Eyeworld

EW CATARACT 26 July 2015 Pharmaceutical focus by Maxine Lipner EyeWorld Senior Contributing Writer Holland said, adding that there have been shortages of the drug, and the epinephrine isn't always bisulfite- free, which can lead to complica- tions. "Secondly, if we need additional dilation during the case, we have added. "Most surgeons add epineph- rine to the bag or the bottle—that's what we've been using," Dr. Holland said. "Epinephrine helps maintain pupillary dilation." While this has been a go-to agent for many, it hasn't been without problems, Dr. can be used intracamerally to keep pupils dilated during surgery, Dr. Donnenfeld said. Of these only preservative- and bisulfite-free Omidria and one brand of epineph- rine, which contains bisulfites, are FDA-approved for this use. An important tool Edward J. Holland, MD, professor of ophthalmology, University of Cincinnati, likewise stressed the importance of mydriatic agents. "When we have a widely dilated pu- pil we take that for granted—the op- eration is inherently less complicat- ed," he said, adding that when the pupil comes down to 4, 5, or 6 mm, everything gets harder. "Whatever we can do to maintain a large pupil [allows us to be] better surgeons, and our patients have better outcomes," Dr. Holland said. "Even the seemingly straight- forward cataract, a 1 to 2+ nuclear sclerotic cataract, an 8-mm pupil, and a cooperative patient becomes a challenge when the pupil constricts to 4 mm. That case now becomes a difficult one," Dr. Holland said. "Every case benefits from a widely dilated pupil." To keep the pupil from con- stricting, different dilating drops are given to the patient preoperatively, and in the OR other agents may be The latest on these dilating drugs T hey're an extremely helpful part of cataract surgery and are used in nearly all cases—mydriatic agents. "Mydriatic agents are the unsung hero in cataract surgery," said Eric D. Donnenfeld, MD, clini- cal professor of ophthalmology, New York University Medical Center, New York. "Good pupillary dilation is what separates good surgeons from great surgeons, and having a good dilation makes the surgery more efficacious, safer, and less stressful." What's more, initial dilation isn't enough, he continued. Pupils will constrict during cataract surgery and physicians have to maintain dilation during the procedure; otherwise it becomes more difficult throughout the case, he explained. For cataract surgery, practi- tioners routinely turn to short-acting dilating agents such as Mydriacyl (tropicamide, Alcon, Fort Worth, Texas) or Cyclogyl (cyclopentolate, Alcon), as well as sympathomimetics like epinephrine or phenylephrine, he said. These can all be used pre- operatively. In the operating room, epinephrine or phenylephrine and now Omidria (phenylephrine and ketorolac injection, Omeros, Seattle) Eye-opening mydriatic agents A large pupil such as this one can make cataract surgery less complex for the physician. Source: Eric Donnenfeld, MD Billing for Omidria T he new mydriatic agent, Omidria, is in an unusual reimbursement position—the drug was granted transitional pass-through payment status by the Centers for Medicare & Medicaid Services (CMS) as of Jan. 1, 2015, according to Kevin J. Corcoran, COE, CPC, CPMA, FNAO, president of Corcoran Consulting Group, San Bernardino, Calif. "Under the pass-through payment principle, you get reimbursed separately for the cost of Omidria instead of bundling it with other supplies as part of the facility fee. For Omidria, pass-through payment is effective until Dec. 31, 2017," Mr. Corcoran said. He described this as a "honeymoon period" so surgeons can become acquainted with a new technology drug that took more than 10 years to develop and get FDA approved. Pass-through comes from the implementation of the Outpatient Pro- spective Payment System (OPPS) in the year 2000, as authorized by Con- gress in the Balanced Budget Act of 1997. At that time, hospitals operated under a cost-based Medicare payment system, with dramatically different payment rates for cataract surgery from place to place, Mr. Corcoran said. CMS retired the cost-based system and instituted a prospective payment system and announced it was only going to give hospitals a $1,500 flat fee for cataract surgery. Efficient hospitals would keep the difference in Medicare payment and their costs, while inefficient hospitals would lose money on cataract surgery. In 2000, ambulatory surgery centers (ASC) already received reimbursement under a prospective payment system but much less than hospitals received for the same service. A few years ago this changed, too. "The ASC's payment rates were linked to hospital rates in a 3 to 2 ratio," he said. "So if the hospital got $3, the ASC got about $2." "The new OPPS payment rates were derived from historical Medicare payments. However, those historical payments did not account for new products after 2000," Mr. Corcoran said. Congress and CMS created the pass-through payments to handle new devices and drugs that were never accounted for in the OPPS payment rates. Under CMS' pass-through regulation, outpatient hospitals and am- bulatory surgery centers are reimbursed for the manufacturer's wholesale price of Omidria (currently $465) plus a 6% handling fee subject to the usual deductible. Copayments apply to ASCs but not hospitals. This obscure regulation affects about 70% of all Medicare beneficiaries— those that are covered by Part B Medicare. Those with Part C Medicare or Medicare Advantage are likewise covered, but the amount of payment (if any) is a matter for contract negotiation. "The collective reimbursement for all drugs and devices subject to the pass-through payment is a tiny part of the Part B Medicare program— about 0.01% of the $500 billion Medicare budget," Mr. Corcoran said. After expiration of pass-through for Omidria, a readjustment of the OPPS payment rate for cataract surgery will occur, and separate payment for Omidria will stop. Editors' note: Mr. Corcoran is president and co-owner of Corcoran Consulting Group, which provides reimbursement consulting services to eyecare providers and industry. Contact information Corcoran: kcorcoran@corcoranccg.com

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