Making Disease Treatment Standardization Work in

Community Practice

Jim Koeller, M.S.

Professor

University of Texas at Austin & the Health Science Center, San

Antonio

Expectations For 2007?

• The bottom line:– Things will get worse (revenues will tighten even more), we are not close to the bottom yet.

– Not everyone will survive or probably need to survive (this is somewhat Darwinian ~ the strong will survive)

– You do not have to change, but their Will Be consequences for your lack of action!

– You can control much of your own destiny, or much of it will controlled for you.

– Those who survive will be leaner, stronger, more efficient and just better! (look at the dialysis model…)

Expectations For 2007?

• Core reimbursement shifts continue to change the oncology business model (drug vs. service dependence)– CMS practice expense (some decreases)– Imaging procedure cuts (technical component to be paid at OPP’s rate)

– Pt shifting to increase?• ASP remains (GAO, MedPac, OIG all think it works!)– Stabilizing quarterly rate fluctuations– Continuing issues: 2 quarter fee increase lag and exclusion of the prompt-pay discount

Expectations For 2007?• Commercial payers

– Continue to switch to ASP-based payment (BCBS)– Continued push for specialty pharmacy use

• Will CAP survive?– 300+ physicians (22 oncologists)

• Demonstration project discontinuation– Was considered a precursor to P4P initiatives

• Practices to continue work on efficiency, controlling costs and expanding revenue sources

• More emphasis on quality, P4P, transparency– Making costs and MD-to-MD quality comparisons available to all

• Most clinics have done ‘OK’ in 2006…

The New Face of Oncology

• Oncology is being moved in the direction of demonstrating quality of care, P4P, and transparency..– Transparency is becoming the new theme– ie., making cost and physician-to-physician quality comparisons available » Data will become KING (which makes EMR a necessity)

» Note: just having the data will not be enough!» Everyone cannot get everything ~ demonstrating that you can control the use of resources will be critical

– You will need to format your data to tell this story» Will need to be able to demonstrate a control of resources and still able to provide quality patient care

– Benchmarking will become critical

Pay For Performance - P4P(ie., Quality Measures)

• Most of this to date has been hospital-based– Probably over 120 different P4P programs now– Most of these are medicare/medicaid (10+ different demonstration initiatives)

– Reporting Hospital Quality Data for Annual Payment Update (RHQDAPU), has 21 quality measures that if not reported result in a 2% payment decrease

– Premier Hospital Quality Initiative involved 272 hospitals and 34 quality indicators for 5 clinical conditions providing a 2% bonus for the top stratum

• Community-Based– 3-year CMS demonstration project with 10 large (200+ docs). The goal for now is to save money

Pay For Performance - P4P(ie., Quality Measures)

• Quality care measuring in oncology– CMS’s 2005/2006 demonstration projects dealt with side

effects and adherence to guidelines– Most agree that true quality measures should address

clinical outcomes– Cancer pt outcomes depend on P.S, type & grade of

tumor, metastases, treatment type and generally are measured only over a longer period of time

– This will require documentation and extensive data capture - EMR

– Until that time we expect CMS to focus on:» Utilization and cost management» Narrowly focused effectiveness of treatment» Pt. safety» Adverse events

– To report on such measures means clinics will need to define treatment plans in terms of standardized regimens

What are Community Practices Doing Now?

• Benchmarking can take on many identities• For all in tense and purposes, practice benchmarking

is in its infancy• Manages have benchmarked macro practice performance

measures for some time– Patient visits– New patients– Patients treated– Charge and revenue information (by category)

• Some electronic drug boxes are providing drug use information

• I am unaware of the existence of a sophisticated clinical database (this isn’t to say the data doesn’t exist in some cases)– Presenting clinical data by disease type which

would include demographics, treatment, toxicity and specific end-point measures

So, what major changes to how you are ‘practicing’ oncology do you

make?

Where do you start…

Practice Changes

• The community practice’s core business will become the infusion center ~ will need to put more emphasis on it...

• Work efficiency, overhead, , personnel issues, evaluating services provided, looking at new services to provide (diversifying revenue streams)

• Documenting quality of care (transparency)– EMR is necessary– Standardization of chemo regimens will ensure consistent drug use

– Standardizing treatment strategies for common cancers (ensures consistent patterns of drug use)

– Must be able to demonstrate control of resources with a ‘positive’ outcome

Understanding the Basis of Your Practice

In Community & Hospital Oncology Practice,

chemotherapy infusion is becoming the

oncologists ‘Procedure’.

Understanding the Basis of Your Practice

• Business 101– What is the “cost” of your unit of business (procedure)» Your procedure is the chemotherapy infusion

– What revenue is generated by that unit of business» Most businesses are allowed to set their price to make a margin (which covers costs and provides a profit)

» For oncology, your revenue amount is set for you!

Understanding the Basis of Your Practice

• Understand the cost of your procedure ~ Infusion

– Cost per hour of infusion chair time

» Practice overhead (fixed)

» Nursing time

» Support personnel (LVN,MA)

» Chemotherapy preparation

– Typical chair per hour cost ~ $68 - $300+

A Few Suggested Basic Rules

• Put more emphasis on your infusion center• A new pt. Should not be treated on the 1st-day visit

• Nurses should not education in the infusion chair• 75% of pts. need not be treated between 10:30am & 1:30pm

• Infusion & Injections should be two separate processes

• Nurses should not mix chemotherapy (technicians)• Pts. should not spend 2+ hrs. in the clinic to receive a 10 sec. injection

• Nurses need to control the primary care nursing they perform at the infusion chair

• Lost drug charges need to stop• When possible, have an ‘expert’ manage your chemotherapy

Treatment Variability in Practice Today

• If you provide a single patients case to 10 oncologists, how many different treatment plans would be suggested? (at least 10 probably)

• Physicians typically treat by an N=1.– Physicians do not process data by groups of patients

– Do physicians really know what happens to a cohort of patients they treat?» What happened to the last 50 metastatic breast cancer ladies you treated as a group?

• Physicians generally do not have organized clinical databases on treated cohorts of patients

Standardized Regimen Orders

• Create standardized regimen “recipes” (including pre-meds)– Helps control nurse administration variation» Which has been measured to exceed 200%

– Sets a standard for the specific administration method and time for each agent» All AC regimens in your practice should basically be given the same, and so on…

» The top 40 regimens make up 80% of what’s given

Chemotherapy Order Form

[Carboplatin (AUC 5-6) + Gemcitabine 750 - 1000 mg/m2 Day 1 & 8) Q3wk](One cycle)

Date:_____________ Pt. Name: _____________________ Dr. _________________Ht (in): Wt (lbs): BSA: Cr = Est. CrCl =______ Dose = mg=____ • ( + 25) target AUC CrCl

DRUG ORDERS: (Week One) (total infusion time= 1 hr. 30 min.)1. Hydration – 1000ml NS – to infuse at 175ml/hr2. Decadron 20 mg in 50ml NS to infuse over 20 min.3. Aloxi 250 mcg, give IV push over 1 min.4. Carboplatin (AUC-___) =______ mg in 250ml NS to infuse over 30 min.5. Gemcitabine (____ mg/m2)= ____ mg in 250ml NS to infuse over 30 min.

Week Two – Date:_________ (total infusion time= 1 hr. 15 min.)1. Hydration – 1000ml NS – infuse at 175ml/hr2. Decadron 10 mg in 50ml NS to infuse over 20 min.3. Aloxi 250 mcg, give IV push over 1 min.4. Gemcitabine (_____mg/m2)=_____mg in 250ml NS to infuse over 30 min.

If ANC > 1000 & Plt. > 100,000 ~ give full dose If ANC 500 – 999 & Plt. 50 – 99.000 ~ give 75% dose If ANC 500 – 999 & Plt. 30 – 49,000 ~ give 50% dose

5. Neulasta 6mg SC inj. (for full-dose tx with ANC 500 – 999) Date: ____

Dr. Signature: _______________________________

The Hypothesis Is …

If you provide the “right” information on a specific cohort of patients including their treatment to those who provide the care, they will make the appropriate treatment decisions.

Koeller - 1991

Making the Right Care Decisions

• Treatments for the primary diseases of breast, lung and colon cancer have become increasingly complicated– Newer active agents

» Including targeted therapy – More lines of therapy– More options for each line of therapy– Many more supportive care options– The need to take into account patient & toxicity issues (including QOL)

Why is Controlling Disease Treatment So Important?

• Current community practice has shown a variation in treatment approach of over 400% (resources utilized) for advanced Lung, Breast and Colon cancer– Variation causes significant treatment inefficiencies

• Infusion and injection numbers and frequencies are established by individual physician practice patterns– By being more consistent with disease treatment approaches, a clinic can have a better handle and control over the number of infusions & injections administered

– What diseases do you manage: Advanced NSCLC, Breast, Colon, Ovarian, & Prostate cancer (roughly 65+% of a clinics pts).

Koeller, et al. Data on file, 2006.