Reimbursement Consulting Insights

CMS and Third-Party Payer Clinical Trial Reimbursement: Part 1 -Why

Wed, 17 Jan 2024 14:05:15 GMT

Consider seeking reimbursement for your medical technology’s clinical trial to help long-term commercialization efforts.

This article is the first in a planned multi-part series on clinical trial reimbursement for medical devices. We first wrote about this topic in an article entitled “Seeking Reimbursement During IDE Clinical Trials” published on MedTech Intelligence in 2015.

Clinical trial reimbursement policy is a layered maze that changes depending upon the direction you look. Despite the confusing landscape, obtaining payer reimbursement during an Investigational Device Exemption (IDE) clinical trial can be advantageous for the long-term commercialization strategy of a medical technology. When done correctly, it can be the first step onto what eventually becomes a technology’s successful reimbursement pathway. While the reimbursement pathway for every medical device is different, here are the top eight reasons you should consider investing effort into seeking payer reimbursement for patients enrolled in your clinical trial:

Enhanced Patient Access/Accrual: While patients will likely benefit from the innovative technology being tested, some might be deterred from participating in a trial due to potential out-of-pocket costs. Reimbursement ensures that costs aren't a barrier, allowing broader patient access to potentially beneficial treatments.
Financial Offset: Clinical trials are notoriously expensive, often involving significant costs associated with patient care, recruitment, monitoring, data collection, and more. Reimbursement during the IDE phase can help defray some of these expenses, which is particularly beneficial for startups or smaller companies with constrained budgets.
Payer Engagement: Interacting with payers during the IDE trial phase can provide manufacturers valuable insights regarding evidence requirements and potential barriers to future widespread reimbursement. Early engagement can pave the way for smoother discussions and negotiations post-approval. Additionally clinical trial reimbursement can be a valued entry point for obtaining an approved continued access program.
Real-World Economic Data: Reimbursement during the trial creates an opportunity for savvy manufacturers to gather real-world data on health economics outcomes for the device. Health economic data, when tied to efficacious clinical outcomes, can be invaluable when making a case for the device's cost-effectiveness in later medical policy coverage discussions with payers.
Market Preparedness: Establishing reimbursement pathways during the trial phase can facilitate quicker market adoption post-approval. Healthcare providers are more likely to integrate a device into their practice if they're familiar with it and if reimbursement structures are already in place. Complex medical technologies often require training and may require a physician mentor under a preceptor to become qualified to use a technology. Today’s investigators are a reserve pool of qualified users to help your technology spread and a jumping-off point of early adopters/champions for its utilization with payers.
Stakeholder Relationships: Securing reimbursement during clinical trials can enhance the relationship between manufacturers, healthcare providers, and payers. These early relationships can lead to better collaboration, education, and an understanding of the device's value proposition.
Positive Indicator for Investors: Reimbursement during the trial phase can serve as a positive signal to investors. It suggests that there's a potential revenue stream even before full commercialization has been achieved, and that funds raised can be put toward other key initiatives. It hints at the device's acceptance in the broader healthcare market.
Feedback and Iteration: Engaging with payers and providers about providing reimbursement can also facilitate the provider’s education and allow feedback about the device’s value proposition itself, which can be used in decision-making prior to full market launch.

Not all medical devices or trials will be eligible for reimbursement during the IDE phase. The Centers for Medicare & Medicaid Services (CMS) and private payers have specific criteria that need to be met, and the device’s study protocol must be set up to demonstrate a direct clinical benefit to the patient. The strategy of seeking reimbursement during IDE clinical trials needs to be well thought out, balancing regulatory requirements, financial considerations, and the ultimate goal of bringing a beneficial device to market.

Argenta Advisors has experience navigating CMS and commercial payer requirements and supporting the process of securing reimbursement for Investigational Device Exemption clinical trials for medical technology. We are ready to help you plan and support your strategy.

Is A.I. Going to Make Medical Device Reimbursement Consultants Obsolete?

KMunroe@argentaadvisors.com (Kris Munroe) — Wed, 30 Aug 2023 14:12:54 GMT

A short experiment with Chat GPT to see how useful it is for learning about medical device reimbursement strategy.

Artificial intelligence (AI) has made significant advancements in recent years, revolutionizing various industries by automating tasks and augmenting human capabilities. All this progress has led to one question that is really important to us: “Is A.I. going to make medical device reimbursement consultants obsolete?” We really like our jobs and the lifestyle they afford us. Are innovators going to be able to replace the experts that have historically shepherded them through the process that goes from idea to product?

To get to the bottom of the situation, we conducted a brief three-question experiment with Chat GPT (outlined below) to see how close AI is to replacing the expert reimbursement consultants at Argenta Advisors.

The Test

Question 1: Are you familiar with medical device reimbursement strategy?

Yes, I am familiar with medical device reimbursement strategy. Reimbursement strategy refers to the plan and approach taken by medical device companies to obtain coverage and payment for their products from healthcare payers, such as insurance companies, government programs, and other reimbursement authorities. It involves understanding the reimbursement landscape, navigating regulatory requirements, demonstrating the value and cost-effectiveness of the device, and engaging with stakeholders to secure reimbursement.

A well-developed reimbursement strategy is crucial for the success and commercialization of medical devices. It helps ensure that healthcare providers have the financial incentives and mechanisms to adopt and utilize the device, and that patients have access to the technology without undue financial burden. Reimbursement strategy may involve activities such as conducting health economic evaluations, clinical studies to generate evidence, developing coding and billing strategies, negotiating with payers, and educating healthcare providers about the device's value proposition.

By effectively navigating the reimbursement landscape, medical device companies can increase the likelihood of securing coverage and payment for their products, which is essential for market access, adoption, and revenue generation.

Question 2: How do I get health insurance payers to create coverage policies for a new medical device?

Getting health insurance payers to create coverage policies for a new medical device can be a complex process, but there are several steps you can take to increase the likelihood of success. Here are some strategies to consider:

Generate compelling clinical and economic evidence: Payers want to see robust evidence that your medical device provides clinical benefits and is cost-effective compared to existing treatments. Conduct well-designed clinical studies and health economic evaluations to generate evidence that demonstrates the value of your device. This evidence can be pivotal in convincing payers to create coverage policies.
Engage with key stakeholders: Build relationships and engage with key stakeholders in the payer community. This includes medical directors, policy analysts, reimbursement decision-makers, and health technology assessment (HTA) organizations. Seek opportunities to present your evidence, participate in payer meetings or conferences, and engage in dialogues to understand their perspectives and address any concerns they may have.
Develop a strong value proposition: Clearly articulate the value proposition of your medical device to payers. Highlight how it improves patient outcomes, reduces healthcare costs, and addresses unmet needs. Emphasize the potential impact on quality of care, patient satisfaction, and long-term cost savings. Align your value proposition with the payer's goals and priorities, such as improving patient outcomes, reducing hospital readmissions, or managing population health.
Address reimbursement challenges: Understand the specific reimbursement challenges and barriers for your device. Identify any existing codes, coverage limitations, or reimbursement policies that may hinder coverage. Develop strategies to address these challenges, such as seeking new or revised codes, advocating for policy changes, or providing additional evidence to address payer concerns.
Collaborate with professional societies and advocacy groups: Partner with relevant professional societies, patient advocacy groups, and industry associations that have influence with payers. These organizations can support your efforts by advocating for coverage policies, providing clinical expertise, or participating in policy discussions.
Seek expert reimbursement guidance: Consider engaging reimbursement consultants or experts with experience in navigating payer systems and developing reimbursement strategies. They can provide valuable insights, guidance, and assistance in navigating the complexities of the reimbursement process.
Build relationships with healthcare providers: Engage with healthcare providers who will be using your device. Their support and advocacy can be influential in encouraging payers to create coverage policies. Demonstrate how your device improves patient outcomes, reduces healthcare utilization, and enhances clinical workflows.
Stay informed about policy changes: Stay up-to-date with changes in healthcare policies, reimbursement regulations, and guidelines that may impact coverage for your device. Actively monitor updates from CMS, private payers, and other relevant organizations. Being aware of policy changes allows you to proactively adapt your reimbursement strategy and engage with payers accordingly.

Remember that the process of obtaining coverage policies for a new medical device can take time and persistence. It often requires a multifaceted approach, combining scientific evidence, strategic advocacy, relationship-building, and effective communication with payers.

Question 3: How is reimbursement strategy related to finding investors for my medical device company?

Reimbursement strategy can play a significant role in attracting investors for your medical device company. Here's how reimbursement strategy is related to finding investors:

Market potential and revenue generation: Investors are interested in understanding the revenue potential of your medical device. A well-defined reimbursement strategy demonstrates how your device can obtain coverage and payment, ensuring a market for the product. It provides investors with confidence that there is a viable path to revenue generation, which can make your company more attractive for investment.
Commercialization and adoption: Reimbursement strategy is closely tied to the commercialization and adoption of your medical device. Investors want to see a clear plan for how your device will be introduced into the market, including how it will be reimbursed by payers and adopted by healthcare providers. A robust reimbursement strategy demonstrates that you have considered the market dynamics and have a plan to overcome reimbursement challenges, thereby increasing the likelihood of successful commercialization.
Competitive advantage: A well-executed reimbursement strategy can give your medical device a competitive advantage in the market. If you can demonstrate that your device has secured favorable coverage and payment terms compared to competitors, it positions your company as a more attractive investment opportunity. Investors are more likely to support a medical device company that has a clear strategy for reimbursement success and differentiation in the marketplace.
Long-term sustainability: Reimbursement strategy is essential for the long-term sustainability of your medical device company. Investors are interested in companies that can demonstrate not only short-term profitability but also long-term viability. A solid reimbursement strategy indicates that your company has considered the reimbursement landscape, understands the evolving healthcare policies, and has plans in place to adapt to changes, ensuring sustainable revenue growth.

In summary, a well-developed reimbursement strategy can help attract investors by showcasing the market potential, revenue generation capability, commercialization plan, competitive advantage, and long-term sustainability of your medical device. It demonstrates that you have a clear understanding of the reimbursement landscape and have a plan to overcome reimbursement challenges, increasing the confidence of investors in the success of your company.

Review of the results

Chat GPT’s answers were not wrong, but they were certainly missing insight and at times described wildly oversimplified steps in the process of developing or navigating a reimbursement pathway. This is perhaps seen most acutely in the answer to Question 2. While objectives such as “engage with key stakeholders” and “build relationships with healthcare providers” are the cornerstones of a good reimbursement strategy, they are often big tasks requiring a lot of work, skill, and experience to navigate successfully. To Chat GPT’s credit, it did recommend that a reader should “consider engaging reimbursement consultants or experts with experience in navigating payer systems and developing reimbursement strategies.” This would indeed be a very wise move.

Generally, the reimbursement consulting industry has relied on human expertise and strategic thinking. However, there are limitations to human thinking, particularly in areas involving data analysis, pattern recognition, and predictive modeling. Machine learning algorithms can analyze vast amounts of data, extract insights, and provide recommendations—replicating, and perhaps improving on, some tasks traditionally performed by human consultants. AI-powered tools can conduct market research, identify trends, and even simulate scenarios to aid in decision-making.

However, there are inherent limitations that will prevent the complete replacement of human consultants. AI lacks the intuition, creativity, and empathy that human consultants bring to client engagements. Building trust, understanding complex organizational dynamics, and navigating nuanced client relationships require human expertise and judgment. AI does not have longstanding relationships with key decision-makers at the healthcare payers. Although policy is an important part of the healthcare system, it is important to remember that the reason policy exists is to provide a framework for the vast number of people using individual discretion who make up the healthcare system, and that at some level human-to-human contact and persuasion will remain core to how decisions are made in healthcare.

Rather than a complete replacement, a more likely scenario is collaboration between AI and human consultants. AI technologies can augment human capabilities by automating certain tasks, enhancing data analysis, and providing insights to improve decision-making. Human consultants can leverage AI tools to augment their expertise, increase efficiency, and deliver more value to clients. The key lies in striking a balance between AI-driven automation and the unique skills and insights that human consultants possess.

While the rise of AI presents risks for some consulting jobs, it is unlikely to completely replace human consultants in any industry, never mind the highly nuanced practice of medical device reimbursement consulting. AI technologies can automate routine tasks, provide data-driven insights, and drive efficiency gains, but they currently lack the critical thinking, creativity, and human connection that consultants offer. The successful integration of AI into consulting will involve a collaborative approach in which human consultants leverage AI tools in order to enhance their capabilities and deliver more value to clients. The successful consultants of the future will focus on the things that AI cannot replicate—relationships.

Medical device reimbursement consultants are not going to be replaced by AI, but they will be replaced by other such consultants who know how to leverage the use of AI.

Critical Marketing Considerations for Medical Device Manufactures Impacting Reimbursement Strategy

Wed, 11 Jan 2023 15:58:40 GMT

Patient and provider messaging that is inconsistent with payer messaging can help sink a medical device reimbursement strategy

Balancing competing interests defines medical device marketing and launch strategy.

Successfully marketing a new medical technology is notoriously challenging because it must answer to multiple different constituencies with differing agendas. Patients may respond to ads touting a state-of-the-art product or respond to claims of increased convenience, such as a minimally invasive procedure. Additionally, patients may be prompted to seek medical care by “disturb” ads that highlight risks or describe ominous symptoms.

Physician adoption of medical technologies may also be driven by convenience and competitive advantage, but physicians will likely also be sensitive to how a new technology, such as a new office-based laboratory test, will impact their bottom lines. Healthcare facilities will be sensitive not only to the demands of physicians, but also how a new test or treatment, such as a new surgical tool or implantable device, impacts payment rates.

Finally, healthcare insurers are probably the most important audience for any product launch. Quite simply, a technology’s success is unlikely in the absence of insurance coverage and payment. Furthermore, the insurer is the one stakeholder who is most explicitly focused on evidence-based medicine, often requiring more data—in both quality and quantity—than required by the patient, physician, or facility. The key question is how to align the marketing messages across all of these constituents. Specifically, how do marketing messages targeted at patients and healthcare providers impact third-party payers?

The creators of a medical device marketing launch strategy need to consider its reception by payers to understand the strategy’s potential impact on reimbursement pathways.

When payers become aware of a new medical technology—based on publicity in trade publications, a new FDA clearance/approval, a new CPT or HCPCS code, or inquiries from physicians, manufacturers, or patients—one of their first decisions is whether to manage the technology through an evidence-based coverage policy. Clearly, payers can only create, implement, and update medical policies for a small subset of medical technologies, and their impact on budgets is a key consideration in this decision. While payers typically don’t have a clear picture of the full scope of the budget impact, they generally will consider both the cost of the technology per episode of care and the potential size of the target population.

Once payers decide to create a medical policy, the next decision focuses on the evidence requirement. What are the key health outcomes for a technology? What type of data is required to validate these outcomes, i.e., randomized trials or observational studies?

It is important to understand that marketing messages to physicians and patients may prompt payers to subject a medical technology to an evidence-based coverage policy AND impose a challenging evidentiary requirement, resulting in negative coverage.

Policies posted on payer websites focus entirely on the published medical literature; however, payers will also review manufacturer websites and other ancillary sources to increase their understanding of how a technology will be integrated into the healthcare delivery system. A common “disturb” point for payers is the potential size of the target population. Here is where patient and physician marketing can intersect in unexpected and negative ways with the payer’s agenda. Manufacturer websites noting that a physician can expect a high volume of referrals and direct-to-consumer ads proposing a minimally invasive solution to a chronic problem can prompt payers to prioritize a technology for an explicit coverage policy. For example, if a website for laser surgery states that “a less than one-inch incision can give you relief from chronic neck or back pain,” this statement is an immediate red flag for payers to investigate the technology further.

A case study comparison of strategies for balancing medical device marketing with medical device reimbursement strategy

In the 2000s, a variety of minimally invasive procedures were promoted as alternatives for the treatment of gastroesophageal reflux disease (GERD). Some manufacturer websites encouraged patients to ask their physicians about alternatives to GERD medication. Although these campaigns successfully drew attention to minimally invasive procedures that could offer a permanent solution for GERD, they also prompted payer concerns regarding the potentially large size of the target population for the treatments. Patient-targeted marketing campaigns contributed to the payer’s focus on the impact of the immediate up-front costs of the procedures. In some cases, payers responded with explicit coverage policies featuring the extremely high evidence requirement of large, placebo-controlled randomized clinical trials with long-term follow up, far exceeding the evidence required by the FDA through the 510(k)-clearance pathway. As of the most recent republication of this article in December 2022, many of those technologies are still facing reimbursement challenges due to inconsistent coverage policies across the US.

In contrast, in the late 2010s, a similar phenomenon happened with implantable stimulators for treating sleep apnea etiologies, but with different results. The maker of an implantable hypoglossal nerve stimulator (HGNS) for treating obstructive sleep apnea (OSA) began a nationwide marketing push that included direct-to-consumer marketing. Because of the perceived breadth of the possible OSA markets, in addition to the dubious clinical results of earlier surgical options, payers raised concerns regarding the potentially large size of the target population for the new technology. Similar to GERD, many payers responded with explicit coverage policies characterized by extremely high evidence requirements. However, in the case of HGNS, the aggressive medical device market launch strategy was paired with an equally aggressive clinical data collection and reimbursement strategy. The launch was timed to coincide with the release of three-year follow up and registry data. Early adopters were then supported by a ground-up strategy that engaged the specialty societies and enabled patient access through appeals support. By the time the manufacturer released five-year follow-up data and a significant registry, HGNS had already began to receive general payer acceptance and broad coverage. In the case of HGNS, balancing the agenda of patients, providers, and payers required balancing an investment in developing clinical outcomes data and physician support with other investments as part of the national commercialization launch.

There is no easy solution to balancing the competing agendas of patients, providers, facilities, and payers. However, at the very least, manufacturers’ reimbursement and marketing departments should work together very closely to ensure that patient and provider marketing does not get ahead of payer concerns.

The following article was originally contributed by Argenta Advisors to Reimbursement Report in MedTech Intelligence (MTI) on December 3, 2015. It was then edited and republished on Nov. 17, 2020. We have chosen to update and republish it again because of its popularity. It is a deeper dive into an issue we recently discussed in our article, The 7 Market Access and Payer Outreach Mistakes That Will Haunt Your Medical Device or Therapeutic.

Contact Argenta Advisors' market access team and reimbursement consultants for help with understanding how your medtech marketing strategy will impact your reimbursement strategy.

The 7 Foundational Reimbursement Strategy Issues: What to Review Before Your First Meeting with a Reimbursement Consultant

Thu, 24 Feb 2022 19:35:49 GMT

Being prepared with foundational information before your first meeting with a reimbursement consultant can help your reimbursement strategy or market access plan climb to the next level before you even write your first check to a consultant.

Developing a successful reimbursement strategy or market access plan means seeking help from reimbursement or market access experts. However, before the parties enter into any agreement for reimbursement services, there is always at least one preliminary call. During this call, both parties are trying to learn as much as possible about each other to gauge the potential for success in a future working relationship. Consultants, for their part, are trying to provide as much detail about their skillset while learning as much as they can about the technology they will encounter. The following list of foundational reimbursement strategy issues is intended to help innovators conduct a brief self-assessment. Argenta Advisors recommends that all innovators use this list as a self-assessment prior to having a call or meeting with a reimbursement consultant to discuss their reimbursement issues or needs.

1. Have a clear and written clinical vignette outlining the expected clinical use case(s) for your medical device or test.

Creating a clear written clinical vignette is the first and most important step in reimbursement strategy. In the context of medical device or test development, a clinical vignette is an abridged report relating to a typical patient, summarizing any relevant history, physical examination findings, investigatory data, and treatment scenario. It should make it clear to a reader when (e.g., preoperative, peri-operative), where (e.g., inpatient, outpatient, ASC, MD office), and on whom (e.g., all ages, pediatric-only, Medicare age range) a particular treatment, test, or procedure will be used by a provider, along with the expected medical specialty that is being targeted. It should describe the most common course of any medical care using a particular technology.

In the reimbursement and market access strategy development phase, example vignettes describing how patient care will proceed form the foundation of the entire reimbursement process. Post-commercial launch, the reimbursement cycle begins with physician medical record notes and documentation that is then translated into billing codes and that are then submitted to third-party health insurance payers. A clear written clinical vignette in the pre-commercial launch strategy phase serves as a surrogate for physician documentation in the clinic.

For very early-stage companies, the clinical vignette may be entirely hypothetical. As the technology matures, it may be based upon a typical subject in a clinical trial. For mature products, it might be based on de-identified representative case studies from the real world. For all products, it should be based on clinical use in practice, available data, and applicable guidelines.

According to the American College of Physicians , a good clinical vignette “follow[s] the basic rules of medical communication; describe[s] in sequence the history, physical examination, investigative studies, and the patient's progress and outcome.” Additionally, it should “avoid the use of medical jargon and excessive reliance on abbreviations. Limit abbreviations to no more than three, and favor commonly used abbreviations. Always spell out the abbreviations the first time they are mentioned unless they are commonly recognized (e.g., CBC).”

A well-written clinical vignette will help a reimbursement consultant identify the potential value proposition; that is, the outcome-supported details demonstrating why payers should provide coverage and payment for your product. It is the most important foundational document and necessary for a reimbursement consultant or strategic coder to assess your technology.

2. Be prepared with details about your FDA clearance, approval, or authorization pathway, and, most importantly, the indications for use and your intended claims.

The balance between regulatory and reimbursement starts at the very beginning of development. The best practice is to get your basic regulatory strategy and information out in front of any reimbursement consultant as soon as possible at your first meeting discussing a possible strategic partnership.

The FDA regulates the label and labeling (e.g., indications for use, safety, and complications) of medical devices. Generally, the FDA considers a product to be a medical device if it is intended to diagnose, cure, mitigate, treat, or prevent disease in a human or if it is intended to affect the structure or any function of the body. A medical device is different from a drug because it does not achieve its primary intended purpose by chemical action or by being metabolized. For a claim of efficacy to be made, you must demonstrate that your product is substantially equivalent to a legally marketed product making similar claims or you must independently establish that your product is safe and effective for the intended use associated with reducing, preventing, or eliminating disease.

For established products, the easiest way to communicate this information is by sharing your FDA approval or clearance letter containing your indications for use. In the case of an exempt device, share your basis for making claims. If your product has not yet received regulatory approval, be prepared to talk about its probable regulatory pathway and your expectations as to labeling, including indications for use and claims of efficacy.

Your indications for use and intended claims should be consistent with your clinical vignette; together they create the framework for how you can talk about your medical device with payers. Regulatory missteps can have high-stakes consequences, including the scrapping of a reimbursement strategy. Additionally, reimbursement collateral and support should always be consistent with labeling; providing that information early to your reimbursement consultant is a key to success.

3. Know the standard of care or gold standard in the field of medicine of your medical device or test as well as the alternative and competing treatments available in the market.

The standard of care is a recommended treatment process that a clinician should follow for a certain type of patient, illness, or clinical circumstance. Typically, the standard of care is defined by broad market adoption or through clinical guideline support from the medical community, such as medical societies or specialist societies that outline the suggested course of treatment for a disease or condition.

Tests and diagnostics are measured against the gold standard. The gold standard refers to the method or test (diagnostic, prognostic, blood test, biopsy, etc.) that the medical community has broadly adopted as the current best means of diagnosing a particular condition. The gold standard for any specific disease is not set in stone and can change over time, as the available evidence from randomized clinical trials (RCTs), guidelines, and clinician behavior changes.

When having your first meeting with a reimbursement consultant, you should be able to answer questions like, Why does your treatment matter in the continuum of care? Why would healthcare providers want to use your technology instead of another one? How does your technology improve net health outcomes over the standard of care or gold standard?

Experienced reimbursement consultants are generally familiar with multiple therapeutic areas, and are likely familiar with yours; however, you should be the person most aware of your competitive environment and be prepared to discuss it.

4. Don’t assume that what you think is the problem is the problem.

Reimbursement strategy and the reimbursement process depend upon three elements: coding, coverage, and payment. None of these elements operates independently.

A popular misconception of innovators entering the medical device space is that finding or obtaining a code (e.g., CPT or HCPCS) is the ultimate step toward making your product available to patients and reimbursable by third party payers. Codes do not guarantee coverage or payment. Even more surprising, coverage does not always ensure payment. A technology can have a code and a coverage policy but still be listed at $0 payment.

Reimbursement strategy and market access issues often require solving or navigating an interwoven set of puzzle pieces, and changing one variable can impact the rest. When working with a reimbursement consultant, it is important to walk through the factors affecting each of the elements before making assumptions.

5. Know where your publication strategy has been and where it is going.

Just like “Location, Location, Location” drives real estate strategy, “Data, Data, Data” drives reimbursement strategy. While the first call with a reimbursement consultant is not going to be a full and thorough review of your outcomes evidence package, a cursory discussion or mention of a few key clinical publications, either available or in process, is important to helping your potential reimbursement consultant get their bearings on where your product stands and where a successful reimbursement strategy could take it.

It is important to note: your clinical outcomes must be available in published, peer-reviewed manuscripts. This does not include abstracts or presentations made at medical society meetings, nor does it include white papers outlining your technology.

Well-developed products that are close to market launch should be supported by a current bibliography and at least a list of key publications, including pivotal trials and a plan for real-world evidence generation. For early-stage innovators that are still at proof-of-concept stage and do not have any published peer-reviewed clinical data, it is important to at least have a sense of what your anticipated budget or expectations for data generation will be.

If you do not have a written publication strategy, stop whatever you are doing and consider what that strategy may look like on paper. The availability of clinical data is one of the most important tools in the reimbursement strategy toolbox. Good planning and execution of a publication plan can help remove one of the most confounding obstacles to a reimbursement or a market access strategy.

6. Be prepared to talk about your plans for fostering adoption among the medical community for your product.

At your first meeting with a reimbursement consultant, you will field some questions about what your efforts have been to engage with the medical community about your product. Having a snapshot of your key opinion leaders (KOLs), centers of excellence (COEs), and your work to date with applicable medical societies will be important for assessing where your plan is and where it is going.

KOLs or “champions” are the launching point for most medical devices. The availability or need to develop KOLs or COEs is something that needs to be taken into account in the earliest stages of planning a reimbursement or market access strategy. As we discussed in our post, The 6 Critical Digital Health Reimbursement Mistakes Holding Innovators Back , failing to recognize that healthcare purchasing is still dominated by physicians can hobble the launch of a technology. In addition, the physician community, through clinical physician stakeholders and champions, helps make sure that the new technology fills a clinical need and is practical to use in the real world. Additionally, support from the clinical community is the key to opening doors with payers for medical policy coverage support and at the American Medical Association CPT committee for coding support.

7. Be aware of the target geography of your sales or sales targets.

Geography matters in market access launch efforts. A common characteristic of effective reimbursement strategies is the creation of an alignment between reimbursement and sales+marketing, with respect to which reimbursement has some input into sales targeting, but ultimately follows targeted sales and provider demand. It is important to remember that reimbursement can have an impact on sales targeting strategy but cannot dictate your development and sales strategy. Different states and different cities use different mixes of various local and national health insurance payers. The mix of payers involved early on in a product launch can have long-lasting implications for a reimbursement strategy or market access plan. Being able to discuss the geography of your sales or sales targets with your reimbursement consultants gives them a picture of where the pieces are on the board and how they might be played to get you the best outcome.

Technologies near launch should be able to look to the marketing sales plan or investigator sites to obtain this information. Early-stage innovators can look to where their development partners are or where their investigation sites are likely to be.

Healthcare provider demand translates into demonstrated utilization. As discussed in our other articles, demonstrated utilization is the linchpin to an effective reimbursement strategy. Third-party payers will generally not consider a medical device or test for medical policy review and acceptance without demonstrated utilization. Being able to discuss the target geography of your sales or sales targets will help your potential reimbursement consultant gauge the potential to leverage early adopters and sync this evaluation with a targeted sales and reimbursement strategy to advance your goals.

Conclusion

Not all reimbursement consulting groups are the same and gauging fit early on is important to developing a strong working relationship with your reimbursement partner. If you are prepared to discuss the seven foundational reimbursement strategy issues discussed above, you will be able to get the most out of your time spent auditioning reimbursement consultants.

As the innovator, developer, or product manager, you are the best-informed person in the world on your technology. Although reimbursement consultants should be subject matter experts on reimbursement strategy and market access planning, you will always be the most knowledgeable subject matter expert on your product/technology. Be prepared to provide a concise outline of your technology in the marketplace as outlined above. This will enable a good reimbursement consultant to provide you with a frank and accurate assessment and help guide them in tailoring their available services to your needs.

Now that you are familiar with the 7 foundational reimbursement strategy Issues -take the next step. Contact Argenta Advisors' strategy team and reimbursement consultants to take the next step towards a successful commercialization and reimbursement strategy.

The 6 Critical Digital Health Reimbursement Mistakes Holding Innovators Back

Tue, 16 Nov 2021 18:11:50 GMT

The clash of cultures between the medical device and high-tech worlds creates a chasm between the expectation and the reality of payer adoption and reimbursement.

It is no surprise that our team of reimbursement consultants has been inundated with entrepreneurs developing digital health therapeutics that are attempting to build reimbursement strategies and implement market access plans. The digital health therapeutic sector has been growing at an average of 40 percent per year over the last several years. In the first half of 2021, digital health companies brought in $14.7 billion, already more than they raised in all of 2020, according to Rock Health . This investment growth, combined with needs created by the COVID-19 pandemic, have led to a boom in the development of digital health technologies. However, despite the flow of attention into digital health, relatively few digital health technologies have garnered payer interest or consistent and reliable reimbursement.

While working with the deluge of innovators, our reimbursement consulting team has noticed some common challenges with the reimbursement strategies and market access plans that have been proposed by these digital health technology companies. These potential obstacles are being created by the clash of cultures between the fast-paced technology innovation community that is developing these products and attempting to launch them into the more traditional healthcare innovation ecosystem. While many of these missteps and philosophical issues are common to all innovators, they are particularly pronounced in the digital health therapeutic space because so many of the leaders of this revolutionary new sector were formerly leaders in the consumer technology sector. To be successful in launching a digital health therapeutic, innovators will need to be aware of the following six critical mistakes they are making:

1. Approaching entry to market with a digital healthcare technology in the same way as with an ordinary digital consumer technology.

The regulation of both healthcare and of healthcare sales and marketing creates a level of complexity that is not paralleled in consumer products. Further, the relationship between patient, provider, and insurer causes the healthcare marketplace to work differently from ordinary consumer or business-to-business markets. It is not coincidental that reimbursement strategy is colloquially referred to as a “reimbursement pathway.” The first to market a healthcare technology gets to be the first to work through all the issues related to coding, coverage, and payment. Think of a hiker or cross-country skier after a three-foot snow. The first person down the trail has quite a bit of work to move forward, but each successive person that follows gets to enjoy a better-packed pathway until finally there is a well-groomed trail. Unlike in consumer goods, where first to market is usually an advantage, fastest to market does not mean first to be reimbursed. Additionally, the need to navigate regulatory pathways in healthcare often requires a level of commitment that stifles the ability to fail fast and pivot quickly.

2. Attempting to influence medical policy by asserting that health economics data is a substitute for health outcomes data.

Value is one of the most misunderstood concepts in healthcare technology. While the ability to show savings in healthcare (cost effectiveness/cost avoidance) is an important factor driving market access, health economics data cannot stand on its own. We frequently see innovators from consumer technology espousing the naive belief that saving money is always better and should be good enough for Medicare or a commercial insurer to establish coverage. It is not. Value in healthcare means demonstrating an improvement in net health outcomes for patients without adding to overall cost. Published peer-reviewed clinical data demonstrating that a technology directly results in improved patient outcomes as compared to the current standard of care is a NECESSITY before costing information is considered by payers.

3. Designing a product at the bench or programming terminal instead of designing it from the clinic.

While novel technology that fills an unmet medical need often faces a challenging pathway, novel technology that is not a response to an unmet medical need faces a nearly impossible climb up a cliff. Really interesting and innovative technology can draw investment dollars based upon vision and potential, but this potential does not translate into coding, coverage, and payment. The ability to fill a clinical need and demonstrate that ability with published data does. It is vital for a digital health technology innovator to understand which physician specialty will be drawn to utilize the device(s) for their patients, along with how it will impact medical decision-making and result in higher-quality outcomes for their patients.

4. Failing to recognize that healthcare purchasing is still dominated by physicians.

Working with and involving clinical physician stakeholders and champions early on is one of the keys to success for any new healthcare technology. In addition to helping make sure that the new technology fills a clinical need and is practical to use clinically, support from the medical community is a necessity for successful commercialization. Technologies that reduce physicians’ workload or usurp their judgment without good reason are not always welcome. Additionally, CPT codes are maintained by the American Medical Association’s CPT Editorial Panel, and additions and changes to these are voted on by physicians. Most applications without the support of a medical specialty society are dead-on-arrival. However, by working with physician stakeholders early on, innovators can find out reasons the medical community may have to object and then develop an appropriate value statement and positioning to deal with their objections before they become an issue. Physicians are ultimately the only determinants of whether a treatment or technology is medically appropriate for a particular patient/diagnosis.

5. Making assumptions about CPT payment codes without understanding that clinical data, utilization, and societal support are all necessary to obtain a CPT code along with coverage.

Not every innovation requires a new CPT code. However, the decision to recommend or use an existing code should be researched and reviewed by a certified coder before it becomes part of a commercialization strategy. Should a new CPT code be necessary because no currently available code is appropriate, the AMA’s CPT Editorial Panel will require the submitter to provide support for it by demonstrating the demand for the product in addition to published peer-reviewed clinical outcomes data. Not unlike a payer, AMA’s CPT is not interested in establishing new CPT codes for physician services related to technology that is not able to demonstrate a broad utilization demand in addition to favorable clinical outcomes. Codes for new technology are created when it becomes apparent to the medical community that currently available codes are inadequate to report a new procedure, service, or treatment. They are not created for the purpose of aiding the marketing of a new technology.

6. Assuming that the creation of payer policy will lead to sales and not vice versa.

The purpose of medical policy is to provide a basis for utilization management decisions—it is not to create a marketing channel for your digital health technology. Payers do not typically take the time to develop medical policy for technologies that have not demonstrated sufficient utilization. While the development of clinical data is necessary for creating a basis for medical policy, utilization creates the impetus for its creation. Payer medical policy and technology evaluation teams have bandwidth limitations—unless there is a need, a demonstrated demand made by providers and patients, to address and manage a technology or treatment, it will likely not be addressed. A review that is requested by a manufacturer without a contracted or network physician submitting claims or expressing a desire to submit claims soon is not likely to succeed. Over our years of practice, we have heard consistently from medical directors that they become resentful when a medical device, diagnostic, or therapeutic manufacturer consistently attempts to use medical policy to get the payer to create a market to sell their product. It is one of the seven common ways to disenfranchise payer medical directors. For the others, read “ The 7 Market Access and Payer Outreach Mistakes That Will Haunt Your Medical Device or Therapeutic .”

With improving technology, the availability of investment money, and the opportunities created as a result of the pandemic, the push to create and commercialize digital health therapeutics will continue. While there are areas of care, such as behavioral health, that face challenges calling for digital therapeutic solutions, not every area has a problem that needs solving. The digital health innovators that are successful in commercializing their technologies and receiving coding, coverage, and payment will be the ones that respect and acknowledge the requirements of the parties already existing in the healthcare ecosystem. While digital healthcare will likely change the healthcare system over time, it will need to modify its philosophy to gain acceptance by payers to achieve favorable medical policies, and to create access to new technologies for providers and patients.

Contact Argenta Advisors' market access team for help avoiding these mistakes today >>

8 Utilization Topics You Need to Understand to Drive Your Market Access Plan or Reimbursement Strategy

Tue, 27 Apr 2021 15:38:23 GMT

Obtaining Coverage Coding and Payment for Your Technology Means Understanding and Demonstrating Utilization

Successfully establishing coverage, coding, and payment requires a top-down and bottom-up approach. Top-down efforts usually take the form of market access efforts focused on direct payer education and a discussion of published clinical outcomes data. The bottom-up approached revolves around the demonstration of patient and provider demand that, in healthcare, is referred to as utilization. Understanding and effectively driving utilization in the absence of definitive coding, coverage, and payment forms the foundation of successful reimbursement and market access strategies. Utilization is a significant factor that influences a payer’s decision to create or modify coverage policy and it leads to demonstrating when a medical device, diagnostic, or therapeutic has become a standard of practice.

1. Utilization, from a reimbursement strategy and market access perspective, describes demonstrated demand.

Ordinarily, utilization in healthcare is the quantification or description of the use of services by persons for the purpose of preventing and treating health problems, promoting maintenance of health and well-being, or obtaining information about one's health status and prognosis. In the context of market access and reimbursement strategy, the term utilization describes the level of demand demonstrated to health insurance payers from patients and providers. Literally speaking, it defines “who wants to use it” and “how often is it used.”

2. Not every product sold equates to a utilization datapoint in the context of a reimbursement strategy.

If a new technology is being used in a way in which it would not generate a trackable metric for a health insurance payer, such as in cash pay cases or miscellaneous CPT code billing, it does not create utilization data from a reimbursement strategy perspective. Failing to understand that product sold or used does not always translate to demonstrated utilization is a potential pitfall for unwary manufacturers.

3. Payers do not often take the time to develop medical policy for technologies that have not demonstrated sufficient utilization.

The desire for management of utilization explains the reason that medical policy is established. While the development of clinical data is necessary for creating a basis for medical policy, utilization creates the impetus for the creation of medical policy. Payer medical policy and technology evaluation teams have bandwidth limitations. Unless there is a need, demonstrated demand by provider and patient, to address and manage a technology or treatment, it will likely not be addressed. A review that is requested by a manufacturer without a contracted or network physician submitting claims, or expressing a desire to submit claims in the near future, is not likely to succeed. Such a request has the potential to be seen as a waste of time by policy teams with limited resources, and it is unlikely to lead to a thorough review at most payers. The purpose of medical policy is to provide a basis for utilization management decisions—it is not to create a marketing channel for your medical device, diagnostic, or therapeutic.

Market access and payer outreach efforts should not outrun your company’s targeted sales strategy and provider use. Over our years of practice, we have heard constantly from medical directors that they become resentful when a medical device, diagnostic, or therapeutic manufacturer consistently attempts to use medical policy to get the payer to create a market to sell their product. It is one of the seven common ways to disfranchise payer medical directors. For the others, read “The 7 Market Access and Payer Outreach Mistakes That Will Haunt Your Medical Device or Therapeutic.”

4. Utilization for a product is demonstrated through patient and provider demand that is communicated to health insurance payers.

Provider demand is best demonstrated when payers receive claims or predetermination requests for a technology or treatment. Although there are other methods of expressing demand such as supporting letters, social media interactions, and telephone requests, the clearest and most effective way to generate utilization is for providers to express their desire to use a technology or treatment for their patients through the submission of claims.

5. Showing utilization for a medical device, diagnostic, or therapeutic that has no coverage can be challenging and is one of the greatest barriers to a successful medical device product launch.

Demonstrating utilization for a product that is not receiving coverage or payment from payers is typically the greatest challenge facing innovators that are introducing new technology and attempting to develop a reimbursement pathway. Providers are often reluctant to select a product for use if they are uncertain that they will be reimbursed. However, without providers requesting or using a particular technology, it is unlikely that it will garner enough attention to justify the review of supportive clinical data and the creation of a positive medical policy. The resulting chicken-and-egg scenario is frustrating to innovators looking to successfully drive adoption of their products or technology. For medical policy to be created, first, demonstrating demand is required. And established demand providers, at risk for the purchase price of the technology, need to know that they will be reimbursed.

6. There are some tools and techniques available to manufactures to help with the chicken-and-egg problem created by the challenges of driving utilization.

Although the challenge can seem daunting, there are strategies that medical device manufactures can implement to increase patient and provider comfort about the ability to garner reimbursement for new medical technology. Often manufactures will overcome this problem by offering, or offering through a reimbursement consultant, reimbursement support programs such as a reimbursement support hotline designed to help providers locate information and appeal denials of claims or pre-authorizations.

Manufacturers of medical devices can help promote access to care by providing reimbursement support and information. According to the AdvaMed Code Of Ethics 2020 , activities permissible for a medical device manufacturer include “Facilitating patient access to the Company’s Medical Technologies by providing Health Care Professionals with assistance in obtaining patient coverage decisions from payors, including providing information on payor policies and training on procedures for obtaining prior authorization, providing sample letters and information on medical necessity and appeals of denied claims. In addition, at the request of a Health Care Professional to facilitate patient access to the Company’s Medical Technology, and subject to appropriate privacy safeguards, the Company may assist the patient by facilitating the preparation and submission of requests for coverage determinations, prior authorizations, pre-certifications and appeals of denied claims, relating to a Company’s own Medical Technology; however, such assistance should not be provided as an unlawful inducement.” In short, the code does not discourage medical device manufacturers from taking some actions to promote patient action to care, so long as there are safeguards. Except for large companies, those safeguards are best managed by an experienced reimbursement consultant working on an established reimbursement support hotline. Argenta Advisors can help you with your reimbursement support line .

7. Utilization is necessary for a CPT code.

Should a new CPT code be necessary, as no currently available code is appropriate, the AMA CPT Editorial Panel will require the submitter to provide support, demonstrating the demand for the product. Not unlike a payer, AMA CPT is not interested in establishing new CPT codes for technology that is not able to demonstrate broad utilization demand in addition to supportive clinical outcomes.

8. Even denied authorizations and appeals can help drive utilization.

Denied claims and appeals still matter. Appeals communicate to payers the demand for a policy revision. Whether or not the appeal is successful the appeal still communicates that patient and provider was invested enough in the desire to use a particular new technology to take the time to prepare an appeal. Appeals cost time and effort for the appellant and for the payers. Appeals that go all the way to independent external review show substantial commitment to a technology. Requests and overturned appeals from external review organization can send a clear message that medical policy is outdated, unrealistic, or otherwise in need of review.

Even the most promising medical device technologies can end up in the scrap heap of history by not demonstrating adequate utilization. Demonstrating early utilization most often means fighting for coverage of a new technology on a case-by-case basis. It requires providers and patients to be willing to advocate for the product and building a successful case story to support the claim. Without support, many patients may not elect to receive treatment with a new technology without the comfort that their out-of-pocket costs will not skyrocket because of a denied claim. Developing effective reimbursement support programs such as a reimbursement hotline can help if done properly.

Figuring out the most effective way to show utilization for a new medical device or therapeutic technology is not always straightforward. Talk to our experienced reimbursement strategy consultants today to help develop a successful reimbursement strategy and market access plan to drive utilization for your technology by helping providers get access to the patients that want and need it.

Living with a Legacy: Reimbursement Barriers Based on Technologies that Came Before

Tue, 16 Mar 2021 15:49:51 GMT

Reimbursement Barriers Based on Technologies that Came Before

The following article was originally contributed by Argenta Advisors to the Medical Device Summit (MDS) “Summit News” ( www.medicaldevicesummit.com ) Although this article was originally published by MDS on March 11, 2015, the ideas in it are as true today as they were then.

Living with a Legacy: Reimbursement Barriers Based on Technologies that Came Before

Commercialization of any medical device requires consideration of the reimbursement environment in the corresponding therapeutic or diagnostic space. While one would like to think that a technology supported by positive data from a well-designed trial would result in positive coverage, that is often not the case. The frustrating truth is that, at best, the reimbursement environment is characterized by baseline payer skepticism. At worst, the environment can seem hostile, particularly if the technology is entering a space where the payer has had negative prior experiences. Prior “aggressive” tactics of manufacturers launching new technology can poison the reimbursement environment for a related, but distinct technology occupying the same space. The following discussion traces the history of two of the most challenging reimbursement environments: wound healing and spine technologies.

Wound Healing

The challenging reimbursement environment for wound healing technologies dates back at least twenty or more years to the advent of wound healing clinics using autologous platelet cell preparations, which were aggressively marketed without supporting evidence such as randomized trials. In addition, during this time there was a plethora of products that were proposed for wound healing, including such technologies as electrical stimulation, noncontact normothermic wound therapy, and negative pressure wound therapy (NPWT). At their introduction to the market, these devices were similarly not supported by randomized trials. In particular, NPWT was aggressively marketed by suppliers who organized effective grass roots support resulting in widespread overturned payer appeals. Essentially, payers were forced into making a business decision to initiate coverage for NPWT rather than a purely evidence-based coverage decision.

This adversarial environment has now bled into other wound care technologies. Skin substitutes are a particularly notable area of controversy. For example, a variety of human dermal allografts with different trade names have been used to treat diabetic ulcers. While these products may vary in the details of their processing, essentially all consist of acellular dermal tissue that is used as a scaffold for wound healing. Payer policies have addressed these allografts individually by their trade names instead of considering them collectively as a commodity. Additionally payers have imposed a very high evidence requirement consisting of randomized trials comparing the allografts either to each other, standard wound care or other bioengineered skin substitutes. This challenging environment is further compounded by the sheer volume of wound care technologies that are often grouped together in a single payer policy. The Anthem policy titled, “Allogeneic, Xenographic, Synthetic and Composite Products for Wound Healing and Soft Tissue Grafting” ( http://www.anthem.com/ca/medicalpolicies/policies/mp_pw_a053309.htm ) addresses 150 products individually by trade name. In general, all of these products are subjected to the same standard of randomized trials. In reviewing this jumbo policy, it is difficult to understand a payer’s interest in addressing these technologies with such granularity, but this is the road that was first established some twenty years ago, dating back to the negative experience with wound healing clinics.

Spine Technologies

Similar to wound healing, payers may feel that they have been “burned” by prior spine technologies. Examples include minimally invasive alternatives for discogenic back pain, such as IDET (intradiscal electrothermal therapy) or laser discectomy. These technologies, cleared by the FDA through the 510(k) pathway, were not initially supported by results of controlled trials. The technologies were aggressively marketed by manufacturers and payers responded by issuing negative coverage policies. Payers were able to maintain these policies despite the considerable push back from providers and manufacturers, requiring considerable administrative dollars for payers to manage the appeals process. This created the initial adversarial coverage environment. Percutaneous vertebroplasty (PV) is a minimally invasive technique for the treatment of vertebral body fracture, a completely different indication than discogenic back pain. However, PV inherited the same adversarial reimbursement environment. In the absence of randomized studies, payers responded with negative coverage policies, and a pitched battle broke out between payers and PV advocates. Similar to NPWT, payers ultimately conceded to the grass roots support and began covering PV, but the experience left a bitter taste. The positive coverage appeared to be a defeat for evidence-based medicine, particularly when two small randomized sham-controlled Australian trials did not report positive results.

A variety of fusion technologies then entered this heightened environment of payer skepticism. Payers have been reluctant to cover different surgical approaches to a standard fusion procedure, even though the therapeutic component of the overall procedure, i.e. the fusion itself as opposed to the access, involves standard surgical principles. In reviewing these policies, one has to wonder why payers are devoting the time and resources to tightly managing the access component of an otherwise standard fusion. The answer lies partially in the overall reimbursement environment of the spine space itself. Likewise, artificial discs have been subject to this same phenomenon. The pivotal trials consisted of noninferiority trials comparing artificial discs with standard fusion techniques. Payers responded negatively to this trial design, stating that the control fusion group was a flawed gold standard since it had never been proven superior to conservative treatment in a controlled trial. This rationale essentially created a double standard of accepting fusion as the gold standard, but requiring that artificial discs meet a higher level of evidence that the covered gold standard fusion would not meet.

Conclusion

Understanding the reimbursement environment is a critical exercise when planning the commercialization of a medical technology. Unfortunately, this environment is influenced by more than just clinical data. Payers’ negative experiences with prior technologies in the same space can implicitly raise the payer evidence requirement. Manufacturers should anticipate skepticism (healthy or otherwise) within the payer community when launching new products, particularly in these areas of medicine. Understanding the history of technologies that have come before, and identifying ways in which to avoid some of the same pitfalls, is critical. As evidenced above, this may not always be possible. However, the more new technologies can be differentiated from products in the same space that built support based on limited clinical data, the more successful these new products will be in defying old biases and turning payers’ skepticism into pragmatism or, dare it be said, enthusiasm.

Contact Argenta Advisors' strategy team and reimbursement consultants for help understanding how you can overcome the barriers left by prior life science technologies that might be impacting your reimbursement strategy.

The 7 Market Access and Payer Outreach Mistakes That Will Haunt Your Medical Device or Therapeutic

Thu, 01 Oct 2020 21:15:34 GMT

Learn how to avoid the common mistakes that can permanently haunt the reimbursement and market access efforts for your medical device or therapeutic from experienced reimbursement consultants

The modern workplace is filled with so much information that most modern workers have become information conduits, sorting information from one electronic pile to another. Payer medical directors face the same challenges, doing so with mountains of highly technical information with literal life and death stakes while managing billion dollar spends.

At the end of the day, payer medical directors and their staff want to ensure they get their members the highest quality care for the money they spend. However, during the day, they are bombarded with information from industry and requests from providers. The product presentations that negatively affect their workday are going to be remembered. Companies that burn up their credibility never quite get it back, and reimbursement staff and provider offices that create busywork wear down hard-earned goodwill. Through over twenty years of practice as reimbursement consultants doing market access work with medical directors at national, regional, and local payors, we compiled this list of ways to fail (or what not to do) while conducting payer outreach.

1. Send everything that could ever possibly apply to your product with no index or organizational scheme.

“If it fits it ships” might be a good moniker for the USPS, but it is a terrible philosophy for any market access team conducting payer outreach. Most payer medical directors suggest including additional information if it is relevant and helpful to a claim, request for individual considerations, or a request to review a technology. However, including any and all information that may be relevant, is the fast track to having nothing read. We have seen medical device and therapeutic manufacturers implement payer packages attached to claims that are many hundreds of pages long and sent with no index or organizational scheme. Often when these packages are sent with a claim or preauthorization, they land at the payer in electronic faxes as enormous pdfs that are unwieldy to review or share within the company. As a result, they are not shared, and they make reviewing difficult.

Alternatively, in support of a technology, a market access team may send an email with attachments—often with nondescript file names—containing every study ever published, as well as any relevant policy, news story, and technical manual. Unorganized attachments with unclear names can become so difficult to follow that they will be ignored.

The best practice is to send what is most relevant and helpful for reviewing the case or reviewing the technology—and nothing extra. Although it may seem challenging to sort out what is relevant and helpful, an experienced reimbursement firm like Argenta Advisors can help you develop your most effective payer dossier for claims and payer outreach.

2. Push a medical device or therapeutic directly to the payer when providers are not currently requesting it.

Payer medical directors have no shortage of things to do during their day. Often, they must prioritize what work to do based upon the number of people affected or the potential budgetary risk. If your medical device or therapeutic is interesting, but not yet utilized or in demand by providers for their patients, it will not garner the attention to get a full and reasonable review. Products without demand from the provider or patient may be interesting from an academic standpoint, but they seldom get the attention for a full policy review. Market access and payer outreach efforts should not outrun your company’s sales department and provider demand. Over our years of practice, we have heard constantly from medical directors that they become resentful of a medical device or therapeutic manufacturer that consistently attempts to use medical policy to get the payer to create a market to sell their product.

3. Repeatedly use form letters instead of sincere appeals.

Payer medical directors are not always obligated to respond to market access teams from medical device or therapeutic manufacturers. Most of the time, manufacturers are not parties to a contract with the payers; therefore, the only driver compelling a response to a request or questions from a manufacturer is professional courtesy and goodwill. However, providers and patients are contract parties with payers (have privity), and those contracts most often require a response within a certain amount of time. Many manufacturers take the logical jump to use providers and patients to send in their materials. Although that is one element of an effective market access strategy, the common mistake is to send the same form letter from every patient and provider to save time and expense. Once it becomes obvious that it is a form letter campaign, the payers will respond with a form letter denial, and a non-nominal amount of goodwill will be burnt off. Patient and provider campaigns for payer outreach can be one of the most effective market access tools, but if they are not managed by an experienced reimbursement consulting firm like Argenta Advisors, they can backfire and create more hurdles for a product to establish market access.

4. Cherry-pick outcomes data.

Of course, you are going to put your best foot forward when presenting your medical device or therapeutic technology to a payer. However, only acknowledging the favorable data for your product is a fast way to lose credibility and send payer teams searching for additional data to understand your product. Unless a product has only been studied a limited amount, it is likely that some negative data is out there. While no one expects you to put together a presentation, executive summary, or clinical dossier focused on the unfavorable data, addressing it in a way that distinguishes it from the case at hand or the current patient population can help you maintain credibility and strengthen your case. Placing negative data in an appropriate context while not undermining your arguments is difficult, but an experienced reimbursement consulting firm like Argenta Advisors can help you learn how to present all your data with our medical director discussions and focus groups.

5. Position your product with only clinical data or only economic data.

Since the late 2000s, the drumbeat of value has been getting louder. At the time of the writing of this article in mid-2020, the drumbeat of value is taking over the band. At one point, being able to position a product as better than its comparators was enough to get coverage, but that is not the current environment. Argenta has offered medical director focus groups since 2001, and since that time, the discussions at the table have shifted. Price has moved from being an afterthought to being one of the first questions. “Well that technology looks great, but the only thing that could hold it up is price” is now one of the most common statements in our focus groups. While better than and cheaper than the comparator is ideal, we know that is not always commercially feasible. Developing a coherent value proposition in support of the benefit your product brings and the reasoning for its cost is now a prerequisite. Cost matters, and the strength of the lens applied to review “medical necessity” increases as product or treatment cost rises.

Although the drumbeat of value has become the loudest, it is still not a drum solo. Positioning a product solely on its economic benefit or on its price being lower than the current standard of care telegraphs the possible issues with the clinical data, clinical utility, or demand. Less costly than the comparator can be a strong argument, but only if there is published peer-reviewed data demonstrating clinical superiority or equivalency to the comparator.

6. Be inconsistent in messaging between payer materials and website marketing materials.

Decision-makers at the payers conduct independent research using Google in addition to medical journal reviews. A manufacturer website that tells an inconsistent story from the executive summary or other payer positioning documents creates a risk of causing payer disenfranchisement. For example, a manufacturer approaching payers with a focus on patient need and benefits to the healthcare system that then dedicates it website to how much money an office practice could make by switching to its product is undermining its own credibility. Payers often need help understanding new technology, but they will not accept that help from someone who has given away their credibility. As frustrating as it can sometimes be to get a new product covered, an important goal of a manufacturer is to maintain their credibility and avoid an adversarial relationship with the payer.

7. Fail to position your medical device or therapeutic with clinical utility or fail to describe the positive net health outcomes delivered by your medical device or therapeutic.

Does your clinical data show that your product is effective in a meaningful way? We all set out to develop and market technology that improves patient outcomes, but whether the improvement is clinically meaningful is subjective.

Imagine a product that improves the ability to walk for a person with an uneven gait. Intuition will tempt you to take for granted that the product is “medically necessary.” However, getting a patient to return to a normal gait may not be inherently “medically necessary.” It might not be medically necessary to walk to the store two minutes faster if a comparator product the patient already uses works but is slower and is also one-fourth of the cost. However, if the manufacturer can show with data that the product reduces or eliminates other complications such as falls and that those falls would have otherwise been injury-producing, the company that produces the more expensive product may have a stronger position in demonstrating medical necessity for coverage.

There are some questions to ask when determining if this imaginary product improves net health outcomes in a meaning full way. Does the data demonstrate real cost savings and the prevention or treatment of real harm to patients? Does the data show a reduction of ER visits for fracture treatment, concussions, and/or other resource cost to the system?

Remember market access and payer out reach mistakes can haunt you.

Getting your message out to the payer community can be challenging, but by committing any of the above common errors, it can become a Sisyphean task. Companies that burn up their credibility never quite get it back and can be haunted buy those mistakes for years. Reimbursement staff and provider offices that create busywork wear down hard-earned goodwill. Remember, payer medical directors and their staff want to ensure that their members get the highest quality care at the lowest cost. If your goal is to produce the best product to help patients, then your goal should naturally align with the payer. If you are not sure how to position your product to show that your mission is aligned with the payer mission, the reimbursement consultants at Argenta Advisors can help.

Contact Argenta Advisors' market access team for help avoiding these mistakes today >>

8 Reasons to Invest in a Medical Director Focus Group

Mon, 31 Aug 2020 18:59:17 GMT

Getting reimbursement for your technology means understanding how to get past the noise and make your message heard. A medical director focus group (advisory board) can help.

Are you being bombarded by emails and information from every angle every day? Payer medical directors are, too. The same cultural phenomenon that is affecting you is affecting them. Since the early 2000s, it has been more and more difficult to get the attention of payers with new technologies to tell the story of your technology and product. When you present your technology, your time will be limited. Furthermore, payer medical directors are under increasing pressure to manage behemoth pharmaceutical benefits formularies and complicated genetic therapy coverage.

With Argenta’s Medical Director focus groups or interviews, you can learn how to sharpen your case for medical policy coverage and make sure you will get the attention you deserve. For the eight reasons below, medical director focus groups (formerly called medical director advisory boards) are a sound investment.

1. A medical director focus group can help gather market data from a key customer group: payers.

Most of the healthcare purchasing decisions in the US market are made by some combination of patient, provider, and payer (health insurer). While most manufacturers have conducted patient and provider research during the product development process, many fail to conduct the same research with payers. A focus group provides you an opportunity to hear the factors that will influence the decision to purchase your product. The assumption that payer decisions are based purely upon clinical data and economics without context can cause a seemingly sure thing to fail. If you build it, they won’t always come. Don’t speculate about how much and what kind of data is needed for your product: work with Argenta and find out.

2. The best way to test payer messaging is with payer medical directors.

Securing coverage and payment for your product first requires getting the attention of the decision-makers. Payer medical directors are under constant demand to provide high quality care for the least amount of money. They want to pay for care that will help their members stay or become healthy, but they have a budget to consider. They are also under constant pursuit by innumerable vendors, all with messages about how their product can change the world. Are you confident that your value messaging will cut through the noise and garner the time and attention it takes to receive a thorough review?

3. Confidently go to market after receiving an honest assessment of the viability of your product.

Don’t test your commercialization and reimbursement theory in the field! The best time to test your market strategy is before you have invested your time, talent, and treasure. Commercialization of new and innovative medical technology is expensive and is not a do-no-harm proposition. Failed commercialization strategies and methods can create precedents that are difficult to overcome and can mire a technology indefinitely. Argenta’s medical director focus groups are double blinded to provide manufacturers the opportunity to test their product’s messaging and value proposition in a blinded no-harm-no-foul environment. Finding problems with your commercialization or reimbursement strategy through a focus group instead of in the field is comparable to the difference between a bench failure and failure in a pivotal trial. With Argenta’s help, you can ensure the highest likelihood of success.

4. Discover opportunities to pivot for success before strategic gaps become critical failure points.

Finding pivot points and opportunities to adjust strategies is limited in a simple survey or one-on-one call with a payer. Although surveys and medical director discussions can be helpful in specific circumstances, the dynamic environment of a focus group creates interactions among the medical directors that raise points and issues that are nearly impossible to discover in other test environments. Often manufacturers discover unanticipated issues with their commercial strategies at medical director focus groups. Focus groups make it possible to redevelop lines of questioning on the fly and discover opportunities to revise strategies that increase the likelihood of successfully securing coverage for your product.

5. Gain insight into the payer policy development process from a spectrum of payers.

Unless you have worked within a payer organization, you can only speculate about the payer policy process. Most of the information available to manufacturers regarding the medical policy development process is secondhand hearsay. If your organization is lucky enough to have had meetings with a payer about your technology, then you may have a good sense about one payer. But each payer is subject to different economic forces and may have varying clinical evidentiary requirements . All payers have different motivators, processes, and procedures for creating medical policy. Working with a diverse group of payer medical directors in a focus group setting will highlight many of these differences and give you the insight you need to create a robust approach.

6. Elevate your in-house reimbursement staff by exposing them to insider knowledge.

Argenta will invite your reimbursement team to the focus group as blinded participants and prior to the focus group we will work with them to think critically about reimbursement challenges and opportunities, to maximize the focus group’s time. At the focus group, they will have the opportunity to hear payer medical directors relate experiences with comparable technologies and how medical policy was created for those products. Each focus group includes multiple medical directors, exposing your reimbursement team to multiple insights and points of view. Historically, Argenta’s focus groups have comprised some of the most experienced active medical directors in the industry, each of them bringing decades of experience in policy development and review.

7. Create a foundation for a methodical reimbursement and commercialization strategy.

Medical devices and biologics are developed through sound, well-defined scientific processes—and so should reimbursement and commercialization strategy. Argenta recommends that clients develop a draft reimbursement strategy and then test it. Medical director focus groups are an important tool for receiving valuable feedback on draft plans for payer messaging and the probable impact of existing and planned clinical data and publications strategies. The creation of clinical data is expensive. Before spending the money on more data, make sure that the data you are planning to collect is the right data. A methodical approach to your commercialization strategy is just as important as a methodical approach to product development.

8. The interplay among medical directors in a focus group yields far more information than one-on-one interviews.

While medical director surveys or calls may be less expensive than doing a panel with a focus group, they are no substitute for the interaction and interplay that takes place among the members of an in-person medical director focus group. Argenta uses experienced moderators who are also former medical directors. Our moderators help create an environment where the panelists feel comfortable enough to challenge the product value story and challenge each other to dig for deeper insights.

Life science technology is tested before we rely on it: your strategy and messaging should be tested the same way. Medical director focus groups (advisory boards) allow manufacturers to test messaging and strategy in a safe place and learn things about their product’s pathway that may not have been apparent. Best yet, the panels don’t just find problems: they often recommend solutions. Don’t wait for the market to teach you the adjustments your products need to go forward.

There is only a limited number of focus group dates available each year.

Contact Argenta today to learn more and book yours >>

5 Tips to Overcoming Claim or Appeal Denials for Your Innovative Medical Device.

Tue, 04 Aug 2020 00:24:22 GMT

Obtaining Coverage Coding and Payment for Your Technology Means Navigating Initial Utilization Barriers

Introduction:

Payer denials can be confusing and too many of them can undermine a reimbursement strategy based on demonstrating utilization. While some denials are based upon the lack of supportive clinical data, many denials are the product of ineffective advocacy or missing details. While the easiest approach to overcoming denials is to work with an experienced reimbursement support hotline vendor like Argenta, understanding the basics of why denials happen can help guide overall strategy and increase the likelihood that a reimbursement strategy is going to be successful.

1. Thoroughly review the denial letter and take time to identify and understand any reasoning presented. Denials often state the reason for the denial and outline next steps for the patient. Following the outlined process and addressing the reasons for the denial are first steps to making an appeal process run smoothly. When you read a denial ask yourself:

Why was the request denied?
What type of policy or criteria is the payer using?
What is the type of health plan the patient has?
Is it an emergency or lifesaving technology for patient?
Where there any mistakes made with the applicable billing and coding?

2. Be persistent, patient, and prepared . Unless the technology is lifesaving or has a high community impact, it may not receive the most thorough evaluation during the initial review process. However, every time you submit a claim or appeal you will be slowly educating the payer. When filing an appeal for a service or procedure involving medical technology that is considered experimental or investigational:

Build your appeal documentation package clearly and carefully with a clear patient story and history substantiated with records
Provide data that supports what you are proposing for the patient since new technologies will require peer reviewed published clinical data to be covered by payers
Make sure there are clear expectations with the patient and that the patient understands that agreeing to pursue appeals may mean being committed for an extended period of time
If an additional supporting information that further describes the technology’s clinical outcomes is available, consider including it in the package.

3. Focus on the unique circumstances of the patient that is the subject of the appeal . Write an organized and focused letter that builds upon the medical need for approval and describes why reconsideration for this patient is critical. It is essential to convey the benefit a patient will gain from the technology.

Demonstrate why the appeal case is different from a typical case and why no other treatment is acceptable for this patient
Outline any and all previous treatments/therapies related to the illness or injury that have not been successful
Focus on applicable peer reviewed clinical data that shows the same favorable net health outcome as you are requesting for the patient
If there is a similar device that is covered, discuss the equivalence and highlight why that similar device is not appropriate for this patient
Use emotive storytelling to describe each case

4. Know your audience and understand the background of your reviewer. Depending on the type and level of review, or appeal, different staff with varying levels of training will be looking at your submission. For your initial submission, the individual reviewing your submission for approval at the payer level is usually a staff member in a utilization management department. The staffer reviewing your case could possibly be reviewing review hundreds of requests per day. The submission should be concise and informative.

Make it easy to see how you are meeting the payer’s requirements by including the appropriate forms and authorizations when necessary
If your review requires advanced or specialized clinical knowledge, state so early in the request such as asking for a same specialist review
Determine the level of review that will be applied and make it easy to find the elements that show that the standard is met

5. Determine the appropriate appeal pathway early in the process. Every case is different. Different patients may have different basis for being eligible to the same care. Every payer has its own set of policies and procedures and each insurance plan within a payer may have its own criteria and benefits. States have differing external review process and some states or plans use the Federal process. The appeal pathway should be designed to follow the correct approach in a timely fashion. Every patient’s case is different. Every product is different. Every payer’s understanding of the situation is different. Consideration of these differences is crucial.

Every patient with employer provided healthcare plan has a member’s handbook or summary plan description and there are meaningful differences between these documents across payers and plans
Knowing the right request to make at the appropriate time is one of the keys to success. Re-Determination, Re-consideration, Single Case Agreement, Benefit Exception Approval, Administrative Law Judge Review, Department of Appeal Board Reviews, and Federal Court (Judicial) Review are all different appeal activities utilized at different times
If a patient is eligible for a third-party external review, understand the steps that are required to trigger it, because often times the steps are not always the same
Peer to peer reviews can be a powerful tool but only if used on appropriate cases
Self-funded grandfathered ERISA plans can be exempt from the Affordable Care Act protections and can have unique appeal pathways that exclude a patient from an appeal or external review of a pre-service review.

Even the most promising medical device technologies can end up in the dustbin of history by not demonstrating adequate utilization. Demonstrating early utilization most often means fighting for coverage of a new technology on a case by case basis. It requires providers and patients to be willing to advocate for the product and building a successful case story to support the claim. If you do not have the internal staff to support your reimbursement efforts, Argenta can help. Over decades in practice we have accumulated relationships with industry leaders and policymakers at payers across the country that can help you promote access to care. Not only can we help you develop a successful strategy, we can work cooperatively to implement it with market access staff, reimbursement support, or case management support.

Learn more about to overcome claim or appeal denials for your innovative medical device or therapeutic technology from our experienced reimbursement support hotline consultants -talk to Argenta Advisors today .

The Medical Director View From Inside a Payer

Fri, 12 Jun 2020 18:51:59 GMT

A Major National Health Plan Medical Director Shares Insights on How Coverage Decisions are Made

The following article was originally contributed by Argenta Advisors to the Medical Device Summit (MDS) “Summit News” ( www.medicaldevicesummit.com ). Although this article was originally published by MDS on February 3, 2015, it is as true today as it was then.

Reimbursement Report: A Major National Health Plan Medical Director Shares Insights on How Coverage Decisions are Made

The following question-and-answer session reveals important information and attitudes toward coverage of new/existing technologies and standards of evidence. This information is provided by an active Regional Medical Director involved in traditional health plan policy and payment development as well as emerging value-based models (e.g., accountable care organizations and pay-for-performance initiatives).

Q: Can you give us some insight into the health plan’s process to review a technology for coverage/non-coverage?

A: Health Technology assessment (HTA) examines a whole host of issues important to the health plan (HP) and its purchasers/customers. This process is deemed of utmost importance and afforded the due diligence deserved. Domains examined in detail include evidence as pertains to safety and efficacy, outcomes from randomized, controlled trials (RCTs) that may include patient-reported outcomes (PRO) as one of a number of appropriate endpoints. Real-world evidence (RWE) is becoming increasingly important to lend further insight into utilization and outcomes outside of the “rarefied air” of the hyper-controlled trial environment designed to isolate the studied “signal” for approval by regulatory bodies. Cost-effectiveness in addition to the “softer” considerations of ethical, legal, political and social remain in the mix to be weighed.

HTA committee members include medical and pharmaceutical professional and support staff as appropriate, additional insight is garnered from actuarial, business line-of-service and the executive functions. Key opinion leaders (KOLs) are utilized as necessary to inform about current market dynamics and frontline practice. Research teams, under the direction of the HTA leadership, conduct the building of the “internal technology dossier” which may consist of any or all of the following materials: published literature review (with preference given to RCTs, especially those with head-to-head comparison against standard-of care (SOC) if available); other HTA body guidance published previously ( examples might include-Blue Cross and Blue Shield Association Technology Evaluation Center, Cochrane Collaboration, ECRI Institute, Hayes, Inc., Institute for Clinical and Economic Review (ICER), Center for Medical Technology Policy (CMTP) and Institute for Clinical Systems Improvement (ICSI) to name a few. Other payers HTA assessments are also collated when available. Manufacturer-produced dossier can also be utilized. Professional society guidelines are reviewed for timeliness and pertinence to the HTA review.

HTA occurs in a dual-track pattern to allow for the development of a clinical efficacy and safety consensus which will then be “married” with economic considerations. This process of activity was formally described by Sullivan et al to include the following domains: 1) horizon scanning; 2) topic determination and queuing; 3) collection and assessment of evidence; 4) appraisal; 5) funding and policy implementation.

Q: What factors determine whether a technology will be reviewed?

A: Factors that are considered to determine the need for technology review may include any or all of the following: existing unmet need; disruptive versus incremental improvement in standard-of care; better safety and patient satisfaction; advocacy by utilizers that may include patients, healthcare professionals, health systems; cost-effectiveness; personalized healthcare; competitive positioning and regulatory issues may pertain as well. In addition, budget constraints at the HP, costs for review and policy implementation and “noise” around utilization and projected demand for the technology will factor in the queuing of the assessment.

Q: What factors determine whether a technology will be written into a formal policy?

A: There are many factors for consideration when weighing the need for issuance of formal policy after HTA. The principal forces that will predominate in this deliberation may include the following: 1) level of disruption projected to current SOC; 2) regulatory (mandate) pressures; 3) degree of advocacy by providers and patients; 4) projected costs driven by rapid uptake and utilization; and/or 4) competitive pressures in the HP’s marketplace that may drive adverse or positive selection in the served populations.

Costs of prior authorization/appeals review and adjudication of these issues may also impact the HP’s perceived need to formalize policy issuance from a regulatory and financial perspective.

Q: In general, what type of data do you prefer (or require) in order to establish positive coverage for a technology?

A: The preponderance of the evidence should demonstrate that in randomized controlled trials (RCTs), the technology preferably performed in regards to excellent efficacy and safety when contrasted against existing SOC. Appropriate approval should have been obtained from regulatory bodies. In addition to the technology providing “clinical utility” (i.e., it has an impact on medical decision-making in terms of testing and/or outcomes), it should be cost-effective, either in its own right or when compared against current SOC. It should demonstrate either a reduction in total cost of care (TCOC)/per defined care episode (or) a cost-offset equal to the innovation’s cost with or without improved safety and customer satisfaction, the “triple aim”. Further evidence around real world evidence (RWE) and patient-reported outcomes (PRO) may be sought. Comparative effectiveness research (CER) is greatly appreciated.

Q: What are your views on the need for health economic information to demonstrate the value of a product/service? Can you give an example?

A: Whether a manufacturer hears that health economics outcomes research (HEOR) is of little or secondary importance in payer decision-making, it has become an imperative going forward. As payers increasingly enter into accountable care organization (ACO) contracting arrangements, these data will be very important if manufacturers want their technologies preferred or utilized at all by the delivery system. As financial risk is transferred to ACO entities, they will require elegant HEOR modeling tailored to their entity and requisite competitive marketplace that meet their “triple aim” goals. Examples: thrombolytic therapy/coronary artery stent for acute myocardial infarction (AMI), mammography for breast cancer screening, implantable cardiac defibrillators (AICD) for cardiac disease/arrest patients.

Q: Does the coverage review process allow for external stakeholder input? If so, how does that typically work?

A: External stakeholder input remains important but is variously perceived (or) utilized. Most payers utilize key opinion leader (KOL) panels by line of service (LOS) or specialty. If they do not recruit and maintain these panels themselves, they will contract to vendors that perform this function (i.e., Hayes, Inc. or others). Manufacturers may approach the HP via clinical directors and/or the ACO entities they are party to if they possess a cogent story around HEOR and the triple aim. While there exists no one true track as regards payers, they should include a simultaneous multi-track plan to speak with financial, clinical and sales broker channels both internal to the plan and as regards their ACO partners engaged in remodeled delivery of healthcare in the marketplace.

In summary, if this glimpse into the decision-making process within a national health plan tells us anything, it is that a well-designed and tailored reimbursement strategy is crucial in preparing for- and engaging in discussions with payers. Companies developing and marketing medical technologies should be prepared to rise to the level of changing clinical and economic evidentiary standards as the U.S. healthcare system continues to evolve toward value-based care and payment models. At the end of the day, life science companies should strive to be as thoughtful and innovative in the approach to reimbursement as in the approach to technology development.

Learn more about how the payers make decisions - t alk to Argenta Advisors today.

5 Tips for Understanding Payer Evidence Requirements

Mon, 27 Apr 2020 13:32:30 GMT

Medical Device Manufacturers Must Develop the Right Payer Story

FDA approval, or clearance, is not the last step in getting a medical device or other life science technology on the market. It is just a step. Innovators that focus solely on these steps without looking at the hurdles ahead are on a path to trouble. Payer acceptance can make or break the long-term viability of a product and even a company. Having an idea of what the payers may look for, before you commit to a course that may be hard to reverse, will save you a mountain of time and money. Every product has a different path, so there is no substitution for working with an experienced reimbursement consulting firm like Argenta Advisors, but the following tips will help you understand the road ahead.

1. FDA Evidence Requirements Differ from Payer Evidence Requirements

A medical device entering the market through a pre-market approval must show safety and efficacy to the FDA through clinical trials to gain approval. A device seeking 510(k)clearance must be able to presume efficacy from a predicate device and then show safety in clinical trials. However, to receive coverage from a commercial payer, a product must demonstrate medical necessity. Medical necessity is a term of art that is usually defined in a member contract or a handbook and usually contains criteria such as the following:

The technology must have final approval from the appropriate governmental regulatory bodies;
The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;
The technology must improve net health outcomes;
The technology must be as beneficial as any established alternatives; and
The improvement must be attainable outside the investigational settings.

2. Evidence Requirements Differ from Payer to Payer.

Different payers have different evidence requirements for covering or creating a policy for a new technology. The different evidence standards are often driven by economic forces and the resource limitations of the payer. For example, large regional payers have well-developed technology evaluation committees that have the time and resources to make independent evaluations of clinical studies. They often reach out to specialty societies and consider additional factors related to a technology when making policy decisions. Smaller local payers often have resource limitations that force them to rely on information aggregation services and third-party technology evaluation services.

3. Your Product’s Therapeutic Area Can Change Its Evidence Requirement.

Even though a plan may have published criteria for medical necessity, the strength of the lens that is applied to determine whether the medical necessity criteria are met varies based upon population size, unmet clinical need, riskiness, and capacity for saving lives. Products that focus on unmet clinical need and a well-defined population often face fewer roadblocks.

4. Economics Data May Change Your Evidence Requirement.

Cost and value matter. Payer medical directors are the stewards of a limited set of resources for providing for the care and well-being of their members, and they are concerned with attempting to do the most good with the amount of money budgeted for them by their plan actuaries. They face challenging economics that make it difficult for them to cover every technology. Overly aggressive pricing can exacerbate an evidence or utilization barrier.

5. When Breaking into a Crowded Space, Evidence Must Show at Least Two Elements of “Better, Cheaper, or Faster.”

It is not a guarantee that your product will receive coverage and payment with a certain level of evidence just because a similar technology received coverage and payment with that same level of evidence. If your product is competing against a gold standard, you will need the ability to differentiate it, or you could be expected to create a head-to-head comparative study against the applicable gold-standard technology. If your product costs more money than an equivalent that is already on the market, you will need to show that it provides a better net health outcome than the equivalent. Manufacturers that leverage data showing real-world net positive health outcomes have an advantage over technologies that have demonstrated only a narrow band of effectiveness of a single symptom or biomarker in a purely clinical trial setting.

Conclusion

Payer data differs from FDA data. Manufacturers must remember the physicians and the policy teams that are writing policy for the payers—they are the final audience for your data. Most are healthcare professionals that see themselves as the custodians of a limited amount of resources. They care very much about the quality of care that their members receive. Manufacturers need to look for opportunities to demonstrate, with peer-reviewed data, the information they want in the evaluation criteria. Manufacturers need to develop a good payer story or value dossier based upon objective data.

At the end of the day, if you manufacture a great technology and have thoughtfully collected strong supporting clinical data, physicians will want to order it, patients will want to use it, and medical directors will want to provide both coverage and payment for it.

Learn to be more successful by learning how to improve your payer story and value dossier - t alk to Argenta Advisors today.

Platinum Sponsorship of M2D2 - 2020 | Argenta Advisors

Wed, 22 Jan 2020 18:35:44 GMT

“We are excited for this opportunity to support our local life science community and the innovators that are driving it into the future”

Argenta Advisors is proud to announce its sponsorship of the Massachusetts Medical Device Development Center (M2D2) in 2020. M2D2 is an incubator and resource connector for Massachusetts’ smaller medical device companies. It offers inventors and executives easy, affordable, and coordinated access to world-class researchers and resources at the UMass Lowell and the UMass Medical School campuses of the University of Massachusetts.

“We are excited for this opportunity to support our local life science community and the innovators that are driving it into the future,” says Argenta President Louise Guy. “We want to recognize the exceptional efforts of the people who are sustaining the industry through innovation by participating in and sponsoring M2D2. We appreciate the contributions that M2D2 has made to the now-thriving ecosystem that exists around the Greater Boston area for life science and particularly medical device startups.”

Over the last several years, M2D2 has grown into one of the area’s most important innovation ecosystems. It has opened three shared laboratory facilities, including one on the UMass Medical School campus. M2D2 resident companies have been awarded nearly $10 million in grants while receiving over $80 million in angel financing and private venture capital. The work of M2D2 has led to the direct creation of jobs for over 100 people and over 50 student interns directly employed by M2D2 resident companies and created a strong a vibrant network for development.

Argenta brings to the M2D2 community decades of experience gathered from supporting the reimbursement and commercialization goals of hundreds of companies, ranging from startups to some of the largest medical device and life science companies. In addition, Argenta brings relationships with industry leaders and policymakers at payers across the country. Argenta’s team includes strategic reimbursement consultants and staff specialized in market access, reimbursement support, and case management support to help innovators and executives impact coverage, coding, and payments through direct and grassroots efforts.

Ms. Guy remarked, “We wanted to honor the commitment of the innovators that drive the life sciences industry by making our own commitment to the future of it. I personally can’t wait to see the next crop of companies at the next yearly challenge.”

Dose of the Valley Conf. Prentation | Argenta Advisors

Sun, 18 Mar 2018 08:48:25 GMT

The Consulate General of Canada is hosting The Dose of the Valley conference in San Francisco on February 22-23 for a select group of high potential Canadian life science companies from the biotech, medical device and digital health subsectors.

The two day program features workshops, mentoring, partnering meetings, speakers and a pitch session. Argenta Advisors provides strategic and tactical reimbursement support to life science companies based in and outside the United States looking to commercialize their technology within the U.S. market. Jessica Holmes , Argenta’s Executive Director of Reimbursement, is pleased to have been asked to present information on the U.S. healthcare reimbursement landscape for a second year at the Dose of the Valley Conference.

CA Life Sciences Assoc FAST Program | Argenta Advisors

Thu, 27 Jul 2017 12:51:51 GMT

Argenta is pleased to be a part of California Life Sciences Association (CLSA) and its efforts as the state’s largest and most influential life sciences advocacy and business leadership organization.

CLSA works closely with industry, government, academia and others to shape public policy, improve access to innovative technologies and grow California’s life sciences economy.  Founded in 2015 when the Bay Area Bioscience Association (BayBio) and the California Healthcare Institute (CHI) merged, CLSA serves biotechnology, pharmaceutical, medical device and diagnostics companies, research universities and institutes, investors and service providers throughout California.

Argenta is also pleased to act as an advisor for the California Life Sciences Institute’s Fellows All-Star Team (FAST) Advisory Program for select entrepreneurs in the medical technology field.

Argenta attends Fall NAMCP in Vegas | Argenta Advisors

Thu, 27 Jul 2017 07:18:19 GMT

Argenta will attend the Fall NAMCP Conference taking place in Las Vegas in November, 2016.

Argenta Advisors will be attend the Fall NAMCP Conference taking place in Las Vegas in November, 2016.

Jessica Holmes | EDC Life Sciences | Argenta Advisors

Thu, 27 Jul 2017 07:18:19 GMT

EDC in Collaboration with BioNova & MaRS and in Partnership with Global Affairs Canada is hosting two Life Sciences & Health Care roadshow events.

They are great opportunities to connect with key industry leaders, better understand the market and commercialization opportunities in the US, and help your company identify solutions to the challenges companies face in the sector. Jessica will be participating in a panel discussion entitled “Demystifying the US Healthcare and Life Sciences Market”

Reimbursement Consulting Insights

CMS and Third-Party Payer Clinical Trial Reimbursement: Part 1 -Why

Consider seeking reimbursement for your medical technology’s clinical trial to help long-term commercialization efforts.

Is A.I. Going to Make Medical Device Reimbursement Consultants Obsolete?

A short experiment with Chat GPT to see how useful it is for learning about medical device reimbursement strategy.

The Test

Question 1: Are you familiar with medical device reimbursement strategy?

Question 2: How do I get health insurance payers to create coverage policies for a new medical device?

Question 3: How is reimbursement strategy related to finding investors for my medical device company?

Review of the results

Critical Marketing Considerations for Medical Device Manufactures Impacting Reimbursement Strategy

Patient and provider messaging that is inconsistent with payer messaging can help sink a medical device reimbursement strategy

​Balancing competing interests defines medical device marketing and launch strategy.

​The creators of a medical device marketing launch strategy need to consider its reception by payers to understand the strategy’s potential impact on reimbursement pathways.

A case study comparison of strategies for balancing medical device marketing with medical device reimbursement strategy

The 7 Foundational Reimbursement Strategy Issues: What to Review Before Your First Meeting with a Reimbursement Consultant

Being prepared with foundational information before your first meeting with a reimbursement consultant can help your reimbursement strategy or market access plan climb to the next level before you even write your first check to a consultant.

The 6 Critical Digital Health Reimbursement Mistakes Holding Innovators Back

The clash of cultures between the medical device and high-tech worlds creates a chasm between the expectation and the reality of payer adoption and reimbursement.

8 Utilization Topics You Need to Understand to Drive Your Market Access Plan or Reimbursement Strategy

Obtaining Coverage Coding and Payment for Your Technology Means Understanding and Demonstrating Utilization

Living with a Legacy: Reimbursement Barriers Based on Technologies that Came Before

Reimbursement Barriers Based on Technologies that Came Before

The 7 Market Access and Payer Outreach Mistakes That Will Haunt Your Medical Device or Therapeutic

Learn how to avoid the common mistakes that can permanently haunt the reimbursement and market access efforts for your medical device or therapeutic from experienced reimbursement consultants

8 Reasons to Invest in a Medical Director Focus Group

Getting reimbursement for your technology means understanding how to get past the noise and make your message heard. A medical director focus group (advisory board) can help.

5 Tips to Overcoming Claim or Appeal Denials for Your Innovative Medical Device.

Obtaining Coverage Coding and Payment for Your Technology Means Navigating Initial Utilization Barriers

The Medical Director View From Inside a Payer

A Major National Health Plan Medical Director Shares Insights on How Coverage Decisions are Made

5 Tips for Understanding Payer Evidence Requirements

Medical Device Manufacturers Must Develop the Right Payer Story

Platinum Sponsorship of M2D2 - 2020 | Argenta Advisors

“We are excited for this opportunity to support our local life science community and the innovators that are driving it into the future”

Dose of the Valley Conf. Prentation | Argenta Advisors

The Consulate General of Canada is hosting The Dose of the Valley conference in San Francisco on February 22-23 for a select group of high potential Canadian life science companies from the biotech, medical device and digital health subsectors.

CA Life Sciences Assoc FAST Program | Argenta Advisors

Argenta is pleased to be a part of California Life Sciences Association (CLSA) and its efforts as the state’s largest and most influential life sciences advocacy and business leadership organization.

Argenta attends Fall NAMCP in Vegas | Argenta Advisors

Argenta will attend the Fall NAMCP Conference taking place in Las Vegas in November, 2016.

Jessica Holmes | EDC Life Sciences | Argenta Advisors

EDC in Collaboration with BioNova & MaRS and in Partnership with Global Affairs Canada is hosting two Life Sciences & Health Care roadshow events.

Balancing competing interests defines medical device marketing and launch strategy.

The creators of a medical device marketing launch strategy need to consider its reception by payers to understand the strategy’s potential impact on reimbursement pathways.