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
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.
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.
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.
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.