1. Coverage and Reimbursement to Genetic Testing
Lee N. Newcomer, MD, MHA
UnitedHealthcare

2. Overview The tension we feel Two components for cancer
Treatment guidance
Assessing risk
The business of testing
Recommendations
Confidential Property of UnitedHealth Group. Do not distribute or reproduce without express permission of UnitedHealth Group.

3. Why We Have to Do Something
Household Income
Year 3
Source: Annals of Family Medicine: March/April 2012, vol. 10 no. 2,

4. Scope of the Issue UnitedHealthcare
$521M spent for 1.2M claims last year
Annual trend increase is 40%
Most utilization is within 10 genetic test categories, performed by less than 15 labs but billed with 100s of CPT code combinations
US national spend estimate for 2021 is $15B to $25B
Two major issues in oncology:
Treatment guidance
Cancer risk

5. Treatment Guidance: Core Issues
The Fundamentals:
Analytic Validity
Clinical Validity
Clinical Utility
The Question for Oncology:
Basket Trials for Discovery?
And/Or
Generalized Treatment Strategy?

6. Discovery of New Indications
Slide courtesy of David Hyman, MD

7. Basket Trial Success Discovery of New Indications
In the cohort with Erdheim–Chester disease or Langerhans’-cell histiocytosis, the response rate was 43%; the median treatment duration was 5.9 months (range, 0.6 to 18.6), and no patients had disease progression during therapy.

8. What are the barriers to completing this trial?
Generalized Strategy?
Exome testing and directed therapy for specific mutations
New diagnosis metastatic cancer
Random
Assignment
Standard of care with bona fide palliative care
What are the barriers to completing this trial?

9. When the evidence is there the payers will be there
Many individual gene mutations and targets are proven in specific cancers
AND
The general strategy of gene mutation and targeted therapy regardless of tumor type is still unproven.

10. Assessing Cancer Risk: The Issues
Is generalized screening affordable?
Would the $250 test answer this question?
Long, Ganz. Cost-effectiveness of Universal BRCA1/2 Screening Evidence Based Decision Making JAMA Oncology
Why resistance to genetic counseling?
Where is the evidence for follow up surveillance on patients with risk?

11. The Business of Testing
Prior authorization
Test recognition codes
Preferred laboratories
Validity
Collaboration
Service including clinical trial referral
Cost

12. Recommendations
Implement and complete a national trial testing generalized gene directed therapy
Establish national code system for test identification
Establish national standards for analytic validity
There will be constant tension between developing the science and commercializing the concepts
When the evidence is there the payers will be there