/sosiukin, stock.adobe.com
Berlin – The Bundestag has passed the Medical Investigation Act (MFG). There was also strong criticism of this today. The National Association of Statutory Health Insurance Physicians (KBV) warned of a “massively increasing recourse risk” for doctors. Health insurance companies were also unhappy with some of the law’s key content.
KBV is particularly concerned about the controversial proposal to allow confidential reimbursement prices for newly introduced drugs. There has already been considerable concern from many sides – including health insurance companies and the Federal Joint Committee (G-BA) – was criticized because doctors would no longer be able to follow the cost-effectiveness requirement.
Finally, confidential reimbursement prices are no longer displayed in practice management systems, so physicians can no longer easily assess whether a given drug is more expensive or cheaper than the alternative without a confidential reimbursement amount.
This should now be addressed by requiring primary care providers to include information and advice that allows prescribers to estimate the economic viability of a drug with a confidential reimbursement price, without knowing the specific amount. However, exactly how this should happen is not explained in the text of the law.
“Such a project is unrealistic, unilaterally burdens practices with a higher appeal risk and additional bureaucratic effort,” criticize KBV board members Andreas Gassen, Stephan Hofmeister and Sibylle Steiner. “The responsibility for agreeing benefit-oriented and therefore cost-effective reimbursement prices lies solely with pharmaceutical companies and health insurance companies, not with prescribing doctors.”
Furthermore, the expected delay is “completely inappropriate”. The framework specifications for medicines must be agreed annually by 30 September of each calendar year. The corresponding economic efficiency information would then have to be incorporated into the prescribing software by the software providers, which in turn would take an implementation period of three to six months.
“There is therefore a significant time lag until the relevant information reaches the individual doctor. This increases the risk of appeals enormously,” the KBV board warned. “It is unacceptable that the conflict of objectives between strengthening Germany as a pharmaceutical location on the one hand and stabilising drug expenditure on the other is being carried out at the expense of contract doctors. It must not happen that the already poor general conditions become even worse.”
Doctors in hospitals may also face additional burdens, he criticizes Marchburger pact. An amendment to the Hospital Fees Act by the MFG stipulates that data on medical personnel must also be transmitted by hospitals in future, broken down by service group.
The result is extensive data reporting obligations for hospitals, which require minute-by-minute documentation of medical activities. “This is absurd, demotivating and takes even more time away from doctors and their patients,” criticizes the president of the Marburg Association, Susanne Johna.
The obligation for hospitals to distribute medical activities on a percentage basis between service groups is incompatible with modern forms of teamwork between different professional groups and medical disciplines. “The administrative effort of a detailed allocation of medical work time to service groups is completely disproportionate and is in clear contradiction with 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 simply impossible to assign medical staff to groups of services that the individual hospital may not yet be aware of, because they have not yet been decided as part of the legislative process for hospital reform. “Such requirements do not add value to the quality of patient care – they detract from it because they take up an unnecessary amount of time that is not needed for patient care.”
Health insurance companies particularly criticized the increase in pharmaceutical expenses allegedly caused by the law. “We have nothing against the government’s economic development. “But we reject the fact that the federal government allows this financing to be financed from the GKV contribution funds,” explained the vice-chairwoman of the board. National Association of Statutory Health Insurance FundsStefanie Stoff-Ahnis. “We do not believe that increasing contributions to supermarket cashiers and truck drivers to ultimately finance higher profits for the pharmaceutical industry is good health policy.”
One of the so-called AMNOG protective barriers, which was introduced with the GKV Financial Stabilization Act (GKV-FinStG) and sets limits on reimbursement prices in the event of no or little additional benefit, will be lifted for drugs in which at least five percent of the test subjects in Germany participated in the clinical trial.
This and confidential reimbursement pricing have made care more expensive without improving it, Stoff-Ahnis criticized. In addition, the reimbursement mechanism threatens to create a significant amount of additional bureaucracy when it comes to reimbursement pricing.
The federal association AOK also warned of rising costs for taxpayers. Exceptions to the AMNOG guardrail would make drugs disproportionately more expensive and this increase could also be disguised by confidential reimbursement prices, criticized CEO Carola Reimann.
“Given the billions in contributions being spent here on behalf of an industry that is making above-average returns under the label of promoting location, this is shocking,” she explains. “Instead of keeping an eye on the affordability of care for policyholders, corporate interests and location issues have taken precedence. And given the lack of financing options, politicians are outsourcing economic development to the GKV.”
However, Franz Knieps, chairman of the BKK umbrella organisation, is more satisfied. “The improvements to the Medical Research Act are an important partial success that shows that there is no widespread acceptance of confidential reimbursement amounts,” he explained. This is due to the commitment and persistence of some members of the Bundestag.
“The fact that drug manufacturers can still pull out the secrecy card is primarily a matter of saving face for the federal government,” Knieps continued. The hurdles to 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 sound” once its validity period has expired.
The Research-Based Drug Manufacturers Association (vfa), on the other hand, seems quite satisfied with the law. It is the most important result of the federal government’s pharmaceutical strategy to date, explained vfa chairman Han Steutel: “The government is showing that it trusts the research-based pharmaceutical industry as a key sector. The law will significantly improve the framework conditions for drug development in Germany.”
It is understandable that the law requires that at least 5% of German participation in international study programmes be exempt from AMNOG protection. However, this is an overly ambitious target for companies that cannot meet retroactively. This requires a period of several years.
“To ensure that this does not keep any more drugs off the market in the meantime, the most recent interventions in drug pricing – the so-called firewall discount regulations – must be completely suspended for at least three years,” Steutel demanded. © lau/aerzteblatt.de