Law for medical care with remedies and medical aids

A consolidation for the medical care with remedies and medical aids?

In recent months – especially in the field of wound care providers – much discussion has been taking place, and the law for medical care with remedies and medical aids has been challenged on all sides with courageous commitment.

Many medical societies, the Federal association of Medical Technology (BVMed), and the leading association of statutory health insurances (GKV) submit their comments. After the third reading and after the 2nd round in the Federal Council, the law for medical care with remedies and medical aids was announced on 04/10/2017 in the official gazette.

Why was a revision of the regulation of the sector for remedies and medical aids necessary?

„In an aging society, the supply of remedies and medical aids is becoming ever more important,“ Federal Minister of Health Hermann Gröhe confirmed the importance of the law for the strengthening the medical care with remedies and medical aids at the beginning of the year in the German Bundestag.

To this end, a regulation had to be made for the future, which would enable the further development of the supply with remedies and medical aids and be borne by the providers, suppliers, insurance companies and patients.

To combine the interests of all involved parties was certainly the biggest challenge.

In the valid form, the law for medical care with remedies and medical aids entails major changes. The main points have already been adequately described and partly commented on the pages of the Federal Ministry of Health, the insurance companies and on the sides of the associations and the representations of interests.

Since the most important changes are already known to most of us, we would now like to discuss the consequences of § 31 para. 1 SGB V for future medical care.

What are the changes for the future in the context on the supply of wound dressings?

A study by the German Medical Technology Association (BVMed) says that around 900,000 people are affected by severe chronic wounds.

These patients usually need a regular supply of wound dressings.

Thanks to significant advances in research and technology, the dressing materials have become more developed and innovative in recent years. A targeted treatment of different wound types could be carried out with the use of different wound dressings, infections in parts avoided and a better healing process could be supported.

As a result, the diversity of the wound dressings also increased and, over the years, this diversity required a clear definition of the term „dressing material“, in order to allow a clear demarcation.

The required definition for this was previously lacking in the old version of § 31 para 1 SGB V.

This merely said; „Insured persons are entitled … to the supply with bandages and dressings, … „.

Thus, in the last few years, Article 31 (1) SGB V increasingly caused conflicts between the insurance companies and medical device industry. On both sides the pure conceptuality of „bandages and dressings“, without a more detailed definition, gave too much room for free interpretation and the associated reimbursement.

This circumstance has now been remedied by the amended version.

In Paragraph 31 of the Social Code (SGB V) also introduced paragraph 1a, which now includes the following definition; „Bandages and dressings are articles, including material for fixation, whose main activity is to cover surface-damaged body parts, absorb body fluids from surface-damaged body parts, or doing both. The property as a bandage or dressing does not cease, in particular, when an article keeps a wound moist. Articles which are used for the one-time production of individual dressings, if needed be used several times, on body parts which are not surface-damaged in order to stabilize, immobilize or compress body parts are also included … „.

At the present time, this definition includes most of the established dressing materials and thus strengthens an innovative supply of bandages and dressings without any exclusion of services from reimbursement in favour of sustainable patient care.

The Joint Federal Committee (G-BA) has to regulate the demarcation between bandages and dressings and other wound care products in the directives pursuant to Article 92 (1), second sentence, point 6 until 04/30/2018.

It is only after the submission of this directive by the Federal Joint Committee (G-BA) that it will be possible to assess which medical devices will does not meet any longer the definition of dressing materials.

Even if the supply of bandages and dressings is clearly regulated by definition and will thus certainly contribute to a clear reduction in the conflicts on reimbursement issues between insurance companies and manufacturers, we can already expect future questions regarding cost-effectiveness in wound care due to the tense financial economic situation in the health care system.

According to § 12 SGB V, „… benefits must be sufficient, appropriate and economic; They must not exceed the extent of the necessary. Benefits that are not necessary or uneconomical cannot be claimed by insured persons, cannot be caused by the service providers and cannot be granted by the health insurance companies …“, considerable challenges already today arise for the research, development and production of marketable bandages, dressings and medical devices.

Conclusion

Even though the law for medical care with remedies and medical aids (HHVG) has set the right course for the future in many areas, the health care system continues to raise the question of profitability due to the financial situation.

To be well positioned on this point is, from our point of view, still a challenge for all parties involved. To demonstrate the economic benefit with authoritative figures for a product next to the medical benefit is still not self-evident.

Is the cost-effectiveness of your medical devices secured?

We are looking forward to answering your questions about this exciting and challenging topic.

About „use it AG“

As an independent partner, „use it AG“ combines industry-specific know-how and focuses on the disruptive innovation of existing business models, products, technologies and services.

The company is focussing on the digitization of the organizational structure and the development of new solutions in an increasingly challenging digital world, taking into account human performance.

The references include international corporations, major medium-sized companies, important organizations such as cooperatives, associations, societies and institutions of public law.


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