preventest final go live training get ready to sell! presented by david gruber national sales...
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PREVENTEST Final Go Live Training
Get Ready to Sell!
www.PrevenTests.com
Presented by David GruberNational Sales Director, GeneID
914-262-5042 [email protected]
GeneID and all of its Distributors and Sales Representatives must comply with all Federal, State, and Local Healthcare Laws, Policies and Procedures
This Includes: Anti-Kickback, Stark, and HIIPA
GeneID employs a “No Tolerance” approach to compliance violations
Conducting Business the “Right” Way
Easy test to “Sell”But the Key is in the
“Execution”1. Give 10 Point Questionnaire to Each
Patient who comes into office (on clipboard)
2. If patient scores 10 or more points they are eligible for test
3. Fill out Requisition form, and Consent form and perform mouthwash and swab
4. Put all back into black envelope and send fed ex after a minimum of 5 tests
Can be emailed or mailed to patients in practice database
To be included on clipboard for all patients coming in for appointment
Questionnaire to determine if patient qualifies
GeneID is a CLIA and CAP (College of American Pathology) Certified Molecular Laboratory specializing in Next Generation DNA Gene Sequencing using the Ion Torrent Micro Chip Technology by Life Technologies
The microchip contains over 140 million mini Test Tubes which allow us to be very accurate, cost effective, do many tests at once and have a very quick turnaround time
We are based in Ramsey, NJ and service all states except NY
Our staff includes a CEO, Scientific Director, Medical Director, Billing Department, Lab Technicians, Sales Support, Access to Genetic Counselors, and a National Field Sales Team
About GeneID?
About Our Scientific DirectorDr. Daniel Cohen, M.D.
Double Board Certified M.D. in OB/GYN and
Genetics Expert in NGS Human Genome Project BRCA Protocol Lead,
Argentina Twice Listed in Who’s Who of Science: 1996 and
2013 Director of 4 molecular laboratories Oversees all testing in the GeneID Laboratory
Why Genetic Testing for Cancer Risk is so
important…
• Patients who have or had cancer caused by a genetic mutation are at significant risk for another related cancer
• Family members of patients with cancer are at a higher risk for developing a related cancer
• Preventing Cancer is a much better than being treated for cancer
Catching Cancer Early is Critical
Introducing The GeneID PREVENTEST; a New, First-to-Market, non-invasive cancer risk pre-disposition test analyzing 31 Genes linked to 8 of the most common solid tumor hereditary cancers:
Qualifying PREVENTEST Cancer Types
We are in the Right Space at the Right Time!!
1. The Next Generations Sequencing (NGS) Market is growing exponentially!
2. The Affordable Care Act has made Precision Medicine and Genetic Testing a Priority
3. There is a tremendous investment being made into Research and Technology resulting in more knowledge about which Gene mutations contribute to which cancers and suggesting even more people should be tested
4. The Competition is Helping Us! Myriad Labs (company that started BRCA testing) is helping spread the message that “testing more genes results in the detection of more cancers” through their MyRISK test
The NGS market is the fastest growing in Genomics…2014 Revenue was $2.4 Billion growing to almost $28 Billion by
2022
Expected Market Growth:
Next Generation Sequencing Market Is Anticipated To Grow To $27.87 Billion In 2022: New Report By Grand View Research, Inc.
Fueled by Cancer Genetics!
See more at:
http://globenewswire.com/news-release/2015/06/13/744356/10138308/en/Next-Generation-Sequencing-Market-Is-Anticipated-To-Grow-To-27-87-Billion-In-2022-New-Report-By-Grand-View-Research-Inc.html#sthash.05I27CkA.dpuf
Obama Announces “Precision Medicine Initiative” (Jan. 30,
2015) and Affordable Care Act
$217 Million dollar initiative that moves away from one-size-fits-all treatments
-Scientists will assemble databases of about a million volunteers to study their genetics …to learn how to
individualize treatment and preventative care.
BRCA Testing Granted “Preventative Care Designation Under the Affordable Care Act”
-Women who have a high risk of developing breast cancer can receive genetic counseling and BRCA testing for free as a preventive service under the law, says a spokeswoman for the Department of Health and Human Services.
-According to federal guidelines regarding the implementation of the Affordable Care Act, "genetic counseling and BRCA testing,
if appropriate, must be made available as a preventive service without cost-sharing."
Published: In the prestigious New England Journal of Medicine August 7th, 2014 (http://www.nejm.org/doi/full/10.1056/NEJMoa1400382)
Title: Breast-Cancer Risk in Families with Mutations in PALB2
Results:
The absolute breast-cancer risk for PALB2 female mutation carriers by 70 years of age ranged from 33% for those with no family history of breast cancer to 58% for those with two or more first-degree relatives with breast cancer at 50 years of age.
***PALB2 is on our PREVENTEST Panel
New Clinical Studies Discovering More Gene Mutations that Cause
Cancer
What is Genetic Testing for Cancer Risk?
Predictive testing that can help predict the likelihood that an individual will develop cancer in his or her lifetime
Not everyone with a cancer-related gene will develop cancer
Who may be at risk for developing hereditary cancer and who should
be tested? What criteria determine Medical Necessity?
People with Personal history of cancer
People with a family member who tested positive for a BRCA mutation
People with a Family history of cancer: Combination of 1, 2 or 3 Family members on the same side of the family with a related cancer (Depending on type cancer and age)
Evolution of Hereditary Cancer Risk Testing… from 2 Genes to
Multi-Gene Panel Testing Early 90’s -BRCA 1 and 2 Discovered by several scientists (Mary Claire King)
-Myriad granted a patent on the BRCA 1-2 Genes and has monopoly on market
-Myriad launched BRCAnalysis, a predictive medicine product for hereditary breast and ovarian cancer (testing BRCA 1-2) in 1996
-Supreme Court Overturns Myriad BRCA 1-2 Patent in June 2013 opening market to other labs (Ambry, GeneDx, LabCorp, Quest, etc)
-Move FROM just testing for BRCA 1&2 to Multiple Gene Testing
We are ahead of the Competition…
“After the Supreme Court last year ruled that Myriad Genetics could not patent the BRCA1 and BRCA2 genes, the company announced that by 2015 it would replace its BRCAnalysis test with a broader MyRisk panel that analyzes 25 genes associated with hereditary cancers, including breast, colorectal, ovarian, endometrial, pancreatic, prostate, gastric, and melanoma”
***And they will be using Next Generation Sequencing!***Have been piloting for about 6 months ($50m in sales)
***Blood Draw vs. Cheek Swab with PREVENTEST***25 Genes vs. 31 with PREVENTEST
Testing More Genes identifies more Cancers?
2013 San Antonio Breast Cancer Symposium (Myriad Funded Study)
It was found that myRisk testing for 25 genes has the ability to identify 51% more patients with higher risk of hereditary breast and ovarian cancer than testing of BRCA1 and BRCA2 genes alone.
2013 Collaborative Group of the Americas on Inherited Colorectal Cancer (CGA) Annual Meeting (Myriad Funded Study)
Myriad had reported a 61% improvement in detection of hereditary colon cancer by testing 25 Genes
1. “Why Should I test for Cancer Risk?”
The Risk for Cancer
is significantly increased
with a Genetic Mutation
2. “Why would my patients want to know this
information?”
Because if they know that they are genetically pre-disposed to any of these 8 cancers, they can reduce the risk or even PREVENT the cancer from occurring!
What this information allows you to do…Take Control and develop a preventative plan!
People at a higher risk for cancer may have the option of having:
1. More frequent cancer screenings
2. Avoiding specific risk factors
3. Making lifestyle changes to lessen additional risk
4. Taking preventive medication (chemoprevention)
5. Having risk reducing surgeries in order to reduce their risk
3. “What do I do with the information?”
You do the same thing that you would do if you have an out of control diabetic or blood pressure patient…refer them to a Specialist…a Genetic Counselor
1. First bring patient back into office and review results
2. If positive refer them to a local Genetic Counselor or utilize Telephone Consultation Genetic Counselor experts (Informed DNA)
31 Genes Linked to 8
Cancers
6 more genes than Myriad
RETELAC2HRAS1
MRE11APTCH1RAD50
The Panel of Genes
What Myriad is Missing
Gene Breast Ovarian Colorectal Endometrial Melanoma Pancreatic Gastric Prostate Other
ELAC2 ● HRAS1 ● MRE11A ● ● PTCH1 ● ● RAD50 ● RET ● ●
• Meta-analysis of associations of the ser217-to-leu and ala541-to-thr variants in ELAC2 (HPC2) and prostate cancer. Camp NJ et al. Am. J. Hum. Genet. 71: 1475-1478, 2002.
• Association of HPC2/ELAC2 genotypes and prostate cancer. Rebbeck TR et al. Am. J. Hum. Genet. 67: 1014-1019, 2000.
• Cancer Epidemiol Biomarkers Prev. 2003 Dec;12(12):1528-30.The HRAS1 variable number of tandem repeats and risk of breast cancer.Tamimi RM, Hankinson SE, Ding S, Gagalang V, Larson GP, Spiegelman D, Colditz GA, Krontiris TG, Hunter DJ
• Damiola, F., et al., Rare key functional domain missense substitutions in MRE11A, RAD50, and NBN contribute to breast cancer susceptibility: results from a Breast Cancer Family Registry case-control mutation-screening study. Breast Cancer Res, 2014. 16(3): p. R58
• http://ghr.nlm.nih.gov/gene/PTCH1
• Screening for BRCA1, BRCA2, CHEK2, PALB2, BRIP1, RAD50, and CDH1 mutations in high-risk Finnish BRCA1/2-founder mutation-negative breast and/or ovarian cancer individuals. Kuusisto KM et al. Breast Cancer Research 2011, 13:R20.
• Hum Genet. 2005 Jul;117(2-3):143-53. A newly identified RET proto-oncogene polymorphism is found in a high number of endocrine tumor patients. Gartner W, Mineva I, Daneva T, Baumgartner-Parzer S, Niederle B, Vierhapper H, Weissel M, Wagner L.
One Mutation can increase the likelihood of many
cancersLynch Syndrome:
A “Cancer Syndrome” defined by a mutation in one of 5 Genes: MLH1MSH2MSH6PMS2EPCAM
Increases risk of Colon, Endometrial, Ovarian, Skin and Stomach Cancer
Selling the PREVENTEST
Tips and Tactics that Work!
2 Steps to Success
1. Qualify the Patient for the Test -ensure Medical Necessity is met based on personal and family history of cancer
2. Insurance Approval -ensure the test will be
paid for with zero to minimal out of pocket expense for the patient
Performance Goals
Ramp up to 50-100 Paid Tests/Month minimum
Sept: 10-15 Tests
Oct: 15-25 Tests
Nov: 25-50 Tess
And Upward from There!
Where Does Your Business Come From?
1.PCPs (40+ tests/month)
2.OB/GYNs (20+ tests/Doc/Month)
3.General Oncologists (40+ tests/month)
4.Breast Surgeons (40+ tests+/month)
5.Others: Large Practices (GI, Wellness, etc.)
Insurance Approval Process
Medicare or Medicaid
1. Verification of Active Insurance
2. Patient called to verify history listed on Requisition form
3. Test Run
4. Test Reported and Billed
5. Test Collected
Commercial Insurance or Medicare Advantage Plans
1. Verification of Active Insurance
2. Confirm that our CPT codes are covered by the plan for that patient
3. Submit any additional information they require (mostly Medical Notes)
4. Get approval from Insurance to Run (3 days-3 weeks)
5. Test Run
6. Test Reported and Billed
7. Test Collected
Submit Tests with Clinical Notes (to speed things up)
Good Screening is the Key to Success!
Related Cancers (2 categories)
BRCA Cancers
•Breast•Ovarian•Prostate•Pancreas
Lynch Cancers
• Colon/Colorectal• Uterus/Endometrial• Pancreas• Ovarian• Stomach/Gastric• Brain• Kidney
Genetic Testing Criteria (Commercial Insurance Female and Male)
Personal History of (any one of the below):
Breast cancer diagnosed at age <50
Ovarian cancer diagnosed at any age
Colon cancer diagnosed at age <50
Prostate or Pancreatic cancer plus 1 or more family member with Pancreatic, Prostate, Breast (diagnosed <50) or Ovarian Cancer
Colon cancer (any age) plus 1 or more family members with Pancreas, Stomach, Brain, Uterine, or Kidney cancer (any age)
If Ashkenazi Jewish, no additional family history may be required
Family History of (any one of the below): 1 Relative w/Ovarian cancer (any age)
1 Relative w/Breast cancer (diagnosed <45)
1 Relative w/Breast cancer (diagnosed <50) plus 1 or more Relatives with Breast, Pancreas, Prostate or Ovarian cancer (any age)
1 Relative w/Breast cancer (any age) plus 2 or more Relatives with Breast, Pancreas or Prostate Cancer (any age)
2 or more Relatives with Breast, Prostate, Ovarian and/or Pancreatic cancer with 1 diagnosed <50
2 or more Relatives with Colon, Uterus, Pancreatic, Stomach, Brain and/or Kidney cancer with 1 diagnosed <50
3 or more Relatives with any of the above groups of cancer diagnosed at any age
Genetic Testing Criteria (Medicare Insurance Female and Male)
Personal History of (any one of the below):
Breast cancer, Ovarian cancer or Colorectal cancer For breast, ovarian and colorectal cancers, the patient must have
cancer – defined as current or has been in remission for less than 5 years
Pancreatic Cancer or Prostate Cancer For pancreatic and prostate cancers, patient must also have 1
relative with either: breast cancer < 50, ovarian cancer, pancreatic cancer or prostate cancer
Cancer History that does NOT Qualify
1. Lung Cancer2. Skin Cancer3. Liver Cancer4. Bone Cancer5. Throat Cancer6. Esophageal Cancer7. Heart Cancer8. Cervical Cancers9. Thyroid10. Blood Cancers (Leukemia,
Lymphoma, Hodgkin's)
Some key rules to Remember• Colon and Breast are not “Related Cancers”• Skin is not “In” and does not count as a qualifier• Family Members need to be on same side of family and 1st or 2nd degree relatives (mother, father, sister, brother, aunt, grandmother, grandfather, son, daughter, uncle, niece, nephew, ½ brother/sister)
Requisition Form
Very Important:
Fill in All Applicable Information
-Need Ages of Cancer Diagnosis
-Need Doc Sig
-Need Patient Sig
-Need Insurance Info
Write your name on
the top of the Req
form
ICD 9 Codes for Personal History
“Does This Test Qualify?”
“Does This Test Qualify?”
“Does This Test Qualify?”
“Does This Test Qualify?”
The “Kit”
Requisition Form
Pre-Paid Fed Ex Return Label
Sample Collection Instructions
Consent Form (signed by doc and patient
Envelope Test Kit
Test Kit
Tube for Mouthwash
1 Swab
Mouthwash
Non-Invasive Sample Collection Method
To Complete Kit:
Pick up softpack FedEx Express envelopes and insert in kits and leave with offices
-PREVENTEST Website www.PrevenTests.com
-Video illustrating “PREVENTEST” (Great to mail to potential customers)PREVENTEST 2 Minute Video Description in English:https://vimeo.com/96718022
PREVENTEST 2 Minute Video Description in Spanish:https://vimeo.com/112819235
-Sales Support
-Dropbox with sales materials
-Sales Status Reports once/week
-Test Kits and Patient Education leave behinds
-Genetic Counseling Referral company
Marketing/Support Materials
The “New Client” Form
Fill out completely and send to you distributor lead:
Or fax to lab: (201) 825-0191
This is what links the Doctor/Office to you so you will get credit for the tests that are sent into the lab
Keys to Success
Keep it Simple with your customers…so don’t overcomplicate the message by trying to talk “high science”
Our message is: “Doctor, with NGS technology, you can now, with a simple cheek swab, predict the risk of 8 serious solid tumor cancers so that your patients can put a preventative plan in place”
Don’t mistake “Excitement” for “Commitment”
High Frequency on a few (3-5) Offices until they routinely send tests
#1 Key to Success
Make Screening for Cancer a “standard” in the office (just like
they screen for cholesterol and blood pressure)
USE THE CUSTOMIZABLE OFFICE POSTERS and PATIENT QUESTIONNAIRE
to profile the most appropriate candidates
Office Posters to be placed in waiting room and exam rooms to generate awareness)
(Version 1)
Office Posters to be placed in waiting room and exam rooms to generate awareness (Version 2)
(Version 2)
Can be emailed or mailed to patients in practice database
To be included on clipboard for all patients coming in for appointment
Questionnaire to determine if patient qualifies
Simple Test Process
1. Give 10 Point Questionnaire to Each Patient
2. If patient scores 10 or more points they are eligible for test
3. Fill out Requisition form, and Consent form and perform mouthwash and swab
4. Put all back into black envelope and send fed ex after a minimum of 5 tests
Ask Office to text or call you when a test is coming in and let your distributor know
Conference Calls to share successes (GeneID call every Friday at 11:15AM EST)
Encourage Multiple tests/Fed Ex shipment
Request additional kits through your distributor (New Kits will only be sent once we receive 5 tests)
Feedback Mechanism/Other
Suggestions
To the Dropbox…
Selling Materials