Understanding the New Landscape of Diagnostic Market Access

calendar iconMay 23, 2022

Hologic is an innovative medical technology company that designs and develops groundbreaking products that advance women’s health and well-being. Camille Grubbs has worked in women’s health for 13 years and 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.[1] Camille currently leads Hologic’s 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.

Trends Impacting the Diagnostic Industry

According to 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. More regulatory frameworks have been emerging in Europe and the U.S., and just this week, there has been movement in the Senate on the VALID Act, which seeks to improve the regulation of diagnostic tests.

At Hologic, the focus is on preventive screenings for cervical cancer, breast cancer and osteoporosis. A big trend they’ve seen is the rate at which patients are accessing cancer screening, which has been decreasing. Camille attributes a lot of that to 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.[2]

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.[3]

Key Differences in Market Access in the Diagnostic Space

At its highest level, market access is generally the same across the medical industry by trying to ensure that patients have access to tests at the right time and in the right care setting. 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 comparing 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.

Hologic operates off the Clinical Laboratory Fee Schedule (CLFS) in the diagnostic world. Within the CLFS, there isn’t 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.

The Evolving Role of the Market Access Team

Market access is a critical function. It’s where the rubber meets the road. Camille points out that studies have shown that a well-thought-out market access plan developed at product conception can lead to 20% higher revenue.

The cost of healthcare has been a debate in the U.S. for decades. There has been 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 to 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.

Market Access Teams Driving Shareholder Value

Camille discusses that the goal of market access is to ensure that the right patient gets the right test and in the right care setting. 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, 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 they can’t get back.

How Did T&Co by Cherry Bekaert Help?

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 by Cherry Bekaert helped filter through their projects and create a strategic plan that was well thought out and focused.

Our Strategic Growth & Innovation (SG&I) team also helped Hologic with communication and the creation of resources to ensure that they are 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.” – Camille Grubbs

Develop the Right Tools for Your Team

T&Co by Cherry Bekaert helped Hologic develop several tools. Camille stated that the most impactful was identifying a tracking and reporting mechanism for payer coverage. They 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. The T&Co by Cherry Bekaert team evaluated several options and landed with Smartsheet, then helped Hologic to learn the system and create meaningful trackers and dashboards that allow them to keep records organized and report critical analytics to leadership.

After working with T&Co by Cherry Bekaert, Camille says her team is better organized and has tools with the right level of detail that are easy and digestible to use. There’s a thoughtful strategy behind what they are doing with data and analytics. Hologic is able to focus on key priorities, and the team is seeing results.

Why T&Co by Cherry Bekaert?

Our experienced Strategic Growth & Innovation team acts as an extension of your team. They integrate themselves, listen, and understand what your company needs without having all the pieces to the puzzle. Our team keeps you up to date on process, delivering a packet of resources. Let us be your guide forward.

[1] Hologic, data on file.

[2] A. DeGroff, J. Miller, K. Sharma, J. Sun, W. Helsel, W. Kammerer, T. Rockwell, A. Sheu, S. Melillo, J. Uhd, K. Kenney, F. Wong, M. Saraiya, L.C. Richardson, COVID-19 impact on screening test volume through the National Breast and Cervical Cancer early detection program, January–June 2020, in the United States, Preventive Medicine, Volume 151, 2021, 106559, ISSN 0091-7435,

[3] 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