for Improving the Eﬃciency of the Genetics Workforce...for Improving the Eﬃciency of the...

for Improving the Efficiencyof the Genetics Workforce

a CME Breakfast Symposium

This Symposium is not part of the official American College of Medical Genetics andGenomics (ACMG) Annual Meeting program. ACMG does not approve or endorseany commercial products or services discussed during the symposium or offeredfor sale by the corporate supporter of the symposium. ACMG has reviewed andapproved this symposium as appropriate for presentation as an independenteducational activity held in conjunction with the ACMG Annual Meeting.

Jointly provided by the Elsevier Office of Continuing Medical Educationand Miller Medical Communications, LLC.

This live activity is supported by an independent educational grant from Counsyl.

Charlotte Convention Center

Technology and Services

Friday, april 13, 20186:45 aM – 7:15 aM On-site Check-in and

Breakfast7:15 aM – 8:45 aM CME Symposium

CME Credit (Physician)This activity has been planned and implemented in accordance with the accreditation requirements and policies of theAccreditation Council for Continuing Medical Education (ACCME) through the joint providership of the Elsevier Office ofContinuing Medical Education and Miller Medical Communications, LLC. The Elsevier Office of Continuing MedicalEducation is accredited by the ACCME to provide continuing medical education for physicians.

The Elsevier Office of Continuing Medical Education designates this live activity for a maximum of 1.5 AMA PRA Category 1Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

P.A.C.E.® and NSGC credits are provided by ACMG.

Disclosure of Conflicts of InterestIt is the policy of the Elsevier Office of Continuing Medical Education that all faculty, instructors, and planners disclose anyreal or apparent conflict of interest (COI) relating to the topics of this educational activity. The faculty reported thefollowing financial relationships or relationships to products or devices they or their spouse/life partner have withcommercial interests related to the content of this CME activity:

Faculty Relationship Identified with: Quinn Stein, MS, CGC Has no relationships with commercial interests

Leslie Ciarleglio, MS, LCGC Has no relationships with commercial interests

Jessica M. Salamone, ScM, CGC Consultant/Advisor: Counsyl GeneticsSpeakers Bureau: Myriad Genetics

Non-facultyLyerka Miller, PhD; Sandy Breslow; Alison Kemp; and Bernard M. Abrams, MD, hereby state that neither they nor theirspouse/life partner have any financial relationships to products or devices with any commercial interests related to thecontent of this activity of any amount during the past 12 months.

Disclosure of Unlabeled UseThis educational activity may contain discussion of published and/or investigational uses of agents that are not indicatedby the FDA. The Elsevier Office of Continuing Medical Education; Miller Medical Communications, LLC; and Counsyl do notrecommend the use of any agent outside of the labeled indications.

DisclaimerParticipants have an implied responsibility to use the newly acquired information to enhance patient outcomes and theirown professional development. The information presented in this activity is not meant to serve as a guideline for patientmanagement. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in thisactivity should not be used by clinicians without evaluation of their patients’ conditions and possible contraindications ondangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations ofother authorities.

Method of ParticipationIn order to claim credit, participants must complete the following:1. Read the educational objectives, accreditation information, and faculty disclosures before this live activity.2. Attend this live symposium.3. Complete and return the evaluation form at the end of the symposium or complete the online evaluation form at

https://courses.elseviercme.com/gctechsympo18.

CME Inquiries/Special NeedsFor all CME inquiries or special needs, please contact [email protected].

Continuing Medical Education Information

©2018 Miller Medical Communications, LLC. 3020M April 2018

7:15 aM – 7:25 aM Welcome and IntroductionQuinn Stein, MS, CGC (Program Chair)

7:25 aM – 7:40 aM assessing Efficiencies in Genetic Counseling: Current Landscape and Novel Service ModelsQuinn Stein, MS, CGC

7:40 aM – 8:00 aM achieving a High-Throughput, Efficient Workflow:Examples from Genetic Counseling in Cancer Jessica M. Salamone, ScM, CGC

8:00 aM – 8:20 aM Making Novel Technologies Work for You: Practical Considerations From Prenatal Counseling Leslie Ciarleglio, MS, LCGC

8:20 aM – 8:30 aM Scalability of Informed Consent for a PrecisionScreening Microarray on Healthy adultsQuinn Stein, MS, CGC

8:30 aM – 8:45 aM Q&a

agenda

Program ContentThe program presentation slide deck will be available to download for 1 month (Expiration: May 13, 2018)at https://courses.elseviercme.com/gctechsympo18.

Target audienceThis activity has been designed to meet the educational needs of genetics professionals.

Program OverviewThere is a shortage of genetics professionals to meet an ever-increasing demand for interpretation ofgenetic test results. As a result, patients who can benefit the most may never receive testing or necessarycounseling. Novel approaches are needed to improve the efficiency of the genetics workforce so thatpatients have full access to the potential benefits of personalized insights from genetic testing.

This session will introduce technology and services that have the potential to address limitations in the available number of genetic counselors and geneticists by streamlining discussion around billing, aiding pre- and post-test education, and increasing the level of genetic care by medical providers.

Educational ObjectivesUpon completion of this activity, participants will be better able to do the following: • Identify service models that can improve the efficiency of genetic counseling • Describe novel technologies that can improve genetic counseling workflow

Quinn Stein, MS, CGC, is director of the Augustana-Sanford Genetic Counseling Graduate Program at AugustanaUniversity in Sioux Falls, South Dakota, where he also is an associate professor and chair of the Genetic CounselingDepartment. Prior to his role at Augustana, he was the senior genetic counselor at Sanford Health, an integrated healthsystem headquartered in the Dakotas. Mr Stein earned his undergraduate degree from the University of Jamestown, inNorth Dakota, majoring in biology and minoring in chemistry and religion. His master of science degree in medicalgenetics-genetic counseling is from the University of Wisconsin–Madison.

Mr Stein’s professional interests include pediatric/metabolic genetics, rare disease, genetics in primary care, workforcedevelopment, and genesurance counseling. He has published numerous articles on topics such as hereditary cancer,autism, obesity, newborn screening, genetic diseases in the Hutterite population, billing-reimbursement, and on severalrare genetic disorders. He has earned grants to establish a pediatric hearing loss clinic and to help study rare diseasesdiagnosed by newborn screening. Having served as vice chair of the National Society of Genetic Counselors (NSGC)annual conference in Boston, Massachusetts, in 2012 and as chair of the same conference in Anaheim, California, in 2013,Mr Stein sat on the NSGC Board of Directors in 2014-2015; in 2016 he was honored with NSGC’s Strategic Leader award. He holds professional certification from the American Board of Genetic Counselors and is licensed by the South DakotaBoard of Medical and Osteopathic Examiners, holding Genetic Counselor License #0001.

Faculty

Leslie Ciarleglio, MS, LCGC, is a genetic counselor in maternal fetal medicine (MFM) with Hartford Healthcare,Hartford, Connecticut. Prior to joining MFM, she was at the University of Connecticut Division of Human Genetics,Farmington, Connecticut, and then at Yale University School of Medicine, New Haven, Connecticut, in its maternal-fetal medicine practice. Ms Ciarleglio received her master of science degree in human/medical genetics from SarahLawrence College in Bronxville, New York, where she fulfilled her ambition to study prenatal diagnosis.

Her professional interests focus on emerging technologies in prenatal testing, then creating workflow to implementthose technologies into clinical practice. She is gratified to have been involved in the development of the ConnecticutCenter for Fetal and Neonatal Care, a multidisciplinary group dedicated to comprehensive care for both mother andbaby from prenatal evaluation through delivery and postnatal management. In her work at the Center, Ms Ciarleglioendeavors to coordinate this effort with patients, referring providers, and colleagues in the pediatric subspecialties.

Jessica M. Salamone, ScM, CGC, director of Genetic Counseling & Cancer Risk Assessment at Elizabeth Wende BreastCare (EWBC), a large free-standing Breast Imaging Center in Rochester, New York, is an adjunct professor at RochesterInstitute of Technology, where she teaches medical genetics and introductory genetic counseling courses. She is agraduate of the Johns Hopkins University Genetic Counseling Training Program at the Bloomberg School of PublicHealth in Baltimore, Maryland, and a board certified genetic counselor.

Before joining EWBC in 2012, Ms Salamone worked at the University of Rochester Medical Center for 10 years, whereshe provided genetic counseling to patients in a variety of clinical settings, including reproductive, pediatric,craniofacial, and cancer. She was a 2015 Rochester Business Journal Medical Professional Honoree.

Quinn Stein, MS, CGC (Program Chair)Program Director and Associate ProfessorAugustana-Sanford Genetic Counseling Graduate ProgramAugustana UniversitySioux Falls, South Dakota

Leslie Ciarleglio, MS, LCGCGenetic Counselor, Maternal Fetal MedicineHartford HealthcareHartford, Connecticut

Jessica M. Salamone, ScM, CGCAdjunct ProfessorRochester Institute of TechnologyDirectorGenetic Counseling & Cancer Risk AssessmentElizabeth Wende Breast CareRochester, New York

for Improving the Efficiencyof the Genetics Workforce

a CME Breakfast Symposium

This Symposium is not part of the official American College of Medical Genetics andGenomics (ACMG) Annual Meeting program. ACMG does not approve or endorseany commercial products or services discussed during the symposium or offeredfor sale by the corporate supporter of the symposium. ACMG has reviewed andapproved this symposium as appropriate for presentation as an independenteducational activity held in conjunction with the ACMG Annual Meeting.

Jointly provided by the Elsevier Office of Continuing Medical Educationand Miller Medical Communications, LLC.

This live activity is supported by an independent educational grant from Counsyl.

Charlotte Convention Center

Technology and Services

Friday, april 13, 20186:45 aM – 7:15 aM On-site Check-in and

Breakfast7:15 aM – 8:45 aM CME Symposium

CME Credit (Physician)This activity has been planned and implemented in accordance with the accreditation requirements and policies of theAccreditation Council for Continuing Medical Education (ACCME) through the joint providership of the Elsevier Office ofContinuing Medical Education and Miller Medical Communications, LLC. The Elsevier Office of Continuing MedicalEducation is accredited by the ACCME to provide continuing medical education for physicians.

The Elsevier Office of Continuing Medical Education designates this live activity for a maximum of 1.5 AMA PRA Category 1Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

P.A.C.E.® and NSGC credits are provided by ACMG.

Disclosure of Conflicts of InterestIt is the policy of the Elsevier Office of Continuing Medical Education that all faculty, instructors, and planners disclose anyreal or apparent conflict of interest (COI) relating to the topics of this educational activity. The faculty reported thefollowing financial relationships or relationships to products or devices they or their spouse/life partner have withcommercial interests related to the content of this CME activity:

Faculty Relationship Identified with: Quinn Stein, MS, CGC Has no relationships with commercial interests

Leslie Ciarleglio, MS, LCGC Has no relationships with commercial interests

Jessica M. Salamone, ScM, CGC Consultant/Advisor: Counsyl GeneticsSpeakers Bureau: Myriad Genetics

Non-facultyLyerka Miller, PhD; Sandy Breslow; Alison Kemp; and Bernard M. Abrams, MD, hereby state that neither they nor theirspouse/life partner have any financial relationships to products or devices with any commercial interests related to thecontent of this activity of any amount during the past 12 months.

Disclosure of Unlabeled UseThis educational activity may contain discussion of published and/or investigational uses of agents that are not indicatedby the FDA. The Elsevier Office of Continuing Medical Education; Miller Medical Communications, LLC; and Counsyl do notrecommend the use of any agent outside of the labeled indications.

DisclaimerParticipants have an implied responsibility to use the newly acquired information to enhance patient outcomes and theirown professional development. The information presented in this activity is not meant to serve as a guideline for patientmanagement. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in thisactivity should not be used by clinicians without evaluation of their patients’ conditions and possible contraindications ondangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations ofother authorities.

Method of ParticipationIn order to claim credit, participants must complete the following:1. Read the educational objectives, accreditation information, and faculty disclosures before this live activity.2. Attend this live symposium.3. Complete and return the evaluation form at the end of the symposium or complete the online evaluation form at

https://courses.elseviercme.com/gctechsympo18.

CME Inquiries/Special NeedsFor all CME inquiries or special needs, please contact [email protected].

Continuing Medical Education Information

©2018 Miller Medical Communications, LLC. 3020M April 2018

Assessing Efficiencies in Genetic Counseling: Current Landscape and

Novel Service Models (The Genesurance Story)

Quinn Stein, MS, CGC Program Director and Associate Professor

Augustana-Sanford Genetic Counseling Graduate Program Augustana University

Sioux Falls, South Dakota

Insurance Billing and the Genetic Testing Process

Patient Genetic

Counselor

Genetic Testing

Laboratory

Patient Insurance

Visits

Orders

Bills

Pays

Deductible Co-pays

OOP max

genesurance counseling [jeen-shoo r-uh nss] [koun-suh-ling]

That portion of a genetic counseling session, whether intentional or non-intentional, that is devoted to the topic of costs and insurance/3rd party coverage (particularly for genetic testing)

Brown S et al. J Genet Couns. 2017 December 4. [Epub ahead of print]

The Study and Demographics

Survey • 29 Questions

Targeted clinical GCs • Those who saw patients

on a regular basis

571 responses

Does genesurance counseling occur? 99% YES

Is genesurance counseling an important aspect?

Is genesurance counseling part of your genetic counseling job description, role, and responsibility?

85% YES

86% YES

Time Devoted to Genesurance

3 Years Ago 12% of a counseling session

8 minutes/session

4.5 hours/week outside of a session

Currently 8.5% of a counseling session

5.5 minutes/session

58% of respondents believed

their roles and responsibilities pertaining

to financial/insurance matters have changed

“Now with the patient financial plans some labs are offering, it takes some time to explain that they will get a

large bill but can reduce it. Additionally without prior authorization explaining the lab policy about calling over $x amount is time consuming. With the number of labs

offering similar tests, navigating which is the best for the patient while taking into account the financial aspect is a

bigger part of the session today”

“I'm seeing many more patients now and the complexity of options for testing has increased significantly. All

patients want to know if a panel test will cost more than limiting testing to one or two genes. There are also more labs competing for business, so I often explain to a patient that I am selecting a particular lab to use for their testing based on their insurance and whether or not they meet criteria, etc. I describe the lab's approach to billing, the

max OOP cost, etc. and explain the difference between an EOB and a bill.”

Different Specialties

571 Participants

Cancer Prenatal Pediatric Other

Genetic Specialties and Genesurance Counseling Beliefs

P = .0002

Patients’ Decisions

95% of respondents believed genesurance counseling

had some form of influence over a patient’s decision regarding testing

Quotes

“Insurance guides what lab we use, what test we order, who needs pre-authorizations, etc. Unfortunately, it is often not the

patient's medical and family history that is directing us towards a lab/test, but actually the details of their insurance plan.”

“Yes, we almost always delay send-off due to needing to check with insurance.”

genesurance counseling

Patient

Lab +

Billing

Genetic Counselor

3rd Party Payor

“I wasn't trained to address these questions. Maybe we can have more training on insurance and what it means

(the terms, approval, etc.).”

“It sometimes concerns me that no other medical providers discuss costs, so I'm not sure that GCs should be either. I'm not overly

concerned, but sometimes wonder about the liability associated with my providing ‘financial counseling’.”

Additional Thoughts From Participants

Wagner C et al. J Genet Couns. 2018 January 19. [Epub ahead of print]

Research Question

What do patients expect from genetic counselors in regard to the discussion of insurance coverage of

offered genetic tests or procedures during a genetic counseling session?

Methods and Analysis

38-item survey • Health Insurance Literacy Measurement • Inclusion criteria: 18 years or older, English-speaking

Completed prior to receiving prenatal or cancer genetic counseling at 11 approved sites • UTHealth and Baylor College of Medicine: Texas • Sanford Health: North Dakota, South Dakota, and

Minnesota

Statistical Analysis: Chi-square and Multivariate Logistic Regression

Response Demographics

365 total responses • 5 responses excluded because only

completed demographics

• 360 responses included in analysis

Demographics consistent with 2015 Census Data • Ethnicity • Type of Insurance (public vs private) • Native US Citizens

Prenatal 60%

Cancer 28%

Unsure 12%

Responses by Specialty

Prenatal Cancer Unsure

n=214 n=102 n=42

What Do You Expect From Your Genetic Counselor?

43.3

61

80.5

81.2

82.1

83

56.4

39

19.5

18.9

17.9

17

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Provide exact OOP

Know individual plan/coverage info

Discuss during GC apt

Provide contact info for additional ?'s

Know if test is covered benefit

Provide an estimate OOP

Yes No

28

86

97

131

131

142

185

0 20 40 60 80 100 120 140 160 180 200

Diagnostic Laboratory

Office Staff

Physician

Insurance Company

Billing representative

Self

Genetic Counselor

Number of Responses

Who Is Responsible for Discussing Insurance Topics?

Addressing Expectations in Practice

Providing OOP estimate (83%) • List prices • Billing support or online tools • Billing policies (ex: lab will contact patient if OOP is over a certain amount) • Self-pay prices

Knowing if a test is a covered benefit (82%) • National guidelines and professional statements

– (ex: NCCN guidelines, ACOG practice bulletins)

• Clinical judgment

Providing contact information for further questions (81%) • Insurance company contacts • Clinic staff and available resources

ACOG-The American College of Obstetricians and Gynecologists; NCCN=National Comprehensive Cancer Network.

Additional Strategies for Addressing Expectations

Visual Aids and Patient Educational Materials “Talk about it with everyone, visual aids & explanations are always helpful.”

Provide patients with CPT codes to contact insurance company

“Provide complete diagnosis testing codes [so] that I may contact my

insurance to confirm prices for testing.”

“Prompt [patients] to contact insurance company to check the genetic tests

recommended. Perhaps give a checklist of things for individuals to ask of their

insurance.”

Differences In Primary Care Providers

Patients expected insurance-related topics to be discussed in GC sessions more than in primary care provider visits

Possible contributing factors? • Lack of familiarity with genetic counseling

• Testing presented as an “option”

• Term “genetic testing” may generate anxiety

• Different expectations of specialty providers?

GC: 80%

PCP: 37%

Conclusions From This Particular Study

Patients want to have genesurance discussions • Patients have specific expectations

Patients believe genetic counselors are responsible for these discussions • Also feel a personal responsibility

Highlights opportunity: • Patient education (eg, professional societies, diagnostic laboratories, etc)

– Diagnostic laboratories: o Patient education: education materials, videos, online tools o Ordering providers: simplify the conversation (transparent billing policies, dedicated billing support

team, easily accessible information, etc)

• Conversation addressing efficiency and where/if these fall within the scope of practice of GCs

Genetic Counselors’ Knowledge, Confidence, and Practices With Insurance and Billing

for Genetic Testing

https://cloudfront.escholarship.org/dist/prd/content/qt4cn373kg/qt4cn373kg.pdf

Lead Investigator: Molly Lehman from University of California - Irvine

Purpose of the Study

Survey clinical genetic counselors to: • Characterize their interactions with health insurance • Characterize training received

– Compare training received to confidence and preparedness

Results

The average percent of a genetic counseling session spent discussing insurance:

14%

Average Hours Spent Managing Insurance

Per Week (n=225)

Total

n %

Less than 1 hour

1-5 hours

6-10 hours

10-15 hours

More than 15 hours

46

140

26

9

4

21%

63%

12%

4%

2%

Institutional vs. Direct Lab Billing

Total

n %

Use institutional billing, at least sometimes

NO

YES

Use direct lab billing, at least sometimes

NO

YES

126

26

37

189

56%

44%

16%

84%

About how many

hours per week would

you say you spend

managing insurance

or billing

(outside of a session)?

Do you use institutional billing? Do you bill through laboratories?

No Yes No Yes

n % n % n % n %

5 hrs or less

More than 5

109

16

58.9

41.0

76

23

41.1

59.0

28

8

15.1

20.5

157

31

84.9

79.5

p=0.04 p=0.4

Scenario

You order a microarray for a 5-year-old diagnosed with autism. You indicate on the test requisition form that the

laboratory should bill the insurance company on the patient’s behalf. You believe the test is medically

necessary and fulfills the insurance company’s policy for testing. However, the test is later denied by insurance.

Which of the following are you most likely to do next?

Options for Scenario

Do Nothing

Appeal the insurance company’s decision

Contact the insurance company for more information about why the test was denied

Contact the laboratory for more information about why the test was denied

Ask the patient’s caregiver to contact the insurance company for information about why the test was denied

Ask the patient to contact the laboratory for information about why the test was denied

Look for other testing options

Microarray Scenario (n=221) Total

n %

Do nothing

Appeal the insurance company’s decision

Contact the insurance company for more information

Contact the laboratory for more information

Ask the patient to contact the insurance company

Ask the patient to contact the laboratory

Look for alternative testing options

Other

1

75

54

60

6

2

5

18

0

34

24

27

3

1

2

8

Results for the Microarray Scenario

Majority of respondents who selected ‘pediatric’ as subspecialty reported next best step would be to appeal the insurance company’s decision (56%)

Those who did not specialize in pediatrics, said the next best step would be to contact the lab (42%). Only 10% of those in ‘pediatrics’ would consider contacting the lab itself as the next best step

Microarray Scenario Decision Making by Clinical Specialty

As a clinical genetic counselor, what

specialty (or specialties) of genetic counseling

are you currently practicing?

Microarray Scenario

Appeal the

insurance

company’s decision

Contact the insurance

company for more

information about

why the test was

denied

Contact the

laboratory for more

information about

why the test was

denied

n % n % n %

Pediatric

Not pediatric

28

44

56.0

33.3

17

33

34.0

25.0

5

55

10.0

41.7

p<0.001

Observed Differences in Pediatrics

94% of cancer genetic counselors report using laboratory billing

76% of pediatric counselors report using institutional billing

Table 10: Years of Practice as a Genetic Counselor and Graduate School Training

How many years total have

you been a practicing clinical

genetic counselor?

Did your genetic counseling Master’s program provide

any training specifically about billing or insurance?

Yes No

n % n %

< 2

2-5

5-10

Over 10

57

51

19

16

98.3

79.7

55.9

23.9

1

13

15

51

1.7

20.3

44.1

76.1

p<0.001

GENC 550: Genomics and Business

Health care professionals, including those in the field of medical genetics, have traditionally received an abundance of training regarding the clinical aspects of their field. The business side of medicine, however, is not often well understood. This course provides an introduction to many business and legal topics encountered by working genetic professionals, such as coding, billing, reimbursement, marketing, budgeting, public policy, business development, and working with the media

Current Trends in Genetic Counselor Workforce Training

More genetic counseling programs are opening up • 8 in the last 3 years • 4 more in accreditation-seeking process

Existing programs are increasing their class size • Number of overall training slots up substantially

Students are receiving more “business” training

ACHIEVING A HIGH-THROUGHPUT

EFFICIENT WORKFLOW:

Examples from Genetic Counseling

in Cancer

JESSICA M. SALAMONE, ScM, CGC

ADJUNCT PROFESSOR

ROCHESTER INSTITUTE OF TECHNOLOGY

DIRECTOR

GENETIC COUNSELING & CANCER RISK ASSESSMENT ELIZABETH WENDE BREAST CARE

ROCHESTER, NEW YORK

Elizabeth Wende Breast Care

Practice Setting

Internationally recognized as a leader in the field of breast

imaging and breast cancer diagnosis

One of the largest free-standing breast imaging centers in the United States

Largest single-site breast imaging center in New York State

Classified as a Breast Imaging Center of Excellence by the American College of Radiology

Embedded a “Cancer Risk Assessment & Genetic Counseling Office”

Initial High Risk Program

Began in ~2009–2010

MRI nurse and medical assistant ordered testing based on the radiologist’s recommendation

<10 patients were tested that first year and <50 were tested the second year

Majority of “high-risk” patients were instructed to follow

up with their PCP or GYN for further risk assessment

Initial Revision to the High Risk Program

Formal genetic counselor-led program began in 2011

~250 patients were counseled by a CGC the first year

All EWBC patients were actively screened via family and personal history at check-in

High Risk status was given within our EMR on the basis of points system

2 or more points generated a high risk (HR) letter, which was given to the patient and her physician

Initial Metrics for EWBC Patients

Daily Weekly Monthly Yearly

Patients Served

All Appointment Types 450 2250 8-9000 100,000

“High Risk” Patients 120 600 2,400 28,000

Initial Workflow

Screen

Evaluate

Diagnose

Manage

• Patient checks in for yearly appointment

• Completes or revises family history form

• Front desk enters patient responses

• Alert generated for high risk patients on the basis of points system

• Patient contacts genetics office to schedule appointment

• Genetic counseling session and blood draw

• Genetic counselor contacts patient ~3 weeks later regarding results

• Patient returns for follow-up counseling, if appropriate

• Management guidelines based on results and/or estimated lifetime risks provided

• Continued support for family members

Genetic Counseling

Family/Personal history 3-generation family history and review of personal history

Is it appropriate to test? Motivation for testing?

Overview of Genetics BRCA1/BRCA2 and, eventually, additional genes

Testing process and logistics Will insurance cover the testing? Who should be tested first?

Genetic Counseling

Associated cancer risks Cancer types and the possibility of a cancer syndrome

Medical management options Screening vs Surgery

Implications for family members Reproductive counseling

Psychosocial counseling

Impact on insurance Medical, Life, Long-term Care

Early Metrics for Genetics Patients


Patients Served


“High Risk” Patients 100-125 500 2000 24,000

“High Risk” Patients Counseled 4 20 80 960

Incredible Press With Incredible Impact

One Response:

Community Lecture Series

Offered ~6-8x per year; held in the EWBC lobby

“For additional information, please consider attending an upcoming

community lecture when our certified genetic counselor will discuss

the differences between genetic/familial and sporadic breast

cancer, EWBC’s protocol for genetic testing, insurance coverage

criteria and how testing may impact your future management.”

Approximately 35-40 attendees; ~2500 patients have attended

Staff available to answer questions and complete intake process

Simultaneously:

Testing Strategy Change

Spring 2014

Began offering a cancer panel approach

Benefits include: • Identify alternate genes with clinical implications

• More cost effective

• Decreased turnaround time

• BRCA mutations account for only a portion of hereditary cancers

Number of Appointments per Year

43

256

471

930 900

1270

1456

1625

2010 2011 2012 2013 2014 2015 2016 2017

Tota

l N

um

be

r o

f G

C

Ap

po

intm

en

ts

Total

Opportunistic Discussions

We have all the data for large-scale, whole patient population risk

assessment within our EMR

Patients note that conversations with staff propelled them to act

Biopsy results can dramatically impact risk assessment and often

change a patient’s perspective on genetic testing Negative (hyperplasia, atypia, radial scars) results can modify risk

Approximately 37% of all patients with a personal diagnosis of breast cancer meet NCCN guidelines for genetic testing

Purpose of Large-Scale Risk Assessment

To utilize available data to classify patients as: Eligible for MRI

Eligible for Genetic Counseling Eligible for both

To manage High Risk patients Long-term data collection of risk status and adherence to guidelines

Two Outcomes of Risk Assessment

The chances of developing breast cancer over a given

timespan or lifetime

The chances of a mutation in a BRCA gene

To assess breast cancer risks over time as accurately as possible, all known risk factors for breast cancer need to be assessed

Risk Assessment Thresholds

Eligible for MRI Lifetime risk for breast cancer >20%

Eligible for Genetic Counseling/Testing Risk for a mutation >5%

Or Personal/family history of breast cancer by age 45 years

Or Personal/family history of ovarian cancer at any age

Revised Workflow

Screen

Evaluate

Diagnose

Manage

• Patient checks in for yearly appointment • Completes or revises family history and personal history via patient portal

• CRA with Avairis completes a risk assessment

• Alert generated for high risk patients

• Both a lifetime risk for breast cancer and a mutation risk is visible

• High Risk Program staff can speak to patient after screening appointment

• Review eligibility for MRI and Genetic Counseling (same day appointments available) • All newly diagnosed patients meeting NCCN criteria are contacted for combination

MRI/Genetic Counseling visit • Patient can still contact Genetics office to schedule appointment

• Patient enrolled in High Risk program, if eligible

• Management guidelines based on results and/or estimated lifetime risks provided • Continued support for family members/ up-to-date information on specific genes, variants

CRA=Computing Research Association.

Current Metrics for Genetics Patients


Patients Served


“High Risk” Patients 100 400 1,600 19,000

“High Risk” Patients Counseled 7-8 35-40 140 1600

“High Risk” Patients who meet with

Medical Assistants to discuss risk during screening appointments

50 250 1000 10-12,000

EWBC Risk Assessment to Date

December 2016 – February 2018

109, 079 patients have completed the family history questionnaire

12.2% Eligible for MRI (Lifetime likelihood above 20%)

• 13, 282

9.8% Eligible for genetic testing (Mutation likelihood >5% or NCCN)

• 10, 673

Who Reviews Individual Risk Scores

With the Patient?

Screening Population “Stayers”: Genetics Staff conduct in-person discussion

“Leavers”: Letter, patient education video

Diagnostic Appointments Physician

Medical Assistant

Ultrasound Sonographers

Satellite Offices Letter, patient education video

Protocol to Assess/Confirm Eligibility

Screeners “Stayers”

• Genetics Staff reviews normal mammogram results

• Highlights breast density and availability of ultrasound

• 5-minute discussion related to risk assessment

• Provide patient appropriate materials

o Schedule genetic counseling appointment and/or enter into recall for MRI

• Identify errors and update information, as appropriate

Proactive Protocol:

Recently Diagnosed Patients

Core Log reviewed daily to identify those patients meeting NCCN guidelines

Patients called via phone to offer genetic counseling on same day as

extent of disease MRI

39% of patients from our positive Core Log qualified for genetic testing in 2015-2017

~70% of those qualifying for genetic testing opted to pursue analysis

• 12%-13% were found to carry a genetic mutation

• 29% were found to carry a variant of uncertain significance

Proactive Protocol:

Unaffected Patients With Recent Biopsies

Core Log reviewed daily for patients who do NOT have cancer,

but meet criteria for MRI and/or genetic testing

Notified via letter of appropriate risk category Negative, but meets criteria for continued, screening MRI

Negative, but meets criteria for genetic testing

Atypical, and meets criteria for continued, screening MRI

Atypical, and meets criteria for genetic testing

• Some atypias are upgraded to cancer at surgical excision and we proactively reach

out to those patients via phone

Benefits

Front-line Genetics

Enable the development of a patient-specific, real-time medical management plan

Target increased surveillance and other interventions specifically to individuals with a known mutation or to those with a qualifying lifetime risk

Significantly improve outcomes and reduce medical costs through earlier diagnosis and treatment of cancer

Avoid unnecessary interventions for family members who do not test positive for the known familial mutation

Discussions with trusted medical team rather than referral to a specialist

Challenges

Large number of patients

Constantly need to change and re-evaluate the workflow

Community/Referring physician education

Staffing needs and training

Incorporating technology changes BRCA, only to panel testing

Obtaining outside records Genetic testing, biopsy results, surgical pathology reports

Patient inaccuracies in reporting both personal and family history

Incidental findings on panels We are a breast imaging center

Challenges: Variants

21.5% of our patients have 1 or more Variants of Uncertain Clinical Significance

Reclassification efforts and amended reports to patients and their physicians generated

Devoted Medical Assistant who reviews amended reports

Practical Considerations From Prenatal Counseling

Leslie Ciarleglio, MS, LCGC

Genetic Counselor, Maternal Fetal Medicine Hartford Healthcare

Hartford, Connecticut

PARTNERSHIPS ◦ Referring providers

◦ Clinic staff

◦ Laboratory

◦ Patient

Sequenom/MaterniT21: Launch 2011

Integrated Genetics Harmony

Verinata Verifi

Natera Panorama

Quest QNatal

Counsyl Informed Pregnancy Screen/Prelude

Sequenom VisibiliT

Ariosa Harmony

Sequenom MaterniT GENOME

Insurance on board NIPT=noninvasive prenatal genetic testing.

0200400600800

100012001400

2012 2013 2014 2015 2016 2017 2018

est

Cell-Free DNA Samples

Cell-Free DNA Samples

Scheduling

Insurance pre-auth

Pre-test counseling

Inventory

Requisitions

Tracking of results

Informing patient

Post-test counseling

Insurance appeals

CELL-FREE DNA TESTING

HIGH RISK PATIENT:

1. AMA

2. Abnormal serum screen

result

3. Abnormal ultrasound

4. Previous affected

pregnancy/child or parent

with a translocation

LOW RISK PATIENT

INSURANCE:

Anthem PPO

Bluecare HMO

INSURANCE:

Medicaid

No insurance

INSURANCE:

Any other insurance

INSURANCE:

AETNA

Anthem PPO

Bluecare HMO

Cigna

Connecticare

Medicaid/Husky

Oxford

United HealthCare

COUNSYL

Price estimator available

Online order available

Email prompts to patients with billing

info and also results

Phlebotomy agreements

COUNSYL

$349.00 Direct bill

Does not go through insurance


ARIOSA

$130.00 direct bill

does not go through insurance

No phlebotomy agreements

SEQUENOM

Price estimator available

Complete req online and PRINT

Once rejected by insurance (for low

risk status), pt will be billed; then pt

contact Sequenom for $200.00 total


SEQUENOM

BILLING FOR LOW

RISK PATIENTS:

Sequenom submits

claim to insurance

Claim rejected due to

low risk

Sequenom bills patient

for full amount of test

Patient contacts

Sequenom directly to

reduce cost to $200.00

High Risk

patients

who do

not want

to go

through

insurance

PREFERRED NIPT COMPANIES BY INSURANCE

INSURER NIPT LAB NOTES

AETNA

Counsyl Sequenom Illumina Quest Diagnostics

ANTHEM PPO Counsyl Illumina Quest Diagnostics

BLUECARE HMO Quest Diagnostics No preauthorization needed

CIGNA

Counsyl Sequenom Illumina Quest Diagnostics

CIGNA requires preauthorization, however Counsyl and Sequenom will do that for us. If using Illumina or Quest Diagnostics, we need to request preauthorization.

CONNECTICARE Counsyl Illumina Quest Diagnostics

Counsyl and Illumina take care of preauthorization

CT MEDICAID Sequenom N

OXFORD/UNITED HEALTHCARE Counsyl Illumina

Notes:

Counsyl has a system for patients to get estimated of out of pocket expense for NIPT: www.counsyl.com/price

Once Counsyl receives a sample, if the estimated out of pocket cost for a patient exceeds $200, Counsyl will contact the patient directly

to confirm they want to go forward with testing.

Clinical Lab Partners:

We can send a patient for blood draw for NIPT at CLP if they have a completed Sequenom test requisition and Sequenom collection kit.

We can send a patient for blood draw for NIPT at CLP if they have a completed Counsyl test requisition and Counsyl collection kit.

Quest Diagnostics:

We can send a patient for blood draw for NIPT at Quest Diagnostics if they have a completed Quest Diagnostics test requisition. No

collection kit needed.

Appropriate referrals

Pre-test information

Scheduling

http://www.hartfordhealthcaremedicalgroup.org/index.php


Scheduling

Check in – MAAs give patient tracking form

Ultrasonographers – collect medical data

Paperwork/online test requisitions

Phlebotomy

Packaging/Federal Express

Ordering supplies/inventory

Informational resource ◦ Laboratory genetic counselors

◦ Concierge service ◦ Laboratory representative

Online ordering

Partnerships with other phlebotomy resources ◦ Option to have blood collected

outside of clinic

Price estimator

Communication with patients ◦ Out-of-pocket cost ◦ Option for self-pay ◦ Results, including fetal sex

Outcome data


Sharing in the responsibility for her care ◦ Packet

◦ Email/text message

Set up account with laboratory

Respond to prompts

Billing/insurance

Test results

◦ Post-test information sheet

Review referral ◦ Scheduled appropriately ◦ Documentation received

Available to patient at time of appointment

Review all results ◦ NORMAL results

Contact patient if requested

◦ ABNORMAL results

Notify patient Notify referring provider Coordinate follow-up

Resource to PARTNERS

Laboratory representative

Team meetings and in-services

Pre-test and post-test information sheets

Re-evaluate and

EVOLVE

Scalability of Informed Consent for a Precision Screening Microarray on

Healthy Adults

Quinn Stein, MS, CGC Program Director and Associate Professor

Augustana-Sanford Genetic Counseling Graduate Program Augustana University

Sioux Falls, South Dakota

Our Online Secure Consent is Led by Primary Care Physicians Working Hand-in-Hand With Genetic Professionals

Short Videos Are Accompanied by a Narrator

Terms Are Highlighted So They Can Be “Clicked On” for More Information

If someone does have a question, and slides the bar to the left, he or she is given the option to highlight the Section(s) he or she would like to review with a genetic counselor

OR… If the person understands, he or she slides the bar to the right and moves to the next Section

Sample Text to Accompany Videos. Audio, Audiovisual, and Written Communication Are All Employed

Genetic Counselors and Geneticists Are Available on the Front End, the Back End, and Throughout

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