PLUGS Ideas. Collaboration. Results.

PLUGS Ideas. Collaboration. Results.

Laboratory Stewardship: Partnering With Payers to Get the Right Test and Get Paid Shannon Stasi, MS, LCGC Laboratory Genetic Counselor PLUGS Account Manager Project Manager - Communications & Outreach Disclosure Statement Employed by Seattle Childrens Hospital Overview Laboratory Stewardship PLUGS Statement of the problem Improving relations between payers and labs Conclusions Laboratory Stewardship Refers to a healthcare ethic that embodies responsible planning and management of resources

Quality Value = Cost National Research Council. Controlling Costs and Changing Patient Care?: The Role of UM. Washington, DC: The Natl Academies Press, 1989. Laboratory tests are both over-utilized and under-utilized Meta-analysis of 15 years of lab utilization literature showed: Mean rate of overutilization was 20.6% (16.2-24.9%, n = 114 studies) Inappropriate repeat testing rate was 7.4% (2.5-12.3%, n = 55) Inappropriate testing rate for low-volume tests was higher than for medium- and high-volume tests (32.2% vs. 19.8% vs. 10.2%) Mean rate of underutilization was 44.8% (33.8-55.8%, n = 18) Zhi et al. The Landscape of Inappropriate Laboratory Testing, 2013, PLoS ONE 8(11): e78692 Stewardship involves improving these areas: 1. Misordering tests 2. Misinterpreting test results 3. Failure to retrieve and act on test result

4. Unnecessary cost to patients and healthcare system Gandhi, TK, et al. Missed and Delayed Diagnoses in the Ambulatory Setting Ann Int Med. 2006;145(7). Utilization Management - Interventions Gentle Gentle Guidance Medium Strong Guidance Solomon DH et al. Techniques to improveuse of diagnostic tests. JAMA. 1998; 280:2020-2027. Calderon-Margalit et al. An administrative intervention to improve the utilization of laboratory tests within a university hospital International Journal for Quality in Health Care 2005; 17(3): 243248 Dickerson, J.A.; Fletcher, A.H.; Procop, G.W.; et al. Transforming laboratory utilization review into laboratory stewardship: Guidelines by the PLUGS National Committee for Laboratory Stewardship. Journal of Applied Laboratory Medicine. 2017; 2(2): 259268. We are in good company Antimicrobial stewardship Pharmacy formularies

Blood utilization committees Radiology utilization management The Choosing Wisely Campaign Laboratory Stewardship Stewardship, practiced locally, is effective 2016 2012 Case review at time of Preauth 4 Lab GCs Formed Hospital-wide committee Implemented UM program Lab UM Committee meets weekly 2014 Grown to 3 lab GCs

Expand case review criteria Laboratory Stewardship Committee meets weekly Committee includes: 3 pathologists, 2 clinical chemists, 4 laboratory genetic counselors, 2 medical geneticists, specialty labs manager, lab business operations manager, clinical genetic counselors Weekly working meeting includes: Case review Test build & reference lab discussions (e.g. lab formulary) Focused intervention project development/management PLUGS now stands for PLUGS Network Our Members Represent Over 150 Institutions and Counting Akron Children's Hospital Arkansas Childrens Hospital Baylor Genetics

Blueprint Genetics Boston Childrens Hospital Bronson Methodist Hospital Cardinal Glennon, SSMH CentraCare Health Centura Health Laboratories Childrens Healthcare of Atlanta Children's Hospital & Clinics of MN Children's Hospital of Colorado Childrens Hospital of Los Angeles Childrens Hospital of Philadelphia Childrens Hospital of Pittsburgh of UPMC Childrens Hospital of Wisconsin Childrens Mercy Hospitals and Clinics Childrens National Medical Center Childrens of Alabama

Cincinnati Childrens Hospital Cleveland Clinic Cleveland Clinic Abu Dhabi Cook Childrens Medical Center Dayton Childrens Hospital Dell Childrens Medical Center Fairview Health Services Froedtert Health GeneDx Laboratories Health Partners- Regions & Park Nicollet Hospital InformedDNA Intermountain/Primary Childrens Hospital John Hopkins University Kaiser Permanente NW Regional Laboratory Lancaster General Hospital Le Bonheur Childrens Hospital Legacy Health Lurie Childrens Hospital Chicago

Mercy Childrens Hospital St. Louis Meriter-Unity Point Health MultiCare Tacoma General Nationwide Children's Hospital Nemours/Alfred I. duPont Hospital for Children Norton Healthcare Ochsner Health System Oregon Health & Sciences University Phoenix Childrens Hospital Providence Health and Services Providence Sacred Heart Medical Center Quest Diagnostic Laboratory Royal North Shore Hospital Salem Health Care Seattle Cancer Care Alliance Stanford Health Care Stony Brook University Hospital

St. Louis Childrens Hospital St. Lukes Health System Texas Childrens Hospital Tricore Reference Lab UCSF Benioff Children's Hospital Oakland University of Florida Shands University of Kansas Medical School - Wichita University of Michigan University of Washington UW Health University Hospital Valley Childrens Hospital Wake Forest Baptist Health York Hospital (WellSpan Health System) PLUGS Four Initiatives CaseCase Management Management

National Committee for Laboratory Stewardship Insurance Advocacy Tools for Stewardship Program Development Mission: Improve test ordering, retrieval, interpretation and reimbursement. SBAR: Case Review Situation: Genetic send-outs are costly and error prone. Background: SCH spends ~ $1,000,000 annually on genetic sendout cases. Without review, it is likely that 20-30% of orders were either in error or duplicates. Assessment: By implementing a review process for expensive genetic sendout tests, we will save $ and improve value for patients. Recommendation: Utilize Lab GCs to review cases which meet defined cases before they are sent out.

Making the case for case management Net New Genetic Testing Products March 1st, 2015 March 1st, 2017 9,000 8,000 8-10 new testing products per day 7,000 6,000 5,000 4,000 3,000 2,000 1,000 0 ar M

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F A S N D M A S N D M M Singles Panels Total March 1st, 2017 Concert Genetics

Case Management from Reference Labs Case Management in the Hospital Setting Case Review Criteria at SCH Hypothesis: By implementing a review process for expensive genetic sendout tests, we will save $ and improve value for patients. Sample Test Review Criteria Tests costing the lab > $700

All genetic send out tests Requests to send to non-preferred laboratory Requests to send to international laboratories Requests to send tests performed in-house Tests defined as under management Seattle Childrens Laboratory Stewardship Program Two phase review process has a positive impact on patients, providers, institution & payers

4001 PREAUTH requests reviewed between Jan 16 Oct 17 6279 ORDER requests reviewed between Sept 11 Oct 17 22% modification/ cancellation rate 6% error rate $1,400,000

cost avoidance since 2011 Genetic Testing Case Management ROI PLUGS Four Initiatives Case Management National Committee for Laboratory Stewardship Insurance Advocacy Tools for Stewardship Tools for Stewardship Program Development Program Development

PLUGS: Education & Support Resources created for PLUGS members Policies Workflow Extensive materials on how to get a test stewardship program started in a lab or hospital Inspiring & educational talks/webinars Provider satisfaction survey Sample presentations to payers Insurance Preauthorization 101 > Learn More PLUGS Four Initiatives Case Management

National Committee for National Committee for Laboratory Stewardship Laboratory Stewardship Insurance Advocacy Tools for Stewardship Program Development National Committee for Laboratory Stewardship (NCLS) Short term goal is to create a set of voluntary standards modeled after the antimicrobial stewardship effort Four basic elements of lab stewardship programs: 1. 2. 3. 4.

Governance Interventions Data extraction and monitoring Review and improve Long term goal is to break the denial loop by having insurance companies fast track claims from those labs that meet the standards JALM Volume 2, Issue 2 PLUGS Four Initiatives Case Management National Committee for Laboratory Stewardship Insurance Advocacy Insurance Advocacy Tools for Stewardship

Program Development Problems with current insurance reimbursement system Distant, Disconnected Wasteful Complex Variable Problems with insurance reimbursement system Distant and Disconnected Decision making is too far removed from the patient Clyde Robinson, CPR mannequin 1 Loss of caring Loss of accountability Loss of system control Lack of teamwork Loss of trust

4/7/2017: Dear everybody: Can you please not make a long distance call and wait 2 days for preauth before you CPR me? Sincerely, The patient Problems with insurance reimbursement system Wasteful Clinic Note Includes Medical Necessity Language Hospital Clyde Robinson, CPR mannequin 1 RN MD Pre-Auth Orderable in

EMR GC Insurance Company Lab Genetic Counselor EPIC billing system Dual Preauthorization drives all parties insane Insurance Processing Dept

Pre-Auth Complete Problems with insurance reimbursement system Complexity From: Big Insurance Company May 5, 2017 Dear Michael Mike Astion: Attached please find an EOB that you will not understand followed by 4 more pages in different languages including a useless privacy notice whose purpose is to kill trees. Based on our 2-hour conversation in which you yelled at me --and in which I told you that you cant talk to anybody with medical policy knowledge--, I am informing you in an extremely nonbinding way that for this particular covered test, the allowed amount is $149 , your deductible is or is not met, and your co-payment is likely to be $30 . Your max out of pocket for the year is $5250 and may or may not matter in this case. We may still determine that you are too sick or too well to have this testing in the future. In summary screw you, and a confusing, poorly-numbered , form letter will follow. Your Insurance Ambassador, Phyllis G. P.S. It is impossible to find me in a directory or reach me by email or text, and everything you say is on a recorded line.

Problems with insurance reimbursement system Complexity in Insurance Claims Three types of policies and procedures; all are error prone: 1. Medical necessity. This test is a covered benefit for the following conditions. 2. Administrative In- vs out-of-network labs Forms, coding requirements Time limits on claims Multi-stage grievance procedures 3. Payment rules, fee schedules Problems with current insurance reimbursement system. VARIABILITY Significant variation between insurance companies regarding policies and procedures. The overall insurance system for lab claims is unpredictable

and fragmented, and needs a new foundation and a new design. It fails to detect abuse sufficiently and fails to pay complicated, but necessary claims. A well-designed system could achieve the equivalent of using $$$ saved from blocking fraud/misuse to pay for medicallynecessary, properly coded tests. MTHFR * c-testing-for-hereditary-thrombophilia/ Medicare 2014: MTHFR testing Despite the Choosing Wisely Recommendation $14 million spent on 239,000 tests (239,000 patients) from 130 labs. Top 10 labs (no PLUGS members) are as follows: Last Name/Organization Name of the Provider HEALTH DIAGNOSTIC LABORATORY,

INCORPORATED # of tests Ave Submitted Ave Medicare Charge Payment Total payment 42,448 $ 415.84 58.36 $ 2,477,213

PRIMEX CLINICAL LABORATORIES INC. 27,744 $ 96.49 58.25 $ 1,616,097 BLACKFLY INVESTMENTS LLC 18,077 $ 208.98

58.35 $ 1,054,878 GENETIC TECHNOLOGICAL INNOVATIONS, 15,997 $ 278.76 58.35 $ 933,446 COMPANION DX REFERENCE LAB- HAWAII,

AMERICAN INTERNATIONAL BIOTECHNOLOGY AIBIOTECH 11,912 $ 278.76 58.36 $ 695,184 10,161 $ 148.98 58.36

$ 592,996 AFFILIATED GENETICS, INC. 9,896 $ 154.70 58.35 $ 577,439 MILLENNIUM HEALTH, LLC 7,937

$ 59.55 58.02 $ 460,536 ALTHEADX, INC. 7,827 $ 150.00 58.35 $

456,692 Medicare Data: Patients face the following Lack of transparency regarding out-of-pocket expenses High out-of-pocket expenses Difficulty talking to Drs about testing costs

Opaque grievance procedures from insurance companies Waiting (preauth, grievances) and uncertainty Look at that copay for a VUS !!! Clinical labs face. A battle for inclusion in insurance networks A fight for a reasonable fee schedule.

Uninsured patients Different rules for each insurer An insurance preauth process after they have performed their own medical necessity determination Providers bypassing their UM system to avoid oversight. -and-patients-to-keep-testing

Laboratory stewardship programs both hospital-based and commercial lab-based are the foundation for cooperation with insurance companies. Improving the relationship between payers, lab, and patients involves Understanding each others problems Building Trust Enhancing Communication Assuming good intent Collaborating on solutions that solve each others problems. Improving the relationship between payers, lab, and patients involves Insurers problems Difficulty developing and maintaining lab testing policies and procedures and therefore deny genetic tests as experimental/ investigational.

Understanding Commercial labs breaking member contracts with patient forgiveness programs. Complaints, grievances from patients and providers Lawsuits from patients Fraud, abuse, misuse Improving the relationship between payers, lab, and patients involves Build your lab stewardship program. It is the basis for all collaboration. PLUGS is leading the laboratory stewardship movement to improve test ordering, retrieval, interpretation, and reimbursement

Supporting voluntary, national standards regarding lab stewardship programs, and push to have insurance companies recognize them. Partnering with your insurance processing team and push to meet directly with insurance companies. Get to the table! Building Trust Improving the relationship between payers, lab, and patients involves Thru PLUGS, leaders from multiple labs partnered with eviCore Healthcare (a 3rd party benefits manager servicing the insurance industry) and other payers to create a whole exome sequencing policy.

In the next year, the whole exome sequencing policy will be associated with > 9 million covered lives through multiple payers. SCH was able to share the policy to bolster provider recognition program request, and is using the policy to open the door with other local payers. Other policies are in the works (e.g. mitochondrial testing) using this collaboration, and we hope they will have large national impact. Collaborate Improving the relationship between payers, lab, and patients involves Pushing gold carding, which means insurance company

accepts and audits your laboratory stewardship system and agrees to eliminate dual systems of preauth and medical policy. Partnering with insurance companies to block fraud and abuse. Collaborate Applying pressure and partnering with reference labs to stop engaging in bad practice, especially running obsolete or magic tests. Sharing success stories about insurance collaboration with other labs. Advocating for insurance systems that make coverage decisions faster, more transparent, and closer to the patient. 2011 2014 Patients complain about $$$

bills Grown to 3 lab GCs Expand case review criteria Preauth Pilot 2012 Implemented UM program Lab UM Committee meets weekly 2017 Gold card status with one major payer Exome Policy

2016 Case review at time of Preauth 4 Lab GCs Formed Hospital-wide committee Insurance Advocacy: Systematic Solutions Le Bonheur Childrens Hospital Standard SOP for genetic testing preauthorization Childrens Hospital of Los Angeles Streamlined process that is integrated in Cerner and improves insurance reimbursement rates, reduces time required to obtain authorization and significantly improves efficiency

Childrens Hospital of Pittsburgh of UPMC Strong partnership with local payer resulted in significant improvement in authorization & reimbursement for WES Seattle Childrens Robust case review process supports efforts to obtain exemption from payer preauthorization process Trust-building, collaborative approach to insurance advocacy Assume good intent Accept that bad systems, are not necessarily staffed by bad people. Meet frequently Share food and drink Share data Understand that apparent contradictions are often both true.

Example: you can dislike and love the same person or pet. You can love and hate your job at the same time. Give up on being right to achieve being effective *Courtesy of Mike Astion The foundation of a better system is collaboration between health systems, insurance companies, and patients Before Insurance After Physician Physician and Insurance Co discuss recent denial. A group of payers, labs, and patients, working together. Acknowledgements

Seattle Childrens Faculty Michael Astion, MD, PhD Jane Dickerson, PhD Bonnie Cole, MD Cristina Pacheco, MD Jimmy Bennett, MD, PhD Stephanie Wallace, MD Rhona Jack, PhD Joe Rutledge, MD Patrick Mathias, MD, PhD Lab Genetic Counselors Darci Sternen Jessie Conta Sarah Clowes Candadai Sendouts Team Emma Waychoff David Stanley Shamus Riley Lab Client Services Team Business Operations Nitasha Kumar

Monica Wellner Lisa Wick Joanne Simpson Allison Do Brittany Russo Thank You!

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