As a surgeon sworn to protect my patients, I strive to provide the best possible care and to “do no harm.”
One of the reasons I entered ophthalmology, where I specialize in cataract surgery and LASIK, is to help people enjoy the gift of sight to the fullest. While some pain may be unavoidable, the benefits of every procedure I perform outweigh the potential risks involved.
But at a time when a shocking number of patients are being hurt by the treatments supposed to help them, something is seriously wrong.
In Dallas, for example, nearly 70 patients were blinded (either fully or partially) when their surgeons unwittingly injected their eyes with a tainted compound during cataract surgery. Since drugs made at compounding pharmacies do not go through review by the FDA, the risk of a similar tragedy occurring remains high. And though patients bear the brunt of these disastrous drug mishaps, doctors and pharmacies are at significant risk of being sued—or in some cases, jailed—for improper practice.
Though safer and more effective alternatives have cleared the FDA and are easy for veterans and Americans under the age of 65 to access, seniors still struggle to access the most clinically up-to-date treatments due to flawed Medicare policies.
Take the case of cataract surgery.
Performed millions of times each year, the procedure is designed to improve patients’ vision by removing their clouded natural lens and replacing it with an artificial one.
A drug comprised of phenylephrine and ketorolac and approved by the FDA to prevent pupil constriction during surgery and block postoperative pain has also been shown to reduce the risks of sight-threatening cystoid macular edema by three- to 12-fold over the current standard of care as well as the need for postoperative topical steroid anti-inflammatory drops. Just as importantly, it decreases the need for ophthalmologists to rely on unregulated compounded drugs, which can seriously harm patients if not properly manufactured, stored, shipped or used.
In addition, the FDA-approved drug significantly reduces the need to prescribe opioids—a boon to patients, especially seniors, who are at increased risk of opioid dependency and opioid use disorder.
According to new peer-reviewed research by Dr. Eric Donnenfeld, clinical professor of ophthalmology at New York University Medical Center and recent past president of the American Society of Cataract and Refractive Surgery, the phenylephrine/ketorolac drug reduces patient pain scores by 50% and lowers the need for opioids during cataract surgery by nearly 80%. In short, the innovative drug is safer and significantly improves patient outcomes both during and after surgery.
So why do so many seniors face barriers to accessing this drug even though it reduces surgical time, cost and the risk of complications? Put simply, Medicare has been slow to update its payment policies to reflect the rapid advances in eye care.
Like many of my colleagues across the country, I am concerned that the Centers for Medicare & Medicaid Services (CMS) considers certain FDA-approved drugs to be “surgical supplies”—placing them alongside gauze, scalpels or stitches—which disincentivizes their use in practice. Because surgical facilities are reimbursed for cataract surgery through a single surgical payment package, the incremental cost of using the superior phenylephrine/ketorolac drug over other, riskier alternatives is not covered by CMS.
In order to defray costs and ensure their practices remain financially viable, many ophthalmologists have little choice but to use unregulated drugs from compounding pharmacies. In turn, this increases the likelihood that patients will suffer from complications related to substandard safety procedures, super-potent doses or dangerously inadequate sterilization processes. Meanwhile, current Medicare policy encourages more doctors to use and prescribe opioids to their cataract patients because they are reimbursed under Medicare Part D, which is paid for separately from the rest of the surgery.
While the phenylephrine/ketorolac drug is covered by the majority of private and public payers—including the Department of Veterans Affairs—Medicare has yet to catch up.
Unfortunately, CMS missed yet another opportunity to cover groundbreaking drugs for use during cataract surgery in the recently released Hospital Outpatient Prospective Payment System (PDF) final rule. By failing to apply the “non-opioid exclusion” to take these innovative drugs out of the surgical package, the administration is ensuring providers will continue to be disincentivized from using safe and effective treatments that lower the risk of patients’ developing addiction.
The government should be doing everything it can to ensure that non-opioid pain treatments are used whenever possible – especially when they’ve been proven to have superior results to other available treatments.
I urge Congress to quickly pass the bipartisan Non-Opioids Prevent Addiction in the Nation (NOPAIN) Act (H.R. 5172), which was recently introduced by Representatives Terri Sewell (D-AL), David McKinley (R-WV), and Anthony Brindisi (D-NY).
Doing so will help ensure that Medicare payment policy truly reflects the best interests of America’s seniors.
Cathy McCabe, M.D., is the vice president and president-elect of the Outpatient Ophthalmic Surgery Society.