Hospital.Help

Berlin – The Bundestag has approved the Medical Research Act (MFG). Today, too, there was strong criticism of it. The National Association of Statutory Health Insurance Physicians (KBV) warned of a “hugely increasing risk of recourse” for doctors. The health insurance companies also expressed dissatisfaction with some of the key aspects of the law.

The KBV is particularly concerned about the controversial plans to allow confidential reimbursement prices for newly introduced medicines. Many sides – including health insurance companies and the Federal Joint Committee (G-BA) – had already criticized the fact that doctors would then no longer be able to follow the principle of cost-effectiveness.

Finally, confidential reimbursement prices would no longer be shown in practice management systems, meaning that practitioners would no longer be able to easily assess whether a drug in question was more or less expensive than the alternative without a confidential reimbursement amount.

This is now to be addressed by requiring providers of primary systems to include information and instructions that enable prescribers to assess the cost-effectiveness of a drug with a confidential reimbursement price without knowing the exact amount. However, the text of the law does not explain exactly how this is to be done.

“Such a plan is unrealistic and burdens practices with a higher risk of recourse and additional bureaucratic effort,” criticize KBV board members Andreas Gassen, Stephan Hofmeister and Sibylle Steiner. “The responsibility for agreeing on benefit-oriented and thus economical reimbursement prices lies exclusively with the pharmaceutical companies and health insurance companies, not with the prescribing doctors.”

In addition, the expected delay is “completely inappropriate”. This is because the framework specifications for medicinal products must be agreed annually by 30 September of each calendar year. The corresponding cost-effectiveness information must then be incorporated into the prescription software by the software providers, which in turn involves an implementation period of three to six months.

“There is therefore a considerable time gap before the relevant information reaches the individual doctor. This increases the risk of recourse enormously,” warned the KBV board. “It is unacceptable that the conflict of objectives between strengthening Germany as a pharmaceutical location on the one hand and stabilizing drug spending on the other is being played out at the expense of contract doctors. It must not be the case that the already poor framework conditions are made even worse.”

Doctors in hospitals could also face additional burdens, criticizes the Marburger Bund. This is because a change in the Hospital Remuneration Act by the MFG stipulates that in future, hospitals will also have to submit data on medical staff broken down by service group.

The result is extensive data delivery obligations for hospitals, which require minute-by-minute documentation of medical activities. “This is absurd, demotivating and robs doctors of even more time for their patients,” criticizes the chairwoman of the Marburger Bund, Susanne Johna.

An obligation for hospitals to distribute medical activities on a percentage basis to the service groups is not compatible with modern forms of teamwork between different professional groups and medical disciplines. “The administrative effort of a detailed temporal allocation of medical work to service groups is completely disproportionate and is in clear contradiction to the promise of the government coalition and the Federal Minister of Health to reduce the bureaucratic burden on doctors in hospitals,” explains Johna.

She criticizes that it is objectively impossible to assign medical staff to service groups that the individual hospital may not yet know about because they have yet to be decided as part of the legislative process for hospital reform. “Such requirements have no added value for the quality of patient care – they harm it because they take up an unnecessary amount of time that is then missing from patient care.”

The health insurance companies were particularly critical of the alleged increase in pharmaceutical costs as a result of the law. “We have nothing against state economic support. But we reject the idea that the federal government should finance this support from the contributions of the statutory health insurance funds,” explained the deputy chairwoman of the GKV umbrella association, Stefanie Stoff-Ahnis. “We do not believe that increasing contributions for supermarket cashiers and truck drivers in order to ultimately finance higher profits for the pharmaceutical industry is good health policy.”

One of the so-called AMNOG guard rails, which was introduced with the GKV Financial Stabilization Act (GKV-FinStG) and provides limits for reimbursement prices in the event of no or little additional benefit, is to be suspended for medicinal products in whose clinical trials at least five percent of subjects from Germany took part.

Stoff-Ahnis criticised that this and the confidential reimbursement prices made care more expensive without improving it. In addition, the reimbursement mechanism for reimbursement prices threatened to create a considerable amount of additional bureaucracy.

The AOK Federal Association also warned of rising costs for contributors. The exceptions to the AMNOG guard rail would make medicines disproportionately more expensive and this increase in price could also be concealed by the confidential reimbursement prices, criticized CEO Carola Reimann.

“This is somewhat astonishing, given the billions in contributions that are being spent on an industry with above-average returns under the label of location promotion,” she explains. “Instead of keeping an eye on the affordability of care for the insured, company interests and location issues were given higher priority. And given the lack of financing options, politicians are outsourcing economic development to the statutory health insurance.”

Franz Knieps, the chairman of the BKK umbrella association, is more satisfied. “The improvements to the Medical Research Act are an important partial success that shows that there is no broad acceptance of confidential reimbursement amounts,” he explained. This is thanks to the commitment and persistence of a few members of the Bundestag.

“The fact that drug manufacturers can still play the confidentiality card is primarily a question of saving face for the federal government,” Knieps continued. The hurdles for confidentiality are now so high that it will probably not play a major role in practice. He would not be surprised if the regulation “disappears again without a trace” after its expiry.

The Association of Research-Based Pharmaceutical Manufacturers (vfa), on the other hand, is largely satisfied with the law. It is the most important result of the federal government’s pharmaceutical strategy to date, explained vfa President Han Steutel: “The government is showing that it is relying on the research-based pharmaceutical industry as a key sector. Because the law will significantly improve the framework conditions for drug development in Germany.”

The fact that the law stipulates that at least five percent of international study programs must be German in order to qualify for an exemption from the AMNOG guard rail is understandable. However, it is too ambitious a target for companies and they cannot meet it retroactively. This would require several years of lead time.

“To ensure that this does not keep other drugs off the market in the meantime, the most recent interventions in the pricing of drugs – the so-called guard rail discount regulations – should be suspended completely for at least three years,” demanded Steutel. © lau/aerzteblatt.de