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 affects the location of sales reps

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Mid-Tier Company

Institutional investor uses payer data

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Emerging Company

Securing codes prior to product launch

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Start-up Company

Reimbursement planning begins in the R&D phase

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Incubators & Accelerators

Reimbursement affects regulatory & clinical plans

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University-based Company

Payer interviews give insight for university 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 portable, both important for use in the patient’s home during a session.

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 selling their products based on “how they are covered and reimbursed by the Payers,” and not necessarily “how the products are sold”. and is the intent of this case study.

For our client we developed algorithms to research and query Medicare, Medicaid and U.S. private payer databases so we identify and prioritize these three payer groups based on the most favorable telemedicine policies and reimbursement amounts.

The results from our data analytics found Medicaid as the beachhead payer and is where focused our efforts from here on out.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 providers 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, hospital 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 the neurocritical care unit, a high-end system was 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 1) the most current procedure data for the mild, moderate and severe TBI for a variety of diagnostic tests and 2) the (TBI) patient discharge volume from the emergency room and the hospital for the entire U.S.A.

Our Approach

To determine the TBI diagnostic procedure data and the TBI patient discharge volume, we first had to identify from a vast array of U.S. commercial and public payer databases and confidential third-party reports. Once identified we had to prioritize the most relevant data sources.

Our next step was to query, extract and consolidate the data for our analysis and presentation to our institutional investor client.We often use payer databases for our market intelligence work because we consider this data to be of high quality for the following reasons,

1) The data is actual and is not forecasted.

2) The data is current with the availability of historical data for trending purposes.

3) The data is available for multiple sites of care like the emergency room and hospital.

4) The data is derived from reputable sources such as United Healthcare, Aetna and Medicare.

The Results

Our customized market analysis determined the TBI diagnostic 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.

A primary reason for the disparity between our findings and the client's expectations have to with the high level of data specificity we can achieve in our analysis, compared to third party, boilerplate-marketing reports, which the client was using.

We use actual, not forecasted, data and from multiple sites of care not one site of care. This type of data specificity is not possible with the third party, boilerplate-market reports because of the use of forecasted data to calculate aggregate forecasts.

To further enhance our data specificity, we will conduct longitudinal analysis. Our high-level of specificity and customized approach to 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 shows how we identified multiple monetization pathways for a smartphone/ tablet-based test. It is also intended to demonstrate that reimbursement planning should had begun (3) years, not (1) year, 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 company’s mobile test offers benefits to the surgeon and physical therapist relative to the current subjective test and the office-based rehab equipment testing methods, they are;

  1. Real time comparative and systematic normative data analysis.

  2. Mobile platform allows the company’s test to be conducted in many sites of care, the physician office, the physical therapy center, the hospital, and hospital outpatient settings

  3. Electronic integration of test results with the patient’s electronic medical record.

 4. Faster test times without compromising specificity and sensitivity.

 5. Lower per price test for the mobile platform.

The client’s business need was for us to define and implement the U.S. monetization plan for their smart phone/ tablet based orthopedic rehab assessment and monitoring test. In addition, the company wanted us to integrate the U.S. plan into the ongoing product launch planning efforts. The company contacted us with less than (1) year from launch date.

Our Approach

While the mobile test incorporated the gold standard rehab tests accepted by providers and payers, we were more concerned about coding and reimbursement amounts, than coverage, for the company’s 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 less than one year away. Alternative pathways would had been less of a concern for us if we were contacted (3) years prior to launch.

The Results

The screening criteria and stratification noted above determined Medicare was a payer of interest. Medicare had in place traditional reimbursement mechanisms as well as 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 Medicare’s current reimbursement mechanisms and policies. However, we believed Medicare would soon eventually deny the providers' claims for a variety of reasons such as costs.

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 company and us.

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 reimbursement planning commencing in the R&D phase. It was also shows why payers’ coverage policy decisions, not coding, is a major reason for payers to deny reimbursement of 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 U.S. launch of the company’s catheter-based therapy is three years away.

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 the physician and hospital 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.

2) Include competitive therapies and multiple provider types.

3) Identify the Beachhead Payer.

As noted above the company initially requested us to focus our work solely on their procedure, that is conduct an absolute analysis. We strongly believed it was to the company’s best interests to understand if and how competitive procedures such as drug therapy and other catheter-based approaches are reimbursed. The company agreed.

In addition, the company initially asked us to concentrate our work on identifying physician reimbursement pathways. We concluded it was to the company’s advantage to understand the reimbursement pathways for the hospital provider as well as the physician, and not to focus solely on the physician. We made this recommendation after reviewing payer and hospital admission data and recent payer policy changes. These new policies placed more financial responsibly for patient care on the hospital providers.As a result the hospital would have more authority in the purchasing decision.

Identifying the Beachhead Payer is one of several key strategic decisions made by companies in their reimbursement planning. Identifying the Beachhead Payer, required us to write 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 Beachhead Payer.

The Results

Based on our analysis we identified the Target Payer. Relative to the U.S. private payers, Palmetto (Medicare Administrative Contractor) was an ideal Beachhead 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 Palmetto reimbursement pathways for competitive therapies, which included pharmaceuticals and other catheter-based procedures.

Our work identified hospital and physician reimbursement from Palmetto was adequate. However, all catheter-based procedures to treat this cardiac condition were vulnerable to possible policy changes due to overuse. These changes, if enacted, will materially reduce physician and hospital reimbursement.

This potential policy change demonstrates an often-overlooked fact; payers’ coverage policy decisions do affect reimbursement for new technologies. Based on the potential of the policy changes we put into place an ongoing monitoring program designed to alert the company if and when Medicare, including Palmetto, and (selected) commercial payers would consider 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. We were available to speak with investors, on behalf of the company, to explain the reimbursement pathways for the company's procedure and to put into context the risks and opportunities that lie ahead.

 


 




Incubator-based Company

The Client’s Business Need

This case study demonstrates two points. First in the absence of traditional reimbursement that other monetization pathways maybe available. The other point is to show how reimbursement can be used to define their Indications for Use (IFU), and the claims and labeling language 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 market was 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 who are admitted to the hospital.

Based on this intelligence the company believed the test’s FDA regulatory and clinical trial efforts should focus on the test’s use during the admission period. This period is defined as the time between patient admission until hospital discharge.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 based on the regulatory strategy of test use during the admission period would affect hospital reimbursement.

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 who are admitted to the hospital. We are able to do this work because we have licensing access to actual (not forecasted) data for UTI incidence and prevalence during the admission period. Our analysis did re-confirm our client’s conclusion and the Beachhead Payer.

The Results

The reimbursement and alternative monetization pathways analysis we conducted determined the following;

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

2) An alternative monetization pathway for the hospital is possible.

This alternative pathway to traditional reimbursement financially we identified does financially penalize any hospital in the event a patient acquires UTI during the admission period. However, if UTI is detected at the point of admission, the Beachhead Payer will not financially penalize the hospital.

Based on our analysis the company’s the company changed its FDA regulatory and clinical strategy. The revised regulatory and clinical strategy re-positioned the test for use at point of hospital admission and not during the admission period. Again, this was done to ensure there was a viable monetization pathway for the test after FDA clearance and product launch.

 


 

 




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 in order to assist a university with de-risking its corporate licensing efforts.

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 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 university’s POC test in a less expensive site of care: the physician office setting. Collectively these two objectives could 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 pathways would be one way to improve the test’s marketability to corporate licensing partners.

Our Approach

Because of the test’s disruptive factor and its uniqueness are high, we suggested a combination of secondary (data analysis) and primary research methods be used. 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 the interview with each Medical Director over a three and half week period. We summarized each interview in a written report and along with a 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 POC 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 begin de-risking for corporate licensing partners. The next step will be to work with the university to consolidate the action items and road maps outlined by the Medical Directors. Once consolidated, we will stratify and prioritize selected action items including budgets and other 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.

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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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