From gene therapies that cure the rarest of diseases to new methods of reprogramming the body’s immune system to fight cancer cells, America’s pharmaceutical sector has blessed this country with some truly amazing innovations in recent years. Such ingenuity can be found in many forms –– and not just as new treatments for previously incurable diseases. Innovative therapies that improve how we do procedures that have been around for centuries to make them less painful, less invasive, and less likely to result in complications are incredibly valuable in their own right.
Take, for example, cataract surgery. Historical records show the procedure has been around since at least the 5th century BCE, although the methods used then would horrify most people today. But thanks to centuries of research and innovation, cataract surgery is now safer than ever, benefiting millions each year.
This doesn’t mean, however, that the procedure is 100% risk-free. For patients with smaller pupils, as well as those with intraoperative floppy iris syndrome (IFIS), sight-threatening complications are a very real possibility — especially if patients have ever used Flomax or other urinary flow drugs even for a short time.
Under today’s conventional approach to cataract surgery, ophthalmologists must often use devices such as iris hooks to mechanically expand the pupil and hold it open during surgery. This process can damage the iris, causing incredible pain and increasing the likelihood that a patient will need to be prescribed an opioid-based painkiller such as fentanyl. Opioid use, as we have seen collectively as a country over the last few decades, carries its own risks, including the possibility of addiction. As one of the most vulnerable patient populations, Medicare patients represent the fastest growing group of Americans with opioid use disorder — skyrocketing 377% over the last decade alone.
To address these issues and improve patient outcomes, scientists have developed an innovative treatment called Omidria®. A relatively new drug, Omidria was approved by the Food and Drug Administration specifically to reduce post-operative pain, as well as the need for pain medication and to prevent miosis. Since its introduction to the market, Omidria has also been found to reduce complication rates, prevent patients from developing IFIS, and reduce surgical time and the need for pupil expanding devices.
Despite the benefits, Medicare refuses to appropriately cover Omidria in the same way that other innovative drugs are covered. Under recent landmark legislation designed to address the opioid epidemic, Congress created a pathway for non-opioid treatments (drugs, devices, and biologics) to be covered separately from the cost of surgery. Unfortunately, Omidria is set to be included in Medicare’s “surgical package” for cataract surgery instead. This means Medicare effectively considers Omidria to be in the same category as gauze, scalpels, and latex gloves –– a far cry from the innovative treatment it has been demonstrated to be. As a result, physicians are disincentivized from using the drug in their practice and may stop making it available to patients altogether.
Even though Omidria is covered appropriately by the Department of Veterans Affairs and virtually all commercial payers, Medicare’s failure to adequately pay for the drug creates significant access barriers for older Americans. By refusing to appropriately cover Omidria, Medicare is inadvertently incentivizing doctors to use unregulated compounded drugs or opioid-based pain medications as workarounds to the only FDA-approved treatment for these conditions and one that carries far less risk for patients. In fact, a recent peer-reviewed study of patients undergoing cataract surgery found that Omidria lowered pain scores by nearly 50%, while reducing the need for opioid analgesics by 80% compared to conventional treatment.
If Medicare is denying appropriate coverage due to costs, then its concerns are unfounded: This innovative drug is used only a handful of times in a patient’s life and will likely save the system money by improving patient outcomes and reducing costly complications. Packaging a drug such as Omidria is problematic, because the way CMS sets the rates for the package, Omidria will never be able to be directed to the care of the patients who need it. A systemic methodological problem should not become a barrier to patient access.
It’s time for Medicare to fix its broken reimbursement policy so patients in need can continue to access innovative therapies such as Omidria. The evidence is in and the results are clear: Omidria reduces pain, the risk of sight-threatening complications, and the need for potentially addictive painkillers. Policymakers should listen to the evidence and work to ensure Medicare’s payment policies reflect patients’ best interests.
To be very clear, I am not compensated by the makers of Omidria for writing this. Rather, I am speaking out because I strongly believe that innovation is what makes America great and ensures a healthier future for us all. It’s time for Medicare to implement payment policies that reward scientific achievements and ensure access to breakthrough treatments.
Josi is a veteran of international center-right / libertarian politics, and a frequent columnist for a variety of publications. He is the founder and managing director of C. Josi & Company, a global communications resource firm based in Virginia Beach and Washington.
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