The New Oncology Practice - Global Health Care

The New Oncology Practice - Global Health Care

Proving Value in Oncology: The Visible and Invisible Issues Dawn Holcombe, FACMPE, MBA, ACHE President, DGH Consulting Executive Director, Connecticut Oncology Association Todays Agenda Understanding Oncology and Specialty Pharmacy Overview of CMS and Private Initiatives Practices: Proving Quality Care

Implications and Future Issues 02/09/20 Part I - Evolution of Oncology The future lies in the past: Need to know how we got here To determine how to move forward In 1971, President Nixon signed into effect the National Cancer Act of 1971, declaring war on cancer and the devastation it wreaked on American life. From this initiative, millions of dollars flooded universities and research centers.

02/09/20 The Evolution of Oncology new specialty, born in the early 1970s. Love Story Brians Song Dramatized trauma of terminally ill patients leaving homes and families to seek treatment, but more often concluding their lives in hospital beds, after having struggled with their illness and the side effects of cancer treatments

Inpatient, lengthy stays Toxic, single agent drugs Debilitating side effects 02/09/20 DGH Consulting A new breed of primary specialist 1973, medical oncology programs were graduating a new breed of physicians specially trained in multidisciplinary oncology practice and clinical research. While surgeons had dominated cancer care during the 1950s and 1960s, medical oncologists soon became the primary clinicians for patients with malignancies, coordinating multi-disciplinary care 02/09/20

Supportive Care Evolution -Side Effect Management -Outlook on Life -Allowed toxic drugs to be delivered in outpatient settings while avoiding complications 02/09/20 Infrastructure Grew More Similar to Infusion Suites than Physician offices Emergency Care Watch Constant Adverse Reaction Management Oncology Certified Nurses OSHA Management of bio and hazardous waste 02/09/20 Inherent Flaws in Payment System RVU Basis

Created in Early 1990s on older data Profile of Oncology vastly different 02/09/20 AWP and Professional Payments Aggregated an Efficient Care Delivery Stream Mislabeled Buckets, Same Net Amount of Money Years of MisLabeling lead to confusion and Frustration on all Sides Cancer Care Continued to Evolve, despite Stagnant Payment System 02/09/20 Specialty Pharmacy Management and Payer Perspective New Opportunity for successes in other specialties

Big dollars, big target Slow and sporadic entry Mixed understanding of oncology issues Does Spec. Pharmacy add value or costs in oncology? Specialty Pharmacy Started in 1970s High cost specialized drugs (hemophilia) Unreliable delivery/availability Addition of PBM tools Oncology as a target before understanding the specialty SPs. PBM lines blurring What is Specialty Pharmacy? MD call and order treatment Reviewed and approved by SP Drug shipped to MD or patient for

administration within 24 48 hours After shipment, SP bills insurer for drugs MD bills insurer for drug administration only Oncology A Too Quiet Success Story Other SP and PBM success were in less complex specialties Oncologists Do: Manage comprehensive multispecialty care Understand old and new treatments and toxicities and

side effects Balance drug choices on multiple decision trees Manage adverse outcomes Provide patient education and support, case management What are issues in oncology re specialty pharmacy? Distribution Cost, Reliability, Safety New and Combination Therapies drive cost, not correctable purchasing decisions Waste and Inefficiency

Risk Focus on Drug Prices without considering cost of professional services is short-sighted Oncologist becomes Primary Caregiver, specializing in Care Coordination Medical Decision-making in Oncology Needed by Physicians familiar with the Patient No Visa, No Drug Redundancy and Malpractice Distribution Cost, Reliability, Safety A generic is not the same for quality and useability Price is the last deciding factor You get what you pay for (short dated, improperly stored, adulterated, counterfeit) Risks and Liability too great Extra Steps and Players mean extra confusion, = Extra Risk

New and Combination Therapies drive cost, not correctable purchasing decisions Medical Effectiveness Toxicities Combination Regiment change above Rapidly changing rules and status Single source, multi source, few generics Discounts increasingly hard to come by Waste and Inefficiency Single centralized inventory Each drug compounded re Pnt height, weight, physical condition and dose intensity of other drugs in regimen

Daily patient health status changes Waste Duplicate storage Non returnable product A dispensed drug for one patient cannot be used on another patient, so it should not be placed into the general office stock under any circumstances.The drug would be considered adulterated under Chapter 499, F.S., Jerry Hill, RPh, CPh, chief of pharmacy services for the Florida Department of Health. Risk Waiver of liability Malpractice coverage Interference with clinical controls and the direct

communications that allows the medical care team to ensure the safety and use of drugs. MVI Breaks the chain of custody, imposes unnecessary and dangerous delays in treatment Payors may be held criminally liable for violation of the Federal Food, Drug, and Cosmetics Act (FFDCA) if, even if unbeknownst to them, drugs obtained from other countries by vendors were dispensed to health plan enrollees and paid for by their insurer. Limited Program Successes Brownbagging starts and stops Illinois, Fla, Virginia, CT Experience

Waste Millions of dollars of double insurer payments for unused drug Treatment delays late arrivals, wrong shipments Liability hold harmless clauses Non oncology specialties dermatologists, rheumatologists, gastroenterologists and neurologists may embrace for lack on infrastructure themselves Our Future Evidence Based Medicine Value Driven Healthcare Proving It 02/09/20 History of Quality Measurement Programs In other specialties such as cardiology and endocrinology (diabetes management)

CMS Private Payers Quality Organizations Hospitals Learning Curve = Communication Issues American College of Cardiology. See http://www.acc.org/qualityandscience/quality/quality.htm http://www.acc.org/qualityandscience/quality/quality.htm Accessed August 9, 9, 2007 American Diabetes Association. See http://docnews.diabetesjournals.org/cgi/content/full/2/8/4#REF1 Accessed August 9, 2007 Pay for Performance & Oncology Practices, At the Crossroads, What Your Oncology Practice Can Do Today, By Dawn Holcombe 02/09/20

Oncology Quality Studies The landmark 1999 Institute of Medicine (IOM) report "Ensuring Quality Cancer" raised concerns about the quality of care provided to cancer patients and the lack of systems to assess quality.1 Feb 1, 2006 The National Initiative on Cancer Care Quality (NICCQ), which analyzed data from nearly 1,800 patient surveys and medical records of people with early-stage breast and colorectal cancer, found that the large majority of patients are receiving highquality care, though certain areas of care are in need of improvement. Hewitt M, Simone JV: Ensuring Quality Cancer Care. Washington, DC, National Academy Press, 1999 The Quality Oncology Practice Initiative : Assessing and Improving Care Within the Medical Oncology Practice ,

Kristen McNiff, MPH , Journal of Oncology Practice, Practice, Vol 2, No 1 (January), 2006: pp. 26-30 2006 American Society of Clinical Oncology. http://jop.ascopubs.org/cgi/content/full/2/1/26 1 02/09/20 What can be Quality/Value What treatment does for a patient Transparent Reductions in Variation IOM:

Safe Effective Patient-centered Efficient Equitable Timely Committee on Quality of Health Care in America, Institute of Medicine: Crossing the Quality Chasm: A New Health System for the 21 st Century, page 5 of the Executive Summary, Washington, D.C., The National Academies Press, 2001. Accessed August 9, 2007. Pay for Performance & Oncology Practices, At the Crossroads, What Your Oncology Practice Can Do Today, By Dawn Holcombe, Oncology Issues , published by the Association of Community Cancer Centers (ACCC), March/April 2007 issue, Pages 26 30 02/09/20 Performance/Quality/Value is a matter of perspective.. 02/09/20 Current Quality Programs in infancy and very

limited in scope CMS Data needs to be quantifiable Non-oncology Demonstration Projects 2005, 2006 Oncology Demonstration Projects 2007 Physicians Quality Reporting Initiative Private Payers Often based upon claims data Non-oncology pay for performance program Reporting to members physician quality rankings Varying co-payments and deductible incentives for plan members for choosing quality physicians

ASCO QOPI Initiative Early stages of implementation Practice Specific Use Voluntary Pay for Performance & Oncology Practices, At the Crossroads, What Your Oncology Practice Can Do Today, By Dawn Holcombe, Oncology Issues , published by the Association of Community Cancer Centers (ACCC), March/April 2007 issue, Pages 26 30 02/09/20 Trends In Private Payers Oncology no longer business as usual, but rarely P4P

Assumption of ASP + x% With or Without professional service adjustments Without recognition of ASP flaws Specialty Injectables Programs Issues: Quality, Cost, Access to Treatment, Care Delays, Medical Decision-making if formularies involved Blanket Prior Authorizations Mother May I Medical Decision-making Issue, plus care delays, cost burdens Insertion of Care Management Entities Affecting site of care and talking to patients outside of MD/Patient loop Disease Management, Oncology Management

Pay for Performance & Oncology Practices, At the Crossroads, What Your Oncology Practice Can Do Today, By Dawn Holcombe, Oncology Issues , published by the Association of Community Cancer Centers (ACCC), March/April 2007 issue, Pages 26 30. 02/09/20 Where are we re P4P? Lots of fanfare, little actual happening re oncology Over use and under use focus Disease management programs stop and start fitfully Pilots will build in 2008 and 2009, different approaches No national solution Pay for Performance & Oncology Practices, At the Crossroads, What Your Oncology Practice Can Do Today, By Dawn Holcombe, Oncology Issues , published by the Association of Community Cancer Centers (ACCC), March/April 2007 issue, Pages 26 30. 02/09/20 Initial Efforts

CMS Physician Quality Reporting Initiative (PQRI) United PA Horizon, Highmark 02/09/20 Is the Government Paving the Way? PQRI measures include oncology Rough estimate less than half of practices participating Design flaws Proves issues with cart before the horse Lesson: Practice, Incur Costs, and expect

no money (not auspicious) 02/09/20 P4P or Value in Care Cloudy Waters? Measurement and Data difficulties Technology Challenges Imbalance and errors in drug and professional services payments Intrusion of third party entities Core Patient MD interaction This is Cancer Care 02/09/20 Pay for Value A Growing Concept

Value for patients results and outcomes Perspectives may differ strongly between MDs and payers Health outcome per dollar of cost expended Value measured over care cycle, not per unit Avoidance of interventions Ongoing management to forestall recurrence Local may not be the best value Competing on results measured and widely available Migrate patients to truly excellent providers Competition on results, not standardized care

Shift strategies, structures and processes to measure and improve results Pay for Performance & Oncology Practices, At the Crossroads, What Your Oncology Practice Can Do Today, By Dawn Holcombe, Oncology Issues , published by the Association of Community Cancer Centers (ACCC), March/April 2007 issue, Pages 26 30. Is your practice ready for an uncertain future? The questions you should be asking your staff By Dawn Holcombe , Community Oncology, VOLUME 3, NUMBER 3 (March 2006) 02/09/20 Preparing to Prove Value in Oncology Education Assess/Strategize/Plan Standardize Network Partner/collaborate up and down the continuum of care Measure Document Build value portfolio

Pay for Performance & Oncology Practices, At the Crossroads, What Your Oncology Practice Can Do Today, By Dawn Holcombe, Oncology Issues , published by the Association of Community Cancer Centers (ACCC), March/April 2007 issue, Pages 26 30. Is your practice ready for an uncertain future? The questions you should be asking your staff By Dawn Holcombe , Community Oncology, VOLUME 3, NUMBER 3 (March 2006) 02/09/20 DGH Consulting Arent we ready to Prove Value? Traditional reports (volume, staffing, flow, case mix, drugs, regimens, financials) EMR level reports (tx by stage, drugs, standards, some guidelines, symptoms, history, etc.) Taken for Granted (disease management, complication avoidance, reviews of alternatives, patient support, etc., responsive action)

Invisible (questions not even thought of yet, but integral to care) If you pay, but not reimbursed, for What Value? Pay for Performance & Oncology Practices, At the Crossroads, What Your Oncology Practice Can Do Today, By Dawn Holcombe, Oncology Issues , published by the Association of Community Cancer Centers (ACCC), March/April 2007 issue, Pages 26 30. 02/09/20 Oncologists Provide Quality but now think Value internally and externally Common Practice and even services must be catalogued, measured, valued, and marketed Incoming/outgoing phone calls (reason and resolution) Avoided ER visits and hospitalizations Admissions and Readmissions per cancer case Prescriptions and resulting outcomes ER visits/hosp. Admissions Counted, identify reason, followup

Conversations re EOL, hospice, palliative care Disease and Symptom management steps, coaching and counseling documented every time Proving Value may still not be enough in times of limited resources Pay for Performance & Oncology Practices, At the Crossroads , What Your Oncology Practice Can Do Today, By Dawn Holcombe, Oncology Issues , published by the Association of Community Cancer Centers (ACCC), March/April 2007 issue, Pages 26 30. Is your practice ready for an uncertain future? The questions you should be asking your staff By Dawn Holcombe , Community Oncology, VOLUME 3, NUMBER 3 (March 2006) 02/09/20 Oncology Stepping Up - QOPI

The Quality Oncology Practice Initiative: Frequently Asked Questions Q: What is the Quality Oncology Practice Initiative? A: The Quality Oncology Practice Initiative (QOPI) is a quality improvement program based on retrospective chart reviews conducted within oncology practices. QOPI includes a set of oncology quality measures, a specified chart selection strategy, a secure system for data entry, automated data analysis and reporting, and a network of resources for improvement. The Quality Oncology Practice Initiative : Assessing and Improving Care Within the Medical Oncology Practice , Kristen McNiff, MPH , Journal of Oncology Practice, Practice, Vol 2, No 1 (January), 2006: pp. 26-30 2006 American Society of Clinical Oncology. http://jop.ascopubs.org/cgi/content/full/2/1/26 02/09/20

Q: What are the QOPI quality measures? A: Practicing oncologists and quality experts developed and update the QOPI measures, which are derived from clinical guidelines or published standards

adapted from the National Initiative on Cancer Care Quality (NICCQ) consensus based and clinically relevant Areas addressed by the current QOPI measures include end-of-life care appropriate chart documentation (e.g., staging, pathology report, chemotherapy consent) pain assessment and control antiemetic administration erythroid growth factor administration hormonal therapy administration (breast cancer patients) adjuvant chemotherapy administration (breast and colorectal cancer patients) granulocyte growth factor administration (lymphoma patients) The Quality Oncology Practice Initiative : Assessing and Improving Care Within the Medical Oncology Practice , Kristen McNiff, MPH , Journal of Oncology Practice, Practice, Vol 2, No 1 (January), 2006: pp. 26-30 2006 American Society of Clinical Oncology. http://jop.ascopubs.org/cgi/content/full/2/1/26 02/09/20 Outcomes, processes, measures?

QOPI measures processes of careone of the three components of quality, along with environment of care and outcomes of care (Donabedian A. JAMA 260:1743-1748, 1988). With a potentially fatal illness, most would define the highest quality as that which achieves the best survival. For that reason, we should focus on outcomes such as survival. However, with cancer, in which improvements may not show up in the survival measurements for years, quality improvement efforts must focus on assessing and improving care processes that have been previously demonstrated (either in randomized clinical trials or other methods) to enhance survival. Defining Quality: QOPI Is a Start , Douglas W. Blayney, MD Editors Desk, Journal of Oncology Practice, Practice, Vol 2, No 9 (September), 2006: 2006 American Society of Clinical Oncology. http://jop.ascopubs.org/cgi/content/full/2/1/26 02/09/20 Quality Care In Process

Patients with early-stage breast cancer received 86% of generally recommended care, based on 36 quality-care measures, while patients with early-stage colorectal cancer received 78% of generally recommended care, based upon 25 quality-care measures. These overall rates of adherence suggest that the quality of care for cancer is better than that observed for other chronic medical conditions. The study commissioned by the American Society of Clinical Oncology (ASCO) and undertaken by researchers at the Harvard School of Public Health and the RAND Corporation showed strikingly higher adherence than anticipated to processes of care believed to be essential for improving patient outcomes. DETAILED RESULTS RELEASED FROM FIRST-EVER NATIONAL STUDY ON CANCER CARE QUALITY IN THE UNITED STATES, Press Release for January 31, 2006, The Rand Co., http://www.rand.org/news/press.06/01.31b.html 02/09/20

The Obvious Holes in Professional Rates might be indicators of Quality Pharmacy Facilities (Drug inventory, acquisition and handling costs) Oncology Treatment Planning Patient Coaching, Counseling and Education Patient symptom Management/triage re urgent care Nutrition, Social services Screening and Prevention Fully Informed Patients

Management of Imaging and End of Life Enrollment in Clinical Trials Determination of preferred treatments and drugs Pharmacoeconomic analyses on regimens/treatments/even choices for palliative care vs treatment Management of Hospitalization and ER Visits/Avoidance Pay for Performance & Oncology Practices, At the Crossroads, What Your Oncology Practice Can Do Today, By Dawn Holcombe, Oncology Issues , published by the Association of Community Cancer Centers (ACCC), March/April 2007 issue, Pages 26 30. Is your practice ready for an uncertain future? The questions you should be asking your staff By Dawn Holcombe , Community Oncology, VOLUME 3, NUMBER 3 (March 2006) 02/09/20 Oncology Scorecard Ideas Phase I Basic Oncology Measures Documented stage and diagnosis, stages from the AJCC version 6 % compliance reported quarterly

Documented line of therapy, 1st, 2nd, 3rd, 4th and higher % compliance reported quarterly Documented patient performance status at every visit, NED, SD, PD, PR, CR type nomenclature % compliance reported quarterly Recurrence Local or distant ER visits

Admissions Readmissions Symptom occurrence and prevention Pay for Performance & Oncology Practices, At the Crossroads, What Your Oncology Practice Can Do Today, By Dawn Holcombe, Oncology Issues , published by the Association of Community Cancer Centers (ACCC), March/April 2007 issue, Pages 26 30. 02/09/20 Oncology Scorecard Ideas continued Phase II Quality Care Indicators Assessment of fatigue, nausea, and pain % compliance reported quarterly Assessment of depression and anxiety measures % compliance reported quarterly

Written consent obtained for all therapies % compliance reported quarterly EOL: Hospice discussion and Advanced Directive discussion for all Stage III and IV patients documented % compliance reported quarterly Clinical trials considered for all Stage 4 patients % compliance reported quarterly Pay for Performance & Oncology Practices, At the Crossroads, What Your Oncology Practice Can Do Today, By Dawn Holcombe, Oncology Issues , published by the Association of Community Cancer Centers (ACCC), March/April 2007 issue, Pages 26 30. 02/09/20

Oncology Scorecard Ideas: Further Phases Phase III Standards and Outcomes Adoption of Evidence-Based Guidelines (identify and show compliance for one - Colon) NCCN % compliance reported quarterly Adopt and use standard delivery of chemotherapy regimens % compliance reported quarterly Adopt and verify compliance with safety guidelines NIOSH % compliance reported quarterly

Adopt and use standard Anti-Emetic Guidelines ASCO/NCCN % compliance reported quarterly Pay for Performance & Oncology Practices, At the Crossroads, What Your Oncology Practice Can Do Today, By Dawn Holcombe, Oncology Issues , published by the Association of Community Cancer Centers (ACCC), March/April 2007 issue, Pages 26 30. 02/09/20 Oncology Scorecard Ideas: Further Phases continued Phase IV Standards and Outcomes Advanced Expand symptom/side effect measures to all 4 parameters of psychosocial distress: physical symptoms, psychological, social, and spiritual % compliance reported quarterly

Adopt and show compliance for other cancers (breast, lung, prostate, lymphoma, and ovary - 80% of all chemo used) NCCN % compliance reported quarterly Generation of family history with approach to risk counseling and testing % compliance reported quarterly Develop and adopt guidelines for follow-up for patients after cancer NCCN % compliance reported quarterly Pay for Performance & Oncology Practices, At the Crossroads, What Your Oncology Practice Can Do Today, By Dawn Holcombe, Oncology Issues , published by the Association of Community Cancer Centers (ACCC), March/April 2007 issue, Pages 26 30. 02/09/20

P4P in Oncology? Limited Pilots Localized A lot of data gathering Few dollars have actually changed hands P4P a misnomer? Reduction of hassle factor ROI undefined Measures undefined Preferred ranking

02/09/20 External or Internal Development The Core The Barrier Technology and data The Key

Patient-MD relationship Collaboration and communication - MD to Payer Building Bridges It will take both, but external entities value in question 02/09/20 The Core Intimate knowledge of patient individual disease, health status changes, family and supportive care MD/Nurse available 24/7 in community oncology Pnts get confused easily re cancer, too many points of contact detrimental to health/treatment

02/09/20 The Barrier Technology Cant rely on EMR penetration in short time Variation the norm Unintended Knowledge will reduce, not punishment Data 02/09/20 Silos payer, provider, patient

Trust, PHI The Key Numerous Initiatives started around practice collaboration and tracking of data Practice/provider collaboration and tracking Provider networks Education, trust and awareness cannot be understatedprogress requires all 02/09/20 Value Portfolio Individual to practice Prove process, review, analysis, and change and especially

outcomes www.clevelandclinic.com/quality http://www.clevelandclinic.org/quality/outcomes/ hematologyAndOncology/default.htm Answers to invisible or assumed questions, what we have taken for granted Pay for Performance & Oncology Practices, At the Crossroads, What Your Oncology Practice Can Do Today, By Dawn Holcombe, Oncology Issues , published by the Association of Community Cancer Centers (ACCC), March/April 2007 issue, Pages 26 30. Is your practice ready for an uncertain future? The questions you should be asking your staff By Dawn Holcombe , Community Oncology, VOLUME 3, NUMBER 3 (March 2006) 02/09/20

Only those who see the invisible, can do the impossible, Anonymous 02/09/20 Attachment: Key Players in Quality National Committee for Quality Assurance (NCQA) http://www.ncqa.org

Bridges to Excellence (BTE) health plan and purchaser program for select providers http://www.bridgestoexcellence.org/ AMA Physician consortium for Performance Improvement 70 national medical societies Seen by CMS as leading organization to drive policy The Leapfrog Group www.leapfrog.org National Quality forum (NQF) http://www.qualityforum.org/ Ambulatory Care Quality Alliance (AQA) NCQA, AMA Consortium, and NQF along with CMS and AHRQ Integrated Healthcare Association (IHA) quality initiative in CA http://www.iha.org Disease Management Consortium Academic Professional Societies such as ASCO and NCCN Community Oncology Alliance Cancer Clinics of Excellence 02/09/20 Resources Dangerous Doses: How Counterfeiters are Contaminating Americas Drug Supply by Katherine Eban, 2005 Harcourt Press

Is Oncology Compatible with Specialty Pharmacy? By Dawn Holcombe, Community Oncology, VOLUME 2, NUMBER 2 (March/April 2005) http://communityoncology.net/journal/articles/0202173.pdf Redefining Health Care: Creating Value-Based Competition on Results, Michael Porter & Elizabeth Teisberg, Harvard Business School Press, 2006 Pay for Performance & Oncology Practices, At the Crossroads, What Your Oncology Practice Can Do Today, By Dawn Holcombe, Oncology Issues , published by the Association of Community Cancer Centers (ACCC), March/ April 2007 issue, Pages 26 30. Is your practice ready for an uncertain future? The questions you should be

asking your staff By Dawn Holcombe , Community Oncology, VOLUME 3, NUMBER 3 (March 2006) 02/09/20 Final Words MD-Patient-Payer Triangle Network, Collaborate, Pilot Do Not minimize complexity of oncology Process is more important than outcomes at start Evolution will lead to outcomes Aggregate Value Information and Initiatives War on Cancer Derail or On Track?

02/09/20 Thank You, and Good Luck Dawn Holcombe, MBA, FACMPE, ACHE DGH Consulting and Connecticut Oncology Association 33 Woodmar Circle South Windsor, CT 06074 860-305-4510 860-644-9119 fax [email protected] 02/09/20

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