Wegovy, Ozempic, and Rybelsus (Semaglutide) clearances with Spakinect

Wegovy, Ozempic, and Rybelsus (Semaglutide) clearances with Spakinect


Info
Any additional questions please email our clinical team at clinicalsupport@spakinect.com
We have the ability to approve your patients for the use of Wegovy, Ozempic, and Rybelsus (semaglutide). But we do have a couple of restrictions.


  1. At this time, our providers do not prescribe any medications. The prescription, administration instructions, dose, frequency, and route will need to come from the clinic's medical director/prescriber. 
  2. While our providers will ask patients for their weight and calculate a BMI during the visit, all required ongoing monitoring, including blood work and BMI verificatio,n should also be facilitated by your onsite supervising physician or Medical Director through your established protocols and policies.
  3. 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).
  4. All off-label use or use of other brands and/or compounded substances should also be established by your Medical Director through your medical spas SOPs.
  5. Most of our clients have established protocols for all off-label use or use of other brands and/or compounded substances. This is acceptable by medical board standards of care and will enable you to use our virtual good faith exam service for your semaglutide program. 
Some General FAQs:
What are Wegovy, Ozempic, and Rybelsus?

  1. Wegovy® (semaglutide) injection is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of ≥30 kg/m2 (obesity) or ≥27 kg/m2 (overweight) in the presence of at least 1 weight-related comorbid condition (eg, hypertension, type 2 diabetes mellitus, or dyslipidemia).
  2. Ozempic (semaglutide) is a glucagon-like peptide 1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. 
  3. Rybelsus (semaglutide) is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated to improve glycemic control in adults with type 2 diabetes mellitus as an adjunct to diet and exercise. 
Can we add generic Semaglutide as a treatment?

  1. At this time, we do not approve generic or compounded Semaglutide. We currently approve brand-name medications only, including Wegovy, Ozempic, and Rybelsus (semaglutide), as we cannot guarantee the consistency, ingredients, or dosing of generic or compounded formulations. 
  2. If your clinic offers generic or compounded semaglutide, it must be addressed within your established SOPs using our GLP-1 approval framework, documented in the patient-specific order, and approved by your supervising MD in accordance with state medical board guidance. 
Why do we need to verify height/weight/BMI?

  1. Since this in an FDA-approved weight loss treatment, it is essential to obtain and document an accurate baseline BMI prior to initiating therapy. Ongoing BMI monitoring throughout the course of treatment is required to ensure patient safety and is the responsibility of the onsite medical director. This includes facilitating and overseeing all required ongoing monitoring, including laboratory work, in accordance with established clinic protocols and polices. 
  2. While out providers will collect a patient-reported height and weight and calculate BMI during the visit, heigh and weight must be verified using a calibrated onside scale, or in accordance with established clinic policy, prior to treatment initiation. 
  3. For patients whose BMI falls outside labeled indications, treatment may only proceed if the clinic's medical director has developed and implemented appropriate off-label treatment protocols specific to that BMI range. 
I am implementing this in my medical spa. Can you provide guidance on what medical screening should be occurring? 

  1. All information about prescribing, including dosages, administration frequencies, and routes, should be established by your MD. Recommend that they contact their drug rep and reference the full prescribing information. 
What is involved in the screening process?

  1. The screening process involved a thorough examination by healthcare providers, including a review of the individual's medical history, current medications, and contraindications to treatment, as well as calculation of Body Mass Index (BMI). The specifics of the monitoring required during the screening process may vary based on the physician who is responsible for monitoring the patient's progress throughout their treatment. Additionally, the full prescribing information for Wegovy, Ozempic, and Rybelsus can be found on their website, and patients can also contact the drug representative for further information and support. 
Does Spakinect help patients get approved by their insurance? 

  1. If a patient would like to get Wegovy, Ozempic, and Rybelsus (semaglutide) approved by insurance, they need to provide documentation from their primary care physician with the necessary IDC-10 diagnosis codes for insurance approval, which should be managed either by the physician responsible for the monitoring of the patient by their PCP.  
Do I need to do a GFE every time a patient wants an injection?

  1. Our evaluations for Wegovy, Ozempic, and Rybelsus (Semaglutide) GFE approval are valid within 12 months of the timestamp documented on the GFE. Should there be any changes in the patient's clinical status within the 12 month timeframe, the GFE is null and void and a new GFE must be completed prior to administration of the requested medication. This can be found in the treatment plan.



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