Reimbursement remains a major challenge to the widespread adoption of genomics in the clinical setting. Significant challenges remain in establishing payment for diagnostic tests that reflect the value of care, making it difficult for payers to set rates. Some of these associated issues include that those payers are challenged with understanding why a specific test is ordered and that there are only about 200 billing codes associated with 70,000 tests.

We had a chance to talk to some key stakeholders across the industry – Philip Febbo (SVP & Chief Medical Officer at Illumina), Aleks Rajkovic (Chief Genomics Officer at UCSF), and John J. Sninsky (Consultant at Translational Sciences) to discuss the challenges of reimbursement and the value they see in clinical genomics applications. (See full interviews on our blog.)

Following are some key discussion points.

Aleks Rajkovic (UCSF) – “Successful Genomics Programs from Research to Clinical” Track 3 Chair
“Delivery of clinical genetic testing services, although not profitable, is critical across the spectrum of specialties since almost all specialties are now using genetic testing and ideally require local genetic expertise.”

“Clinical genetic testing within a health system overall is not profitable. The primary reason being poor reimbursement and undersourced billing and authorization services at medical centers,” Rajkovic mentioned. “As a result, some health systems have decided to outsource genetic testing. Clinical geneticists see complex patients that require a significant amount of time and they are poorly reimbursed. Genetic counselors themselves are not profitable because they cannot bill Medicare and require significant time with their patients as well as potentially affected family members.”

Phil Febbo (Illumina) – PMWC 2020 Session Chair
“Reimbursement will only be prioritized if testing improves patient outcomes without adding excessive financial burden to the patient or the system.”

“Health care systems across the globe are economically strained and administrators have the unenviable position of having to allocate already constrained resources across a broad range of rapidly changing and inspirational medical advances,” Febbo pointed out. “Thus, the major challenges to reimbursement are the availability of evidence that link testing to improved outcomes, and clear linkage between the modest incremental cost of the test and the resulting benefits to the system due to the improved outcomes.”

“To address the evidence gap, the healthcare industry has to establish a diagnostic-based evidentiary framework of utility.”

“Currently, most evidentiary frameworks used during health technology assessment are modeled after drugs with randomized controlled trials representing the highest level of evidence while “observational” studies have often been relegated to studies of poor quality,” Febbo said. “We need the development of a utility framework that still allows for and rewards investments in randomized controlled trials but recognizes there are also very high quality studies that can be performed through retrospective analyses and real world data. Consistent evaluation of evidence with such frameworks will better allow diagnostic companies to de-risk investment in the appropriate studies. Second, we need to ensure health systems are incentivized to improve the quality of care and not the quantity.”

John J. Sninsky (Translational Science Inc.) – “Navigating the Challenges of Reimbursement” Session Chair
“We owe it to patients to reimburse tests that have demonstrated rather than inferred performance.”

“The estimated cost to develop a diagnostic not linked to a medicine from a company with an existing infrastructure is approximately $65M not including commercial launch costs. That magnitude of investment requires and merits a transparent path to reimbursement at the value the diagnostic brings to the targeted clinical utility rather than simply the cost to literally perform the test,” Sninsky said. “Payors should recognize and support first-in-class tests. If medicines have exclusivity to protect investment of innovation shouldn’t diagnostics be protected the same way?”

The scarcity of evidence for the clinical utility of genomic testing as well as the resultant lack of alignment of reimbursement methods to drive transformational change in healthcare, remains a principal barrier to implementation. Since we do not have the evidence for utility for many of the testing approaches, pooling data to accelerate knowledge should be a consideration.

PMWC 2020 Silicon Valley is the right forum to discuss solutions for genomic testing reimbursement and to understanding the latest clinical genomics achievements which have resulted in increased survival and improved quality of life for patients. Benefit from this relevant discussion by securing your seat at the table today. And take advantage of the series of sessions that address the reimbursement aspects including:

• Regulatory & Reimbursement Risk/Reward In Clinical CDx – chaired by Hannah Murphy (Coalition for 21st Century Medicine) focusing on the rapidly evolving regulatory and reimbursement landscape and the impact of new FDA and CMS policies on investor/company approaches to manage companion diagnostic development risk.
– Sheila Walcoff, Goldbug Strategies
– Pamela Bradley, Adaptive Biotech
– Tina Hambuch, Invitae

• Navigating the Challenges of Reimbursement – chaired by John J. Sninsky (Translational Sciences) discussing how convincing payers of the medical necessity of a new diagnostic test is a challenge. Providing timely access for patients with the most compelling unmet needs requires the reimbursement environment to transition to a transparent value-based model using fit-for-purpose levels of evidence.
– Bruce Quinn, Bruce Quinn Associates
– Steve Anderson, LabCorp
– Gabriel A Bien-Willner, Palmetto GBA
– Susan Xu, Association of American Medical Colleges

With the above in mind, we recognize that considerable debate exists as to whether reimbursement is the most pressing challenge, or whether it’s an organization’s culture and leadership being open enough to embrace the disruptive approach of clinical genomics/precision medicine. Therefore we have lined up the following sessions for your consideration:

• Successful Clinical Genomics Program – chaired by Clara Lajonchere (UCLA Institute for Precision health) discussing why population sequencing of healthy individuals has enormous value for preventive care.
– Steven Smith, Advent Health
– Anthony D. Slonim, Renown Health
– Debra G.B. Leonard, Vermont Health Network
– Euan Ashley, Stanford

• Adoption of Clinical Profiling in the Clinical Setting – chaired by Chris Cournoyer (QIAGEN) – a panel with leaders representing diverse medical organizations discussing their approaches and strategies to implementing molecular profiling to meet their internal patient and organizational goals.
– Elad Sharon, NCI
– Cassie Hajek, Sanford Imagenetics
– Peter Hulick, NorthShore U. HealthSystem

• Unique Population Study Collaborations – chaired by Aleks Rajkovic (UCSF Health) providing an update on several collaborative population studies that illustrate opportunities and resulting benefits for each partner.
– Jennifer Low, 23andMe
– Lincoln Nadauld, Intermountain Healthcare
– Olena Morozova Vaske, UC Santa Cruz

• Implementing Precision Medicine in Community Hospitals – chaired by Michael Pellini (Section 32) features community hospital representatives who will discuss their institution’s experience and challenges in implementing precision medicine programs.
– Adrian V. Lee, University of Pittsburg & UPMC
– Costanzo Di Perna, Dignity Health
– Terry Wooten, St. Joseph Health

• Creating A Sustainable Genomic Testing Service Within A Healthcare System That Improves Outcomes – chaired by Phil Febbo (Illumina)
– Lee Newcomer (Newcomer Consulting)
– Anthony Gregg (Baylor University Medical Center)

Don’t miss this outstanding opportunity to engage with thought leaders and decision-makers across these disciplines of Precision Medicine and Clinical Genomic Testing – sign up today!