower premium rate. For example, if you are being treated for hypertension, certain companies will allow you to qualify for their best underwriting classification while others will not.
Resolve errors on your credit report. Each year, you are entitled to 3 free credit reports, so there is no excuse to not look at this
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important financial report annually, especially since errors are common. If you find information that is outdated, incorrect, or misleading upon review, you should contact the credit reporting agency as soon as possible. If the disputed data are found to be incorrect, the lender or information provider must notify all credit reporting agencies nationwide to correct the information in your file. If the negative information proves to be correct, you still have the right to insert a brief commentary (100 words) about the entry on your credit report. Order your free report at www.annualcreditreport.com.
Conclusion The New Year is a good time to review your financial goals and make sure that your plan is up to date. It is also possible that you will need to modify your plan due to changes in your personal circumstances or the economy. These 8 steps are a great place to start. l About the Authors Andrew D. Schwartz, CPA, is a partner in the Boston CPA firm Schwartz & Schwartz, P.C. and is also the founder of the MDTAXES Network (www.mdtaxes.com), a national network of CPAs who specialize in tax and accounting services for healthcare professionals and their practices. He can be reached for questions or comments at 800-471-0045 or by e-mail at Andrew@mdtaxes.com. Lawrence B. Keller, CFP®, CLU®, ChFC®, RHU®, LUTCF, is the founder of Physician Financial Services, a New York–based firm specializing in income protection and wealth accumulation strategies for physicians. He can be reached at 800-481-6447 or by e-mail at Lkeller@physicianfinancialser vices.com with comments or questions.
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