PLUGS: A National Collaboration that Helps Guide the Proper Use of Genetic and Other Clinical Lab Tests

• Michael Astion, MD, PhD, HTBE

• Division Chief, Laboratory Medicine, Seattle Children’s

• Clinical Professor of Laboratory Medicine, University of Washington Dept of Laboratory Medicine

Speaker Financial Disclosure Information

• Univ Washington Intellectual Property licensed to:• CareCore National Inc. ,(Guide to Lab Utilization)• Medical Training Solutions (Educational software)

• Grant /Research Support: AHRQ; Beckman-Coulter Foundation

• Consultant Fees: Bio-Rad

• Medical Advisory Board: Health123

• Expenses: Bio-Rad; Beckman-Coulter

Acknowledgements

• Seattle Children’s / Univ Washington • John Tait• Jessie Conta• Bonnie Cole• Jane Dickerson• Darci Sternen• Stephanie Wallace• Rhona Jack• Monica Wellner / Lisa Wick and the

Sendouts and CPA Teams• Joe Rutledge• Mark Del Beccaro• Mike Bamshad• Holly Tabor• Suzanne Vanderwerf• Geoff Baird • Linda Eckert• Kevin O’Brien • John Brunzell

• SCH-PLUGS business team• Barry Weisband• James Britt• Nitasha Kumar• Jeff Taylor

• Mayo Clinic• Jim Hernandez• Curt Hanson• Don Flott• Tony Ebert

• Brian Jackson (ARUP)• Kim Ridell (Group Health

Cooperative)

• CareCore National: Bartley Bryt, Alyson Mandel, and Melissa Bennet

Overview

• UM: background, interventions

• Seattle Children’s UM plan

• Pediatric Laboratory Utilization Guidance Service (PLUGS)

• Conclusions

Learning Objectives

1. Describe 3 methods for optimizing lab test utilization.

2. Describe how an email template can improve UM.

3. Describe the role of a lab genetic counselor in UM.

Why improve lab utilization?

patient costs direct lab costs societal costs false + results

• especially with pretest probability

• worry• false Dx, associated harms

unnecessary work

• Warren JS. Lab test utilization program… Am J Clin Path. 2013;139:289-297.• Lewandrowski K. Managing utilization of new diagnostic tests. Clin Leadersh Manag Rev. 2003 Nov-

Dec;17(6):318-24. • Kim JY et al. Utilization management in a large urban academic medical center. AJCP. 2011;135:108-

118

Value = Quality /Cost

*

Healthcare Trends influencing Utilization Management

• Lab including AP $60B industry • Lab: 4% of total spend and growing

• “Molecular” = 15% of lab, 22% trend

• Capitation is a key Obamacare theme:• Bundled payments = capitation• ACOs = those who are capitated

• UM initiatives ride the capitation wave

• Labs that monetize UM initiatives are using hedging as a business strategy

capitation

Overutilization is gaining increased attention….

www.preventingoverdiagnosis.net

www.choosingwisely.org

All payers put price pressure on labs.

Lab

Private Insurance

Federal Government

HMOs

State Government

Employers, patients

Root causes of lab overutilization

Care providers

Patients Labs

testing

Health system

google … $$ incentive…

fee for service malpractice fear..

gene patents.. $ incentive…

dissatisfaction…

more is better..

Mktg pressure… coding system..

Patient pressure…

wellness movement…

UW- CareCore collaboration to study lab utilization in commercially-

insured populations in the USA (2008 – present)

• Study of national, regional lab insurance claims databases

• Characteristics of largest insurance dbase we studied:• 1 year of data (2009)• 3.5 million covered individuals (members)• 8.2 million doctor’s visits in 48 states•Total spent on lab was $668 million. • Lots of overutilization.

•Example: 2.3% of members had ANA test (about $ 1 million spent). Prevalence of Lupus in population is 0.2 – 1.5 per 1000

Eckert LO, Tait JF, Astion ML, et al 2010. Use of Molecular Diagnostics for Lower Genital Tract Complaints: Comparison of Practice Patterns with Published Guidelines. Am College of Obstetrics and Gynecology Annual Meeting.

Eckert LO, Astion ML, Tait JF, et al. 2011.Use of molecular diagnostics in women without genital symptoms presenting for Pap smear: How common? How costly? Infectious Disease Society for Obstetrics and Gynecology (winner of outstanding poster award).

Bradley SM, Tait J, O’Brien KD, et al. 2011. Use of novel cardiovascular risk biomarkers in clinical practice. Annual Meeting for Quality of Care and Outcomes Research in Cardiovascular Disease and Stroke.

Major domains of overutilizationBundling and nonstandard tests are drivers in all domains.

• Wellness• CVD risk• Woman’s health (cervicitis, vaginitis)• Nutrition and metals• Flow cytometry• Allergy • Autoantibodies (e.g. celiac test bundles)• Inpatients: Daily labs• Genetic testing, especially by non-geneticists

Adults

Peds

Eckert LO, Tait JF, Astion ML, et al 2010. Am College of Obstetrics and Gynecology Annual Meeting. Eckert LO, Astion ML, Tait JF, et al. 2011.Infectious Disease Society for Obstetrics and Gynecology Bradley SM, Tait J, O’Brien KD, et al. 2011. Annual Mtg, Quality of Care and Outcomes Research in Cardiovascular Disease and Stroke.

Overutilization and Nonstandard Testing in the Diagnosis of Allergy

• Guidelines

• Allergen-specific IgE is useful but usually need <20 allergen panel (e.g., 8 allergens account for >90% of food allergies)

• Following allergen-specific tests not considered useful1:• IgG-IgG4 antibody testing• antigen leukocyte cellular (ALC) antibody test

• Despite guidelines, many doctors and labs market overuse of IgG-IgG4 allergy tests, other nonstandard tests, and/or large IgE panels.

Guidelines for the Diagnosis and Management of Food Allergy in the United States: Report of the NIAID-Sponsored Expert Panel. Journal of Allergy and Clinical Immunology. Volume 126, Issue 6, Supplement 1, December 2010, p. S1-S58.

Objectives /Methods

We examined the use of the following allergen-specific tests:• IgE test• IgG-IgG4 test• antigen leukocyte cellular antibody test

Cross sectional study of our largest national insurance database (3.5 million commercially insured patients, 1 year)

500+ clinical labs represented in the database.

Used combination of ICD9 and CPT codes (e.g., 86003, 86001) to select patients having an allergy workup.

Astion M, Tait J, et al. CareCore collaboration, unpublished data

Results: Allergen-specific tests Novel biomarkers are overused (4.4% waste of $)

Allergen specific test # visits (Dates of Service)

$ spent (% of total)

IgE allergy test 18553 $2,315,447 (95.7%)

IgG-IgG4 allergy test 28 $71,420 (3.0%)

ALC antibody 48 $33,267 (1.4%)

Astion M, Tait J, et al. CareCore collaboration, unpublished data

For allergen-specific IgE testing, 28 tests per doctor’s visit is the norm! (N = 18,553 doctor’s visits)

1 - 10 u 11 - 20 u

21 -30 u 31 - 40 u

> 40 u0

1000

2000

3000

4000

5000

600026 %

19 %

24 % 23 %

7 %

Range of IgE units

DOS

•Ave units of allergen specific IgE : 28 (SD:13, Range: 12 – 71)

•54% of workups are associated with testing > 21 allergens

Nonstandard Tests during 1st eval of vaginal / cervical infections: 1 year of results from an insurance database

(Eckert LO et al. 2010. Am College Obstet Gyn Ann Meeting)

• Used our largest annual database of 3.5 million covered individuals

• 26% of 82,400 visits for eval of vaginal /cervical infections had unnecessary1,2molecular testing.

• Recommended: C. trachomatis, N. gonorrheae, T. vaginalis, herpes simplex

• Not recommended: Candida species and subspecies, G. vaginalis, staphylococcus, streptococcus, enterococcus, and cytomegalovirus

• 22% ( > $1,400,000) of molecular spend on these evals is waste.

• One lab responsible for 50% of unnecessary testing.

1ACOG Practice Bulletin: 72, May 2006, reaffirmed 2008.2Eckert LO, NEJM 2006;355:1244-52

INTERVENTIONS to improve utilization require backbone and energy

I’m revitalized and ready to decrease Vitamin D testing

Where should we focus our interventions? It is most realistic to focus on care providers.

MD, RN, PA,

other

Patient Pressure

Marketing Pressure Lab

Test result

Test order

Perverse Financial

Incentives

Astion M. Quackery interventions: The hopelessness and the hope. Laboratory Errors and Patient Safety.2007. 4(1): 1 – 6.

Common weaker interventions to improve lab utilization

• Memos

• Call for enhanced vigilance

• Training

• Distribution of materials

• Formal continuing education

MEMO 10/07/10To: All Providers in Clinic XFrom: Dr. BigEgo, Clinic ChiefRe: Lab test utilization

Stop ordering the wrong tests, and start ordering the right tests. Please, don’t order too many tests. Be more careful. You all don’t know what you are doing.

Interventions to improve lab use from gentle to strong. Strong interventions involve structural changes.

Gentle Guidance Strong Guidance

Solomon DH et al. Techniques to improve…use of diagnostic tests. JAMA. 1998; 280:2020-2027.

Warren JS. Laboratory test utilization program: structure and impact in a large academic medical center. Am J Clin Pathol. 2013;139:289-297

Seattle Children’s Hospital approach to utilization management (UM)

• Utilization management committee, meets weekly• 2 genetic counselors• 4 - 6 Doctoral level staff including pathologists, medical

geneticists, and clinical chemists• 2 lab managers• Subcommittees for special topics (e.g. exome testing)

• 1 GC, 1 doctor on call for UM each week.

• All UM cases recorded in database. Dbase allows case tracking, consistency in case resolution, and enables research and QI

• Emphasis is on sendout tests, but all aspects of UM are covered.

Typical UM committee work

• Policy and Procedures• Review of subcommittees / ad hoc groups• Periodic review of sendouts / send-ins• Research / Academic progress• Case review• PLUGS review

Seattle Children’s Hospital: What test requests are placed under active management with review?

• Tests > $1000

• Tests ordered for multiple genes

• Requests to use alternate labs

• Requests for banned tests or labs

• Request for test labeled in lab system as “Under Management” (e.g., reverse T3)

23

Dickerson J, et al. Ten Ways to Improve the Quality of Send-out Testing. Clin Lab News. 2012;38(4): 12-13. www.aacc.org/publications/cln/2012/april/Pages/SendOutTesting.aspx#

Dickerson JA, Cole B, Conta JH, et al. 2013. Improving the value of costly genetic reference laboratory testing with active utilization management. Arch Path Lab Med. In Press.

Examples of Banned Tests

• IgG Allergy

• IgM Helicobacter

• Genetic scoliosis prognosis

• Lab asked to draw blood and mail “special” kit to “special” lab.• Autism spectrum

• Fibromyalgia panel

• Hair testing that is not arsenic

1,25 Dihydroxyvitamin D Intervention

Problem:

•1,25 Dihydroxyvit D is common send-out with > 300 tests/yr

•Retrospective chart review found 68% of 1,25 Vit D were ordered in error and 25 Vit D was intended.

Intervention

•Email describing use of the two Vit D tests, and asking if provider wants to change to 25 Vit 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; In press.

1,25 Vitamin D Intervention

The lab received a request for 1,25 dihydroxy vitamin D on your patientIn our lab, we found that this is ordered accidentally 68% of the time.

Utility of 25- Vit D vs. 1,25 Vit D

Two options:1. Cancel and add-on 25-OH Vit D2. Proceed with original order

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. In press.

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InterventionPrivileging added

Effect of an email to doctors on Vitamin 1,25 D orders (2012-2013, 7 months)

After intervention:

• 58% (n=134) of the 1,25 Vit D orders were changed to 25 Vit D.

• 1,25 Vit D now <10 /mo

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. In press.

Doctors Love the 1,25 Vitamin D Intervention

I am not making these up.

“Thanks so much for your help (and education.)  You are exactly right—please cancel the order of 1,25 and I’ll add on for 25 hydroxy. ”

“Thank you so much for the email.  You are correct I wanted 25-hyroxy.  I will cancel and reorder.”

Privileging

“Dear Seattle Children’s Send-out Team,I’ve created a list of our privileged providers who do

not need to be contacted regarding ______ orders. Simply, send these tests out. ”

Stronger interventions involve structural changes such as privileging and test formularies

Gentle Guidance Strong Guidance

Solomon DH et al. Techniques to improve…use of diagnostic tests. JAMA. 1998; 280:2020-2027.

Warren JS. Laboratory test utilization program: structure and impact in a large academic medical center. Am J Clin Pathol. 2013;139:289-297

Genetic Counselors as a form of enhanced supervision

• In this study: 1 / 3 of genetic test orders were in error and correcting the order improved patient care and saved $ for patients and hospitals.

Miller C. Clin Lab News. 2012: 38(1). www.aacc.org/publications/cln/2012/january

Email template to physicians who are not Medical Geneticists but who are ordering expensive genetic tests

Lab received expensive, unusual request on your patient:

You have 3 options:

1. Involve genetics or lab GC

2. Hold for pre-authorization

3. Proceed after telling $cost to patient

Info on completing insurance pre-auth

Utilization Management Case:Two improvements on one order

• Female with macrocytic anemia since 6 wks of life

• Save 1: Immunologist ordered Fanconi breakage testing.

• UM test (send to 1 of 2 reference labs based on CBC)

• Same test was normal in 2005

• Immunologist approved cancelling repeat test

• Positive outcomes:

• Cost savings ~$750

• Cancelled duplicate order

Utilization Management Case (continued)

• Save 2: Immunologist ordered simultaneous Dyskeratosis Congenita and Shwachman-Diamond sequencing • Tests ordered for multiple genes• Diamond Blackfan Anemia sequencing panel also in

progress. • Immunologist approved sequential testing. • DBA sequencing detected mutation. Other tests canceled.• Positive outcome: Cost savings ~$2400

• Total savings for this patient= $3150!

UM Results: 25% of genetic test requests are canceled or decreased

Utilization Management DataOrder

ClassificationAll Cases (n = 696)

Genetic Cases (n = 483)

Approved 70% (478) 75% (364)

Sequential 10% (67) 14% (62)

Cancelled 21% (143) 11% (51)

Order Modification Rate Over Time (N=696 cases)

Sep 11 - Dec 11 Jan 12 - Apr 12 May 12 - Aug 12 Sept 12 - Dec 12 Jan 13 - Apr 130

10

20

30

40

50

60

70

80

90

100Approved

Sequential

Cancelled

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f Tes

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uest

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The rate of order modification for genetic tests is higher among non geneticists (N=483 cases).

Non-Genetics Providers Genetics Providers

Approved83%

Cancelled2%

Sequential15%

Ap-proved

72%

Can-celled16%

Sequential12%

It is more laborious to resolve cases involving non genetics providers (N=483 cases of genetic testing)

All requests Genetics Providers Non-genetics Providers

57%

74%

43%43%

26%

57%

Chart reviewPhone call or e-mail

Financial Implications$437 sendout cost avoidance per requisition under management

*Data collected September 2011 – April 2013

$1,286,920*Total genetic

requests

$211,299 savings

$1,075,620Actual

25% order modification

~$437 saved per request

Seattle Children’s Hospital: Results from the Pilot(N=483 genetic test sendouts)

• Summary re genetic sendouts: • 25% requests canceled or modified ↓ • $437= ave savings per case

• Qualitative results:

• Insurance pre-auth implemented in Neuro, Heme-Onc, Immunol.

• Proactive insurance preauth

• Proactive sequential testing

Dickerson JA, Cole B, Conta JH, et al. 2013. Improving the value of costly genetic reference laboratory testing with active utilization management. Arch Path Lab Med. In Press.

Insurance preauth policy

From our pilot, PLUGS is born…

PLUGS mission and vision

• PLUGS Vision: create a collaboration that exchanges vital UM information and services regarding pediatric lab testing

• PLUGS Mission: increase sendout test value to patients while reducing sendout expense to hospitals.

• Target Market: CHA hospitals, pediatric component of adult health systems

• PLUGS provides tools to support UM services

PLUGS: For an annual fee, members receive…

• UM tools including:•Test-specific policies•List of obsolete tests•Sendouts Lab Formulary •Phone Scripts •Email templates •FAQ and their answers•Risk assessment tool

• Education: cases, webinars, literature summaries

•Needs assessment

• Communications:•Website•weekly emails•Teleconferences (two so far)•Office Hours/call center

• Future: •Tracking & reviewing data submitted by PLUGS members regarding effect of UM interventions

•Also considering on site consultation for additional fee

PLUGS: A Brief History (Part 1)

• 3/ 2007: Research grant from CareCore to study lab utilization.

• 1/2011: Review all sendout tests > $2500

• 6/2011 ↑ patient complaints re genetic test costs to SCH

• October 2011: UW business students under Barry Weisband choose UM business plan as one of 4 projects

• 8/2011: Hire Bonnie Cole M.D. onto faculty

• 7/2011: Post-doc Jane Dickerson starts project “CPI in sendouts”

• 10/2011: AHRQ grant regarding assessing risk of sendout tests

PLUGS: A Brief History (Part 2)

• 2/2012: Hire Jessie Conta MS (GC), form UM committee, and formal inclusion criteria for UM case management

• 3/ 2012: Create UM case dbase

• 4/2012: Drs. Cole and Wallace get AEF grant for UM

• 7/2012: Dr. Dickerson hired

• 9/2012: First UM subcommittee is Exome Committee

• 10/2012: UM results shown at CHA meeting. PLUGs conceived.

• 11/2012: PLUGS launched as pilot, 13 institutions opt in.

• 12/12: Collaboration with Mayo Clinic begins

• 2/2013: SCH approves PLUGS business plan (legal, service, billing)

• 4/2013: PLUGS call center launched

• 4/2013: 2nd genetic counselor (Darci Sternen) hired.

List of First 13 PLUGS members

CHOPTexas Children's HospitalCincinnati Children's HospitalNationwide Children's HospitalChildren's Hospital AkronCooks Children's Medical CtrChildren's Hospital ColoradoChildren's , Los AngelesChildren's Mercy Hospital Children's , New OrleansChildren's Hospital, MinnesotaStanford (Lucille Packard) Mayo Clinic

PLUGS: February 2013Business Plan Approved by SCH strategic planning

• The case for PLUGS:

• ↑value for patients

• ↑value for CHA hospitals and pediatric part of other hospitals• UM/ Send Out tests is a problem at CHA hospitals and in the pediatric

portions of adult-focused health systems. • Significant and increasing expense item for labs• Many hospitals don’t have resources to tackle the problem. • Those that do have resources still gain thru partnering

• Chance to develop national consensus policies

• Strong research opportunities for faculty / trainees

• The plan: 5 year, addition of GCs, faculty, business support

47

Needs Assessment:Results from first 8 needs assessments

≥ 3 sites•Have created UM Committee

•Want more education

•Struggling with IT/LIS/CPOE

• Patient safety concerns • ordering wrong test• long TAT• result data entry error

All Sites

• $ Genetic testing eating us alive

• Want national guidelines for specific areas of Peds testing

• Difficult to manage “misc” test

• Testing algorithms helpful

Goal: PLUGS will provide UM service for CHA hospitals and the pediatric component of adult-oriented health systems.

CHA Hospital 2

CHA Hospital 1

Adult Health System 1

Adult Health System 2

PLUGSPediatric UM

Adult UM PEDS UM

All UM

CHA= Children’s Hospital Association

Call Center for PLUGS Participants

• Mayo clinic providing call center support during PLUGs pilot

•Participants talk to genetic counselor or doctoral level staff regarding:

• specific tests / algorithms

•tips for communicating with docs

•how to implement UM strategies

•Advice about a group of cases

PLUGS fulfills the academic mission and expresses itself thru many channels. As a lab business, it is a hedging strategy riding on the capitation trend.

National policy

Research

Education: Webinars, software

Clinical Service Website and Print media

PLUGS

*

PLUGS is academically important PapersDickerson JA, Cole B, Conta JH, et al. 2013. Improving

the value of costly genetic reference laboratory testing with active utilization management. Arch Path Lab Med. In press. 2013.

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. Submitted April 20, 2013.

Abstracts:Cole B, Dickerson JA et al. 2013. A prospective tool for

risk assessment of send-out testing. Clin Chem. In press.

Dickerson J, Jack RM, Astion ML. 2012. A Systematic Approach to Improve the Quality and Economics of Laboratory Send-outs in a Pediatric Reference Laboratory. Modern Pathology;25:342-343.

Dickerson J, Astion ML. 2012. A door not closed: a systematic review of unacknowledged sendout results. Clin Chem.

Conta JH, Cole B, Dickerson J, et al. 2012. A strategy to improve the quality and economics of laboratory send-outs at Seattle Children’s Hospital: the role of the laboratory genetic counselor. Journal of Genetic Counseling.

Editorials Dickerson J, Cole, B and Astion ML. 2012. Ten Ways

to Improve the Quality of Send-out Testing. Clinical Laboratory News. 38(4): 12-13.

Epner P and Astion M. 2012. Reducing Diagnostic Errors by Focusing on Test Ordering Practices. Clinical Laboratory News. 38(7).

PLUGS: Next Steps

• Pilot phase:• Expand the toolkit• Help participating

sites use tools.

• Continue assessments, selected site visits.

• Partner for adult UM

• Growth: National launch in late 2013.

Conclusions and Thanks!

• Stronger UM interventions are structural

• SCH experience:• $437 cost avoidance per genetic test

under management • Banning useless tests• Email scripts as guidance• Privileging

• From our UM experience, we are piloting PLUGS, an outreach with components of service, research, and teaching Value = Quality /Cost