Eyeworld

32 | EYEWORLD | DECEMBER 2019 ATARACT C PHARMACEUTICAL FOCUS By Liz Hillman EyeWorld Editorial Co-Director facility payment. As Ms. McCann explained it, CMS estimates and sets aside (from small adjustments to all Medicare hospital outpatient departments and ASCs) how much Medicare will spend on pass-through drugs to cover this payment. While a drug has pass-through status, data about its use is collected to inform the increase in Medicare's APC group once the drug comes off pass-through. As Ms. McCann put it, un- der the current payment policy, pass-through drugs get added to the facility fee bundle. The increase to the facility fee bundle, however, is not enough to cover the true cost of the drug, so, use of the drug after pass-through often significantly drops, particularly in the ASC, Ms. McCann said. "Which is why we are trying to get these drugs out of the bundle," Ms. McCann contin- ued, specifically those that have a postoperative indication. "CMS says they are 'surgical sup- plies' and as a result need to be bundled in the facility payment. Our argument is these drugs have nothing to do with the surgical procedure and have been approved for a postoperative indication, so they're replacing postop drops that are paid for separately under Medicare Part D. So, why should the facility be absorbing the cost for these drugs that replace postop drops that are covered and paid for separately?" Ms. McCann said these drugs can help with compliance of postop medications that are traditionally difficult for patients to administer themselves. In addition, she said, it can also be less expensive compared to drops. A separate issue the Ophthalmic Pharma- ceutical Coalition is seeking to address is the in- clusion of drugs with pass-through status in the 2019 MIPS cataract surgery episode-based cost measure. Omidria (Omeros)—a drug added to the irrigating solution during cataract surgery with indications for maintaining pupil size and reducing postop pain—was included in this measure. This means that use of Omidria will negatively impact a physician's cost score on MIPS, which Ms. McCann said defeats the pur- pose of pass-through. However, physicians will S everal years ago, the Ophthalmic Phar- maceutical Coalition was formed with the goal of advocating for payment pathways that would encourage inno- vation and progress for ophthalmic drugs to ultimately improve patient care. The coalition is led by ASCRS and includes the Outpatient Ophthalmic Surgery Society, as well as companies (Allergan, Ocular Therapeu- tix, Omeros, and EyePoint Pharmaceuticals). Overarchingly, it has been seeking separate payment for drugs with a postoperative indi- cation that are administered during cataract surgery at an ASC. The current policy is to bundle these types of drugs into the facility payment after they come off pass-through. In addition, the coalition is advocating that drugs with pass-through status not be included in the Merit-Based Incentive Payment System (MIPS) cataract surgery episode-based cost measure. "ASCRS is concerned that including pass- through drugs in the cost measure could stifle innovation," Parag Parekh, MD, chair, ASCRS Government Relations Committee, told Eye- World in a previous article. 1 Furthermore, Nancey McCann, director of ASCRS Government Relations, which manages the Ophthalmic Pharmaceutical Coalition, said bundling drugs into the ASC facility fee (after they no longer have pass-through status) has a stifling effect as well. As an example, Ms. Mc- Cann said, it's unlikely a company will take on the expense for development, trials, and process for FDA approval for an intracameral antibiotic without an adequate payment pathway. "It jeopardizes innovation and the future," Ms. McCann said. Let's take a step back for a moment to better understand what pass-through status is, how it's paid for, and the bundling of drugs into ambulatory payment classifications (APCs). Pass-through status is a designation for devices, drugs, and biologics that are new and innovative where the "cost is not insignificant." 2 Compa- nies apply for this status, which is granted for up to 3 years. While a drug has pass-through status, it is paid for separately, outside of the Efforts of the Ophthalmic Pharmaceutical Coalition About the sources Nancey McCann Director ASCRS, Government Relations Fairfax, Virginia Parag Parekh, MD Chair ASCRS Government Relations Committee State College, Pennsylvania

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