Restrictions on the choice of treatment and medication in Germany

Unfortunately, the choice of treatment and medication is not solely dependent on the suitability for the optimal treatment of people with ADHD.

Since the principles of the market economy for determining fair prices only work in areas where market participants have a free choice, and health needs are so essential that free choice is significantly impaired, pharmaceutical companies have achieved profit margins that are far above what large companies can otherwise achieve. Otherwise, only IT companies that have integrated their products into monopoly-like structures (Apple & Co.) can achieve a return on sales of over 20%. The manufacturing industry typically has a return on sales of around 6%.
Germany has some of the highest per capita healthcare expenditure in the world.
As always, when market mechanisms fail, legislative intervention is necessary to avoid unfair conditions.

The German healthcare system therefore has various regulations that restrict doctors’ freedom to prescribe medication.
This also applies to the prescription of medication for ADHD.

Doctors can be held liable for medical services or prescriptions.
Although there were fewer than 100 recourse proceedings in 2018¹, there is also the instrument of individual case assessment, which occurs much more frequently.
Regardless of the frequency, these instruments are a considerable nervous burden for doctors and are also perceived as a threat due to their punitive nature. It is anything but pleasant for doctors to have to worry every time they receive a letter from a health insurance fund or the KV that they will be subject to recourse or an individual case review, which can severely affect or even destroy the economic existence of their own practice. If, for example, a doctor is once held liable for around €480 in recourse for a prescription of Vyvanse adult over 6 months due to a case being coded as F98.8 (ICD 10: Other specified behavioral and emotional disorders with onset in childhood and adolescence), it is understandable that this leads to a great reluctance to prescribe something that the German approval system does not provide for - no matter how medically sensible the prescription may be from a scientific point of view.
This threat can lead to a doctor worrying about such recourse or individual case reviews every day for every patient.

In adults, ADHD should always be coded as F90.0, regardless of the form of presentation (ADHD-HI, ADHD-C or ADHD-I). If necessary, the words “predominantly inattentive type” can be added.
While a coding of F90.0 provides a secure legal basis for prescribing ADHD medication, a coding of F98.8 (other behavioral and emotional disorders with onset in childhood and adolescence) can lead to problems with the reimbursement of ADHD medication, as this diagnosis is not an approved indication in adulthood.

The following restrictions apply to statutory insured persons.

• 1. Drug recourse
• 2. Minimum prescription quotas
• 3. Obligation to prescribe
• 4. Who is allowed to prescribe which medication?
• 5. Maximum quantity limit for BtM lifted

1. Drug recourse¶

The statutory health insurance (SHI) concludes agreements with the Associations of Statutory Health Insurance Physicians (KV) as representatives of doctors and pharmacists on the permissible and economical use of medicines.
If these agreements are breached, the KGV can reclaim the costs from a doctor or pharmacist. Such a recourse against medicines is an administrative act.
The Audit Committee determines the amount to be reimbursed by the doctor in the reference price review.
Consequences are that the total remuneration of the Association of Statutory Health Insurance Physicians is reduced by the doctor’s reimbursement amount.
The review committee works towards a settlement agreement with the panel doctor, § 106 Para. 5 a SGB V. Such an agreement can reduce the reimbursement amount by up to one fifth, but at the same time excludes legal recourse:

There are various reasons why a drug recourse can be imposed. These include over-prescribing expensive medicines, prescribing unauthorized medicines or prescribing medicines that are not necessary.

Doctors may be exposed to recourse for medicinal products if they are legally insured²

• Drugs are prescribed that are not approved
  • for approval status see above
  • the admission status depends on the diagnosis made
    • the diagnosis F90.0G (coded according to ICD-10) for ADHD in adults opens up a wider and different scope for medication than the ICD-10 F98.8G for ADHD-I, which is still frequently used in children and adolescents
• Drugs are prescribed that are not necessary
• the prohibition of economic efficiency is violated
  • Economic efficiency requirement = basic principle of SHI according to § 12 SGB V
    • The therapy must be necessary, appropriate, sufficient and economical.
    • Less expensive treatment alternatives that have been assessed as equivalent under AMNOG must be prescribed first.
    • More expensive alternatives of equal value may only be used if the cheaper alternatives have no or insufficient effect or inappropriate side effects
      • Undesirable side effects can be documented as ICD-10 Y57.9G
    • Exceeding the legal maximum dosage quantities is uneconomical if, in individual cases, it is neither³
      • justified in accordance with Section 2 (2) of the Narcotics Prescription Ordinance (BtMVV) nor
      • is exceptionally permissible due to fulfillment of the requirements for “off-label use”
    • over-prescription of expensive medicines
    • over-prescription of non-drug treatment, e.g. occupational therapy

Specific application to stimulants for people with statutory health insurance²

• Examination: does the prescription history show insufficient or lacking efficacy or side effects of MPH?
  • no: prescribe MPH
  • yes. Prescribe lisdexamfetamine and/or atomoxetine
• Off-label use:¹
  • Check and document indication (confirmed diagnosis), duration and quantity
• Aut idem, generics
  • since 2023 at the latest, doctors will only be charged for prescriptions at the most favorable rate under the SHI discount agreements and will no longer be charged a higher pharmacy dispensing price for auto-idem substitution in pharmacies.⁴

2. Minimum prescription quotas¶

Numerous associations of statutory health insurance physicians have set minimum prescription quotas for stimulants, which were agreed as framework specifications between the GKV-Spitzenverband and the KBV in accordance with Section 84 (6) SGB V - Drugs²
In these, a proportion of MPH-containing medicinal products in the total group of medicinal products with the active ingredients MPH and atomoxetine is agreed.
Examples:
Saarland 2022: MPH had to comprise at least 95.2% of the total volume of MPH+ATX prescriptions
Rhineland-Palatinate: MPH had to comprise at least 70.4% of the total quantity of MPH+ATX+Lisdexamfetamine prescriptions

A higher proportion of lisdexamfetamine and atomoxetine prescriptions is to be expected in ADHD-focused practices²
An ADHD practice focus exists under social law if a practice is at least 50% above the specialist group average ICD frequency of F90.0G.
These are derived from the ICD frequency statistics of the associations of statutory health insurance physicians
In the area of adult ADHD, however, a practice specialty is not recognized, even if the above criteria are met. This in turn means that doctors who primarily treat adults with ADHD are subject to the prescribing requirements that exist for a non-specialized practice.
In addition to the BTM problem, the lack of an ADHD specialist practice for adults is probably the main reason why ADHD patients over the age of 18 are unable to find a secondary or primary care provider. As a result, the SHI funds promote the development of comorbidities (e.g. anxiety disorders, depression) and deaths (accidents, suicides) Consequences of ADHDinstead of avoiding their occurrence through guideline-compliant ADHD therapy. And this despite the fact that ADHD therapy would be much more beneficial than treating the comorbidities resulting from ADHD, which often remains unsuccessful for years because the underlying ADHD that triggers them is not treated.

3. Obligation to prescribe¶

Patients are legally entitled to necessary prescriptions from their doctor if they have a corresponding medical condition⁵
A doctor can and must issue necessary prescriptions taking into account the principle of economic efficiency.
The refusal to prescribe necessary medicines on the grounds that the reference value budget has been exceeded is inadmissible.
Exceeding the reference size budget on this basis does not justify any right of recourse. The doctor is responsible for explaining the necessity of the prescription to the KV.

4. Who is allowed to prescribe which medication?¶

In Germany, only doctors are allowed to prescribe medication. Psychologists are not allowed to prescribe medication in Germany.
In other countries, prescribing by psychologists is permitted. German psychologists rejected a change in the law that would give them permission to prescribe medication because a proper assessment of active ingredients, reactions, side effects, interactions and cross-effects, differences in metabolization and influences of internal comorbidities requires considerable knowledge that could barely be taught in a few courses.

In principle, any doctor can prescribe anything.
For reimbursement by statutory health insurance companies (SHI), a doctor must have a license to practice.
However, there are different budgets and therefore different recourse risks.
GPs are therefore allowed to prescribe anything, but often have to exercise great restraint for budgetary reasons.
According to the GBA Drug Guideline as of 02/2019, Annex III Overview of prescription restrictions and exclusions in drug supply by the Drug Guideline and § 34 I .6, III SGB V), general practitioners may prescribe stimulants as a follow-up prescription if supervision by a specialist for behavioral disorders is guaranteed.⁶
A specialist in behavioral disorders:

• Specialist in pediatrics and adolescent medicine
• Specialist in child and adolescent medicine and psychiatry
• Specialist in psychiatry and psychotherapy
• Specialist in psychosomatic medicine and psychotherapy
• Specialist in neurology

Supervision must take the form of semi-annual consultations.
A prescription outside of these conditions is associated with a risk of recourse for the general practitioner.

Specialists usually have larger drug budgets than GPs.
Neurologists and psychiatrists are therefore likely to have the greatest opportunities to prescribe ADHD medication.

In practice, 58% of ADHD medication was prescribed to adults by specialists in 2008; in 2018, this figure was 80%. In children, 41% of ADHD medication was prescribed by specialists in 2008 and 63% in 2018. This clearly shows a shift in prescribing from general practitioners to specialists. Of n = 77,504 ADHD patients included, 38% were treated with ADHD medication at least once.⁷

In order for a medication to be prescribed at the expense of the SHI, it must be approved for the treatment of the established diagnosis. Off-label prescriptions represent an off-label use, the costs of which do not have to be covered by the SHI and which can be reviewed retrospectively for up to 3 years and, in case of doubt, billed to the doctor (individual case review or recourse).
Every doctor has the option of issuing a private prescription in which the costs of the medication are borne by the patient. Privately insured patients can submit these to their private health insurer (PKV) and have them reimbursed under their existing insurance contract.

Not every doctor has BtM prescriptions.
BtM prescriptions are personalized and numbered, must be ordered from the Federal Opium Agency and should be kept in a safe. Stolen prescriptions can be blocked.
While the prescription ordering process is very simple, the prescriptions cannot be issued using a laser or inkjet printer due to the carbon copies⁸ required. They must either be issued using a (expensive and space-wasting) dot matrix printer or by hand.⁹ This effort (handwriting or expensive extra printer) is a cost driver for the medical profession.
The introduction of electronic prescriptions, including for BtM, has not yet been implemented by German legislators as of March 2026. Presumably, the Ministry of Health is still waiting for the invention of digital dot matrix printers for digital prescriptions
In addition, there is the administrative burden of storing the carbon copies of the BtM prescriptions for 3 years and the constant possibility of the health authorities checking the storage¹⁰

5. Maximum quantity limit for BtM lifted¶

The previously applicable maximum quantity limit for BTM prescriptions was lifted with effect from 08.04.2023.
Since then, doctors have also been allowed to prescribe BtM for long-term needs. Nevertheless, they are well advised to only prescribe them to trustworthy patients.