Pharmacists and the battle over medical foods
Community pharmacists are caught in the middle of a battle between patients and their health insurers over how the federal government defines medical foods and how patients are paying for them.
Community pharmacists are caught in the middle of a battle between patients and their health insurers over how the federal government defines medical foods and how patients are paying for them.
In May, 2016, FDA issued guidance on medical foods. While the agency doesn’t require a prescription, the Orphan Drug Act stipulates that medical foods must be formulated to be consumed or administered enterally under the supervision of a physician.
But some patients are surprised to learn that when they purchase a medical food product, it isn’t covered by their health insurance.
Debbie Townsend, RPh owner of Wake Forest Pharmacy, in Wake Forest North Carolina, says that the confusion has become a dilemma for pharmacists.
“We see a lot of this happening in our pharmacy.”
Townsend said that a physician at an ADHD clinic in town prescribes Vayarin, a lipid-based medical food from Baltimore-based Vaya Pharma, for ADHD patients who have uncontrolled behavioral outbursts.
“It's getting hard for us to fill Vayarin because patients don’t understand why it won’t get paid for by their insurance company,” said Townsend.
Townsend added that the pharmacy stocks a number of medical foods and she sees the situation as very frustrating, particularly for the ADHD population.
“Some people are willing to pay. Others say, ‘maybe I'll pay for it and try it for a month or so,’ and some are not willing to do that for financial reasons.”
At the root of the problem is claims processing software that doesn’t code medical foods as a prescription, but rather as an OTC.
“When a pharmacist enters a prescription for Vayarin, the electronic system reports it as an OTC product, said Gali Artzi, PhD, director of scientific affairs at Vaya Pharma. But, this is not an OTC, and there is nothing over- the- counter that can substitute for it. The current [electronic] system has patients very confused. Not only is it listed as OTC, but the system reports it is also no longer covered by insurance,” said Artzi.
Bruce Burnett, PhD, Vice President of Compliance, Regulatory & Medical Affairs for the Cary, North Carolina-based medical food company Entera Health said: “There are no over the counter products that legally require medical supervision as the FDA clearly states medical foods must have.”
Burnett, current head of the Nutrition and Medical Food Coalition, added that this scenario is having a devastating effect on the medical foods market as well as patients. He noted that patients must foot the entire bill rather than a $30 or $40 co-pay.
Marc FluittMarc Fluitt, RPh, vice president of Health and Risk Services with Trumbull, Ct.-based National Institute of Collaborative Healthcare asserted that medical food products are distinctly different from other categories of pharmaceutical products, such as dietary supplements, OTC drugs, and Rx-only drugs.
“It is a mistake to lump them together. Aggregating medical food products with other product categories can cause payer problems that can decrease patient access and increase out-of-pocket cost of these products to patients," said Fluitt.
The proper use of medical food, said Fluitt, requires medical supervision, but not a prescription.
“Yet a prescription for a medical food product is a mechanism that shows evidence of medical supervision both by a prescribing physician and a dispensing pharmacist.”
FDA’s guidance document states: “Medical foods are not drugs and, therefore, are not subject to any regulatory requirements that specifically apply to drugs.” FDA distinguishes medical foods from the broader category of foods for special dietary use in these ways:
- Medical foods must be intended to meet distinctive nutritional requirements of a disease or condition.
- Medical foods must be used under supervision.
- Medical foods must be intended for the specific dietary management of a disease or condition.
Fluitt believes medical food products need to be classified appropriately and consistently within databases, physician e-prescribing systems, and pharmacy information systems.
“No one wants or should tolerate misinformation or conflicting information in systems designed to enhance patient care. There is an urgent need for all payers, practitioners, and medical food companies to collaborate on these issues so patients can safely access products that can benefit them,” Fluitt said.
Artzi said that Vaya and other medical food companies are reaching out to physicians so they may direct their patients to an online fulfillment source whereby a prescription can be submitted and paid for electronically and is thereby in compliance with Federal law and regulation.
Medical Foods: A Few Basic Questions
Q. Does FDA regulate medical foods as drugs?
A. No. Medical foods are not drugs and, therefore, are not subject to any regulatory requirements that specifically apply to drugs.
Q. What labeling requirements apply to medical foods?
A. Labeling must comply with all applicable food labeling requirements except for those specific requirements from which medical foods are exempt.
Q. What other FDA requirements apply to medical foods?
A. Manufacturers of medical foods must comply with all applicable FDA requirements for foods, including the following regulations:
- Current good manufacturing practice
- Registration of food facilities
- Thermally processed low-acid foods packaged in hermetically sealed containers
- Acidified foods
- Emergency permit control
Q. Does FDA maintain a list of medical foods?
A. No, FDA does not maintain a comprehensive list of medical food products.
Q. How does FDA interpret “under the supervision of a physician”?
A. FDA considers the requirement that a medical food be formulated to be consumed or administered enterally under the supervision of a physician to mean that the intended use of a medical food is for the dietary management of a patient receiving active and ongoing medical supervision (e.g., in a health care facility or as an outpatient) by a physician who has determined that the medical food is necessary to the patient’s overall medical care. The patient should generally see the physician on a recurring basis for, among other things, instructions on the use of the medical food as part of the dietary management of a given disease or condition.
Source: FDA
