Understanding the new landscape of diagnostic market access
Her entire professional career, Camille Grubbs has been in women’s health. For the past 13 years, she’s held various roles at Hologic, an innovative medical technology company designing and developing groundbreaking products that advance women’s health and well-being.
Camille has done everything from sales to market access for Hologic, focusing on medical policy, health policy, and reimbursement across the entire company. She has broken barriers in the industry and played a significant role in securing coverage for 3D mammography. Over 95% of women now have access to 3D mammography through their insurance and don’t have to pay out of pocket.
She currently leads the diagnostic market access team and is responsible for identifying relevant opportunities and challenges related to M&A, leading the strategy for payment policy within product development, and defending coverage and payment for the entire portfolio.
We’re thrilled to have Camille join us for our virtual panel discussion on May 25th, the Future of Market Access. But first, she was kind enough to sit down with us and answer some pre-panel questions about the diagnostics industry, the market access team, and the role T&Co has played in helping Hologic. Let’s dive right in!
What are some trends impacting the diagnostic industry and where do you see it heading?
Camille: There are numerous things impacting the industry today such as an increased focus on point of care and at-home testing; genetic testing; companion diagnostics; the advancement of next-generation sequencing testing; integrating artificial intelligence into diagnostic testing through lab optimization; and imaging systems and the impact of telehealth expansion. We are also seeing more regulatory frameworks emerge in Europe and the U.S. Just this week, we’ve seen movement in the Senate on the VALID Act, which seeks to improve the regulation of diagnostic tests.
At Hologic, we’re focused on preventive screenings for cervical cancer, breast cancer, and osteoporosis. The rate at which patients are accessing cancer screening has been decreasing. A lot of that can be attributed to the fact that we’re over two years into the pandemic. Many people might not realize that their last screenings were two and a half to three years ago.
With respect to cervical cancer screening, specifically, about 10 women die of cervical cancer every day. We’re seeing cervical cancer on the rise as many women haven’t gotten back to regular screenings. The total number of cervical cancer screenings through the CDC’s National Breast and Cervical Cancer Early Detection Program declined by 84% in April 2022 from the historical five-year averages.
We’ve seen the numbers rebound, but when we looked at June 2020—the period when things were starting to normalize—the rate remained at 40% below the five-year averages for that month. This is very concerning.
Do you see any key differences in market access in the diagnostic space?
Camille: At its highest level, market access is generally the same thing across the medical industry. You’re trying to ensure that patients have access to your tests at the right time, and in the right setting of care. Market access ensures that patients, who are appropriate for a particular test or procedure, don’t face barriers. That said, there are significant differences when you compare the medical device industry to the diagnostic industry.
The most notable and obvious difference is the Medicare payment system. Within the medical device world, payment is typically made through the Physician Fee Schedule (PFS) or the Hospital Outpatient Prospective Payment System (OPPS). Within those fee schedules, there’s a lot of focus on quality metrics and payment tied to clinical performance.
We operate off the Clinical Laboratory Fee Schedule (CLFS) in the diagnostic world. Within the CLFS, you don’t see the same connection to quality metrics or payment tied to performance. There’s also a different methodology used when assigning payment rates for the CLFS. Medicare reimbursement on the CLFS is done through a multi-year extensive commercial payer reporting program under PAMA.
Another notable difference is the Current Procedural Terminology (CPT) coding process, timelines, and stakeholders.
How do you think the role of the market access team will evolve in the future?
Camille: Market access is a critical function: it’s where the rubber meets the road. Studies have shown a well-thought-out market access plan that’s developed at product conception can lead to 20% higher revenue.
The cost of healthcare has been a debate in the U.S. for decades. We’ve seen a tremendous amount of growth in the medical device and diagnostic space with significant medical, scientific, and technological advancements. With all these advancements, payers have raised the bar on their evidentiary requirements to cover procedures and tests, and it is becoming harder and harder to meet those requirements. It’s critical that you have this perspective in the early days of product development. Imagine leaving marketing, clinical, regulatory, or research and development out of that planning process. Leaving market access out is no different.
What role do market access teams play in driving shareholder value?
Camille: It’s huge. As I mentioned before, the goal of market access is to ensure that the right patient gets the right test and is done in the right setting of care. In order to make that happen, you must have clinical and economic data demonstrating clinical validity, analytical validity, and clinical utility of the test. Market access teams can provide critical insight during the product development process to ensure that the appropriate evidence is being built before the product is commercialized.
Oftentimes, you see companies forget that market access is a critical factor, and they face significant headwinds with coding, coverage, and payment before or after the product is launched. That’s time that you can’t get back.
What was T&Co’s role in helping the team overcome some of the challenges that you were facing in the market access space?
Camille: Hologic is a $5B company with a lot of different products, a handful of acquisitions, and numerous products in the pipeline. There are a lot of moving pieces.
T&Co has helped my team filter through all our projects and create a strategic plan that’s well thought out and focused.
They’ve also helped us with communication and the creation of resources to ensure that we’re getting the right information to the right internal stakeholders.
I really feel like they were an extension of my team—their commitment to quality is unparalleled.
What were some of the tools that T&Co developed for your team to get payers down the pipeline?
Camille: They have helped us with several tools, but the most impactful was identifying a tracking and reporting mechanism for payer coverage. We needed a system that was cloud-based, reliable, and easy to use. Cutting down on redundant reports and ever-changing analytics was also a critical need.
We evaluated several options and landed with Smartsheet. The T&Co team helped us to learn the system and create meaningful trackers and dashboards that allow us to keep records in an organized fashion and report out critical analytics to leadership.
What was the feedback from your team bringing T&Co in?
Camille: The feedback has been excellent. We’re better organized and have tools with the right level of detail that are easy and digestible to use. There’s a thoughtful strategy behind what we’re doing with our data and analytics.
With the tools and resources that we have because of our work with T&Co, we’re able to focus on key priorities. And the team is seeing results.
Why did you choose T&Co over the competition?
Camille: T&Co isn’t your typical consulting firm; they act as an extension of our team. They do a great job of integrating themselves, listening, and understanding what you need without having all the pieces to that puzzle.
They do a fantastic job of keeping you up to date on where they are in the process. I’ve worked with other firms on projects where you are not informed of the project’s progression. With T&Co, you always get a readout and a nice packet of resources. It makes a big difference.
 Hologic, data on file.
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 Suran M. Why US Cervical Cancer Survival Rates Haven’t Improved for Decades. JAMA. Published online May 04, 2022. doi:10.1001/jama.2022.4681