Second opinion procedure in the Drugs Directive

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The “procedure for obtaining a second opinion” (second opinion) was included in the fifth book of the Social Security Code ( Section 73d SGBV). From October 2008, the Federal Joint Committee regulated the details in the Drugs Directive (AMR). The procedure concerned the prescription of so-called “special drugs”, which are prescribed within the framework of statutory health insurance. A contract doctor was only allowed to deviate from the provisions in the Drugs Directive in exceptional cases. The regulation for prescribing special drugs (second opinion) was abolished in 2010 by the Medicines Market Reform Act.

Special medicines

Special medicinal products within the meaning of the law were "in particular products with high annual therapy costs or medicinal products with considerable risk potential, which, due to their special mode of action to improve the quality and economic efficiency of their use - especially with regard to patient safety and therapeutic success - require special specialist knowledge that is beyond the Go out the usual ".

Pulmonary arterial hypertension

The following preparations for the treatment of pulmonary arterial hypertension were affected by the procedure:

The second opinion procedure was not used if these drugs were used in diseases other than PAH or in off-label use .

Procedure

Before starting treatment with one of the drugs mentioned, there had to be an agreement between the attending physician and a physician for special drug therapy. The insured must have previously agreed to the procedure. This coordination between the doctors could usually take a maximum of ten working days. The treating doctor could only deviate from the second opinion of his colleague in exceptional cases, but then had to give special reasons for such a deviation.

Specialist drug therapy doctor

The requirements for the physician for special drug therapy were specified drug-related and only applied to the above-mentioned drugs in the PAH indication. They were specified in Annex XI (previously: Annex 13) in the section on prescribing special drugs:

  • Specialist in internal medicine with a focus on pneumology
  • Specialist in internal medicine with a focus on pneumology
  • Specialist in internal medicine and pulmonology
  • Specialist in internal medicine with a focus on cardiology
  • Specialist in internal medicine with a focus on cardiology
  • Specialist in internal medicine and cardiology

The Specialist Drug Therapy Doctor had to be experienced in treating PAH. For that he had to

  • have treated at least 10 patients per year (in the previous year of appointment) and
  • Document at least 10 certification points for disease-specific training every year.

criticism

While the G-BA expected the second opinion procedure to improve the safety and cost-effectiveness of drug therapy, the procedure was criticized in the run-up to its introduction by specialist medical societies, but also by the German PH patient self-help organization. The criticism mainly focused on the fact that

  • the second-opinion doctors do not have to have sufficient experience for the rare and complex disease PAH due to the legal requirements,
  • a sufficient structure cannot be established (too few second opinion doctors in many regions),
  • There are legal deficiencies (no objection procedure, no arbitration board in the event of contradicting findings from the treating doctor and the second doctor).

Current status

A detailed description of the second opinion procedure and a list of second opinion doctors can be found on a website of the Hannover Medical School. With the publication in the Federal Law Gazette 2010, Part I No. 67 under Item 10, Section 73d was repealed on Dec. 27, 2010 and thus the Directive no longer applies since January 1, 2011.

Second opinion procedure for surgical interventions

Regardless of the drug directive, there is a legal right to a second opinion in the case of interventions on the palatine and / or pharynx ( tonsillectomy , tonsillotomy ) and in the case of removal of the uterus ( hysterectomies ). Doctors can apply to their Association of Statutory Health Insurance Physicians to settle second opinions. These doctors must meet the requirements of the Federal Joint Committee for procedure-specific qualifications. There must be no conflict of interest to prevent the independence of the second opinion. Information about doctors who are allowed to give a second opinion is published by statutory health insurance associations and regional hospital societies on websites. Insured persons can also contact their health insurance company when searching.

Individual evidence

  1. ↑ a b c http://www.g-ba.de/downloads/39-261-730/2009-01-22-AMR13-Zweitmeinung_BAnz.pdf
  2. ↑ http://www.g-ba.de/downloads/34-215-263/2008-10-16-Zweitmeinung.pdf
  3. ↑ Joint press release ( memento of February 4, 2010 in the Internet Archive ) by pulmonale hypertonie ev (ph ev) and the scientific advisory board in ph ev, as well as the joint working group pulmonary hypertension of the medical societies, German Society for Pneumology (DGP), German Society for Cardiology (DGK), German Society for Pediatric Cardiology (DGPK)
  4. ↑ http://www.zweitmeinung-pah.de/
  5. ^ Karl-Josef Steden: Before the operation: Right to a second opinion? April 26, 2019