Kalms Consulting Newsletter 01/2018

Kalms Consulting Newsletter 01/2018

out-patient reimbursement code received/

SUCCESSFUL SUPPORT FOR ALLERGAN

Kalms Consulting is happy to announce the successful support and execution of our client Allergan’s reimbursement strategy to receive an outpatient reimbursement code for the physicians treating the over-active bladder with BOTOX® injections. Starting on 1st January 2018, physicians get an extrabudgetary add-on payment for the treatment on top of the insufficient codes that could be used until 2017.

BOTOX® is FDA approved to treat overactive bladder symptoms such as a strong need to urinate with leakage, urgency and frequency in adults when another type of medication (anticholinergic) does not work well enough or cannot be taken. The transurethral injections can be done in an inpatient as well as in an outpatient setting for suitable
patients. 

Over three years, Kalms Consulting was involved in Allergan’s efforts to initiate a dialogue with relevant stakeholders of the decision-making process –

convincing them of the benefit for patients and of potential cost-cutting for health funds by shifting a part of the cases from the hospital to the outpatient setting. Furthermore we have supported selective contracts between single public health funds and regional physicians associations - to put pressure on the process on the federal level and bridge reimbursement until a nationwide solution. 

Receiving an outpatient reimbursement code is a long-term project in the German public health system. Contrary to the formalized procedures in hospital reimbursement, the process in the outpatient sector is based on open negotiations between the federal association of health funds and the federal physicians association. In most cases – contrary to the Botox case – a prior formalized benefit assessment is obligatory. 

Kalms consultants are happy to inform you about the details of the rules and the necessary steps to take.

 

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MARKET ACCESS STRATEGY WITH SELECTIVE CONTRACTS/

AN ALTERNATIVE APPROACH IN ACCESSING THE GERMAN HEALTHCARE SYSTEM

The German healthcare system has two comprehensive Reimbursement systems, one being the DRG-Catalogue in Hospitals, the other being the EBM-Catalogue for the outpatient sector. These catalogues value diagnostics and therapeutical interventions for reimbursement. In the private
sector, there is a further catalogue, the honorary table for physicians (GOÄ).

These catalogues are final. There are several approaches for new methods to be included in one of the catalogue and thereby obtain a reimbursement value. Due to the strong
regulation of the German healthcare system and in particular due to the strict separation of hospital and outpatient care, lawmakers in Germany created an additional instrument to give patients access to integrated care or special outpatient care. This instrument is called selective contracts and creates opportunities for additional reimbursement or use of methods not approved for the regular outpatient care.  In a selective contract, one or more
medical provider (physicians, doctors’ offices or hospitals) negotiate with one or more health funds on a special care pathway with the respective payment of a specific treatment or diagnostics.

This care is accessible for all patients insured with this health fund.  Selective contracts are a relatively „fast“ track into the German healthcare system, especially if the method is positioned at the boundary between hospital and outpatient care or if an outpatient method is creating special economic benefits for the health fund.  The negotiation of selective contracts is complex. A vigorous and complete preparation is necessary. Economic and medical advantages need to be evaluated and clearly explained for the negotiating partners. Equally important is the selection of the service providers and health funds for the initial negotiations. Moreover, any selective contract should always be seen in context of a broader market access strategy to align on mid-term goals. For example, negotiating an open contract with the possibility to allow other service providers and health funds to enter the contract is enlarging the potential market.

Kalms Consulting has been part of negotiations and execution of selective contracts and possesses the right amount of experience to embed the element of a selective contract into a market access strategy. This ensures that this vital instrument is used at the right time.

 
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ROADSHOW TO CHINA/

SIGNIFICANT INTEREST OF CHINESE INVESTORS IN EUROPEAN AND US MED TECH AND LIFE SCIENCE COMPANIES

For the first time in the company’s history, Kalms Consulting was on a roadshow to China mid of
October. Starting in Shanghai and continuing to Beijing, we met with various important players on the Chinese med tech and life science market, including distributors and investors.

The Chinese healthcare market for European and US med tech and life science companies

The Chinese healthcare market is of growing importance and (by overall volume) already on the third place worldwide. Presence on this market can significantly increase revenue and company valuation. With the right partner in place, market access in China will be successful and the time needed for regulatory obligations can be minimized. There is a fast-growing interest of strong and  countrywide distributors for new and innovative products – capital goods as well as expensive disposables and consumables. Various kinds of agreements, including risk sharing and market development activities executed by the distributor, are possible.

 

Significant interest of Chinese investors in European and US med tech and life science companies

The interest of Chinese investors in med tech and life-science companies in Europe and in the US is tremendous. Investments can range from minority to majority or even acquisition of the entire company. In the past, investors tended to move IP and infrastructure to China. This has significantly changed in the past years. In most cases the European / US business remains
unchanged, but new sales channels in China and other countries with strong links to China become accessible.

Our roadshow to China took place in collaboration with Taylor Wessing, a full-service international law firm, working with clients in the world’s most dynamic industries. Taylor Wessing attorneys can support our clients with protecting their IP, all needed contracts and legal advice when entering the Chinese market.

In case of any interest in the Chinese market, you are very welcome to contact Stephan Binder at Kalms Consulting.

 
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SHORT NEWS/

RESULTS OF THE 2018 NUB APPLICATIONS

On January 30th, 2018, the Institute for the Reimbursement System in Hospitals (InEK) published the results of the 2018 applications for extra reimbursement for New Diagnostic and Treatment Methods (NUB).

The annual procedure of hospitals’ submissions of NUB Inquiries to InEK has the purpose to achieve the opportunity to negotiate extra reimbursement, if the new method requires funding exceeding the level of the existing DRG yields for standard of care treatments. For new methods which constitute a new theoretical scientific concept and use  medical devices with specific risk class and invasive approach, the Joint Federal Committee (G-BA) is obliged by law (§137h SGB V) to conduct an early benefit assessment on the new method. Especially the latter assessment requires distinct preparation.

Kalms Consulting is advising clients in the phases of NUB draft preparation and conduct of the NUB procedures with and without required §137h assessments.

In both cases, our primary target is a positive NUB status for our client. Therefore, profound submission documents must be prepared for hospitals. The client must be guided to support hospitals through the NUB negotiation steps with the health funds to finally agree on a sufficient NUB extra fee value. 

The results of the 2018 NUB applications are available at www.kalmsconsulting.com

Kalms Consulting services include the analysis of likelihood of success as well as risk assessment and risk management. Next to this, we support you and your customers in hospitals at all stages of the application process including support of budget
negotiations in case of a successful NUB application.

You are very welcome to contact us to discuss if your product(s) might be applicable for the next NUB application period.

Results of the 2018 NUB applications

Results of the 2018 NUB applications

On January 30th, 2018, the Institute for the Reimbursement System in Hospitals (InEK) published the results of the 2018 applications for extra reimbursement for New Diagnostic and Treatment Methods (NUB). 
The annual procedure of hospitals’ submissions of NUB Inquiries to InEK has the purpose to achieve the opportunity to negotiate extra reimbursement, if the new method requires funding exceeding the level of the existing DRG yields for standard of care treatments. For new methods which constitute a new theoretical scientific concept and use  medical devices with specific risk class and invasive approach, the Joint Federal Committee (G-BA) is obliged by law (§137h SGB V) to conduct an early benefit assessment on the new method. Especially the latter assessment requires distinct preparation.

Kalms Consulting is advising clients in the phases of NUB draft preparation and conduct of the NUB procedures with and without required §137h assessments. In both cases, our primary target is a positive NUB status for our client. Therefore, profound submission documents must be prepared for hospitals. The client must be guided to support hospitals through the NUB negotiation steps with the health funds to finally agree on a sufficient NUB extra fee value. 

The results of the 2018 NUB applications are available at
http://www.g-drg.de/G-DRG-System_2018/Neue_Untersuchungs-_und_Behandlungsmethoden_NUB/Aufstellung_der_Informationen_nach_6_Abs._2_KHEntgG_fuer_2018

Kalms Consulting services include the analysis of likelihood of success as well as risk assessment and risk management. Next to this, we support you and your customers in hospitals at all stages of the application process including support of budget negotiations in case of a successful NUB application.

You are very welcome to contact us to discuss if your product(s) might be applicable for the next NUB application period.

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Roadshow to China - Significant interest of Chinese investors in European and US med tech and life science companies

Roadshow to China - Significant interest of Chinese investors in European and US med tech and life science companies

ROADSHOW TO CHINA/

For the first time in the company’s history, Kalms Consulting was on a roadshow to China mid of October. Starting in Shanghai and continuing to Beijing, we met with various important players on the Chinese med tech and life science market, including distributors and investors.

 

The Chinese healthcare market for European and US med tech and life science companies

The Chinese healthcare market is of growing importance and (by overall volume) already on the third place worldwide. Being present on this market can significantly increase revenue and company valuation. With the right partner in place market access in China will be successful and the time needed for regulatory obligations can be minimized.

There is a fast-growing interest of strong and countrywide present distributors for new and innovative products – capital goods as well as expensive disposables and consumables. Various kinds of agreements, including risk sharing and market development activities executed by the distributor are possible.

Significant interest of Chinese investors in European and US med tech and life science companies

The interest of Chinese investors in med tech and life-science companies in Europe and in the US, is tremendous. Investments can range from minority to majority or even acquisition of the entire company. While in the past investors tend to move IP and infrastructure to China, this has significantly changed in the past years. In most cases the European / US business remains unchanged but new sales channels in China and other countries with strong links to China become accessible.

Our roadshow to China was in collaboration with Taylor Wessing, a full-service international law firm, working with clients in the world’s most dynamic industries. Taylor Wessing attorneys can support our clients with protecting their IP and all needed contracts and legal advice when entering the Chinese market.

In case of any interest in the Chinese market you are very welcome to contact me.

Stephan Binder

Kalms Consulting Newsletter 01/2017 - The new American Division of Kalms Consulting

Kalms Consulting Newsletter 01/2017 - The new American Division of Kalms Consulting

THE NEW AMERICAN DIVISION OF KALMS CONSULTING/

PROVIDING AMERICAN FIRMS FASTER ACCESS TO THE EUROPEAN HEALTH CARE MARKET 


Kalms Consulting is pleased to announce that it is opening two new American offices in the most vibrant healthcare technology regions of the United States: San Francisco and Minneapolis.

Navigating FDA approval can be a significant investment in time and dollars. Executing a dual pathway strategy via the European market can provide a streamlined opportunity that quickly allows manufacturers to jumpstart revenue gains, develop a strong health economics story, and aggregate additional clinical data needed to successfully gain approval in the U.S. The European market is also an attractive target for well-established companies looking to expand beyond their native country. Kalms Consulting enjoys longstanding relationships with small, mid-cap and large, US-based medical device, biotech, biopharma and life science clients who continue to benefit from broadening their revenue pathways in Europe. Establishing permanent offices in the United States to better serve existing and future clients made perfect sense. The Kalms Consulting team is comprised of experienced and highly qualified experts who deliver affordable, data-driven solutions to clients worldwide. The U.S. division will specifically focus its efforts on market access, strategic business development, technology assessment and market analysis while working in concert with their European counterparts.

MARCO KALMS
Founder & CEO

“It is my pleasure to introduce the American Division of Kalms Consulting. With these offices we’re giving American firms a better opportunity to access the German and European market.” 

 

Kalms Consulting GmbH
Rheinstrasse 45–46 Aufgang 1
12161 Berlin | GERMANY


KALMS CONSULTING SAN FRANCISCO/

HEALTH CARE IS THE BIGGEST INDUSTRY IN THE BAY AREA 

San Francisco is the cultural, commercial, and financial center of Northern California.
California has a great history of innovation in life sciences, developing new technologies to solve health problems.

As the birthplace of biotechnology California stands for the innovation in life sciences in particular. Genomic technologies help detect diseases, while new therapies and devices help to treat them. Digital health technologies help prevent diseases and provide patients with better tools to manage their conditions.

Life Sciences is a cornerstone of California’s economy and contributes to a healthier society and advances new medical technologies.
California’s life sciences community continues to grow, with 3,040 life sciences companies – 192 more than the previous year – producing new technologies and boosting the state’s economy. In 2015, the Golden State’s life sciences industry employed more than 287,000 people. This highly trained and diverse workforce helped develop novel drugs, devices and diagnostics, while also exploring other applications, such as leveraging biotechnology to produce sustainable energy. “Life sciences companies have been incredibly successful. As of September 7, 2016, 1,269 drugs from Californian companies were in the FDA pipeline. In 2015, 264 new devices developed by Californian companies were approved. Academic excellence, forward-thinking public policy and the commitment of thousands of entrepreneurs and business leaders has translated into new ways to address some of the world’s most severe medical conditions: cancer, hepatitis, HIV, rare diseases and many others. These efforts help power our economy and provide health for millions around the world.”1

1CLSA California Life Sciences Association/ 2017 California Life Sciences Industry Report 

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ADRIAN NUNN
Business Development U.S.

“Being the center of technological innovation on the West Coast San Francisco is the perfect location for opening a Kalms Consulting office. We are going to provide start ups with easier access to the rich European market.” 

 

Kalms Consulting US, Inc.
San Francisco Office
101 Montgomery Street Suite 2050
San Francisco | CA 94104

KALMS CONSULTING MINNEAPOLIS/

A HEALTH AND MEDICAL INDUSTRY HUB WITH TRADITION 

Minneapolis is the county seat of Hennepin County, and the larger of the Twin Cities.
Minneapolis and Saint Paul anchor the second-largest economic center in the Midwest, after Chicago. Minneapolis lies on both banks of the Mississippi River, just north of the river’s con uence with the Minnesota River, and adjoins Saint Paul, the state’s capital. The city is abundantly rich in water, with thirteen lakes, wetlands, the Mississippi River, creeks and waterfalls.

Minneapolis has a great tradition of making an impact on the health eld and continues to do that today. It hosts the University of Minnesota, which ranks in the top three research universities in the USA. Medical device research is robust at the University of Minnesota. One of the most innovative health providers in the nation, Mayo Clinic, is just an hour and a half drive to the south in Rochester.

Multiple Fortune 500 companies in the health eld were founded in Minneapolis, and the impression these companies have left via innovations reverberates throughout the world.
According to the Minnesota-based Medical Alley Association more than two-thirds of last year’s PMAs out of FDA went to applicants out of California and Minnesota. 

TIMOTHY ZIAJA
Business Development U.S.

“With Minneapolis’ history of Medical Innovation and achievement the founding of the Minneapolis division of Kalms Consulting will provide existing firms and start ups a gateway to the international stage.” 

 

JIM KAZMIERKOSKI
Business Development U.S.

“The location of Minneapolis in the midwest region provides easy access to firms in Cleveland, Madison and Milwaukee.” 

 

Kalms Consulting US, Inc.
Minneapolis Office
701 N. 3rd Street
Suite 202 | North Loop Minneapolis | MN 55401


EVENTS

GERMANY FIRST, AMERICA SECOND?
TAKING THE FASTER ROUTE TO MARKET FOR HEALTH CARE COMPANIES

May 23rd, 2017 | wework Transbay | San Francisco

An expert panel discussion about what challenges healthcare companies will face, but the experts also addressed the rewards that lie in international expansion. What is the best way to set up a company, how do you go about reimbursements and tax issues? For those in the initial planning phase of expansion there was a general discussion about strategic decisions a healthcare company needs to make when discovering new markets and how to approach this. Michael Kauch, Associate Partner Strategy & Public Affairs to Kalms explained in his talk the current situation of “Reimbursement and developments in Health Policy in Germany“. The panel discussed key factors for succeeding and investing in the German market as a starting point for further international expansion.

Organized by: Kalms Consulting, Osborne Clarke, Rueter und Partner, Invest in Bavaria and GACC 

 

KALMS CONSULTING SUPPORTING VISITS OF
GERMAN BUSINESS DELEGATIONS TO INTUITIVE SURGICAL 

May 25th, 2017 | Intuitive Headquarter | Sunnyvale

Supported by Kalms Consulting, high level German business delegations have visited our client Intuitive Surgical in the headquarter in Sunnyvale, California. 60 entrepreneurs, VC companies and supporting agencies were part of the Silicon Valley tour of the German start-up association (Bundesverband Deutsche Startups). Also the German Ministry of Economic Affairs had been represented. Furthermore, a delegation of the Vodafone Enterprise Forum, led by a Vodafone Germany board member, came to see the latest technological developments in robotic assisted surgery. Both groups were impressed how Intuitive Surgical has made its way from a start-up to a market leader - and how Intuitive Surgical is constantly improving its technologies for the benefit of surgeons, hospitals and patients. 

Germany first, America Second? Panel Discussion in San Francisco, May 23, 2017

Germany first, America Second? Panel Discussion in San Francisco, May 23, 2017

„Please join us for a panel discussion on how to enter the European market via Germany as a life sciences company. We will discuss key factors for succeeding and investing in the German market as a starting point for further international expansion.

Our experts will discuss what challenges healthcare companies will face, but will also address the rewards that lie in international expansion. What is the best way to set up a company, how do you go about reimbursements and tax issues? For those in the initial planning phase of expansion there will be a general discussion about strategic decisions a healthcare company needs to make when discovering new markets and how to approach this.

After the panel discussion we hope you join us for little bit less of a 'healthy' happy hour with appetizers and drinks. We look forward to seeing you there!“

Organized by:

Kalms Consulting GmbH, Osborne Clarke, Rueter und Partner, Invest in Bavaria and GACC West

Agenda and more information

Market Access Workshop, 12.05.2017, Berlin

Market Access Workshop, 12.05.2017, Berlin

Von der erfolgreichen Produktentwicklung zur rechtzeitigen Reimbursement-Planung

Powered by Kalms & Partner und NAMSA

Berlin, Rheinstraße 45 – 46, Aufgang 1, 12161 Berlin
12.05.2017

Die Teilnahmegebühr beträgt 99 € pro Person und wird in vollem Umfang an Ärzte ohne Grenzen e.V. gespendet
Die Teilnehmerzahl ist begrenzt
Anmeldungen bitte mit Name, Firma und Branche an info [at] kalmsconsult.com
Anmeldeschluss 17.04.2017

Programm:

9:00 Uhr              Registrierung

9:30 Uhr              Zulassungsstrategie – Wichtige Eckpfeiler für eine erfolgreiche Produktentwicklung und Vermarktung by NAMSA

10:15 Uhr            Frühstückspause

10:45 Uhr             Marktzugang und -akzeptanz in Deutschland: Systeme verstehen und Herausforderungen meistern by Kalms Consulting

11:30 Uhr            Mittagspause mit Zeit zum Networking

13:15 Uhr             Neue Innovationskultur im Gesundheitssystem - Medizintechnischer Fortschritt 2.0. Erwartungen und Angebote der Medizintechnologie-Branche an die Politik by BVMed

Ab 14:00 Uhr      gibt es die Möglichkeit persönliche Face-to-Face Gespräche mit den Referenten zu führen. (Bei Interesse, bitte in der Anmeldung angeben, da es nur sehr begrenzte Plätze gibt.)

Anreise:

Ab Bahnhof Zoologischer Garten mit der U9 bis Walter Schreiber Platz
Ab Hauptbahnhof mit der U55 bis Brandenburger Tor von dort mit der S 1 bis Feuerbachstraße

 
 

Referenten:

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Olaf Winkler
BVMed

ist seit 2001 Leiter des Referats Gesundheitssystem im BVMed. In dieser Zeit war er zudem für das BMGS, das DIMDI und für die Deutsche Wirbelsäulengesellschaft in unterschiedlichen Ausschüssen tätig.

Des Weiteren hat er einige Artikel zu den Themen Budgetierung, Marktetablierung und Vergütung von Medizinprodukten verfasst. 

Stephan Buttron
NAMSA

ist seit 2016 Principal Medical Research Manager bei NAMSA. Er hat über 20 Jahre Berufserfahrung in EU-US-FDA und Weltweiter Zulassung von Produkten aus dem Bereich Medizintechnik und leitete bereits einige Workshops und Trainings im Bereich des Risikomanagements und Marktzugangs.

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Dr.Benjamin Schulz
Kalms Consulting

 ist bei Kalms Consulting der Experte für bio-physikalische- und medizinische Technologie sowie für Marktanalyse und strategisches Business Development.

Er hat sowohl im Sektor der erneuerbaren Energien wie auch in dem der Medizintechnik als Strategie- und Technologischer Berater gearbeitet. 

J.P. Morgan 35th Annual Healthcare Conference 2017 in San Francisco

J.P. Morgan 35th Annual Healthcare Conference 2017 in San Francisco

Kalms & Partner Consulting will participate in the J.P. Morgan 35th Annual Healthcare Conference 2017 in San Francisco. At this event, investors and executives from all over the world meet with companies presenting their latest innovations and new partnerships are decided.

35th Annual J.P. Morgan Healthcare Conference
Monday, January 9 - Friday, January 13, 2017

For more information visit https://www.jpmorgan.com/country/US/en/jpmorgan

Kalms & Partner Consulting Newsletter 03/2016

Kalms & Partner Consulting Newsletter 03/2016

REIMBURSEMENT OPTIONS IN THE
GERMAN HEALTHCARE SYSTEM

DIRECT CONTRACTS AS AN OPPORTUNITY FOR
INNOVATIVE MEDICAL DEVICES

In outpatient medical care, the direct contract is the counterpart of the collective contract. Collective contracts are agreed on the national level by the associations of physicians and the association of health insurance companies. Collective contracts are binding for doctors and health funds. The direct contract, on the other hand, offers individual agreements of health funds with service providers and producers of medical devices.

This enables contractual partners to flexibly respond to needs that exist in specific types of care or when treating particular illnesses. The areas in which direct contracts can be used have been widened considerably in the past few years. For patients this results in better care from one provider. The implementation of the new law for strengthening the provision in statutory healthcare insurance (Versorgungsstärkungsgesetz) in 2015 created new opportunities for direct contract arrangements. 

It also simplified existing forms of contractual arrangements. The new law envisages a systematic continued development of opportunities for direct contracts for all service providers. So far, the types of contracts were regulated by different sections of the health code (Sozialgesetzbuch V). They have now been condensed in a new clause (§ 140a SGB V) as ‘special care provision’. 

These contracts can cover matters such as services for early diagnosis, specialized outpatient care, as well as new examination and treatment methods whose applications follow medical good practice.

Content of the new article of law

§ 140a SGB V Special Care Provision

Health funds may enter contracts concerning special care provision for insured persons with service providers shown in Illustration 1.

It enables a cross-sector care concepts or an interdisciplinary approach (integrated care). These are legal prerequisites and not negotiable. It also allows contracts for special medical outpatient care involving approved contracted medical service providers or their associations. Insured persons who want to benefit from the special care of their health fund have to submit their voluntary participation in writing to their health fund. Insured persons can revoke their consent with the health fund within two weeks of submission either in written form or as a written transcript without giving a reason. It needs to be stressed that treatments already rejected by the Joint Government Committee (Gemeinsamer Bundesausschuss) may not be part of the contracts. The contractual parties also have to prove within a certain fixed timeframe (usually four years) that the treatment specified in the contract constitutes an improvement with regard to quality and cost effectiveness for the community.

The number of direct contracts will rise

We are aware of approximately 800 contracts in 2012. In 2014 the Association of Statutory Health Insurance Physicians reported 1,850 direct contracts. This trend points towards a considerable rise in the coming years.

Great opportunities for medical device companies

It is an aim to promote competition for members between health funds as well as competition between service providers. Direct contracts should therefore increase the efficiency and quality of patient treatment and also facilitate innovation. Kalms and Partner have excellent contacts in the German healthcare sector, also in the health funds. We would be pleased to support our customers with initiating contacts with individual health funds to initiative contracts – if the legal prerequisites.

According to the new law healthcare insurance companies may enter contracts with the following entities:

  1. Individual medical suppliers or associations of suppliers e.g. physicians, practices.
  2. Boards of institutions offering special treatments for insured persons on the basis of Chapter 4 of the law
  3. Statutory nursing care insurers and approved care institutions on the basis of §92b Book 11
  4. Healthcare centres on the basis of §115 Section 2 Sentence 1 Number 1
  5. Pharmaceutical companies
  6. Medical device companies as de ned by the law for medical devices
  7. Associations of Statutory Health Insurance Physicians in order to support members taking part in special care provision 


Author | Barbara Senger
Reimbursement,
Market Access & PR

ABOUT

YOUR EXPERTS

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ELLEN HOLTMANN
Project Management & Reimbursement

Ellen Holtmann is our team member for Quality Management, Quali cation for market access (incl. national and international requirements for the development and manufacture of medical products also in respect to product liability), national and international requirements for clinical assessment and approval of medical products, national and international aspects of the bringing to market and monitoring of products during the product life cycle. Ellen Holtmann holds a University certification being a qualified Manager Regulatory Affairs Medical Devices International.

During her work in the Medical Device Market since 2000 and besides collecting multiple experiences in the field of Customer Service, Customer Relation Management, Office Management, Marketing, Healthcare Compliance, Quality Management , International Sales Management (Austria and Switzerland) and Business Development. Ellen Holtmann is looking back on a working partnership with Marco Kalms for more than 14 years. She is a native speaker in German and fluent in English. 

HOLGER SCHAFFRATH, Ph.D.
Market Access & Reimbursement

Dr. Holger Schaffrath has 25 years of experience in sales, marketing, operations and General management for entities of primarily US based medical device companies in Central European markets. This has included working for Boston Scientific for 5 years and in aggregate for Medtronic and AVE 13 years, acquired by Medtronic in 2000. In recent years he has focused on managing startups launching vascular intervention and neurostimulation products, and has steered related therapies through the phases of market access and adoption in Germany, including clinical, reimbursement related and commercialization aspects. As a Senior Consultant he provides our clients with a broad portfolio of profound knowledge of the German health care system combined with insider knowledge of the medical device industry and related markets.

Holger received a diploma in information sciences and holds a Ph.D. degree in biomedical engineering. To round his professional skills off he is a certified psychological adviser and management coach. 

 

EVENTS

MEMBER OF PARLIAMENT AT LIVE SURGERY WITH DaVinci

Intuitive Surgical is the leading company in robotic assisted surgery and has developed the DaVinci surgical system. Kalms & Partner Consulting is supporting Intuitive Surgical in the field of Public Affairs. To demonstrate the impact of the technology for high quality surgery, we have initiated a visit by Dr. Georg Kippels, Member of the German federal Parliament, to the St. Antonius Gronau hospital - the leading center for robotic surgery in Europe. Dr. Kippels was able to take part in a 3D live transmission of a minimally invasive prostate surgery - an impressive experience for a policy dialogue on quality medicine. 

SHORT NEWS

PROGRESS FOR OUR CLIENT ALLERGAN

Curing severe forms of incontinence - this is the aim of the Botox injection to the overactive bladder. Kalms & Partner Consulting is supporting Allergan, the producer of Botox, in regard to the application of the method to the outpatient sector. One instrument are contracts with major health funds. Allergan and Kalms & Partner Consulting can now report further progress in the efforts to improve access of patients in ambulatory surgeries. 

After a DAK contract in the region of Westphalia-Lippe two more contracts have included the Botox injection to the overactive bladder: DAK in Bavaria and AOK in Baden-Württemberg. 

This is good news for the patients and for the physicians who nally get a much better reimbursement than before. 

SHORT NEWS

KALMS & PARTNER CONSULTING IS SUPPORTING THE U.S. COMMERCIAL SERVICE'S CORPORATE EXECUTIVE OFFICE (CEO) PROGRAM AT MEDICA.

Taking place in Düsseldorf November 14th – 17th,  MEDICA is the world’s largest event for the medical sector with more than 5,500 exhibitors (including more than 500 U.S. exhibitors) in 19 exhibit halls and expected and 130,000 trade-only visitors from 120 countries. 

The CEO program was developed by theU.S. Commercial Service in order to offer US companies a unique opportunity to promote their exports and to meet customers and qualified distributors from all over Europe and the world at affordable cost.

Kalms & Partner Consulting is happy to participate in this event in order to continue our activities in successfully supporting US based companies with their German and European activities.

 

KALMS & PARTNER CONSULTING EXPERT MEETING ON NEW BENEFIT ASSESSMENT

In July 2016, Kalms & Partner Consulting successfully gave an expert workshop on the New Benefit Assessment (NUB) implemented in the German reimbursement system. It applies to certain methods with medical devices provided an NUB application is submitted by a hospital.

In the workshop, Kalms & Partner consultants explained details of the new law, its implications for the medtech companies and strategy recommendations for our clients. Additionally, participants had the opportunity to discuss the matter with high-level representatives of the Association of German University Hospitals and of the Joint Federal Committee, the most important self-administration body of the German health system.

If you missed the workshop, but are planning an NUB application in 2017, please contact your Kalms & Partner consultant as early as possible, as applications that may be subject to a benefit assessment have to be carefully prepared several months ahead of the deadline.