We are excited to introduce Prescription Weight Loss Therapy as a new umbrella treatment category.
This category includes several FDA-approved prescription medications that may be used for weight management, including:
Wegovy® (Semaglutide)
Ozempic® (Semaglutide)
Rybelsus® (Semaglutide)
Zepbound® (Tirzepatide)
Semaglutide (Wegovy®, Ozempic®, and Rybelsus®) and Zepbound® (Tirzepatide) will continue to be available as standalone clearance options. The new Prescription Weight Loss Therapy category simply streamlines the evaluation process by grouping these therapies under a single treatment umbrella.
During a Good Faith Examination (GFE), a provider will review:
Medical history
Current medications
Relevant health information and potential contraindications to treatment
Height, weight, and calculation of Body Mass Index (BMI)
Review of system
This information is used to determine whether a patient may be an appropriate candidate for treatment.
Please Note: Spakinect's evaluations are based on FDA-approved medications within the Prescription Weight Loss Therapy category. Clinics utilizing compounded products, generic substitutes, alternative brands, or off-label prescribing should maintain Medical Director-approved protocols and SOPs in accordance with applicable state regulations.
Our clearance will be for the FDA-approved brand name Wegovy, Ozempic, and Rybelsus which is listed in our treatment database as semaglutide (Wegovy, Ozempic, and Rybelsus).
Because we cannot verify the ingredients, concentration, sourcing, consistency, or dosing of compounded or generic formulations, Spakinect cannot provide approval for these products. If your clinic utilizes compounded products, generic substitutes, off-label indications, or alternative brands, your Medical Director should:
Develop and approve written SOPs and protocols
Establish patient-specific orders
Ensure compliance with state regulations
Oversee prescribing and monitoring requirements
Many clinics successfully utilize Spakinect's GFE service while maintaining Medical Director-approved protocols for compounded or off-label use.
Accurate documentation of baseline height, weight, and Body Mass Index (BMI) is essential for patient safety and appropriate treatment selection.
During the GFE, Spakinect providers will obtain patient-reported height and weight and calculate BMI.
However, the clinic remains responsible for:
Verifying height and weight onsite using calibrated equipment or according to clinic policy
Documenting an accurate baseline BMI
Monitoring BMI throughout treatment
Facilitating any required laboratory testing
Conducting ongoing medical monitoring according to established clinic protocols
Since these medications are utilized within a weight management program, accurate baseline and ongoing monitoring are critical components of safe treatment.
For patients whose BMI falls outside FDA-labeled indications, treatment should only proceed if the Medical Director has established appropriate off-label treatment protocols.
All Prescription Weight Loss Therapy approvals are conditional upon verification of height, weight, and BMI prior to treatment initiation and throughout the duration of treatment.
No, Spakinect providers do not prescribe medications.
All prescriptions must be issued by the clinic's Medical Director or other authorized prescribing provider. This includes:
Medication selection
Dosing
Route of administration
Frequency
Duration of therapy
Monitoring requirements
These elements should be documented within clinic SOPs and prescribing protocols.
No. Prescription Weight Loss Therapy approvals are valid for 12 months from the date and time documented on the GFE, provided there are no changes in the patient's clinical status.
A new GFE is required if:
The 12-month approval period expires, or
There is a change in the patient's clinical status that may affect treatment eligibility
Any significant change in health status renders the previous approval invalid and requires reevaluation before treatment may continue.
All prescribing information, including medication selection, dosing, administration frequency, route of administration, laboratory monitoring, and ongoing treatment management, should be established by your Medical Director.
Clinics are encouraged to:
Review the manufacturer's prescribing information
Consult with pharmaceutical representatives as needed
Develop treatment-specific SOPs and monitoring protocols
Ensure compliance with applicable state regulations
No. Patients seeking insurance coverage should work with:
Their primary care provider, or
The physician responsible for managing and monitoring their treatment
Insurance approval typically requires:
Appropriate ICD-10 diagnosis codes
Supporting medical documentation
Prior authorization documentation, when required by the payer
For additional questions regarding Prescription Weight Loss Therapy or any other treatment available through Spakinect, please contact the Clinical Support Team at: