Continuing Requirements for Prequalification in Healthcare Supplies

The recent changes in regulations surrounding the prequalification process for healthcare supplies have sparked important discussions within the pharmacy community. While the introduction of the Supply Chain Shortage Act (ALBVVG) has led to the elimination of prequalification requirements for pharmacy-related products, many pharmacy owners remain unaware that this does not apply universally to all healthcare items.

According to the AfPQ (Agency for Prequalification), a total of 21 categories of supplies, which are not classified as pharmacy-related, still require prequalification. This distinction is critical for pharmacies to avoid potential financial penalties linked to reimbursement claims for these products.

Oliver Launhardt, the managing director of AfPQ, has emphasized the necessity for pharmacies to stay informed about these ongoing obligations. He noted that the misconception regarding the complete removal of prequalification has led many pharmacy owners to mistakenly believe they are entirely exempt from these requirements.

Products that still necessitate prequalification include essential medical aids such as wound drainage systems, pump systems, and walking frames. Launhardt pointed out that these categories are particularly significant for smaller pharmacies located in rural areas that strive to provide comprehensive healthcare services to their communities.

The Supply Chain Shortage Act was enacted in July 2023, but the specific exemption for pharmacy-related products was only clarified several months later after discussions between the German Pharmacists Association (DAV) and health insurance providers. The definition of what constitutes 'pharmacy-related' was a key point of contention during these negotiations.

Despite the positive reception of the regulatory changes by many in the pharmacy sector, particularly regarding the reduced bureaucratic burden, it is crucial for pharmacies to recognize that they are still bound by certain prequalification requirements for a significant number of medical supplies. Failure to comply could lead to retaxations and financial losses.

Moreover, the recent legal challenge by a medical supply company regarding the prequalification regulations highlighted the ongoing complexities in the healthcare supply chain. The Federal Constitutional Court dismissed the company's claims, reinforcing the notion that while some regulations have changed, others remain firmly in place.

As the healthcare landscape continues to evolve, pharmacies are encouraged to stay vigilant and informed about the specific requirements that govern their operations. Understanding these regulations not only ensures compliance but also promotes better patient care through the availability of necessary medical supplies.