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A Shortcut to Medical Device Reimbursement in the UK

1. The Problem

You developed a new and innovative medical device that provides substantial clinical benefits in a cost effective manner.

You know the UK has one of the largest medical device markets in the world, positioned alongside France as the second largest in Europe behind Germany.

You plan on getting your product approved in Europe and complete the CE mark process relatively quickly and you already signed agreements with local UK distributors.

The only problem – will your device be reimbursed, or in other words, will the UK National Health Service (NHS) pay for it?

Since your device is new, there are probably no existing reimbursement mechanisms (codes, coverage and payment rates) into which it could fit. On the other hand, in order to apply for the development of new reimbursement mechanisms, your device should first be in wide use by UK physicians for the local patient population. But since your device doesn’t currently fit into any reimbursement mechanisms, physicians are reluctant to use it, and therefore it will never reach a wide user base to justify the creation of new reimbursement mechanisms…

Sounds like a Catch-22, right?

Luckily, the NHS operates an Innovation Procurement Plan designed to encourage the quick uptake of innovative new technologies. Similar to the USA Centers for Medicare & Medicaid services (CMS) “Health Care Innovation Awards” program, the UK’s NHS understands that “innovation must be central to the NHS”, indicating that innovation will be driven regionally by strategic health authorities (SHAs) with a legal duty to promote innovation; and that front-line innovation will be supported through the creation of substantial new innovation funds held by SHAs.

In this article, we will try to describe the requirements, the relevant decision makers and the overall process that may help you leverage this plan to expedite the commercialization of your product in the UK market.

But first, we provide a short description of the NHS below.

2. The UK Healthcare System

* The United Kingdom of Great Britain and Northern Ireland (commonly known as the UK) consists of England and the devolved administrations of Northern Ireland, Scotland and Wales, each with varying powers.

* Population: 62 million.

* Type of Healthcare System: Single Payer / national health service (NHS).

Public health system: England provides public healthcare to all of its permanent residents. Public healthcare is free at the point of need. The responsibility for providing NHS healthcare services in England is divided between 10 Strategic Health Authorities.

SHAs issue guidelines for healthcare in their region, verify appropriate distribution of funds and carry out regional plans and projects to improve public healthcare. In addition, each SHA is responsible for the Primary Care Trusts (PCTs) in its region.

PCTs examine local needs and negotiate with healthcare providers to provide health care services to the local population. PCTs have their own budgets and set their own priorities, within the overriding priorities and budgets set by the relevant SHA and ultimately the national Department of Health (DH).

PCTs provide a range of community health services, including: funding for general practitioners, medical prescriptions, and commissioning of hospital and mental health services, as such they are considered key stakeholders in healthcare decision making.

Altogether, there are 151 PCTs in England.

3. National Innovation Procurement Plan

As mentioned above, the NHS is interested in encouraging the diffusion of innovation into the healthcare system and has launched a package of proposals to promote this. One of them is the National Innovation Procurement Plan which seeks to bring clarity and coherence by organizing the adoption of technology-led innovation at the regional level. Supporting this legal duty, an Innovation Fund has been created worth £220m over five years. This fund will support faster innovation and more universal diffusion of best practice – innovation will be encouraged, recognized and rewarded.

a. Process

1) Medical device companies, usually partnered with local healthcare providers, may submit details of specific medical technologies that can contribute to the NHS by downloading a submission form from the DH website and submitting details of innovative technologies using the email address that appears there.

2) NICE (National Institute for Health and Clinical Excellence)[1]- analyzes and prioritizes submitted technologies according to their potential to increase the quality of care provided to patients, whilst reducing the overall cost of care for the NHS. The NICE Implementation Collaborative (NIC) supports implementation of NICE guidance within each SHA.

The prioritized list is then shared to inform the technology selection process with:

3) NTAC (NHS Technology Adoption Centre) – formed in 2007 following recommendations by the Health Care Industries Taskforce who recognized that the NHS, despite the potential of innovative healthcare technologies to improve health outcomes and productivity, is slow to adopt healthcare technology when compared to health care systems in other developed countries. NTAC was commissioned by the DH to support NHS regional Innovation Leads to facilitate the selection of high impact technologies for wide adoption across their regions. Working with key regional influencers, NTAC helps individual NHS organizations to deploy the selected technologies

4) Regional Innovation Leads – each SHA holds a legal duty to promote innovation, raising the profile of innovation and encouraging a more rapid adoption of innovation throughout the health service. ‘Innovation leads’ are employed in each SHA to deliver this requirement.

5) Commercial Support Units (CSUs) are being created in each region, and as part of their role, will support their innovation lead by providing a key interface between industry and the NHS.

b. Application

All companies that make in-scope submissions will be offered an initial meeting with the iTAPP team (now, NICE). This meeting will be used to clarify any queries relating to the submission and to:

* Gain a deeper understanding of the potential benefits for patients and taxpayers.

* Explain how the program operates.

* Agree any next steps.

Technology submissions will be made up of three sections:

* Management Case: To demonstrate the overall benefits and challenges of adopting the proposed technology.

* Clinical Case: To demonstrate the clinical benefits offered by adoption of the proposed technology.

* Financial Case: To demonstrate the costs and savings applicable to adoption of the proposed technology.

c. Prioritization

The process does not provide a pass/fail approach to inclusion of technologies on the list. Instead, all technologies remain on the list so that they can be re-categorized and reprioritized in response to changing circumstances. Technologies are categorized on the list as follows:

* Level 3: On the market, with sufficient evidence for wide adoption

* Level 2: On the market, without sufficient evidence for wide adoption

* Level 1: Not yet on the market

* Level 0: Out of scope (ie not a medical technology)

* Level -1: Pending categorization

* Level -2: Withdrawn by manufacturer

Levels 1, 2 and 3 represent a pipeline of innovative medical technologies. The overarching aim of iTAPP (now, NICE) to realize benefits from technology adoption earlier than would otherwise be the case, supports high impact technologies to move through the pipeline more quickly.

Within each category, technologies are prioritized based on an impact scoring calculation, as follows:

Low:

* Benefitting population: Less than 250k

* Net financial savings: Less than £250k

* Deployment timescale: 3 yrs

Medium:

* Benefitting population: 250k – 2.5m

* Net financial savings: £250k – £2.5m

* Deployment timescale: 2 yrs

High:

* Benefitting population: More than 2.5m

* Net financial savings: More than £2.5m

* Deployment timescale: 1 yr

In each case, high scores 3, medium scores 2, and low scores 1. To calculate the total score, the scores are multiplied together. This gives a maximum score of 27 and a minimum score of 1. Advice is sought from National Clinical Directors at the Department of Health to enable a clinical perspective to be added to each technology.

The list of all technologies, indicating their level and primary benefit, can be downloaded from the DH website.

As can be noted, the device’s score is not affected by the number of UK physicians that currently use the device for the local population.

4. The Strategy

Each of the SHAs publishes calls for applications for its regional innovation fund. Prior to submitting an application, we recommend taking the following Steps.

a. Step 1 – Reimbursement Landscape Report

The purpose of this Step is to understand the current reimbursement landscape for the company’s device. It includes:

* Identification of relevant coding systems, available coverage policies, limitations and guidelines, relevant payment mechanisms and payment rates, outside of the National Innovation Procurement Plan.

* Identification of existing reimbursement mechanisms that could be utilized or compared to the company’s device, regardless of the National Innovation Procurement Plan. Recommendation on whether new mechanisms will have to be developed and if so, which mechanisms.

* Identification of the main decision makers and their specific incentives and a description of the typical path towards obtaining third-party reimbursement, including milestones and typical timelines.

b. Step 2 – Plan Evidence

Following the completion of Step 1, the company should clarify what ‘evidence’ needs to be developed in order to receive high prioritization according to the above mentioned criteria of: (1) Benefitting population; (2) Net financial savings; and (3) Deployment timescale. This step includes:

1) Development of a Value Story, indicating specific claims that explain how the use of the new device promotes the above criteria in comparison with the current alternatives.

2) Development of an Economic Model, quantifying the economic benefits and allowing for sensitivity analysis.

3) Verification of available clinical data supporting the clinical and economic claims in the above Value Story and Economic Model. If needed, the addition of reimbursement related aspects to any planned clinical study protocols.

4) Presentation of the above Value Story, Economic Model and existing/planned clinical data to relevant stakeholders within the NHS. It is important to verify, in advance, that these stakeholders understand the benefits and would agree to provide funding for the new device, should the generated data support the claims in the Value Story and Economic Model.

In case of negative feedback consider changing the Value Story, Economic Model, clinical data or product. Repeat this step until receiving positive feedback from the relevant stakeholders.

c. Step 3 – Generate Evidence

Perform clinical study/ies to substantiate the claims in the value Story or verify that existing clinical data supports them. Compile the Value Story, Economic Model and clinical data to a Dossier.

d. Step 4 – Establish Support / Demand

Use the developed dossier to:

1) Convince the relevant healthcare providers in the clinical and economic benefits of using the new device.

2) Convince the local key opinion leaders to provide lectures, write articles and issue supportive letters highlighting the benefits of using the new device.

3) Similarly, convince the relevant medical societies and organizations to provide position statements.

Add these documents to the dossier.

e. Step 5 – Implementation

Use the developed dossier as a sales tool and apply for funding from the Innovation Fund.

5. Conclusion

According to an assessment conducted by PwC, the UK, with its largely single-payer, government-controlled system, ranks third in ease of reimbursement and significantly above European countries such as Germany and France. The NHS’s focus on innovation may make it even easier for smaller companies, introducing their first product into the market.

It should be noted that in order to prepare a winning application, a great deal of preparatory reimbursement related work should take place, in advance. This preparatory work should result in the development of evidence, supporting the required criteria for high prioritization on the list of new devices, which are candidates for funding from the Innovation Fund.

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[1] Initially, this task was assigned with the Department’s Procurement Investment and Commercial Division (PICD) which later on was renamed as the Innovation Technology Adoption Procurement Programme (iTAPP). In 2012, according to the “Innovation Health and Wealth” document, NICE replaced iTAPP and took responsibility for these applications.

A Review of the Health O Meter Line of Weighing Scales

Health o meter has developed a reputation as a popular weighing scale manufacturing company. They offer a long line of various scales, including dial scales, digital scales and larger, balance-beam scales that are well-known for medical use. When choosing a scale that will fit your specific needs, keep a few things in mind when shopping. Budget, display type (digital or dial) and spring-based or balance-beam weighing functionality are all key things to consider. Fortunately, Health o meter features a long line of scales that can fit any bathroom décor or health need.

Bathroom Scales

For the standard bathroom scale, you have a plethora of choices to fit the bill. Health o meter focuses its retail arm on this type of scale, so you’ll have no trouble finding the perfect bathroom scale. The two main types of bathroom scales in use today are dial and digital displays. Both tend to be spring-based because they use a spring system to measure weight. The only difference is the display, which can be digitally shown on an LCD screen or with an old-fashioned dial. Both tend to have similar accuracy, so most users usually opt for the digital variety. The display shows a large, easily read number that users can quickly interpret. Dials can be a bit harder to get an exact reading for those with poor eyesight. So, if anyone in the family has eyesight issues, digital display scales are the way to go.

You’ll find that design choices are plentiful when selecting a bathroom scale. Glass-topped bathroom scales are all the rage these days, and for good reason – most people think they look modern and high-tech. Again, accuracy plays no part here, so just go with the look that makes you happy. You can even find some scales with a wooden grain pattern on them if your bathroom has a heavy wood theme. Health o meter offers plenty of glass-topped models to fit any budget.

Medical and Balance Scales

For those that want premium, physician-quality accuracy, the balance-beam scale is the way to go. Health o meter offers its popular 402KL upright balance-beam scale for users needing the ultimate in accuracy. This is the most popular choice for retail customers looking for a balance scale, and the price is pretty competitive at around $200. This unit features a measuring stick as well, just like the doctor’s office medical scale.

Balance beam scales are extremely accurate when they have been calibrated. Technically, they can even withstand changes in the Earth’s gravitational pull – something that flat, spring-based scales cannot claim. Since the scale is measuring your weight versus a known, smaller amount of weight on the opposite side of a balance-beam, the gravitational pull will always be equal on both sides, therefore rendering the comparison accurate regardless of the pull. Thankfully, wild fluctuations in the Earth’s gravitational pull don’t occur often, but the fact remains the balance-beam scales are very popular when accuracy is integral.

Conclusion

Health o meter is one of the most popular brands of scales in the world, and they offer a wide range of scales to meet any need. They are wholly recommended, but you should choose your scale wisely so that it reflects your budget, tastes and needs.

Beyond Incentives – Seven Strategies to Drive Utilization of Your Medical Travel Benefit Plan

Medical Travel Benefits

You may have noticed that many U.S. employers are investigating whether they can reduce health care expenses by using medical travel. But how does this work? Can your business reduce healthcare costs by using foreign providers? The answer is complicated.

Medical travel is the practice of patients receiving care for certain procedures in foreign countries. Medical travel professionals have built networks of distinguished providers in India, Costa Rica, Singapore and Thailand who are accredited and serving American patients. These providers offer the same procedures by similarly qualified surgeons at state of the art hospitals for 30% to 50% off of negotiated prices in the U.S.

Employers and medical travel professionals are putting their heads together to design health plans that allow employees to travel for care and save. The employers who are embracing medical travel generally either go at it alone or collaborate with a medical travel company to design a benefit add on. Medical travel companies and other industry experts have a lot of experience and expertise to contribute to this process and should be consulted while building a medical travel benefit.

Here’s why. Medical travel experts generally focus on financial incentives to drive utilization of foreign providers. However, your business will see better results if you invest early in the process to understand the employee population. By analyzing your employee demographics and understanding health consumer behavior, you can design a plan that connects with your target beneficiary group and changes their behavior.

The Anatomy of a Medical Travel Benefit Package

Health care consumers, both individuals and groups, are demanding competitive prices, more transparency and better quality care. Beneficiaries and patients have become health care consumers. The movement is called consumer-driven health care. Employers that offer health benefits are responding to this phenomenon with packages that let beneficiaries to take greater responsibility for their care and consumption decisions.

Global health benefits (as it is referred to by some in the industry) generally follow the health care consumerism model of high deductibles, behavior-inducing co-payments, and a health savings account. Global health benefits go one step further and offer financial incentives for patients who travel abroad for certain procedures.

The Role Of Incentives

Generally global health benefit plans use three types of incentives: financial incentives for patients to use preferred providers, non-use dependent incentives to attract beneficiaries. Like other low-cost health plans, global health benefits give patients more responsibility for health-related decisions. Enrollees choose from a network that includes preferred out-of-country providers. Financial incentives encourage patients to choose foreign providers for specific procedures.

Financial incentives reward patients who have certain procedures performed abroad. Employers may have a lower co-pay for foreign providers, pay enrollees cash for choosing foreign providers and/or cover the cost of travel to and from the location of the procedure. Employers may also let employees use non-vacation or personal time for in-country recovery.

Non-use dependent incentives attract new beneficiaries with low cost premiums and reward patients for taking advantage of preventative services like annual health check-ups, mammograms, prostate screenings and immunizations. While non-use dependent incentives won’t directly drive utilization of foreign providers, they support the structure of plans that encourage patients to take control of their health consumption.

There are limits to the ability of financial incentives to increase utilization of preferred foreign providers. Incentives do not address what drives health care consumption. Without understanding the decision drivers at work, global benefit plans may not reduce health care cost significantly. A benefit plan must narrowly tailored to the target beneficiary demographic to change their behavior.

Beyond Incentives: Seven Strategies to Designing Medical Travel Benefits That Work

Below are seven strategies to help employers design a medical travel benefit that will achieve better results than incentives alone.

1. Assemble A Team Of Medical Travel Experts

As with all projects, it is critical to assemble the right team. Designing a medical travel benefit is no different. Identify medical travel experts and third party benefit administrators who want to collaborate with you. Having an experienced and knowledgeable team of experts is imperative.

2. Analyze Beneficiary Demographics

The foundation of a successful global health benefit is a complete understanding of the covered population, the group’s demographics and behaviors, and what drives their health care decision-making. Approach the benefit design process from the ground up.

Start by identifying and analyzing the demographics and health care consumption patterns of the employee population. You may want to survey the group to find out their opinions about their current doctors, traveling to certain countries, and about health care in those countries. You may also want to find out how the group spends its health care dollars now and what types of incentives are most likely to work. The answers to these questions will help you build the right global provider network and design an appropriate beneficiary education campaign.

3. Build A Benefit Program That Responds To The Needs Of Your Beneficiaries

Armed with the information learned during the investigatory phase, build a benefit plan and a global provider network that reflects the needs and consumption patterns of the beneficiary population. For example, if you learn that the beneficiary population is generally over weight and has a proclivity for travel in Latin America over Asia, that information may be used to build a plan that encourages beneficiaries to investigate weight loss surgery in Costa Rica and Mexico. Surgeons in these countries are expert in bariatrics. You may also learn that your employee population is more likely to have orthopedic issues and favors Asia. In that case, a plan that highlights the orthopedic expertise of doctors in India, Singapore and Thailand is more likely to be utilized. Either way, the plan should specifically address the beneficiary population to increase the likelihood of utilization.

4. Educate Employee About The Benefits Of Medical Travel

Work closely with medical travel experts to design and implement a comprehensive employee education campaign that demonstrates the advantages of using foreign providers and the added incentives and benefits available through the medical travel plan.

5. Create A Tiered Provider Network

Create a tiered provider network that favors higher quality, lower cost providers with lower co-payments. Enrollees that select preferred foreign providers for specific treatments may have lower or no co-payments associated with that service. Tiered provider networks are a common health care benefit strategy that can be utilized to encourage beneficiaries to use foreign providers for certain services.

6. Increase Provider Transparency And Patient Responsibility

Increased transparency and patient responsibility enhances savings. Enrollees can make cost savings choices about whether or not to see a doctor (with information about disease self-management), which doctor to see (with information about provider quality, success rates, and costs), and disease treatment and management (with information about symptoms, treatments, risks, and costs). Plan providers should be encouraged to be transparent with their quality data and pricing. Giving enrollees the information necessary to make important care decisions aligns their interests with the payer. By aligning the interests of the consumer and payer, excesses can be eliminated and costs can be contained.

7. Implement Internet-Based Care Management Tools

Finally, easy-to-use internet-based care management tools encourage efficient use of wellness programs, on-line nurses, on-line training and more. Recent studies indicate that patients welcome more and better information that is easily accessible. Patients indicate that they will use salient and easy-to-use information to make informed choices about their health care consumption.* By making relevant information accessible and easy-to-use, patients can make more efficient health care consumption choices.

Conclusion

Consumer-driven health care is here to stay. The ability to maximize the benefit of cost containment strategies depends on the ability to innovate and respond to new information. Health care consumers should not be underestimated. They are discerning and scrutinizing. Their behavior is not monolithic. To predict future consumption, health care payers should carefully analyze beneficiary demographics and consumption patterns and employ sophisticated benefit design strategies that address those findings. Without a firm understanding of the covered population, incentives alone are insufficient to drive the kind of utilization necessary to realize measurable savings from medical travel.

* Consumer-Oriented Strategies for Improving Health Benefit Design: An Overview, Prepared by Stanford University-UCSF Evidence-based Practice Center, Stanford, CA for Agency for Healthcare Research and Quality, U.S. Department of Health and Human Services, July 2007.