The Interconnectedness of Investment, Innovation, Reimbursement and Patient Access

Author: Susan Thompson

After I was convinced of the revolutionary nature and the thousands of patients that SCINTIX? therapy would have the potential to help, one of my very next concerns before joining RefleXion Medical in 2019, was how patients would access this novel technology. After 15+ years in the radiation oncology space, I knew that often, the annual release of the Centers for Medicare and Medicaid (CMS) reimbursement rules delivered news of declining reimbursement for most radiotherapy procedures. SCINTIX therapy would require physicians and physicists to fundamentally rethink how a radiotherapy treatment plan is created and delivered. And for that learning to occur and fuel clinical adoption, they deserved compensation.

Fueling Growth in Innovation

Experts agree that securing adequate reimbursement for new procedures and technologies is hugely influential in determining which products and services that are eventually commercialized and available to patients.[1] The opportunity for accretive reimbursement facilitates investment by venture firms in companies willing to innovate. Investment, innovation, reimbursement, and patient access are tightly intertwined.

CMS must stay abreast of emerging new technologies and ensure timely accessibility for Medicare beneficiaries.[2] In 2000, CMS created the Ambulatory Pathway Classification (APC) system, which groups procedures and services performed in the hospital outpatient setting (OPPS), into payment bands based on clinical and resource similarities. A New Technology classification was added with the intent of providing payment in the OPPS for procedures, like SCINTIX therapy, that cannot be appropriately reported or described by existing codes.[3] In other words, they are truly new and, in the case of SCINTIX therapy, provide the opportunity to treat new patient populations.

SCINTIX therapy is the world’s first autonomous radiotherapy, whereby signals generated from within the tumor itself, in response to an injected radiopharmaceutical, direct radiation delivery. By doing so, it overcomes two of the longest standing barriers in our industry: targeting and motion management. Surmounting these challenges facilitates the expansion of this technology to treat multiple tumors in the same treatment session. This approach is so novel compared to existing radiotherapy, that it was designated by the FDA as a Breakthrough Device for lung cancer treatment in November 2021, and subsequently cleared via their De Novo pathway for tumors in the lung and bone in February 2022.

CMS Awards Accretive New Technology Codes for SCINTIX Therapy

CMS subsequently confirmed the newness of SCINTIX therapy by granting two new and accretive reimbursement codes effective Jan. 1, 2024, for use in the hospital outpatient setting using its new technology APC pathway. The first code, C9794, defines a separate pre-treatment procedure in which radiopharmaceutical emissions data is collected for use in creating the SCINTIX treatment delivery plan. The second code, C9795, is for the actual delivery of the SCINTIX treatment plan to one or more targets and is billed after each treatment session. The creation of these two codes, with a payment rate significantly higher than existing image-guided stereotactic body radiotherapy, acknowledges that SCINTIX therapy is a revolutionary approach to treating cancer patients. Both codes are expected to retain NT APC status for two to three years while CMS collects procedural cost data to develop payment rates based on actual usage at RefleXion clinical sites across the U.S.

Without accretive payment for technology innovation, it is challenging for early clinical adopters to adopt novel treatment options because they bear a disproportionate share of the innovation risk. In the words of our president and CEO, Todd Powell, “We are grateful that CMS recognizes the potential of our SCINTIX therapy and, with this decision, has addressed provider payment as a barrier to clinical adoption”. We are even more buoyed that the risk of adopting this new technology no longer rests solely on the shoulders of our early clinical adopters, a concern aptly described by our professional societies, the American and European Societies for Radiation Oncology (ASTRO and ESTRO), in their recent news release, Maintaining the Cycle of Innovation in Radiation Oncology.[4]

Susan joined?RefleXion in December 2019 as?senior director of patient access and has over 15 years of experience in securing reimbursement for different technologies in the radiation oncology industry including at Accuray, where she was instrumental in securing coverage, coding, and payment for CyberKnife. In addition to her role at RefleXion, she also serve as the chair of the AdvaMed Radiotherapy Sector Payment Committee.

[1]The Impact of Reimbursement Policies and Practices on Healthcare Technology Innovation: Final Report. Feb 2016. https://aspe.hhs.gov/sites/default/files/private/pdf/188741/ImpactofReimbursementonInnovation.pdf

[2]Federal Register, vol. 86, no.39, Mar 2, 2021, p.12193. https://www.govinfo.gov/content/pkg/FR-2021-03-02/pdf/2021-04303.pdf

[3]Process and Information Required for a New Technology Ambulatory Payment Classification (APC) Assignment Under the Hospital Outpatient Prospective Payment System (OPPS). https://www.cms.gov/medicare/medicare-fee-for-service-payment/hospitaloutpatientpps/downloads/newtechapc.pdf

[4]ASTRO and ESTRO (2023, Nov. 23). Call for action: Maintaining the cycle of innovation in radiation oncology [News release]. https://www.astro.org/News-and-Publications/News-and-Media-Center/News-Releases/2023/ASTRO-and-ESTRO-call-for-action-Maintaining-the-cy