U.S. Market Access
Together with our US based partners, Kalms Consulting supports international companies entering the U.S. market.
Learn moreMarket Assessment
With continuing or post-completion initiatives to secure reimbursement in the German sectorial healthcare environment, the appropriate moment of launching your product in the market must be considered.
Learn moreReimbursement Strategies
We focus on preparing and implementing reimbursement applications in Germany and selected markets thus ensuring that the requirements and submission deadlines of healthcare authorities are met.
Learn moreDRG Application
The partners involved in the self-administration process of the German Health Care system – mainly statutory health funds and hospitals – seek competent external advice to improve and optimize the G-DRG based hospital reimbursement system.
Learn moreNUB Application
The NUB process allows to obtain short term reimbursement for innovative diagnostic or treatment methods in case the standard hospital DRG reimbursement is insufficient.
OPS Application
An OPS (Operations- und ProzedurenSchlüssel) is used to appropriately, precisely and unambiguously code for a health care procedure.
Application for the Medical Aid Catalogue
Medical aids are objects that are required in individual cases in order to ensure the success of an emergency treatment.
Learn moreBVL Registration
The Federal Office of Consumer Protection and Food Safety (BVL) is the German contact point for the inspections of the Food and Veterinary Office of the European Commission.
Learn moreEarly Benefit Assessment
On its way into the market, a medical product must master a steeplechase and reach consecutive milestones before it is regularly reimbursed.
Public Affairs & Relations
In order to achieve a favorable reimbursement or regulatory framework, public affairs strategies should be an integral part of every market access strategy.
Health Economics & Business Development
Our experts are constantly recording information on health economics with the aim of creating an individual analysis for different departments with an international focus.
Learn moreExtended Services & Event Management
Our extended services include distribution and warehousing in cooperation with our associated partners.
Learn moreZE Application
The procedure to submit a supplemental fee (Zusatzentgeld = ZE) is part of the regular annual DRG-system update process.
§137h Consulting and Guidance
New Treatment and Diagnostic methods (NUBs) often require additional funding above the established DRG level for standard of care hospital methods.
Learn moreASV – Outpatient Specialist Care
Outpatient specialist care (ASV) sums up additional treatment services for patients with severe or rare conditions, according to guidelines published by the Federal Government.
Learn moreGuideline Analysis
Treatment guidelines serve to make the consensus on diagnostics and therapy reliable by means of evidence, to avoid lobbying in patient care and to optimize an interdisciplinary treatment approach.
Learn more§137e “Trial Regulation”
The objective of the §137e “trial regulation”was to enable the G-BA to support the generation of high level evidence for benefit assessments of innovative diagnostic or treatment methods.
Learn more§87 SGB V Application
All new medical methods that are covered by the statutory health insurances in Germany in general have to be evaluated previously by the G-BA (Federal Joint committee).
Selective Contracts / Integrated Care
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.
Learn moreDue Diligence
Due diligence (DD) is the basis of any successful negotiation for agreement or contract with another party (e.g., merger and acquisition). As such it can make the difference between a non-successful or a profitable merger & acquisition (M&A) transaction.
Learn moreInterim Management
The unforeseen occurrence of complex problems and challenges in companies, which are mostly confronted with limited human resources, can be overcome through the targeted use of interim management.
Learn moreBusiness models and plans
A business plan can be used to attract investment before a company has a proven track record, or to structure and evaluate business opportunities for established companies.
Learn moreDiGA and DiPA
Digitalisation offers opportunities and possibilities to make workflows and processes more efficient to meet the current and future challenges of the health care system: demographic change, cost explosion and staff shortages.
Learn morePZN-Registration
The pharmaceutical registration number (PZN) is the national identification key for products sold in pharmacy division according to the declaration of obligation, in particular according to § 131 Abs. 4 SGB V; excl. individual imports.
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