Mandatory benefit assessments soon to be enforced


As a result of Germany’s 2015 health care reform, the country’s health care system will soon begin enforcing mandatory benefit assessments for certain medical examination and treatment methods carried out using Class IIb or III devices or active implants. An assessment is triggered when a hospital submits a New Examination and Treatment Methods (Neue Untersuchungs- und Behandlungsmethoden, NUB) application that is the rst ever for a given method.

These NUB applications aim to improve reimbursement for new methods in the form of extra- budgetary add-on payments that can be negotiated with the health insurers once the German Institute for the Hospital Renumeration System (Institut für das Entgeltsystem im Krankenhaus, InEK) has approved the application. However, the introduction of mandatory assessments means that, in the worst case scenario, the method with this device can be excluded from reimbursement entirely based on the outcome of the assessment.

This doesn’t mean that you should avoid the whole process and generally not support NUB applications. In fact, you might miss reimbursement opportunities. There would also be nothing to gain from this course of action – hospitals can submit NUB applications without the approval of the manufacturer.

It’s therefore important to focus on the following activities: working on proper applications; providing strategic advice to hospitals; and preparing in advance for an assessment of products already 

  Joint Federal Committee (Gemeinsamer Bundesausschuss G-BA) Image  Source: G-BA

Joint Federal Committee (Gemeinsamer Bundesausschuss G-BA) Image Source: G-BA

planned for the next few years. Preparations in the long term can and should anyway include the adjustment of planned clinical trials.

Three criteria are used to assess whether it is necessary to submit an NUB application for your product. The rst one has already been mentioned – a method with a Class IIb or III device or active implant plus a ‘ rst ever’ NUB application. Secondly, the method has to be especially invasive based on the de nition of the relevant ministerial order. Thirdly, it has to constitute a new scienti c- theoretical concept. 

 Image Source: G-BA

Image Source: G-BA

It is therefore in the interest of the manufacturer that this information is correct – and it is also in your and your consultants’ interests to ensure this is in place via communication with hospitals. This has to be done regardless of the risks involved regarding a bene t assessment.

The G-BA will use this information (along with an additional internet consultation) as a basis for assessing whether the method meets the criteria for a bene t assessment. The G-BA will also use it to assess whether there is enough information available on risks and bene ts. If the bene t is unclear but it demonstrates potential, then the G-BA will order an assessment. However, if the evidence presented or assessed doesn’t show a bene t, then the G-BA will exclude the method from reimbursement. So – if you have a new device at risk Class IIb or III or an active device and an NUB application for such a method hasn’t been submitted yet – then start preparing now. 


Author | Michael Kauch
Associate Partner for Strategy,
PR and Public Affairs


You can discuss with your Kalms & Partner consultant whether your products meet the criteria and what the implications are for them.

In unclear cases we advise taking up the opportunity of a consultation with the Joint Federal Committee (Gemeinsamer Bundesausschuss G-BA). We recommend giving the G-BA a well prepared dossier about the new method before the consultation. This enables the G-BA to give a binding statement as to whether the criteria for a reimbursement assessment are applicable. This statement is then available for further consideration before an NUB inquiry is submitted by a hospital.

The Joint Federal Committee has also set a new guideline for NUB applications for methods with Class IIb or III devices or active implants. In order to ful l the guideline requirements, the hospital has to submit information on the method and product. This means that the hospital has to consult the involved manufacturer(s) prior to submission. 



Project Management & Reimbursement

Dr. Madeleine Künz is our expert for biochemistry, pharmaceuticals and market analysis. In her previous research activities, she focused on pharmaceutical developments and innovative approaches. Beside her studies she worked as a paramedic and thus is still familiar with the diverse medical approaches and procedures. Her responsibility includes evaluation of new and established treatment options and methods, market analysis, project management and KOL relationship management.

Dr. Madeleine Künz holds a Ph.D. degree in chemistry in the section of biochemistry and biophysics. During her studies and working experience she became uent in English. As a result of her interdisciplinary scienti c experience she is skilled in the communication of medical topics to different target groups. 

Reimbursement, Market Access & PR

Barbara Senger is our expert for medical marketing, market access & development and patient related PR. After over 10 year experience in commercial marketing & communication positions she started to work in 2006 in leading positions for medical devices companies in Germany and DACH region.

Her responsibilities included operative downstream marketing as well as strategic upstream marketing, planning and implementing product launches and KOL relationships. She is well experienced in change & integration management of medical brands and companies. She also has experience in indirect leadership in matrix organizations.

Barbara Senger holds a degree in marketing (IHK) and communication management equivalent to the bachelor of arts media & communication. During her working experience she became uent in English and has considerable knowledge of French. 

Public Affairs, PR & Strategy, Economist, Former Member of Parliament

Michael Kauch is our partner for Public Relations and Public Affairs. He has a 20 year experience in these elds. From 2003 to 2013, Michael Kauch was Member of the Bundestag, the German federal Parliament.

In Parliament, Michael Kauch specialized in environment and health. He was member of the Special Committee on “Ethics and law of modern medicine”, substitute member of the Health Committee and liberal spokesperson on bioethics, transplantation and palliative medicine. Besides his work in Parliament, he was consultant in the Innovation Council of a major German health insurance.

Before his time in Parliament, Michael Kauch worked as press spokesman, PR and policy expert and later as managing director of the German young entrepreneurs association BJU. He is an expert in political communication with press, TV and social media. Additionally, he gained experience in organizing stakeholder dialogues, events and conferences.

Michael Kauch has political experience both in the German political system and in the processes within the European Union. By former projects for a medical device company, he is familiarized with the challenges of market access and reimbursement of medical devices.

Michael Kauch provides a relevant cross-party network of politicians and stakeholders in Germany. Especially from his former position as Vice President of the Global Legislators Organisation GLOBE, he also has relevant contacts in Europe and beyond.

Michael Kauch holds a degree as “Diplom-Volkswirt”, the German equivalent to a Master degree in economics with specialization in economic policy and marketing. He is a native speaker in German, uent in English and has considerable knowledge of Italian and French. 




September 1st 2016 – October 31st 2016

The InEK Data Portal is expected to accept NUB inquiries for 2017 by hospitals between September 1st and October 31st. NUB inquiries should be prepared well in advance. Hospitals might request them from manufacturers early on in the submission process. Please note that in a case of a rst-time NUB submission for a Medical Device with high risk classi cation according to the newly introduced § 137h SGB V, information to the Federal Joint Committee (G-BA) might be required in parallel with the NUB submission. If applicable, the production of the information dossier according to §137h requires exceptional additional efforts for drafting. You should consider asking your consultant for speci c details as soon as possible.

DEADLINE: October 31st 2016

Applications sent in later than October 31st 2016 will not be taken into account. 


We launched our new Kalms & Partner Consulting website in June. Having been in the works for several months, it’s now completely refurbished and updated.

The new design now makes it easier to nd out information about our company and our consultancy network and services.

We’ll also keep you updated on important facts regarding the European Health Care system. Enjoy! 



Kalms & Partner Consulting founder Marco Kalms and our Associate Partner Michael Kauch informed delegates about the opportunities and the challenges of the German medtech market at the networking event. One of the keynote speakers of this event, Doug Kohrs, who also was Marco Kalms’ former CEO during his time at American Medical Systems, was awarded the “Champion of the Alley” for his lifetime achievements for the industry in Minnesota.

Author | Dr. Stephan Binder
COO & Business Development

Kalms & Partner Consulting has just become a member of the Medical Alley Association, representing the health technology industry in the State of Minnesota. We are proud of this membership as several of our clients have their headquarters in the innovative health technology cluster of the Medical Alley region. We were also excited about the opportunity to be a Gold Sponsor at the Association’s annual meeting on April 27th in Minneapolis. 

  Kalms & Partner at Medical Alley 2016 Annual Meeting

Kalms & Partner at Medical Alley 2016 Annual Meeting




The new mandatory benefit assessment for a number of medical devices with NUB applications is a challenge for your strategy. How do you have to adjust it and how can you avoid new risks? What does it mean for communication with hospitals and what do you have to prepare if there is a risk that an NUB application could trigger a bene t assessment? Kalms & Partner consultants, as well as external experts, will provide input on these issues. Our workshop has a limited number of participants, therefore providing opportunities to discuss your questions with the experts.

The workshop will be in German and is taking place on July 14 2016 in Berlin.


09.30 am Registration with Coffee (Foyer Femina)
10.00 am Welcome & Introduction by Marco Kalms, Founder of Kalms & Partner Consulting

10.20 am Overview
New §137h SGB V and the Medizinproduktemethodenbewertungsverordnung (MeMBV):
What are the key points and the most important provisions?
Introduction: Michael Kauch, Associate Partner Strategy, PR and Public Affairs Kalms & Partner Consulting

11.00 am Coffee Break

11.15 am In-depth Analysis
When does the bene t assessment according to §137 affect procedures and what are the steps affecting the decision-making process?
Introduction: Dr. Holger Schaffrath, Senior Consultant Market Access & Reimbursement Kalms & Partner Consulting

12.15 pm Communication with Hospitals
What are the views of hospitals towards the new provisions and what does this mean for the cooperation of hospitals and manufacturers regarding NUB applications and bene t assessment?
Introduction: Jens Bussmann, Deputy Supervisor of theAgency of the German University Hospital Union (VUD)

1.00 pm Lunch

1.45 pm The Testing Period
What happens when my procedure needs to undergo a bene t assessment and how can I prepare for this before an NUB query is raised?
Introduction: Dr. Katja Schröder, Senior Consultant Market Access & Reimbursement Kalms & Partner Consulting

2.45 pm The Decision Makers
Which future processes inside G-BA are planned and what opportunities for consultancy are there for manufacturers?
Introduction: Rolf Bäumer, Joint Federal Committee, Personal Advisor to the impartial Member responsible for assessing procedures.

3.45 pm Coffee Break

4.00 pm Strategy in Dialogue
The new §137h SGB V and its strategic in uence on potential NUB requests in the future:
Under which conditions should future NUB requests be initiated and when should they be avoided? Introduction: Dr. Benjamin Schulz, Senior Consultant Project Management & Health Care Economics, Kalms & Partner Consulting

6.00 pm Wrap-up & Feedback
Under the direction of: Michael Kauch, Associate Partner Kalms & Partner Consulting

6.30 pm Close

Location: Ellington Hotel Berlin
Nürnberger Str. 50-55
10789 Berlin


The participation fee is 795,00 € per person excluding 19% VAT. This fee includes lunch, refreshments and workshop documents.


In writing by 1 July 2016. The number of participants is limited.
If you are interested in receiving an invitation and updated information regarding the program and speakers please contact Ellen Holtmann - eholtmann [at]