Societies and Guidelines
Organizational Influence Over the Adoption of New Technology
Many types of organizations can impact the success of a new technology. These include professional specialty societies, large multidisciplinary organizations like the American Medical Association (AMA) and the National Comprehensive Cancer Network (NCCN), and nationally recognized technology assessment groups.
Robotic surgery and intensity-modulated radiation therapy (IMRT) were well received by their respective professional societies and were included in many issued clinical guidelines after several years of use. Neither altered patterns of care delivery, and neither negatively affected physician compensation. Despite the lack of level 1 evidence for robotic surgery, surgical robots were seen as an “enabling technology” by many surgeons. This allowed them to provide complex, minimally invasive procedures to a broad range of patients, and therefore receive support from professional societies. For instance, robots were included into the general category of prostate surgery when prostate cancer treatment guidelines were issued by the American Urology Association (AUA).
Similarly, there was no differentiation made regarding IMRT when it came to most clinical guidelines related to the use of radiation therapy. IMRT is a specific way of delivering radiation therapy, but it still uses ionizing radiation to realize a clinical benefit. Therefore, IMRT is considered appropriate whenever radiation therapy is considered appropriate.
This has not always been the case from an insurance payor point of view, however. Although radiation therapy is considered clinically appropriate for most cancers, IMRT is not always covered by a payor given that its use carries with it additional codes and therefore a larger payment. In these cases, a higher level of clinical evidence – due to a paucity of existing level 1 evidence – may be required before IMRT is considered appropriate for coverage in all cases.
Based on its assessment of the clinical literature, the AUA did not include high-intensity focused ultrasound (HIFU) in its primary prostate cancer treatment guidelines released around the same time as the devices were authorized for sale. Lack of guideline inclusion led private payors to deem the technology experimental. Major technology assessment groups, such as UpToDate and Hayes, also did not give HIFU ablation technology a favorable recommendation for the treatment of prostate cancer, citing lack of long-term follow-up data.
The AUA has indicated that including HIFU in its guidelines would require level 1A or 1B evidence, namely at least one randomized comparative trial. Because of the insidious nature of prostate cancer, such a trial would require a large number of patients with a long period of follow-up, a considerable cost that neither of the two current HIFU manufacturers of devices used for prostate cancer have been in position to undertake. A clinical trial involving a total of almost 3,000 patients is underway currently in the UK, underwritten by the National Health Service, but data will not be available until approximately 2025. As a result, AUA recommendations for inclusion in guidelines have been, and look like they will continue to be, based on “expert opinion,” with the expert chosen by the oversight committee, not favorably inclined toward the technology, especially focal HIFU, as a treatment for prostate cancer. As a result, insurance coverage has lagged behind the real-world clinical adoption of HIFU.
Professional societies, medical foundations, institutes, and technology assessment associations play a significant role in the success of any new technology. Failure to consider this role, or to plan for securing support from these entities, can lead to sizable delays in achieving clinical and commercial success for a nascent technology. It can even lead to corporate demise.
This role centers around reimbursement, especially coverage decisions. Current Procedural Terminology (CPT) codes are developed, maintained, and copyrighted by the AMA and determine payment for facility and physician services. Professional societies influence the CPT code issuing process by participating in the closed-door hearing of the CPT panel meeting convened to consider a new code request. The AMA seeks out the opinion of the appropriate professional societies to assess the society’s level of support for the technology. Beginning work to secure the support of the appropriate professional society well in advance of the start of the CPT code granting process can help shorten a process that can take two years or more once initiated.
The Role of Medical Guidelines and Clinical Assessments
Professional societies, as well as professional organizations like the NCCN, issue clinical guidelines used by practitioners, commercial payors, and hospital certification boards to guide medical interventions.
It is important to recognize that most societies are organized into committees devoted to specific aspects of the field covered by the society. For instance, the AUA has one committee that evaluates and addresses new CPT codes and a separate committee that determines whether the AUA will include a new technology in its published guidelines. Prostate HIFU was supported by the CPT committee, but not supported by the clinical guidelines committee. Knowing which society members are on which committees may aid in targeting appropriate individuals for support through the entire society engagement process.
Furthermore, in the absence of a national health technology assessment body in the United States, many hospitals, healthcare systems, government agencies, health plans, and employers rely on private technology assessment bodies to produce (presumably) unbiased reports on new, emerging, and controversial technologies and practices. Among the leading groups in the US producing such reports and assessments are Hayes, ECRI, and UpToDate.
Additional Data May be Necessary
Societies and organizations usually require clinical data from published comparative or randomized clinical trials for a technology to be included in issued guidelines. These data may be of a rigor that has not been required by the FDA to secure regulatory authorization. It can come as a shock to a new company that a set of clinical data, despite being sufficient to realize even the most rigorous premarket approval type of regulatory authorization, may be insufficient to garner inclusion in clinical guidelines, and by extension, insufficient to gain reimbursement coverage. While inclusion in a guideline does not ensure coverage by any payor, if a new technology is not included in published guidelines or technical reports and assessments, physicians may be reluctant to use it. Moreover, hospitals may be reluctant to allow it to be used, and payors may deem it “experimental” or “unproven” and therefore not appropriate for coverage.
Thus, it is prudent to anticipate the obstacles these groups may present and do what is possible to mitigate the risks of not being included favorably in their issued reports and guidelines. This anticipation is especially appropriate since third-party review is not performed in real-time; assessments are intermittent and may not correspond to noteworthy publication of clinical data. If data supporting a new technology are not available at the time an assessment is performed, it may be years before the field is reassessed and the benefit of new supporting data can be realized. Keeping guideline-issuing organizations informed as to pending release of data may be of value to help align data availability with clinical field review.
Unfortunately, it can be nearly impossible for manufacturers to create productive relationships with societies and technology assessment bodies, because most categorically refuse to interface with manufacturers. Using clinical partners, respected leaders in the field, and members of the company’s medical advisory board to provide notification to assessment bodies may be a possible way to transfer information to the appropriate players. Furthermore, knowing the exact kind of data that will be required for guideline inclusion, and making sure those data are collected as part of an early clinical trial, may reduce the need to conduct additional trials late in the game that would lengthen the time required to realize guideline inclusion and favorable coverage decisions.
The Role of External Economic Valuation
In addition to third-party clinical assessment, many hospitals are now requiring external economic valuation before adopting a new technology. The Institute for Clinical and Economic Review (ICER) has emerged as a leading voice in evaluating healthcare technologies on their economic value.
Unlike societies and technology assessment organizations, ICER notifies stakeholders when a topic is selected for review. Following stakeholder feedback, ICER issues an evidence report that includes ‘health benefit price benchmarks’ that represent a price range that it believes aligns fairly with a treatment’s added benefits for patients over their lifetime. More and more payors and hospitals are using ICER’s recommendations as a factor in determining the role a new technology will play in the delivery of healthcare. As such, it behooves a manufacturer to engage with ICER early in the commercialization process so that any data required by ICER can be included in the clinical work being performed by early adopters of the technology.
In summary, third parties, including professional societies and technology assessment organizations, play a role in determining the success of a new technology. These groups influence decisions about the clinical appropriateness of using the technology, as well as whether the technology will be covered when it is used. Since negative guideline decisions and economic evaluations by these players can result in delays in a new technology realizing mainstream status, internal company deliberations and discussions with external bodies as to what might be required to realize guideline inclusion is prudent before deciding on a regulatory and clinical trial path and may save money and time years later.
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
- Part 14: Conclusion