Performance-based Risk Sharing (PBRS) has grown significantly in recent years. Although most PBRS is used in the manufacture of expensive drugs, PBRS has been used in medical and pharmaceutical equipment. The PBRS device / detector may differ from the medical device for a number of reasons. First, even though health insurers carry large amounts of medical bills, equipment and diagnostics can be reimbursed by hospitals or health systems. Second, most tools and inspections do not have consistent testing evidence to support their implementation, so there may be some uncertainty about the benefits of new and detection equipment. Third, tools and equipment are often cheaper than medical equipment.
How are PBRS available to manufacturers of medical and diagnostic equipment? To answer that question, a recent paper by Chen and Carlson (2022) uses data that is publicly available on PBRS in technology. Specifically, the approach taken by the authors was as follows:
We also reviewed PBRSA publicly available diagnostics and tools, using the University of Washington Performance Based Risk Sharing (PBRS) Database. We have supplemented this review with the use of PubMed, Google, and corporate websites, including the top 15 medical and diagnostic equipment companies and the top 10 health insurance companies based on market value. [Carlson 2010; Carlson 2014]. Three main categories were used: (1) dissemination and development of evidence (CED), only for research; (2) CED, only by research; and (3) system performance improvement (PLR).
Based on this approach, the authors found that:
The review identified 52 programs established between 2001 and 2019. Of these, 23 (44.2%) were CEDs, by survey alone; 17 (32.7%) were PLR; and 12 (23.1%) were CED, only with research…
The use of PBRS has increased over time.
PBRS was widely used in cardiology and oncology. Many of the PBRS systems in oncology were detectors used to diagnose accurate medical procedures such as classifier assays, genomic profiling scores, or epigenetic testing. Examples of accurate oncology tests for these are ConfirmMDx Epigenetic Molecular Assay, Prolaris, Decipher, and Oncotype DX Prostate Cancer Assay. Insulin pumps were the only thing that was often covered by the PBRS system.
How does the use of PBRS differ from government agencies and the general public?
Most of the arrangements were part of the CED system at Centers for Medicare & Medicaid Services (CMS) or CMS contractors… of arrangements 52, 34 (65.4%) were CEDs printed on the CMS page and included 20 (58.8%). National coverage determinations (NCDs) for CMS are 14 (41.2%) local coverage determination (LCDs) by Medicare contractor Palmetto GBA. The remaining adjustments (18, 34.6%) were identified from individual payer websites...
Of all the plans, 5 (9.6%) were provided by private or commercial insurance companies, with 4 Medtronic diabetes insulin pump equipment and others linked to the UnitedHealthcare system linking the return of the Genomic Health’s Oncotype DX assay to a data collection program in Women considering adjuvant breast cancer treatment. Finally, hospital-based interventions (11, 21.2%) and integrated health systems (2, 3.8%) covered many areas of medical device disease.
Note that due to PBRS using public information, the findings of this study may be substantially detrimental to PBRS ‘public use of public records since the secret agencies would not be willing to disclose the use of any PBRS system. Results may also be confusing in obtaining the latest PBRS as more information may be available online in recent years.
Despite these limitations, having an overview of how operational flexibility works in high-risk areas between equipment and monitoring is very helpful in the literature.