By Eric Donnenfeld
December 2, 2019 at 5:00 am ET
Cataract surgery is one of the most commonly performed elective procedures in all of medicine, touching the lives (and eyes) of millions of Americans each year.
As the Medicare population surges over the next decade, the rate of these surgeries and their associated complications will only grow. While cataract procedures are generally successful in improving vision and quality of life, each patient undergoing surgery faces different risk factors — a reality that underscores the need to encourage new, safer and more effective treatments to ensure that patients achieve good outcomes.
Take, for example, patients with smaller pupils or those at risk for intraoperative floppy iris syndrome, a common side effect of medications used to improve urinary flow that can markedly increase cataract surgery complications. In cataract surgery for patients with IFIS, the pupil constricts, and the surrounding iris — the colored part of the eye — billows like a sail and can prolapse out of the eye through the surgical incision.
IFIS can occur in anyone who has ever taken an alpha-blocker medication such as tamsulosin (Flomax), a frequently prescribed drug to increase urinary flow, but a quarter of all patients with IFIS have no identifiable risk factor. The known complications of IFIS during cataract surgery can be sight-threatening.
To address IFIS and small pupils in general, ophthalmologists often use mechanical pupil expansion devices such as iris hooks or rings to pull the pupil open during surgery. These mechanical devices can damage the iris, too often causing abnormally shaped pupils with pain and light sensitivity as well as loss of iris color. These devices turn a standard cataract procedure into a complex case, adding surgical time and cost.
Ophthalmologists like me need innovative, new approaches to improve cataract surgery and reduce potentially sight-threatening complications for our patients. One breakthrough that is helping eye surgeons is called Omidria, the first and only Food and Drug Administration-approved drug that prevents pupil constriction and reduces both pain and the need for opioids. Added to the standard irrigating solution used during cataract surgery, Omidria has not only proven to provide significantly better surgical outcomes, but it also greatly reduces the risk of problems for high-risk patients.
In fact, the results of a prospective, controlled clinical trial that I recently conducted were published recently in the peer-reviewed journal Clinical Ophthalmology and show that Omidria lowered pain scores by nearly 50 percent while reducing the need for intraoperative opioid analgesics by approximately 80 percent compared to conventional treatment. These results have particularly important implications for elderly patients, who not only undergo cataract surgery at far higher rates than other age groups but are also more sensitive to opioids and are at greater risk of opioid dependence and opioid use disorder: Cataract surgery patients receiving postoperative opioids have a 60 percent increased risk of long-term opioid use.
Beyond mitigating pain both during surgery and postoperatively, recently published research demonstrates that Omidria reduces sight-threatening cystoid macular edema by three- to 12-fold over current standard of care. CME has been shown to double the average cost to treat cataract surgery patients.
Omidria also reduces the need for topical steroid anti-inflammatory drops — part of the current regimen of postoperative care with which the majority of cataract surgery patients can’t or won’t adequately comply. As the only FDA-approved product of its kind, Omidria avoids the need for unregulated and risky compounded products that can cause significant and sight-threatening complications.
The advantages of Omidria have not gone unnoticed. In 2018, the Department of Veterans Affairs directed that the drug be made available in all VA facilities performing ophthalmic surgery. Despite this positive development, however, patient access to this important drug still faces significant obstacles.
In contrast to the VA, the Centers for Medicare and Medicaid Services has not taken steps to ensure beneficiary access to this drug. Notably, Medicare’s Outpatient Prospective Payment System final rule considers Omidria to be a “surgical supply” such as gauze or stitches rather than the innovative drug that it is. So it is treated like a supply and reimbursed through a single surgical package — which is supposed to cover labor and supply costs — instead of being appropriately reimbursed with a separate payment like other drugs.
This packaging policy as designed does not capture the cost of innovative drugs such as Omidria that are necessary to treat higher-risk patients with specific problems. As a result, the fear of not being adequately reimbursed disincentivizes physicians from using the drug and leads many to use alternatives that may not be appropriate for all patients.
This misclassification of Omidria as a surgical supply also highlights CMS’ unwillingness to acknowledge the many clinical benefits of the treatment, including its ability to reduce opioid use both during and following surgery. In fact, despite Trump administration rhetoric about the need to combat the opioid crisis, CMS policy continues to financially disincentivize the utilization of treatments such as Omidria in favor of older approaches that expose patients to the risk of opioid use and addiction.
Unfortunately, CMS missed the opportunity to reverse this trend. Under federal law, Congress required CMS to evaluate and identify drugs that will help mitigate opioid utilization among America’s patient population. Put simply, the agency didn’t live up to this requirement in its review of Omidria, even after Sens. Jeanne Shaheen (D-N.H.) and Shelley Moore Capito (R-W.Va.) sent a letter to CMS urging it to unbundle non-opioid alternatives.
Fortunately, Congress is stepping in to right the situation. Reps. Terri Sewell (D-Ala.) and David McKinley (R-W.Va.) recently introduced the Non-Opioids Prevent Addiction in the Nation Act (H.R. 5172). This bipartisan bill is designed to address the payment disincentives for practitioners to prescribe non-opioid treatment alternatives in surgical settings. It will also require CMS to treat non-opioid treatments and other separately paid drugs and devices under Medicare Part B equally.
By creating a level playing field for non-opioids such as Omidria, CMS has the ability to ensure continued access to a treatment that has been shown to reduce the risk of costly and vision-threatening complications and will likely save the Medicare system money down the road.
As America’s graying population is increasingly affected by cataracts, access to innovative treatments such as Omidria will be crucial. Congress should quickly pass the NOPAIN Act in order to help patients avoid unnecessary risks and ensure Medicare’s payment policies reflect the best interest of patients.
Eric D. Donnenfeld, MD, a recent past-president of the American Society of Cataract and Refractive Surgery and a current member of the executive boards of both ASCRS and the International Intraocular Implant Society, is a clinical professor of ophthalmology at New York University Medical Center and a member of the board of overseers at Dartmouth Medical School.
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