Experience

Our work often integrates with clinical, regulatory and marketing operations with the intent of reducing the technology’s market adoption risks. The case studies below describe our experience and possible integration scenarios.

Fortune 500 Company

Payer policies affect sales models

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Mid-Tier Company

Investment research using payer data

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Emerging Company

Securing codes prior to product launch

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Start-up Company

Preparing for coverage during the R&D phase

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Incubators & Accelerators

Reimbursement affects regulatory & clinical plans

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University-based Company

Payer interviews provide insight for corporate licensing

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Fortune 500 Company

The Client’s Business Needs

This case study illustrates the use of payer and reimbursement data for decisions related to a company's sales and marketing operations.

The company's technology platform was comprised of an integrated camera and conferencing system capable of conducting real-time, simultaneous telemedicine sessions with multiple individuals located in different locations. The telemedicine platform integrates with major patient Electronic Medical Record (EMR) enterprises. It is capable of real time sending, editing and sharing a variety of formatted data between all the participants before, during and after the telemedicine session. The telemedicine platform has a small footprint and is very portable. Important for use in the patient’s home.

The company’s business need was for us to help them determine where to locate their sales representatives in the U.S. based on telemedicine coverage policies and reimbursement amounts.

Our Approach

We believe companies should consider positioning their products on how they are covered and reimbursed by the Payers, and not necessarily on how the products are sold. We do this by using payer and reimbursement data to,

1) Identify clinical sites and sales customers.

2) Outline pricing strategy models.

3) Provide input for marketing position statements, websites and revenue models.

4) Guidance for product design.

5) Placement of sales representatives as illustrated in this case study.

For our client we developed algorithms to research and query Medicare, Medicaid and U.S. private payer databases so we  stratify the payers based on the most favorable telemedicine policies and reimbursement amounts. The results from our data analytics identified the Target Payer, Medicaid.

We researched all (50) U.S. states Medicaid telemedicine coverage policies, rules and regulations. The outcome of this analysis was for us to build a database that allowed us to categorize and query the (50) states into three categories relative to the company's telemedicine platform. The categories were, states with Medicaid telemedicine polices with restrictions, states with negative coverage policies and states with inconclusive telemedicine coverage policies.

 

The U.S. states with inconclusive polices where moved to the next research phase. This phase required us to conduct primary research to outline and categorize the state's telemedicine reimbursement from Medicaid. States that do not cover telemedicine services where eliminated because reimbursement is not possible.

States with Medicaid coverage and reimbursement for telemedicine services where further stratified based on the degree of restrictive coverage policies, licensing and credentialing, the breath of services reimbursed,and the amount reimbursed to the healthcare provider for preforming telemedicine session.

The Results

 

Based on our stratification of the states with telemedicine policies, we recommended to our client to consider placing sales representatives in five Midwest states based on the following rationale. 

1) Broad spectrum of covered telemedicine services is available.

2) Least number of restrictions for the available telemedicine services.

3) Physician reimbursement amounts, including other providers, were average to above average and had little historical fluctuations.

4) Good sized metropolitan areas serviced by major airports and highways. Automobile driving terrain is flat and time zone differences minimal.



Mid-Tier Company

The Client’s Business Need

This case study illustrates the use of payer, utilization and other reimbursement data to assist with investment decision making.

An institutional investor contacted us regarding a potential investment in a Seattle, Washington based company. The company was developing a product line of non-invasive systems to diagnosis, monitor the regression or progression of the Traumatic Brian Injury (TBI) following testing and treatments. Diagnosis and monitoring is possible because the company's system can be used over the entire TBI spectrum and in a variety of care settings. There is a portable system designed for use in memory centers and sporting events. For moderate care intensive sites of service, such as the skilled nursing facility, the development of a mid-range system was underway. For the most care intensive site of service, the hospital neurology ward and neurocritical care unit, a high-end system is also under development.

The client’s business need was for us to help them with their investment due diligence. To do this they asked us to provide them with the most current diagnostic procedure data for the mild, moderate and severe TBI and the patient discharge volume for the Emergency Room and the Hospital in the U.S..

Our Approach

To determine the TBI procedure and patient discharge volume, we first identified and prioritized a vast array of U.S.private and public Payer databases and confidential reports. Once completed we selected the most relevant data sources. We consider Payer databases and confidential reports to be a source of high quality market intelligence because the data is,

1) Actual and is not forecasted.

2) Current with the availability of historical data for trending purposes.

3) Includes multiple sites of care like the Emergency Room and Hospital.

4) Derived from reputable sources such as United Healthcare, Aetna and Medicare.

Our next step was to write algorithms to extract and to help us analyze the vast volume of data for the final selection of databases and reports for U.S. private and public payers.

The Results

Our customized market analysis determined the TBI diagnostic and monitoring procedure volume data was larger than the client had originally thought.  In addition, the TBI patient discharge volume data was materially different than what the client was expecting. The client incorporated our data into their financial models to help them with their investment decision making.

A couple of reasons for the disparity between our findings and the client's expectations have to with the high level of specificity we can achieve in our analysis, relative to third party, boilerplate-marketing reports. Second, we use actual, not forecasted, data from multiple sites of care. This type of data is not possible with third party, boilerplate-market reports because of the use of forecasted data to calculate general aggregate data.  Our high-level of specificity and customized approach to healthcare market sizing is cost competitive and uses different research methodologies than the third party, boilerplate- market reports.



Emerging Company

The Client’s Business Need

This case study demonstrates how we identified multiple monetization pathways for a smartphone/ tablet based test. In addition, this case study demonstrates that reimbursement planning should had begun (3) years prior to product launch.

A German medical software company began preparation for the U.S. launch of its FDA 510K class II cleared test. The test is capable of transforming the medical professional's smart phone or tablet into a full suite of the gold-standard orthopedic rehabilitation assessment and monitoring tests conducted following knee and hip replacement and ACL reconstruction. The initial focus is the U.S. orthopedic surgeon office market. The providers of interest were the surgeon and the physical therapist.

The client's test is capable of comparative and systematic normative data analysis. This type of analysis is difficult to do with the current subjective rehab testing methods. Since the rehab assessment test is on a mobile platform it can conducted in many sites of care, this is not possible with stationary office-based rehab assessment equipment. The company’s test results can be integrated with the patient’s electronic medical record. This level of integration is not possible with the current subjective testing and the office-based rehab equipment. The time to conduct an assessment test using the company’s mobile platform is 50% faster than current testing methods. Finally, the pricing strategy for the mobile test was materially lower than price the office-based rehab assessment equipment.

The client’s business need was for us to define and implement the U.S. reimbursement plan for their smart phone/ tablet based orthopedic rehab assessment and monitoring test. In addition, our work was to also contribute to the product launch planning efforts underway by the company. The company contacted us less than (1) year from launch date.

Our Approach

While the mobile test used the gold standard rehab tests accepted by providers and payers, we were more concerned about coding and reimbursement amounts, than coverage, for the mobile test. We decided to conduct a comprehensive payer stratification based on reimbursement amounts and the availability of alternative monetization pathways outside of traditional reimbursement. We believed alternative pathways were going to be important since launch was only a year away. Alternative pathways would had been less of a concern for us if we were contacted three years prior to launch.

The Results

The screening criteria and stratification noted above determined Medicare was a payer of interest. Medicare had an in place traditional reimbursement mechanisms and an alternative monetization pathway. While the Medicare reimbursement amount was lower relative to other payers, the value of Medicare's alternative payment pathway was paramount.

Reimbursement for the providers using the mobile-based test could be possible under the current reimbursement mechanisms and policies. However, we believed Medicare would soon deny the providers' claims under the current reimbursement mechanisms and policies. This was not to be the case for the alternative monetization pathway we identified because its mechanisms are different from traditional reimbursement.

As a result, the alternative monetization pathway was more important than traditional reimbursement in supporting the company's near-term commercialization efforts. It would be primary payment mechanism used while concurrent efforts to secure new coding and revised reimbursement amounts were underway by the client and Rowinski Group.

The key takeaway from this case study is the work described above should have started at least three-four years prior to launch.  Doing so gives a company the time to establish relationships with the payers, apply for codes and collect the evidence needed to help justify the need to amend current or create new payer decisions. 


Start-up Company

The Client’s Business Need

This case study demonstrates the importance of why and how reimbursement planning can support and enhance fundraising efforts. It was also shows why coverage, not coding, is a major reason for payers to deny reimbursement for new medical technologies.

A privately held startup company based in Boston and with 45 employees was preparing to raise its Series C round. The company is developing substantial procedural improvements to an accepted catheter-based cardiac therapeutic procedure.   Collectively the improvements will translate into expanding the number of physicians and centers who can perform the client’s procedure.

The company’s business need was for us to help them with the preparation for their Series C fund raising efforts. We did this by identifying the most favorable reimbursement pathways for key healthcare providers and to outline the plan to secure the payer approvals in the absence of reimbursement mechanisms.

Our Approach

We made three strategic decisions early in our work, they were,

1) Use comparative, not an absolute, analysis methodologies. The company initially requested an absolute analysis.

2) Include competitive therapies. The company wanted us to focus ONLY on their procedure.

3) Identify the Target Payer. This was an entirely new concept for the company.

As noted above the company initially requested us to focus our work solely on their procedure and one provider type. We strongly believed it was to the company’s best interests to understand if and how competitive procedures are reimbursed.

We also believed it was to the client's advantage to understand the reimbursement pathways for the facility provider and not to focus solely on the physician provider as requested by the company. We made this recommendation after reviewing payer and hospital admission data and recent payer policy changes. The new policies placed more financial responsibly for patient care on the hospital providers and as a result the hospital would have more authority in the purchasing decision.

Identifying the Target Payer is one of several key strategic decisions made by companies in their reimbursement planning. To identify the Target Payer, we wrote algorithms to extract multiple consecutive years of anonymized data from U.S. private and public payers. Following the data extraction phase, we conducted a longitudinal analysis to determine the Target Payer.

The Results

Based on our analysis we identified the Target Payer. Relative to the U.S. private payers, Medicare was an ideal Target Payer for the following reasons;

1) Established reimbursement pathways and a lower claims denial rate relative to the U.S. commercial payers.

2) Reimbursement was possible for multiple facility providers.

3) Aggregate reimbursement amounts similar to U.S. commercial payers.

4) A patient population who could benefit from our client’s procedure.

Just as invaluable to our client was a definitive understanding of the reimbursement pathways for competitive therapies that we outlined and summarized for them. Competitive therapies included pharmaceuticals and other catheter-based procedures.

Our work concluded all catheter-based procedures were vulnerable to possible policy changes due to overuse. These changes, if enacted, will materially reduce physician and hospital reimbursement and demonstrates it is coverage policy, not coding, a one key reason why new procedures and technologies are not reimbursed by the payers. Based on the potential of the policy changes noted above we put into place an ongoing monitoring program designed to alert the company in the event Medicare was considering implementing the policy.

Regarding the company's more immediate need, preparing for the Series C round, our work and findings were included in documents, presentations shared with investors. In addition we were available to speak with investors, on behalf of the company, to explain the reimbursement pathways for the company's technology and highlight how the company is well positioned for the coverage opportunities and risks which may lie ahead.  

 



 

Incubator-based Company

The Client’s Business Need

This case study demonstrates in the absence of traditional reimbursement that other monetization alternatives could be available. This case study also shows how reimbursement can be used to help companies define their regulatory Indications for Use, claims and labeling prior to formal discussions with the FDA.

A company, under the guidance of a Minnesota-based incubator, was developing a Point of Care (POC) diagnostic test to detect the presence or absence of Urinary Tract Infection (UTI). The test’s flagship market included U.S. acute stay hospitals.  The company’s third-party market intelligence concluded the incidence and prevalence of UTI is higher than normal in older patients and particularly those admitted to the hospital. Based on the intelligence the company believed the test’s FDA regulatory and clinical trial efforts should focus on the test’s use during the patient admission period. This period is defined as the time between patient admission to discharge from the hospital. As a result, the proposed regulatory claims, Indications For Use (IFU), labeling and FDA clinical trial design were geared to secure 510K clearance for the POC test use during the admission period.

The client’s business need was for us to determine if and how the POC-UTI test proposed regulatory claims, IFU and labeling for patient admission period would affect hospital reimbursement the POC-UTI test.

Our Approach

Our first step in our work was to confirm, unequivocally, the company's conclusion that UTI incidence and prevalence is higher in older patients and for those admitted to the hospital. We can do this work because we have licensing access to actual (not forecasted) data for UTI incidence and prevalence during the hospital admission period. Our analysis did re-confirm our client’s conclusion.  Our analysis also determined who is the Target Payer when it comes to diagnosing and treating UTI from which to determine the impact, if any, of the company's proposed regulatory and clinical trial plans for their POC test.

The Results

The reimbursement and alternative monetization pathway analysis we conducted determined the following. 

1) Hospital reimbursement for the POC-UTI test is structurally not possible. 

2) An alternative monetization pathway does exsist for the POC-UTI test. This alternative pathway to traditional reimbursement financially penalizes the hospital in the event a patient acquires UTI during the patient admission period. However if UTI is detected at the point of admission, the Target Payer will not financially penalize the hospital. 

Based on our analysis the proposed FDA regulatory and clinical strategy supporting the use of the POC-UTI test during the patient admission period was changed. The revised regulatory and clinical strategy re-positioned the test for use at point of hospital admission. In addition to revisions on the regulatory and clinical strategy, we helped our client revise their marketing and business plans based.

 

 



University-based Company

The Client’s Business Need

This case study illustrates the use of well-crafted interviews with Medical Directors from U.S. private insurance carriers to help a university reduce its licensing risks using early reimbursement planning.

The faculty of a major university was developing a molecular Point of Care (POC) test to detect selected autoimmune diseases. The test’s objectives were first is to reduce the unnecessary use of an expensive hospital-based test. The hospital test is considered the diagnostic gold standard. The second objective is to use the POC test in a less expensive site of care: the physician office setting. Collectively these two objectives would assist physicians with triaging their patients and saving U.S. insurance carriers money.

The university was referred to us to help them better position the POC test to corporate licensing partners. The university believed a better understanding the POC test's reimbursement could do this.

Our Approach

Because of the test’s disruptive factor and uniqueness were high, we suggested a combination of secondary research (data analysis) and primary research. The primary research we conducted included one-on-one interview with Medicare Directors from U.S. private payers. whom we have established professional relationships with.

Medical directors have the authority to 1) manage the use of new technologies outside their traditional sites of care, 2) define evidentiary requirements for coverage and reimbursement for new and unproven tests, 3) can speak of the concerns related to changing workflow and usage outside traditional settings and 4) provide input into the POC test pricing strategy.

Because we conduct interview with Medical Directors we know first-hand the need to invest the time into properly selecting and vetting the interviewees and the importance of preparing them for their interview, both crucial elements for a successful interview that meets the client’s objectives.

We identified, recruited and confirmed five Medical Directors to participate in a private interview. The Medical Directors were from different private insurance payers based around the U.S. All had experience with new medical technologies and were comfortable with those technologies that disrupt traditional workflow and cost structures. To prepare each Medical Director for their interview we created an interview packet and provided pre-interview support mechanisms.

We conducted one-on-one interview with each Medical Director over a three and half week period. We summarized each interview in a written report and provided it along with each interview’s video recording to the university. We sent this information prior to the meeting to discuss the interview results.

The Results

The feedback from the interviews helped the university clarify how to improve the test’s positioning with potential licensing partners. The Medical Directors realigned our client’s expectations in terms of the overall potential market size, the proposed pricing strategy, concerns of the overuse and the type of evidence needed to code and reimburse this novel and disruptive test. The Medical Directors also outlined action items and road maps to improve the test’s appeal to payers and in doing so position, it of favorably to licensing partners. The next step will be to work with the university to consolidate the road maps outlined by the Medical Directors. Once consolidated, we will stratify and prioritize selected action items including resource allocation.


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Rowinski Group LLC makes no representation or warranty on the case studies and other content found on this website or the completeness, accuracy, timeliness of such content or the applicability to a specific patient.

Rowinski Group LLC disclaims all liability or responsibility for any and all results or consequences of any actions taken in reliance on the information provided on this website.

Rowinski Group LLC encourages all providers to submit accurate and appropriate claims for services. Laws, regulations and payer policies concerning reimbursement are complex and change frequently.

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