Health Care Clinic Establishment Permit
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, prescription drugs can now be purchased for use by the practice by a designated Qualifying Practitioner, 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 3rd 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 3rd 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 status lapses, they move, retire, resign, 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.
This necessitates manufacturers and distributors to frequently check for HCCE updates against their customer list. 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.
How MedPro Systems Can Help
MedPro Systems have been pulling and linking HCCE data for years, compiling more than 16,500 HCCE records in our premier MedProID healthcare license database. HCCE data is automatically pulled and updated weekly to our database from the state website via the latest API, with changes flagged for visibility. This process eliminates the need for customers to manually pull and compare data, saving time and effort.
All data can be quick searched at the practice level, with the related QP’s key license data attributes attached for ease of use or delivered via bulk updates to your CRM/MDM universe. We ensure our customers have the latest data to drive informed compliance and commercial operations, accessible when and where they need it.
Finally, MedPro can work with each customer to create a customized program to contact, educate and capture HCCE licenses based on their specific needs and requirements. MedPro has been trusted for more than 30 years helping Life Sciences organizations solve business and regulatory challenges, like HCCE, and can help your organization meet your compliance goals.
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