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Stage 4: Clinical Trial

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Reimbursement Assessments

Today’s Reimbursement Picture and Options for Improvement

  • What reimbursement obstacles are in the way and how long will it take to clear them?
  • What short-term strategies can be applied?
  • What timeline should a manufacturer/investor count on?

A medical device reimbursement assessment is designed to answer these questions in detail and address specific questions that pertain to coding, coverage, payment, the payer-mix, site of service differentials, competitive product research, and trends in medical device product lines.

Our expert medical device reimbursement assessments provide a comprehensive overview of the medical device reimbursement landscape for your product and options for improvement, if needed. A reimbursement assessment is the foundation of future implementation, development and strategy.

Reimbursement During Clinical Trials
RPI is recognized among our peers as the leader in clinical trial reimbursement. Most IDE clinical trials are eligible for reimbursement from Medicare and commercial payers during the clinical trial of all standard-of-care expenses, including the device. Most study sites lack the time or expertise to optimize the clinical trial reimbursement process. At RPI, we can help at a cost that is a fraction of the savings our efforts can generate.
Daily Coverage Policy Review
Daily Coverage Policy Review (CPR) lets you know exactly when payers’ published coverage policies are updated and scheduled for draft review. It can be confusing to understand which policies need to be monitored for your company. We take out the guess work and the confusion with our CPR system. We monitor only those US payers and coverage policies that reflect your healthcare technologies and notify you of any policy changes, from both Medicare and US commercial payers, which are of specific interest to your company.
Reimbursement Hotlines

Our toll-free and email reimbursement hotlines are designed to help your hospital and physician customers with everyday reimbursement questions. RPI’s qualified reimbursement specialists are ready to answer questions like:

  • How should this procedure be coded?
  • How do we preauthorize this procedure with private payers?
  • Does Medicare require preauthorization?
  • What do we do in the event of claims denial or low payment?
  • What documentation do we need to submit with our claim?

Answering your client’s reimbursement questions can make or break your sale. Get a quick and accurate response from RPI’s reimbursement hotlines.

Reimbursement Billing Guides and Coding Sheets

Your customers will greatly appreciate coding and billing guidance for procedures which are new to them. We prepare coding and other billing guidance materials (such as documentation of medical necessity) for your website and customer leave-behinds.

Coding guidelines for:

  • Medicare Billing Guidelines
  • ICD-10 CM and ICD-10-PCS Coding Guidelines
  • HCPCS Coding Guidelines
  • C-Code Guidelines

If Reimbursement Principles is managing a hotline service for you, you may include that information on these materials.

Healthcare Economics and Outcomes Planning

Medical Device Marketing Consulting

Healthcare Economics – Comparative Effectiveness Research

Comparative effectiveness is the standard by which payers judge new technologies and procedures. Payers want to know how patient outcomes and provider costs of the new method compare to the current standard(s). Comparative effectiveness is a broad healthcare economics concept which includes cost effectiveness and technology assessment, but also may take into account the types of evidence previously excluded by technology assessment methods. Our health economists are experts in effectively presenting your comparative effectiveness story.

Setting the right price point and conducting the studies are important steps in determining the healthcare economic viability of your medical device.

Outcome Planning

New technologies typically lack sufficient clinical evidence to permit a full comparison with the standard of care. With outcome planning, we can help you plan for the outcomes data that will be needed to complete the evidentiary picture, then help you identify some time- and cost-efficient ways to obtain the data, and finally we can help you present it. Presenting your outcome plan to the appropriate audiences is important for securing buy-in from payers.

Read success stories of effective healthcare economics and outcome planning strategies.

Payer Educational Campaigns

RPI has developed powerful relationships with current and former payer medical directors who can assess your medical device technology and provide relevant feedback on what is required to establish positive coverage policies.

Our insight even extends to identifying when you should approach Payer Medical Directors for education. Approaching payers too early in the product life cycle can have detrimental effects like forcing a non-coverage policy. We have years of experience in the payer educational field and will advance your business with this industry knowledge.

By conducting focus groups that consist of former medical directors who give valuable insight, we are able to reveal potential problems early. Physician focus groups are a safe and efficient way for medical device manufacturers to get inside the payer’s head about a new technology or a procedure before arbitrarily misdirecting the investment of time and resources.

Clinical Trial Critique

If you are doing a clinical trial as part of the regulatory process, you have the pieces in place to capture valuable data to support reimbursement for a modest incremental cost. A clinical trial critique will highlight these opportunities for you.

As part of the clinical trial critique, we review gaps in the evidence needed to support reimbursement coverage and identify opportunities to fill those gaps to piggyback with your existing trial design. This is the data payers will most want to see, and capturing it will not interfere with your regulatory pathway. Please call us to discuss how a clinical trial critique can help solidify reimbursement in addition to your regulatory goals.

Preparing Articles for Publication
Preparing quality articles for peer-reviewed journals is a challenging and time-consuming necessity. With Key Opinion Leaders as primary authors, RPI co-authors or ghostwrites publishable articles that bring your research results into the realm of peer-reviewed evidence.
Coding Assessments

Expertly Evaluated by Certified Professional Coders

Assessing the appropriate codes for procedures based on new technologies or, in limited cases, for the products themselves, is a high-stakes endeavor. Using the wrong code can shortchange your customers or make them the target of billing fraud.

Why Coding Assessments Are Critical

Making sure that these codes are appropriate for your business ensures that the correct payment will be received. Coding must be scrupulously appropriate and adhere to the rules of the American Medical Association (AMA), in the case of CPT codes, and the ICD 10 Committee, in the case of ICD 10 codes.

RPI has a thorough grasp of the rules of the AMA, including both codes and their authoritative interpretation. Several of our coders are professionally certified to deal with coding assessments.

Sales Representative Training
Knowledge of medical device reimbursement is key. Customer or sales representative uncertainty about medical device reimbursement can derail the sales process. We provide the training and the tools for representatives to remove the uncertainty of medical device reimbursement from the equation and get back to selling. Please give us a call to discuss how we may equip your sales team with the tools and knowledge to stay in charge.

Preauthorization of individual medical treatments using a new technology gets those treatments paid while at the same time educating the payers about the technology. The process compels the payer’s attention because network doctors want to treat real patients. We bring instant expertise to your customers preauthorization efforts and will even do it for them.

*Preauthorization is not available for Medicare at this time


Medical review is often the best way to get new technologies paid, and paid adequately. An effective avenue for obtaining medical review is the appeals process. Appealing a medical claim is a process that should be dealt with in a professional manner. There are multiple steps that need to be taken to ensure that the appeal will be examined and processed efficiently.

Beyond the original appeal (which is usually dealt with by a computer software system or a clerk), there are other deadlines that need to be met. The additional criteria required within your appeal needs to be brought to the appropriate level in order to force a medical review. RPI understands these steps within the appeals process.

Claim denials can be frustrating and costly to your customers. Talk to RPI about how an appeals process can help your customers.

Value Analysis

The way in which the reimbursement value of your medical device is determined, proven, and communicated is essential to generating success in the marketplace. The results of a reimbursement value analysis will have serious implications on your medical device’s clinical and market development.

There are three main aspects to reimbursement value analysis:

  • Setting The Right Price
  • Conducting The Right Studies
  • Sending The Right Message

The medical device’s price is important to your customers and plays a significant role in medical device reimbursement.

Its important to send the correct message to the appropriate target market and at RPI, we acknowledge that this is an extensive and time-consuming undertaking. We can help you articulate and document your value effectively.

Payer Market Analysis


Healthcare Economics – Comparative Effectiveness Research

There are multiple aspects about the payer market that need to be understood to successfully launch and sustain a place within the medical market.

  1. How do you target a payer?
  2. What are the details that you should know?

You need to know the payers who are already receptive to your technology and those who need further payer education. RPI will profile and segment the relevant payers for you by examining their medical policies which are applicable to your product. With this knowledge, you can target appropriate actions for each payer segment and, if needed, identify additional data requirements for building payer acceptance.

Data Analysis
Your stakeholders have different data requirements in order to answer various questions.

  • Prospective investors want hard numbers: Potential market size; current treatment strengths, weaknesses and inefficiencies; defensible pricing strategies.
  • Facilities want to know why they should invest: Why devote capital and equipment and provide healthcare professional training when their facilities are already skilled at performing the current gold standard procedures?

Data Analysis of Disease Demographics

RPI has the tools and expertise to identify quality disease demographic data sources, mine that data, and then analyze it. The data are the results reported by medical providers and can help our clients target their accessible, regional, and national markets more effectively. This, in turn, allows your investments to create larger returns. RPI can help figure out where the best placement for your medical device is through data analysis of disease demographics.

Economic Analysis
An economic analysis can provide the financial information today’s payers want to know in terms of the comparative cost effectiveness of diagnostic and treatment methods using new medical device technologies in relation to current standard-of-care methods.

The Value of Economic Analysis

While many new products enable improved outcomes and reduced costs, both the data and its presentation are subject to comparative effectiveness methodology in order to be credible.

Pricing Analysis

Establishing the right price for your medical device requires three things: extensive knowledge of documented and expected clinical outcomes, documented and expected provider costs, and competitive data. The most credible data for medical device pricing generally comes from the published medical literature which can sometimes be spotty. We build our medical device pricing models on the best available documented data and probable results for your product, yet we also allow you to alter the variables in the event of new information. Multiple medical device pricing scenarios and what if exercises maximize your confidence in medical device pricing decisions.

Examples of Evidence Based Medicine

Examples of Economic Model

Payer-Mix Analysis

Determining the dominate payers for specific disease states is important to medical device manufacturers. As the following pie charts demonstrate, different payer types are associated with breast and prostate cancer.

To give an example, within the realm of breast and prostate cancer, the payer-mix is very different.



Within the breast cancer market, private payers are 49% of the payer mix compared to the prostate cancer market where only 15% of the payers are private. Medicare actually leads the prostate payer market with 64%.

Knowing which types of payers from the payer-mix will dominate your product’s market enables you to choose education and advocacy methods targeted specifically to them. The right combination of clinical, regulatory, and contract expertise will vary by payer. At RPI, we equip you with the right blend of expertise for the payer-mix within your marketplace.

Competitive Analysis


A competitive analysis brings everything into question.

  1. Is medical device reimbursement a competitive advantage, a disadvantage, or a neutral factor in this marketplace?
  2. What is the status of coding, coverage, and payment for competitive products?
  3. What kind of medical device reimbursement program do your competitors have in place?

Understanding your competition through competitive analysis is one of the main ways to stay ahead of the game. We provide you with your competition’s medical device reimbursement profile which not only keeps you informed but also allows you to understand what you are up against. RPI is always working to push you ahead of your competition.

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