Simplified History of Genetic Testing...From: Big Blue Insurance Company . April 30, 2018 . Dear Michael “Mike” Astion: Attached please find an EOB that you won’t understand

Get Paid: Achieving Alignment with Payers by Advancing the Stewardship of Genetic Testing

Michael Astion, MD, PhD Medical Director, Department of Laboratories

Jessie Conta, MS, CGC Supervisor, Patient-centered Laboratory Utilization Guidance Service (PLUGS)

Seattle Children’s Hospital

Disclosure Statement

Michael Astion and Jessie Conta are employees of Seattle Children’s Hospital. Through the University of Washington and Seattle Children’s, Dr. Astion has intellectual property and contracts with eviCore healthcare, a third party benefits management company servicing the insurance industry.

Outline

• Background: The current payment system is a mess.

• Laboratory Stewardship Programs focus on improving test ordering, retrieval, interpretation and payment. They are carried out by hospital or commercial labs and are sometimes called Utilization Management (UM) programs. Stewardship programs are the foundation for getting paid by insurers.

• Specific Examples: stewardship triumphs and tribulations regarding payment • A successful systematic preauthorization system for genetic testing • A more problematic path toward payment for cancer genomic testing

• A new proposal to improve payment for genetic testing

Background: The system is a mess From: Big Blue Insurance Company April 30, 2018 Dear Michael “Mike” Astion: Attached please find an EOB that you won’t understand followed by 4 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 can’t talk to anybody with medical policy knowledge--, I am informing you that for this particular $4500 genetic test, the allowed amount is $0. Your max out of pocket for the year is $5250 and does not matter in this case as the genetic test is not a covered benefit. I have attached our unreadable, maddening grievance policy if you think we have made a mistake. The grievance is your opportunity to be denied and humiliated again while we explain –using opaque medical and insurance jargon-- why you are too sick or too well to have genetic testing. 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.

Systematic Challenges in Genetic Testing

Multiple payers with multiple policies and rules

Complex systems that are distant from the patient

Complex CPT coding – lack of discrete CPT codes

Policy & Coverage Challenges in Genetic Testing

Lack of policies lead to lack of coverage When policies exist, inclusion criteria are often too strict Hard to keep policies up-to-date Administrative policies block access to the medical policy Time limits Documentation requirements Forms

Lab Stewardship Programs as the Foundation for Payment

Dickerson, J et al. Journal of Applied Laboratory Medicine. 2017; 2(2): 259-268.

Four elements of lab stewardship programs

Governance

Interventions Data Extraction & Monitoring

Review & Improve

Dickerson, J et al. Journal of Applied Laboratory Medicine. 2017; 2(2): 259-268.

The people who make the program happen, and the way they are organized.

To improve test ordering, result retrieval, accuracy of interpretation, and payment.

To identify problems, & assess interventions.

To periodically assess and improve the whole program.

The Elements of Governance of the Lab Stewardship Program

Leadership commitment to

resource the program

Accountability to a high level

executive

Committees: Permanent and ad

hoc

Lab expertise deployed

throughout the program

Networking to professional

societies, initiatives

Committee Hierarchy

Utilization Review

Laboratory Stewardship Committee

Exome Sub-committee

Heme-Onc Sub-committee

Insurance Advocacy Sub-

committee

Hospital Lab Stewardship

CMO/VP of Medical Affairs CMIO Senior Inpatient provider Director Revenue Cycle Laboratory medical leadership

Required by CMS

Typical work of the Lab Stewardship Committee

Laboratory Stewardship Committee

• Case review

• Policy making

• Project selection

• Project tracking and data review

Governance


Review & Improve

To improve test ordering, result retrieval, accuracy of interpretation, and payment.


Lab Stewardship Interventions to Improve Test Ordering. These can directly impact payment.

Gentle Medium

Gentle Guidance Strong Guidance Dickerson, JA 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): 259-268.

Genetic Case Management in the Hospital Setting

Governance


Review & Improve


To identify problems, and assess interventions

Data Extraction and Monitoring 4 important items to measure

Appropriateness of test orders

Retrieval of lab test results

Appropriateness of result

interpretation

Impact of stewardship

interventions

Lab genetic counselor review of genetic testing produces steady 24% order modification/cancellation rate over 5 years

(N= 7560 genetic cases SCH, Sept 2011 – April 2018)

• Reasons for cancellation include duplicate testing and “not medically necessary”

• Modifications include correcting erroneous test orders and improving an order.

• >$1.6 million in cost avoidance since 2011.

74%

76%

16% 8%

Governance


Review & Improve

To periodically assess and improve the whole program

Four basic elements of lab stewardship programs

Provider Feedback Survey

• Important for identifying trends year over year

• Useful to inquire about

program changes

“Review and Improve” means that the stewardship program can prove that it …

TOPIC: IDENTIFYING STEWARDSHIP OPPORTUNITIES

• Does your facility have a system in place for identifying potential laboratory stewardship projects?

Yes No

• If yes, which of the following are used to identify potential projects (check all that apply).

Frequency data such as test tallies by clinical section or individual care provider1

Conformance to a published guideline, recommendation, or scholarly work2.

Conformance to a benchmark3 Surveys of care providers4 Surveys of laboratory staff including pathologists and

other doctoral level staff. Incident reports, occurrence reports or patient safety

reports5. Cost data Alignment with strategic priorities6 External assessment/consulting engagement/inspection

finding7 Analysis of send out (reference lab) testing8 ? Other data. Describe _____________________________

• Identifies stewardship opportunities • Prioritizes opportunities • Maintains sufficient resources (IT,

people) • Regularly reviews the results of the

overall program • Continuously improves…

• Collects more accurate data • Expands meaningfully in all domains

of stewardship • Updates its goals

Outline

• Background. The current payment system is a mess.

• Laboratory Stewardship Programs focus on improving test ordering, retrieval, interpretation and payment. They are carried out by hospital or commercial labs and are sometimes called Utilization Management (UM) programs. Stewardship programs are the foundation for getting paid by insurers.

• Specific Examples: stewardship triumphs and tribulations regarding payment • A successful systematic preauthorization system for genetic testing • A more problematic path toward payment for cancer genomic testing

• A modest proposal for further supporting payment for genetic testing

A Systematic Solution Standardized, integrated, hospital-wide insurance preauthorization process for genetic tests

A little history…it’s complicated…

GOALS

• Create a simple and transparent process for all

• Standardized support, regardless of who recommends the test

• Right person doing right work

• Garnered institutional support and champions

• Integrated with lab stewardship case review process

• Improved efficiencies by providing required details with initial request

OUR APPROACH

Genetic Test Preauthorization & Coordination Workflow

Evaluates patient Selects test Enters preauth

order Documents

medical necessity

PROVIDER

Reviews request & insurance plan requirements

Submits required elements

Communicates outcome to care team

Insurance Processing Dept

Communicates outcome to patient/family, including out-of-pocket estimates

Coordinates test order and logistics

NURSE

Reviews request & helps select optimal test/lab

Suggests language to bolster rationale & necessity

Submits required elements

LAB GC

Outcomes

• Improved patient safety by ensuring the right test, right time, efficiently

• N=5500 cases processed since Jan 2016, 17% modified, 6% cancelled, $310K cost avoidance

• Reduced handoffs, decreased turn-around time (reduce testing delays)

• Baseline = 8 weeks & 15 handoffs, Current: 3 weeks & ≤ 7 handoffs

• Increased provider & staff satisfaction • Process is transparent & reliable

“I deeply appreciate the assistance I have gotten from the lab GCs. It has made a difference in the documentation that I now include in my notes, and they have helped me ensure that I am ordering testing appropriately and in a cost-effective manner (i.e.-reflex). Thank you!”

Impact

Trust within institution

Leverage for other

initiatives

Partnership with payer advocate

Trust with local payers

Gold card with a private

payer

Improved collaboration

with WA Medicaid

Partnering on Policy Local and National Examples of Genetic Testing Advocacy

Local Coverage Policy for Microarrays

Lack of policy for chromosome

microarray coverage in state

Medicaid, increase in volume of

requests/ denials

Local Medicaid reviewing policy related to microarrays

Outside consultant provided draft evidence review with some concerning evidence

Local experts submitted written feedback and public testimony, as well as guidance during committee process

Rational microarray coverage policy

for patients with congenital anomalies, intellectual

disability, & autism

National Coverage Policies for Mitochondrial Disease

Lack of policies for mitochondrial

conditions, but an opportunity

to leverage expertise and

funding

Collaborative approach to create testing coverage policies for mitochondrial conditions using national experts

Promote the spread of these policies at healthcare institutions and insurance companies

Implemented 5-7

mitochondrial policies

now covering >19 million lives

National Coverage Policy for Exome Sequencing

Many payers considered

exome sequencing

“experimental/ investigational”

Leveraged existing partnership with payer who was willing to consider draft policy

Utilized team of experts facing same challenges & engaged to do the work

Created policy with input from experts

Implemented exome

sequencing policy

that is now covering

>9 million lives

Example: Cancer genomic profiling Turmoil, rather than collaboration, produces insurance coverage.

• Coverage. CMS proposes that the evidence is sufficient to cover Next Generation Sequencing (NGS) as a diagnostic laboratory test, including the test results, when performed in a CLIA-certified laboratory and when ordered by a treating physician, and when both 1 and 2 are met.

1. Patient has recurrent, metastatic, or advanced stage IV cancer; and not been previously tested using the same NGS test; and decided to seek further cancer treatment (e.g., therapeutic chemotherapy) 2. The diagnostic laboratory test using NGS meets all the following criteria: the test is an FDA-approved companion in vitro diagnostic; and the test is used in a cancer with an FDA-approved companion diagnostic indication; and the test provides an FDA-approved report of test results to the treating physician that specifies FDA-indicated treatment options for their patient’s cancer.

• Results from this test must be used in the management of the patient to include guiding selection of treatments proven to improve health outcomes.

• Noncoverage. CMS proposes non-coverage of NGS as a diagnostic laboratory test when patients do not have the above-noted indications for cancer or when the test does not meet the above-noted criteria.

• 11/17/17: Foundation Medicine requests National Coverage Determination for cancer genomic profiling in advanced solid tumors.

• 11/30/17: CMS proposed decision required FDA approval for cancer genomic profiling, thereby excluding many labs.

• > 300 responses to proposal including CAP, AACC, universities…

Edited version: CMS proposed decision 1/30/17

Example of Response to Proposal (From AACC, edited for space) • Dietzen, PhD, DABCC, FAACC, Dennis J. ; The American Association for Clinical Chemistry; Date: 01/16/2018

• “Proposed Draft Would Supersede Local Coverage Determinations AACC is also concerned how this NCD may affect patient access to care….This proposed NCD…could invalidate those local coverage determinations that are already in place and serving their local communities. Many patients could be forced to pay for these tests on their own or decline the testing because of Medicare non-coverage.

• Proposed NCD Interferes in Ongoing Policy Discussions Pertaining to LDT Oversight Most NGS-based tests are laboratory developed tests (LDTs) subject to CLIA. ….Further, it sets a precedent that FDA clearance or approval could serve as the basis for whether a test is reimbursed by Medicare. ….

• Proposed NCD Would Hinder Innovation and Patient Access to Testing …. Most clinical laboratories performing tests using NGS technology do not have the resources to seek FDA approval or clearance for the tests … Academic medical centers, which are at the forefront of cancer research, will be particularly harmed by this proposal. Many of these testing facilities could be forced to stop developing and offering NGS-based tests… ”

https://www.cms.gov/medicare-coverage-database/staticpages/public-comment.aspx?commentID=30409&ReportType=nca

In response to comments, CMS made the final NCD more inclusive in that it allowed LDTs

3/16/18 (edited for space) “Medicare Administrative Contractors (MACs) may determine coverage of other NGS as a diagnostic lab test for patients with cancer only when the test is performed in a CLIA-certified lab….and the patient has:

• either recurrent, relapsed, …cancer; and • either not been previously tested using the same NGS test …and • decided to seek further cancer treatment …”

https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=290&bc=AAAAAAAAACAA&

The Insurance Advocate: A new PLUGS® project to improve payment for medically necessary genetic testing

Three strategies for improving insurance coverage for genetic tests:

1. Develop medical policies that insurers will implement

2. Collaborate with insurers to reduce administrative barriers

3. Win insurance grievances

1 and 2 involve collaboration between labs and insurance companies, and 3 helps motivate that collaboration.

The importance of winning grievance procedures when genetic testing is medically necessary

• Usually, grievances can be won in 2 ways: 1. Patient shows that the testing was consistent with a medical necessity policy 2. Patient shows that the medical necessity policy is not up to date, and is unfair

• Grievances create significant expenses for insurers and represent dissatisfaction by their customers.

• Dissatisfaction translates into decreased sales. • The likelihood of an insurer changing from a “no coverage” to a coverage

decision for a genetic test is directly related to how frequently grievances are won.

Develop tools to improve insurance

coverage for medically necessary

genetic testing (cancer or germline)

Tools will be tested for success

in a large set of individual cases

Tools will be refined and made available for use.

For patients with a clearly identified inherited disease or cancer where the disease has had a significant impact on their life…

The Insurance Advocate: Scope of Project

GOAL

The Insurance Advocate:

The Tools

General guide to grievance procedures

Description of patient rights and how to exercise those rights

Communication template to obtain insurer’s internal documents regarding a patient’s case

Case studies to illustrate ways a grievance procedure can be won

Checklist of elements needed to win at the external reviewer (IRO) level

Guide to determining usefulness of hiring lawyer or other advocate

Conclusions: How to be part of the solution, and get paid…

Standardize workflow within institution

Align approach with payer systems

Develop tools for improved Denial Management

Collaborate/create rational policies using experts

Distribute policies freely Contribute expertise/feedback

when public input is sought to ensure alignment

Systematic Solutions to improve preauth

processes / workflow

Policy Creation & Improvement

LABORATORY STEWARDSHIP

What can you do?

• Do something! Be part of the solution, not part of the problem – don’t see insurance payer as adversary, seek ways to partner

• Start a laboratory stewardship program (join PLUGS)

• Come to the PLUGS Summit http://www.seattlechildrenslab.org/plugs/plugs-summit.aspx

Acknowledgements

Seattle Children’s Faculty Jane Dickerson, PhD Bonnie Cole, MD Cristina Pacheco, MD Karen Chisholm, MD Jimmy Bennett, MD, PhD Stephanie Wallace, MD Katrina Dipple, MD Rhona Jack, PhD Joe Rutledge, MD Patrick Mathias, MD, PhD Lab Genetic Counselors Darci Sternen Shannon Stasi Sarah Clowes Candadai

Sendouts Team Natalie Burke Emma Waychoff David Stanley Shamus Riley Insurance Processing Department Barbara Wallace Business Operations Joanne Simpson Monica Wellner Lisa Wick

Questions?