Neither intensity-modulated radiation therapy (IMRT) nor robotic surgery required a publication strategy for the purposes of obtaining initial reimbursement codes, because these procedures co-opted existing codes. Publications were required for the issuance of additional IMRT codes that were added later for coverage by private payors, but the papers were produced organically through the development of the field and the widespread clinical use of the technology. Because there were no additional codes issued for robotic surgery, there was no need for robotic-specific publications to justify the use of the technology to attain payment.
The American Medical Association (AMA) authorized a Current Procedural Terminology (CPT®) code for focused ultrasound ablation of prostate cancer in 2020, one year after the application was filed and approximately six years after the procedure gained regulatory approval from the US Food and Drug Administration. The CPT code, which is used to report the procedure to entities such as physicians, health insurance companies, and accreditation organizations, was slated to be introduced in January 2021. Publications containing clinical data produced by users of each of the two focused ultrasound devices for the prostate were submitted to meet this requirement.
The CPT code set the payment level for Medicare patients at the same rate assigned to the temporary C-Code in 2016, and a physician payment was added. However, most private payors have continued to consider the treatment experimental due to lack of inclusion in society guidelines and therefore have not provided coverage. Obtaining guideline inclusion is, most likely, dependent on publishing Level I data, which is randomized comparative clinical trial data. To provide these data, two academic-led clinical trials are underway in the UK and Europe. Each was planned, initiated, and undertaken without participation by either manufacturer.
Among the possible hurdles to timely and successful commercialization, one of the least likely to be considered at the initial stages of corporate planning is a publication strategy. Publications are not required to receive regulatory authorization and may not be required to realize certain reimbursement codes, such as a C-Code. However, a failure to produce peer-reviewed clinical data publications in a timely manner can lead to a procedure being excluded from of clinical guidelines. This, in turn, can lead to a delay in achieving certain payment codes or commercial payor coverage for a procedure.
The AMA requires the following publications before issuing a new CPT code:
- At least five peer-reviewed articles
- A minimum of two articles with no overlapping patients
- At least one article must provide no lower than Level IIA evidence (systematic review of cohort studies)
- Abstracts, book chapters, white papers, and other non-peer reviewed publications are not allowed
A company cannot apply for a CPT code until the article requirement is met. It can also take up to two years for a new code to make its way into use. Without a publication strategy that ensures that these requirements are met in a timely manner, the issuance of a code – the first step in securing payment and coverage – will be delayed.
Clinical Trials and Incentives
When planning the clinical trials that will lead to the necessary publications, it is important to ensure that sites are collecting data in a manner that will help facilitate the submission of journal articles. It may be worthwhile to consider discounts on disposables or service to clinical partners in exchange for obligations on the part of the user(s) to make sure results are published in a timely fashion.
Society Acceptance is Essential
As discussed previously, commercial payors often conduct their own or adopt a third-party assessment of peer-reviewed literature when making coverage decisions. Few payors have published detailed rules about how much evidence constitutes “adequate evidence” for a given coverage decision. Most coverage policies are based on an in-house or consultant-generated review of credible scientific evidence published in peer-reviewed medical literature, relying primarily on controlled clinical trials. A review of the websites of major commercial insurance carriers shows that most, if not all, place significant importance on professional society recommendations and/or guidelines when determining whether a procedure or technology is reasonable and necessary and therefore appropriate for coverage.
Because guidelines are data driven, realizing as many supportive high-quality, peer-reviewed publications as possible becomes the first order of business toward being granted a code. Most societies and assessment organizations require Level IA evidence (obtained from a systematic review of randomized controlled trials) or Level IB evidence (obtained from an individual randomized controlled trial) to make a favorable guideline recommendation. Therefore, preference and attention should be spent on securing clinical partners who will conduct and report on a randomized clinical trial, if possible. At a minimum, there needs to be someone outside the company working on implementing and reporting on a comparative prospective controlled trial or on propensity matched studies.
In summary, a successful publication strategy, including input from and consultation with clinical partners, will map out how a manufacturer will get required clinical data into peer-reviewed journals in a timely manner. The strategy should address authors, target journals, guideline requirements, substance, and format of the material. A successful plan will help ensure that favorable coverage decisions will be reached in the most timely manner possible. Making decisions about publications late in the game, after milestones like regulatory authorization and code and payment issuance have occurred, will result in a significant delay in meaningful coverage and may require repeating clinical work. A failure to plan for publication requirements could ultimately cause technology to languish on corporate and user shelves, and patients will be unable to access what may be a better treatment option.
Mark Carol, MD, is a senior consultant at the Focused Ultrasound Foundation.
Read the Series
- Part 1: The Complex Ecosystem of a Medical Device Startup
- Part 2: Novel Technology Development
- Part 3: Regulatory Authorization
- Part 4: Reimbursement
- Part 5: Physicians
- Part 6: Patients
- Part 7: Facilities
- Part 8: Societies and Guidelines
- Part 9: Commercialization
- Part 10: Technology Advancement
- Part 11: Publication Strategy
- Part 12: Cybersecurity
- Part 13: Financial Challenges