Can Physicians Recommend Supplements? A look at the rules and regulations
By Eziah Syed, CEO MEND
Note: we provide here summary guidelines interpreted from our readings of the published rules and regulations. This article is for informational purposes only and should not be used in lieu of legal advice. It is always advisable for physicians to do their own investigation and/or seek independent counsel.
In this article
A Common Question
We get this question from time to time as we work with physicians to make our clinical nutrition products available to patients. “Am I allowed to offer this to my patients and make money from it?” “Is it a violation of Stark Law?” We have studied the law and in this article we answer these questions and aim to bring some clarity and simplicity, so that medical professionals can have peace of mind knowing that they are fully compliant to the laws when choosing to implement a nutrition program.
Preliminary Consideration
The first thing to consider, and which supports the first requirement as to whether or not offering nutritional supplements is permissible, is that many leading hospitals have implemented clinical nutrition programs. They have done this in light of established science and a growing body of placebo controlled randomized trials demonstrating that nutritional optimization of a patient can lead to better outcomes. [1] The science on dietary supplements has come a long way and is becoming standard practice at leading hospitals.
The Law
While laws can vary by state, the following set of guidelines generally apply to most states – it is important to check to see if your state guidelines are different. The first requirement is whether or not there is clinical and scientific merit to the nutrition product that is being recommended to a patient. If there is an established scientific reason to believe that the condition a physician is treating could benefit from the supplement, such as published studies in established journals, then this permissibility test has been met.
The second requirement is that there must be a disclosure of the financial benefit. While not all states require this, we think it’s better to err on the side of caution and to take the ethical high road. The disclosure may be made orally, in writing or both. Typically a disclosure is handled in much the same way as most FDA disclosures on dietary supplements. A call out disclosure box is placed somewhere readily visible on product literature that is being provided to the patient. It may look something like this:
†Our office makes a markup and wholesale cost for this product. You are under no obligation to purchase this product from our office and may purchase it elsewhere.
Of course it is also possible for a physician to make a product recommendation or product available without taking any financial benefit, such as providing the patient the product to the patient at cost or recommending that the patient purchase directly from the manufacturer or other channel. If a physician feels the science is compelling and would like the patient to consider the nutrition supplement as a part of their treatment, then they can simply make available without taking any financial benefit. In this case, the disclosure may look something like this:
†Our office has a no financial interest in this product. You are under no obligation to purchase this product from our office and may purchase it elsewhere.
Finally, the last requirement is that the doctor cannot be the sole distributor of the product. The patient needs to be able to buy it elsewhere, either directly from the manufacturer, through retail stores or online.
A summary of the three requirements
- There must be scientific merit to the product recommendation
- There should be a disclosure of financial interest
- There must be other channels through which the patient purchase the product
If these three conditions are met, physicians are compliant with all laws, including Stark Law.
Case Study
MEND has developed a line of highly specialized clinical nutrition products that are supported by clinical trials. For example, we have a perioperative product called MEND Joint Replacement, which has shown in a number of randomized trials to prevent surgical muscle atrophy and enhance return to function. It is perfectly sensible for joint replacement surgeons to make this product available to their patients as a part of their pre and post surgery protocol. It is highly specialized, has strong scientific merit and can be purchased directly from MEND. A surgeon simply needs to make the right disclosure and it is perfectly ethical and permissible under law to make this product available to patients.
Patient Demand
We know from an abundance of market data that an overwhelming majority of patients (75%+) are buying nutrition supplements products to enhance their health outcomes and this number is only growing. Further, MEND studies have shown that 91% of patients would like a nutrition recommendation from their medical professional. It makes perfect sense for patients to utilize products recommended by a trusted scientific authority who knows about their personal health needs and is qualified to understand the scientific literature and provide an expert medical opinion.
We believe the doctor’s office is the right place for a patient to get a recommendation on a product specifically designed to the condition for which they are seeing their physician. It is preferred to patients walking the aisles of grocery or drug stores independently looking for a product that may or may not be supported by rigorous science or for which they might not be qualified to evaluate the scientific efficacy and safety.
Physicians can implement a nutrition program and can be compliant with all laws. The research suggests that patient outcomes can be enhanced with scientifically valid solutions and that patients will welcome their doctor’s recommendations.
If you have any further questions regarding the regulations on recommending supplements, or are you interested in offering our clinical nutrition products to patients, please contact us at info@mend.me
