What we do

Market Access & Reimbursement

What we can offer

Kalms Consulting supports your European business at all stages: market introduction,
(increasing) competition, growing or changing markets, changes in legislation,
and so on with a straight focus on your success.

U.S. Market Access

Together with our US based partners, Kalms Consulting supports international companies entering the U.S. market.

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Market 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.

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Reimbursement 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.

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DRG 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.

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NUB 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.

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OPS Application

An OPS (Operations- und ProzedurenSchlüssel) is used to appropriately, precisely and unambiguously code for a health care procedure.

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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.

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BVL 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.

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Early Benefit Assessment

On its way into the market, a medical product must master a steeplechase and reach consecutive milestones before it is regularly reimbursed.

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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.

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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.

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Extended Services & Event Management

Our extended services include distribution and warehousing in cooperation with our associated partners.

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ZE Application

The procedure to submit a supplemental fee (Zusatzentgeld = ZE) is part of the regular annual DRG-system update process.

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§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.

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ASV – 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.

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Guideline 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.

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§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.

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§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).

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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.

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Due 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.

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Interim 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.

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Business 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.

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DiGA 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.

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PZN-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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Your business is our business. So weather you need first ideas
or a second opinion: We’re here to listen – and ready to answer.

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