Prescription digital therapeutic products can improve health for the underserved, especially in the area of mental health. Apart from addressing the severe shortage of mental health professionals by increasing access to care, recent science would suggest the digital therapeutic modality can be particularly effective at treating widespread conditions, including those made worse by the pandemic.

But there’s a regulatory problem, and it’s not FDA’s fault: The problem is with the industry. 

The root of the problem is, I think, a misunderstanding. I suspect there are many in the industry who believe that a prescription digital therapeutic product can only be made available to patients through physicians, dentists and veterinarians who have prescribing authority under state law. 

But that’s wrong. More healthcare professionals than just those three have the ability to order the use of prescription medical devices.

Background on federal law  

The misunderstanding probably arose because people tend to be more familiar with the prescribing process for pharmaceuticals that includes authorized prescribers under state law and authorized dispensers such as pharmacies. But the law for prescription medical devices is quite different.

I don’t normally like to quote a law in a post, but I think it’s important to be very clear here what the law actually says. The FDA’s regulation creating the prescription device category (21 CFR Sec. 801.109(a)(2)) provides in part that a prescription device must be “sold only to or on the prescription or other order of such practitioner for use in the course of his professional practice.”

The required labeling must include “The symbol statement ‘Rx only’ or ‘℞ only’ or the statement ‘Caution: Federal law restricts this device to sale by or on the order of a ___,’ the blank to be filled with the word ‘physician,’ ‘dentist,’ ‘veterinarian,’ or with the descriptive designation of any other practitioner licensed by the law of the State in which the practitioner practices to use or order the use of the device.” (Emphasis added.)

The flexibility is pretty obvious. The FDA regulation allows for an order rather than a prescription. Further, instead of “prescription-only” labeling, the regulation allows the use of labeling restrictions that identifies a broader category of healthcare professionals that can order the device beyond only those who have prescribing authority under state law.

The policy issues

Why are prescription devices treated differently from prescription drugs? The answer is in both the comparative risk of the products, but also how the products are used as a part of medical practice.

Indeed, some medical devices are used exclusively by professionals, and those devices may never even touch the patient. Think about laboratory testing equipment. Some are put in or on patients, like pacemakers. 

Some are used jointly by healthcare professionals and their patients. Think about medical sensors that the patient has to wear, but the data is sent back to the professional to interpret.

The whole idea behind “prescription” is that certain products are too complicated for patients to understand from the product’s labeling alone. It’s impossible to adequately convey all that needs to be communicated in the product labeling, so we ask that a specially trained professional be in the loop in order to help the patient make the right decision. 

In some cases, that may not be a physician. There may be other professionals who would do a better job of advising on the need and appropriate use for a particular prescription medical device. 

For example, acupuncture needles are ordered by acupuncturists, manipulation devices are ordered by chiropractors, voice-level recorders are ordered by speech language pathologists, certain concussion assessment tools are ordered by athletic trainers, exoskeletons systems are ordered by physical therapists, and devices that help patients breathe easier during a panic attack are ordered by and through psychologists. 

All of those are prescription medical devices.

Current Options and Process

So is it the Wild West with regard to prescription medical devices? Not at all. Access to such products has to be managed by someone who is licensed by state law to practice a particular kind of healthcare, and who is identified at least generally in the intended use statement submitted to FDA at the time of clearance or approval.

When assigned prescription status as a part of the 510(k) process or premarket approval, the product can only be made available to or through those types of professionals  identified by the manufacturer in the cleared or approved intended use statement.

The regulation does not say that just anybody can be a professional who orders a prescription medical advice. The regulation specifies that, if the ordering professional is not a physician, dentist or veterinarian, the prescription status must designate a “practitioner licensed by the law of the State in which the practitioner practices to use or order the use of the device.” 

State health professional regulation covers a variety of professionals, including physical therapists, chiropractors, acupuncturists, speech language pathologists, psychologists and audiologists. They are licensed by law to provide certain health services, and therefore authorized by law to order the use of devices that are intended for their health specialty and their patients.

After FDA clearance or approval, to comply with the prescription requirement, the manufacturer needs to put in to place a system designed to reasonably assure that such products end up in the hands of the intended users, on the order of the intended healthcare professional.

Such products are not limited in distribution through only licensed pharmacies. But distribution needs to be nonetheless controlled.

Third party reimbursement

Sometimes I wonder if manufacturers think they have to limit prescribing authority to physicians in order to obtain reimbursement. I can’t speak for payers, but I don’t know why that would be. From a payer perspective, it’s important to understand that these are all treated as prescription medical devices by the FDA, and must meet the same evidentiary standards.

The FDA doesn’t distinguish among these products and expect less evidence when the product is prescribed by a psychologist, instead of a psychiatrist. But from a utilization standpoint, use of the product is controlled by an appropriate healthcare professional who, in the FDA’s opinion, has the training and licensing appropriate to manage access to the particular product.

Thus, payers wouldn’t have to worry about the overutilization that might occur, for example, with over-the-counter medical devices where no professional is involved.

Conclusion

Manufacturers need to think more broadly about who would be an appropriate prescriber for their prescription digital therapeutic products. In the area of mental health, psychologists have the training and licensing to be prescribers of such products, and in fact are often in a better position to do so.

Limiting mental health digital therapeutics to be only prescribed by physicians excludes a huge swath of patients who desperately need the treatment these products offer. In my observation, the FDA understands this need, and companies should not be reluctant to explore with the agency the appropriate prescriber categories for their products.

About the Author: Bradley Merrill Thompson is a member of the firm at Epstein Becker & Green, P.C. There, he counsels medical device, drug and combination-product companies on a wide range of FDA regulatory, reimbursement and clinical trial issues. The opinions in this piece are Thompson's, and don't necessarily reflect the opinions of MobiHealthNews or HIMSS.