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Surgeons address need for payment strategy for drop therapy alternative
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Today, most patients undergoing cataract surgery must self-administer multiple eye drops pre- and postoperatively. Surgeons often prescribe an antibiotic, a steroid and an NSAID to prevent infection and inflammation after cataract surgery.
According to data from the U.S. Census Bureau and the National Eye Institute, CMS will fund more than 38 million cataract surgeries over the next decade. Projections show that Medicare is expected to pay for 96% of the total and Medicaid likely to cover the other 4%. The cost of drop therapy is an additional expense with cataract surgery.
An alternative to the complex surgical drop regimen has emerged in the form of Dropless Therapy (Imprimis Pharmaceuticals), which entails the administration of a single injection at the conclusion of surgery. We think that reviewing our experience at two VA hospitals is a helpful lens through which to consider the benefits of a dropless protocol for cataract surgery.
Tri-Moxi (Imprimis Pharmaceuticals) is a proprietary compounded formulation comprised of the steroid triamcinolone and the antibiotic moxifloxacin. The company has reported that the therapy has been used in more than 500,000 cataract procedures and has, in a vast majority of cases, supplanted the need for topical eye drop therapy.
Currently, CMS policy is such that dropless therapy is not covered nor can patients pay out of pocket for access to the regimen. Instead, the cost must be absorbed by the surgical facility or the surgeon. This puts dropless cataract surgery at a disadvantage compared with drop therapy.
The problem with drops
Eye drops are problematic for many older patients. Traditional cataract surgery protocol requires that a patient or caregiver administer multiple topical eye drops for about 4 weeks. This is inconvenient, cumbersome and often unrealistic for some cataract surgery patients, given their age and additional comorbidities.
Application of antibiotic and steroid eye drops requires accurate placement on the eye for effectiveness, and touching the ocular surface with the bottle can cause contamination and potentially infection. Drops must be administered several times per day for a month, and the frequency of each eye drop often changes throughout the treatment period. Patients’ physical limitations may be compounded by memory issues. When patients cannot or forget to administer their drugs, their surgical outcomes suffer and complications may result.
Examples
Pantanelli: I have been using Dropless Therapy for about 7 months. Many VA patients who undergo cataract surgery, like those in the general population, have barriers to adhering to a complicated drop regimen. Issues like dementia, physical impairments such as arthritis, or having to rely on a family member to administer drops all add additional burdens on patients and caregivers.
We had a recent situation where the VA went to the extreme length of admitting a patient who was unable to administer drops for the duration of his postoperative period. This is something that simply would not happen in a different setting. I also recently had a patient who misunderstood the drop instructions and stopped using them after a week. The patient came in to the VA emergency department with rebound inflammation and required transfer to another emergency department to see the on-call doctor, solely to be put back on drops. This extremely expensive endeavor could have been avoided with a dropless option.
The Lebanon VA is a residency-driven service. Where appropriate, the resident will let the attending physician supervising the procedure know when a given patient is a good candidate for Tri-Moxi. If the patient has significant barriers to compliance with postoperative eye drops and has no contraindications to Dropless Therapy, such as glaucoma, then the patient may receive Tri-Moxi.
The VA is unique, in that everything is often paid for by the institution itself (the surgery as well as the postoperative eye drops). This means that when Tri-Moxi is used, compliance becomes a nonissue and the facility itself realizes a significant cost savings. I also practice in a university setting and perform surgery at its ASC. In this situation, the ASC pays the incremental cost.
One of the most important aspects of using Dropless Therapy is appropriate counseling of patients. We do let them know that they could experience some clouding of vision on the first day or two and that floaters can occur. The possibility of breakthrough inflammation may be as high as 8%, so it is crucial that patients know to call if they experience irritation or light sensitivity. We tell patients that with Dropless Therapy it is likely they will not need postoperative drops. If breakthrough inflammation does occur, we prescribe a short course of eye drops (Pred Forte, prednisolone acetate ophthalmic suspension 1%, Allergan), and they usually feel better in 1 day.
Hesemann: I have been using Dropless Therapy since Imprimis received 503B status earlier this year. With regard to drops, my staff and I work hard to ensure patients understand the postoperative schedule, and at the VA, we employ a nurse navigator. Even so, we have about a 15% noncompliance rate with drops. When we find these patients, we offer them Tri-Moxi for the second eye.
I recognized during my training that there had to be a dropless option for cataract patients. Essentially, I see it as a choice between the approach popularized by Kaiser Permanente, subconjunctival triamcinolone with a separate moxifloxacin injection intracamerally, or a single injection. I have always wanted to move to dropless because of compliance and patients’ costs. I looked at the evidence showing it to be safe and effective in many surgeons’ experience.
My VA is also resident-directed, and residents are comfortable with pars plana injections. The decision between two syringes or one is easy, so logistically it is certainly simpler. I would say for us the costs are about the same. About 15% of patients I see are disqualified from being eligible for Dropless Therapy.
During the cataract evaluation, we let the patients know they will need to take drops after surgery, and we ask how they do on drops. When we explain they will be taking multiple drops four times a day for 4 weeks, a certain number of them visibly cringe. We let them know they have another option. I track patients after surgery and ask how they are doing without drops, and 100% have been happy.
None of my dropless patients asked to go back to drops for their second surgery,
Conclusion
We believe VA’s experience with Dropless Therapy is instructive. Hundreds of thousands of other Americans have the same issues as typical VA patients, but a major barrier to widespread adoption is that surgeons and ASCs need to bear the cost of the medicine. Allowing patients to sign an Advanced Beneficiary Notice like they do for noncovered services such as premium IOLs, for example, and accept responsibility for the cost of dropless cataract surgery is one solution that might overcome that obstacle. This gives patients the option of skipping complicated drop regimens and potentially saving them high out-of-pocket costs for drops. - By and
References:
Cataract Surgeons for Improved Eyecare and Andrew Chang & Company. Analysis of the economic impacts of dropless cataract therapy on Medicare, Medicaid, state governments, and patient costs. http://stateofreform.com/wp-content/uploads/2015/11/CSIE_Dropless_Economic_Study.pdf. Published October 2015. Accessed July 12, 2017.
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Disclosures: Hesemann and Pantanelli report no relevant financial disclosures.