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Why It Takes So Long to Develop a Medical Technology (Part 6)

Written by Mark Carol, MD
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Patients

In general, patients are attracted to novel, technologically advanced treatments. As mentioned in the blog on novel technology development, intensity-modulated radiation therapy (IMRT) and Da Vinci robotic surgery are prime examples of widely accepted medical technologies that took many years to develop. In terms of patient experience, there is little difference between IMRT and robotic surgery and the procedures they replaced or improved. Robotic surgery still requires a surgical procedure with small incisions, but it carries the allure of high technology robots performing surgery. Lying on the radiation treatment table, a patient receiving IMRT is blind to the intricacies of the improved technology controlling the treatment. Because both technologies sound more advanced than the technologies they replaced – and cost a lot for a hospital to acquire – most patients assume these technologies are better and therefore must produce better outcomes. In addition, from the first clinical introduction of IMRT and robotic surgery, patients believed their procedures would be covered by their insurance payor, be it public or commercial. There was never a need for an upfront conversation between physician and patient about whether a cash payment would be required.

Focused ultrasound for prostate cancer presents a different picture to the patient on many fronts. First, there is nothing nuanced about the benefits of focused ultrasound for prostate cancer. A prostatectomy for prostate cancer, with or without a robot, takes two to four hours, requires an overnight stay in the hospital, necessitates the use of adult diapers for 30 days or more, and requires 60 to 90 days before a patient can return to full pre-procedure activities. Moreover, prostatectomies have a 20% chance of prolonged urinary dysfunction, an 80% chance of erectile dysfunction, and a 100% chance of ejaculatory dysfunction.

A focal focused ultrasound procedure takes one to two hours, has disease control arguably equivalent to prostatectomy and radiation therapy, has a 1% risk of urinary dysfunction, 20% risk of erectile dysfunction, and 20% risk of ejaculatory dysfunction. Patients can return to normal daily activities after only a day or two.

However, unlike IMRT and robotics, focused ultrasound for prostate was not covered by insurance payors at the time it was introduced into clinical practice, and the procedures are still not covered in many regions of the country. Despite the benefits of focal therapy, patients understandably have an issue paying cash for a procedure that is cleared by the US Food and Drug Administration (FDA); most Americans expect that medical insurance will cover FDA-authorized procedures. When this is not the case, especially when there are alternatives that are covered, patients may be disinclined or unable to spend out of pocket for a procedure even if the cash procedure can be life changing.

Patient Impact on the Adoption of New Healthcare Technologies

The impact patients can have specifically on bringing a new product to market is limited. The FDA has objective criteria for technology authorization. The Centers for Medicare and Medicaid Services (CMS) depends on claims data when it sets payment rates. Commercial insurance payors base their coverage decisions mostly on the clinical literature and published clinical guidelines or assessments. It is only after a technology is introduced into the market and is available to the general population that patients have a role to play in influencing the success of the technology as well as the timeline for that success.

Patients today are more empowered to take control of their own health care decisions – and are better informed when making those decisions – than ever before, thanks to the internet, health blogs, patient support organizations, and local news organizations. Patients often go into a doctor’s office having strong opinions as to how they want to be treated. Especially for those who are willing and able to travel for care, patients will seek out novel treatments if they believe it will result in better outcomes.

There will always be a group of patients who invariably want the latest and greatest treatment available, especially if it will improve the outcome or if their doctor or “the press” say they must have it. While many patients welcome and seek out the opportunity to try something new, that are reluctant to pay out of pocket for that something if existing treatments are covered by insurance. They may be willing to spend money on the latest face lift treatment, since all face lift treatments are cash pay, but hesitate to pay cash for a focused ultrasound treatment when a surgical treatment would be covered by insurance, even if the focused ultrasound treatment is better. Of course, if the technology offers something the patient perceives to be truly beneficial or demonstrably better, and if the patient is aware of the benefit, then they might be willing to pay for it. This “something” could include better disease control, fewer side effects, less invasiveness, or a shorter hospital stay or recovery period.

Direct to Patient Marketing

Patient demand can drive sales and adoption of a new technology. As a result, companies may find it worthwhile to reach out to potential patient populations and their disease-specific support groups to educate them with the goal of increasing patient demand. However, patients can become frustrated if the technology they have been led to believe is the next great thing is not available where they live. Money spent on direct-to-patient marketing must be timed correctly to coincide with product availability and market penetration, which are determined by regulatory approvals, reimbursement, and physician and hospital interest. When to spend, how much to spend, and where to spend will vary from technology to technology.

Profitability

As an example, a medical facility will generally only acquire a new technology if the procedure is profitable or, at a minimum, cash flow neutral. IMRT systems initially were acquired because they produced arguably better outcomes or at least reduced side effects. As coding changed over time, IMRT generated a much higher payment per patient and, therefore, was a desirable technology for hospitals to acquire.

There are exceptions to the need for profitability, of course. The Da Vinci robot has been universally adopted for several surgical procedures, driven to a large degree by patient demand, but it results in negative cash flow when provided to Medicare patients for most procedures. In general, facilities will be motivated to develop programs based on a new technology if they feel there will be a loss of business if they do not, such as patients traveling for a treatment that is not available at their local hospital. This has been the case with the Da Vinci robot.

Reimbursement

One area where patient impact is noticeable is the issuance of certain codes by CMS. For instance, CMS will issue temporary Healthcare Common Procedure Coding System (HCPCS) codes, called C codes, for procedures that have not yet secured a CPT code but where there is a demonstrated need for or interest on the part of the Medicare patient population for a procedure. Patient interest in a new technology, as evidenced by a willingness to spend out of pocket for it before there is a code and coverage, can encourage CMS to issue a C code, thereby making it easier for facilities to offer the technology to more patients.

Public payors also base certain coverage decisions on patient demand for a technology. CMS divides the US into 12 separate Medicare Administrative Contractor (MAC) regions, each with independent authorization to administer Medicare claims and coverage decisions. The more the procedure is performed in a given region, the greater is the likelihood the MAC will cover the procedure.

FDA

While marketing directly to patients can drive utilization, it is a complex undertaking that can easily run afoul of the FDA. Manufacturers can only market and promote the authorized use(s) for their technology. For instance, if the regulatory authorization is for prostate tissue ablation, and it is used by physicians to treat prostate cancer, the manufacturer cannot market it to patients as a treatment for prostate cancer. However, the physician is not impacted by this limitation and can advertise its use for treating prostate tissue.

This is a point raised in an earlier blog about the path to regulatory authorization (see Part 3 – Regulatory Authorization). Each manufacturer must be smart in selecting a path that allows it to market the technology to physicians and patients, once authorized, in the manner the manufacturer feels is required to gain market traction. To compete with existing technologies, a manufacturer may need to follow a regulatory route that affords it the same “indication for use” as others in the market. This will allow the manufacturer to market its device to patients in the same manner used by the existing technology.

Mark Carol, MD, is a senior consultant at the Focused Ultrasound Foundation.

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