1. Advantages in Developing a MDx Lab
RCM Enterprise Services
Mark Droste

2. Brief History
For decades Genetic testing was associated with Universities, and Reference Labs focused on rapid DNA sequencing.
DNA sequencing provided the groundwork for the molecular diagnostics market that focuses on Personalized Medicine
Sequencing has evolved to be incredibility useful by providing an optimal approach in the areas of preventive and therapeutic patient care.

3. Genetic Testing Genetics
Genetic testing analyzes the individual’s genetic characteristics….these are the traits you inherit from your parents.
The chromosomes act as carriers of the genetic material. Abnormalities in the chromosomes number or structure and can result in disease:
Cystic Fibrosis
Sickle Cell Anemia
Huntington's Disease
Down syndrome

4. Types of Genetic Testing
Reproductive (NIPT)
Noninvasive Prenatal Testing
Infectious Disease
Facilitates determining the susceptibility to particular microbes and the course of infection.
Oncology
Cancer is a genetic disease caused by changes in genes that control the way our cells function
Pharmacogenomics
The study of how genes affect a person's response to drugs

5. Molecular in Facilities
Type of Facility

6. Influences Driving Molecular Development
Reimbursement Resolution
Development and success of the molecular diagnostics market will require:
A focused effort in the resolution of reimbursement issues
Acceptable descriptive CPT codes

7. Influences Driving Molecular Development
Clear FDA Guidance
Ongoing guidance from the Food and Drug Administration (FDA) regarding definitions for:
Research Use Only
Laboratory Developed Tests
Analyze Specific Reagents

8. Influences Driving Molecular Development
 Pharmacogenomics
 Ongoing interaction between pharmaceutical companies and molecular diagnostics manufacturers is key to developing new assays.
This communication will aid in determining whether a given patient qualifies for a particular drug.   

9. Influences Driving Molecular Development
Point-of-Care Testing
Continued incremental improvements in the molecular diagnostics devices used for point-of-care testing shortens the result wait times.
End result
A clinically useful result in minutes to several hours instead of…. half a day or 24 hours. 

10. Who Needs Molecular Diagnostics?
Cancer clinics
NICU
Children Hospitals
Pharmacogenomics
Hospitals

11. Technology is Driving the Molecular Industry
Advantages in Adoption of MDx
Molecular diagnostics has progressed the last 15 years. No longer restricted to academic or reference laboratory settings.
Organization embracing molecular are enjoying:
Fast turnaround times
Improved sensitivities
Increased accuracy
Costs savings from not sending out samples

12. Technology is Driving the Molecular Industry
Disadvantages of not Adopting MDx
Organizations who have not adapted due to the challenges and expense of opening a molecular lab are not on an equal footing in the marketplace.
These new techniques have significantly improved the detection of:
Genetic disorders
Multiple viral and bacterial infections

13. Why Perform Molecular Testing In-House?
Accessibility
With recent improvements in the industry, developing a molecular lab is much more straightforward than it previously was in the past.
Improvements in instrumentation
Simplified testing profiles
Automated testing platforms driving quality results
Streamlined workflow focused on creating efficiencies

14. Why Perform Molecular Testing In-House?
Clinical Demand
Healthcare continues to drive efficiency incorporating standards of care for specific diseases.
Vendors in the laboratory market are looking to fill this need with increased automation and molecular diagnostics to improve lab productivity.
This improvement includes automated, user-friendly techniques, combined with enhanced sample preparation, analysis, and data evaluation rolled into one.

15. Why Perform Molecular Testing In-House?
Cost-effective
The annual reference laboratory budget will increase up to 15% with MDx testing with increased demand. Combined with 2 to 4 day turnaround time is not in the best interest of patient care.
Expedited results are required in order to provide exceptional patient care:
VZV infections in pediatrics
MRSA screening prior to a surgical procedure
CMV quantification in transplant patients

16. Why Perform Molecular Testing In-House?
Faster diagnostic process
The molecular lab of today can prosper from:
Expedited techniques that diagnose disease conditions and medical disorders quickly
A reliable tool for rapid therapy decisions
Accurate expeditious results can lead to improved treatment of patient care and lead to a decreased length of hospital stays

17. Why Perform Molecular Testing In-House?
Managing your data
Genome sequencing produces thousands of variants however a relatively minuscule percentage of those are of any diagnostic value.
A scalable in-house system needs to provide a smart workflow methodology of filtering, identifying variants, collecting the sequencing and presenting the generated data in an organized approach

18. Potential Revenue Reimbursement
Cost per test
Genetic testing costs range from: $100 to more than $2,000
Nature and complexity of the test will dictate price.
The cost increases if:
More than one test is necessary
If multiple family members are required
Note: newborn screening, costs vary by state

19. Molecular Billing & Reimbursement
Revenue Cycle Complexity
Genetics represents a rapidly growing field for laboratories. This growth brings significant challenges for:
Preauthorization
Molecular coding
Billing
Denial Follow-up
Reimbursement

20. Molecular Billing & Reimbursement
Revenue Cycle Complexity CMS reviews yearly which genes are tested the most and rewrites CPT codes to address the top gene tests. Along with frequent coding changes, some codes may cover up to 10 genes. To ensure proper payments for services rendered it is imperative for laboratories to stay on top of the sometimes daily coding and billing updates that come from CMS and commercial insurance carriers.

21. Before starting a Molecular Lab….
Market Analysis
Before starting a Molecular Lab….
Know your Market
Before embarking on opening a molecular lab, you should generate some critical questions:
Does my community need a molecular lab?
Which tests does my patient population need most?
How can we be profitable?
Who is our competition?

22. Market Analysis Before starting a Molecular Lab…. Conduct a Survey
An excellent method to assess market requirements is to interview the potential clients that would benefit from a molecular lab.
Recommendation: conduct interviews with a selective sampling of administrators, directors, lab managers, tech support, and clinicians.

23. Molecular Billing & Reimbursement
Before starting a Molecular Lab….
Perform a S.W.O.T Analysis
Strength
Weaknesses
Opportunities
Threats
A recommended method is to itemize on paper and to see what you have going for your organization and what challenges are in your market space

24. Molecular Billing & Reimbursement
Before starting a Molecular Lab….
Access and Reports
A comprehensive market assessment should aid in understanding the opportunities, revenue potential, and your ability to make it happen.
This method should act as a preliminary proposal that will assist in determining whether the project moves forward or not based on the assessment.

25. Pulling It All Together
Hospital labs looking to start or scale an MDx program must begin by establishing these three critical components of laboratory informatics:
A LIMS designed to handle the complexity of molecular testing
An intuitive, expanding knowledge base for rapid filtration and annotation of relevant variants
Straightforward, accessible reporting to translate results into clear, clinically actionable information

26. Pulling It All Together
How do you make your case to key stakeholders?
Making a case for critical stakeholders
Establish a steering committee
Write a business plan
Create a Presentation
Create an ROI
Quoting the lyrics of an 80’ band
“Should I stay or should I go now”…when it comes to pulling the trigger on MDx testing