Is profit getting in the way of life-changing technology?

Dr. Rosevear is a urologist in community practice in Colorado Springs, CO. Urology Times blogs present opinions, advice, and news from urologists and other urology professionals. Opinions expressed by bloggers are their own, and do not necessarily reflect the views of Urology Times or its parent company, UBM Medica.

I find the intersection of medicine and business fascinating. Say what you want about the American health care delivery system, but it is tough to argue that we lead the way in ensuring that the patient (or consumer if you will) has their needs met, assuming of course, there is a dollar to be made in the process.

I’ll give you a very urology-specific example of the reality of this business model.

There exists a group of devices that are advertised to treat a very common and debilitating medical condition; namely, vulvovaginal atrophy and the dyspareunia associated with it. I have decided not to name any of these devices to avoid the suggestion of either positive or negative publicity. For discussions sake, let’s call these products “pink pill” devices.

Before I continue, though, a warning is in order. These devices are controversial. Most were cleared under the original 510(k) process with the indications of “incision, excision, ablation, vaporization, and coagulation of body soft tissues in medical specialties, including aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynaecology, neurosurgery, orthopaedics, general and thorasic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery.” Most of the devices were advertised, however, for the treatment of vulvovaginal atrophy and the dyspareunia associated with it.

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In July of this year, the FDA published a warning about various “vaginal rejuvenation” procedures that questioned the claims in the advertising of these devices. Seven different companies were sent letters regarding various claims that the companies were making. I give the FDA credit for addressing these concerns and feel that further discussion of this topic will help our patients.

With that in mind, though, I don’t want to talk about the actual devices or the controversy surrounding them. Rather, I want to focus on the business model that these companies used, as I think that itself is worthy of discussion.

From a business standpoint, you would think pink pill devices would be a slam-dunk success. Dyspareunia (assuming that is the symptom being treated with the caveats above about what the devices were specifically cleared for) is exceptionally common, being reported in almost 8% of all women and a significantly higher percentage of postmenopausal women (BJOG 2017; 124:1689–97). Further, these devices are not estrogen-based treatments, meaning women who have a contraindication to estrogen replacement or vaginal estrogen creams might be able to use them. And seriously, if there was a simple, minimal-risk, FDA-cleared device that would make intercourse better, who wouldn't be interested? Sounds like the advent of Viagra all over again.

I will concede that treatment using these devices isn’t as perfect as Viagra. The treatments are invasive, vaginal-based procedures, and that alone is a tough selling point for some women. But given the lack of other options available, if the devices work and work safely, they certainly sound like a game changer.

From a urologist’s point of view, though, discussing dyspareunia is a conversation that not all of us are comfortable having with our patients. I’m reminded of the late 1990s when Bob Dole appeared in Viagra commercials; suddenly, talking about erectile dysfunction became acceptable. With the arrival of these devices, is this the moment when talking about dyspareunia should now be common too?

This is where the business of medicine comes into the equation. The problem with Viagra was the cost. As we all know, a 100-mg Viagra tablet could cost anywhere between $20 and $40, maybe more, depending on insurance. And while that was a barrier for many patients, pink pill devices are in a different league entirely. These devices can cost over $150,000, and that does not include the yearly maintenance contract or the costs of ancillary equipment. Many people might argue that $150K seems a steal for a device that works well and for whom there exists a huge patient population.

Next:"The problem with this code is that it does not pay. At all."

The problem with the device is with the billing and coding. (My work on billing and coding was recently summarized here by the White Coat Investor for those who want to read more about it.) Specifically, the problem with these devices is that there is no CPT code associated with the procedure, and as such your only choice of billing is to use the code 58999, which is "Unlisted procedure female genital system (nonobstetrical).”

The problem with this code is that it does not pay. At all. And for those less mathematically inclined, I don't care how many patients you successfully treat, at $0 reimbursement per treatment, you're never getting your investment back.

Why is there no code? Is this yet another opportunity for me to mock the government? No, actually, this time it is completely the company's decision. It turns out that, in the case of an FDA-cleared device, its manufacturer must submit the device and supporting information to the AMA; if accepted, the AMA creates the code. You can read about that process here.

Importantly, if a company decides, for whatever reason, not to submit its device to the AMA for a CPT code, no CPT code will be given. And if there is no code given, providers can’t submit the treatment to an insurance company. That is exactly what the companies that make these pink pill devices have decided to do.

Read: Want to engage with patients? Hang a digital shingle

I was at first confused by that decision. If the devices work as well as claimed, given the prevalence of the conditions being treated, why not submit your data and get a CPT code? My confusion lessened when I had a very honest conversation with a rep for one of these devices at an event in San Francisco earlier this year. I learned from the rep that the company’s business model relies on businesses like mine to buy the device at a premium, spend a significant amount of money to keep the device running, and pass on that cost to consumers by making this a cash-based treatment.

In other words, even though millions of Americans may benefit from treatment from these devices, the company has decided that by turning it into a cash-only business, their profit is maximized.

Think about that for a moment. Should the teachings of Adam Smith, the 18^thcentury economist who laid the groundwork for free trade, dictate all decisions on health care? You can argue that these devices treat a “quality of life” and not a “quantity of life” condition and so maybe they should be covered, but that seems a stretch to me.

I'm not opposed to making a profit, and certainly businesses that take the risk to develop new technology should be financially rewarded for bringing that technology to market. But should life-changing technology be limited to those who can pay?

I don't know. I do know that these devices seem to be appearing everywhere so maybe the company is right after all. Whether we as a society want Adam Smith to make all of these decisions is another question entirely.