Florida HCCE

Overview

To facilitate the purchase of prescription drugs in the name of Florida-based entities providing health care or veterinary services, state legislators passed HB 7049, establishing the creation and need for Health Care Clinic Establishment (FL HCCE) permits.

Before its enactment in January 2009, physicians and veterinarians at a practice would have to purchase prescription drugs under their individual licenses and would be prohibited, by law, from transferring their drugs to another physician at that practice for use on that physician’s patients.

Under HCCE, a designated Qualifying Practitioner can purchase prescription drugs for use by the practice, streamlining the management and allocation of drugs at registered HCCEs.

Who Is a Qualifying Practitioner?

Florida-based organizations purchasing prescription drugs at the practice level must employ a Qualifying Practitioner (QP) to maintain compliance. This is a designated health care or veterinarian professional at the location with an active state license responsible for overseeing the practice’s purchasing, handling, storage and record-keeping of prescription drugs.

In turn, pharmaceutical manufacturers or third-party distributors selling prescription pharmaceuticals to these locations are required under HCCE to capture both the practice’s address and license data, as well as the name, SLN and license expiration date of the QP.

Challenges for Manufacturers and Third-Party Distributors

Despite being active for over a decade, Florida HCCE regulations are still not widely known by many operating practices, placing a burden on pharma manufacturers and distributors to educate their customers and a challenge to verify the required licensing information.

If the QP’s license lapses, the QP moves, retires or resigns, or the practice designates a new QP, the practice must notify the Florida Department of Business and Professional Regulation (DBPR) within ten days of the change. Due to the dependency upon the QP’s license, the HCCE license is subject to unpredictable changes.

Manufacturers and distributors need to check their customer lists for HCCE updates frequently. The structure of the state’s website requires multiple steps to obtain the HCCE and QP information. Manually searching, capturing and verifying an HCCE and the assigned QP is a cumbersome process.

Based on MedPro Systems’ work with existing manufacturers and distributor customers in this area, we understand Florida regulators have become increasingly active in recent years, monitoring and auditing the space. A violation of HCCE provides regulators an opening to investigate across all of an organization’s activities.