Lab Institute 2016 Highlights:
Convergence, Compliance and Genetics

Attendees at G2 Intelligence's 34th annual Lab Institute were treated to a history lesson about diagnostics as well as forward-looking discussions that illuminated the current state and the future of the laboratory industry and clinical diagnostics.

Kristin Pothier, EY's Global Head of Life Sciences, Transaction Advisory Services

Convergence with Life Sciences, Patients
Opening keynote speaker, Kristin Pothier, EY's Global Head of Life Sciences, Transaction Advisory Services, highlighted key areas of life sciences that are driving convergence among various previously independent sectors within the health care marketplace: pharmaceutical research and development, precision medicine and patient information. Pothier's presentation demonstrated how new technologies and business models, precision medicine and the increasing prevalence of companion diagnostics are highlighting the value of diagnostics and driving alliances and acquisitions involving in-vitro diagnostics companies. Big data and increased access to patient information, mobile technology and rising consumerism are also revolutionizing patient care, according to Pothier.

Dr. Gregory Henderson, president of BioReference Laboratories

In his keynote addressing the state of the laboratory industry, Dr. Gregory Henderson, president of BioReference Laboratories, discussed a convergence of a different kind—the convergence of diagnostics and healthcare providers with patients and their data. He emphasized the importance of the patient and patient access to data in an increasingly mobile and data-intense age. Henderson discussed the lab industry's need to educate and involve patients in the health care delivery process—providing "actionable medical knowledge" and explaining for patients the data generated in health care. He discussed this challenge in the context of the diagnostic industry's history. He began his presentation highlighting the differing viewpoints of chemists and vitalists about the need for lab testing to assist diagnosis roughly 200 years ago to gain perspective on the industry's current challenges. He concluded that labs must confront similar challenges faced those many years ago to demonstrate the value of diagnostic testing and manage utilization.

Compliance Issues Permeate Discussions Throughout Lab Institute
During three days of presentations, compliance issues for laboratories and pathologists permeated most of the discussions. Beginning with a workshop on workforce issues, speakers addressed compliance risks that can arise in recruiting, hiring, managing and terminating members of the workforce. Panel discussions prepared laboratories for the compliance challenges they'll face with new payment methodologies and regulation and oversight of new technologies such as next generation sequencing, laboratory developed testing and direct-to-consumer testing. Throughout the conference, concurrent and general sessions addressed compliance issues relating to reimbursement, managing data generated by diagnostics, and ensuring patient access to test results.

Health care attorney Karen Lovitch (left) and Kelly A Hardy,
Editorial Director, Plain Language Media

Health care attorney Karen Lovitch capped off a morning of general sessions addressing regulatory, reimbursement and policy issues by highlighting three key compliance hotspots for labs to watch out for—medical necessity, arrangements with physicians, and increasing coverage restrictions. Within those key issues, she also discussed increased individual accountability under the Yates memo, private payer enforcement, waiver of copayment amounts and surprise medical bill legislation that addresses patient bills for out-of-network services.

Lovitch was only one of several speakers to address the challenges raised by surprise medical bill legislation. This legislation protects patients from unexpected bills from out-of-network providers after they sought services from an in-network facility. New York and California both have passed such legislation within the last two years. Lovitch and other speakers cautioned labs to make sure they understand state laws and reimbursement policies that govern such out-of-network billing.

Continuing Rise of Genetic Testing
Increasing diagnostic options for providers and patients was a common theme throughout the conference. Speakers noted that more opportunities also require more education and better resources to help providers and patients understand their options, select the most appropriate diagnostics, and properly manage utilization.

Keynote speaker Mara Aspinall, chief executive officer of Health Catalysts and Executive Chairman of GenePeeks, said diagnostics will change with the rising importance of genetic testing. She explained that identification of genetic mutations rather than site of a tumor will drive cancer treatment in the future. The future of diagnostics, Aspinall predicted, will involve algorithms and integrated data gathered from multiple sources—in short, "an information business with a wet lab on the side."

Gillian Hooker, VP Clinical Development, NextGxDx

The final presentation, by Gillian Hooker, vice president of clinical development at NextGxDx, similarly addressed the explosion in the genetic testing market with tens of thousands of tests currently on the market and new genetic tests being introduced every day. NextGxDx research indicates there are more than 65,000 genetic testing products on the market compared to less than 13,000 just three years ago. Hooker addressed challenges providers face in identifying the right test and a need for standardization in terminology not only to simplify ordering but to facilitate coding and reimbursement as well.

Takeaway: Industry leaders indicate the future of diagnostics is patient- and data-focused yet brings familiar compliance and business challenges.