Here is one possible, intermediate mechanism, designed to serve as a gateway for introducing innovative medical devices into the German Inpatient reimbursement system.

1. The Problem

Just as in the US acute care hospital inpatient stays are reimbursed according to Medicare Severity Diagnosis Related Groups (MS-DRGs), in Germany they are reimbursed according to German Diagnosis Related Groups (G-DRGs).

In both cases, if your new device does not fit into an existing DRG, the hospital may not get paid for using it and thus may not want to use it. On the other hand, forming a new DRG code for your device (in the US or in Germany) requires data collection of procedure utilization. But since your device doesn’t currently fit into an existing DRG, hospitals are reluctant to use it, and therefore it will never reach sufficient utilization to justify the creation of a new DRG code.

Sounds like a Catch-22, right?

To encourage entry of new and innovative technologies into the German healthcare system, there is a short-term, intermediate reimbursement mechanism that provides hospitals with the required financial incentive to use a new device, before it is properly reimbursed under the G-DRG system. However, it seems as if most US medical device companies are unaware of this mechanism that could shorten their time-to-market and even increase their chances of obtaining a relevant G-DRG code in the future.

In the next part I will provide a short description of the German G-DRG system, and then discuss the NUB mechanism.

2. German G-DRG System

The German DRG system, or G-DRG system, groups several parameters, such as: the patient’s main and sub diagnosis (using ICD-10 diagnostic codes), performed procedures (using OPS procedure codes) as well as additional characteristics including the patient’s age, complications and co-morbidities into a single G-DRG code and assigns each code with a price tag (with different adaptations that are outside the scope of this article).

The G-DRG system is a ‘leaning system’, relying on quantitative data supplied to the Agency for the Hospital Payment System (IneK) by the ~250 reporting hospitals throughout the year. The data gathered during 2010 is applied in the 2012 catalog.

3. NUB Reimbursement

Article 6.2 of the Hospital Remuneration Law (KHEntgG) allows hospitals to submit requests for reimbursement of “new and innovative diagnosis and treatment methods” that did not obtain a G-DRG code yet.

It should be emphasized that the device manufacturer is not the one applying for NUB reimbursement. Mediclever typically assists the manufacturer in preparing the application and then each relevant hospital receives a copy and submits it on its own.

3.1 Required Criteria

The NUB reimbursement request must fulfill the following criteria:

* The new and innovative method affects several existing G-DRGs.

* The new and innovative method can be clearly defined.

* The cost of using this new and innovative method affects the cost structure of the relevant procedure and the overall cost structure of the hospital.

* The requesting hospital’s financial situation would be worse if the request is rejected.

3.2 The Application Process

Any hospital, interested in submitting a request for NUB reimbursement, should fill out a request form, which could be downloaded from the InEK site (www.g-drg.de). The application must be submitted by October 31st and provide information regarding the substituted (old) method, date of first applying the new method, number of patients treated and expected number of patients that will be treated according to this new and innovative method. Furthermore, a cost analysis comparing between the old and new methods should be added.

InEK checks all submitted applications and replies with a value of 1 to 4 for each application by January 31st.

* Value 1:

- The innovative method corresponds with the requirements and will be reimbursed.

- Usually, InEK will not have a national database that enables a uniform reimbursement rate, therefore each hospital and local GKV negotiation committee will negotiate the reimbursement rate.

- InEK will also check if the innovative method can be adapted into the G-DRG framework.

* Value 2:

- The innovative method does not correspond with the requirements.

- The hospital is not allowed to negotiate reimbursement with any Sickness Fund.

* Value 3:

- InEK is overloaded and cannot reply to the submitted application until the deadline of Jan 31st.

- The hospital may negotiate NUB reimbursement with interested Sickness Funds

* Value 4:

- The application was not clear or did not explain clearly why NUB reimbursement is needed.

- The hospital may negotiate NUB reimbursement with interested Sickness Funds.

3.3 Benefits and Disadvantages

* Benefits:

- Obtaining NUB reimbursement takes a relatively short time. This could lead to immediate increase in procedure and sales volume.

- There are no risks in receiving a rejection and a negative reply will not affect chances of obtaining another reimbursement mechanism in the future.

* Disadvantages:

- NUB reimbursement only applies to submitting hospitals and requires bilateral negotiations between each hospital and the local Sickness Funds.

- Each agreement is only valid for one year, but may be renewed, relatively easy, unless it has become a part of the G-DRG system.

In a recent research conducted by the Institute of Health Economics (IFG), it was suggested that hospital submissions will be available throughout the year and innovative methods that received a value 1 reply will automatically be reimbursed until included in G-DRG and apply to all relevant hospitals.

3.4 Statistics

For 2010, out of 13,865 requests for 546 new methods, 7,480 (representing 87 new methods) were assigned with Value 1, 6,005 (representing 444 new methods) were assigned with Value 2, none with Value 3 and 245 (representing 11 new methods) were assigned with Value 4. (Source: InEK).

4. Summary

The German healthcare system is trying to cope with the built-in delays of integrating innovative diagnostic and therapeutic treatments into the system. Similar to the German NUBs, comparable reimbursement mechanisms exist in the UK and in some regions of Italy. Utilizing these mechanisms can help US companies obtain reimbursement in Europe faster, bring their products to market sooner and increase their chances of obtaining a specific DRG code at a later stage.

To verify the existence of relevant DRG codes or any other reimbursement mechanisms for your product in the US or any European country, to develop and implement an appropriate reimbursement strategy and for any additional questions, please contact:

Amir Inbar, CEO

Mediclever Ltd.

www.mediclever.com

Amir Inbar founded Mediclever (www.mediclever.com), which provides end-to-end reimbursement consulting services to life-science companies, selling pharmaceuticals and medical technology products in the US and Europe. As an expert reimbursement consultant Amir has consulted for organizations ranging from incubator startups to large, publicly traded companies.

These drugs go under several different brand names but all belong to a class of drugs known as Statins. While there are approximately 12 million people taking these drugs the problem comes because they carry with them some very serious side effects.

One of the more common side effects that people experience is pain and weakness in their muscles. This is a condition that can take a long time to resolve and is caused by statins increasing the levels of a muscle enzyme called CPK. This condition can be extremely painful for some that experience it because of the inflammation it causes in the muscle. In some rare cases this can set off a series of more serious events. The reason that doctors want a blood test for most people new to statins is that it can cause the kidneys to work overtime in discarding the byproducts of muscle breakdown through the urine. Proteins from this muscle damage can build up in the kidneys and cause permanent damage and possibly death.

Another problem that statins can cause is the depletion of Coenzyme Q10 also known as CoQ10. This enzyme is present in the mitochondria of your cells. The mitochondria are responsible for the production of energy in the cells. This is a compound that you do not want to deplete. CoQ10 is also needed for the production of ATP which is needed for muscle contraction and protein production in the body. You can see how depletion of CoQ10 can have some very negative affects on the body.

Studies have shown that having adequate levels of CoQ10 can be of benefit to preventing the onset of heart disease as well as its treatment. Additional benefits from this are in blood clotting capacity and the role it plays as an antioxidant. For these reasons people need to know the affects that statins have on the levels of this important enzyme.

It has been documented that people experiencing a heart attack have low levels of CoQ10. Studies have also shown that when levels of this enzyme are brought up to normal there is less chance of the patient having a subsequent attack and in those who do the level of chest pain is greatly reduced.

It has been shown that in patients with lower levels of CoQ10 cholesterol levels are higher than in people with adequate levels of the enzyme. This is true even when they are taking statin medications to lower cholesterol. If you take a person that already has lower levels of this enzyme introduction of statins can further reduce it.

People need to understand that Statin drugs are not the only way to lower cholesterol. There are more natural ways to do this that involve some simple lifestyle changes. If your doctor suggests drugs to do this make sure you ask about these alternatives and have a good understanding of the side effects of the drugs he or she are prescribing. Your pharmacist is also a very good source of information.

Remember that knowledge equates to power. Get all the information and do your research on the side effects of any medication that is being prescribed to you. Demand that your health care professional provide you with this information.

If you are serious about lowering your cholesterol levels you need to know that there are alternatives to the side effects of Statins. You need to find out how to lower cholesterol using these means immediately. You will be on your way to a happier and healthier life.

1. Do – Develop your reimbursement strategy early.

Don’t – Delay developing your reimbursement strategy until just before your product launch.

Real life examples:

Example #1: Company A developed a 4-sensor product that competed with other available 6-sensor products. This product was clinically better and less expensive than its competitors. The company invited Mediclever to check whether they could utilize existing reimbursement mechanisms in France. A short assessment revealed available codes, a positive coverage policy, and payment rates that exceeded the company’s expectations. However, the wording in the identified existing codes specifically indicated 6 sensors! Redesigning the product at that stage was too difficult, and the company was left out of the French market.

Example #2: Company B developed and launched a product in the US market. Unfortunately, the pressure settings employed by their product deviated from the allowable range specified under existing reimbursement mechanisms. The CEO asked Mediclever to provide them with a ‘reimbursable’ specification. The company is currently redesigning their product according to this spec.

Remember: Your reimbursement strategy could affect your product design.

2. Do – Consider reimbursement factors when selecting the most appropriate application to start with.

Don’t – Choose your “killer app” only on the basis of R&D, regulatory criteria, or marketing.

Real life example: Company C developed a platform that could be used for a few applications. The company invited Mediclever to develop and implement its reimbursement strategy, while its pivotal trial, focused on Application I, was underway. Mediclever’s assessment discovered that if the company proceeded with the current Application I, the likelihood for reimbursement was low and might only be granted in five to ten years at a considerable investment. On the other hand, if the company used the same device for Application II, immediately upon receipt of the CE mark, the device would be reimbursed at a lucrative rate. Obviously, the company realized that by continuing with Application I, the company would probably not survive to reach profitability. Consequently, the company abandoned Application I and is currently selling its product, under existing reimbursement mechanisms, for Application II.

Remember: Your reimbursement strategy could affect the first application of your product.

3. Do – Leverage your clinical trial(s) to gather reimbursement related data.

Don’t – Focus only on the regulatory aspects.

Real life example: Company D developed outstanding clinical data for their product and invited Mediclever to help them develop specific reimbursement mechanisms for it. All Payers that Mediclever approached were impressed by the developed clinical ‘evidence’, but wanted the company to also present data regarding a few economic aspects. Since these economic aspects were not observed during the company’s previous clinical trial, the company had to perform a new trial to gather the requested data. Had the company thought about its reimbursement strategy prior to initiating the clinical trials, those economic aspects could have been easily integrated into their previous trials making the investment in a new trial, and the delay in the sale of their product, redundant.

4. Do – Develop your regulatory and reimbursement strategies in parallel.

Don’t – Think that since regulatory clearance comes before obtaining reimbursement that this is a serial process.

Real life example: Company E asked Mediclever to start working on its reimbursement strategy after applying for, and receiving, the regulatory clearance. Unfortunately, the wording that was used in the application substantially decreased the likelihood of reimbursement. Consequently, the company re-applied for the regulatory clearance, this time, with a modified indication for use. Needless to say, this delayed the launch of the product resulting in substantial loss to the company.

Remember: Short regulatory path ≠ optimal reimbursement.

These real-life examples can help you avoid these common mistakes, reduce costs, and reach the market sooner.

To verify the existence of relevant reimbursement mechanisms for your product in the US or any European country, to develop and implement an appropriate reimbursement strategy and for any additional questions, please contact:

Amir Inbar, CEO

Mediclever Ltd.

www.mediclever.com

amir@mediclever.com

Amir Inbar founded Mediclever (www.mediclever.com), which provides end-to-end reimbursement consulting services to life-science companies, selling pharmaceuticals and medical technology products in the US and Europe. As an expert reimbursement consultant Amir has consulted for organizations ranging from incubator startups to large, publicly traded companies, assisting them to obtain reimbursement.

While everyone knows that end of life is inevitable , what a doctor does it make absolutely certain that a person is no more. In medical terminology, a person is declared dead when all the vital functions of the lungs, heart and brain stop. Scientifically speaking death occurs in two different stages, clinical and molecular death.

In the case of being declared clinically dead, sometimes life can persist in certain organs or cells of the body. The parts that are showing signs of life can sometimes also respond to thermal, electrical or chemical stimuli. The period of time that the remaining cells survive usually varies from person to person. When all the cells die , it is then declared as a molecular death.

While there are various causes for a person losing his life, broadly speaking a person is declared dead when his or her lungs, heart and brain stop functioning. There could be various other reasons for it such as drugs, infection, malnutrition, starvation, poisoning and injury, to mention only a few. There could also cases when a person suddenly passes away due to accidents or suicide or gets killed.

There are some clear cut signals that doctors look for when they are diagnosing whether a person is alive or not. One of the immediate signs is the lack of EEG rhythm. The ECG would also be flat and circulation would stop. The respiratory system will not be functioning and the person will not have any kind of sensation or reflexes. Cessation of movements may sometimes occur due to other reasons also such as epilepsy, electrocution and narcosis , to mention only a few with the absence of heart sounds. These conditions are therefore taken into consideration during the diagnosis. It is only when the doctor is sure about the total cessation of vital functions of the body.

There are other signs too that doctors look for whenever they are certifying that a person is no longer alive. The cooling of the body after a person passes away known scientifically as Algor Motris is one of the signs that is noted . Discoloration of the body that starts after a few hours a person has passed away is another sign that is noted. Similarly signs of decomposition and the stiffness of the body after death are all signs that doctors take note of whenever they are certifying a person is dead. It is only when they are absolutely sure about all these factors that they declare a person dead.

I am basically a graduate at the University of Hamburg and you can get awesome articles and valid information from the ones which I submit specially for you to take a look at. Check out Death Images, Death Graphics or Death Pictures.

The most common ones include:

A-Steroids

• beclomethasone (Beclovent®, Vanceril®, Becloforte®)
• budesonide (Pulmicort®)
• flunisolide (Bronalide®)
• fluticasone (Flovent®)

B-Non-Steroidal

• sodium cromoglycate (Intal®)
• nedocromil (Tilade®)

Corticosteroid Inhalers

Corticosteroid drugs are the most effective Preventers. They work by reducing and preventing airway inflammation, swelling and mucus.

They must be used regularly and do not have an instant effect. This means they have no value whatsoever if an effect is needed straight away.

The Side effects of Corticosteroid Inhalers
There are few side effects at low doses

• High doses might cause growth suppression; studies have shown children whose asthma is not controlled don’t grow as quickly as other children.
• side effects, in general, are usually restricted to the throat:
  • hoarseness and sore throat
  • Thrush or yeast contamination which can be prevented by rinsing the mouth and gargling, Using a holding chamber can also help prevent side effects.

Corticosteroid Tablets

Corticosteroid tablets or Prednisone®:

• These are used when inflammation becomes severe
• They reduce inflammation, swelling & mucus, and help bronchodilators work better
• They start to work within a few hours, but may take several days to have a full effect
• They are often used for short periods of time just to get the inflammation under control

There are lots of side effects if used on a long-term basis such as water retention, bruising, puffy face, increased appetite, weight gain and stomach irritation.

Other Preventers

Other preventers are Intal® and Tilade®. They are non-steroidal and again used to reduce inflammation.

• sodium cromoglycate (Intal®)
  - for mild asthma
  - this can protect against the effects of cold air and exercise
  - it requires 4-6 weeks to be effective
  - it has few side effects.
• nedocromil (Tilade®)
  - is similar to Intal®
  - is requires 3-4 weeks to be effective
  - it has a bad taste
  - it has fewer doses/canister; therefore, you will probably need more than one canister per month.
• ketotifen (Zaditen®)
  - is used for mild asthma
  - it can be useful for asthmatics who also suffer from hay fever
  - it helps to reverse inflammation of the airways
  - it can be used orally and comes in tablets or syrup
  - it requires regular use of 8-12 weeks to become effective
  - it’s side effects include drowsiness and weight gain

Bronchodilator Medications (Relievers)

Bronchodilators are the most extensively used medications for controlling unexpected asthma attacks and for preventing attacks brought on by physical activity or exercise. Theophylline is a bronchodilator that works by relaxing the muscles surrounding the airways.

These:-

• Are rescue medications, therefore are used only when needed, and rarely on a regular basis (unless the asthma is under inadequate control)
• Provide quick relief of symptoms shown
• Relax the muscles of the airways
• Are useful with exercise induced broncho-spasm
• Are usually in blue devices

Types of Bronchodilator Drugs

The most common bronchodilators are:

• B 2-Agonists
• Anticholinergic Inhaler
• Theophylline

• B 2-Agonists
• - salbutamol (Ventolin®, Apo-Salvent®, Novo Salmol®)
• - fenoterol (Berotec®)
• - terbutaline (Bricanyl®)
• - pirbuterol (Maxair®)

B 2-Agonists are rescue medications which:

• Relax the muscles around the airways which allows the breathing to become much easier within minutes.
• Are used only when needed and rarely on a regular basis, unless the asthma is under inadequate control.
• Make the airway muscle less likely to contract.
• Are usually in blue devices.

When to use B<SUB2< sub>-Agonists

• to relieve symptoms of cough, chest tightness, wheezing and shortness of breath
• a few minutes before exercising or before exposure to any trigger known that might worsen asthma

Side effects of B 2-Agonists include:

• trembling
• nervousness
• flushing
• increased heart rate

• Anticholinergic Inhaler

Atrovent®

Atrovent opens the airways by blocking signals from the nervous system which cause the airways to become contracted. It takes one to two hours to reach its maximum effect; therefore, it shouldn’t be used as an immediate emergency medication.

Side effects
There are few side effects, a bad taste is probably the only one.

• Theophylline
• - TheoDur®
• - Uniphyll®
• - Phyllocontin®
• -TheoLair®
• Theophylline is an oral bronchodilator which works directly to relax the airway muscle.

It can be used at night-time if shortness of breath disturbs sleep or more frequently if the asthma condition is very severe. Theophylline levels can be affected by other medications – so it’s important the physician is aware of all medications asthmatics are taking, including over-the-counter drugs.

Side effects include:

• - Diarrhoea
• - Nausea
• - Heartburn
• - Loss of appetite
• - Headaches
• - Nervousness
• - Rapid heart beat
• - Upset stomach
• - Theophylline is not now commonly used in the treatment of asthma