Healthcare Reform and Hematology - cdn.prod-carehubs.net · ©2014 MFMER | slide-1 Healthcare Reform and Hematology The Value of a Laboratory & Pathology Utilization Program Curtis

©2014 MFMER | slide-1 ©2014 MFMER | slide-1

Healthcare Reform and Hematology The Value of a Laboratory & Pathology Utilization

Program

Curtis A. Hanson, M.D.

©2014 MFMER | slide-2

DISCLOSURES:

Relevant Financial Relationship(s) None

Off Label Usage

None


Laboratory Test Utilization Definition • A strategy for performing appropriate laboratory

and pathology testing with the goal of providing high-quality, cost-effective patient care

• Laboratory tests in the USA, including pathology: • $60 - $70 billion; ∼4% of healthcare costs • Conventional wisdom is that 20 to 40% of laboratory

testing is unnecessary • 20-25% increase annually in molecular/genetics • Molecular / Genetics is 15% of laboratory costs;

anticipated to reach 25% soon • Largest growth: proprietary tests, genetic tests, and

test bundling


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

Dr. William Osler (1849 – 1919)

“Information is the resolution of uncertainty.”

Dr. Claude Shannon (1916 – 2001)


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!


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


“UnitedHealth, doctors study way to lower cancer treatment costs”

• “In a study, per-patient lump payments to doctors and better monitoring led to a reduction in the price tag for treatments. The costs of cancer care fell 34 percent in a study in which UnitedHealth Group Inc. paid doctors a lump sum to treat each patient rather than for each drug or service the doctors provided.”

• 810 patients with breast, lung and colon cancer were treated. Drug markups were eliminated and replaced with flat, per-patient fees that varied for each type and stage of cancer.

• Five medical groups using the per-patient payments spent $64.8 million over the three-year study, compared with estimated costs of $98.1 million under the per-treatment payments – ~$40,000 per patient.

• Chemotherapy costs for patients increased during the study. Other costs, such as for hospitalization or therapeutic radiology, went down.

• UnitedHealth gave doctors information on their spending and the use of certain procedures, as well as how often patients were hospitalized.

• Star and Tribune (Minneapolis): July 14, 2014 • Journal of Oncology Practice: May 2014; 10(3): 187-189


Do we have utilization issues in

medicine – including hematology?


Dartmouth Atlas of Healthcare

Geographic Variation in Patient Care


A Bone Marrow Study

BM morphology Immunohistochemical stains Flow cytometry T-cell gene rearrangement

studies

Cytogenetic karyotype BCR-ABL1 FISH MDS FISH Gene array analysis JAK2 V617F JAK2 exon 12 sequencing MPL exon 10 sequencing

Laboratory assays performed:

Patient comes to Mayo; outside work-up; straight forward diagnosis of a myeloproliferative neoplasm: primary myelofibrosis

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

Utilization: Heme-Associated Assays

Assay Utilization Guideline MCR Data

JAK2 V617F Blood and bone marrow are equal 1624 ordered over 3 yrs

JAK2 exon 12 Only possible PV and JAK2V617F is negative 42% over-ordered 10% under-ordered

MPL exon 10 Only 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

KIT 816V - 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



Why do we have laboratory

utilization issues?


• 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


Why Do We Have Laboratory Test Utilization Issues?

• Knowledge gap between clinicians and how to use today’s increasingly complex laboratory assays

• Patients with particular diseases may not see that disease subspecialist

• Clinical knowledge, when a test is ordered, is incomplete. The clinician is compelled to order everything as it may be the only chance get that information.

• Initial laboratory and pathology studies can help narrow the diagnostic choices and testing needs. But if laboratories don’t have a review and ordering process in place, clinicians have no choice but to order excess testing.

• Fee for service does not encourage appropriate use


How do we address laboratory

utilization issues?


How Do We Get Started? • Identify your target tests • Understand clinical needs and 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!


Utilization Management Tools • Provide clinician education – albeit little lasting impact • Obsolete certain tests

• Examples: Bleeding time, band counts, 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 • Use order entry pop-ups and online decision support tools • Use physician profiling or report cards as feedback • Develop a test formulary for complex and hi-cost tests


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



Unbundle Your Laboratory Tests Flow cytometry: Mayo uses a triage approach

• 8 antibodies to screen for B-cell clonality, increase in blasts, and abnormal T-cell phenotype

• Results drive whether to stop or to add more disease specific antibodies

• 80% of our flow requests stop at the triage step

• Integrate with morphologic features, previous or concurrent studies, and any provided or known clinical history

• Don’t use the “shotgun” approach with every possible antibody


Data source: commercial insurance payer, 2009 calendar year

Cost Depends on Number of Antibodies Used

Cost drivers

$ p

er w

orku

p

Copy of slide Tait JF, Astion ML, Mandel AN, Bryt AB, unpublished data University of Washington, and CareCore National Inc.

Mayo


Send-and-Hold Process

• Offer “Send-and-Hold” tests to be sure that the right

specimens get drawn, but requests are then reviewed

in the lab or driven by initial test results

• Be clear that labs and clinicians know how long a

specimen will be held (i.e., validated) for those cases

in which an incorrect decision gets made

• Build systems that allow for sequential testing as part

of an algorithmic process


Send-and-Hold Examples • Flow cytometry in a lymphoma staging

• Wait for bone marrow morphology

• Cytogenetics in a lymphoma staging

• Wait for bone marrow morphology

• T-cell gene rearrangements for cytopenia

• Wait for flow cytometry results

• AML molecular prognostics (cytogenetic negative)

• Wait for cytogenetic results

• Plasma cell FISH in a MGUS evaluation

• Wait for flow cytometry results


Send-and-Hold: A Real-Life Example

• Average size hospital on east coast • Data is from YTD 2014 • Send-and-hold used for chromosome and FISH studies

requested on bone marrows and sent to Mayo • Chromosome requests

• 47% of chromosome studies were canceled • Est. annual savings = $41,400

• FISH requests • 50% of FISH studies were canceled • Est. annual savings = $8820


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


Order is processed

Lab performs

test

Lab sends results

MD interprets

test

MD acts on the results

MD requests

tests

The Patient


Utilization efforts need to focus here! IT solution:

Time of order

Manual solution: In the lab


Method

• Identify opportunities • Review practice data and

literature • Derive recommendations • Achieve consensus • Final guidelines approved • Design process and

implement • Audit and adjust

algorithms

2 Differential Diagnosis Generated

3 Tests Ordered

4 Morphology Review

5 Differential Diagnosis Refined

6 Algorithm Consulted Test Order Refined

Collaborative Process for

Optimizing Test Utilization

1 Patient Evaluated

©2013 Mayo Foundation for Medical Education and Research. All rights reserved.


Progress! • Complete

• Lymphoma staging bone marrows

• Chronic lymphocytic leukemia

• Evaluation of plasma cell proliferative disorders

• Chronic myeloid leukemia diagnosis & follow up

• Evaluation of myeloproliferative neoplasms

• Evaluation of myelodysplastic syndromes

• Acute myeloid leukemia

• Acute promyelocytic leukemia diagnosis & follow up

• Eosinophilia/mast cell disorders


http://www.mayomedicallaboratories.com/media/articles/algorithms/mpn-bonemarrow.pdf


Assay # tests canceled Assay # tests canceled

Chromosomes 595 Imatinib FISH 13

BCR-ABL FISH 65 CHIC2 FISH 1

PCPD FISH 331 B-GR* 8

CLL FISH 9 T-GR* 35

B-lymphoma FISH 12 JAK2 V617F 98

T-lymphoma FISH 23 JAK2 exon 12 32

MDS FISH 65 MPL exon 10 8

AML FISH 50 KIT 26

ALL FISH 19 CSF Flow studies* 254

2013 summary: 1462 tests canceled; cost savings = $822,529.51

Algorithm and Guideline Impact on Test Ordering in Hematopathology: 2013


Chromosome Analysis – Utilization Review

Original Post-Utilization Implementation

% of total BMs

Abnormalities per 100 BM

% of total BMs

Abnormalities per 100 BM

Mayo Rochester 51% 20

Hospital C 95% 21 42% 21

$600,000 annual cost savings


Optum Labs: 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)


Questions & Discussion

Documents

Healthcare Reform and Hematology - cdn.prod-carehubs.net · ©2014 MFMER | slide-1 Healthcare Reform and Hematology The Value of a Laboratory & Pathology Utilization Program Curtis