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.