Last month, Germany’s Federal Joint Committee (G-BA) proposed significant changes to the medical cannabis prescription process, opening the door for medical cannabis to be prescribed via statutory health insurance (gesetzliche Krankenversicherung or GKV)
This would enable around 70% of practicing German physicians to prescribe medical cannabis without prior approval from health insurance companies, which would be reimbursed for patients.
While logic dictates these changes would lead to a spike in reimbursed prescriptions across the country, some industry insiders have suggested that the threat of ‘recourse’, in which doctors can still be held financially liable, is likely to continue to see prescribing practicians be extra cautious.
Germany’s previous medical cannabis prescription process through statutory health insurance, which covers around 90% of the population, has until now been challenging due to strict regulations requiring doctors to obtain prior approval from health insurance companies before prescribing cannabis that could be reimbursed.
In July, the Federal Joint Committee (G-BA) proposed sweeping changes to this process, significantly broadening the list of specialist practitioners who would be able to prescribe medical cannabis without the prior approval of the health insurance company.
Under the new proposals, a total of 16 specialist and specialty titles, along with five additional titles, have been listed, which the G-BA assumes ‘can conclusively assess the requirements for a cannabis prescription’, and prescribe without health insurance approval.
This, as Business of Cannabis previously reported, would mean that around 70% of all doctors in the country would now be able to prescribe via health insurance without receiving prior approval, a move that could have a ‘major effect on basically the entire German market, because suddenly the statutory health insurers are required to pick up the cost of medical cannabis.’
However, there is ‘a catch’ according to Bloomwell’s CEO and Co-Founder, Niklas Kouparanis. He told Business of Cannabis: Regarding the statutory health insurance market and the recent regulatory changes, if you look closely, the changes aren’t as significant as they might seem.
“Specialists can now prescribe cannabis, and health insurance companies are required to cover it. But, there’s a catch—doctors can be held financially liable by the insurance companies after prescribing medical cannabis. This creates a significant risk for doctors, which makes many hesitant to prescribe it.”
“So, while we expect some growth in the health insurance market, the real opportunity lies in the private payer market, where we’re seeing exponential growth. The new regulations might help, but they won’t be a game changer for the widespread adoption of insured cannabis.”
Recourse, or ‘Regress’, allows health insurance companies to hold doctors financially liable if they prescribe treatments or medications, including medical cannabis, that are later deemed unnecessary or inappropriate.
This system creates a financial risk for doctors, as they could be required to repay the costs of the prescribed treatments to the insurance company.
This is often determined on a cost basis, so it’s worth bearing in mind the fact that medical cannabis is often cheaper than other pharmaceutical alternatives.
Carsten Schütz, Market Access Manager Grünhorn Group, who has 30 years of pharmaceutical experience, explained: “These procedures are well-known to doctors and apply to all prescriptions under statutory health insurance (GKV). With the elimination of the requirement for cost coverage approval, various specialists can now prescribe cannabis without prior approval from the insurance company.
“However, it is important to note that the legal prerequisites to avoid recourse have not changed. This means that the following conditions must be met: The condition must be serious, there must be no alternative to a treatment with cannabis-based medicines (or alternatives must not be applicable in the specific case based on the physician’s justified assessment), and there must be an expectation of a noticeable positive impact on the course of the disease or on severe symptoms.
“If these conditions are met when prescribing cannabis, the doctor should not fear recourse under § 106 SGB V.”
He added that this process is not rigid, meaning that each federal state can negotiate different rules during their annual discussions in the pharmaceutical budget, including cost-effectiveness goals and audit agreements.
For prescribers who are still cautious about the prescribing due to the threat of recourse, the new proposals continue to enable them to seek prior-approval from the insurance companies.
In a recently published statement, board member of the Kassenärztliche Bundesvereinigung (National Association of Statutory Health Insurance Physicians or KBV), Dr. Sibylle Steiner, said “From our point of view, it is important that doctors continue to have the opportunity to obtain advance approval from the health insurance company if they so wish.”
The Ministry of Health will now have two months to raise any legal objections to the proposals, after which time it will automatically be published in the Federal Gazette, effectively passing it into law, with them widely expected to be given the green light.
If passed, the impact this may have on the flourishing medical cannabis market, alongside the impact that concerns around recourse will have, are still unclear.
Mr Schütz continued: “There are some concerns from doctors about the potential for recourse, which is common with the introduction of new therapies or medications. In my over 30 years of experience in the pharmaceutical industry, this has always been the case with the introduction of new therapies/medications.
“However, in our many conversations with doctors, we have also heard that they definitely plan to take advantage of this new regulation. We have already received some of the first prescriptions.
“Patients who had their applications rejected by health insurance companies in recent years (30-40%) now have renewed hope. These applications were medically justified by the treating physician and are well documented. We do not anticipate any limitations to market growth as a result.”
The post German Doctors May Remain Cautious of Prescribing Medical Cannabis Despite New Rules Opening Up Access For Millions appeared first on Business of Cannabis.
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This would enable around 70% of practicing German physicians to prescribe medical cannabis without prior approval from health insurance companies, which would be reimbursed for patients.
While logic dictates these changes would lead to a spike in reimbursed prescriptions across the country, some industry insiders have suggested that the threat of ‘recourse’, in which doctors can still be held financially liable, is likely to continue to see prescribing practicians be extra cautious.
What happened?
Germany’s previous medical cannabis prescription process through statutory health insurance, which covers around 90% of the population, has until now been challenging due to strict regulations requiring doctors to obtain prior approval from health insurance companies before prescribing cannabis that could be reimbursed.
In July, the Federal Joint Committee (G-BA) proposed sweeping changes to this process, significantly broadening the list of specialist practitioners who would be able to prescribe medical cannabis without the prior approval of the health insurance company.
Under the new proposals, a total of 16 specialist and specialty titles, along with five additional titles, have been listed, which the G-BA assumes ‘can conclusively assess the requirements for a cannabis prescription’, and prescribe without health insurance approval.
This, as Business of Cannabis previously reported, would mean that around 70% of all doctors in the country would now be able to prescribe via health insurance without receiving prior approval, a move that could have a ‘major effect on basically the entire German market, because suddenly the statutory health insurers are required to pick up the cost of medical cannabis.’
However, there is ‘a catch’ according to Bloomwell’s CEO and Co-Founder, Niklas Kouparanis. He told Business of Cannabis: Regarding the statutory health insurance market and the recent regulatory changes, if you look closely, the changes aren’t as significant as they might seem.
“Specialists can now prescribe cannabis, and health insurance companies are required to cover it. But, there’s a catch—doctors can be held financially liable by the insurance companies after prescribing medical cannabis. This creates a significant risk for doctors, which makes many hesitant to prescribe it.”
“So, while we expect some growth in the health insurance market, the real opportunity lies in the private payer market, where we’re seeing exponential growth. The new regulations might help, but they won’t be a game changer for the widespread adoption of insured cannabis.”
What is ‘recourse’?
Recourse, or ‘Regress’, allows health insurance companies to hold doctors financially liable if they prescribe treatments or medications, including medical cannabis, that are later deemed unnecessary or inappropriate.
This system creates a financial risk for doctors, as they could be required to repay the costs of the prescribed treatments to the insurance company.
This is often determined on a cost basis, so it’s worth bearing in mind the fact that medical cannabis is often cheaper than other pharmaceutical alternatives.
Carsten Schütz, Market Access Manager Grünhorn Group, who has 30 years of pharmaceutical experience, explained: “These procedures are well-known to doctors and apply to all prescriptions under statutory health insurance (GKV). With the elimination of the requirement for cost coverage approval, various specialists can now prescribe cannabis without prior approval from the insurance company.
“However, it is important to note that the legal prerequisites to avoid recourse have not changed. This means that the following conditions must be met: The condition must be serious, there must be no alternative to a treatment with cannabis-based medicines (or alternatives must not be applicable in the specific case based on the physician’s justified assessment), and there must be an expectation of a noticeable positive impact on the course of the disease or on severe symptoms.
“If these conditions are met when prescribing cannabis, the doctor should not fear recourse under § 106 SGB V.”
He added that this process is not rigid, meaning that each federal state can negotiate different rules during their annual discussions in the pharmaceutical budget, including cost-effectiveness goals and audit agreements.
Doctors can still seek preapproval
For prescribers who are still cautious about the prescribing due to the threat of recourse, the new proposals continue to enable them to seek prior-approval from the insurance companies.
In a recently published statement, board member of the Kassenärztliche Bundesvereinigung (National Association of Statutory Health Insurance Physicians or KBV), Dr. Sibylle Steiner, said “From our point of view, it is important that doctors continue to have the opportunity to obtain advance approval from the health insurance company if they so wish.”
The Ministry of Health will now have two months to raise any legal objections to the proposals, after which time it will automatically be published in the Federal Gazette, effectively passing it into law, with them widely expected to be given the green light.
If passed, the impact this may have on the flourishing medical cannabis market, alongside the impact that concerns around recourse will have, are still unclear.
Mr Schütz continued: “There are some concerns from doctors about the potential for recourse, which is common with the introduction of new therapies or medications. In my over 30 years of experience in the pharmaceutical industry, this has always been the case with the introduction of new therapies/medications.
“However, in our many conversations with doctors, we have also heard that they definitely plan to take advantage of this new regulation. We have already received some of the first prescriptions.
“Patients who had their applications rejected by health insurance companies in recent years (30-40%) now have renewed hope. These applications were medically justified by the treating physician and are well documented. We do not anticipate any limitations to market growth as a result.”
The post German Doctors May Remain Cautious of Prescribing Medical Cannabis Despite New Rules Opening Up Access For Millions appeared first on Business of Cannabis.
Continue reading...