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In 2006, the State of California passed legislation (Assembly Bill 1195) mandating that CME providers based within California provide content on Cultural and Linguistic Competency (CLC).
Program Written Summary
Audio-Digest Oncology
Volume 04, Issue 13
July 7, 2013

Bundling of Health Care Costs – Robert Lorenz, MD, MBA
Laryngeal Preservation – David Adelstein, MD

Sponsored By Cleveland Clinic Foundation Center For Continuing Education
Digital Media $24.99
Audio CD $27.99

The following is an abstracted summary, not a verbatim transcript, of the lectures/discussions on this audio program.

Oncology Program Info  Accreditation InfoCultural & Linguistic Competency Resources

Highlights from the 2013 multidisciplinary 
head and neck cancer update

Sponsored by Cleveland Clinic Foundation Center for Continuing Education

Educational Objectives

The goals of this program are to improve efficiency and patient outcomes through use of a bundling payment system, and to improve management of patients with advanced laryngeal cancer. After hearing and assimilating this program, the clinician will be better able to:

1. Explain the steps involved in building a treatment bundle.

2. Identify effects of high-risk patients on bundle pricing.

3. Recognize the implications of bundling for clinicians, insurers, and patients.

4. Consider the evidence on approaches to management of stage III and IV laryngeal cancer.

5. Choose appropriate candidates for laryngeal preservation among patients with advanced laryngeal cancer.

Faculty Disclosure

In adherence to ACCME Standards for Commercial Support, Audio-Digest requires all faculty and members of the planning committee to disclose relevant financial relationships within the past 12 months that might create any personal conflicts of interest. Any identified conflicts were resolved to ensure that this educational activity promotes quality in health care and not a proprietary business or commercial interest. For this program, the following has been disclosed: Dr. Adelstein receives research support from AstraZeneca, GlaxoSmithKline, and sanofi-aventis US. Dr. Lorenz and the planning committee reported nothing to disclose. In his lecture, Dr. Adelstein presents information that is related to off-label or investigational use of a therapy, product, or device.

Bundling of Health Care Costs

Robert Lorenz, MD, MBA, Department of Head and Neck Surgery, Cleveland Clinic Head and Neck Institute, and Medical Director, Payment Reform, Risk, and Contracting, Cleveland Clinic Health System, Cleveland, OH

Introduction: bundled payment — one payment to one organization for all services and procedures provided for patient for one disease condition and/or procedure over specified period of time; current fee-for-service system pays for productivity (individual payments for procedures and orders) and performance (no reimbursement given for, eg, medical errors, care of decubitus ulcers); employers shifting to bundling to minimize costs of insuring employees; controlling health care costs — currently, Medicare costs make up 25% of US budget; government efforts include fraud prevention via recovery audit contractors (RACs), improved prevention and detection of disease via Affordable Care Act, and shifting of financial risk to providers and patients (ie, creating incentive to minimize costs) via bundling

Cleveland Clinic model: all professional and technical revenue flows to “same bucket” (not tied salaries); this provides motivation to participate in innovative payment structures

Assumption of risk: disease prevention — important for cutting costs in self-insured company; risk assumed through health maintenance organization structure; international self-pay patients — “lump sum” price quoted for procedures (covers cost of, eg, related reoperation); joint replacement — entire revenue to be bundled into one fee; organ transplantation — bundling of fees already commonplace

Initial Steps in Development of Bundle

1) Develop governance structure: ie, all individuals and entities (eg, quality and outcomes, information technology, inpatient and outpatient resources, finance, decision support, marketing, internal operations [eg, supply chain, pharmacy]) involved in providing care

2) Choose “episode” to bundle: determine quality and outcome metrics, data sources, attribution (party responsible for costs and outcome); characteristics of ideal candidates — complicated; expensive; has limited variability in costs and outcomes; has superior outcomes at institution; long-term longitudinal outcome data available; Cleveland Clinic — databases on patient outcomes and internal costs for cardiac surgery and cardiac catheterization started in 1970s; because costs known and variability limited, appropriate definition and pricing of bundle can be determined with confidence; head and neck cancer (HNC) also good candidate due to availability of longitudinal data

3) Define services included in bundle package: use of “care path” (ie, a priori algorithm for treatment, including elements necessary for diagnosis [eg, providers, referrals, tests, timing of care]) promotes limitations on variability

4) Identify episode anchors: define duration of bundle and point in care process at which it begins and ends; may start before diagnosis and end long after procedure

5) Risk adjustment: determine total internal costs of inpatient and outpatient services included in bundle; bundle modifier system considers internal costs and current pricing for services

Example (percutaneous coronary intervention): Cleveland Clinic looked at associated costs over 10-yr period for all patients; care (and costs) varies from, eg, stenting and rapid discharge to prolonged stay in hospital and/or intensive care unit in patient with comorbidities; risk adjustment allows provider to analyze data to determine causes of variability and means of reducing it; need to identify high-risk patients in order to offer appropriately priced bundle or exclude patient from bundle

A priori determinants of risk: known patient characteristics (eg, history of smoking and drinking in patient with HNC)

Unknown determinants of risk: unknown until treatment has begun (eg, occult nodes found on lymph node dissection); have insurer agree to allow modification of bundle during treatment (anchor not necessarily first contact with patient)

Negotiations with payers: determine which data (provider’s, payer’s, or government’s) to use (patient characteristics of population to be treated must not differ significantly from those in data used)

6) Continuous improvement: maintain communication; have ongoing performance reviews for outcomes, quality, and costs (improves profit margin and allows bundles to remain competitive)

Implications of bundling: centralization of care needed to allow creation of infrastructure and coordination essential to use of bundling; increased need for accuracy of disease coding (because payment based on complexity of patient and outcome rather than on procedure performed); greater emphasis placed on documentation and utilization rates (eg, number of tests, procedures, complications); having both claims and clinical data advantageous (provider can offer to partner with payer to improve value to patients); predictive modeling — anticipation and prevention of complications associated with procedure on basis of patient characteristics; allows improvement in clinical outcomes and mitigates risk associated with creation of bundles; velocity of care — having care path facilitates rapid diagnosis and treatment (improves outcomes and decreases costs); reduced administrative costs — bundling eliminates costs associated with approval process for medical services

Comparative effectiveness research: 2008 American Recovery and Reinvestment Act — US government allocated $1.1 billion for filling gaps in evidence needed by clinicians and patients to make informed decisions; analyzes determinants of outcomes rather than treatment algorithm (ie, looks at outcomes while accounting for differences among patients in, eg, access to treatment, compliance, timeliness of treatment, ability to afford treatment, social support)

Examples: diabetes study — lifestyle modification found to be as effective as metformin in preventing complications of diabetes; coronary stenting vs optimal medical treatment (COURAGE trial) — outcomes of 2 options equivalent in long term

Framework: studies to be done in priority populations (eg, elderly, very young) and for priority conditions (eg, heart failure, heart disease, asthma); many types of procedures and medications to be studied; funds also allocated for creating infrastructure for and dissemination of data

Conclusions: having data on past patient outcomes allows providers to assume risks (patients stratified early in course of care; charges based on past experience, with added margin); ultimately, not only costs reduced, but patients benefit from alignment of survival outcomes with quality of life after treatment

Laryngeal Preservation

David Adelstein, MD, Professor of Medicine, Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, and Staff Physician, Department of Solid Tumor Oncology, Taussig Cancer Center, Cleveland Clinic, Cleveland

Introduction: French meta-analysis compared concurrent chemoradiation (CCRT) vs induction chemotherapy (ICTX) plus radiation therapy (RT) vs adjuvant chemotherapy (ACTX) plus RT, and found increased overall survival (OS) with CCRT; ICTX does not increase local control (LC) or OS but does predict response to RT; patients who respond to ICTX may be downstaged and subsequently treated with RT instead of surgery

Veterans Affairs study (Wolf et al, 1991): randomized trial comparing laryngectomy vs ICTX followed by RT in responders; equivalent OS predicted; goal to decrease need for laryngectomy; trial positive (OS equal in 2 arms; two-thirds of survivors in CRT arm did not require laryngectomy); conclusion — organ preservation possible with CRT

Radiation Therapy Oncology Group (RTOG) 91-11: patients with stage III or IV glottic or supraglottic squamous cell carcinomas randomized to RT alone vs ICTX followed by additional CTX in responders vs CCRT; patients with T1 or T4 disease excluded; patients in CCRT arm had higher rates of laryngeal preservation than those RT alone or ICTX arm; ICTX arm showed trend towards better OS, compared to CCRT arm; however, death rates due to laryngeal cancer equivalent in CCRT and ICTX arms, while death rate not due to laryngeal cancer higher in CCRT arm; patients requiring salvage surgery had same OS as patients with laryngeal preservation; authors looked at late toxicities and second malignancies in CCRT arm, but unable to link treatment with lower OS; conclusion — laryngeal preservation possible with all nonsurgical regimens tested

Outcomes trends

National Cancer Data Base retrospective review: revealed that 5-yr OS of laryngeal cancer decreased relative to rate 10 to 20 yr ago, while OS of all cancers combined improved; suggests decrease in treatment via surgical resection may be responsible

Emory University data (Chen and Halpern): found poorer OS with RT alone compared to surgery for stage III and IV patients (OS also poorer in stage IV patients who received CRT)

American Society of Clinical Oncology: 2006 guidelines — recommend organ preservation for T3 or T4 disease, excluding tumors with penetration through thyroid cartilage into soft tissues; panel on laryngeal preservation (2008) — candidates should be those with T2 or T3 disease not amenable to partial laryngectomy; not recommended for any patients >70 yr of age, or with laryngeal dysfunction; established new primary end point called laryngoesophageal dysfunction-free survival (LDFS), “which considers death, local relapse, laryngectomy (partial or total), tracheostomy at 2 yr, or feeding tube at 2 yr as failure”

Improving induction regimens: study by Pointreau et al — compared 3-drug induction regimen (docetaxel, cisplatin, and 5-fluorouracil [5-FU]) to 2-drug regimen (cisplatin and 5-FU); in both arms, responders treated with RT with or without CTX, and nonresponders had surgery followed by RT with or without CTX; at 3 yr, 3-drug regimen had better response rate, rate of laryngeal preservation, and LDFS, but OS no better than with 2 drugs; few patients received CCRT (study confirms superiority of 3-drug regimen, but does not test hypothesis that ICTX can be followed by CCRT)

Attempt to improve CCRT phase

Tremplin study: phase II randomized trial; responders to ICTX randomized to RT with cisplatin vs RT with cetuximab; toxicity to ICTX — grade 3 to 4 in 25% of patients, and grade 5 (toxic death) in 2 patients; 24% of patients never started CCRT (due to nonresponse and residual toxicities); toxicity to CCRT — grade 3 to 4 mucositis in almost 50% of patients in both arms (no advantage to cetuximab); in-field skin toxicity greater with cetuximab; 22% of patients in cisplatin arm had permanent renal damage; only 43% of patients in cisplatin arm and 70% of those in cetuximab arm completed all therapy; outcomes — OS, LDFS, and local control at 36 mo similar in 2 arms; conclusions— toxicity with 3-cycle ICTX followed by CCRT (or cetuximab plus RT) unacceptable; laryngeal preservation possible with both regimens, but neither can be considered standard therapy

Identifying candidates for CCRT

University of Michigan study: attempted to use CTX as predictor (since response to CTX predictive of response to RT); patients with stage III or IV laryngeal cancer given one cycle of ICTX; responders received definitive nonsurgical treatment (CCRT with cisplatin), while nonresponders had laryngectomy; OS similar in patients treated surgically and nonsurgically; 3-yr OS and LDFS better than in VA and RTOG 91-11 trials; subset analysis of patients with T4 disease — 3-yr OS 78% and 3-yr laryngectomy-free survival good, but LDFS poor

University of Chicago retrospective analysis: results similar to those above; 80 patients with T4 laryngeal cancer (55 with invasion of cartilage or base of tongue) treated with various CCRT regimens; 5-yr OS 51%; 33% feeding tube-dependent (poor outcome)

National Comprehensive Cancer Network guidelines for laryngeal cancer: “for T4a glottic and supraglottic tumors, the standard approach is laryngectomy”

Conclusions: 4 approaches appropriate for patients with advanced laryngeal cancer (no clearly superior option); RT with concurrent cisplatin is standard; ICTX followed by RT reasonable in responders; RT alone reasonable if patient cannot tolerate CTX; laryngeal preservation surgery also important


Drs. Lorenz and Adelstein spoke at the 2013 Multidisciplinary Head and Neck Cancer Update, held February 22-23, 2013, in Weston, FL, and sponsored by the Cleveland Clinic Foundation Center for Continuing Education. Information about upcoming CME conferences from Cleveland Clinic can be found at The Audio-Digest Foundation thanks the speakers and the Cleveland Clinic Foundation Center for Continuing Education for their cooperation in the production of this program.

Suggested Reading

Blanchard et al: Meta-analysis of chemotherapy in head and neck cancer (MACH-NC): a comprehensive analysis by tumor site. Radiother Oncol. 100(1):33-40, 2011; Chen AY and Halpern M: Factors predictive of survival in advanced laryngeal cancer. Arch Otolaryngol Head Neck Surg. 133 (12):1270-6, 2007; Domenge C et al:Randomized trial of neoadjuvant chemotherapy in oropharyngeal carcinoma. French Groupe D’Etude des Tumeurs de la Tête et du Cou (GETTEC). Br J Cancer 83(12):1594-8; Eapen ZJ et al: Do heart failure disease management programs make financial sense under a bundled payment system? Am Heart J. 161(5):916-22; Forastiere AA et al:Long-term results of RTOG 91-11: a comparison of three nonsurgical treatment strategies to preserve the larynx in patients with locally advanced larynx cancer. J Clin Oncol. 31(4):845-52, 2013; Hoffman HT et al: Laryngeal cancer in the United States: changes in demographics, patterns of care, and survival. Laryngoscope 116(9 Pt 2 Suppl 1111):1-13, 2006; Lefebvre JL et al: Induction chemotherapy followed by either chemoradiotherapy or bioradiotherapy for larynx preservation: the TREMPLIN randomized phase II study. J Clin Oncol. 31(7):853-859, 2013; Lefebvre JL and Ang KK: Larynx preservation clinical trial design: key issues and recommendations- a consensus panel summary. Head Neck 31(4):429-41, 2009; Lefebvre JL et al: Larynx preservation in pyriform sinus cancer: preliminary results of a European Organization for Research and Treatment of Cancer phase III trial. EORTC Head and Neck Cancer Cooperative Group. J Natl Cancer Inst. 88(13):890-9, 1996; Pfister DG et al: American Society of Clinical Oncology clinical practice guideline for the use of larynx-preservation strategies in the treatment of laryngeal cancer. J Clin Oncol 24(22):3693-704, 2006; Pignon JP et al: Chemotherapy added to locoregional treatment for head and neck squamous-cell carcinoma: three meta- analyses of updated individual data. MACH-Collaborative Group. Meta-Analysis of Chemotherapy on Head and Neck Cancer. Lancet 355(9208):949-55, 2000; Pignon JP et al: Meta-analysis of chemotherapy in head and neck cancer (MACH-NC): an update on 93 randomised trials and 17,346 patients. Radiother Oncol. 92(1):4-14, 2009; Pointreau Y et al: Randomized trial of induction chemotherapy with cisplatin and 5-fluorouracil with or without docetaxel for larynx preservation. 101(7):498-506, 2009; Stenson et al: Chemoradiation for patients with large-volume laryngeal cancers. Head Neck 34(8):1162-7; Sood N et al: Medicare’s bundled payment pilot for acute and post-acute care: analysis and recommendations on where to begin.Health Aff 30(():1708-17. Urba et al: Single-cycle induction chemotherapy selects patients with advanced laryngeal cancer for combined chemoradiation: a new treatment paradigm. J Clin Oncol 24(4):593-8; Wolf GT et al: Induction chemotherapy plus radiation compared with surgery plus radiation in patients with advanced laryngeal cancer.NEJM 324: 1685-1690, 1991; Worden et al: Chemoselection as a strategy for organ preservation in patients with T4 laryngeal squamous cell carcinoma with cartilage invasion. Laryngoscope 119(8):1510-7.

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