Laboratory Test Utilization and Stewardship 2020.pdfmarket forces & competition Government & payer initiatives Rapid changes in technology Consumer factors Perfect Storm for Disruption:

© 2010 Mayo Foundation for Medical Education and Research. All Rights Reserved.

Department of Laboratory Medicine and Pathology

Laboratory Test Utilization and

Stewardship

Curtis A. Hanson, M.D. Mayo Clinic – Division of Hematopathology

Professor of Laboratory Medicine & Pathology

Chief Medical Officer, Mayo Medical Laboratories



Outline for Today

What is test utilization?

How does utilization fit into our current healthcare

environment?

Do we have utilization issues in medicine – including

pathology and the clinical laboratories?

Why do we have laboratory utilization issues?

How can we get a utilization program started?

What could a practical utilization program look like?



U.S. Demographics

Health care market forces &

competition

Government & payer initiatives

Rapid changes in technology

Consumer factors

Perfect Storm for Disruption: The U.S. Health Care Market



“It’s the only treatment option he has under

his current health plan.”

New Yorker Magazine



Laboratory Test Utilization – Definition

A strategy for performing appropriate

laboratory and pathology testing with

the goal of providing

high-quality, cost-effective patient care



MOLECULAR GENETICS IS

15–25% OF TOTAL; FASTEST

GROWTH AREA

LABORATORY COSTS ACCOUNT FOR

~4% OF HEALTH CARE COSTS; BUT ARE INCREASING AT

A RAPID ANNUAL RATE

CONVENTIONAL WISDOM IS THAT

20–40% OF LABORATORY

TESTING IS UNNECESSARY

Laboratory Spend is Gaining Attention from Payers and Patients

• Niche Laboratories

• Explosion of New Tests

• Clunky Pre-authorization

• Claims Denials

• Medical Policy

• Undocumented Clinical

Utility

• High Deductibles &

Copays

• General Confusion



How does utilization fit into our

current healthcare

environment?




Healthcare Delivery is Changing

More and more primary care is being performed by non-

physicians in non-traditional settings – which can offer superior

IT, access and location.

Employer / Insurer Market Transformation – examples • High Deductible Plans paired w/ HSA

• Public Exchanges

• Direct Contracting between employers and providers

• Private Exchanges

7,600+

locations

4,700+ locations 8,600+ locations



Transition From Volume to Value

Gap

Management

VOLUME-BASED

LEGACIES

FEE-FOR-SERVICE REIMBURSEMENT

HIGH QUALITY NOT REWARDED

NO SHARED FINANCIAL RISK

ACUTE INPATIENT HOSPITAL FOCUS

LIMITED IT INVESTMENT INCENTIVES

STAND ALONE CARE SYSTEMS CAN THRIVE

REGULATORY ACTIONS IMPEDE COLLABORATION

VALUE-BASED MUST

HAVE CAPABILITIES

REWARDS FOR QUALITY & EFFICIENCY

QUALITY IMPACTS REIMBURSEMENT

SHARED RISK

INCREASED PATIENT SEVERITY

IT CAPABILITIES ARE ESSENTIAL

SCALE INCREASE IN IMPORTANCE

REALIGN INCENTIVES, COORDINATION ENCOURAGED



Do we have utilization issues in

medicine – including pathology

and the clinical laboratories?


Department of Laboratory Medicine and Pathology Dartmouth Atlas of Healthcare

Geographic Variation in Patient Care



Utilization: Heme-Associated Assays Assay Utilization Guideline MCR Data

JAK2V617F Blood and bone marrow give equivalent results 15% over-ordered

JAK2 exon 12 Only if a possible PV and JAK2V617F is negative 42% over-ordered

10% under-ordered

MPL exon 10 Only if a possible MPN with equivocal morphology 38% over-ordered

5% under-ordered

Chromes - lymphoma staging Only useful if unexplained cytopenias 31% over-ordered

MDS FISH Only if <20 metaphases or cytogeneticist needs 68% over-ordered

KIT816V – blood Negative in SM; use only if heme-associated SM 95% over-ordered

B- and T-cell lymphoma FISH –

blood and marrow Only to follow morph and flow studies 73% over-ordered

T-GR – blood and marrow Only in context of T-cell phenotyping studies 43% over-ordered

B-GR – blood and marrow Almost never useful 98% over-ordered

PML-RARA FISH Not useful in follow-up APL 27% over-ordered

CLL FISH Only useful in CLL 15% over-ordered

Plasma cell FISH Not useful if no monotypic plasma cells 13% over-ordered

©2013 MFMER | slide-12



Everybody Has Examples

HIV – both qualitative and

quantitative on same order

Serum bacterial antigens

Heliobacter pylori, IgM

Stool ova and parasites

Mumps, measles, and varicella

serologies

Lyme serologies

Plasma thiamin

Red blood cell folate

Zinc protoporphyrin (ZPP)

Coag DNA assays before

functional assays

Factor V Leiden vs. APC

resistance (functional)

VWF multimers before you have

a diagnosis of VWF

Free thyroxine index (FTI) and T3

uptake

Uroporphyrinogen III synthase

“Known” mutations vs. screening

assay for mutations

Anti-reticulin antibodies



The Philosophical Challenge with Clinical Laboratory Utilization

How can we help our clinicians deal with the reality of

“uncertainty” with laboratory and pathology testing?

• Medicine is all about being comfortable with degrees

of uncertainty.

› You can never get to “zero” uncertainty.

› There is always “one more test” you can do – “one

more disease” to rule out.

We must use our clinical and laboratory knowledge to

help lower the anxiety of uncertainty.

Remember: Data and information are our friends and

evidence is our trump card.



The Practical Challenge with Laboratory Utilization

It is critical for pathologists and laboratorians to

understand the clinical problem. Pathologists have to be

clinicians!

Deep knowledge of diseases and awareness of clinical

issues in addition to analytical/laboratory management

expertise is a “must have” in today’s laboratory world.

We must change the question that comes from our

clinicians:

• Do you do test XYZ? No!

• Can you help me solve this clinical problem? Yes!



“Medicine is a science of uncertainty and an art of probability.”

Dr. William Osler (1849 – 1919)

“Information is the resolution of uncertainty.”

Claude Shannon (1916 – 2001)

• Realities of practice • Knowledge gap • Marketing • Litigation fear • $$$ incentives

• Fee for service • $$$ incentives • EMR / IT • Coding systems

• Lab systems and processes

• Ordering systems • Test names • Test bundles • $$$ incentives • Patents

•“More” is better • Google • Dissatisfaction

with healthcare • Marketing • Societal demands

Utilization

Why Do We Have Utilization Issues?

Providers

Clinical Labs

Patients

Health Systems




Laboratory Systems and Processes

Reporting process

• Laboratory information systems don’t make it

easy for the clinicians to efficiently get

information

• Laboratory reports do not always transmit the

intended information and are often just lists of

results instead of a correlation and diagnosis

based on all the results for that episode of care



Test Names Contribute to Utilization Mistakes

BCR/ABL, Translocation 9;22, FISH (D-FISH)

BCR/ABL, p190, mRNA Detection, Reverse Transcription-

PCR (RT-PCR), Quantitative, Monitoring Assay

BCR/ABL, mRNA Detection, Reverse Transcription-PCR

(RT-PCR), Qualitative, Diagnostic Assay

BCR/ABL, p210, mRNA Detection, Reverse Transcription-

PCR (RT-PCR), Quantitative, Monitoring Chronic

Myelogenous Leukemia (CML)

BCR/ABL, Tyrosine Kinase Inhibitor Resistance, Kinase

Domain Mutation Screen






How Do We Get Started?

Identify your target tests

• Understand clinical needs

• Know your finances

Identify your strengths and weaknesses

Know your people resources

• Pathologists, technologists, genetic counselors, etc.

Identify your champions

• Laboratory, clinical, and leadership

Know what your IT system(s) can and cannot do for you

Don’t be afraid to use manual solutions for high cost tests

Don’t aim for “perfection” – any progress is good progress!

21



Utilization Management Tools

Provide clinician education – albeit little lasting impact

• Necessary first step

Obsolete certain tests

• Examples: Bleeding time, band counts, most

erythrocyte sedimentation rates, etc.

Establish gatekeeper functions

• Identify tests that require laboratory review

Restrict the frequency of specific tests

• Focus on hospitalized patient

Review admission and treatment templates

• Look for redundancies and test frequency



Utilization Management Tools Use order entry pop-ups and online decision support

tools to provide immediate guidance for ordering

• For example, same day/repeat ordering of non-

emergent tests

Use physician profiling or report cards as feedback

• Use Transfusion Medicine practices on blood

product utilization as a guide

Establish a utilization review process for send-out tests

• Restrict ordering of expensive send-out tests to

certain specialists

• Establish medical criteria for sending out high-cost

tests

• Insert a laboratory review process for certain tests



Use Your Laboratory Staff

Example: Genetic Counselors (GC) and genetic

technologists at Mayo

• Review test requests that “don’t make sense”

• Make phone calls to clinicians

• 10 to 20% of all requests get changed after GC

intervention – add or delete test(s)

• At Mayo:

› ~$500,000 savings per year

› Genetic techs make 200 calls per week to

add or delete testing



Test Formulary

Method used to review/control testing; features similar

to a Pharmacy Formulary

• Primary focus is typically on test send outs, but can

be used for expensive in-house testing

• Laboratory and clinician driven

• Decisions based on established medical and

laboratory criteria; understand medical need and

how test(s) will be used clinically

• Send only to CLIA-approved lab; understand if

insurance pays or whether advanced beneficiary

notices are needed; understand alternative testing



Develop list of acceptable laboratories

Tier test request by specialty:

• Available to all users vs. only to subspecialists vs.

only after review from laboratory committee – need

to understand medical view

Should also be used to review utilization of selected in-

house performed tests

Select tests have to be run through algorithm or

guideline – based on user utilization issues

Identify alternative in-house or less expensive tests

Need to develop genetic knowledge!

Test Formulary Test Formulary



Understand your tools that you

can use



Order is processed

Lab performs

test

Lab sends results

MD analyzes

result

MD acts on the results

MD requests

tests

The Patient

Clinicians & IT

Labs & Techs

GC’s & Pathologists



Laboratory Test Algorithms and Guidelines

Four types of algorithms:

IT-driven: Clinical input and information drive what

testing gets ordered or not

Laboratory-driven: Laboratory results drive

subsequent test selection. Testing is performed by

laboratories using available specimens; specimens are

shared between labs

Pathologist-driven: Review of pathology findings

determine next steps in testing algorithms; cancel or add

appropriate next steps

Genetic Counselor-driven: Review of genetic test

requests require genetic experts with laboratory

knowledge; make phone calls to add or cancel testing



Clinical Decision Support (CDS) Tools

EMR’s, such as EPIC and Cerner, have CDS capabilities

High-cost imaging studies in radiology are required to go

through a CDS for maximum CMS reimbursement

(PAMA)

Middleware:

• Sept. 19, 2017: “Mayo Medical Laboratories and

National Decision Support Company Unveil

CareSelect™ Lab to Provide Real-Time Medical

Guidance When Ordering Laboratory Tests”



How a CDS Tool for Laboratory Tests Works

Trigger: Lab

test

ordered

Rules

Engine

Rule

Output Physician

Advisory

Educational

Soft Stop

Hard Stop Data from EMR

• Labs ordered

• Lab results

• ICD10

• CPTs

• Drug order

• Problem list

• Etc.

Knowledge

• Mayo Clinic

• DLMP • Algorithms

• Choosing

Wisely

• Societies

• Etc.

• Data analytics

• Reports

Proceed

with Order



Order is

processed

Lab

performs

test

Lab

sends

results

MD

analyzes

result

MD acts

on the

results

MD

requests

tests

The Patient

Labs & Techs

GC’s &

Pathologists

CDS & EMR

tools



Real Life Examples




5/1/2010 - 12/31/2013

n=71,379

97.5%

99.2%



Case Study: Celiac Disease Diagnosis Perception: Testing panels that include

multiple tests are the most cost-effective

approach

Analysis of Mayo Clinic patient data identified

the following about celiac panel testing:

4 Tests included the most commonly ordered panel

97% Cases in which

only 2 tests were necessary2

3x Cost of 4 test panel compared to 2-test

approach with reflex



Sometimes more testing is less cost.

$200 Cost of Test

19 Average number of plasma exchanges per misdiagnosed

patient

$38,000 Total cost of

plasma exchanges per patient

(19 plasma exchanges x $2,000 per exchange)

Case Study: ADAMTS13

The exclusion of TTP by this test leads to a potential reduction of costly plasma exchanges.



Utilization: Heme-Associated Assays

Assay Utilization Guideline Mayo Data

JAK2V617F Blood and bone marrow give equivalent results

15% over-ordered

JAK2 exon 12 Only if a possible PV and JAK2V617F is negative

42% over-ordered 10% under-ordered

MPL exon 10 Only if a possible MPN with equivocal morphology

38% over-ordered 5% under-ordered

Chromes - lymphoma staging Only useful if unexplained cytopenias 31% over-ordered

MDS FISH Only if <20 metaphases or cytogeneticist needs 68% over-ordered

KIT816V – blood Negative in SM; use only if heme-associated SM

95% over-ordered

B- and T-cell lymphoma FISH – blood and marrow

Only to follow morph and flow studies 73% over-ordered

T-GR – blood and marrow Only in context of T-cell phenotyping studies 43% over-ordered

B-GR – blood and marrow Almost never useful 98% over-ordered

PML-RARA FISH Not useful in follow-up APL 27% over-ordered

CLL FISH Only useful in CLL 15% over-ordered

Plasma cell FISH Not useful if no monotypic plasma cells 13% over-ordered



http://www.mayomedicallaboratories.

com/media/articles/algorithms/mpn-

bonemarrow.pdf



Test Utilization: Bone Marrow Case Study Below are the results of a study conducted by Optum

Labs with Mayo Clinic data.

Disease or Diagnostic Group Patients who underwent bone marrow biopsy/aspiration

Test Pathway Flow and chromosome testing

Impact of Guideline Reduction in cost of testing per case

Cost Savings Per Case $1,214 (USD)

Incidence of Disease 700,000 bone marrow biopsies in U.S. per year, incidence in U.S. therefore at 0.22%

$ Impact Per 100,000 Lives $267,162 (USD)



Optum Labs (Mayo + Optum): The Impact of Concurrent ESR and CRP

ESR is an antiquated test that has many causes of false positive and

negative results. ESR, when ordered in addition to CRP, rarely yields

additional diagnostic information except in some specific

rheumatologic disorders. CRP is a more reliable and reproducible

laboratory assay as a marker of an underlying inflammatory

condition.

Data pulled from Optum Labs (Dr. Darci Block)

From 2009 – 2013:

Only ESR 4,465,492 (54.2%)

Only CRP 1,173,131 (14.2%)

CRP and ESR within 7 days 2,606,775 (31.6%)

Also looked at test orders as they relate to diagnosis codes.



Do we need to do RBC Folate Testing?

0

100

200

300

400

500

600

700

1 3 5 7 9 11 13 15 17

Serum Folate (ng/mL)

Fre

qu

en

cy

Mayo patient data

24,177 serum folates (2008-2010)

35 < 2.0 ng/mL (0.14%)

125 < 3.0 ng/mL (0.52%)

Unpublished Mayo data

Serum Folates



RBC Folate Testing is Unwarranted: Equivalence of Serum and RBC Folate

Simultaneous serum and RBC folate assays (1999 to 2009; n=1082)

• Prevalence of deficiency =0.09% (n = 1, both low)

3 difficult to interpret – results weren’t reproducible; 1 was non-fasting patient

No clinical value – old dogma about RBC folate is just not true in today’s world

A manual test – high labor costs

Negative reimbursement relative to costs

Serum Folate (ng/mL)

Deficient (< 3.0) Sufficient (> 3.0)

RBC Folate

(ng/mL)

Deficient (<140) 1 (0.09%) 4 (0.4%)*

Sufficient (>140) 8 (0.7%) 1069 (98.8%)



1,25 Dihydroxyvitamin D Intervention Problem:

• 1,25-Dihydroxyvitamin D is common send-out

• 68% of the 1,25-Vitamin D were ordered in error; 25-Vitamin D was

intended test

Intervention

• Email template describing the use of the two Vitamin D tests

• Asked provider if want to cancel and change order to 25-Vitamin D

• Email managed by front-line sendouts staff.

Dickerson J, Cole B, Jack R, Astion M. Another laboratory test utilization

program: our approach to reducing unnecessary 1,25 Vitamin D orders

with a simple intervention. Am J Clin Pathol. 2013.

0

5

10

15

20

25

30

35

Nu

mb

er

of

Ord

ers

Cancelled

Approved

Intervention Privileging added

After intervention:

• 58% (n=134) of the 1,25-

Vitamin D orders were

canceled and changed to

25-Vitamin D.



Reduce Laboratory Testing in the Hospital Patient

Testing patterns from your practice

Reduce repeat testing. Examples:

• Serum magnesium and phosphorus – reduce frequency of repeat

Mg/Phos checks in patients with normal levels

• CBC with differential – Change to CBC without diff in patients with

normal diff within 3 days

• Ionized calcium – Reduce frequency of iCAL when previous value

normal

• NT pro BNP – Reduce frequency of measurement during

hospitalization

• ANA (and others) no more than once per week

• Hereditary tests no more than once ever

• Other tests based on per day, per week, or per hospitalization

44



Order Entry Decision Rule: Results

iCAL, Mg, NT pro BNP rules implemented

Test volumes 30 day before and after rule

Test Volume

pre (30 days)

Volume

post (30 days) % change

iCAL 1465 582 - 60%

MG 4828 2297 - 52%

NT Pro BNP 140 125 - 11%

Controls

ELPN 3858 3810 - 1%

PHOS 2138 1711 - 20%

Bilirubin 796 810 + 2%

AST 936 932 - <1%



Renaming tests

hCG: useful to diagnose/monitor pregnancy

and useful as a tumor marker

hCG pregnancy assay:

hCG tumor marker assay:

46



Ordering System – ‘Moderate complexity’ interventions

Rearrange how tests appear on ordering cards or

screens

Consider:

• How are your tests currently listed?

• Have you seen your ordering screens?

• Are the tests simply listed alphabetically or in a

way designed to guide use?



Next

Cancel

Guide

Comments

Stool (Micro)

Common Procedures C. difficile Toxin PCR 83124

Select Either Enteric Pathogens Culture OR PCR (not both) Bacterial Enteric Pathogens Culture, Stool 8098 ***Includes Shiga Toxin PCR Bacterial Enteric Pathogens PCR 60235 ***Rapid test for Salmonella, Shigella, Yersinia, Campylobacter, Shiga Toxin ***Reflexive culture performed if positive

Fecal Leukocytes 8046 Fecal Parasite Screen (See Guide for Algorithm) Giardia Ag 80231 Cryptosporidium Ag 80335

Rotavirus Ag 8886

Additional procedures Helicobacter pylori Ag 81806 Vibrio Culture 89658 VRE PCR 84406

Acid Fast Smear for Mycobacterium 8213 M. tuberculosis Complex PCR 88807 Mycobacterial Culture 8205

Fungal Smear 84390 Fungal Culture, Routine 84389 Adenovirus PCR 89074 Viral Culture, Non-Respiratory 87266

Cyclospora Stain 81506 Microsporidia Stain 81507 ***Microsporidia found primarily in immunocompromised patients

Parasitic Examination (O&P) 9216 ***Order only if appropriate history (see Guide for Algorithm)

Tiered testing

shows

preferred order

Microbiology

Stool Testing

Outpatient

Ordering system

We saw a 30%

decrease in O&P

orders over expected

volumes (based on

the previous year)

since we changed the

ordering system



Getting information from our

physicians or patients…



Trying to get information from the

ordering clinician or referring lab

Stool specimen for Giardia antigen testing



Trying to get information from the

patient…

“Have been in car for 1 hr 40 min”



Working with our clinical

colleagues…



This all sounds great, but how am I going to deal with Dr. “Pain-in-the-A**”

Repeat after me… •Data is your friend and processes are key. •I’m an MD, too – Appeal to patient care! •Patience and persistence! •90% of the noise comes from 10% of the people •Perfection is the enemy of the good! •Aim for the “80-20” •Differentiate between the routine and the “special”



Outline for Today

What is test utilization?

How does utilization fit into our current healthcare

environment?

Do we have utilization issues in medicine – including

pathology and the clinical laboratories?

Why do we have laboratory utilization issues?


What does a successful utilization program look like?



Move from philosophy of laboratory passively performing tests – any test, any time, any way you want it

to Laboratory and pathologists collaborating with clinicians to solve diagnostic and laboratory problems



Thank You!

Documents

Laboratory Test Utilization and Stewardship 2020.pdfmarket forces & competition Government & payer initiatives Rapid changes in technology Consumer factors Perfect Storm for Disruption: