Case 1

Global market access strategy for virtual patient monitoring systems (VPMP): A Clinical Decision Support System

Our team successfully launched 3 HEOR studies, 2 retrospective and 1 prospective, which identified the health economic value of the clinical decision support system. We collected, evaluated and reported the patient outcome and cost impact compared to the current standard of care in hospitals. We then isolated the value proposition for providers, payers, physicians, and patients. The combined results informed our global market access strategy for product acceptance and uptake by hospitals and health authorities around the world.

Case 2

Software as a Medical Device (SaMD)

Our team worked with the product development team of a software (SaMD) client to design an automated intervention for sepsis. The software was designed to automate sepsis detection and timing of intervention in order to improve overall patient outcomes. Algorithms were built from published medical society guidelines and CDC standards of care documentation. Our team evaluated the sepsis SaMD to determine and guide feature development that addressed existing care gaps and workflow inefficiencies. Our team developed relevant value propositions for the sepsis software based on current and trending health policy, federal and state legislation, and reimbursement policy, including NQF and CMS quality measures. We reviewed all relevant health technology assessments (HTAs), and peer reviewed publications on patient outcomes associated with detection, and timing of interventions. A retrospective analysis of an all payer medical claims database was conducted to identify the volume, prevalence, incidence, location, timing, and overall cost of care during the hospital stay. This information was used to evaluate and estimate the hospital and payer economics associated with the sepsis SaMD compared to existing standards. All existing and potential coding, coverage and reimbursement was reviewed and summarized. We then synthesized all information to develop the potential health economic value this sepsis SaMD would provide to patients, physicians, nurses, hospitals, and payers. The combined results informed our global market access strategy for product acceptance and uptake by hospitals and health authorities around the world.

Case 3

Health economic proof to overcome payer coverage objections

Our team developed health economic evidence for an Intermittent Pneumatic Compression Device. We created a customizable budget impact model comparing IPC to commonly used drug interventions for the prevention of venous thromboembolism. The US version of the BIM was adapted to Germany, Australia, Canada, India and published in peer reviewed medical journals and presented at medical society meetings. A groundbreaking two country cost-effectiveness study, Australia and the United States, was completed in collaboration with global clinical experts in VTE prevention and published in ClinicoEconomics and Outcomes Research Journal in 2017. From this health economic work we were able to develop value based healthcare agreements with LTC, SNF and hospital groups.

Case 4

Payer acceptance at launch for new technologies

We planned and developed payer market research, pricing and contract strategy, and payer materials for launch of 5 difference HIV and HCV biologic therapies. Our team conducted health economic evaluations along with reimbursement evaluation to inform the ideal price range for market acceptance. Our team managed the collection, evaluation, and reporting of payer market research. We combined the health economic price range and the payer market research to arrive at the appropriate market position for optimal payer acceptance and uptake. We achieved 100% public and private payer coverage within the first six months after launch for each of our new biologics.

Case 5

Successfully reassigned cardiac procedure to new and higher paying DRG

Our team determined that DRG reclassification was necessary for the endovascular abdominal aneurysm repair (EVAR) procedure. Under existing DRGs, there was no room to grow with technological advances. We worked for over 1 year analyzing Medicare DRG 237 and 238, and validating the needed elements to argue our case with CMS for DRG reassignment. After two attempts with CMS applications for reassignment our team was successful in gaining higher paying DRG 268 and 269 assignment for the EVAR procedure. This allowed room for the technology to grow and offer patients a less invasive, and safer option to correct this cardiac condition.

Case 6

VBHC partnerships with US Hospital Systems and Payers

Our team followed a specific methodology to identify, qualify, assess, and summarize value for a several different interventions including biologics, devices, and digital health products. We then determined the likelihood these interventions could deliver for select patient outcomes, the cost expenditure to achieve those outcomes and the number needed to treat to realize the expected outcomes. Then we compared our end result to the “standard of care” to determine a viable VBHC arrangement. We have successfully completed VBHC agreements for reduction in pre-mature births, VTE events, respiratory compromise events, and morbidities associated with cardiac procedures with over 20 payers and providers in the USA and OUS. These partnerships have resulted in increased utilization of the right intervention, at the right time, in the right patient.

Our Philosophy

We can accomplish more together than we can alone.

Our Promise

Full collaboration with experienced professionals who will take responsibility for delivering top quality work and excellent customer service.

Our Aprroach

DaVinci Health Group will handle all of your market access needs to overcome regulatory, clinical, health economic, health policy, and reimbursement barriers in order to gain rapid and sustainable access to healthcare markets. We believe partnership at the product concept stage for medical devices and at Phase II-III for biologics is the most efficient and effective approach for our clients: saving them time, effort, and money in the long run. Strategic market access planning and generation of clinical and economic evidence will support the proof of value required in today’s healthcare marketplace. However, we work with clients at any point along the product development process and have demonstrated market access successes in the post-launch phase.