Total Health Law Blog
Our healthcare and business law firm works with many providers and medical practices to ensure compliance with state and federal laws, rules, and regulations for given procedures, treatments, and prescriptions. A hot topic and sometimes controversial category of drug right now is weight loss drugs (also called weight management drugs). A provider should generally prescribe a drug or treatment pursuant to a patient-provider relationship when the drug is medically necessary and appropriate, but some states have laws and rules specifically governing prescribing weight loss drugs. If your state has rules or guidance on prescribing weight loss drugs, it’s important, of course, to follow that guidance. This blog post outlines potential state guidance using Florida’s weight loss statute as an example. If you need assistance understanding your state’s guidance on weight loss treatments or would like to discuss this blog post, you may contact our healthcare and business law firm at (404) 685-1662 (Atlanta) or (706) 722-7886 (Augusta), or by email, info@hamillittle.com. You may also learn more about our law firm by visiting www.hamillittle.com.
Some states have not taken any public stance on weight loss drugs. But if the state in which you practice has published such guidance, then it is important to follow it. Furthermore, even if your state has not taken any public stance, it may be useful to review guidance from other states to create “best practices.” Let’s examine the Florida statute governing weight loss treatment.
Florida’s legislature created statute 64B8-9.012 titled “Standards for the Prescription of Drugs to Treat Obesity.” The general standard is: “The prescribing of anti-obesity drugs should only be performed by physicians qualified by training and experience to treat obesity.” The rule allows mid-level providers to participate in the treatment in some ways, but the physician is still required to participate in the patient’s treatment.
The statute identifies when such drugs are appropriate:
(1) To justify the use of anti-obesity drugs as set forth above, the patient must have an initial Body Mass Index (BMI) of 30 or above, or an initial BMI of greater than 27 with at least one comorbidity factor, or an initial measurable body fat content equal to or greater than 25% of total body weight for male patients or 30% of total body weight for women. The treating physician may also take into account other factors such as ethnicity-specific values and markers such as waist circumference when justifying the use of anti-obesity drugs. BMI is calculated by use of the formula BMI = weight(kg)/height(m2).
The statute identifies limits on what types of drugs may not be used. It also limits weight loss prescriptions for children only for “children with an initial BMI greater than 120th percent of the 95th percentile with significant comorbidity or an initial BMI greater than 140th percent of the 95th percentile.”
The statute requires “written informed consent” prior to prescribing weight loss drugs. The consent must identify “potential benefits versus potential risks of weight loss treatments.” The prescribing physician must also provide the patient with a copy of the Weight-Loss Consumer Bill of Rights. The patient must be re-evaluated every three (3) months.
Florida also has advertising requirements around weight-loss drugs. The statute declares that an advertisement about weight loss treatment “shall be considered false, deceptive, or misleading if it contains representations that:
(a) Promise specific results;
(b) Raise unreasonable expectations;
(c) Claim rapid, dramatic, incredible, or safe weight loss;
(d) State or suggest that diets or exercise are not required, or
(e) Suggest that weight loss is effortless or magical.”
These are just some of the many requirements within Georgia’s weight loss statute.
The above provides information pertaining only to Florida as an example of state laws governing weight loss treatment. If you need assistance understanding your state’s guidance on weight loss treatments or would like to discuss this blog post, you may contact our healthcare and business law firm at (404) 685-1662 (Atlanta) or (706) 722-7886 (Augusta), or by email, info@hamillittle.com. You may also learn more about our law firm by visiting www.hamillittle.com.